☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Delaware | 61-1807780 | |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
29 Hartwell Avenue Lexington, Massachusetts | 02421 | ||
(Address of principal executive offices) | (Zip Code) |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
Common Stock, $0.001 par value | TBIO | The Nasdaq Global Select Market |
Large accelerated filer | ||||||
☒ | ☐ | |||||
Non-accelerated filer | ☐ | Smaller reporting company | ☐ | |||
Emerging growth company | ☐ |
Page | |||||||
PART I. | 1 | ||||||
Item 1. | 1 | ||||||
1 | |||||||
2 | |||||||
3 | |||||||
4 | |||||||
6 | |||||||
7 | |||||||
Item 2. | 25 | ||||||
Item 3. | |||||||
Item 4. | |||||||
PART II. | |||||||
Item 1. | |||||||
Item 1A. | |||||||
Item 6. | |||||||
87 |
June 30, 2020 | December 31, 2019 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 272,193 | $ | 84,580 | ||||
Short-term investments | 20,029 | 104,098 | ||||||
Collaboration receivables | 15,131 | 4,596 | ||||||
Prepaid expenses and other current assets | 7,918 | 9,391 | ||||||
Restricted cash | 950 | 950 | ||||||
Total current assets | 316,221 | 203,615 | ||||||
Property and equipment, net | 15,154 | 12,539 | ||||||
Right-of-use assets, net | 10,130 | 10,400 | ||||||
Goodwill | 21,359 | 21,359 | ||||||
Intangible assets, net | 81,280 | 85,536 | ||||||
Other assets | 10,134 | 2,752 | ||||||
Total assets | $ | 454,278 | $ | 336,201 | ||||
Liabilities and Stockholders’ Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 12,912 | $ | 15,968 | ||||
Accrued expenses | 11,126 | 7,072 | ||||||
Current portion of deferred revenue | 27,109 | 18,100 | ||||||
Current portion of operating lease liability | 619 | 530 | ||||||
Total current liabilities | 51,766 | 41,670 | ||||||
Contingent consideration | 109,550 | 103,655 | ||||||
Deferred revenue, net of current portion | 9,818 | 25,256 | ||||||
Operating lease liability, net of current portion | 11,751 | 12,084 | ||||||
Total liabilities | 182,885 | 182,665 | ||||||
Commitments and contingencies (Notes 3, 4 and 12) | ||||||||
Stockholders’ equity: | ||||||||
Preferred stock, $0.001 par value; 10,000,000 shares authorized as of June 30, 2020 and December 31, 2019, respectively; 0 shares issued and outstanding as of June 30, 2020 and December 31, 2019 | — | — | ||||||
Common stock, $0.001 par value; 200,000,000 shares authorized as of June 30, 2020 and December 31, 2019; 69,359,509 shares and 60,022,067 shares issued and outstanding as of June 30, 2020 and December 31, 2019, respectively | 69 | 60 | ||||||
Additional paid-in capital | 680,850 | 512,231 | ||||||
Accumulated deficit | (410,066 | ) | (359,496 | ) | ||||
Accumulated other comprehensive income | 540 | 741 | ||||||
Total stockholders’ equity | 271,393 | 153,536 | ||||||
Total liabilities and stockholders’ equity | $ | 454,278 | $ | 336,201 | ||||
March 31, 2021 | December 31, 2020 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 155,746 | $ | 342,027 | ||||
Investments | 499,007 | 312,001 | ||||||
Collaboration receivables | 23,240 | 26,598 | ||||||
Prepaid expenses and other current assets | 16,721 | 11,741 | ||||||
Restricted cash | 4,826 | 4,826 | ||||||
Total current assets | 699,540 | 697,193 | ||||||
Property and equipment, net | 16,563 | 15,372 | ||||||
Right-of-use | 71,154 | 72,957 | ||||||
Goodwill | 21,359 | 21,359 | ||||||
Intangible assets, net | 77,106 | 79,127 | ||||||
Other assets | 4,918 | 3,928 | ||||||
Total assets | $ | 890,640 | $ | 889,936 | ||||
Liabilities and Stockholders’ Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 17,068 | $ | 8,839 | ||||
Accrued expenses | 16,240 | 13,202 | ||||||
Current portion of deferred revenue | 72,373 | 67,563 | ||||||
Current portion of operating lease liability | 12,084 | 11,733 | ||||||
Income tax liability | 254 | — | ||||||
Total current liabilities | 118,019 | 101,337 | ||||||
Contingent consideration | 108,251 | 152,230 | ||||||
Deferred revenue, net of current portion | 226,876 | 228,659 | ||||||
Operating lease liability, net of current portion | 48,604 | 50,953 | ||||||
Total liabilities | 501,750 | 533,179 | ||||||
Commitments and contingencies (Notes 3 and 12) | 0 | 0 | ||||||
Stockholders’ equity: | ||||||||
Preferred stock, $0.001 par value; 10,000,000 shares authorized as of March 31, 2021 and December 31, 2020; 0 shares issued and outstanding as of March 31, 2021 and December 31, 2020 | 0 | — | ||||||
Common stock, $0.001 par value; 200,000,000 shares authorized as of March 31, 2021 and December 31, 2020; 75,217,672 shares and 75,029,625 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively | 75 | 75 | ||||||
