DOCUMENT AND ENTITY INFORMATION
DOCUMENT AND ENTITY INFORMATION - shares | 6 Months Ended | |
Jun. 30, 2024 | Aug. 01, 2024 | |
DOCUMENT AND ENTITY INFORMATION | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Fiscal Period Focus | Q2 | |
Current Fiscal Year End Date | --12-31 | |
Document Period End Date | Jun. 30, 2024 | |
Document Transition Report | false | |
Entity File Number | 0-29889 | |
Entity Registrant Name | RIGEL PHARMACEUTICALS INC | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 94-3248524 | |
Entity Address, Address Line One | 611 Gateway Boulevard, Suite 900, | |
Entity Address, City or Town | South San Francisco | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94080 | |
City Area Code | 650 | |
Local Phone Number | 624-1100 | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Trading Symbol | RIGL | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Central Index Key | 0001034842 | |
Amendment Flag | false | |
Entity Common Stock, Shares Outstanding | 17,594,977 | |
Document Fiscal Year Focus | 2024 |
CONDENSED BALANCE SHEETS
CONDENSED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 36,053 | $ 32,786 |
Short-term investments | 13,049 | 24,147 |
Accounts receivable, net | 28,904 | 30,550 |
Inventories | 8,059 | 5,522 |
Prepaid and other current assets | 8,658 | 6,261 |
Total current assets | 94,723 | 99,266 |
Property and equipment, net | 115 | 165 |
Intangible asset, net | 28,275 | 13,878 |
Operating lease right-of-use asset | 560 | 861 |
Other assets | 4,735 | 3,055 |
Total assets | 128,408 | 117,225 |
Current liabilities: | ||
Accounts payable | 6,130 | 7,142 |
Accrued compensation | 6,373 | 8,676 |
Accrued research and development | 4,672 | 3,513 |
Acquisition-related liabilities | 15,000 | |
Revenue reserves and refund liability | 18,547 | 15,684 |
Loans payable, net, current portion | 7,229 | |
Other accrued liabilities | 5,933 | 5,334 |
Lease liabilities, current portion | 639 | 692 |
Deferred revenue | 1,355 | 1,355 |
Other long-term liabilities, current portion | 3,642 | |
Total current liabilities | 58,649 | 53,267 |
Long-term portion of lease liabilities | 285 | |
Long-term portion of loans payable, net | 59,692 | 52,373 |
Other long-term liabilities | 39,981 | 39,944 |
Total liabilities | 158,322 | 145,869 |
Commitments | ||
Stockholders' deficit: | ||
Common stock | 17 | 17 |
Additional paid-in capital | 1,386,905 | 1,378,881 |
Accumulated other comprehensive (loss) income | (9) | 8 |
Accumulated deficit | (1,416,827) | (1,407,550) |
Total stockholders' deficit | (29,914) | (28,644) |
Total liabilities and stockholders' deficit | $ 128,408 | $ 117,225 |
CONDENSED BALANCE SHEETS (Paren
CONDENSED BALANCE SHEETS (Parenthetical) | Jun. 27, 2024 |
CONDENSED BALANCE SHEETS | |
Stock split, conversion ratio | 0.1 |
CONDENSED STATEMENTS OF OPERATI
CONDENSED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Total revenues | $ 36,841 | $ 26,886 | $ 66,375 | $ 52,956 |
Costs and expenses: | ||||
Cost of product sales | 2,807 | 1,075 | 4,832 | 2,052 |
Research and development | 5,540 | 4,772 | 11,566 | 14,861 |
Selling, general and administrative | 28,047 | 26,306 | 56,496 | 54,035 |
Total costs and expenses | 36,394 | 32,153 | 72,894 | 70,948 |
Income (loss) from operations | 447 | (5,267) | (6,519) | (17,992) |
Interest income | 552 | 529 | 1,145 | 922 |
Interest expense | (2,029) | (1,862) | (3,903) | (3,066) |
Net loss | $ (1,030) | $ (6,600) | $ (9,277) | $ (20,136) |
Net loss per share, basic (in dollars per share) | $ (0.06) | $ (0.38) | $ (0.53) | $ (1.16) |
Net loss per share, diluted (in dollars per share) | $ (0.06) | $ (0.38) | $ (0.53) | $ (1.16) |
Weighted average shares used in computing net loss per share, basic (in shares) | 17,549 | 17,356 | 17,534 | 17,365 |
Weighted average shares used in computing net loss per share, diluted (in shares) | 17,549 | 17,356 | 17,534 | 17,365 |
Product sales, net | ||||
Total revenues | $ 33,450 | $ 23,881 | $ 59,453 | $ 47,626 |
Revenues from collaborations | ||||
Total revenues | $ 3,391 | 2,005 | $ 6,922 | 4,330 |
Government contracts | ||||
Total revenues | $ 1,000 | $ 1,000 |
CONDENSED STATEMENTS OF OPERA_2
CONDENSED STATEMENTS OF OPERATIONS (Parenthetical) | Jun. 27, 2024 |
CONDENSED STATEMENTS OF OPERATIONS | |
Stock split, conversion ratio | 0.1 |
CONDENSED STATEMENTS OF COMPREH
CONDENSED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
CONDENSED STATEMENTS OF COMPREHENSIVE LOSS | ||||
Net loss | $ (1,030) | $ (6,600) | $ (9,277) | $ (20,136) |
Other comprehensive (loss) gain: | ||||
Net unrealized (loss) gain on short-term investments | (4) | 2 | (17) | 128 |
Comprehensive loss | $ (1,034) | $ (6,598) | $ (9,294) | $ (20,008) |
CONDENSED STATEMENTS OF STOCKHO
CONDENSED STATEMENTS OF STOCKHOLDERS' DEFICIT - USD ($) $ in Thousands | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | Total |
Balance at Dec. 31, 2022 | $ 17 | $ 1,368,979 | $ (153) | $ (1,382,459) | $ (13,616) |
Balance (in shares) at Dec. 31, 2022 | 17,339,816 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Net loss | (13,536) | (13,536) | |||
Net change in unrealized gain (loss) on short-term investments | 126 | 126 | |||
Issuance of common stock upon exercise of options | 1 | 1 | |||
Issuance of common stock upon exercise of options (in shares) | 95 | ||||
Issuance of common stock upon vesting of restricted stock units (RSUs) (in shares) | 26,625 | ||||
Stock-based compensation expense | 2,768 | 2,768 | |||
Balance at Mar. 31, 2023 | $ 17 | 1,371,748 | (27) | (1,395,995) | (24,257) |
Balance (in shares) at Mar. 31, 2023 | 17,366,536 | ||||
Balance at Dec. 31, 2022 | $ 17 | 1,368,979 | (153) | (1,382,459) | (13,616) |
Balance (in shares) at Dec. 31, 2022 | 17,339,816 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Net loss | (20,136) | ||||
Net change in unrealized gain (loss) on short-term investments | 128 | ||||
Balance at Jun. 30, 2023 | $ 17 | 1,374,488 | (25) | (1,402,595) | (28,115) |
Balance (in shares) at Jun. 30, 2023 | 17,435,790 | ||||
Balance at Mar. 31, 2023 | $ 17 | 1,371,748 | (27) | (1,395,995) | (24,257) |
Balance (in shares) at Mar. 31, 2023 | 17,366,536 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Net loss | (6,600) | (6,600) | |||
Net change in unrealized gain (loss) on short-term investments | 2 | 2 | |||
Issuance of common stock upon exercise of options | 554 | 554 | |||
Issuance of common stock upon exercise of options (in shares) | 52,379 | ||||
Issuance of common stock upon vesting of restricted stock units (RSUs) (in shares) | 16,875 | ||||
Stock-based compensation expense | 2,186 | 2,186 | |||
Balance at Jun. 30, 2023 | $ 17 | 1,374,488 | (25) | (1,402,595) | (28,115) |
Balance (in shares) at Jun. 30, 2023 | 17,435,790 | ||||
Balance at Dec. 31, 2023 | $ 17 | 1,378,881 | 8 | (1,407,550) | (28,644) |
Balance (in shares) at Dec. 31, 2023 | 17,482,513 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Net loss | (8,247) | (8,247) | |||
Net change in unrealized gain (loss) on short-term investments | (13) | (13) | |||
Issuance of common stock upon exercise of options | 89 | 89 | |||
Issuance of common stock upon exercise of options (in shares) | 9,066 | ||||
Issuance of common stock upon vesting of restricted stock units (RSUs) (in shares) | 48,658 | ||||
Stock-based compensation expense | 5,144 | 5,144 | |||
Balance at Mar. 31, 2024 | $ 17 | 1,384,114 | (5) | (1,415,797) | (31,671) |
Balance (in shares) at Mar. 31, 2024 | 17,540,237 | ||||
Balance at Dec. 31, 2023 | $ 17 | 1,378,881 | 8 | (1,407,550) | (28,644) |
Balance (in shares) at Dec. 31, 2023 | 17,482,513 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Net loss | (9,277) | ||||
Net change in unrealized gain (loss) on short-term investments | (17) | ||||
Balance at Jun. 30, 2024 | $ 17 | 1,386,905 | (9) | (1,416,827) | (29,914) |
Balance (in shares) at Jun. 30, 2024 | 17,594,117 | ||||
Balance at Mar. 31, 2024 | $ 17 | 1,384,114 | (5) | (1,415,797) | (31,671) |
Balance (in shares) at Mar. 31, 2024 | 17,540,237 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Net loss | (1,030) | (1,030) | |||
Net change in unrealized gain (loss) on short-term investments | (4) | (4) | |||
Issuance of common stock upon exercise of options | 252 | 252 | |||
Issuance of common stock upon exercise of options (in shares) | 36,130 | ||||
Issuance of common stock upon vesting of restricted stock units (RSUs) (in shares) | 17,750 | ||||
Stock-based compensation expense | 2,539 | 2,539 | |||
Balance at Jun. 30, 2024 | $ 17 | $ 1,386,905 | $ (9) | $ (1,416,827) | $ (29,914) |
Balance (in shares) at Jun. 30, 2024 | 17,594,117 |
CONDENSED STATEMENTS OF STOCK_2
CONDENSED STATEMENTS OF STOCKHOLDERS' DEFICIT (Parenthetical) | Jun. 27, 2024 |
CONDENSED STATEMENTS OF STOCKHOLDERS' DEFICIT | |
Stock split, conversion ratio | 0.1 |
CONDENSED STATEMENTS OF CASH FL
CONDENSED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Operating activities | ||
Net loss | $ (9,277) | $ (20,136) |
Adjustments to reconcile net loss to net cash (used in) provided by operating activities: | ||
Stock-based compensation expense | 7,662 | 4,930 |
Loss on sale and disposal of fixed assets | 398 | |
Depreciation and amortization | 1,013 | 653 |
Net amortization of discount on short-term investments and term loans | (364) | (114) |
Changes in assets and liabilities: | ||
Accounts receivable, net | 1,646 | 19,501 |
Inventories | (4,505) | (1,640) |
Prepaid and other current and non-current assets | (2,088) | 3,391 |
Right-of-use assets | 301 | 933 |
Accounts payable | (1,012) | (2,268) |
Accrued compensation | (2,303) | (2,127) |
Accrued research and development | 1,159 | (1,882) |
Revenue reserves and refund liability | 2,863 | 1,539 |
Other accrued liabilities | 532 | (1,472) |
Lease liability | (338) | (1,011) |
Deferred revenue | (14) | |
Other current and long-term liabilities | 1,175 | |
Net cash (used in) provided by operating activities | (4,711) | 1,856 |
Investing activities | ||
Maturities of short-term investments | 26,950 | 27,400 |
Purchases of short-term investments | (15,348) | (8,780) |
Payments for acquisition of intangible assets | (360) | (15,000) |
Proceeds from sale of property and equipment | 127 | |
Net cash provided by investing activities | 11,242 | 3,747 |
Financing activities | ||
Net proceeds from term loan financing | 19,950 | |
Net proceeds from issuances of common stock upon exercise of options | 341 | 554 |
Cost share payments to a collaboration partner | (3,605) | (1,754) |
Net cash (used in) provided by financing activities | (3,264) | 18,750 |
Net increase in cash and cash equivalents | 3,267 | 24,353 |
Cash and cash equivalents at beginning of period | 32,786 | 24,459 |
Cash and cash equivalents at end of period | 36,053 | 48,812 |
Supplemental disclosure of cash flow information | ||
Interest paid | 3,457 | $ 2,485 |
Intangible assets included within acquisition-related liabilities | $ 15,000 |
ORGANIZATION AND SUMMARY OF SIG
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 6 Months Ended |
Jun. 30, 2024 | |
