☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
2021
☐ | TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
801 1250
Large accelerated filer | ☐ | Accelerated Filer | ☒ | |||
Non-accelerated filer | ☐ | Smaller reporting company | ☐ | |||
Emerging growth company | ☐ |
| PART I. FINANCIAL INFORMATION | |||||||||
Item 1. | FINANCIAL STATEMENTS | |||||||||
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Item 2. | ||||||||||
Item 3. | 35 | |||||||||
Item 4. | 36 | |||||||||
PART II. OTHER INFORMATION | ||||||||||
Item 1. | 36 | |||||||||
Item 1A. | 37 | |||||||||
Item | 37 | |||||||||
Item 3. | 37 | |||||||||
Item 4. | 37 | |||||||||
Item 5. | 37 | |||||||||
Item 6. | 38 | |||||||||
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March 31, | December 31, | |||||||
2020 | 2019 | |||||||
(unaudited) | ||||||||
ASSETS | ||||||||
Current Assets: | ||||||||
Cash and cash equivalents | $ | 101,750,937 | $ | 89,511,710 | ||||
Short-term investments | — | 5,007,050 | ||||||
Accounts receivable, net | 6,918,563 | 10,536,997 | ||||||
Inventory | 2,211,338 | 1,956,792 | ||||||
Prepaid expenses and other current assets | 6,062,715 | 4,351,074 | ||||||
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Total current assets | 116,943,553 | 111,363,623 | ||||||
Operating leaseright-of-use asset | 730,284 | 793,252 | ||||||
Property and equipment, net | 196,926 | 210,467 | ||||||
Deposits | 8,888 | 8,888 | ||||||
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Total assets | $ | 117,879,651 | $ | 112,376,230 | ||||
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LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Current Liabilities: | ||||||||
Accounts payable | $ | 1,347,577 | $ | 4,117,447 | ||||
Accrued expenses and other liabilities | 16,287,936 | 19,981,295 | ||||||
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Total current liabilities | 17,635,513 | 24,098,742 | ||||||
Operating lease liability, net of current portion | 568,421 | 647,532 | ||||||
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Total liabilities | 18,203,934 | 24,746,274 | ||||||
Commitments and contingencies | ||||||||
Stockholders’ equity: | ||||||||
Preferred stock, $0.001 par value, 5,000,000 shares authorized: none issued and outstanding at March 31, 2020 and December 31, 2019 | — | — | ||||||
Common stock, $0.001 par value, 150,000,000 shares authorized; 103,408,699 shares and 103,397,033 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively | 103,409 | 103,397 | ||||||
Additionalpaid-in capital | 217,751,166 | 216,205,678 | ||||||
Accumulated deficit | (118,262,609 | ) | (128,688,624 | ) | ||||
Accumulated other comprehensive income (loss) | 83,751 | 9,505 | ||||||
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Total stockholders’ equity | 99,675,717 | 87,629,956 | ||||||
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Total liabilities and stockholders’ equity | $ | 117,879,651 | $ | 112,376,230 | ||||
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March 31, | December 31, | |||||||
2021 | 2020 | |||||||
(unaudited) | ||||||||
ASSETS | ||||||||
Current Assets: | ||||||||
Cash and cash equivalents | $ | 127,328 | $ | 130,237 | ||||
Short-term investments | 15,971 | 10,041 | ||||||
Accounts receivable, net | 5,601 | 5,987 | ||||||
Inventory | 4,390 | 4,651 | ||||||
Prepaid expenses and other current assets | 8,243 | 8,328 | ||||||
Total current assets | 161,533 | 159,244 | ||||||
Operating lease right-of-use | 3,309 | — | ||||||
Property and equipment, net | 944 | 130 | ||||||
Deferred tax assets | 31,421 | 32,971 | ||||||
Deposits | 9 | 9 | ||||||
Total assets | $ | 197,216 | $ | 192,354 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Current Liabilities: | ||||||||
Accounts payable | $ | 2,561 | $ | 4,256 | ||||
Accrued expenses and other liabilities | 11,875 | 18,500 | ||||||
Total current liabilities | 14,436 | 22,756 | ||||||
Operating lease liability, net of current portion | 4,129 | — | ||||||
Total liabilities | 18,565 | 22,756 | ||||||
Commitments and contingencies (Note 10) | 0 | 0 | ||||||
Stockholders’ equity: | ||||||||
Preferred stock, $0.001 par value, 5,000,000 shares authorized: NaN issued and outstanding at March 31, 2021 and December 31, 2020 | 0 | — | ||||||
Common stock, $0.001 par value, 200,000,000 shares authorized; 103,804,590 shares and 103,781,641 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively | 104 | 104 | ||||||
Additional paid-in capital | 224,927 | 223,168 | ||||||
Accumulated deficit | (46,335 | ) | (53,705 | ) | ||||
Accumulated other comprehensive income (loss) | (45 | ) | 31 | |||||
Total stockholders’ equity | 178,651 | 169,598 | ||||||
Total liabilities and stockholders’ equity | $ | 197,216 | $ | 192,354 | ||||
For the Three Months Ended March 31, | ||||||||
2020 | 2019 | |||||||
Product revenue, net | $ | 29,136,472 | $ | 12,448,438 | ||||
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Operating costs and expenses: | ||||||||
Cost of sales | 4,150,866 | 1,711,788 | ||||||
Research and development | 4,222,811 | 3,307,959 | ||||||
Selling, general and administrative | 10,063,048 | 8,416,460 | ||||||
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Total operating costs and expenses | 18,436,725 | 13,436,207 | ||||||
