Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 09, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2022 | |
Document Transition Report | false | |
Entity File Number | 001-38558 | |
Entity Registrant Name | TRICIDA, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 46-3372526 | |
Entity Address, Address Line One | 7000 Shoreline Court | |
Entity Address, Address Line Two | Suite 201 | |
Entity Address, City or Town | South San Francisco | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94080 | |
City Area Code | 415 | |
Local Phone Number | 429-7800 | |
Title of 12(b) Security | Common stock, par value $0.001 per share | |
Trading Symbol | TCDA | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 58,028,254 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Entity Central Index Key | 0001595585 | |
Current Fiscal Year End Date | --12-31 |
CONDENSED BALANCE SHEETS
CONDENSED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 17,744 | $ 21,113 |
Short-term investments | 62,475 | 119,419 |
Prepaid expenses and other current assets | 2,265 | 5,004 |
Total current assets | 82,484 | 145,536 |
Long-term investments | 0 | 10,043 |
Property and equipment, net | 541 | 769 |
Operating lease right-of-use assets | 10,854 | 12,158 |
Total assets | 93,879 | 168,506 |
Current liabilities: | ||
Accounts payable | 4,395 | 10,023 |
Current operating lease liabilities | 2,797 | 2,736 |
Accrued expenses and other current liabilities | 9,735 | 16,721 |
Total current liabilities | 16,927 | 29,480 |
Convertible Senior Notes, net | 195,347 | 127,512 |
Non-current operating lease liabilities | 9,851 | 11,296 |
Other long-term liabilities | 7,852 | 0 |
Total liabilities | 229,977 | 168,288 |
Commitments and contingencies | ||
Stockholders’ equity (deficit): | ||
Preferred stock, $0.001 par value; 40,000,000 shares authorized, no shares issued or outstanding as of September 30, 2022 and December 31, 2021. | 0 | 0 |
Common stock, $0.001 par value; 400,000,000 shares authorized as of September 30, 2022 and December 31, 2021; 55,694,651 and 55,363,461 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively. | 56 | 55 |
Additional paid-in capital | 746,234 | 810,618 |
Accumulated other comprehensive income (loss) | (428) | (91) |
Accumulated deficit | (881,960) | (810,364) |
Total stockholders’ equity (deficit) | (136,098) | 218 |
Total liabilities and stockholders’ equity (deficit) | $ 93,879 | $ 168,506 |
CONDENSED BALANCE SHEETS (Paren
CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in USD per share) | $ 0.001 | $ 0.001 |
Preferred stock, authorized (in shares) | 40,000,000 | 40,000,000 |
Preferred stock, outstanding (in shares) | 0 | 0 |
Preferred stock, issued, (in shares) | 0 | 0 |
Common stock, par value (in USD per share) | $ 0.001 | $ 0.001 |
Common stock, authorized (in shares) | 400,000,000 | 400,000,000 |
Common stock, issued (in shares) | 55,694,651 | 55,363,461 |
Common stock, outstanding (in shares) | 55,694,651 | 55,363,461 |
CONDENSED STATEMENTS OF OPERATI
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Operating expenses: | ||||
Research and development | $ 19,935 | $ 26,635 | $ 55,298 | $ 78,591 |
General and administrative | 4,125 | 9,052 | 23,119 | 28,497 |
Total operating expenses | 24,060 | 35,687 | 78,417 | 107,088 |
Loss from operations | (24,060) | (35,687) | (78,417) | (107,088) |
Other income (expense), net | 277 | 6 | 408 | 155 |
Interest expense | (1,978) | (3,994) | (5,927) | (13,533) |
Loss on early extinguishment of 2018 Term Loan | 0 | 0 | 0 | (6,124) |
Net loss | (25,761) | (39,675) | (83,936) | (126,590) |
Other comprehensive income (loss): | ||||
Net unrealized gain (loss) on available-for-sale investments, net of tax | 47 | (15) | (337) | (141) |
Total comprehensive loss | $ (25,714) | $ (39,690) | $ (84,273) | $ (126,731) |
Net loss per share, basic (in dollars per share) | $ (0.44) | $ (0.79) | $ (1.45) | $ (2.52) |
Net loss per share, diluted (in dollars per share) | $ (0.44) | $ (0.79) | $ (1.45) | $ (2.52) |
Weighted-average number of shares outstanding, basic (in shares) | 58,015,939 | 50,434,879 | 57,854,606 | 50,326,474 |
Weighted-average number of shares outstanding, diluted (in shares) | 58,015,939 | 50,434,879 | 57,854,606 | 50,326,474 |
CONDENSED STATEMENTS OF STOCKHO
CONDENSED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) $ in Thousands | Total | Cumulative Effect, Period of Adoption, Adjustment | Common Stock | Additional Paid-in Capital | Additional Paid-in Capital Cumulative Effect, Period of Adoption, Adjustment | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | Accumulated Deficit Cumulative Effect, Period of Adoption, Adjustment |
Beginning balance (in shares) at Dec. 31, 2020 | 50,210,779 | |||||||
Beginning balance at Dec. 31, 2020 | $ 108,871 | $ 50 | $ 742,555 | $ 64 | $ (633,798) | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of common stock under equity incentive plans (in shares) | 61,946 | |||||||
Issuance of common stock under equity incentive plans | 115 | 115 | ||||||
Stock-based compensation | 6,042 | 6,042 | ||||||
Net unrealized gain (loss) on available-for-sale investments, net of tax | (105) | (105) | ||||||
Net loss | (53,362) | (53,362) | ||||||
Ending balance (in shares) at Mar. 31, 2021 | 50,272,725 | |||||||
Ending balance at Mar. 31, 2021 | 61,561 | $ 50 | 748,712 | (41) | (687,160) | |||
Beginning balance (in shares) at Dec. 31, 2020 | 50,210,779 | |||||||
Beginning balance at Dec. 31, 2020 | 108,871 | $ 50 | 742,555 | 64 | (633,798) | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Net unrealized gain (loss) on available-for-sale investments, net of tax | (141) | |||||||
Net loss | (126,590) | |||||||
Ending balance (in shares) at Sep. 30, 2021 | 50,447,578 | |||||||
Ending balance at Sep. 30, 2021 | 1,902 | $ 50 | 762,317 | (77) | (760,388) | |||
Beginning balance (in shares) at Mar. 31, 2021 | 50,272,725 | |||||||
Beginning balance at Mar. 31, 2021 | 61,561 | $ 50 | 748,712 | (41) | (687,160) | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of common stock under equity incentive plans (in shares) | 156,009 | |||||||
Issuance of common stock under equity incentive plans | 333 | 333 | ||||||
Stock-based compensation | 6,609 | 6,609 | ||||||
Net unrealized gain (loss) on available-for-sale investments, net of tax | (21) | (21) | ||||||
Net loss | (33,553) | (33,553) | ||||||
Ending balance (in shares) at Jun. 30, 2021 | 50,428,734 | |||||||
Ending balance at Jun. 30, 2021 | 34,929 | $ 50 | 755,654 | (62) | (720,713) | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of common stock under equity incentive plans (in shares) | 18,844 | |||||||
Issuance of common stock under equity incentive plans | 14 | 14 | ||||||
Stock-based compensation | 6,649 | 6,649 | ||||||
Net unrealized gain (loss) on available-for-sale investments, net of tax | (15) | (15) | ||||||
Net loss | (39,675) | (39,675) | ||||||
Ending balance (in shares) at Sep. 30, 2021 | 50,447,578 | |||||||
Ending balance at Sep. 30, 2021 | $ 1,902 | $ 50 | 762,317 | (77) | (760,388) | |||
Beginning balance (in shares) at Dec. 31, 2021 | 55,363,461 | 55,363,461 | ||||||
Beginning balance at Dec. 31, 2021 | $ 218 | $ (67,158) | $ 55 | 810,618 | $ (79,498) | (91) | (810,364) | $ 12,340 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Accounting Standards Update [Extensible List] | Accounting Standards Update 2020-06 [Member] | |||||||
Issuance of common stock under equity incentive plans (in shares) | 33,697 | |||||||
Issuance of common stock under equity incentive plans | $ 41 | 41 | ||||||
Stock-based compensation | 6,524 | 6,524 | ||||||
Net unrealized gain (loss) on available-for-sale investments, net of tax | (286) | (286) | ||||||
Net loss | (29,639) | (29,639) | ||||||
Ending balance (in shares) at Mar. 31, 2022 | 55,397,158 | |||||||
Ending balance at Mar. 31, 2022 | $ (90,300) | $ 55 | 737,685 | (377) | (827,663) | |||
Beginning balance (in shares) at Dec. 31, 2021 | 55,363,461 | 55,363,461 | ||||||
Beginning balance at Dec. 31, 2021 | $ 218 | $ (67,158) | $ 55 | 810,618 | $ (79,498) | (91) | (810,364) | $ 12,340 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Net unrealized gain (loss) on available-for-sale investments, net of tax | (337) | |||||||