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 1. Organization and Summary of Significant Accounting Policies Description of Business We are a biotechnology company dedicated to developing and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. We focus on products that address signaling pathways that are critical to disease mechanisms. TAVALISSE ® REZLIDHIA ® (olutasidenib) is o for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. W GAVRETO ® (pralsetinib) is our third FDA-approved product which we began commercializing on June 27, 2024. GAVRETO is a once daily, small molecule, oral, kinase inhibitor of wild-type rearranged during transfection (RET) and oncogenic RET fusions. GAVRETO is approved by the FDA for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. GAVRETO is also approved under accelerated approval based on overall response rate and duration response rate, for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). We acquired the rights to research, develop, manufacture and commercialize GAVRETO in the US from Blueprint Medicines Corporation (Blueprint) pursuant to an Asset Purchase Agreement entered in February 2024. We continue to advance the development of R289, our interleukin receptor-associated kinases 1 and 4 (IRAK 1/4) inhibitor program, in an open-label, Phase 1b trial to determine the tolerability and preliminary efficacy of the drug in patients with lower-risk myelodysplastic syndrome (MDS) who are relapsed, refractory or resistant to prior therapies. We have strategic development collaborations with the University of Texas MD Anderson Cancer Center (MDACC) to expand our evaluation of REZLIDHIA in AML and other hematologic cancers with IDH1 mutations, and with Collaborative Network for Neuro-Oncology Clinical Trials (CONNECT) to conduct a Phase 2 clinical trial to evaluate REZLIDHIA in combination with temozolomide in patients with high-grade glioma (HGG) harboring an IDH1 mutation. We have a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor program in clinical development with our partner Eli Lilly and Company (Lilly). We also have product candidates in clinical development with partners BerGenBio ASA (BerGenBio) and Daiichi Sankyo (Daiichi). Reverse Stock Split We filed with the Secretary of State of the State of Delaware a certificate of amendment to our Amended and Restated Certificate of Incorporation, to effect a 1-for-10 reverse stock split, effective June 27, 2024. As a result of the reverse stock split, every ten issued and outstanding shares of our common stock were automatically combined into one issued and outstanding share of common stock. Accordingly, an amount equal to the par value of the decreased shares resulting from the reverse stock split was reclassified from common stock to additional paid-in capital on the condensed balance sheet and statement of changes in stockholders’ deficit. No fractional shares were issued in connection with the reverse stock split. Stockholders who otherwise would be entitled to receive fractional shares of common stock were entitled to receive the cash value equal to the fraction to which the stockholder would otherwise be entitled, multiplied by the closing price of the common stock as reported by Nasdaq on the last trading day prior to the effective date of the split. As a result of the reverse stock split, proportionate adjustments were made to the number of shares underlying (and as applicable, the exercise or conversion prices of) our outstanding equity awards and to the number of shares of common stock issuable under our equity incentive plans. The reverse stock split did not change the par value of our common stock, which remains $0.001 , or the authorized number of shares of our common stock. All share amounts and per share amounts disclosed in this Quarterly Report on Form 10-Q have been adjusted to reflect the reverse stock split on a retroactive basis for all periods presented. Basis of Presentation Our accompanying unaudited condensed financial statements have been prepared in accordance with United States generally accepted accounting principles (US GAAP), for interim financial information and pursuant to the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities Act of 1933, as amended (Securities Act). Accordingly, they do not include all the information and notes required by US GAAP for complete financial statements. These unaudited condensed financial statements include only normal and recurring adjustments that we believe are necessary to fairly state our financial position and the results of our operations and cash flows. Interim-period results are not necessarily indicative of results of operations or cash flows for a full-year or any subsequent interim period. The balance sheet as of December 31, 2023 has been derived from audited financial statements at that date but does not include all disclosures required by US GAAP for complete financial statements. Because certain disclosures required by US GAAP for complete financial statements are not included herein, these interim unaudited condensed financial statements and the notes accompanying them should be read in conjunction with our audited financial statements and the notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2023. Use of Estimates The preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances. Actual results could differ from these estimates. Significant Accounting Policies Our significant accounting policies are described in “Note 1 – Description of Business and Summary of Significant Accounting Policies” to our “Notes to Financial Statements” contained in Part II, Item 8, “Financial Statements and Supplementary Data” of our Annual Report on Form 10-K for the year ended December 31, 2023. There have been no material changes to these accounting policies except for the accounting consideration related to the Asset Purchase Agreement with Blueprint as discussed below in “Note 5 – In-licensing and Acquisition.” Liquidity As of June 30, 2024, we had approximately $49.1 million in cash, cash equivalents and short-term investments. Since inception, we have financed our operations primarily through sales of equity securities, debt financing, contract payments under our collaboration agreements and from product sales. Based on our current operating plan, we believe that our existing cash, cash equivalents, and short-term investments will be sufficient to fund our expenses and capital expenditure requirements for at least the next 12 months from the date of issuance of this Form 10-Q. Recently Issued Accounting Standards In November 2023, FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. interim disclosures of a reportable segment’s profit or loss and assets. All disclosure requirements under this update are also required for public entities with a single reportable segment. This update is effective for our Annual Report on Form 10-K for the fiscal year ending December 31, 2024, and interim periods thereafter. Early adoption is permitted. The update should be applied retrospectively to all periods presented in the financial statements. We are currently evaluating the impact of adopting this update on our financial statements and disclosures. In December 2023, FASB issued ASU 2023-09, Improvements to Income Tax Disclosures Other recently issued accounting guidance not discussed in this Quarterly Report on Form 10-Q are either not applicable or did not have, or are not expected to have, a material impact on us. |
NET LOSS PER SHARE
NET LOSS PER SHARE | 6 Months Ended |
Jun. 30, 2024 | |
NET LOSS PER SHARE | |
NET LOSS PER SHARE | 2. Net Loss Per Share Basic net loss per share is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during the period. Diluted net loss per share is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during the period and the number of additional shares of common stock that would have been outstanding if potentially dilutive securities had been issued. Potentially dilutive securities include stock options, RSUs and shares issuable under our Employee Stock Purchase Plan (Purchase Plan). The dilutive effect of these potentially dilutive securities is reflected in diluted earnings per share using the treasury stock method. Under the treasury stock method, an increase in the fair market value of our common stock can result in a greater dilutive effect from potentially dilutive securities. The potential shares of common stock that were excluded from the computation of diluted net loss per share for the periods presented because including them would have been antidilutive are as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Outstanding stock options 3,691 3,524 3,691 3,524 RSUs 388 196 388 196 Total 4,079 3,720 4,079 3,720 |
REVENUES
REVENUES | 6 Months Ended |
Jun. 30, 2024 | |
REVENUES | |
REVENUES | 3. Revenues Revenues disaggregated by category were as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Product sales: Gross product sales $ 48,980 $ 33,456 $ 87,406 $ 66,654 Discounts and allowances (15,530) (9,575) (27,953) (19,028) Total product sales, net 33,450 23,881 59,453 47,626 Revenues from collaborations: Delivery of drug supplies, royalty and others 3,391 2,005 6,922 4,330 Total revenues from collaborations 3,391 2,005 6,922 4,330 Government contracts — 1,000 — 1,000 Total revenues $ 36,841 $ 26,886 $ 66,375 $ 52,956 Revenue from product sales are related to sales of our commercial products to our specialty distributors. For detailed discussions of our revenues from collaborations and government contracts, see “Note 4 – Sponsored Research, License Agreements and Government Contracts.” Our net product sales include gross product sales, net of chargebacks, discounts and fees, government and other rebates and returns. Of the total discounts and allowances from gross product sales for the six months ended June 30, 2024 and 2023, $27.6 million and $18.6 million, respectively, was accounted for as additions to revenue reserves and refund liability, and $0.4 million and $0.4 million, respectively, as reductions in accounts receivable (as it relates to allowance for prompt pay discount) and prepaid and other current assets (as it relates to certain chargebacks and other fees that were prepaid) in the condensed balance sheet. The following tables summarize the activities in chargebacks, discounts and fees, government and other rebates and returns that were accounted for within revenue reserves and refund liability, for each of the periods presented (in thousands): Chargebacks, Government Discounts and and Other Fees Rebates Returns Total Balance as of January 1, 2024 $ 8,236 $ 3,517 $ 3,931 $ 15,684 Provision related to current period sales 21,770 5,259 522 27,551 Credit or payments made during the period (20,165) (4,441) (82) (24,688) Balance as of June 30, 2024 $ 9,841 $ 4,335 $ 4,371 $ 18,547 Chargebacks, Government Discounts and and Other Fees Rebates Returns Total Balance as of January 1, 2023 $ 6,213 $ 2,636 $ 3,296 $ 12,145 Provision related to current period sales 14,439 3,725 395 18,559 Credit or payments made during the period (13,139) (3,765) (116) (17,020) Balance as of June 30, 2023 $ 7,513 $ 2,596 $ 3,575 $ 13,684 The following table summarizes the percentages of revenues from each of our customers who individually accounted for 10% or more of the total net product sales and revenues from collaborations: Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 McKesson Corporation 49% 44% 46% 45% Cardinal Health, Inc. 21% 28% 22% 26% Cencora Inc. (formerly ASD Healthcare) 20% 19% 21% 21% |
SPONSORED RESEARCH AND LICENSE
SPONSORED RESEARCH AND LICENSE AGREEMENTS AND GOVERNMENT CONTRACT | 6 Months Ended |
Jun. 30, 2024 | |
SPONSORED RESEARCH AND LICENSE AGREEMENTS AND GOVERNMENT CONTRACT | |