Additional paid-in capital | 775,499 | 769,965 | ||||||
Accumulated deficit | (386,761 | ) | (413,283 | ) | ||||
Accumulated other comprehensive income | 77 | — | ||||||
Total stockholders’ equity | 388,890 | 356,757 | ||||||
Total liabilities and stockholders’ equity | $ | 890,640 | $ | 889,936 | ||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Collaboration revenue | $ | 16,319 | $ | 1,174 | $ | 20,974 | $ | 2,648 | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 29,002 | 16,625 | 50,442 | 34,048 | ||||||||||||
General and administrative | 8,601 | 7,850 | 16,060 | 14,403 | ||||||||||||
Change in fair value of contingent consideration | 15,347 | 4,889 | 5,895 | 16,591 | ||||||||||||
Total operating expenses | 52,950 | 29,364 | 72,397 | 65,042 | ||||||||||||
Loss from operations | (36,631 | ) | (28,190 | ) | (51,423 | ) | (62,394 | ) | ||||||||
Interest income | 343 | 358 | 853 | 878 | ||||||||||||
Loss before benefit from income taxes | (36,288 | ) | (27,832 | ) | (50,570 | ) | (61,516 | ) | ||||||||
Benefit from income taxes | — | — | — | 486 | ||||||||||||
Net loss | $ | (36,288 | ) | $ | (27,832 | ) | $ | (50,570 | ) | $ | (61,030 | ) | ||||
Net loss per share—basic and diluted | $ | (0.58 | ) | $ | (0.57 | ) | $ | (0.83 | ) | $ | (1.30 | ) | ||||
Weighted average common shares outstanding—basic and diluted | 62,282,291 | 48,749,627 | 61,145,254 | 46,866,842 | ||||||||||||
Three Months Ended March 31, | ||||||||
2021 | 2020 | |||||||
Collaboration revenue | $ | 34,600 | $ | 4,654 | ||||
Operating expenses: | ||||||||
Research and development | 41,140 | 21,439 | ||||||
General and administrative | 10,817 | 7,458 | ||||||
Change in fair value of contingent consideration | (43,979 | ) | (9,452 | ) | ||||
Total operating expenses | 7,978 | 19,445 | ||||||
Income (loss) from operations | 26,622 | (14,791 | ) | |||||
Other income, net | 154 | 509 | ||||||
Income (loss) before income tax provision | 26,776 | (14,282 | ) | |||||
Income tax provision | (254 | ) | — | |||||
Net income (loss) | $ | 26,522 | $ | (14,282 | ) | |||
Net income (loss) per share—basic | $ | 0.35 | $ | (0.24 | ) | |||
Weighted average common shares outstanding—basic | 75,189,696 | 60,008,217 | ||||||
Net income (loss) per share—diluted | $ | 0.34 | $ | (0.24 | ) | |||
Weighted average common shares outstanding—diluted | 79,101,624 | 60,008,217 | ||||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Net loss | $ | (36,288 | ) | $ | (27,832 | ) | $ | (50,570 | ) | $ | (61,030 | ) | ||||
Other comprehensive income (loss): | ||||||||||||||||
Unrealized gains ( onlosses )available-for-sale securities, net of tax of $0 | (315 | ) | 219 | (201 | ) | 374 | ||||||||||
Comprehensive loss | $ | (36,603 | ) | $ | (27,613 | ) | $ | (50,771 | ) | $ | (60,656 | ) | ||||
Three Months Ended March 31, | ||||||||
2021 | 2020 | |||||||
Net income (loss) | $ | 26,522 | $ | (14,282 | ) | |||
Other comprehensive income (loss): | ||||||||
Unrealized gains on available-for-sale | 77 | 114 | ||||||
Comprehensive income (loss) | $ | 26,599 | $ | (14,168 | ) | |||
Common Stock | Additional Paid-in | Accumulated | Accumulated Other Comprehensive | Total Stockholders’ | ||||||||||||||||||||
Shares | Amount | Capital | Deficit | Income | Equity | |||||||||||||||||||
Balances at December 31, 2019 | 60,022,067 | $ | 60 | $ | 512,231 | $ | (359,496 | ) | $ | 741 | $ | 153,536 | ||||||||||||
Exercise of stock options | 15,596 | — | 132 | — | — | 132 | ||||||||||||||||||
Stock-based compensation expense | — | — | 3,172 | — | — | 3,172 | ||||||||||||||||||
Unrealized gains on available-for-sale securities | — | — | — | — | 114 | 114 | ||||||||||||||||||
Net loss | — | — | — | (14,282 | ) | — | (14,282 | ) | ||||||||||||||||
Balances at March 31, 2020 | 60,037,663 | 60 | 515,535 | (373,778 | ) | 855 | 142,672 | |||||||||||||||||
Issuance of common stock in connection with public offerings , net of underwriting discounts and commissions and offering costs | 8,544,982 | 9 | 153,602 | — | — | 153,611 | ||||||||||||||||||
Exercise of stock options | 776,864 | — | 5,699 | — | — | 5,699 | ||||||||||||||||||
Stock-based compensation expense | — | — | 6,014 | — | — | 6,014 | ||||||||||||||||||
Unrealized l onosses available-for-sale securities | — | — | — | — | (315 | ) | (315 | ) | ||||||||||||||||
Net loss | — | — | — | (36,288 | ) | — | (36,288 | ) | ||||||||||||||||
Balances at June 30, 2020 | 69,359,509 | $ | 69 | $ | 680,850 | $ | (410,066 | ) | $ | 540 | $ | 271,393 | ||||||||||||