Net loss | $ (83,936) | |||||||
Ending balance (in shares) at Sep. 30, 2022 | 55,694,651 | 55,694,651 | ||||||
Ending balance at Sep. 30, 2022 | $ (136,098) | $ 56 | 746,234 | (428) | (881,960) | |||
Beginning balance (in shares) at Mar. 31, 2022 | 55,397,158 | |||||||
Beginning balance at Mar. 31, 2022 | (90,300) | $ 55 | 737,685 | (377) | (827,663) | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of common stock under equity incentive plans (in shares) | 264,185 | |||||||
Issuance of common stock under equity incentive plans | 639 | $ 1 | 638 | |||||
Stock-based compensation | 7,071 | 7,071 | ||||||
Net unrealized gain (loss) on available-for-sale investments, net of tax | (98) | (98) | ||||||
Net loss | (28,536) | (28,536) | ||||||
Ending balance (in shares) at Jun. 30, 2022 | 55,661,343 | |||||||
Ending balance at Jun. 30, 2022 | (111,224) | $ 56 | 745,394 | (475) | (856,199) | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of common stock under equity incentive plans (in shares) | 33,308 | |||||||
Issuance of common stock under equity incentive plans | 53 | 53 | ||||||
Stock-based compensation | 787 | 787 | ||||||
Net unrealized gain (loss) on available-for-sale investments, net of tax | 47 | 47 | ||||||
Net loss | $ (25,761) | (25,761) | ||||||
Ending balance (in shares) at Sep. 30, 2022 | 55,694,651 | 55,694,651 | ||||||
Ending balance at Sep. 30, 2022 | $ (136,098) | $ 56 | $ 746,234 | $ (428) | $ (881,960) |
CONDENSED STATEMENTS OF CASH FL
CONDENSED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Operating activities: | ||
Net loss | $ (83,936) | $ (126,590) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 231 | 351 |
Non-cash operating lease costs | (80) | 574 |
Amortization of premiums and accretion of discounts on investments, net | (211) | 440 |
Accretion of Convertible Senior Notes and 2018 Term Loan | 677 | 7,047 |
Loss on early extinguishment of 2018 Term Loan | 0 | 6,124 |
Stock-based compensation | 14,382 | 19,300 |
Changes in compound derivative liability | 0 | (202) |
Other non-cash items | 0 | (29) |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | 2,739 | 105 |
Accounts payable | (5,628) | (245) |
Accrued expenses and other liabilities | 1,095 | (8,871) |
Net cash used in operating activities | (70,731) | (101,996) |
Investing activities: | ||
Purchases of investments | (75,637) | (136,345) |
Proceeds from maturities of investments | 142,500 | 200,409 |
Purchases of property and equipment | (3) | (76) |
Net cash provided by investing activities | 66,860 | 63,988 |
Financing activities: | ||
Payments of equity offering costs | (33) | 0 |
Proceeds from issuance of common stock under equity incentive plans | 733 | 462 |
Payments for taxes related to net share settlement of equity awards | (198) | 0 |
Repayment of leasehold improvement loan | 0 | (38) |
Cash paid for early extinguishment of 2018 Term Loan | 0 | (83,285) |
Net cash provided by (used in) financing activities | 502 | (82,861) |
Net decrease in cash and cash equivalents | (3,369) | (120,869) |
Cash and cash equivalents at beginning of period | 21,113 | 137,857 |
Cash and cash equivalents at end of period | 17,744 | 16,988 |
Supplemental disclosures | ||
Cash paid for interest | $ 3,500 | $ 5,274 |
ORGANIZATION AND BASIS OF PRESE
ORGANIZATION AND BASIS OF PRESENTATION | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
ORGANIZATION AND BASIS OF PRESENTATION | ORGANIZATION AND BASIS OF PRESENTATION Organization —Tricida, Inc., or the Company, was incorporated in the state of Delaware on May 22, 2013. The Company is focused on its investigational drug candidate, veverimer (also known as TRC101), a non-absorbed, orally-administered polymer designed to slow chronic kidney disease, or CKD, progression through the treatment of metabolic acidosis in patients with metabolic acidosis and CKD. Funding Requirements —The Company has sustained operating losses since inception. Until recently, the Company’s primary strategic and operational focus was on completion of the VALOR-CKD renal outcomes clinical trial (also known as TRCA-303), which was designed to evaluate veverimer’s ability to slow CKD progression in patients with metabolic acidosis and chronic kidney disease. On October 24, 2022, the Company announced that the VALOR-CKD trial did not meet its primary endpoint, which was defined as the time to the first occurrence of any event in the composite endpoint of renal death, end-stage renal disease, or ESRD, or a confirmed greater than or equal to 40% reduction in estimated glomerular filtration rate, or eGFR, also known as DD40. The outcome of the VALOR-CKD trial has severely harmed the Company’s business, financial condition and prospects as a going concern and has also limited the Company’s access to funds. Through September 30, 2022, the Company has relied primarily on the proceeds from equity offerings and debt financing to finance its operations. The Company has incurred losses and negative cash flows from operations since its inception in 2013 and management anticipates that the Company will continue to incur net losses for the foreseeable future. As of September 30, 2022, the Company had an accumulated deficit of $882.0 million. The Company's existing cash, cash equivalents and investments are not likely to be sufficient to fund the Company's operations through the second quarter of 2023. The Company may be unable to continue operations, particularly with the recently completed reduction in force and in view of the Company's limited access to funds. The Company is considering possible strategic alternatives, including a sale of the Company or its assets, a merger, reverse merger, wind-down, liquidation and dissolution or other strategic transaction. Management recognizes that the Company may need to raise additional capital to continue operations. These conditions raise substantial doubt about the Company’s ability to continue as a going concern for a period of one year from the date of the issuance of these condensed financial statements. The accompanying unaudited condensed financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The unaudited condensed financial statements do not reflect any adjustments relating to the recoverability and reclassifications of assets and liabilities that might be necessary if the Company is unable to continue as a going concern. Basis of Presentation —The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States, or U.S. GAAP, for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. The condensed financial statements as of and for the three and nine months ended September 30, 2022 and 2021 are unaudited, but include all adjustments, consisting only of normal recurring adjustments, which the Company considers necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The condensed balance sheet as of December 31, 2021, has been derived from audited financial statements. Results for any interim period are not necessarily indicative of results for any future interim period or for the entire year. Certain information and footnote information normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission. The accompanying condensed financial statements should be read in conjunction with the financial statements and notes thereto included in the Company's Annual Report on Form 10-K for the year ended December 31, 2021. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES There have been no material changes to the significant accounting policies discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, other than the adoption of ASU No. 