SPONSORED RESEARCH AND LICENSE AGREEMENTS AND GOVERNMENT CONTRACT | 4. Sponsored Research, License Agreements and Government Contracts Sponsored Research and License Agreements We conduct research and development programs independently and in connection with our corporate collaborators. As of June 30, 2024, we are a party to collaboration agreements with Lilly to develop and commercialize ocadusertib (previously R552), a RIPK1 inhibitor, for the treatment of non-central nervous system (non-CNS) diseases and collaboration aimed at developing additional RIPK1 inhibitors for the treatment of central nervous system (CNS) diseases; with Grifols S.A. (Grifols) to commercialize fostamatinib for human diseases in all indications in Grifols territory which includes Europe, the UK, Turkey, the Middle East, North Africa and Russia (including Commonwealth of Independent States); with Kissei Pharmaceutical Co., Ltd. (Kissei) to develop and commercialize fostamatinib in Kissei territory which includes Japan, China, Taiwan and the Republic of Korea; with Medison Pharma Trading AG (Medison Canada) and Medison Pharma Ltd. (Medison Israel and, together with Medison Canada, Medison) to commercialize fostamatinib in all indications, in Medison territory which includes Canada and Israel; and with Knight Therapeutics International SA (Knight) to commercialize fostamatinib in all indications, in Knight territory which includes Latin America, consisting of Mexico, Central and South America, and the Caribbean (Knight territory). Further, we are also a party to collaboration agreements, but do not have ongoing performance obligations with BerGenBio for the development and commercialization of AXL receptor tyrosine kinase ( murine double minute 2 ( Under the above existing agreements that we entered into in the ordinary course of business, we received or may be entitled to receive upfront cash payments, payments contingent upon specified events achieved by such partners and royalties on any net sales of products sold by such partners under the agreements. As of June 30, 2024, total future contingent payments to us under all of the above existing agreements, excluding terminated agreements, could exceed $1.3 billion if all potential product candidates achieved all of the payment triggering events under all of our current agreements. Of this amount, $279.5 million relates to the achievement of development events, $263.1 million relates to the achievement of regulatory events and $796.0 million relates to the achievement of certain commercial events. This estimated future contingent amount does not include any estimated royalties that could be due to us if the partners successfully commercialize any of the licensed products. Future events that may trigger payments to us under the agreements are based solely on our partners’ future efforts and achievements of specified development, regulatory and/or commercial events. We account for the milestone payments when such milestones are considered probable of being achieved, and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within our or the licensee’s control, such as regulatory approvals, are not considered probable of being achieved until uncertainty associated with the approvals has been resolved. The transaction price is then allocated to each performance obligation, on a relative standalone selling price basis, for which we recognize revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, we re-evaluate the probability of achieving such milestones and any related constraint, and if necessary, adjust our estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, and recorded as part of contract revenues from collaborations during the period of adjustment. Global Exclusive License Agreement with Lilly We have a global exclusive license agreement and strategic collaboration with Lilly (Lilly Agreement) entered in February 2021, which became effective in March 2021, upon clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, to develop and commercialize ocadusertib (previously R552) for the treatment of non-CNS diseases. In addition, the collaboration is aimed at developing additional RIPK1 inhibitors for the treatment of CNS diseases. Pursuant to the terms of the Lilly Agreement, we granted Lilly the exclusive rights to develop and commercialize ocadusertib and related RIPK1 inhibitors in all indications worldwide. The parties’ collaboration is governed through a joint governance committee and appropriate subcommittees. Under the terms of the Lilly Agreement, we were entitled to receive a non-refundable and non-creditable upfront cash payment amounting to $125.0 million, which we received in April 2021. We are also entitled to additional milestone payments for non-CNS disease products consisting of up to $330.0 million in milestone payments upon the achievement of specified development, regulatory and commercial milestones, and up to $100.0 million in sales milestone payments on a product-by-product basis. In addition, depending on the extent of our co-funding of ocadusertib development activities, we would be entitled to receive tiered royalty payments on net sales of non-CNS disease products at percentages ranging from the mid-single digits to high-teens, subject to certain standard reductions and offsets. We are also eligible to receive milestone payments for CNS disease products consisting of up to $255.0 million in milestone payments upon the achievement of specified development, regulatory and commercial milestones, and up to $150.0 million in sales milestone payments on a product-by-product basis. We would be entitled to receive tiered royalty payments on net sales of CNS disease products up to low-double digits, subject to certain standard reductions and offsets. Under the Lilly Agreement, we were responsible for performing and funding initial discovery and identification of CNS disease development candidates. Following candidate selection, Lilly is responsible for performing and funding all future development and commercialization of the CNS disease development candidates. Under the Lilly Agreement, we are responsible for 20% of the development costs for ocadusertib in the US, Europe, and Japan, up to a specified cap, and Lilly is responsible for funding the remainder of all development activities for ocadusertib and other non-CNS disease development candidates. Pursuant to the terms of the Lilly Agreement, we have the right to opt-out of co-funding the ocadusertib development activities in the US, Europe and Japan at two different specified times and as a result receive lesser royalties from sales. Prior to us providing our first opt-out notice as discussed below, under the Lilly Agreement, we were required to fund our share of the ocadusertib development activities up to a maximum funding commitment of $65.0 million through April 1, 2024. We accounted for this agreement under ASC 606 and identified the following distinct performance obligations at inception of the agreement: (a) granting of the license rights over the non-CNS penetrant intellectual property (IP), and (b) granting of the license rights over the CNS penetrant IP which will be delivered to Lilly upon completion of the additional research and development efforts specified in the agreement. We concluded that each of these performance obligations is distinct. We based our assessment on the assumption that Lilly can benefit from each of the licenses on its own by developing and commercializing the underlying product using its own resources. At the inception of the Lilly Agreement, given our rights to opt-out from the development of ocadusertib, we believed at the minimum, we had a commitment to fund the development costs up to $65.0 million as discussed above. We considered this commitment to fund the development costs as a significant financing component of the contract, which we accounted for as a reduction of the upfront fee to derive the transaction price. This financing component was recorded as a liability at its net present value of approximately $57.9 million using a 6.4% discount rate. Interest expense was accreted on such liability over the expected commitment period, adjusted for timing of expected cost share payments. No interest was accreted during the three and six months ended June 30, 2024 and 2023. At the inception, we allocated the net transaction price of $67.1 million to each performance obligation based on our best estimate of its relative standalone selling price using the adjusted market assessment approach. The transaction price allocated to the non-CNS penetrant IP of $60.4 million was recognized as revenue upon delivery of the non-CNS penetrant IP to Lilly during the first quarter of 2021. The transaction price allocated to the CNS penetrant IP of $6.7 million was recognized as revenue from the effective date of the Lilly Agreement through the eventual acceptance by Lilly in June 2022 using the input method. There was no outstanding deferred revenue related to Lilly Agreement as of June 30, 2024 and December 31, 2023. On September 28, 2023, we entered into an amendment to the Lilly Agreement which provides, among others that if we exercise our first opt-out right, we have the right to opt-in to the co-funding of ocadusertib development, upon us providing notice to Lilly within 30 days of certain events as specified in the Lilly Agreement, and as a result receive greater royalties from sales. Following the amendment to the Lilly Agreement, on September 29, 2023, we provided the first opt-out notice to Lilly, and our share on the ocadusertib development cost was capped to $22.6 million through April 1, 2024. If we exercise our opt-in right, we will be required to continue to share in global development costs, and if we later exercise our second opt-out right (no later than April 1, 2025), our share in global development costs will be up to a specified cap through December 31, 2025, as provided for in the Lilly Agreement. Lilly billed us $21.4 million for our share of development costs incurred through April 1, 2024, and the amount was fully paid as of June 30, 2024. The outstanding liability to Lilly reported within other long-term liabilities (current and non-current) in the condensed balance sheet as of June 30, 2024 and December 31, 2023 amounted to $40.0 million and $43.6 million, respectively. As discussed above, following the amendment to the Lilly Agreement, and us providing the first opt-out notice to Lilly, our cost share obligation for ocadusertib development ended on April 1, 2024. Although currently we are no longer obligated to pay Lilly for our share in the ocadusertib development cost incurred subsequent to April 1, 2024, the outstanding liability reported in our condensed balance sheet as of June 30, 2024 amounting to $40.0 million has not been recognized as revenue because we cannot conclude that it is probable that a significant reversal of the amount of revenue, if recognized, will not occur until the likelihood of us exercising our opt-in right becomes remote, or when the opt-in right period lapses. Grifols License Agreement We have an exclusive commercialization license agreement with Grifols entered in January 2019 with exclusive rights to commercialize fostamatinib for human diseases, and non-exclusive rights to develop fostamatinib in Grifols territory. Under the agreement, we received an upfront payment of $30.0 million, with the potential for $297.5 million in total regulatory and commercial milestones. We are also entitled to receive stepped double-digit royalty payments based on tiered net sales which may reach 30% of net sales. In January 2020, the European Commission (EC) granted a centralized Marketing Authorization (MA) for fostamatinib valid throughout the European Union (EU) and in the UK after the departure of the UK from the EU for the treatment of chronic ITP in adult patients who are refractory to other treatments. With this approval, in February 2020, we received $20.0 million non-refundable payment, composed of a $17.5 million payment due upon Marketing Authorization Application (MAA) approval by the European Medicines Agency (EMA) of fostamatinib for the first indication and a $2.5 million creditable advance royalty payment, based on the terms of our collaboration agreement with Grifols. The above milestone payment was allocated to the distinct performance obligations in the collaboration agreement with Grifols. We accounted for this agreement under ASC 606 and identified distinct performance obligations at inception of the agreement. We allocated the transaction price to the distinct performance obligations in our collaboration agreement based on our best estimate of the relative standalone selling price, and recognized the corresponding revenue in the periods we satisfied the performance obligations. There was no outstanding deferred revenue related to the Grifols license agreement as of June 30, 2024 and December 31, 2023. We entered into a Commercial Supply Agreement with Grifols in October 2020 to supply and sell our drug product priced at a certain markup specified in the agreement, in quantities Grifols order from us pursuant to and in accordance with the agreement. Prior to the Commercial Supply Agreement, we had a Drug Product Purchase Agreement with Grifols entered in December 2019. There was no revenue recognized related to the delivery of drug supply to Grifols for the three and six months ended June 30, 2024. For the three and six month ended June 30, 2023, we recognized revenue of $1.2 million and $2.8 million, respectively, from the delivery of drug supply to Grifols. We recognize royalty revenue from Grifols included within contract revenues from collaboration. Royalty revenue recognized for the three months ended June 30, 2024 and 2023 was $1.1 million and $0.8 million, respectively, and for the six months ended June 30, 2024 and 