Common Stock | Additional Paid-in | Accumulated | Accumulated Other Comprehensive | Total Stockholders’ | ||||||||||||||||||||
Shares | Amount | Capital | Deficit | Income | Equity | |||||||||||||||||||
Balances at December 31, 2018 | 45,139,955 | $ | 45 | $ | 371,257 | $ | (246,203 | ) | $ | 196 | $ | 125,295 | ||||||||||||
Exercise of stock options | 154,484 | — | 897 | — | — | 897 | ||||||||||||||||||
Stock-based compensation expense | — | — | 1,959 | — | — | 1,959 | ||||||||||||||||||
Unrealized gains on available-for-sale securities | — | — | — | — | 155 | 155 | ||||||||||||||||||
Net loss | — | — | — | (33,198 | ) | — | (33,198 | ) | ||||||||||||||||
Balances at March 31, 2019 | 45,294,439 | 45 | 374,113 | (279,401 | ) | 351 | 95,108 | |||||||||||||||||
Issuance of common stock in connection with private net of placement agent fees and offering costs | 5,582,940 | 6 | 44,128 | — | — | 44,134 | ||||||||||||||||||
Issuance of common stock in connection with a former employee letter agreement | 67,406 | — | 847 | — | — | 847 | ||||||||||||||||||
Forfeited restricted common stock | (1,334 | ) | — | (1 | ) | — | — | (1 | ) | |||||||||||||||
Exercise of stock options | 66,917 | — | 519 | — | — | 519 | ||||||||||||||||||
Stock-based compensation expense | — | — | 2,703 | — | — | 2,703 | ||||||||||||||||||
Unrealized gains on available-for-sale securities | — | — | — | — | 219 | 219 | ||||||||||||||||||
Net loss | — | — | — | (27,832 | ) | — | (27,832 | ) | ||||||||||||||||
Balances at June 30, 2019 | 51,010,368 | $ | 51 | $ | 422,309 | $ | (307,233 | ) | $ | 570 | $ | 115,697 |
Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Income | Total Stockholders’ Equity | ||||||||||||||||||||
Shares | Amount | |||||||||||||||||||||||
Balances at December 31, 2020 | 75,029,625 | $ | 75 | $ | 769,965 | $ | (413,283 | ) | $ | 0 | $ | 356,757 | ||||||||||||
Exercise of stock options | 188,047 | — | 1,550 | — | — | 1,550 | ||||||||||||||||||
Stock-based compensation expense | — | — | 3,984 | — | — | 3,984 | ||||||||||||||||||
Unrealized gains on available-for-sale | — | — | — | — | 77 | 77 | ||||||||||||||||||
Net income | — | — | — | 26,522 | — | 26,522 | ||||||||||||||||||
Balances at March 31, 2021 | 75,217,672 | $ | 75 | $ | 775,499 | $ | (386,761 | ) | $ | 77 | $ | 388,890 | ||||||||||||
Six Months Ended June 30, | ||||||||
2020 | 2019 | |||||||
Cash flows from operating activities: | ||||||||
Net loss | $ | (50,570 | ) | $ | (61,030 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation and amortization expense | 5,617 | 1,960 | ||||||
Stock-based compensation expense | 9,186 | 5,509 | ||||||
Change in fair value of contingent consideration | 5,895 | 16,591 | ||||||
Deferred income tax benefit | — | (486 | ) | |||||
Changes in operating assets and liabilities: | ||||||||
Collaboration receivables | (10,535 | ) | 177 | |||||
Prepaid expenses and other assets | (5,909 | ) | (1,766 | ) | ||||
Right-of-use assets | 270 | 234 | ||||||
Accounts payable | (2,783 | ) | (1,858 | ) | ||||
Accrued expenses | 4,013 | 600 | ||||||
Lease liability | (244 | ) | (170 | ) | ||||
Deferred revenue | (6,429 | ) | (1,206 | ) | ||||
Net cash used in operating activities | (51,489 | ) | (41,445 | ) | ||||
Cash flows from investing activities: | ||||||||
Purchases of investments | (27,409 | ) | (38,438 | ) | ||||
Sales and maturities of investments | 111,277 | 55,756 | ||||||
Purchases of property and equipment | (4,446 | ) | (1,793 | ) | ||||
Net cash provided by investing activities | 79,422 | 15,525 | ||||||
Cash flows from financing activities: | ||||||||
Proceeds from public offering s , net ofunderwriting discounts and commissions | 154,292 | — | ||||||
Payments of public offering costs | (443 | ) | — | |||||
Proceeds from private placement, net of placement agent fees | — | 44,608 | ||||||
Payments of private placement offering costs | — | (474 | ) | |||||
Proceeds from option exercises | 5,831 | 1,416 | ||||||
Net cash provided by financing activities | 159,680 | 45,550 | ||||||
Net increase in cash, cash equivalents and restricted cash : | 187,613 | 19,630 | ||||||
Cash, cash equivalents and restricted cash at beginning of period | 85,530 | 56,224 | ||||||
Cash, cash equivalents and restricted cash at end of period | $ | 273,143 | $ | 75,854 | ||||
Cash, cash equivalents and restricted cash at end of period: | ||||||||
Cash and cash equivalents | $ | 272,193 | $ | 74,904 | ||||
Restricted cash | 950 | 950 | ||||||
Total cash, cash equivalents and restricted cash at end of period | $ | 273,143 | $ | 75,854 | ||||
Supplemental disclosure of non-cash investing and financing activities: | ||||||||