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40), or ASU 2020-06, as described below. Recent Accounting Pronouncements Adopted Standards In August 2020, the FASB issued ASU 2020-06. ASU 2020-06 simplifies the accounting for convertible debt instruments and convertible preferred stock by removing the existing guidance in Accounting Standards Codification, or ASC, 470-20, Debt – Debt with Conversion and Other Options , or ASC 470-20, that requires entities to account for beneficial conversion features and cash conversion features in equity, separately from the host convertible debt or preferred stock. In addition, the amendments revise the scope exception from derivative accounting in ASC 815-40, Derivatives and Hedging – Contracts in Entity’s Own Equity, for freestanding financial instruments and embedded features that are both indexed to the issuer’s own stock and classified in stockholders’ equity, by removing certain criteria required for equity classification. These amendments are expected to result in more freestanding financial instruments qualifying for equity classification (and, therefore, not accounted for as derivatives), as well as fewer embedded features requiring separate accounting from the host contract. The Company adopted ASU 2020-06 effective January 1, 2022, using the modified retrospective method. On adoption, the Company accounted for the Convertible Senior Notes as a single liability measured at amortized cost resulting in reduced prospective non-cash interest expense due to the de-recognition of the remaining debt discount associated with the equity component. The cumulative impact of the adoption of ASU 2020-06 reflected on the Company's condensed balance sheet as of January 1, 2022, is as follows. in thousands Balance at December 31, 2021 Cumulative Impact of ASU 2020-06 Adoption Balance at January 1, 2022 Liabilities Convertible Senior Notes, net $ 127,512 $ 67,158 $ 194,670 Stockholder's Equity Additional paid-in capital 810,618 (79,498) 731,120 Accumulated deficit (810,364) 12,340 (798,024) Under the modified retrospective method, financial information and disclosures for periods before January 1, 2022, will continue to be presented in accordance with ASC 470-20. The adoption did not impact previously reported amounts in our condensed statements of operations and comprehensive loss and cash flows and our basic and diluted net loss per share amounts. |
FAIR VALUE MEASUREMENTS AND FAI
FAIR VALUE MEASUREMENTS AND FAIR VALUE OF FINANCIAL INSTRUMENTS | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENTS AND FAIR VALUE OF FINANCIAL INSTRUMENTS | FAIR VALUE MEASUREMENTS AND FAIR VALUE OF FINANCIAL INSTRUMENTS The fair value of the Company’s financial assets and liabilities are determined in accordance with the fair value hierarchy established in the FASB's ASC Topic 820, Fair Value Measurements and Disclosures, or Topic 820. Topic 820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The fair value hierarchy of Topic 820 requires an entity to maximize the use of observable inputs when measuring fair value and classifies those inputs into three levels: Level 1 —Observable inputs, such as quoted prices in active markets; Level 2 —Inputs, other than the quoted prices in active markets, which are observable either directly or indirectly such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the instrument’s anticipated life; and Level 3 —Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. Our financial instruments consist primarily of cash and cash equivalents, short-term and long-term investments, accounts payable and the Convertible Senior Notes. Cash, cash equivalents and investments are reported at their respective fair values on the Company's condensed balance sheets. Where quoted prices are available in an active market, securities are classified as Level 1. The Company classifies money market funds and U.S. Treasury securities as Level 1. When quoted market prices are not available for a specific security, then the Company estimates fair value by using quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant inputs are observable in the market or can be corroborated by observable market data for substantially the full term of the assets. Where applicable, these models incorporate expected future cash flows and discount the future amounts to a present value using market-based observable inputs obtained from various third-party data providers, including but not limited to benchmark yields, reported trades and broker/dealer quotes. Where applicable the market approach utilizes prices and information from market transactions for similar or identical assets. The Company classifies U.S. government agency securities, commercial paper and corporate debt securities as Level 2. The Company's short-term and long-term investments are classified as available-for-sale. The following tables set forth the value of the Company's financial assets remeasured on a recurring basis based on the three-tier fair value hierarchy by significant investment category as of September 30, 2022 and December 31, 2021. September 30, 2022 Reported as: (in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Cash and Cash Equivalents Short-Term Investments Long-Term Investments Cash $ 1,444 $ — $ — $ 1,444 $ 1,444 $ — $ — Level 1: Money market funds 12,071 — — 12,071 12,071 — — U.S. Treasury securities 13,009 — (112) 12,897 — 12,897 — Subtotal 25,080 — (112) 24,968 12,071 12,897 — Level 2: U.S. government agency securities 5,000 — (66) 4,934 — 4,934 — Commercial paper 47,023 — (137) 46,886 4,229 42,657 — Corporate debt securities 2,009 — (22) 1,987 — 1,987 — Subtotal 54,032 — (225) 53,807 4,229 49,578 — Total assets measured at fair value $ 80,556 $ — $ (337) $ 80,219 $ 17,744 $ 62,475 $ — December 31, 2021 Reported as: (in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Cash and Cash Equivalents Short-Term Investments Long-Term Investments Cash $ 2,965 $ — $ — $ 2,965 $ 2,965 $ — $ — Level 1: Money market funds 18,148 — — 18,148 18,148 — — U.S. Treasury securities 8,028 — (11) 8,017 — — 8,017 Subtotal 26,176 — (11) 26,165 18,148 — 8,017 Level 2: U.S. government agency securities 10,000 — — 10,000 — 10,000 — Commercial paper 107,397 20 (4) 107,413 — 107,413 — Corporate debt securities 4,036 — (4) 4,032 — 2,006 2,026 Subtotal 121,433 20 (8) 121,445 — 119,419 2,026 Total assets measured at fair value $ 150,574 $ 20 $ (19) $ 150,575 $ 21,113 $ 119,419 $ 10,043 The following table presents a reconciliation of financial liabilities related to the compound derivative liability associated with the Loan and Security Agreement, or 2018 Term Loan, with Hercules Capital Inc., or Hercules, measured at fair value on a recurring basis using Level 3 unobservable inputs for the nine months ended September 30, 2021. The key valuation assumptions used were the discount rate and the probability of the occurrence of certain events. In conjunction with early extinguishment of the 2018 Term Loan on March 12, 2021, the Company extinguished the compound derivative liability associated with the 2018 Term Loan. Nine Months Ended (in thousands) 2021 Fair value at beginning of period $ 202 Extinguishment of compound derivative liability upon extinguishment of 2018 Term Loan (202) Fair value at end of period $ — The estimated fair value of the Convertible Senior Notes was $105.2 million as of September 30, 2022 measured using Level 3 inputs. The key valuation assumptions used consist of the discount rate of 27.8% and volatility of 110.0%. |
BORROWINGS
BORROWINGS | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [Abstract] | |
BORROWINGS | BORROWINGS On May 22, 2020, the Company issued $200.0 million aggregate principal amount of 3.5% convertible senior notes due 2027, or the Convertible Senior Notes. The Convertible Senior Notes are convertible into cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock at the Company’s election at an initial conversion rate of 30.0978 shares of the Company’s common stock per $1,000 principal amount of the Convertible Senior Notes, which is equivalent to an initial conversion price of approximately $33.23 per share of the Company’s common stock. The conversion rate is subject to customary adjustments for certain events as described in the Indenture. As of September 30, 2022, the “if-converted value” did not exceed the remaining principal amount of the Convertible Senior Notes. At issuance, the Convertible Senior Notes were bifurcated into liability and equity components and accounted for separately. The carrying amount of the liability component was calculated to be $117.7 million by measuring the fair value of similar debt instruments that did not have an associated convertible feature. The carrying amount of the equity component, representing the conversion option, was determined by deducting the fair value of the liability component from the par value of the Convertible Senior Notes. The carrying