2023 was $2.2 million and $1.5 million, respectively. Kissei License Agreement We have an exclusive license and supply agreement with Kissei entered in October 2018, to develop and commercialize fostamatinib in all current and potential indications in Kissei’s territory. Kissei is responsible for performing and funding all development activities for fostamatinib in the above-mentioned territories. We received an upfront cash payment of $33.0 million, with the potential for up to an additional $147.0 million in development, regulatory and commercial milestone payments, and will receive mid- to upper twenty percent, tiered, escalated net sales-based payments for the supply of fostamatinib. Under the agreement, we granted Kissei the license rights to fostamatinib in Kissei’s territory and are obligated to supply Kissei with drug product for use in clinical trials and pre-commercialization activities. We are also responsible for the manufacture and supply of fostamatinib for all future development and commercialization activities under the agreement. We accounted for this agreement under ASC 606 and identified the distinct performance obligations at inception of the agreement. We concluded that each of these performance obligations is distinct. We determined that the upfront fee represented the transaction price and was allocated to the performance obligations based on our best estimate of the relative standalone selling price and recognized the corresponding revenue in the period we satisfied the performance obligations. As of June 30, 2024 and December 31, 2023, the remaining deferred revenue was related to the material right associated with discounted fostamatinib supply which amounted to $1.4 million In April 2022, Kissei announced that an NDA was submitted to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for fostamatinib in chronic ITP. With this milestone event, we received $5.0 million non-refundable and non-creditable payment from Kissei pursuant to the terms of our collaboration agreement, and such amount was recognized as revenue in the second quarter of 2022. In December 2022, Kissei announced that Japan’s PMDA approved the NDA for fostamatinib in chronic ITP. With this milestone event, we were entitled to receive $20.0 million non-refundable and non-creditable payment from Kissei pursuant to the terms of our collaboration agreement, which we recognized as revenue in the fourth quarter of 2022 . The amount was subsequently collected in January 2023. For the three and six months ended June 30, 2024, we recognized $2.2 million and $4.5 million, respectively, of revenue related to the delivery of drug supply to Kissei mainly for commercial use. No such revenue was recognized during the three and six months ended June 30, 2023. Medison Commercial and License Agreements We have two exclusive commercial and license agreements with Medison entered in October 2019 for the commercialization of fostamatinib for chronic ITP in Medison territory, pursuant to which, we received a $5.0 million upfront payment with respect to the agreement in Canada. We accounted for this agreement under ASC 606 and identified the following combined performance obligations at inception of the agreement: (a) granting of the license and (b) obtaining regulatory approval in Canada of fostamatinib in ITP. However, under the agreement, we have the option to buy back all rights to the product in Canada within six months from obtaining regulatory approval for the treatment of auto immune hemolytic anemia in Canada. We determined that the non-refundable upfront fee represented the transaction price, however, due to the buyback provision, we accounted this upfront payment as financing arrangement under ASC 606. In 2022, management concluded that the likelihood of exercising the buyback option right was remote considering the top-line results from our Phase 3 trial of fostamatinib in warm auto immune hemolytic anemia (wAIHA) which showed that the trial did not demonstrate statistical significance in the primary efficacy endpoint, and the guidance received from the FDA. As such, in accordance with ASC 606, we relieved the outstanding financing liability which included the upfront payment and accreted interest, and recognized such amount as revenue in 2022. There was no outstanding deferred revenue related to Medison license agreement as of June 30, 2024 and December 31, 2023. For the three and six months ended June 30, 2024, we recognized revenue from Medison of $0.1 million and $0.2 million, respectively, related to the delivery of drug supply and earned royalties. There was no material revenue recognized in the three and six months ended June 30, 2023 related to the delivery of drug supply and earned royalties. Knight Commercial License and Supply Agreement We have commercial license and supply agreements with Knight entered in May 2022 for the commercialization of fostamatinib for approved indications in Knight territory. Pursuant to such commercial license agreement, we received a $2.0 million one-time, non-refundable, and non-creditable upfront payment, with potential for up to an additional $20.0 million in regulatory and sales-based commercial milestone payments, and will receive twenty- to mid-thirty percent, tiered, escalated net-sales based royalty payments for products sold in the Knight territory. We accounted for this agreement under ASC 606 and identified that the upfront payment was a consideration for granting Knight the license to commercialize fostamatinib for approved indication in the Knight territory, and no further material deliverables associated to such upfront payment. As such, we recognized the upfront payment as revenue in 2022. We are also responsible for the exclusive manufacture and supply of fostamatinib for all future development and commercialization activities under the agreement. Government Contracts US Department of Defense (DOD) Government contract revenue for the three and six months ended June 30, 2023 of $1.0 million was from an award we received from DOD to support our Phase 3 clinical trial to evaluate the safety and efficacy of fostamatinib for the treatment of hospitalized high-risk patients with COVID-19. No revenue was recognized during the three and six months ended June 30, 2024 from this grant. Biomedical Advanced Research and Development (BARDA) In August 2023, we were awarded up to $0.8 million by BARDA, part of the Office of the Assistant Secretary for the Preparedness and Response at the US Department of Health and Human Services (DHHS), for our evaluation of fostamatinib in mitigating the impact of long-term respiratory distress. No revenue was recognized during the three and six months ended June 30, 2024 from this grant. Through June 30, 2024, we have received $0.1 million of the award. Strategic Development Collaborations with MDACC and CONNECT In December 2023, we entered into a Strategic Collaboration Agreement with MDACC, a comprehensive cancer research, treatment, and prevention center. The collaboration will expand our evaluation of REZLIDHIA (olutasidenib) in AML and other hematologic cancers. Under the collaboration, we will provide MDACC the study materials and $15.0 million in time-based milestone payments as compensation for services to be provided for the studies, over the five-year collaboration term, unless terminated earlier as provided for in the agreement. Through June 30, 2024, we provided $2.0 million funding to MDACC. In January 2024, we announced our collaboration with CONNECT, an international collaborative network of pediatric cancer centers, to conduct a Phase 2 clinical trial to evaluate REZLIDHIA in glioma. Under the collaboration, we will provide funding up to $3.0 million and study material over the four-year collaboration. We account for the funding we provide under the above research collaboration agreements as prepaid research and development in the balance sheet to the extent the payment is made in advance of services being rendered, and recognize such amount as research and development expense within the statements of operations as the collaborative partners render the services under the respective agreement. |
IN-LICENSING AND ACQUISITION
IN-LICENSING AND ACQUISITION | 6 Months Ended |
Jun. 30, 2024 | |
IN-LICENSING AND ACQUISITION | |
IN-LICENSING AND ACQUISITION | 5. In-licensing and Acquisition Asset Purchase Agreement with Blueprint On February 22, 2024, we acquired the US rights to research, develop, manufacture and commercialize GAVRETO (pralsetinib) from Blueprint pursuant to an Asset Purchase Agreement. The acquired assets include, among other things, applicable intellectual property related to pralsetinib in the US, including patents, copyrights and trademarks, as well as clinical regulatory and commercial data and records. The potential regulatory milestones include full regulatory approval of pralsetinib (or related compounds) for the treatment of adult RET-fusion positive thyroid cancer, and maintenance of the current regulatory approval of pralsetinib for the treatment of adult RET-fusion positive thyroid cancer during the period beginning on February 22, 2024 and ending on the third anniversary of the first commercial sale of pralsetinib subject to certain conditions. In accordance with ASC 805 Business Combinations , developed technology, customers, trademarks and trade name, and are considered a single asset as they are inextricably linked. ASC 805 provides for a screen test, wherein if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets, the assets acquired are not considered to be a business. The following table summarizes the total purchase consideration in connection with the asset acquisition (in thousands): Closing purchase price $ 15,000 Transaction costs 360 Total purchase consideration $ 15,360 The closing purchase price was recorded within acquisition-related liabilities in the condensed balance sheet and was outstanding as of June 30, 2024, of which, $10.0 million was paid in July 2024 following our first commercial sale of GAVRETO at the end of June 2024. The transaction costs have been paid in cash as of June 30, 2024. The contingent considerations relating to future commercial and regulatory milestones were not included in the total purchase price consideration, and will be accounted for when the contingency is resolved and the consideration becomes payable. Royalties will be recognized within cost of sales, as revenue from GAVRETO product sales is recognized. In an asset acquisition, the acquiring entity should recognize the assets acquired at cost to the acquiring entity which includes transaction costs and consideration given, allocated based on a relative fair value of the assets acquired measured at acquisition date. The fair value of the developed technology, customers, trademarks and trade name was estimated using a multi-period excess earnings income approach that discounts expected cash flows to present value by applying discount rate that represents the estimated rate that market participants would use to value such assets. The relative fair value are based on estimates that required judgement and certain assumptions, categorized as Level 3 in the fair value hierarchy. Since we acquired a single asset, the total purchase consideration was recorded as intangible assets. The related intangible assets is being amortized on a straight-line basis over the estimated useful life of 12 years , and the related amortization is recorded within cost of sales. Simultaneously and in connection with entering into the Asset Purchase Agreement, we also entered into certain supporting agreements, including a customary transition agreement, pursuant to which, during the transition period, Blueprint will transition regulatory and distribution responsibility for GAVRETO to us. We also agreed to purchase certain drug product inventories from Blueprint under a Material Transfer Agreement, and received such inventories amounting to approximately $6.5 million during the six months ended June 30, 2024. License and Transition Services Agreement with Forma We have a license and transition services agreement with Forma entered in July 2022, for an exclusive license to develop, manufacture and commercialize olutasidenib, a proprietary inhibitor of mutated IDH1 (mIDH1), for any uses worldwide, including for the treatment of AML and other malignancies. Forma became a wholly owned subsidiary of Novo Nordisk following the closing of its acquisition by Novo Nordisk in October 2022. Pursuant to the terms of the license and transition services agreement, we paid an upfront fee of $2.0 million, with the potential to pay up to $67.5 million of additional payments upon achievement of specified development and regulatory milestones and up to $165.5 million of additional payments upon achievement of certain commercial milestones. In addition, subject to the terms and conditions of the license and transition services agreement, Forma would be entitled to tiered royalty payments on net sales of licensed products at percentages ranging from low-teens to mid-thirties, as well as certain portion of our sublicensing revenue, subject to certain standard reductions and offsets. The transaction was accounted for as an acquisition of asset under ASC 730, Research and Development At the acquisition date, the acquired license asset was accounted for as IPR&D, and we anticipated no other economic benefit to be derived from such acquired licensed asset other than the primary indications. As such, we accounted for the upfront fee of $2.0 million Under the accounting guidance, we account for contingent payments when a We account for m The amount recorded as intangible asset is being amortized on a straight-line basis over the estimated useful life of 14 years , and the related amortization is recorded within cost of sales . Royalties are recognized within cost of sales, as revenue from REZLIDHIA product sales is recognized. |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 6 Months Ended |