Purchases of property and equipment included in accounts payable and accrued expenses | $ | 718 | $ | 59 | ||||
Offering costs included in accrued expenses | $ | 238 | $ | — | ||||
Deferred offering costs included in accounts payable and accrued expenses | $ | — | $ | 123 | ||||
Issuance of common stock in connection with a former employee letter agreement | $ | — | $ | 847 |
Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Income | Total Stockholders’ Equity | ||||||||||||||||||||
Shares | Amount | |||||||||||||||||||||||
Balances at December 31, 2019 | 60,022,067 | $ | 60 | $ | 512,231 | $ | (359,496 | ) | $ | 741 | $ | 153,536 | ||||||||||||
Exercise of stock options | 15,596 | — | 132 | — | — | 132 | ||||||||||||||||||
Stock-based compensation expense | — | — | 3,172 | — | — | 3,172 | ||||||||||||||||||
Unrealized gains on available-for-sale | — | — | — | — | 114 | 114 | ||||||||||||||||||
Net loss | — | — | — | (14,282 | ) | — | (14,282 | ) | ||||||||||||||||
Balances at March 31, 2020 | 60,037,663 | $ | 60 | $ | 515,535 | $ | (373,778 | ) | $ | 855 | $ | 142,672 | ||||||||||||
Three Months Ended March 31, | ||||||||
2021 | 2020 | |||||||
Cash flows from operating activities: | ||||||||
Net income (loss) | $ | 26,522 | $ | (14,282 | ) | |||
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: | ||||||||
Depreciation and amortization expense | 2,841 | 1,351 | ||||||
Stock-based compensation expense | 3,984 | 3,172 | ||||||
Change in fair value of contingent consideration | (43,979 | ) | (9,452 | ) | ||||
Changes in operating assets and liabilities: | ||||||||
Collaboration receivables | 3,358 | (1,633 | ) | |||||
Prepaid expenses and other assets | (4,672 | ) | 2,647 | |||||
Right-of-use | 3,049 | 132 | ||||||
Long-term prepaid rent | (1,298 | ) | (3,044 | ) | ||||
Accounts payable | 8,114 | (9,545 | ) | |||||
Accrued expenses | 2,733 | 584 | ||||||
Income tax liabilit y | 254 | — | ||||||
Lease liability | (3,244 | ) | (110 | ) | ||||
Deferred revenue | 3,027 | (1,267 | ) | |||||
Net cash provided by (used in) operating activities | 689 | (31,447 | ) | |||||
Cash flows from investing activities: | ||||||||
Purchases of investments | (186,929 | ) | (27,409 | ) | ||||
Sales and maturities of investments | — | 73,994 | ||||||
Purchases of property and equipment | (1,591 | ) | (2,325 | ) | ||||
Net cash provided by (used in) investing activities | (188,520 | ) | 44,260 | |||||
Cash flows from financing activities: | ||||||||
Payments of public offering costs | — | (57 | ) | |||||
Proceeds from option exercises | 1,550 | 132 | ||||||
Net cash provided by financing activities | 1,550 | 75 | ||||||
Net increase (decrease) in cash, cash equivalents and restricted cash: | (186,281 | ) | 12,888 | |||||
Cash, cash equivalents and restricted cash at beginning of period | 346,853 | 85,530 | ||||||
Cash, cash equivalents and restricted cash at end of period | $ | 160,572 | $ | 98,418 | ||||
Cash, cash equivalents and restricted cash at end of period: | ||||||||
Cash and cash equivalents | $ | 155,746 | $ | 97,468 | ||||
Restricted cash | 4,826 | 950 | ||||||
Total cash, cash equivalents and restricted cash at end of period | $ | 160,572 | $ | 98,418 | ||||
Supplemental disclosure of non-cash investing and financing activities: | ||||||||
Purchases of property and equipment included in accounts payable and accrued expenses | $ | 826 | $ | 764 | ||||
Deferred offering costs included in accounts payable and accrued expenses | $ | — | $ | 120 |
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Collaboration revenue | $ | 16,319 | $ | 1,174 | $ | 20,974 | $ | 2,648 |
Three Months Ended March 31, | ||||||||
2021 | 2020 | |||||||
Collaboration revenue | $ | 34,600 | $ | 4,654 |
June 30, 2020 | December 31, 2019 | |||||||
Contract liabilities | ||||||||
Deferred revenue | $ | 36,927 | $ | 43,356 |
March 31, | December 31, | |||||||
2021 | 2020 | |||||||
Contract liabilities | ||||||||
Deferred revenue | $ | 299,249 | $ | 296,222 |
June 30, 2020 | ||||||||||||||||||||
Estimated Life | Gross Carrying Amount | Accumulated Amortization | Impairment Charge | Net Carrying Amount | ||||||||||||||||
(In thousands) | ||||||||||||||||||||
Definite-lived intangible assets: | ||||||||||||||||||||
MRT | 6 years | $ | 45,992 | $ | (7,003 | ) | $ | — | $ | 38,989 | ||||||||||
Indefinite-lived intangible assets: | ||||||||||||||||||||
IPR&D - CF | Indefinite | 42,291 | — | — | 42,291 | |||||||||||||||
Total intangible assets, net | $ | 88,283 | $ | (7,003 | ) | $ | — | $ | 81,280 | |||||||||||
March 31, 2021 | ||||||||||||||||