amount of the equity component was calculated to be $82.3 million and was recorded in additional paid-in capital. The allocation of proceeds into the equity component resulted in a debt discount for the Convertible Senior Notes that was amortized to interest expense at an effective interest rate of 13.5% through December 31, 2021, over the effective life of the Convertible Senior Notes of 7.0 years, using the effective interest method. As discussed in Note 2. "Summary of Significant Accounting Policies", effective January 1, 2022, the Company adopted ASU 2020-06 using the modified retrospective method and, as a result, accounted for the Convertible Senior Notes as a single liability measured at amortized cost. The following table presents the Convertible Senior Notes' outstanding balances as of September 30, 2022 and December 31, 2021. (in thousands) September 30, December 31, Liability component: Principal $ 200,000 $ 200,000 Unamortized discount - equity component — (68,926) Unamortized underwriter discounts and issuance costs (4,653) (3,562) Net carrying amount $ 195,347 $ 127,512 Equity component, net of underwriter discounts and issuance costs $ — $ 79,498 The remaining unamortized debt discount is being amortized to interest expense at an effective interest rate of 4.1% over the remaining life of the Senior Convertible Notes. The following table presents the interest expense related to the Convertible Senior Notes for the three and nine months ended September 30, 2022 and 2021. Three Months Ended Nine Months Ended (in thousands) 2022 2021 2022 2021 Contractual interest expense $ 1,750 $ 1,750 $ 5,250 $ 5,250 Amortization of debt discount — 2,175 — 6,334 Amortization of underwriter discounts and issuance costs 228 69 677 192 Total interest expense $ 1,978 $ 3,994 $ 5,927 $ 11,776 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIES On October 4, 2019, the Company and Patheon Austria GmbH & Co KG, or Patheon, entered into a multi-year Manufacturing and Commercial Supply Agreement as amended by Amendment No. 1 dated March 30, 2021, Amendment No. 2 dated August 26, 2021, Amendment No. 3 dated July 1, 2022 and Amendment No. 4 dated September 15, 2022, or Amendment No. 4, collectively the Supply Agreement, under which Patheon agreed to manufacture and supply veverimer to support the Company's commercialization efforts. Under the Supply Agreement, the Company is obligated to make certain purchases of API. The Company and Patheon are also parties to a Master Development/Validation Services and Clinical/Launch Supply Agreement, or the MDA, pursuant to which Patheon agreed to manufacture and supply veverimer. Certain manufacturing activities previously governed by the MDA are now subject to the Supply Agreement, whereas other ongoing manufacturing activities under the MDA will continue to be governed by the MDA until such activities are complete. The Supply Agreement may be terminated by either party following an uncured material breach by the other party, in the event the other party becomes insolvent or subject to bankruptcy proceedings, or in connection with a force majeure event that continues beyond 12 months. The Company’s obligation to purchase veverimer is subject to minimum and maximum annual commitments, with the minimum commitments subject to modest reduction in certain circumstances. Patheon has made facility improvements under the Supply Agreement and is the exclusive owner of the purchased equipment and facility improvements. Patheon may manufacture other products with the facility improvements when not occupied by manufacturing veverimer. Under the Supply Agreement, the Company has agreed to reimburse Patheon up to a specified amount for plant modifications. These payments were recorded in research and development expense. The Company has contractual obligations from its manufacturing service contracts as of September 30, 2022. The purchase obligations are comprised of non-cancelable purchase commitments under the Supply Agreement with Patheon. These amounts are based on forecasts that included estimates of future market demand, quantity discounts and manufacturing efficiencies. In addition, purchase commitments under the Supply Agreement are denominated in Euro and therefore subject to changes in foreign exchange rates. For the three months ended September 30, 2022, the Company recognized foreign currency remeasurement gains of $0.5 million, classified as research and development expense in the condensed statements of operations and comprehensive loss. The amounts disclosed below are applicable under the terms of Amendment No. 4; however, actual costs may differ if the Patheon contract is modified and/or terminated. (in thousands) Total 2022 2023 - 2024 2025 - 2026 Thereafter Manufacturing and service contracts 1 $ 470,696 $ 10,364 $ 97,393 $ 96,784 $ 266,155 1 Excludes $7.9 million recorded as other long-term liabilities in the condensed balance sheet as of September 30, 2022. Contingencies On January 6, 2021, a putative securities class action was filed in the U.S. District Court for the Northern District of California against the Company and its CEO and CFO, Pardi v. Tricida, Inc., et al., 21-cv-00076 (the "Securities Class Action"). In April 2021, the court appointed Jeffrey Fiore as lead plaintiff and Block & Leviton LLP as lead plaintiffs’ counsel. In June 2021, the lead plaintiff filed an amended complaint which alleges that during the period between June 28, 2018 through February 25, 2021, the Company and its senior officers violated federal securities laws, including under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder, through alleged public misrepresentations and/or omissions of material facts concerning the Company's New Drug Application, or NDA, for veverimer and the likelihood and timing of approval of veverimer by the U.S. Food and Drug Administration, or FDA. The amended complaint makes claims against the Company and its CEO. In July 2021, the defendants filed a motion to dismiss the amended complaint. On July 29, 2022, the court issued an order granting in part and denying in part the defendants’ motion to dismiss. The court granted the defendants’ motion with respect to all but one of the alleged misrepresentations on the grounds that the lead plaintiff had failed to meet the required pleading standards for a securities fraud claim, but ruled that those requirements had been satisfied with respect to one alleged misrepresentation from May 7, 2020. The court granted the lead plaintiff leave to file an amended complaint within 21 days of the court’s order, but the plaintiff chose to proceed with the case based solely on the surviving alleged misrepresentations. A case management conference was held on September 20, 2022 and, on October 5, 2022, the court entered a scheduling order for the case which provides that, assuming the case proceeds, a jury trial would be held on June 3, 2024. The defendants filed their answer to the amended complaint on October 7, 2022 and the case is currently in the fact discovery phase. No damages amount is specified in the Securities Class Action. On February 15, 2021, a derivative action was filed in the District of Delaware, brought by and on behalf of Tricida, Inc. as a Nominal Defendant, against the Company’s directors as well as its CEO and CFO, Ricks v. Alpern et al., Case No, 1:21-cv-000205 (the "Ricks Derivative Case"). The Ricks Derivative Case is based on the allegations of the Securities Class Action and asserts that by allowing the Company and senior executives to make the allegedly false and misleading statements at issue in the Securities Class Action, the defendants breached their fiduciary duties and wasted corporate assets. Additionally, the complaint asserts claims against the senior officers for violation of Sections 10(b) and 21D of the Securities Exchange Act of 1934. No damages amount is specified in the Ricks Derivative Case. On April 8, 2021 a second derivative action was filed in the District of Delaware, brought by and on behalf of Tricida, Inc. as a Nominal Defendant, against the Company’s directors as well as its CEO and CFO, Goodman v. Klaerner et al., Case No, 1:21-cv-00510 (the “Goodman Derivative Case”). As with the Ricks Derivative Case, the