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Operating income (loss) | 10,699,747 | (987,769 | ) | |||||
Other income, net | 336,233 | 343,266 | ||||||
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Net income (loss) before income taxes | 11,035,980 | (644,503 | ) | |||||
Provision for income taxes | 609,965 | — | ||||||
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Net income (loss) | $ | 10,426,015 | $ | (644,503 | ) | |||
Net income (loss) per share: | ||||||||
Basic | $ | 0.10 | $ | (0.01 | ) | |||
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Diluted | $ | 0.10 | $ | (0.01 | ) | |||
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Weighted average shares outstanding: | ||||||||
Basic | 103,407,347 | 102,747,923 | ||||||
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Diluted | 106,534,600 | 102,747,923 | ||||||
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Net income (loss) | $ | 10,426,015 | $ | (644,503 | ) | |||
Other comprehensive income (loss): | ||||||||
Unrealized gain (loss) onavailable-for-sale securities | 74,246 | 13,560 | ||||||
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Comprehensive income (loss) | $ | 10,500,261 | $ | (630,943 | ) | |||
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For the Three Months Ended March 31, | ||||||||
2021 | 2020 | |||||||
Product revenue, net | $ | 30,205 | $ | 29,137 | ||||
Operating costs and expenses: | ||||||||
Cost of sales | 4,681 | 4,151 | ||||||
Research and development | 3,007 | 4,223 | ||||||
Selling, general and administrative | 12,716 | 10,063 | ||||||
Total operating costs and expenses | 20,404 | 18,437 | ||||||
Operating income | 9,801 | 10,700 | ||||||
Other income, net | 81 | 336 | ||||||
Net income before income taxes | 9,882 | 11,036 | ||||||
Provision for income taxes | 2,219 | 610 | ||||||
Net income | $ | 7,663 | $ | 10,426 | ||||
Net income per share: | ||||||||
Basic | $ | 0.07 | $ | 0.10 | ||||
Diluted | $ | 0.07 | $ | 0.10 | ||||
Weighted average shares outstanding: | ||||||||
Basic | 103,814,725 | 103,407,347 | ||||||
Diluted | 106,680,344 | 106,534,600 | ||||||
Net income | $ | 7,663 | $ | 10,426 | ||||
Other comprehensive income: | ||||||||
Unrealized gain (loss) on available-for-sale | (76 | ) | 74 | |||||
Comprehensive income | $ | 7,587 | $ | 10,500 | ||||
Common Stock | Additional | Accumulated Other | ||||||||||||||||||||||||||
Preferred Stock | Shares | Amount | Paid-in Capital | Accumulated Deficit | Comprehensive Gain (Loss) | Total | ||||||||||||||||||||||
Balance at December 31, 2019 | $ | — | 103,397,033 | $ | 103,397 | $ | 216,205,678 | $ | (128,688,624 | ) | $ | 9,505 | $ | 87,629,956 | ||||||||||||||
Issuance of stock options for services | — | — | — | 1,383,672 | — | — | 1,383,672 | |||||||||||||||||||||
Exercise of stock options for common stock | — | 11,666 | 12 | 26,137 | — | — | 26,149 | |||||||||||||||||||||
Amortization of restricted stock for services | — | — | — | 135,679 | — | — | 135,679 | |||||||||||||||||||||
Other comprehensive gain (loss) | — | — | — | — | — | 74,246 | 74,246 | |||||||||||||||||||||
Net income (loss) | — | — | — | — | 10,426,015 | — | 10,426,015 | |||||||||||||||||||||
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Balance at March 31, 2020 | $ | — | 103,408,699 | $ | 103,409 | $ | 217,751,166 | $ | (118,262,609 | ) | $ | 83,751 | $ | 99,675,717 | ||||||||||||||
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Common Stock | Additional | Accumulated Other | ||||||||||||||||||||||||||
Preferred Stock | Shares | Amount | Paid-in Capital | Accumulated Deficit | Comprehensive Gain (Loss) | Total | ||||||||||||||||||||||
Balance at December 31, 2018 | $ | — | 102,739,257 | $ | 102,739 | $ | 211,265,279 | $ | (160,563,961 | ) | $ | (20,248 | ) | $ | 50,783,809 | |||||||||||||
Issuance of stock options for services | — | — | — | 933,411 | — | — | 933,411 | |||||||||||||||||||||
Exercise of stock options for common stock | — | 65,000 | 65 | 89,285 | — | — | 89,350 | |||||||||||||||||||||
Other comprehensive gain (loss) | — | — | — | — | — | 13,560 | 13,560 | |||||||||||||||||||||
Net income (loss) | — | — | — | — | (644,503 | ) | — | (644,503 | ) | |||||||||||||||||||
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Balance at March 31, 2019 | $ | — | 102,804,257 | $ | 102,804 | $ | $212,287,975 | $ | (161,208,464 | ) | $ | (6,688 | ) | $ | 51,175,627 | |||||||||||||
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2020
Common Stock | Additional | Accumulated Other | ||||||||||||||||||||||||||
Preferred Stock | Shares | Amount | Paid-in Capital | Accumulated Deficit | Comprehensive Gain (Loss) | Total | ||||||||||||||||||||||
Balance at December 31, 2020 | $ | — | 103,782 | $ | 104 | $ | 223,168 | $ | (53,705 | ) | $ | 31 | $ | 169,598 | ||||||||||||||
Issuance of stock options for services | — | — | — | 1,442 | — | — | 1,442 | |||||||||||||||||||||
Exercise of stock options for common stock | — | 90 | — | 188 | — | — | 188 | |||||||||||||||||||||
Amortization of restricted stock for services | — | — | — | 129 | — | — | 129 | |||||||||||||||||||||
Repurchase of common stock | — | (67 | ) | — | — | (293 | ) | — | (293 | ) | ||||||||||||||||||
Other comprehensive gain (loss) | — | — | — | — | — | (76 | ) | (76 | ) | |||||||||||||||||||
Net income | — | — | — | — | 7,663 | — | 7,663 | |||||||||||||||||||||