Estimated Life | Gross Carrying Amount | Accumulated Amortization | Net Carrying Amount | |||||||||||||
(In thousands) | ||||||||||||||||
Definite-lived intangible assets: | ||||||||||||||||
MRT | 6 years | $ | 45,992 | $ | (11,177 | ) | $ | 34,815 | ||||||||
Indefinite-lived intangible assets: | ||||||||||||||||
IPR&D - CF | Indefinite | 42,291 | — | 42,291 | ||||||||||||
Total intangible assets, net | $ | 88,283 | $ | (11,177 | ) | $ | 77,106 | |||||||||
December 31, 2020 | ||||||||||||||||
Estimated Life | Gross Carrying Amount | Accumulated Amortization | Net Carrying Amount | |||||||||||||
(In | ||||||||||||||||
Definite-lived intangible assets: | ||||||||||||||||
MRT | 6 years | $ | 45,992 | $ | (9,156 | ) | $ | 36,836 | ||||||||
Indefinite-lived intangible assets: | ||||||||||||||||
IPR&D - CF | Indefinite | 42,291 | — | 42,291 | ||||||||||||
Total intangible assets, net | $ | 88,283 | $ | (9,156 | ) | $ | 79,127 | |||||||||
December 31, 2019 | ||||||||||||||||||||
Estimated Life | Gross Carrying Amount | Accumulated Amortization | Impairment Charge | Net Carrying Amount | ||||||||||||||||
(In thousands) | ||||||||||||||||||||
Definite-lived intangible assets: | ||||||||||||||||||||
MRT | 8 years | $ | 45,992 | $ | (2,747 | ) | $ | — | $ | 43,245 | ||||||||||
Indefinite-lived intangible assets: | ||||||||||||||||||||
IPR&D - CF | Indefinite | 42,291 | — | — | 42,291 | |||||||||||||||
IPR&D - OTC | Indefinite | 18,559 | — | (18,559 | ) | — | ||||||||||||||
Total intangible assets, net | $ | 106,842 | $ | (2,747 | ) | $ | (18,559 | ) | $ | 85,536 | ||||||||||
Fair Value Measurements as of June 30, 2020 Using: | ||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Assets: | ||||||||||||||||
Money market funds | $ | — | $ | 191,447 | $ | — | $ | 191,447 | ||||||||
U.S. government agency bonds | — | 20,029 | — | 20,029 | ||||||||||||
$ | — | $ | 211,476 | $ | — | $ | 211,476 | |||||||||
Liabilities: | ||||||||||||||||
Contingent consideration | $ | — | $ | — | $ | 109,550 | $ | 109,550 | ||||||||
$ | — | $ | — | $ | 109,550 | $ | 109,550 | |||||||||
Fair Value Measurements as of December 31, 2019 Using: | ||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Assets: | ||||||||||||||||
Money market funds | $ | — | $ | 56,591 | $ | — | $ | 56,591 | ||||||||
U.S. government agency bonds | — | 104,098 | — | 104,098 | ||||||||||||
$ | — | $ | 160,689 | $ | — | $ | 160,689 | |||||||||
Liabilities: | ||||||||||||||||
Contingent consideration | $ | — | $ | — | $ | 103,655 | $ | 103,655 | ||||||||
$ | — | $ | — | $ | 103,655 | $ | 103,655 | |||||||||
Fair Value Measurements as of March 31, 2021 Using: | ||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Assets: | ||||||||||||||||
Money market funds | $ | 0 | $ | 86,637 | $ | 0 | $ | 86,637 | ||||||||
U.S. treasuries | 0 | 441,082 | 0 | 441,082 | ||||||||||||
U.S. government agency bonds | 0 | 57,925 | 0 | 57,925 | ||||||||||||
$ | 0 | $ | 585,644 | $ | 0 | $ | 585,644 | |||||||||
Liabilities: | ||||||||||||||||
Contingent consideration | $ | 0 | $ | 0 | $ | 108,251 | $ | 108,251 | ||||||||
$ | 0 | $ | 0 | $ | 108,251 | $ | 108,251 | |||||||||
Fair Value Measurements as of December 31, 2020 Using: | ||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Assets: | ||||||||||||||||
Money market funds | $ | — | $ | 273,827 | $ | — | $ | 273,827 | ||||||||
U.S. treasuries | 0 | 292,001 | — | 292,001 | ||||||||||||
U.S. government agency bonds | — | 20,000 | — | 20,000 | ||||||||||||
$ | — | $ | 585,828 | $ | — | $ | 585,828 | |||||||||
Liabilities: | ||||||||||||||||
Contingent consideration | $ | — | $ | — | $ | 152,230 | $ | 152,230 | ||||||||
$ | — | $ | — | $ | 152,230 | $ | 152,230 | |||||||||
March 31, 2021 | December 31, 2020 | |||||||||||||||
Amortized Cost | Fair Value | Amortized Cost | Fair Value | |||||||||||||
Due within one year | $ | 299,369 | $ | 299,451 | $ | 201,606 | $ | 201,596 | ||||||||
Due after one year through two years | 199,561 | 199,556 | 110,395 | 110,405 | ||||||||||||
Total available-for-sale | $ | 498,930 | $ | 499,007 | $ | 312,001 | $ | 312,001 | ||||||||
Unobservable Inputs | Fair Value at | |||||||||||
Projected Year of Payment | June 30, 2020 | December 31, 2019 | ||||||||||
Earnout payments | 2026 - 2039 | 101,570 | $ | 96,097 | ||||||||
Milestone payments | 2026 - 2030 | 7,980 | 7,558 | |||||||||
$ | 109,550 | $ | 103,655 | |||||||||
Unobservable Inputs Projected Year of Payment | Fair Value at | |||||||||||
March 31, | December 31, | |||||||||||
2021 | 2020 | |||||||||||
Earnout payments | 2027 - 2039 | $ | 99,122 | $ | 142,250 | |||||||