Goodman Derivative Case is based on the allegations of the Securities Class Action and asserts that by allowing the Company and senior executives to make the allegedly false and misleading statements at issue in the Securities Class Action, the defendants breached their fiduciary duties. Additionally, the complaint asserts claims against the senior officers for violation of Sections 10(b) and 21D of the Securities Exchange Act of 1934. No damages amount is specified in the Goodman Derivative Case. On May 27, 2021, a third derivative action was filed in the District of Delaware, brought by and on behalf of Tricida, Inc. as a Nominal Defendant, against the Company’s directors as well as its CEO and CFO, Verica v. Veitinger et al., Case No, 1:21-cv-00759 (the "Verica Derivative Case" and collectively with the Goodman Derivative Case and Ricks Derivative Case, the "Derivative Cases"). As with the Goodman Derivative Case and Ricks Derivative Case, the Verica Derivative Case is based on the allegations of the Securities Class Action and asserts that by allowing the Company and senior executives to make the allegedly false and misleading statements at issue in the Securities Class Action, the defendants breached their fiduciary duties. Additionally, the complaint asserts claims for violations of Sections 14(a) and 20(a) of the Securities Exchange Act of 1934 and for unjust enrichment and waste of corporate assets. No damages amount is specified in the Verica Derivative Case. The Derivative Cases were consolidated by order of the District of Delaware Court and lead plaintiffs' counsel has been appointed. Pursuant to an agreement between the parties, the Delaware court issued an order on October 12, 2021, staying the consolidated derivative case pending final resolution of any motions to dismiss filed in the Securities Class Action. Because the Securities Class Action case is now moving forward, the derivative plaintiffs have informed defendants that they plan to file an amended consolidated derivative amended complaint. As of September 30, 2022, the Company has not provided for a loss contingency in its condensed financial statements relating to the Securities Class Action and the Derivative Cases since it is not probable that a loss has been incurred. The Company does not believe that any ultimate liability resulting from any of these claims will have a material adverse effect on its results of operations, financial position, or liquidity. However, the Company cannot give any assurance regarding the ultimate outcome of these claims, and their resolution could be material to operating results for any particular period. Further, while there are no other material legal proceedings that the Company is aware of, the Company may become party to various claims and complaints arising in the ordinary course of business. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 9 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
STOCKHOLDERS' EQUITY | STOCKHOLDERS' EQUITY On November 15, 2021, the Company entered into a securities purchase agreement with several investors and an officer of the Company, or Registered Direct Equity Financing, pursuant to which the Company agreed to issue and sell to the investors, in a private placement, an aggregate of (i) 4,666,667 shares of the Company’s common stock, together with warrants, or the Common Warrants, to purchase up to 4,666,667 shares of common stock, with each Common Warrant exercisable for one share of common stock at a price of $11.00, and (ii) 2,333,333 pre-funded warrants, or Pre-Funded Warrants, together with the Common Warrants to purchase up to 2,333,333 shares of common stock at a nominal exercise price of $0.001. Each share of common stock and accompanying Common Warrant and each Pre-Funded Warrant and accompanying Common Warrant were sold together at a combined offering price of $6.00. The Pre-Funded Warrants were exercised in full on October 24, 2022. The Common Warrants are exercisable until the earliest of: (a) November 15, 2024, (b) immediately prior to the closing of certain fundamental transactions or (c) five Net proceeds from the Registered Direct Equity Financing were approximately $41.5 million, after deducting offering costs of $0.5 million. An officer of the Company participated in the Registered Direct Equity Financing and purchased 166,667 shares of common stock and 166,667 Common Warrants at the same terms as the other investors. Common stock reserved for future issuance as of September 30, 2022 and December 31, 2021, consisted of the following. September 30, December 31, Stock options and restricted stock units issued and outstanding 13,918,236 10,889,603 Stock options, restricted stock units and employee stock purchase plan shares authorized for future issuance 7,717,286 8,308,937 Pre-Funded Warrants authorized for future issuance 2,333,333 2,333,333 Common Warrants authorized for future issuance 7,000,000 7,000,000 Total 30,968,855 28,531,873 |
NET LOSS PER SHARE
NET LOSS PER SHARE | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
NET LOSS PER SHARE | NET LOSS PER SHARE The following table sets forth the computation of the basic and diluted net loss per share attributable to common stockholders for the three and nine months ended September 30, 2022 and 2021. Three Months Ended Nine Months Ended (In thousands, except share and per share amounts) 2022 2021 2022 2021 Numerator: Net loss $ (25,761) $ (39,675) $ (83,936) $ (126,590) Denominator: Weighted-average common shares outstanding 55,682,606 50,434,879 55,521,273 50,326,474 Weighted-average Pre-Funded Warrants outstanding 2,333,333 — 2,333,333 — Weighted-average number of shares used in basic and diluted net loss per share 58,015,939 50,434,879 57,854,606 50,326,474 Net loss per share, basic and diluted $ (0.44) $ (0.79) $ (1.45) $ (2.52) Since the Company was in a loss position for all periods presented, basic net loss per share is the same as diluted net loss per share for all periods as the inclusion of all potential common shares outstanding would have been anti-dilutive. The following weighted-average outstanding common stock equivalents were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented because including them would have been antidilutive. September 30, 2022 2021 Warrants to purchase common stock (excluding Pre-Funded Warrants, which are included in weighted-average common shares outstanding) 7,031,352 31,352 Assumed conversion of Convertible Senior Notes 6,019,560 6,019,560 Stock options and restricted stock units issued and outstanding 13,918,236 11,142,994 Total potential common shares excluded from the computation of diluted net loss per share 26,969,148 17,193,906 |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 9 Months Ended |
Sep. 30, 2022 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | SUBSEQUENT EVENTS On October 19, 2022, the Company entered into a loan and security agreement with Hercules, or 2022 Term Loan. The total amount of the 2022 Term Loan was up to $125.0 million of which $100.0 million was subject to the achievement of certain milestones. No amounts were drawn under the 2022 Term Loan and on November 10, 2022, the Company terminated the 2022 Term Loan. On October 24, 2022, the Company announced that the VALOR-CKD renal outcomes clinical trial (also known as TRCA-303) did not meet its primary endpoint, which was defined as the time to the first occurrence of any event in the composite endpoint of renal death, end-stage renal disease, or ESRD, or a confirmed greater than or equal to 40% reduction in estimated glomerular filtration rate, or eGFR, also known as DD40. On November 2, 2022, the Company announced that it had initiated a review of strategic alternatives to maximize stakeholder value and engaged professional advisors, including investment banking and financial advisors, to support this process. The Company is considering possible strategic alternatives, including a sale of the Company or its assets, a merger, reverse merger, wind-down, liquidation and dissolution or other strategic transaction. As the Company pursues its strategic plan, on November 8, 2022, it put into place a reduction in force plan which includes an approximate 57.0% reduction in workforce in November 2022. The Company estimates aggregate costs of approximately $2.0 million, recorded primarily in the fourth quarter of 2022, related to one-time termination severance payments and other employee-related costs that will be paid during the fourth quarter of 2022 and the first quarter of 2023. The estimates of costs that the Company expects to incur in connection with the reduction in force plan are subject to a number of assumptions and actual results may differ materially. The Company may also incur additional costs not currently contemplated due to events that may occur as a result of, or that are associated with, the workforce reduction. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation —The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States, or U.S. GAAP, for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. The condensed financial statements as of and for the three and nine months ended September 30, 2022 and 2021 are unaudited, but include all adjustments, consisting only of normal recurring adjustments, which the Company considers necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The condensed balance sheet as of December 31, 2021, has been derived from audited financial statements. Results for any interim period are not necessarily indicative of results for any future interim period or for the entire year. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Adopted Standards In August 2020, the FASB issued ASU 2020-06. ASU 2020-06 simplifies the accounting for convertible debt instruments and convertible preferred stock by removing the existing guidance in Accounting Standards Codification, or ASC, 470-20, Debt – Debt with Conversion and Other Options , or ASC 470-20, that requires entities to account for beneficial conversion features and cash conversion features in equity, separately from the host convertible debt or preferred stock. In addition, the amendments revise the scope exception from derivative accounting in ASC 815-40, Derivatives and Hedging – Contracts in Entity’s Own Equity, for freestanding financial instruments and embedded features that are both indexed to the issuer’s own stock and classified in stockholders’ equity, by removing certain criteria required for equity classification. These amendments are expected to result in more freestanding financial instruments qualifying for equity classification (and, therefore, not accounted for as derivatives), as well as fewer embedded features requiring separate accounting from the host contract. |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Schedule of Expected Cumulative Impact of the Adoption | The cumulative impact of the adoption of ASU 2020-06 reflected on the Company's condensed balance sheet as of January 1, 2022, is as follows. in thousands Balance at December 31, 2021 Cumulative Impact of ASU 2020-06 Adoption Balance at January 1, 2022 Liabilities Convertible Senior Notes, net $ 127,512 $ 67,158 $ 194,670 Stockholder's Equity Additional paid-in capital 810,618 (79,498) 731,120 Accumulated deficit (810,364) 12,340 (798,024) |
FAIR VALUE MEASUREMENTS AND F_2
FAIR VALUE MEASUREMENTS AND FAIR VALUE OF FINANCIAL INSTRUMENTS (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Financial Assets and Liabilities Measured on a Recurring Basis | The following tables set forth the value of the Company's financial assets remeasured on a recurring basis based on the three-tier fair value hierarchy by significant investment category as of September 30, 2022 and December 31, 2021. September 30, 2022 Reported as: (in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Cash and Cash Equivalents Short-Term Investments Long-Term Investments Cash $ 1,444 $ — $ — $ 1,444 $ 1,444 $ — $ — Level 1: Money market funds 12,071 — — 12,071 12,071 — — U.S. Treasury securities 13,009 — (112) 12,897 — 12,897 — Subtotal 25,080 — (112) 24,968 12,071 12,897 — Level 2: U.S. government agency securities 5,000 — (66) 4,934 — 4,934 — Commercial paper 47,023 — (137) 46,886 4,229 42,657 — Corporate debt securities 2,009 — (22) 1,987 — 1,987 — Subtotal 54,032 — (225) 53,807 4,229 49,578 — Total assets measured at fair value $ 80,556 $ — $ (337) $ 80,219 $ 17,744 $ 62,475 $ — December 31, 2021 Reported as: (in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Cash and Cash Equivalents Short-Term Investments Long-Term Investments Cash $ 2,965 $ — $ — $ 2,965 $ 2,965 $ — $ — Level 1: Money market funds 18,148 — — 18,148 18,148 — — U.S. Treasury securities 8,028 — (11) 8,017 — — 8,017 Subtotal 26,176 — (11) 26,165 18,148 — 8,017 Level 2: U.S. government agency securities 10,000 — — 10,000 — 10,000 — Commercial paper 107,397 20 (4) 107,413 — 107,413 — Corporate debt securities 4,036 — (4) 4,032 — 2,006 2,026 Subtotal 121,433 20 (8) 121,445 — 119,419 2,026 Total assets measured at fair value $ 150,574 $ 20 $ (19) $ 150,575 $ 21,113 $ 119,419 $ 10,043 |
Reconciliation of Liabilities Using Level 3 Unobservable Inputs | The following table presents a reconciliation of financial liabilities related to the compound derivative liability associated with the Loan and Security Agreement, or 2018 Term Loan, with Hercules Capital Inc., or Hercules, measured at fair value on a recurring basis using Level 3 unobservable inputs for the nine months ended September 30, 2021. The key valuation assumptions used were the discount rate and the probability of the occurrence of certain events. In conjunction with early extinguishment of the 2018 Term Loan on March 12, 2021, the Company extinguished the compound derivative liability associated with the 2018 Term Loan. Nine Months Ended (in thousands) 2021 Fair value at beginning of period $ 202 Extinguishment of compound derivative liability upon extinguishment of 2018 Term Loan (202) Fair value at end of period $ — |
BORROWINGS (Tables)
BORROWINGS (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [Abstract] | |
Schedule of Carrying Values and Estimated Fair Values of Debt Instruments | The following table presents the Convertible Senior Notes' outstanding balances as of September 30, 2022 and December 31, 2021. (in thousands) September 30, December 31, Liability component: Principal $ 200,000 $ 200,000 Unamortized discount - equity component — (68,926) Unamortized underwriter discounts and issuance costs (4,653) (3,562) Net carrying amount $ 195,347 $ 127,512 Equity component, net of underwriter discounts and issuance costs $ — $ 79,498 |
Schedule of Convertible Debt | The following table presents the interest expense related to the Convertible Senior Notes for the three and nine months ended September 30, 2022 and 2021. Three Months Ended Nine Months Ended (in thousands) 2022 2021 2022 2021 Contractual interest expense $ 1,750 $ 1,750 $ 5,250 $ 5,250 Amortization of debt discount — 2,175 — 6,334 Amortization of underwriter discounts and issuance costs 228 69 677 192 Total interest expense $ 1,978 $ 3,994 $ 5,927 $ 11,776 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Contractual Obligation, Fiscal Year Maturity | These amounts are based on forecasts that included estimates of future market demand, quantity discounts and manufacturing efficiencies. In addition, purchase commitments under the Supply Agreement are denominated in Euro and therefore subject to changes in foreign exchange rates. For the three months ended September 30, 2022, the Company recognized foreign currency remeasurement gains of $0.5 million, classified as research and development expense in the condensed statements of operations and comprehensive loss. The amounts disclosed below are applicable under the terms of Amendment No. 4; however, actual costs may differ if the Patheon contract is modified and/or terminated. (in thousands) Total 2022 2023 - 2024 2025 - 2026 Thereafter Manufacturing and service contracts 1 $ 470,696 $ 10,364 $ 97,393 $ 96,784 $ 266,155 |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
Schedule of Common Stock Reserved for Future Issuance | Common stock reserved for future issuance as of September 30, 2022 and December 31, 2021, consisted of the following. September 30, December 31, Stock options and restricted stock units issued and outstanding 13,918,236 10,889,603 Stock options, restricted stock units and employee stock purchase plan shares authorized for future issuance 7,717,286 8,308,937 Pre-Funded Warrants authorized for future issuance 2,333,333 2,333,333 Common Warrants authorized for future issuance 7,000,000 7,000,000 Total 30,968,855 28,531,873 |