Balance at March 31, 2021 | $ | — | 103,805 | $ | 104 | $ | 224,927 | $ | (46,335 | ) | $ | (45 | ) | $ | 178,651 | |||||||||||||
Common Stock | Additional | Accumulated Other | ||||||||||||||||||||||||||
Preferred Stock | Shares | Amount | Paid-in Capital | Accumulated Deficit | Comprehensive Gain (Loss) | Total | ||||||||||||||||||||||
Balance at December 31, 2019 | $ | — | 103,397 | $ | 103 | $ | 216,206 | $ | (128,689 | ) | $ | 10 | $ | 87,630 | ||||||||||||||
Issuance of stock options for services | — | — | — | 1,384 | — | — | 1,384 | |||||||||||||||||||||
Exercise of stock options for common stock | — | 12 | — | 26 | — | — | 26 | |||||||||||||||||||||
Amortization of restricted stock for services | — | — | — | 136 | �� | — | — | 136 | ||||||||||||||||||||
Other comprehensive gain (loss) | — | — | — | — | — | 74 | 74 | |||||||||||||||||||||
Net income | — | — | — | — | 10,426 | — | 10,426 | |||||||||||||||||||||
Balance at March 31, 2020 | $ | — | 103,409 | $ | 103 | $ | 217,752 | $ | (118,263 | ) | $ | 84 | $ | 99,676 | ||||||||||||||
For the Three Months Ended March 31, | ||||||||
2020 | 2019 | |||||||
Operating Activities: | ||||||||
Net income (loss) | $ | 10,426,015 | $ | (644,503 | ) | |||
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: | ||||||||
Depreciation | 13,541 | 13,748 | ||||||
Amortization ofright-of-use asset | 62,968 | 59,621 | ||||||
Stock-based compensation | 1,519,351 | 933,411 | ||||||
Change in accrued interest and accretion of discount on investments | 81,296 | (53,674 | ) | |||||
(Increase) decrease in: | ||||||||
Accounts receivable, net | 3,618,434 | (7,251,381 | ) | |||||
Inventory | (254,546 | ) | (40,575 | ) | ||||
Prepaid expenses and other current assets and deposits | (1,711,641 | ) | (231,485 | ) | ||||
Increase (decrease) in: | ||||||||
Accounts payable | (2,769,870 | ) | 602,719 | |||||
Accrued expenses and other liabilities | (3,699,518 | ) | (1,337,155 | ) | ||||
Operating lease liability | (72,952 | ) | (67,155 | ) | ||||
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Net cash provided by (used in) operating activities | 7,213,078 | (8,016,429 | ) | |||||
Investing Activities: | ||||||||
Purchases of property and equipment | — | (5,633 | ) | |||||
Purchases of investments | — | (9,944,974 | ) | |||||
Proceeds from maturities and sales of investments | 5,000,000 | 20,400,000 | ||||||
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Net cash provided by (used in) investing activities | 5,000,000 | 10,449,393 | ||||||
Financing Activities: | ||||||||
Proceeds from exercise of stock options | 26,149 | 89,350 | ||||||
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Net cash provided by (used in) financing activities | 26,149 | 89,350 | ||||||
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Net increase (decrease) in cash and cash equivalents | 12,239,227 | 2,522,314 | ||||||
Cash and cash equivalents—beginning of period | 89,511,710 | 16,559,400 | ||||||
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Cash and cash equivalents—end of period | $ | 101,750,937 | $ | 19,081,714 | ||||
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Non-cash investing and financing activities: | ||||||||
Unrealized gain (loss) onavailable-for-sale securities | $ | 74,246 | $ | 13,560 |
For the Three Months Ended March 31, | ||||||||
2021 | 2020 | |||||||
Operating Activities: | ||||||||
Net income | $ | 7,663 | $ | 10,426 | ||||
Adjustments to reconcile net income to net cash provided by (used in) operating activities: | ||||||||
Depreciation | 97 | 14 | ||||||
Stock-based compensation | 1,571 | 1,519 | ||||||
Deferred taxes | 1,550 | — | ||||||
Change in accrued interest and accretion of discount on investments | (6 | ) | 81 | |||||
Amortization of right-of-use asset | — | 63 | ||||||
(Increase) decrease in: | ||||||||
Accounts receivable, net | 386 | 3,618 | ||||||
Inventory | 261 | (254 | ) | |||||
Prepaid expenses and other current assets and deposits | 85 | (1,711 | ) | |||||
Increase (decrease) in: | ||||||||
Accounts payable | (1,697 | ) | (2,770 | ) | ||||
Accrued expenses and other liabilities | (7,038 | ) | (3,700 | ) | ||||
Operating lease liability | 942 | (73 | ) | |||||
Net cash provided by (used in) operating activities | 3,814 | 7,213 | ||||||
Investing Activities: | ||||||||
Purchases of property and equipment | (911 | ) | — | |||||
Purchases of investments | (6,000 | ) | — | |||||
Proceeds from maturities and sales of investments | — | 5,000 | ||||||
Net cash provided by (used in) investing activities | (6,911 | ) | 5,000 | |||||
Financing Activities: | ||||||||
Proceeds from exercise of stock options | 188 | 26 | ||||||
Net cash provided by (used in) financing activities | 188 | 26 | ||||||
Net increase (decrease) in cash and cash equivalents | (2,909 | ) | 12,239 | |||||
Cash and cash equivalents—beginning of period | 130,237 | 89,512 | ||||||
Cash and cash equivalents—end of period | $ | 127,328 | $ | 101,751 | ||||
Non-cash investing and financing activities: | ||||||||
Unrealized gain (loss) on available-for-sale | $ | (76 | ) | $ | 74 | |||
Repurchase of common stock not yet settled at end of period | $ | 293 | $ | — | ||||
Operating lease liabilities arising from obtaining right-of-use assets | $ | 3,309 | $ | — |
1. | Organization and Description of Business. |
diseases.