Jun. 30, 2024 | |
STOCK-BASED COMPENSATION | |
STOCK-BASED COMPENSATION | 6. Stock-Based Compensation Stock-based compensation for the periods presented was as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Selling, general and administrative $ 2,223 $ 1,796 $ 6,707 $ 3,531 Research and development 305 376 955 1,399 Total stock-based compensation expense $ 2,528 $ 2,172 $ 7,662 $ 4,930 During the six months ended June 30, 2024, we granted stock options to purchase 599,772 shares of common stock with weighted-average grant-date fair value of $9.64 per share, and 9,294 stock options were exercised. The stock options granted during the six months ended June 30, 2024 generally vest over 3 years . As of June 30, 2024, there were 3,691,139 stock options outstanding, of which, 132,250 are outstanding performance-based stock options wherein the achievement of the corresponding corporate-based milestones were assessed not probable as of June 30, 2024. Accordingly, none of the $2.5 million grant date fair value for these awards has been recognized as stock-based compensation expense as of June 30, 2024. The fair value of each option award is estimated on the date of grant using the Black-Scholes option pricing model. The following table summarizes the weighted-average assumptions relating to options granted pursuant to our Equity Incentive Plans (our 2018 Equity Incentive Plan and Inducement Plan, as amended) for the periods presented: Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Risk-free interest rate 4.5 % 3.7 % 4.2 % 3.7 % Expected term (in years) 6.0 6.7 6.2 7.0 Dividend yield 0.0 % 0.0 % 0.0 % 0.0 % Expected volatility 88.1 % 86.0 % 87.4 % 83.1 % During the six months ended June 30, 2024, we granted 291,373 RSUs with a grant-date weighted-average fair value of $12.52 per share, and 66,408 RSUs were released. The RSUs granted during the six months ended June 30, 2024 generally vest over 3 years . As of June 30, 2024, there were 387,729 RSUs outstanding. As of June 30, 2024, there was approximately $14.0 million of unrecognized stock-based compensation cost which is expected to be recognized over a remaining weighted-average period of 2.15 years, related to time-based stock options, performance-based stock options wherein achievement of the corresponding corporate-based milestones was considered as probable, and RSUs. In March 2024 and April 2024, our Board of Directors approved additional 78,232 shares of common stock reserved for issuance under our Inducement Plan. In May 2024, our stockholders approved an amendment to our 2018 Plan, to, among other items, add an additional 650,000 shares to the number of shares of common stock authorized for issuance under our 2018 Plan. As of June 30, 2024, there were 1,412,669 shares of common stock available for future grant under our Equity Incentive Plans. Employee Stock Purchase Plan Our Purchase Plan provides for a 24 -month offering period comprises four six-month purchase periods with a look-back option. A look-back option is a provision in our Purchase Plan under which eligible employees can purchase shares of our common stock at a price per share equal to the lesser of 85% of the fair market value on the first day of the offering period or 85% of the fair market value on the purchase date. Our Purchase Plan also includes a feature that provides for a new offering period to begin when the fair market value of our common stock on any purchase date during an offering period falls below the fair market value of our common stock on the first day of such offering period. This feature is called a “reset.” Participants are automatically enrolled in the new offering period. Our 24 -month offering period under our Purchase Plan ended on June 30, 2024, and a new 24 -month offering period started on July 1, 2024. The fair value of awards under our Purchase Plan is estimated on the date of our new offering period using the Black-Scholes option pricing model, which is being amortized over the requisite service periods. As of June 30, 2024, there was no unrecognized stock-based compensation cost related to our Purchase Plan. During the six months ended June 30, 2024, there were 35,902 shares purchased under the Purchase Plan. As of June 30, 2024, there were 213,681 shares reserved for future issuance under the Purchase Plan. |
OTHER BALANCE SHEET COMPONENTS
OTHER BALANCE SHEET COMPONENTS | 6 Months Ended |
Jun. 30, 2024 | |
OTHER BALANCE SHEET COMPONENTS | |
OTHER BALANCE SHEET COMPONENTS | 7. Other Balance Sheet Components Inventories Inventories for the periods presented consist of the following (in thousands): As of June 30, 2024 December 31, 2023 Raw materials $ 2,145 $ 4,609 Work in process 6,006 1,876 Finished goods 4,368 1,508 Total $ 12,519 $ 7,993 Reported as: Inventories $ 8,059 $ 5,522 Other assets 4,460 2,471 Total $ 12,519 $ 7,993 Inventories as of June 30, 2024 and December 31, 2023 include inventories acquired from Forma pursuant to the license and transition services agreement. Inventories as of June 30, 2024 also include inventories acquired from Blueprint pursuant to a Material Transfer Agreement as discussed in Note 5 – In-licensing and Acquisition. As of June 30, 2024, advance payments to the manufacturer of our raw materials were included within prepaid and other current assets in the condensed balance sheet amounted to $2.2 million. No such advance payment was included within prepaid and other current assets as of December 31, 2023. Non-current inventories consist primarily of active pharmaceutical ingredients classified as raw materials which have multi-year shelf life, as well as certain work in process and finished goods inventories that are not expected to be consumed beyond our normal operating cycle. Intangible assets Intangible assets consist of the following (in thousands): As of June 30, 2024 December 31, 2023 Intangible asset cost $ 30,360 $ 15,000 Accumulated amortization (2,085) (1,122) Intangible asset, net $ 28,275 $ 13,878 See “Note 5 – In-licensing and Acquisition” for related discussions of capitalized intangible assets. Amortization expense recorded within cost of sales in the statements of operations for the three months ended June 30, 2024 and 2023 was $0.6 million and $0.3 million, respectively, and for the six months ended June 30, 2024 and 2023 was $1.0 million and $0.5 million, respectively. The following table presents the estimated future amortization expense of intangible assets as of June 30, 2024 (in thousands): Remainder of 2024 $ 1,176 2025 2,351 2026 2,351 2027 2,351 2028 2,351 Thereafter 17,695 $ 28,275 |
CASH, CASH EQUIVALENTS AND SHOR
CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS | 6 Months Ended |
Jun. 30, 2024 | |
CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS | |
CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS | 8. Cash, Cash Equivalents and Short-Term Investments Cash, cash equivalents and short-term investments for the periods presented consist of the following (in thousands): As of June 30, 2024 December 31, 2023 Cash $ 6,126 $ 8,247 Money market funds 13,805 9,685 US treasury bills 4,963 12,594 Government-sponsored enterprise securities 10,444 11,233 Corporate bonds and commercial paper 13,764 15,174 $ 49,102 $ 56,933 Reported as: Cash and cash equivalents $ 36,053 $ 32,786 Short-term investments 13,049 24,147 $ 49,102 $ 56,933 Cash equivalents and short-term investments include the following securities with gross unrealized gains and losses (in thousands): Gross Gross Amortized Unrealized Unrealized As of June 30, 2024 Cost Gains Losses Fair Value US treasury bills $ 4,963 $ — $ — $ 4,963 Government-sponsored enterprise securities 10,446 — (2) 10,444 Corporate bonds and commercial paper 13,771 — (7) 13,764 Total $ 29,180 $ — $ (9) $ 29,171 Gross Gross Amortized Unrealized Unrealized As of December 31, 2023 Cost Gains Losses Fair Value US treasury bills $ 12,591 $ 3 $ — $ 12,594 Government-sponsored enterprise securities 11,230 7 (4) 11,233 Corporate bonds and commercial paper 15,172 5 (3) 15,174 Total $ 38,993 $ 15 $ (7) $ 39,001 As of June 30, 2024 and December 31, 2023, our cash equivalents and short-term investments had a weighted-average time to maturity of approximately 68 days and 82 days , respectively. Our short-term investments are classified as available-for-sale securities. Accordingly, we have classified these securities as short-term investments on our condensed balance sheets as they are available for use in the current operations. As of June 30, 2024, we had no investments that had been in a continuous unrealized loss position for more than 12 months. As of June 30, 2024, a total of 26 individual securities had been in an unrealized loss position for 12 months or less, and the losses were determined to be temporary. No significant facts or circumstances have arisen to indicate that there has been any significant deterioration in the creditworthiness of the issuers of the securities held by us. Based on our review of these securities, including the assessment of the duration and severity of the unrealized losses, we have no t recognized any credit losses on these securities as of June 30, 2024 and December 31, 2023. The following table shows the fair value and gross unrealized losses of our investments in individual securities that are in an unrealized loss position, aggregated by investment category (in thousands): As of June 30, 2024 Fair Value Unrealized Losses Government-sponsored enterprise securities $ 9,694 $ (2) Corporate bonds and commercial paper 13,265 (7) Total $ 22,959 $ (9) |
FAIR VALUE
FAIR VALUE | 6 Months Ended |
Jun. 30, 2024 | |
FAIR VALUE | |
FAIR VALUE | 9. Fair Value The table below summarizes the fair value of our cash equivalents and short-term investments measured at fair value on a recurring basis, and are categorized based upon the lowest level of significant input to the valuations (in thousands): Assets at Fair Value as of June 30, 2024 Level 1 Level 2 Level 3 Total Money market funds $ 13,805 $ — $ — $ 13,805 US treasury bills — 4,963 — 4,963 Government-sponsored enterprise securities — 10,444 — 10,444 Corporate bonds and commercial paper — 13,764 — 13,764 Total $ 13,805 $ 29,171 $ — $ 42,976 Assets at Fair Value as of December 31, 2023 Level 1 Level 2 Level 3 Total Money market funds $ 9,685 $ — $ — $ 9,685 US treasury bills — 12,594 — 12,594 Government-sponsored enterprise securities — 11,233 — 11,233 Corporate bonds and commercial paper — 15,174 — 15,174 Total $ 9,685 $ 39,001 $ — $ 48,686 |