NET LOSS PER SHARE (Tables)
NET LOSS PER SHARE (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Basic and Diluted Net Loss Per Share | The following table sets forth the computation of the basic and diluted net loss per share attributable to common stockholders for the three and nine months ended September 30, 2022 and 2021. Three Months Ended Nine Months Ended (In thousands, except share and per share amounts) 2022 2021 2022 2021 Numerator: Net loss $ (25,761) $ (39,675) $ (83,936) $ (126,590) Denominator: Weighted-average common shares outstanding 55,682,606 50,434,879 55,521,273 50,326,474 Weighted-average Pre-Funded Warrants outstanding 2,333,333 — 2,333,333 — Weighted-average number of shares used in basic and diluted net loss per share 58,015,939 50,434,879 57,854,606 50,326,474 Net loss per share, basic and diluted $ (0.44) $ (0.79) $ (1.45) $ (2.52) |
Antidilutive Securities Excluded From Computation | The following weighted-average outstanding common stock equivalents were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented because including them would have been antidilutive. September 30, 2022 2021 Warrants to purchase common stock (excluding Pre-Funded Warrants, which are included in weighted-average common shares outstanding) 7,031,352 31,352 Assumed conversion of Convertible Senior Notes 6,019,560 6,019,560 Stock options and restricted stock units issued and outstanding 13,918,236 11,142,994 Total potential common shares excluded from the computation of diluted net loss per share 26,969,148 17,193,906 |
ORGANIZATION AND BASIS OF PRE_2
ORGANIZATION AND BASIS OF PRESENTATION (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Accumulated deficit | $ 881,960 | $ 810,364 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Schedule of Expected Cumulative Impact of the Adoption (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Jan. 01, 2022 | Dec. 31, 2021 |
Liabilities | |||
Convertible Senior Notes, net | $ 195,347 | $ 127,512 | |
Stockholder's Equity | |||
Additional paid-in capital | 746,234 | 810,618 | |
Accumulated deficit | $ (881,960) | $ (810,364) | |
Cumulative Effect, Period of Adoption, Adjustment | |||
Liabilities | |||
Convertible Senior Notes, net | $ 67,158 | ||
Stockholder's Equity | |||
Additional paid-in capital | (79,498) | ||
Accumulated deficit | 12,340 | ||
Cumulative Effect, Period of Adoption, Adjusted Balance | |||
Liabilities | |||
Convertible Senior Notes, net | 194,670 | ||
Stockholder's Equity | |||
Additional paid-in capital | 731,120 | ||
Accumulated deficit | $ (798,024) |
FAIR VALUE MEASUREMENTS AND F_3
FAIR VALUE MEASUREMENTS AND FAIR VALUE OF FINANCIAL INSTRUMENTS - Financial Assets and Liabilities Measured on a Recurring Basis (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Debt Securities, Available-for-sale [Line Items] | ||
Cash and Cash Equivalents | $ 17,744 | $ 21,113 |
Level 2: | ||
Short-term investments | 62,475 | 119,419 |
Long-term investments | 0 | 10,043 |
Fair Value, Measurements, Recurring | ||
Total assets measured at fair value | ||
Amortized Cost | 80,556 | 150,574 |
Gross Unrealized Gains | 0 | 20 |
Gross Unrealized Losses | (337) | (19) |
Estimated Fair Value | 80,219 | 150,575 |
Cash | Fair Value, Measurements, Recurring | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cash and Cash Equivalents | 1,444 | 2,965 |
Level 1: | ||
Estimated Fair Value | 1,444 | 2,965 |
Cash and Cash Equivalents | Fair Value, Measurements, Recurring | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cash and Cash Equivalents | 17,744 | 21,113 |
Cash and Cash Equivalents | Cash | Fair Value, Measurements, Recurring | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cash and Cash Equivalents | 1,444 | 2,965 |
Short-Term Investments | Fair Value, Measurements, Recurring | ||
Level 2: | ||
Short-term investments | 62,475 | 119,419 |
Long-Term Investments | Fair Value, Measurements, Recurring | ||
Level 2: | ||
Long-term investments | 0 | 10,043 |
Level 1: | Fair Value, Measurements, Recurring | ||
Level 2: | ||
Amortized Cost | 25,080 | 26,176 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (112) | (11) |
Estimated Fair Value | 24,968 | 26,165 |
Level 1: | Fair Value, Measurements, Recurring | U.S. Treasury securities | ||
Level 2: | ||
Amortized Cost | 13,009 | 8,028 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (112) | (11) |
Estimated Fair Value | 12,897 | 8,017 |
Level 1: | Money market funds | Fair Value, Measurements, Recurring | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cash and Cash Equivalents | 12,071 | 18,148 |
Level 1: | ||
Estimated Fair Value | 12,071 | 18,148 |
Level 1: | Cash and Cash Equivalents | Fair Value, Measurements, Recurring | ||
Level 2: | ||
Estimated Fair Value | 12,071 | 18,148 |
Level 1: | Cash and Cash Equivalents | Fair Value, Measurements, Recurring | U.S. Treasury securities | ||
Level 2: | ||
Estimated Fair Value | 0 | 0 |
Level 1: | Cash and Cash Equivalents | Money market funds | Fair Value, Measurements, Recurring | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cash and Cash Equivalents | 12,071 | 18,148 |
Level 1: | Short-Term Investments | Fair Value, Measurements, Recurring | ||
Level 2: | ||
Short-term investments | 12,897 | 0 |
Level 1: | Short-Term Investments | Fair Value, Measurements, Recurring | U.S. Treasury securities | ||
Level 2: | ||
Short-term investments | 12,897 | 0 |
Level 1: | Long-Term Investments | Fair Value, Measurements, Recurring | ||
Level 2: | ||
Long-term investments | 0 | 8,017 |
Level 1: | Long-Term Investments | Fair Value, Measurements, Recurring | U.S. Treasury securities | ||
Level 2: | ||
Long-term investments | 0 | 8,017 |
Level 2: | Fair Value, Measurements, Recurring | ||
Level 2: | ||
Amortized Cost | 54,032 | 121,433 |
Gross Unrealized Gains | 0 | 20 |
Gross Unrealized Losses | (225) | (8) |
Estimated Fair Value | 53,807 | 121,445 |
Level 2: | Fair Value, Measurements, Recurring | U.S. government agency securities | ||
Level 2: | ||
Amortized Cost | 5,000 | 10,000 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (66) | 0 |
Estimated Fair Value | 4,934 | 10,000 |
Level 2: | Fair Value, Measurements, Recurring | Commercial paper | ||
Level 2: | ||
Amortized Cost | 47,023 | 107,397 |
Gross Unrealized Gains | 0 | 20 |
Gross Unrealized Losses | (137) | (4) |
Estimated Fair Value | 46,886 | 107,413 |
Level 2: | Fair Value, Measurements, Recurring | Corporate debt securities | ||
Level 2: | ||
Amortized Cost | 2,009 | 4,036 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (22) | (4) |
Estimated Fair Value | 1,987 | 4,032 |
Level 2: | Cash and Cash Equivalents | Fair Value, Measurements, Recurring | ||
Level 2: | ||
Estimated Fair Value | 4,229 | 0 |
Level 2: | Cash and Cash Equivalents | Fair Value, Measurements, Recurring | U.S. government agency securities | ||
Level 2: | ||
Estimated Fair Value | 0 | 0 |
Level 2: | Cash and Cash Equivalents | Fair Value, Measurements, Recurring | Commercial paper | ||
Level 2: | ||
Estimated Fair Value | 4,229 | 0 |
Level 2: | Cash and Cash Equivalents | Fair Value, Measurements, Recurring | Corporate debt securities | ||
Level 2: | ||
Estimated Fair Value | 0 | 0 |
Level 2: | Short-Term Investments | Fair Value, Measurements, Recurring | ||
Level 2: | ||
Short-term investments | 49,578 | 119,419 |
Level 2: | Short-Term Investments | Fair Value, Measurements, Recurring | U.S. government agency securities | ||
Level 2: | ||
Short-term investments | 4,934 | 10,000 |
Level 2: | Short-Term Investments | Fair Value, Measurements, Recurring | Commercial paper | ||
Level 2: | ||
Short-term investments | 42,657 | 107,413 |
Level 2: | Short-Term Investments | Fair Value, Measurements, Recurring | Corporate debt securities | ||
Level 2: | ||
Short-term investments | 1,987 | 2,006 |
Level 2: | Long-Term Investments | Fair Value, Measurements, Recurring | ||
Level 2: | ||
Long-term investments | 0 | 2,026 |
Level 2: | Long-Term Investments | Fair Value, Measurements, Recurring | U.S. government agency securities | ||
Level 2: | ||