2. | Basis of Presentation and Significant Accounting Policies. |
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2. | Basis of Presentation and Significant Accounting Policies (continued). |
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Short-Term Bond Fund
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U.S. Treasuries
U.S. Treasuries2021 are classified asavailable-for-sale securities U.S. Treasuries with stated maturities of greater than three months and less than one year asin short-term investments.Available-for-sale securitiesinvestments, U.S. Treasuries with stated maturities greater than one year are classified as
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2. | Basis of Presentation and Significant Accounting Policies (continued). |
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2. | Basis of Presentation and Significant Accounting Policies (continued). |
Fair Value Measurements at Reporting Date Using | ||||||||||||||||
Balances as of March 31, 2020 | Quoted Prices in Active Markets for Identical Assets/Liabilities (Level 1) | Significant Other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | |||||||||||||
Cash and cash equivalents: | ||||||||||||||||
Money market funds | $ | 23,610,888 | $ | 23,610,888 | $ | — | $ | — | ||||||||
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U.S. Treasuries | $ | 69,997,200 | $ | — | $ | 69,997,200 | $ | — | ||||||||
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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) | |||||||||||||
Cash and cash equivalents: | ||||||||||||||||
Money market funds | $ | 23,963,617 | $ | 23,963,617 | $ | — | $ | — | ||||||||
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U.S. Treasuries | $ | 59,932,200 | $ | — | $ | 59,932,200 | $ | — | ||||||||
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Short-term investments: | ||||||||||||||||
U.S. Treasuries | $ | 5,007,050 | $ | — | $ | 5,007,050 | $ | — | ||||||||
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Fair Value Measurements at Reporting Date Using (in thousands) | ||||||||||||||||
Balances as of March 31, 2021 | Quoted Prices in Active Markets for Identical Assets/Liabilities (Level 1) | Significant Other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | |||||||||||||
Cash and cash equivalents: | ||||||||||||||||
Money market funds | $ | 42,707 | $ | 42,707 | $ | — | $ | — | ||||||||
U.S. Treasuries | $ | 69,999 | $ | 69,999 | $ | — | $ | — | ||||||||
Short-term investments: | ||||||||||||||||
Short-term bond funds | $ | 15,971 | $ | 15,971 | $ | — | $ | — | ||||||||
Balances as of December 31, 2020 | Quoted Prices in Active Markets for Identical Assets/Liabilities (Level 1) | Significant Other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | |||||||||||||
Cash and cash equivalents: | ||||||||||||||||
Money market funds | $ | 15,674 | $ | 15,674 | $ | — | $ | — | ||||||||
U.S. Treasuries | $ | 104,994 | $ | — | $ | 104,994 | $ | — | ||||||||
Short-term investments: | ||||||||||||||||
Short-term bond funds | $ | 10,041 | $ | 10,041 | $ | — | $ | — | ||||||||
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m. | REVENUE RECOGNITION. ® in November 2018. Subsequent to receiving FDA approval, the Company entered into an arrangement with one distributor (the “Customer”), ® 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). |
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2. | Basis of Presentation and Significant Accounting Policies (continued). |
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principallyprimarily of chargebacks that the Customer has claimed, but for which the Company has not yet issued a credit.
2. | Basis of Presentation and Significant Accounting Policies (continued). |
income.
Nonrefundable upfront license fees are recognized upon receipt as persuasive evidence of an arrangement exists, thetransaction price to the collaborator isperformance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation.
2. | Basis of Presentation and Significant Accounting Policies (continued). |
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A milestone is defined as an event (i) that can only be achieved based in whole or in part on either the entity’s performance or on the occurrence of a specific outcome resulting from the entity’s performance, (ii) for which there is substantive uncertainty at the date the arrangement, is entered into thatincluding the event will be achieved,contractual terms, and (iii) that would result in additional payments being due to the vendor.
The Company believes that achievementnature of the milestone will be substantive and there will be no substantive uncertainty once the milestone is achieved.
Since the Company will receive royalty reports 60 days after quarter end, royalty revenue from sales of collaboration products by our collaborator will be recognized in the quarter following the quarter in which the corresponding sales occurred. As of March 31, 2020 and 2019, there was no royalty revenue from sales of the collaborative product.
payments.
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2. | Basis of Presentation and Significant Accounting Policies (continued). |
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On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security (CARES) Act was signed into law making several changes to the Internal Revenue Code. The changes include, but are not limited to: increasing the limitation on the amount of deductible interest expense, allowing companies to carryback certain net operating losses, and increasing the amount of net operating loss carryforwards that corporations can use to offset taxable income.
The tax law changes in the CARES Act did not have a material impact on the Company’s income tax provision.
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For the Three Months Ended March 31, | ||||||||
2020 | 2019 | |||||||
Basic weighted average common shares outstanding | 103,407,347 | 102,747,923 | ||||||
Effect of dilutive securities: | ||||||||
Unvested restricted stock units subject to vesting requirements issued to employees andnon-employees | 352,500 | — | ||||||
Common stock issuable upon the exercise of stock options | 2,774,753 | — | ||||||
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Diluted weighted average common shares outstanding | 106,534,600 | 102,747,923 | ||||||
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For the Three Months Ended March 31, | ||||||||
2021 | 2020 | |||||||
Basic weighted average common shares outstanding | 103,814,725 | 103,407,347 | ||||||
Effect of dilutive securities | 2,865,619 | 3,127,253 | ||||||
Diluted weighted average common shares outstanding | 106,680,344 | 106,534,600 | ||||||
2. | Basis of Presentation and Significant Accounting Policies (continued). |
u. |
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v. |
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In June 2016, the FASB issued ASUNo. 2016-13,Financial Instruments — Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments. The standard amends the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses for most financial assets and certain other instruments that aren’t measured at fair value through net income. Foravailable-for-sale debt securities, entities will be required to recognize an allowance for credit losses rather than a reduction in carrying value of the asset. Entities will no longer be permitted to consider the length of time that fair value has been less than amortized cost when evaluating when credit losses should be recognized. The Company adopted the new standard on January 1, 2020. The adoption of this standard did not have a material impact on the Company’s consolidated financial statements.