Milestone payments | 2027 - 2032 | 9,129 | 9,980 | |||||||||
$ | 108,251 | $ | 152,230 | |||||||||
Fair | ||||
Balance as of December 31, 2019 | $ | 103,655 | ||
Increase in fair value of contingent consideration | 5,895 | |||
Balance as of June 30, 2020 | $ | 109,550 | ||
Fair Value | ||||
Balance as of December 31, 2020 | $ | 152,230 | ||
Decrease in fair value of contingent consideration | (43,979 | ) | ||
Balance as of March 31, 2021 | $ | 108,251 | ||
June 30, 2020 | December 31, 2019 | |||||||
Laboratory equipment | $ | 10,500 | $ | 9,044 | ||||
Computer equipment | 893 | 779 | ||||||
Office equipment | 883 | 883 | ||||||
Leasehold improvements | 5,635 | 5,635 | ||||||
Construction in progress | 5,865 | 3,460 | ||||||
23,776 | 19,801 | |||||||
Less: Accumulated depreciation and amortization | (8,622 | ) | (7,262 | ) | ||||
$ | 15,154 | $ | 12,539 | |||||
March 31, 2021 | December 2020 | |||||||
Laboratory equipment | $ | 17,403 | $ | 12,710 | ||||
Computer equipment | 933 | 922 | ||||||
Office equipment | 941 | 941 | ||||||
Leasehold improvements | 4,822 | 5,730 | ||||||
Construction in progress | 2,498 | 5,189 | ||||||
26,597 | 25,492 | |||||||
Less: Accumulated depreciation and amortization | (10,034 | ) | (10,120 | ) | ||||
$ | 16,563 | $ | 15,372 | |||||
June 30, 2020 | December 31, 2019 | |||||||
Accrued employee compensation and benefits | $ | 3,244 | $ | 3,547 | ||||
Accrued external research and development expenses | 2,820 | 1,763 | ||||||
Accrued consultant and professional fees | 2,165 | 1,390 | ||||||
Other | 2,897 | 372 | ||||||
$ | 11,126 | $ | 7,072 | |||||
March 31, 2021 | December 31, 2020 | |||||||
Accrued external research and development expenses | $ | 5,100 | $ | 2,805 | ||||
Accrued employee compensation and benefits | 3,425 | 5,600 | ||||||
Accrued consultant and professional fees | 1,969 | 1,489 | ||||||
Other | 5,746 | 3,308 | ||||||
$ | 16,240 | $ | 13,202 | |||||
Number of Shares | Weighted Average Exercise Price | Weighted Average Remaining Contractual Term | Intrinsic Value | |||||||||||||
(in years) | ||||||||||||||||
Outstanding as of December 31, 2019 | 8,646,378 | $ | 8.06 | 8.42 | $ | 3,687 | ||||||||||
Granted | 2,861,118 | $ | 8.98 | |||||||||||||
Exercised | (792,460 | ) | $ | 7.36 | ||||||||||||
Forfeited | (220,047 | ) | $ | 7.98 | ||||||||||||
Outstanding as of June 30, 2020 | 10,494,989 | $ | 8.37 | 8.21 | $ | 100,634 | ||||||||||
Exercisable as of June 30, 2020 | 4,422,596 | $ | 7.94 | 7.56 | $ | 44,150 | ||||||||||
Vested and expected to vest as of June 30, 2020 | 10,494,989 | $ | 8.37 | 8.21 | $ | 100,634 |
Number of Shares | Weighted Average Exercise Price | Weighted Average Remaining Contractual Term | Intrinsic Value | |||||||||||||
(in years) | ||||||||||||||||
Outstanding as of December 31, 2020 | 9,557,391 | $ | 8.79 | 7.92 | $ | 93,256 | ||||||||||
Granted | 2,324,110 | $ | 22.77 | |||||||||||||
Exercised | (188,047 | ) | $ | 8.24 | ||||||||||||
Forfeited | (41,941 | ) | $ | 14.88 | ||||||||||||
Outstanding as of March 31, 2021 | 11,651,513 | $ | 11.57 | 8.18 | $ | 73,830 | ||||||||||
Exercisable as of March 31, 2021 | 5,456,919 | $ | 7.84 | 7.21 | $ | 47,181 | ||||||||||
Vested and expected to vest as of March 31, 2021 | 11,651,513 | $ | 11.57 | 8.18 | $ | 73,830 |
Six Months Ended June 30, | ||||||||
2020 | 2019 | |||||||
Risk-free interest rate | 0.79 | % | 2.42 | % | ||||
Expected term (in years) | 6.1 | 6.0 | ||||||
Expected volatility | 68.6 | % | 73.3 | % | ||||
Expected dividend yield | 0 | % | 0 | % |
Three Months Ended March 31, | ||||||||
2021 | 2020 | |||||||
Risk-free interest rate | 1.01 | % | 0.86 | % | ||||
Expected term (in years) | 6.1 | 6.1 | ||||||
Expected volatility | 69.9 | % | 68.0 | % | ||||
Expected dividend yield | 0 | % | 0 | % |
Number of Shares | Weighted Average Grant-Date Fair Value | |||||||
Unvested restricted common stock outstanding as of December 31, 2019 | 34,168 | $ | 1.28 | |||||
Forfeited restricted common stock | — | $ | — | |||||
Vested restricted common stock | (32,477 | ) | $ | 1.28 | ||||
Unvested restricted common stock outstanding as of June 30, 2020 | 1,691 | $ | 1.28 | |||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Research and development expenses | $ | 4,091 | $ | 1,284 | $ | 5,545 | $ | 2,153 | ||||||||
General and administrative expenses | 1,923 | 2,265 | 3,641 | 3,356 | ||||||||||||
$ | 6,014 | $ | 3,549 | $ | 9,186 | $ | 5,509 | |||||||||
Three Months Ended March 31, | ||||||||
2021 | 2020 | |||||||
Research and development expenses | $ | 2,080 | $ | 1,454 | ||||