DEBT
DEBT | 6 Months Ended |
Jun. 30, 2024 | |
DEBT | |
DEBT | 10. Debt The following table summarizes loans payable, net (in thousands): As of June 30, 2024 December 31, 2023 Principal outstanding $ 60,000 $ 60,000 Unamortized debt issuance costs (308) (398) Principal outstanding, net of unamortized debt issuance costs $ 59,692 $ 59,602 Reported as: Loans payable, net, current portion $ — $ 7,229 Long-term portion of loans payable, net 59,692 52,373 $ 59,692 $ 59,602 The outstanding loans payable as of the periods presented was related to our Credit and Security Agreement (Credit Agreement) with MidCap Financial Trust (MidCap) entered into on September 27, 2019 (Closing Date) and amended on March 29, 2021 (First Amendment), February 11, 2022 (Second Amendment), July 27, 2022 (Third Amendment), and on April 11, 2024 (Fourth Amendment). The Credit Agreement provides for a $60.0 million term loan credit facility. At the Closing Date, $10.0 million was funded (Tranche 1), in May 2020, an additional $10.0 million was funded (Tranche 2), at the Second Amendment, an additional $10.0 million was funded (Tranche 3), at the Third Amendment, an additional $10.0 million was funded (Tranche 4), and in March 2023, an additional $20.0 million was funded (Tranche 5). As of June 30, 2024, the outstanding principal balance of the loan was $60.0 million, and no remaining funds are available for draw under the term loan credit facility. The First Amendment to the Credit Agreement extended the period through which Tranche 3 was available to us. The Second Amendment to the Credit Agreement, among other things, amended the applicable funding conditions, applicable commitments and certain other terms relating to available credit facilities (Tranches 3 and 4), added additional term loan credit facility (Tranche 5), and revised certain terms related to the financial covenants. Following the Third Amendment but prior to the Fourth Amendment to the Credit Agreement in April 2024 as discussed below, the term loans would mature on September 1, 2026, and the interest-only period was through October 1, 2024. The term loans bore interest equal to the sum of one-month Secured Overnight Financing Rate (SOFR) , plus an adjustment of 0.11448% , subject to 1.50% applicable floor, plus applicable margin of 5.65% , and a final payment fee of 2.5% of principal due at maturity date. Following the Fourth Amendment to the Credit Agreement in April 2024, the term loans mature on September 1, 2027, and the interest-only period is through October 1, 2025. The term loans bear interest equal to the sum of one-month SOFR plus an adjustment of 0.11448% , subject to a 4.00% applicable floor, plus applicable margin of 6.50% . A final payment fee of 4.25% of principal is due at maturity date. The amendment was accounted for as debt modification in accordance with the standards. The unamortized debt issuance costs are continuously being amortized as interest expense through maturity using the effective interest rate method. We Interest expense, including amortization of the debt discount and accretion of the final fees related to the Credit Agreement for the three months ended June 30, 2024 and 2023 was $2.0 million and $1.9 million, respectively, and for the six months ended June 30, 2024 and 2023 was $3.9 million and $3.1 million, respectively. Accrued interest of $1.8 million was included within other accrued liabilities in the condensed balance sheet as of June 30, 2024. The following table presents the future minimum principal payments of the outstanding loan as of June 30, 2024 (in thousands): Remainder of 2024 $ — 2025 7,500 2026 30,000 2027 22,500 Principal amount (Tranches 1, 2, 3 and 4) $ 60,000 The amended Credit Agreement contains certain covenants which, among others, require us to deliver financial reports at designated times of the year and maintain minimum unrestricted cash and trailing net revenues. As of June 30, 2024, we were not in violation of any covenants. |
LEASES
LEASES | 6 Months Ended |
Jun. 30, 2024 | |
LEASES | |
LEASES | 11. Leases We have a sublease agreement with Atara Biotherapeutics, Inc. (Atara) entered in October 2022 to sublease an office space located in South San Francisco, California. Subject to the terms of the sublease agreement, the lease term commenced in November 2022 and shall expire in May 2025. This leased facility is currently held as our new Headquarters following the expiration of our previously leased facility in January 2023. The weighted average remaining term of our leases as of June 30, 2024 was 0.92 years. We previously leased our prior headquarter space located in South San Francisco, California with Healthpeak Properties, Inc. (formerly known as HCP BTC, LLC), and had a sublease agreement with an unrelated third-party to sublet a portion of the leased facility. Both leases expired in January 2023. The components of our operating lease expense were as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Fixed operating lease expense $ 166 $ 166 $ 332 778 Variable operating lease expense (net credit) 28 (42) 56 30 Total operating lease expense $ 194 $ 124 $ 388 $ 808 Supplemental information related to our operating lease were as follow (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Cash payments included in the measurement of operating lease liabilities $ 184 $ 178 $ 368 1,174 Supplemental information related to our operating sublease was as follow (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Fixed sublease expense $ — $ — $ — 365 Variable sublease expense — — — 77 Sublease income — — — (442) Net $ — $ — $ — $ — The following table presents the future lease payments as of June 30, 2024 (in thousands): Remainder of 2024 $ 371 2025 301 Total minimum payments required $ 672 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Pay vs Performance Disclosure | ||||
Net Income (Loss) | $ (1,030) | $ (6,600) | $ (9,277) | $ (20,136) |
Insider Trading Arrangements
Insider Trading Arrangements | 6 Months Ended |
Jun. 30, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
ORGANIZATION AND SUMMARY OF S_2
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 6 Months Ended |
Jun. 30, 2024 | |
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Reverse Stock Split | Reverse Stock Split We filed with the Secretary of State of the State of Delaware a certificate of amendment to our Amended and Restated Certificate of Incorporation, to effect a 1-for-10 reverse stock split, effective June 27, 2024. As a result of the reverse stock split, every ten issued and outstanding shares of our common stock were automatically combined into one issued and outstanding share of common stock. Accordingly, an amount equal to the par value of the decreased shares resulting from the reverse stock split was reclassified from common stock to additional paid-in capital on the condensed balance sheet and statement of changes in stockholders’ deficit. No fractional shares were issued in connection with the reverse stock split. Stockholders who otherwise would be entitled to receive fractional shares of common stock were entitled to receive the cash value equal to the fraction to which the stockholder would otherwise be entitled, multiplied by the closing price of the common stock as reported by Nasdaq on the last trading day prior to the effective date of the split. As a result of the reverse stock split, proportionate adjustments were made to the number of shares underlying (and as applicable, the exercise or conversion prices of) our outstanding equity awards and to the number of shares of common stock issuable under our equity incentive plans. The reverse stock split did not change the par value of our common stock, which remains $0.001 , or the authorized number of shares of our common stock. All share amounts and per share amounts disclosed in this Quarterly Report on Form 10-Q have been adjusted to reflect the reverse stock split on a retroactive basis for all periods presented. |
Basis of Presentation | Basis of Presentation Our accompanying unaudited condensed financial statements have been prepared in accordance with United States generally accepted accounting principles (US GAAP), for interim financial information and pursuant to the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities Act of 1933, as amended (Securities Act). Accordingly, they do not include all the information and notes required by US GAAP for complete financial statements. These unaudited condensed financial statements include only normal and recurring adjustments that we believe are necessary to fairly state our financial position and the results of our operations and cash flows. Interim-period results are not necessarily indicative of results of operations or cash flows for a full-year or any subsequent interim period. The balance sheet as of December 31, 2023 has been derived from audited financial statements at that date but does not include all disclosures required by US GAAP for complete financial statements. Because certain disclosures required by US GAAP for complete financial statements are not included herein, these interim unaudited condensed financial statements and the notes accompanying them should be read in conjunction with our audited financial statements and the notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2023. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances. Actual results could differ from these estimates. |
Liquidity | Liquidity As of June 30, 2024, we had approximately $49.1 million in cash, cash equivalents and short-term investments. Since inception, we have financed our operations primarily through sales of equity securities, debt financing, contract payments under our collaboration agreements and from product sales. Based on our current operating plan, we believe that our existing cash, cash equivalents, and short-term investments will be sufficient to fund our expenses and capital expenditure requirements for at least the next 12 months from the date of issuance of this Form 10-Q. |
Recently Issued Accounting Standards | Recently Issued Accounting Standards In November 2023, FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. interim disclosures of a reportable segment’s profit or loss and assets. All disclosure requirements under this update are also required for public entities with a single reportable segment. This update is effective for our Annual Report on Form 10-K for the fiscal year ending December 31, 2024, and interim periods thereafter. Early adoption is permitted. The update should be applied retrospectively to all periods presented in the financial statements. We are currently evaluating the impact of adopting this update on our financial statements and disclosures. In December 2023, FASB issued ASU 2023-09, Improvements to Income Tax Disclosures Other recently issued accounting guidance not discussed in this Quarterly Report on Form 10-Q are either not applicable or did not have, or are not expected to have, a material impact on us. |
NET LOSS PER SHARE (Tables)
NET LOSS PER SHARE (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
NET LOSS PER SHARE | |
Schedule of antidilutive securities | Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Outstanding stock options 3,691 3,524 3,691 3,524 RSUs 388 196 388 196 Total 4,079 3,720 4,079 3,720 |
REVENUES (Tables)
REVENUES (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
REVENUES | |
Schedule of revenues disaggregated by category | Revenues disaggregated by category were as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Product sales: Gross product sales $ 48,980 $ 33,456 $ 87,406 $ 66,654 Discounts and allowances (15,530) (9,575) (27,953) (19,028) Total product sales, net 33,450 23,881 59,453 47,626 Revenues from collaborations: Delivery of drug supplies, royalty and others 3,391 2,005 6,922 4,330 Total revenues from collaborations 3,391 2,005 6,922 4,330 Government contracts — 1,000 — 1,000 Total revenues $ 36,841 $ 26,886 $ 66,375 $ 52,956 |