In August 2018, the FASB issued ASU2018-15,Intangibles – Goodwill and Other –Internal-Use Software (Subtopic350-40), Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract. The amendments in this update align the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a services contract with the requirements for capitalizing implementation costs incurred to develop or obtaininternal-use software (and hosting arrangements that include aninternal-use software license). Accordingly, the amendments in this update require an entity in a hosting arrangement that is a service contract to follow the guidance in Subtopic350-40 to determine which implementation costs to capitalize as an asset related to the service contract and which costs to expense. The Company adopted the new standard on January 1, 2020 and applied prospectively to all implementation costs incurred after the date of adoption. The adoption of this standard did not have a material impact on the Company’s consolidated financial statements.
3. | Investments. |
At March 31, 2020: U.S. Treasuries – Cash equivalents At December 31, 2019: U.S. Treasuries – Cash equivalents U.S. Treasuries – ST Total follows:follows (in thousands): Estimated
Fair Value Gross
Unrealized
Gains Gross
Unrealized
Losses Amortized
Cost $ 69,997,200 $ 83,751 $ — $ 69,913,449 $ 59,932,200 $ 2,042 $ — $ 59,930,158 5,007,050 7,463 — 4,999,587 $ 64,939,250 $ 9,505 $ — $ 64,929,745
Estimated Fair Value | Gross Unrealized Gains | Gross Unrealized Losses | Amortized Cost | |||||||||||||
At March 31, 2021: | ||||||||||||||||
U.S. Treasuries – Cash equivalents | $ | 69,999 | $ | 2 | $ | — | $ | 69,997 | ||||||||
Short-term bond funds | 15,971 | — | (47 | ) | 16,018 | |||||||||||
Total | $ | 85,970 | $ | 2 | $ | (47 | ) | $ | 86,015 | |||||||
At December 31, 2020: | ||||||||||||||||
U.S. Treasuries – Cash equivalents | $ | 104,994 | $ | 2 | $ | — | $ | 104,992 | ||||||||
Short-term bond funds | 10,041 | 29 | — | 10,012 | ||||||||||||
Total | $ | 115,035 | $ | 31 | $ | — | $ | 115,004 | ||||||||
There were 0 r available-for-sale securities for the three months ended March 31, 2021 or March 31, 2020. The Company did not hold any securities in an unrealized loss position for more than 12 months as of March 31, 2021. The estimated fair values of available-for-sale securities at March 31, 2021, by contractual maturity, are summarized as follows (in thousands): |
March 31, 2021 | ||||
Due in one year or less | $ | 85,970 |
4. | Inventory, net. |
March 31, 2021 | December 31, 2020 | |||||||
Raw materials | $ | 0 | $ | — | ||||
Work-in-process | 3,593 | 3,555 | ||||||
Finished goods | 797 | 1,096 | ||||||
Total inventory, net | $ | 4,390 | $ | 4,651 | ||||
5. |
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There were no realized gains or losses fromavailable-for-sale securities for the three months ended March 31, 2020 or March 31, 2019.
The Company did not hold any securities in an unrealized position for more than 12 months as of March 31, 2020.
The estimated fair values ofavailable-for-sale securities at March 31, 2020, by contractual maturity, are summarized as follows:
March 31, 2020 | ||||
Due in one year or less | $ | 69,997,200 | ||
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Prepaid Expenses and Other Current Assets. |
March 31, 2020 | December 31, 2019 | |||||||
Prepaid manufacturing costs | $ | 3,471,078 | $ | 1,526,013 | ||||
Prepaid insurance | 995,146 | 1,263,129 | ||||||
Prepaid subscription fees | 492,716 | 501,251 | ||||||
Prepaid research fees | 490,102 | 481,057 | ||||||
Prepaid commercialization expenses | 287,083 | 62,959 | ||||||
Other | 326,590 | 516,665 | ||||||
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Total prepaid expenses and other current assets | $ | 6,062,715 | $ | 4,351,074 | ||||
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March 31, 2021 | December 31, 2020 | |||||||
Prepaid manufacturing costs | $ | 4,266 | $ | 3,328 | ||||
Prepaid tax | 761 | 1,368 | ||||||
Prepaid insurance | 1,011 | 1,285 | ||||||
Prepaid subscription fees | 735 | 729 | ||||||
Prepaid research fees | 426 | 453 | ||||||
Prepaid commercialization expenses | 364 | 199 | ||||||
Due from collaborative arrangements | 404 | 437 | ||||||
Other | 276 | 529 | ||||||
Total prepaid expenses and other current assets | $ | 8,243 | $ | 8,328 | ||||
6. | Operating |
March 31, 2020 | ||||
Operating lease cost | $ | 74,079 |
follows (in thousands):
March 31, 2021 | ||||
Operating lease cost | $ | 56 |
March 31, 2020 | ||||
Cash paid for amounts included in the measurement of lease liabilities: | ||||
Operating cash flows | $ | 84,061 | ||
Right-of-use assets obtained in exchange for lease obligations: | ||||
Operating leases | $ | 5,305 |
March 31, 2021 | ||||
Cash paid for amounts included in the measurement of lease liabilities: | ||||
Operating cash flows | $ | 29 | ||
Right-of-use | ||||
Operating leases | $ | 14 |
March 31, 2020 | ||||
Operating leaseright-of-use assets | $ | 730,284 | ||
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Other current liabilities | $ | 306,677 | ||
Operating lease liabilities, net of current portion | 568,421 | |||
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Total operating lease liabilities | $ | 875,098 | ||
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Operating lease right-of-use | $ | 3,309 | ||
Other current liabilities | $ | 122 | ||
Operating lease liabilities, net of current portion | 4,129 | |||
Total operating lease liabilities | $ | 4,251 | ||
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Remaining lease term | ||||
Discount rate | % |
6. | Operating Lease (continued). |
2020 (remaining nine months) | $ | 255,544 | ||
2021 | 349,788 | |||
2022 | 329,662 | |||
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Total lease payments | 934,994 | |||