General and administrative expenses | 1,904 | 1,718 | ||||||
$ | 3,984 | $ | 3,172 | |||||
Three Months Ended | Six Months Ended | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Numerator: | ||||||||||||||||
Net loss | $ | (36,288 | ) | $ | (27,832 | ) | $ | (50,570 | ) | $ | (61,030 | ) | ||||
Denominator: | ||||||||||||||||
Weighted average common shares outstanding—basic and diluted | 62,282,291 | 48,749,627 | 61,145,254 | 46,866,842 | ||||||||||||
Net loss per share—basic and diluted | $ | (0.58 | ) | $ | (0.57 | ) | $ | (0.83 | ) | $ | (1.30 | ) | ||||
Three Months Ended March 31, | ||||||||
2021 | 2020 | |||||||
Basic net income (loss) per common share: | ||||||||
Numerator: | ||||||||
Net income (loss) | $ | 26,522 | $ | (14,282 | ) | |||
Denominator: | ||||||||
Weighted average common shares outstanding—basic | 75,189,696 | 60,008,217 | ||||||
Net income (loss) per share—basic | $ | 0.35 | $ | (0.24 | ) | |||
Diluted net income (loss) per common share: | ||||||||
Numerator: | ||||||||
Net income (loss) | $ | 26,522 | $ | (14,282 | ) | |||
Denominator: | ||||||||
Weighted average common shares outstanding—diluted | 79,101,624 | 60,008,217 | ||||||
Net income (loss) per share—diluted | $ | 0.34 | $ | (0.24 | ) |
June 30, | ||||||||
2020 | 2019 | |||||||
Options to purchase common stock | 10,494,989 | 8,548,660 | ||||||
Unvested restricted common stock | 1,691 | 119,988 | ||||||
10,496,680 | 8,668,648 | |||||||
Three Months Ended March 31, | ||||||||
2021 | 2020 | |||||||
Options to purchase common stock | 3,053,207 | 10,983,227 | ||||||
Unvested restricted common stock | 0 | 6,763 | ||||||
3,053,207 | 10,989,990 | |||||||
Three Months Ended March 31, | ||||||||
2021 | 2020 | |||||||
Lease cost | ||||||||
Operating lease cost | $ | 4,772 | $ | 673 | ||||
Total lease cost | $ | 4,772 | $ | 673 | ||||
Other information | ||||||||
Operating cash flows from operating leases | $ | 4,968 | $ | 650 | ||||
Operating lease liabilities arising from obtaining right-of-use | 1,246 | — | ||||||
Weighted-average remaining lease term | 5 years | 8 years | ||||||
Weighted-average discount rate | 11.9 | % | 17.5 | % |
March 31, 2021 | December 31, 2020 | |||||||
2021 | $ | 14,421 | $ | 18,067 | ||||
2022 | 15,178 | 15,178 | ||||||
2023 | 15,591 | 15,591 | ||||||
2024 | 16,050 | 16,050 | ||||||
2025 | 12,030 | 12,029 | ||||||
2026 and thereafter | 7,134 | 7,134 | ||||||
Total future minimum lease payments | 80,404 | 84,049 | ||||||
Less: imputed interest | (19,716 | ) | (21,363 | ) | ||||
Present value of lease liabilities | $ | 60,688 | $ | 62,686 | ||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
(in thousands) | ||||||||||||||||
Vaccine program | $ | 9,387 | $ | 288 | $ | 11,976 | $ | 545 | ||||||||
MRT5005 program | 3,350 | 5,263 | 9,444 | 11,884 | ||||||||||||
Discovery program | 2,033 | 1,500 | 5,807 | 3,543 | ||||||||||||
MRT5201 program | — | 2,217 | — | 4,087 | ||||||||||||
Oligonucleotide program | — | 62 | — | 95 | ||||||||||||
Unallocated research and development expenses | 14,232 | 7,295 | 23,215 | 13,894 | ||||||||||||
Total research and development expenses | $ | 29,002 | $ | 16,625 | $ | 50,442 | $ | 34,048 | ||||||||
Three Months Ended March 31, | ||||||||
2021 | 2020 | |||||||
(in thousands) | ||||||||
Discovery program | $ | 8,616 | $ | 3,775 | ||||
Vaccine program | 7,570 | 2,589 | ||||||
MRT5005 program | 6,214 | 6,094 | ||||||
Unallocated research and development expenses | 18,740 | 8,981 | ||||||
Total research and development expenses | $ | 41,140 | $ | 21,439 | ||||
Three Months Ended June 30, | ||||||||||||
2020 | 2019 | Change | ||||||||||
(in thousands) | ||||||||||||
Collaboration revenue | $ | 16,319 | $ | 1,174 | $ | 15,145 | ||||||
Operating expenses: | ||||||||||||
Research and development | 29,002 | 16,625 | 12,377 | |||||||||
General and administrative | 8,601 | 7,850 | 751 | |||||||||
Change in fair value of contingent consideration | 15,347 | 4,889 | 10,458 | |||||||||
Total operating expenses | 52,950 | 29,364 | 23,586 | |||||||||
Loss from operations | (36,631 | ) | (28,190 | ) | (8,441 | ) | ||||||
Interest income | 343 | 358 | (15 | ) | ||||||||
Loss before benefit from income taxes | (36,288 | ) | (27,832 | ) | (8,456 | ) | ||||||
Benefit from income taxes | — | — | — | |||||||||
Net loss | $ | (36,288 | ) | $ | (27,832 | ) | $ | (8,456 | ) | |||
Three Months Ended March 31, | ||||||||||||
2021 | 2020 | Change | ||||||||||
(in thousands) | ||||||||||||
Collaboration revenue | $ | 34,600 | $ | 4,654 | $ | 29,946 | ||||||
Operating expenses: | ||||||||||||
Research and development | 41,140 | 21,439 | 19,701 | |||||||||