Long-term investments | 0 | 0 |
Level 2: | Long-Term Investments | Fair Value, Measurements, Recurring | Commercial paper | ||
Level 2: | ||
Long-term investments | 0 | 0 |
Level 2: | Long-Term Investments | Fair Value, Measurements, Recurring | Corporate debt securities | ||
Level 2: | ||
Long-term investments | $ 0 | $ 2,026 |
FAIR VALUE MEASUREMENTS AND F_4
FAIR VALUE MEASUREMENTS AND FAIR VALUE OF FINANCIAL INSTRUMENTS - Reconciliation of Liabilities Measured using Level 3 (Details) - Fair Value, Inputs, Level 3 - Derivative Financial Instruments, Liabilities $ in Thousands | 9 Months Ended |
Sep. 30, 2021 USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Fair value at beginning of period | $ 202 |
Extinguishment of compound derivative liability upon extinguishment of 2018 Term Loan | (202) |
Fair value at end of period | $ 0 |
FAIR VALUE MEASUREMENTS AND F_5
FAIR VALUE MEASUREMENTS AND FAIR VALUE OF FINANCIAL INSTRUMENTS - Additional information (Details) - Convertible Senior Notes - Fair Value, Inputs, Level 3 $ in Millions | Sep. 30, 2022 USD ($) |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Debt instrument, fair value | $ 105.2 |
Discount rate | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Valuation assumptions as a percentage | 0.278 |
Volatility | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Valuation assumptions as a percentage | 1.100 |
BORROWINGS - Additional informa
BORROWINGS - Additional information (Details) - Senior Notes - 3.50% Due 2027 | May 22, 2020 USD ($) $ / shares | Sep. 30, 2022 USD ($) | Dec. 31, 2021 USD ($) |
Debt Instrument [Line Items] | |||
Debt aggregate principal amount | $ 200,000,000 | ||
Debt interest rate | 0.035% | ||
Carrying amount of liability component | $ 117,700,000 | $ 195,347,000 | $ 127,512,000 |
Equity component, net of underwriter discounts and issuance costs | $ 82,300,000 | $ 0 | $ 79,498,000 |
Effective interest rate (as percent) | 13.50% | ||
Debt instrument, effective life | 7 years | ||
Amortization rate | 4.10% | ||
Debt Instrument, Redemption, Period One | |||
Debt Instrument [Line Items] | |||
Conversion price (in dollars per share) | $ / shares | $ 33.23 | ||
Conversion rate | 0.0300978 |
BORROWINGS - Carrying Amount of
BORROWINGS - Carrying Amount of Liability and Equity Components (Details) - Senior Notes - 3.50% Due 2027 - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 | May 22, 2020 |
Debt Instrument [Line Items] | |||
Principal | $ 200,000 | $ 200,000 | |
Unamortized discount - equity component | 0 | (68,926) | |
Unamortized underwriter discounts and issuance costs | (4,653) | (3,562) | |
Net carrying amount | 195,347 | 127,512 | $ 117,700 |
Equity component, net of underwriter discounts and issuance costs | $ 0 | $ 79,498 | $ 82,300 |
BORROWINGS - Interest Expense (
BORROWINGS - Interest Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Debt Instrument [Line Items] | ||||
Total interest expense | $ 1,978 | $ 3,994 | $ 5,927 | $ 13,533 |
Senior Notes | 3.50% Due 2027 | ||||
Debt Instrument [Line Items] | ||||
Contractual interest expense | 1,750 | 1,750 | 5,250 | 5,250 |
Amortization of debt discount | 0 | 2,175 | 0 | 6,334 |
Amortization of underwriter discounts and issuance costs | 228 | 69 | 677 | 192 |
Total interest expense | $ 1,978 | $ 3,994 | $ 5,927 | $ 11,776 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Sep. 30, 2022 | Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Foreign currency remeasurement gains | $ 500 | |
Total | 470,696 | |
2022 | 10,364 | |
2023 - 2024 | 97,393 | |
2025 - 2026 | 96,784 | |
Thereafter | 266,155 | |
Other long-term liabilities | $ 7,852 | $ 0 |
STOCKHOLDERS' EQUITY - Addition
STOCKHOLDERS' EQUITY - Additional information (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | ||
Nov. 15, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Class of Stock [Line Items] | |||
Offering costs | $ 33 | $ 0 | |
Private placement | |||
Class of Stock [Line Items] | |||
Number of common stock issued (in shares) | 4,666,667 | ||
Number of shares called by warrant (in shares) | 4,666,667 | ||
Number of shares called by warrant (in shares) | 1 | ||
Exercise price of warrant (in USD per share) | $ 11 | ||
Warrants combined offering price (in USD per share) | $ 6 | ||
Proceeds from issuance of common stock | $ 75,000 | ||
Share price (in USD per share) | $ 13.50 | ||
Proceeds from equity offerings, net | $ 41,500 | ||
Offering costs | $ 500 | ||
Common Stock | Private placement | |||
Class of Stock [Line Items] | |||
Stock issued to members (in shares) | 166,667 | ||
Pre-Funded Warrants authorized for future issuance | Private placement | |||
Class of Stock [Line Items] | |||
Number of common stock issued (in shares) | 2,333,333 | ||
Number of shares called by warrant (in shares) | 2,333,333 | ||
Exercise price of warrant (in USD per share) | $ 0.001 | ||
Exercise period | 5 days | ||
Share price (in USD per share) | $ 15 | ||
Common Warrants authorized for future issuance | Private placement | |||
Class of Stock [Line Items] | |||
Stock issued to members (in shares) | 166,667 |
STOCKHOLDERS' EQUITY - Common s
STOCKHOLDERS' EQUITY - Common stock (Details) - shares | Sep. 30, 2022 | Dec. 31, 2021 |
Class of Warrant or Right [Line Items] | ||
Stock options and restricted stock units issued and outstanding (in shares) | 13,918,236 | 10,889,603 |
Total (in shares) | 30,968,855 | 28,531,873 |
Pre-Funded Warrants authorized for future issuance | ||
Class of Warrant or Right [Line Items] | ||
Shares authorized for future issuance (in shares) | 2,333,333 | 2,333,333 |
Common Warrants authorized for future issuance | ||
Class of Warrant or Right [Line Items] | ||
Shares authorized for future issuance (in shares) | 7,000,000 | 7,000,000 |
Stock Options, RSUs and ESPP Shares | ||
Class of Warrant or Right [Line Items] | ||
Shares authorized for future issuance (in shares) | 7,717,286 | 8,308,937 |
NET LOSS PER SHARE - Basic and
NET LOSS PER SHARE - Basic and diluted net loss per share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Numerator: | ||||||||
Net loss | $ (25,761) | $ (28,536) | $ (29,639) | $ (39,675) | $ (33,553) | $ (53,362) | $ (83,936) | $ (126,590) |
Denominator: | ||||||||
Weighted average shares outstanding (in shares) | 55,682,606 | 50,434,879 | 55,521,273 | 50,326,474 | ||||
Weighted-average number of shares outstanding, diluted (in shares) | 58,015,939 | 50,434,879 | 57,854,606 | 50,326,474 | ||||
Weighted-average number of shares outstanding, basic (in shares) | 58,015,939 | 50,434,879 | 57,854,606 | 50,326,474 | ||||
Net loss per share, diluted (in dollars per share) | $ (0.44) | $ (0.79) | $ (1.45) | $ (2.52) | ||||
Net loss per share, basic (in dollars per share) | $ (0.44) | $ (0.79) | $ (1.45) | $ (2.52) | ||||
Pre-Funded Warrants authorized for future issuance | ||||||||
Denominator: | ||||||||
Weighted average shares outstanding (in shares) | 2,333,333 | 0 | 2,333,333 | 0 |
NET LOSS PER SHARE - Antidiluti
NET LOSS PER SHARE - Antidilutive securities (Details) - shares | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities (in shares) | 26,969,148 | 17,193,906 |
Warrants to purchase common stock (excluding Pre-Funded Warrants, which are included in weighted-average common shares outstanding) | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities (in shares) | 7,031,352 | 31,352 |
Assumed conversion of Convertible Senior Notes | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities (in shares) | 6,019,560 | 6,019,560 |
Stock options and restricted stock units issued and outstanding | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities (in shares) | 13,918,236 | 11,142,994 |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) - USD ($) $ in Millions | 1 Months Ended | ||
Nov. 30, 2022 | Dec. 31, 2022 | Oct. 19, 2022 | |
Forecast | One-time Termination Benefits | |||
Subsequent Event [Line Items] | |||
Percent of company's workforce eliminated | 57% | ||
Expected restructuring costs | $ 2 | ||
Term Loan | Subsequent Event | |||
Subsequent Event [Line Items] | |||
Line of credit facility, maximum borrowing capacity | $ 125 | ||
Term Loan | Subject to achievement of milestones | Subsequent Event | |||
Subsequent Event [Line Items] | |||
Line of credit facility, current | $ 100 |