Less imputed interest | (59,896 | ) | ||
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Total | $ | 875,098 | ||
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2021 (remaining nine months) | $ | 80 | ||
2022 | 492 | |||
2023 | 506 | |||
2024 | 522 | |||
2025 | 537 | |||
Thereafter | 3,150 | |||
Total lease payments | 5,287 | |||
Less imputed interest | (1,036 | ) | ||
Total | $ | 4,251 | ||
7. | Property and Equipment, net. |
March 31, 2021 | December 31, 2020 | |||||||
Computer equipment | $ | 51 | $ | 51 | ||||
Furniture and equipment | 134 | 242 | ||||||
Leasehold improvements | 939 | 177 | ||||||
Less: Accumulated depreciation | (180 | ) | (340 | ) | ||||
Total property and equipment, net | $ | 944 | $ | 130 | ||||
8. | Accrued Expenses and Other Liabilities. |
March 31, 2020 | December 31, 2019 | |||||||
Accrued preclinical and clinical trial expenses | $ | 940,963 | $ | 1,183,513 | ||||
Accrued professional fees | 3,309,351 | 1,241,526 | ||||||
Accrued compensation and benefits | 1,814,396 | 3,064,645 | ||||||
Accrued license fees | 3,945,991 | 8,751,991 | ||||||
Accrued purchases | 1,243,991 | 1,313,310 | ||||||
Accrued contributions | 1,135,000 | 1,535,000 | ||||||
Operating lease liability | 306,677 | 300,518 | ||||||
Accrued variable consideration | 1,308,344 | 884,764 | ||||||
Income tax payable | 2,143,490 | 1,533,696 | ||||||
Other | 139,733 | 172,332 | ||||||
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Current accrued expenses and other liabilities | 16,287,936 | 19,981,295 | ||||||
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Leaseliability—non-current | 568,421 | 647,532 | ||||||
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Non-current accrued expenses and other liabilities | 568,421 | 647,532 | ||||||
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Total accrued expenses and other liabilities | $ | 16,856,357 | $ | 20,628,827 | ||||
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March 31, 2021 | December 31, 2020 | |||||||
Accrued preclinical and clinical trial expenses | $ | 766 | $ | 585 | ||||
Accrued professional fees | 1,622 | 1,884 | ||||||
Accrued compensation and benefits | 1,901 | 3,991 | ||||||
Accrued license fees | 4,115 | 10,373 | ||||||
Accrued purchases | 286 | 258 | ||||||
Accrued contributions | 1,100 | 310 | ||||||
Operating lease liability | 122 | 29 | ||||||
Accrued variable consideration | 1,772 | 964 | ||||||
Accrued income tax | 80 | — | ||||||
Other | 111 | 106 | ||||||
Current accrued expenses and other liabilities | 11,875 | 18,500 | ||||||
Lease liability—non-current | 4,129 | — | ||||||
Non-current accrued expenses and other liabilities | 4,129 | — | ||||||
Total accrued expenses and other liabilities | $ | 16,004 | $ | 18,500 | ||||
9. | Collaborative |
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9. | Collaborative Arrangements (continued). |
there was 0 profit-sharing revenue from sales of the collaborative product.
10. | Commitments and Contingencies. |
In 2018, the Company became aware that certain patents granted to Northwestern University (which patents have been licensed by Northwestern to a third party) for a new GABA aminotransferase inhibitor were developed fromCPP-115, which had previously been licensed to the Company by Northwestern. As a result, on October 26, 2018, the Company terminated the license agreement forCPP-115 and commenced an arbitration proceeding against Northwestern seeking damages for alleged breaches of the license agreement. Shortly thereafter, Northwestern filed counterclaims against the Company in the arbitration action seeking damages for alleged breaches by the Company of the license agreement. On May 21, 2019, the Company entered into a settlement agreement with Northwestern that resolved all pending disputes between the parties with no admission of liability by either party, released all claims of liability or wrongdoing between the Company and Northwestern, and dismissed the pending arbitration. Under the settlement agreement, the Company received a $100,000 payment on May 21, 2019, which is reported as income in other income, net in the consolidated statement of operations. The Company is also entitled to receive certain contingent compensation that will be reported when and if received.
proceeding.
11. | Agreements. |
a. |
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During
b. |
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12. | Income Taxes. |
The Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets. As ofthree months ended March 31, 2020 and December 31, 2019, basedis also affected by a valuation allowance provided on the Company’s history of operating losses, thedeferred
13. | Stockholders’ Equity. |
20202021 and December 31, 2019. No2020.NaN shares of preferred stock were outstanding at March 31, 20202021 and December 31, 2019.2020.11.Stockholders’ Equity (continued).150,000,000200,000,000 shares of authorized common stock, par value $0.001 per share. At March 31, 20202021 and December 31, 2019, 103,408,6992020, 103,804,590 and 103,397,033103,781,641 shares, respectively, of common stock were issued and outstanding. Each holder of common stock is entitled to one 1vote of each share of common stock held of record on all matters on which stockholders generally are entitled to vote.2017
13. | Stockholders’ Equity (continued). |
On November 28, 2017,31, 2020. As of the Company filed a prospectus supplement and offered for sale 16,428,572 sharesdate of its common stock at a price of $3.50 per share in an underwritten public offeringthis report, no offerings have been completed under the 2017 Shelf Registration. The Company received gross proceeds in the public offering of approximately $57.5 million before underwriting commission and incurred expenses of approximately $3.7 million.