General and administrative | 10,817 | 7,458 | 3,359 | |||||||||
Change in fair value of contingent consideration | (43,979 | ) | (9,452 | ) | (34,527 | ) | ||||||
Total operating expenses | 7,978 | 19,445 | (11,467 | ) | ||||||||
Income (loss) from operations | 26,622 | (14,791 | ) | 41,413 | ||||||||
Other income, net | 154 | 509 | (355 | ) | ||||||||
Income (loss) before income tax provision | 26,776 | (14,282 | ) | 41,058 | ||||||||
Income tax provision | (254 | ) | — | (254 | ) | |||||||
Net income (loss) | $ | 26,522 | $ | (14,282 | ) | $ | 40,804 | |||||
Three Months Ended June 30, | ||||||||||||
2020 | 2019 | Change | ||||||||||
(in thousands) | ||||||||||||
Direct external research and development expenses by program: | ||||||||||||
Vaccine program | $ | 9,387 | $ | 288 | $ | 9,099 | ||||||
MRT5005 program | 3,350 | 5,263 | (1,913 | ) | ||||||||
Discovery program | 2,033 | 1,500 | 533 | |||||||||
MRT5201 program | — | 2,217 | (2,217 | ) | ||||||||
Oligonucleotide program | — | 62 | (62 | ) | ||||||||
Unallocated research and development expenses: | ||||||||||||
Personnel related (including stock-based compensation) | 8,791 | 4,701 | 4,090 | |||||||||
Other | 5,441 | 2,594 | 2,847 | |||||||||
Total research and development expenses | $ | 29,002 | $ | 16,625 | $ | 12,377 | ||||||
Three Months Ended March 31, | ||||||||||||
2021 | 2020 | Change | ||||||||||
(in thousands) | ||||||||||||
Direct external research and development expenses by program: | ||||||||||||
Discovery program | $ | 8,616 | $ | 3,775 | $ | 4,841 | ||||||
Vaccine program | 7,570 | 2,589 | 4,981 | |||||||||
MRT5005 program | 6,214 | 6,094 | 120 | |||||||||
Unallocated research and development expenses: | ||||||||||||
Personnel related (including stock-based compensation) | 8,757 | 5,985 | 2,772 | |||||||||
Other | 9,983 | 2,996 | 6,987 | |||||||||
Total research and development expenses | $ | 41,140 | $ | 21,439 | $ | 19,701 | ||||||
Six Months Ended June 30, | ||||||||||||
2020 | 2019 | Change | ||||||||||
(in thousands) | ||||||||||||
Collaboration revenue | $ | 20,974 | $ | 2,648 | $ | 18,326 | ||||||
Operating expenses: | ||||||||||||
Research and development | 50,442 | 34,048 | 16,394 | |||||||||
General and administrative | 16,060 | 14,403 | 1,657 | |||||||||
Change in fair value of contingent consideration | 5,895 | 16,591 | (10,696 | ) | ||||||||
Total operating expenses | 72,397 | 65,042 | 7,355 | |||||||||
Loss from operations | (51,423 | ) | (62,394 | ) | 10,971 | |||||||
Interest income | 853 | 878 | (25 | ) | ||||||||
Loss before benefit from income taxes | (50,570 | ) | (61,516 | ) | 10,946 | |||||||
Benefit from income taxes | — | 486 | (486 | ) | ||||||||
Net loss | $ | (50,570 | ) | $ | (61,030 | ) | $ | 10,460 | ||||
Six Months Ended June 30, | ||||||||||||
2020 | 2019 | Change | ||||||||||
(in thousands) | ||||||||||||
Direct external research and development expenses by program: | ||||||||||||
Vaccine program | $ | 11,976 | $ | 545 | $ | 11,431 | ||||||
MRT5005 program | 9,444 | 11,884 | (2,440 | ) | ||||||||
Discovery program | 5,807 | 3,543 | 2,264 | |||||||||
MRT5201 program | — | 4,087 | (4,087 | ) | ||||||||
Oligonucleotide program | — | 95 | (95 | ) | ||||||||
Unallocated research and development expenses: | ||||||||||||
Personnel related (including stock-based compensation) | 14,777 | 8,986 | 5,791 | |||||||||
Other | 8,438 | 4,908 | 3,530 | |||||||||
Total research and development expenses | $ | 50,442 | $ | 34,048 | $ | 16,394 | ||||||
Six Months Ended June 30, | ||||||||
2020 | 2019 | |||||||
(in thousands) | ||||||||
Net cash used in operating activities | $ | (51,489 | ) | $ | (41,445 | ) | ||
Net cash provided by investing activities | 79,422 | 15,525 | ||||||
Net cash provided by financing activities | 159,680 | 45,550 | ||||||
Net increase in cash, cash equivalents and restricted cash | $ | 187,613 | $ | 19,630 | ||||
Three Months Ended March 31, | ||||||||
2021 | 2020 | |||||||
(in thousands) | ||||||||
Net cash provided by (used in) operating activities | $ | 689 | $ | (31,447 | ) | |||
Net cash provided by (used in) investing activities | (188,520 | ) | 44,260 | |||||
Net cash provided by financing activities | 1,550 | 75 | ||||||
Net increase (decrease) in cash, cash equivalents and restricted cash | $ | (186,281 | ) | $ | 12,888 | |||
* | Filed herewith. |
** | Furnished herewith. |
+ |
† | Submitted electronically herewith. |
Translate Bio, Inc. | ||||||
Date: | By: | /s/ Ronald C. Renaud, Jr. | ||||
Ronald C. Renaud, Jr. | ||||||
Date: | By: | /s/ | ||||
Chief Financial Officer and Treasurer |