Schedule of product revenue allowance and reserve categories | Chargebacks, Government Discounts and and Other Fees Rebates Returns Total Balance as of January 1, 2024 $ 8,236 $ 3,517 $ 3,931 $ 15,684 Provision related to current period sales 21,770 5,259 522 27,551 Credit or payments made during the period (20,165) (4,441) (82) (24,688) Balance as of June 30, 2024 $ 9,841 $ 4,335 $ 4,371 $ 18,547 Chargebacks, Government Discounts and and Other Fees Rebates Returns Total Balance as of January 1, 2023 $ 6,213 $ 2,636 $ 3,296 $ 12,145 Provision related to current period sales 14,439 3,725 395 18,559 Credit or payments made during the period (13,139) (3,765) (116) (17,020) Balance as of June 30, 2023 $ 7,513 $ 2,596 $ 3,575 $ 13,684 |
Schedule of revenues from product sales disaggregated by customers | Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 McKesson Corporation 49% 44% 46% 45% Cardinal Health, Inc. 21% 28% 22% 26% Cencora Inc. (formerly ASD Healthcare) 20% 19% 21% 21% |
IN-LICENSING AND ACQUISITION (T
IN-LICENSING AND ACQUISITION (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
IN-LICENSING AND ACQUISITION | |
Summary of total purchase consideration in connection with asset acquisition | The following table summarizes the total purchase consideration in connection with the asset acquisition (in thousands): Closing purchase price $ 15,000 Transaction costs 360 Total purchase consideration $ 15,360 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of stock-based compensation | Stock-based compensation for the periods presented was as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Selling, general and administrative $ 2,223 $ 1,796 $ 6,707 $ 3,531 Research and development 305 376 955 1,399 Total stock-based compensation expense $ 2,528 $ 2,172 $ 7,662 $ 4,930 |
Employee Stock Option [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Summary of weighted-average assumptions relating to options granted | Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Risk-free interest rate 4.5 % 3.7 % 4.2 % 3.7 % Expected term (in years) 6.0 6.7 6.2 7.0 Dividend yield 0.0 % 0.0 % 0.0 % 0.0 % Expected volatility 88.1 % 86.0 % 87.4 % 83.1 % |
OTHER BALANCE SHEET COMPONENTS
OTHER BALANCE SHEET COMPONENTS (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
OTHER BALANCE SHEET COMPONENTS | |
Schedule of Inventories | Inventories for the periods presented consist of the following (in thousands): As of June 30, 2024 December 31, 2023 Raw materials $ 2,145 $ 4,609 Work in process 6,006 1,876 Finished goods 4,368 1,508 Total $ 12,519 $ 7,993 Reported as: Inventories $ 8,059 $ 5,522 Other assets 4,460 2,471 Total $ 12,519 $ 7,993 |
Schedule of intangible assets | Intangible assets consist of the following (in thousands): As of June 30, 2024 December 31, 2023 Intangible asset cost $ 30,360 $ 15,000 Accumulated amortization (2,085) (1,122) Intangible asset, net $ 28,275 $ 13,878 |
Schedule of estimated future amortization expense of intangible asset | The following table presents the estimated future amortization expense of intangible assets as of June 30, 2024 (in thousands): Remainder of 2024 $ 1,176 2025 2,351 2026 2,351 2027 2,351 2028 2,351 Thereafter 17,695 $ 28,275 |
CASH, CASH EQUIVALENTS AND SH_2
CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS | |
Schedule of cash, cash equivalents and short-term investments | Cash, cash equivalents and short-term investments for the periods presented consist of the following (in thousands): As of June 30, 2024 December 31, 2023 Cash $ 6,126 $ 8,247 Money market funds 13,805 9,685 US treasury bills 4,963 12,594 Government-sponsored enterprise securities 10,444 11,233 Corporate bonds and commercial paper 13,764 15,174 $ 49,102 $ 56,933 Reported as: Cash and cash equivalents $ 36,053 $ 32,786 Short-term investments 13,049 24,147 $ 49,102 $ 56,933 |
Schedule of cash equivalents and short-term investments including securities with unrealized gains and losses | Cash equivalents and short-term investments include the following securities with gross unrealized gains and losses (in thousands): Gross Gross Amortized Unrealized Unrealized As of June 30, 2024 Cost Gains Losses Fair Value US treasury bills $ 4,963 $ — $ — $ 4,963 Government-sponsored enterprise securities 10,446 — (2) 10,444 Corporate bonds and commercial paper 13,771 — (7) 13,764 Total $ 29,180 $ — $ (9) $ 29,171 Gross Gross Amortized Unrealized Unrealized As of December 31, 2023 Cost Gains Losses Fair Value US treasury bills $ 12,591 $ 3 $ — $ 12,594 Government-sponsored enterprise securities 11,230 7 (4) 11,233 Corporate bonds and commercial paper 15,172 5 (3) 15,174 Total $ 38,993 $ 15 $ (7) $ 39,001 |
Schedule of fair value and gross unrealized losses of investments in unrealized loss position | The following table shows the fair value and gross unrealized losses of our investments in individual securities that are in an unrealized loss position, aggregated by investment category (in thousands): As of June 30, 2024 Fair Value Unrealized Losses Government-sponsored enterprise securities $ 9,694 $ (2) Corporate bonds and commercial paper 13,265 (7) Total $ 22,959 $ (9) |
FAIR VALUE (Tables)
FAIR VALUE (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
FAIR VALUE | |
Schedule of financial assets measured at fair value on a recurring basis | The table below summarizes the fair value of our cash equivalents and short-term investments measured at fair value on a recurring basis, and are categorized based upon the lowest level of significant input to the valuations (in thousands): Assets at Fair Value as of June 30, 2024 Level 1 Level 2 Level 3 Total Money market funds $ 13,805 $ — $ — $ 13,805 US treasury bills — 4,963 — 4,963 Government-sponsored enterprise securities — 10,444 — 10,444 Corporate bonds and commercial paper — 13,764 — 13,764 Total $ 13,805 $ 29,171 $ — $ 42,976 Assets at Fair Value as of December 31, 2023 Level 1 Level 2 Level 3 Total Money market funds $ 9,685 $ — $ — $ 9,685 US treasury bills — 12,594 — 12,594 Government-sponsored enterprise securities — 11,233 — 11,233 Corporate bonds and commercial paper — 15,174 — 15,174 Total $ 9,685 $ 39,001 $ — $ 48,686 |
DEBT (Tables)
DEBT (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
DEBT | |
Summary of loans payable, net | The following table summarizes loans payable, net (in thousands): As of June 30, 2024 December 31, 2023 Principal outstanding $ 60,000 $ 60,000 Unamortized debt issuance costs (308) (398) Principal outstanding, net of unamortized debt issuance costs $ 59,692 $ 59,602 Reported as: Loans payable, net, current portion $ — $ 7,229 Long-term portion of loans payable, net 59,692 52,373 $ 59,692 $ 59,602 |
Schedule of future minimum payments | The following table presents the future minimum principal payments of the outstanding loan as of June 30, 2024 (in thousands): Remainder of 2024 $ — 2025 7,500 2026 30,000 2027 22,500 Principal amount (Tranches 1, 2, 3 and 4) $ 60,000 |
LEASES (Tables)
LEASES (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
LEASES | |
Schedule of components of operating lease expense | Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Fixed operating lease expense $ 166 $ 166 $ 332 778 Variable operating lease expense (net credit) 28 (42) 56 30 Total operating lease expense $ 194 $ 124 $ 388 $ 808 |
Schedule of supplemental information related to operating lease | Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Cash payments included in the measurement of operating lease liabilities $ 184 $ 178 $ 368 1,174 |
Schedule of operating sublease information | Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Fixed sublease expense $ — $ — $ — 365 Variable sublease expense — — — 77 Sublease income — — — (442) Net $ — $ — $ — $ — |
Schedule of future minimum lease payments | Remainder of 2024 $ 371 2025 301 Total minimum payments required $ 672 |
ORGANIZATION AND SUMMARY OF S_3
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Basis of Presentation and Liquidity (Details) $ / shares in Units, $ in Thousands | Jun. 27, 2024 | Jun. 30, 2024 USD ($) $ / shares | Dec. 31, 2023 USD ($) |
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |||
Stock split, conversion ratio | 0.1 | ||
Common stock, par value (in dollars per share) | $ / shares | $ 0.001 | ||
Cash, cash equivalents and short-term investments | $ | $ 49,102 | $ 56,933 |
NET LOSS PER SHARE (Details)
NET LOSS PER SHARE (Details) - shares shares in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Antidilutive securities excluded from the computation of diluted net loss per share | ||||
Total | 4,079 | 3,720 | 4,079 | 3,720 |
Employee Stock Option [Member] | ||||
Antidilutive securities excluded from the computation of diluted net loss per share | ||||
Total | 3,691 | 3,524 | 3,691 | 3,524 |
RSUs | ||||
Antidilutive securities excluded from the computation of diluted net loss per share | ||||
Total | 388 | 196 | 388 | 196 |
REVENUES - Disaggregated (Detai
REVENUES - Disaggregated (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Disaggregation of Revenue [Line Items] | ||||
Total revenues | $ 36,841 | $ 26,886 | $ 66,375 | $ 52,956 |
Gross product sales | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | 48,980 | 33,456 | 87,406 | 66,654 |
Discounts and allowances | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | (15,530) | (9,575) | (27,953) | (19,028) |
Product sales, net | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | 33,450 | 23,881 | 59,453 | 47,626 |
Delivery of drug supplies, royalty and others | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | 3,391 | 2,005 | 6,922 | 4,330 |
Revenues from collaborations | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | $ 3,391 | 2,005 | $ 6,922 | 4,330 |
Government contracts | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | $ 1,000 | $ 1,000 |
REVENUES - Activity (Details)
REVENUES - Activity (Details) - USD ($) $ in Thousands | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | |||
Balance | $ 15,684 | $ 12,145 | |
Provision related to current period sales | 27,551 | 18,559 | |
Credit or payments made during the period | (24,688) | (17,020) | |
Balance | 18,547 | 13,684 | |
Discounts and allowances | 27,600 | 18,600 | |
Other accrued liabilities | 5,933 | $ 5,334 | |
Accounts receivable and prepaid and other current assets | |||
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | |||
Discounts and allowances | 400 | 400 | |
Chargebacks, Discounts and Fees | |||
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | |||
Balance | 8,236 | 6,213 | |
Provision related to current period sales | 21,770 | 14,439 | |
Credit or payments made during the period | (20,165) | (13,139) | |
Balance | 9,841 | 7,513 | |
Government and Other Rebates | |||
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | |||
Balance | 3,517 | 2,636 | |
Provision related to current period sales | 5,259 | 3,725 | |
Credit or payments made during the period | (4,441) | (3,765) | |
Balance | 4,335 | 2,596 | |
Returns | |||
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | |||
Balance | 3,931 | 3,296 | |
Provision related to current period sales | 522 | 395 | |
Credit or payments made during the period | (82) | (116) | |
Balance | $ 4,371 | $ 3,575 |
REVENUES - Percentage by Custom
REVENUES - Percentage by Customer (Details) - Sales - Customer Concentration Risk | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
McKesson Specialty Care Distribution Corporation | ||||
Disaggregation of Revenue [Line Items] | ||||
Percentage | 46% | 45% | 49% | 44% |
Cardinal Health Inc. | ||||
Disaggregation of Revenue [Line Items] | ||||
Percentage | 22% | 26% | 21% | 28% |
Cencora Inc. (formerly ASD Healthcare) | ||||
Disaggregation of Revenue [Line Items] | ||||
Percentage | 21% | 21% | 20% | 19% |
SPONSORED RESEARCH AND LICENS_2
SPONSORED RESEARCH AND LICENSE AGREEMENTS AND GOVERNMENT CONTRACT (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | 7 Months Ended | 11 Months Ended | 12 Months Ended | |||||||||||||
Aug. 31, 2023 USD ($) | Jul. 27, 2022 USD ($) | Apr. 30, 2021 USD ($) | Feb. 29, 2020 USD ($) | Oct. 31, 2019 USD ($) agreement | Jan. 31, 2019 USD ($) | Oct. 31, 2018 USD ($) | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Dec. 31, 2022 USD ($) | Jun. 30, 2022 USD ($) | Mar. 31, 2021 USD ($) | Jun. 30, 2024 USD ($) period | Jun. 30, 2023 USD ($) | Jun. 30, 2024 USD ($) | Jun. 30, 2024 USD ($) | Dec. 31, 2021 USD ($) | Jan. 31, 2024 USD ($) | Dec. 31, 2023 USD ($) | |