At March 31,Company’s 2020 there is approximately $92.5 million available for future sale under the 2017 Shelf Registration Statement.
14. | Stock Compensation. |
Three months ended March 31, | ||||||||
2020 | 2019 | |||||||
Research and development | $ | 418,053 | $ | 287,721 | ||||
Selling, general and administrative | 1,101,298 | 645,690 | ||||||
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Total stock-based compensation | $ | 1,519,351 | $ | 933,411 | ||||
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follows (in thousands):
Three months ended March 31, | ||||||||
2021 | 2020 | |||||||
Research and development | $ | 389 | $ | 418 | ||||
Selling, general and administrative | 1,182 | 1,101 | ||||||
Total stock-based compensation | $ | 1,571 | $ | 1,519 | ||||
2021.
14. | Stock Compensation (continued). |
$0.1 million and $0.1 million, respectively.no0 grants of restricted stock units to employees or directors during the three-month periods ended March 31, 20202021 and March 31, 2019.2020. During the three-month periodperiods ended March 31, 2021, and March 31, 2020, the Company recorded$135,679. No stock-based compensation related to restricted stocks was recorded during the three-month period ended March 31, 2019.2020,2021, there was approximately $1.5$0.9 million of unrecognized compensation expense related to2.671.74 years.13.
On May 7, 2020, the Company amended the lease for its office facilities. Under the amended lease,
Introduction
ITEM 2. | MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
Introduction |
OVERVIEW |
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OVERVIEW
We were fortunate that all subjects were enrolled in
While we are doing our best to monitor and react tostudies, consistent with the impact ofthat the health crisisour business, there can be no assurance as to the ultimate manner in which these recent events will impact our business and our results of operations.
many biopharmaceutical companies.
Because of theCOVID-19 pandemic, Further, we have recently implemented a number of safety related initiatives among our employees, including a travel ban and a work from home policy for all employees. This included our customer-facing employees, who are working remotely and utilizing telephone andweb-based technologies to provide support to patients and their healthcare providers. We are also continuing to expand our digital and social media activities in order to introduce our product and services to potential patients and their healthcare providers. Since many healthcare providers are delaying seeing patients other than those affected byCOVID-19, this has, starting recently, limited our ability to locate new patients who might benefit from our drug and slowed our efforts to increase our sales from prior periods.
We have
We recently completed the last subject visits in
We were fortunate that all subjects were enrolled in our MuSK-MG trial before the full outbreak of theCOVID-19 health emergency. However, while all subject visits in our MuSK-MG trial have now been completed, delays in closing out trial sites and data-collection from the trial will likely delay our ability to reporttop-line resultsdata from this trial untilin an effort to understand why the third quarter
Ifthe trial and in our trial is successful, weprevious
We are currently conducting aproof-of-concept clinical study evaluating Firdapse® as a symptomatic treatment for ambulatory patients with Spinal Muscular Atrophy (SMA) Type 3. The study, which is being conducted at trial sites in Italy and Serbia, plans to evaluate approximately 12 subjects in a randomized (1:1), double-blind,2-period,2-treatment, crossover, outpatientproof-of-concept study evaluatingdiscussion during the safety, tolerability and potential efficacyfirst half of amifampridine in ambulatory patients diagnosed with SMA Type 3. Details of this trial are available on www.clinicaltrials.gov (NCT03781479).
We have identified and recruited all of the subjects necessary to complete thisproof-of-concept study.2021. However, the last seven subjects will not be able to complete the study until the trial sites conducting the study are permitted to resume clinical trial activities. While there can be no assurance that the FDA will agree with our new protocol design or, even if our new study is successful, accept the results of a single study of a different trial design as sufficient evidence for approval of the
We also plan to begin studies in 2020 evaluating FirdapseKennedy’s Disease and Hereditary Neuropathy with liabilityLiability to Pressure Palsies (HNPP). However, our plansThe scientific basis for these studies have not yet been finalized and we do not yet know what form they will take or what timelines they will be on.
considering this indication is that leakage of neuron potassium channels is observed in HNPP. Since Firdapse
We are also currently in
In October 2019, we submitted an NDS in Canada seeking approvalresults of Firdapse® for the treatment of LEMS. Our application has been accepted for review and we have been granted a priority review. There can be no assurance that our application will be approved. In addition, since there is no orphan exclusivity in Canada, even if our NDS for Firdapse® is approved, there can be no assurance that any application for amifampridine filed by other parties will not be approved as well. As a result, even if our NDS is approved, we may face competition in Canada for LEMS patients.
this proceeding.
Japan or obtain orphan drug designation.
Further, there
Basis of Presentation
Basis | of Presentation |
At
However, as noted in the Overview above, we are prepared to invest in future research and development, including earlier stage opportunities and innovative technology.
We are currently conducting a study of the availability for use of our net operating loss carryforwards and other credits under Section 382 of the Internal Revenue Code, and the results of this study could impact the amounts of net operating losses and other credits that we have available for use in future periods, and the timing of their use.
Non-GAAP Financial Measures.
We prepare our consolidated financial statements and notes thereto which accompany this report in accordance with U.S. GAAP. To supplement our financial results presented on a U.S. GAAP basis, we may usenon-GAAP financial measures in our reports filed with the Commission and/or our communications with investors.Non-GAAP measures are provided as additional information and not as an alternative to our consolidated financial statements presented in accordance with GAAP. Ournon-GAAP financial measures are intended to enhance an overall understanding
2020.
Three months ended March 31, | Change | |||||||||||||||
2020 | 2019 | $ | % | |||||||||||||
Research and development expenses | $ | 3,804,758 | $ | 3,020,238 | 784,520 | 26.0 | % | |||||||||
Employee stock-based compensation | 418,053 | 287,721 | 130,332 | 45.3 | % | |||||||||||
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Total research and development expenses | $ | 4,222,811 | $ | 3,307,959 | 914,852 | 27.7 | % | |||||||||
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follows (in thousands):
Three months ended March 31, | Change | |||||||||||||||
2021 | 2020 | $ | % | |||||||||||||
Research and development expenses | $ | 2,618 | $ | 3,805 | (1,187 | ) | (31.2 | )% | ||||||||
Employee stock-based compensation | 389 | 418 | (29 | ) | (7.0 | )% | ||||||||||
Total research and development expenses | $ | 3,007 | $ | 4,223 | (1,216 | ) | (28.8 | )% | ||||||||
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increasemedical and regulatory affairs, our expanded access programs, and our efforts to develop a long-acting formulation of $130,332 in employee stock-based compensation which isnon-cash and relates to the expenseamifampridine phosphate.
neuromuscular diseases.
Three months ended March 31, | Change | |||||||||||||||
2020 | 2019 | $ | % | |||||||||||||
Selling | $ | 5,804,145 | $ | 5,103,908 | 700,237 | 13.7 | % | |||||||||
General and administrative | 3,157,605 | 2,666,862 | 490,743 | 18.4 | % | |||||||||||
Employee stock-based compensation | 1,101,298 | 645,690 | 455,608 | 70.6 | % | |||||||||||
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Total selling, general and administrative expenses | $ | 10,063,048 | $ | 8,416,460 | 1,646,588 | 19.6 | % | |||||||||
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follows (in thousands):
Three months ended March 31, | Change | |||||||||||||||
2021 | 2020 | $ | % | |||||||||||||
Selling | $ | 5,676 | $ | 5,804 | (128 | ) | (2.2 | )% | ||||||||
General and administrative | 5,858 | 3,158 | 2,700 | 85.5 | % | |||||||||||
Employee stock-based compensation | 1,182 | 1,101 | 81 | 7.4 | % | |||||||||||
Total selling, general and administrative expenses | $ | 12,716 | $ | 10,063 | 2,653 | 26.4 | % | |||||||||
increasetiming of commitments to make contributions to 501(c)(3) organizations supporting LEMS patients of approximately $0.7$2.0 million, 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 experienced inside sales agency;
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increaselitigation fees of approximately $0.5 million in employee stock-based compensation which is non cash and relatesincreased costs due to the expenseexpansion of stock options awardsour operations and headcount required to certain employees and directors.
.
We incurred net operating losses since inception through the three-month period ended March 31, 2019.
differences. The effective tax rate for the three months ended March 31, 2020 is also affected by a valuation allowance provided on our deferred tax assets.
2020.
Income.
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the extent to which we acquire or invest in other products.
31, 2020. As of the date of this Form10-Q, $92.5 million of our 2017report, no offerings have been completed under the 2020 Shelf Registration Statement remains available for future sales.
Statement.
Net cash provided by investing activities was $5,000,000,$5.0 million for the three-month period ended March 31, 2020, consisting primarily of proceeds from maturities and sales of investments. Net cash provided by investing activities was $10,449,393 for the three-month period ended March 31, 2019, consisting primarily of proceeds from sales and maturities of investments of $20,400,000, partially offset by purchases of investments of $9,944,974.
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ITEM 3. | QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK |
ITEM 4. | CONTROLS AND PROCEDURES |
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) and15d-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 March 31, |
b. | During the three months ended March 31, |
ITEM 1. | LEGAL PROCEEDINGS |
labeling.labeling, and Jacobus intervened in the litigation. Our complaint, which was filed in the federal district court for the Southern District of Florida, allegesalleged that the FDA’s approval of Ruzurgiseekssought an order vacatingsetting aside the FDA’s approval of RuzurgiWe recentlyjudgement injudgment. On September 29, 2020, the District Judge adopted the Report and Recommendation of the Magistrate Judge, granted the FDA’s and Jacobus’ motions for summary judgment, and dismissed our case,case.
proceeding.
ITEM 1A. | RISK FACTORS |
ITEM 2. | UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS |
None
Period | Total Number of Shares Purchased | Average Price Paid Per Share | Total Number of Shares Purchased as Part of Publicly Announced Program | Dollar Value of Shares that May Yet Be Purchased (in thousands) | ||||||||||||
January 1, 2021 – January 31, 2021 | N/A | N/A | N/A | N/A | ||||||||||||
February 1, 2021 – February 28, 2021 | N/A | N/A | N/A | N/A | ||||||||||||
March 1, 2021 – March 31, 2021 | 67,049 | $ | 4.36 | 67,049 | $ | 39,707 |
ITEM 3. | DEFAULTS UPON SENIOR SECURITIES |
ITEM 4. | MINE SAFETY DISCLOSURE |
ITEM 5. | OTHER INFORMATION |
ITEM 6. | EXHIBITS |
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 | XBRL Instance Document | |
101.SCH | XBRL Taxonomy Extension Schema | |
101.CAL | XBRL Taxonomy Extension Calculation Linkbase | |
101.DEF | XBRL Taxonomy Extension Definition Linkbase | |
101.LAB | XBRL Taxonomy Extension Label Linkbase | |
101.PRE | XBRL Taxonomy Extension Presentation Linkbase | |
104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
Catalyst Pharmaceuticals, Inc. | ||
By: | /s/ Alicia Grande | |
Alicia Grande | ||
Vice President, Treasurer and Chief Financial Officer |
41