Collaborations | |||||||||||||||||||
Contingent payments | $ 1,300,000 | ||||||||||||||||||
Right to opt out of agreement, different specified times | period | 2 | ||||||||||||||||||
Upfront payment received | $ 125,000 | ||||||||||||||||||
Payment of cost share to collaboration partner | $ 3,605 | $ 1,754 | |||||||||||||||||
Revenue recognized | $ 20,000 | ||||||||||||||||||
Accounts receivable | $ 28,904 | 28,904 | $ 28,904 | $ 28,904 | $ 30,550 | ||||||||||||||
Intangible asset | 28,275 | 28,275 | 28,275 | 28,275 | 13,878 | ||||||||||||||
Accounts payable | 6,130 | 6,130 | 6,130 | 6,130 | 7,142 | ||||||||||||||
Amortization of intangible assets | 600 | $ 300 | 1,000 | 500 | |||||||||||||||
Specified Development Events | |||||||||||||||||||
Collaborations | |||||||||||||||||||
Contingent payments | 279,500 | ||||||||||||||||||
Specified Regulatory Events | |||||||||||||||||||
Collaborations | |||||||||||||||||||
Contingent payments | 263,100 | ||||||||||||||||||
Specified Product Launch Events | |||||||||||||||||||
Collaborations | |||||||||||||||||||
Contingent payments | 796,000 | ||||||||||||||||||
Development and regulatory milestones by non-CNS disease products | |||||||||||||||||||
Collaborations | |||||||||||||||||||
Contingent payments | 330,000 | ||||||||||||||||||
Development and regulatory milestones by non-CNS disease products | Milestone payments on a product-by-product basis | |||||||||||||||||||
Collaborations | |||||||||||||||||||
Contingent payments | 100,000 | ||||||||||||||||||
Development and regulatory milestones by CNS disease products | |||||||||||||||||||
Collaborations | |||||||||||||||||||
Contingent payments | 255,000 | ||||||||||||||||||
Development and regulatory milestones by CNS disease products | Milestone payments on a product-by-product basis | |||||||||||||||||||
Collaborations | |||||||||||||||||||
Contingent payments | 150,000 | ||||||||||||||||||
Grifols | |||||||||||||||||||
Collaborations | |||||||||||||||||||
Upfront payment received | $ 30,000 | ||||||||||||||||||
Deferred revenue | 0 | 0 | 0 | 0 | 0 | ||||||||||||||
Grifols | Delivery of drug supply for commercialization | |||||||||||||||||||
Collaborations | |||||||||||||||||||
Revenue recognized | 0 | 1,200 | 0 | 2,800 | |||||||||||||||
Grifols | Commercial milestones | |||||||||||||||||||
Collaborations | |||||||||||||||||||
Contingent payments | $ 297,500 | ||||||||||||||||||
Kissei | |||||||||||||||||||
Collaborations | |||||||||||||||||||
Contingent payments | $ 147,000 | ||||||||||||||||||
Upfront payment received | $ 33,000 | ||||||||||||||||||
Knight | Commercial and license agreements | |||||||||||||||||||
Collaborations | |||||||||||||||||||
Upfront payment received | 2,000 | ||||||||||||||||||
Knight | Maximum | Commercial milestones | Commercial and license agreements | |||||||||||||||||||
Collaborations | |||||||||||||||||||
Contingent payments | 20,000 | ||||||||||||||||||
Forma | Commercial milestones | |||||||||||||||||||
Collaborations | |||||||||||||||||||
Potential payments | $ 165,500 | ||||||||||||||||||
Forma | Development and regulatory milestones | |||||||||||||||||||
Collaborations | |||||||||||||||||||
Potential payments | $ 67,500 | ||||||||||||||||||
fostamatinib | Grifols | |||||||||||||||||||
Collaborations | |||||||||||||||||||
Collaborative payment received | $ 20,000 | ||||||||||||||||||
fostamatinib | Grifols | Upon EMA approval of fostamatinib for treatment of chronic ITP | |||||||||||||||||||
Collaborations | |||||||||||||||||||
Contingent payments | 17,500 | ||||||||||||||||||
fostamatinib | Grifols | Creditable advance royalty payment | |||||||||||||||||||
Collaborations | |||||||||||||||||||
Collaborative payment received | $ 2,500 | ||||||||||||||||||
fostamatinib | Grifols | Maximum | |||||||||||||||||||
Collaborations | |||||||||||||||||||
Royalty payment as a percentage of net sales | 30% | ||||||||||||||||||
fostamatinib | Kissei | |||||||||||||||||||
Collaborations | |||||||||||||||||||
Revenue recognized | 2,200 | 0 | 4,500 | 0 | |||||||||||||||
Deferred revenue | 1,400 | 1,400 | 1,400 | 1,400 | 1,400 | ||||||||||||||
Revenue recognized associated with remaining performance obligation | 0 | 0 | 0 | 0 | |||||||||||||||
Collaborative payment received | $ 5,000 | ||||||||||||||||||
Accounts receivable | 20,000 | ||||||||||||||||||
fostamatinib | Medison | |||||||||||||||||||
Collaborations | |||||||||||||||||||
Revenue recognized | 100 | 200 | |||||||||||||||||
Deferred revenue | 0 | $ 0 | 0 | 0 | 0 | ||||||||||||||
fostamatinib | Medison | Commercial and license agreements | |||||||||||||||||||
Collaborations | |||||||||||||||||||
Upfront payment received | $ 5,000 | ||||||||||||||||||
Option to buy back product rights within number of months from regulatory approval | 6 months | ||||||||||||||||||
Number of agreements | agreement | 2 | ||||||||||||||||||
fostamatinib | BARDA | |||||||||||||||||||
Collaborations | |||||||||||||||||||
Revenue recognized | 0 | $ 0 | 100 | ||||||||||||||||
fostamatinib | BARDA | Maximum | |||||||||||||||||||
Collaborations | |||||||||||||||||||
Potential payments | $ 800 | ||||||||||||||||||
ocadusertib | |||||||||||||||||||
Collaborations | |||||||||||||||||||
Company's percentage of development costs | 20% | ||||||||||||||||||
Financing component liability | 57,900 | $ 57,900 | 57,900 | 57,900 | |||||||||||||||
Financing liability interest accretion discount rate | 6.40% | ||||||||||||||||||
Financing liability with accreted interest expense | 40,000 | $ 40,000 | 40,000 | 40,000 | 43,600 | ||||||||||||||
Accretion expense | 0 | 0 | 0 | 0 | |||||||||||||||
Development costs due to collaboration partner | 21,400 | 21,400 | 21,400 | 21,400 | |||||||||||||||
Revenue, remaining performance obligation | $ 67,100 | ||||||||||||||||||
Deferred revenue | 0 | 0 | 0 | 0 | 0 | ||||||||||||||
ocadusertib | Amended Lilly Agreement | |||||||||||||||||||
Collaborations | |||||||||||||||||||
Funding commitment | 22,600 | $ 22,600 | 22,600 | 22,600 | |||||||||||||||
Right to opt-back-in co-funding of R552 development, term | 30 days | ||||||||||||||||||
ocadusertib | Maximum | |||||||||||||||||||
Collaborations | |||||||||||||||||||
Funding commitment | 65,000 | $ 65,000 | 65,000 | $ 65,000 | |||||||||||||||
Non-CNS penetrant IP | |||||||||||||||||||
Collaborations | |||||||||||||||||||
Revenue recognized | $ 60,400 | ||||||||||||||||||
CNS penetrant IP | Licensed Rights | |||||||||||||||||||
Collaborations | |||||||||||||||||||
Revenue recognized | $ 6,700 | ||||||||||||||||||
Royalty | Grifols | |||||||||||||||||||
Collaborations | |||||||||||||||||||
Revenue recognized | 1,100 | 800 | $ 2,200 | 1,500 | |||||||||||||||
REZLIDHIA | Strategic collaboration agreement with MDACC | |||||||||||||||||||
Collaborations | |||||||||||||||||||
Development costs due to collaboration partner | $ 15,000 | ||||||||||||||||||
Payment of cost share to collaboration partner | $ 2,000 | ||||||||||||||||||
Collaboration period | 5 years | ||||||||||||||||||
REZLIDHIA | Strategic collaboration agreement with CONNECT | |||||||||||||||||||
Collaborations | |||||||||||||||||||
Development costs due to collaboration partner | $ 3,000 | ||||||||||||||||||
Collaboration period | 4 years | ||||||||||||||||||
REZLIDHIA | Forma | FDA approval and first commercial sale of product | |||||||||||||||||||
Collaborations | |||||||||||||||||||
Intangible asset | $ 15,000 | ||||||||||||||||||
Government contracts | |||||||||||||||||||
Collaborations | |||||||||||||||||||
Revenue recognized | $ 0 | $ 1,000 | $ 0 | $ 1,000 |
IN-LICENSING AND ACQUISITION -
IN-LICENSING AND ACQUISITION - Narrative (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||||
Feb. 22, 2024 | Jul. 31, 2024 | Jul. 27, 2022 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2022 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2023 | |
Asset Acquisition [Line Items] | ||||||||||
Research and development | $ 5,540 | $ 4,772 | $ 11,566 | $ 14,861 | ||||||
Intangible asset | 28,275 | $ 28,275 | $ 13,878 | |||||||
Forma | ||||||||||
Asset Acquisition [Line Items] | ||||||||||
Upfront fee | $ 2,000 | |||||||||
Research and development | $ 2,000 | |||||||||
Forma | Commercial milestones | ||||||||||
Asset Acquisition [Line Items] | ||||||||||
Potential payments | 165,500 | |||||||||
Forma | Development and regulatory milestones | ||||||||||
Asset Acquisition [Line Items] | ||||||||||
Potential payments | $ 67,500 | |||||||||
Forma | Achievement of certain near-term regulatory milestone | ||||||||||
Asset Acquisition [Line Items] | ||||||||||
Research and development | $ 2,500 | |||||||||
GAVRETO (pralsetinib) | ||||||||||
Asset Acquisition [Line Items] | ||||||||||
Intangible assets, estimated useful life | 12 years | |||||||||
REZLIDHIA | ||||||||||
Asset Acquisition [Line Items] | ||||||||||
Intangible assets, estimated useful life | 14 years | |||||||||
REZLIDHIA | Forma | FDA approval and first commercial sale of product | ||||||||||
Asset Acquisition [Line Items] | ||||||||||
Intangible asset | $ 15,000 | $ 15,000 | ||||||||
Blueprint | ||||||||||
Asset Acquisition [Line Items] | ||||||||||
Asset purchase agreement, drug product inventories | $ 6,500 | $ 6,500 | ||||||||
Blueprint | GAVRETO (pralsetinib) | ||||||||||
Asset Acquisition [Line Items] | ||||||||||
Asset acquisition, expected price | $ 15,000 | |||||||||
Blueprint | GAVRETO (pralsetinib) | Subsequent event | ||||||||||
Asset Acquisition [Line Items] | ||||||||||
Acquisition payment | $ 10,000 | |||||||||
Blueprint | GAVRETO (pralsetinib) | Minimum | ||||||||||
Asset Acquisition [Line Items] | ||||||||||
Potential tiered royalties (as a percentage) | 10% | |||||||||
Blueprint | GAVRETO (pralsetinib) | Maximum | ||||||||||
Asset Acquisition [Line Items] | ||||||||||
Potential tiered royalties (as a percentage) | 30% | |||||||||
Blueprint | GAVRETO (pralsetinib) | First commercial sale | ||||||||||
Asset Acquisition [Line Items] | ||||||||||
Asset acquisition, expected price | $ 10,000 | |||||||||
Blueprint | GAVRETO (pralsetinib) | First anniversary of the closing date | ||||||||||
Asset Acquisition [Line Items] | ||||||||||
Asset acquisition, expected price | 5,000 | |||||||||
Blueprint | GAVRETO (pralsetinib) | Commercial milestones | ||||||||||
Asset Acquisition [Line Items] | ||||||||||
Potential milestone payments | 97,500 | |||||||||
Blueprint | GAVRETO (pralsetinib) | Regulatory milestones | ||||||||||
Asset Acquisition [Line Items] | ||||||||||
Potential milestone payments | $ 5,000 |
IN-LICENSING AND ACQUISITION _2
IN-LICENSING AND ACQUISITION - Purchase Consideration (Details) - Blueprint $ in Thousands | Feb. 22, 2024 USD ($) |
Asset Acquisition [Line Items] | |
Closing purchase price | $ 15,000 |
Transaction costs | 360 |
Total purchase consideration | $ 15,360 |
STOCK-BASED COMPENSATION (Detai
STOCK-BASED COMPENSATION (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Stock-based compensation expense related to stock-based awards | ||||
Total stock-based compensation expense | $ 2,528 | $ 2,172 | $ 7,662 | $ 4,930 |
Selling, general and administrative | ||||
Stock-based compensation expense related to stock-based awards | ||||
Total stock-based compensation expense | 2,223 | 1,796 | 6,707 | 3,531 |
Research and development | ||||
Stock-based compensation expense related to stock-based awards | ||||
Total stock-based compensation expense | $ 305 | $ 376 | $ 955 | $ 1,399 |
STOCK-BASED COMPENSATION - Opti
STOCK-BASED COMPENSATION - Options and RSUs (Details) $ / shares in Units, $ in Millions | 6 Months Ended |
Jun. 30, 2024 USD ($) $ / shares shares | |
Employee stock options and Restricted Stock Units | |
Additional disclosures | |
Total unrecognized compensation costs | $ | $ 14 |
Weighted-average recognition period of unrecognized compensation cost | 2 years 1 month 24 days |
Employee Stock Option [Member] | |
Number of Shares | |
Granted (in shares) | 599,772 |
Options exercised during the period (in shares) | 9,294 |
Options outstanding | 3,691,139 |
Additional disclosures | |
Weighted-average grant date fair value (in dollars per share) | $ / shares | $ 9.64 |
Vesting period | 3 years |
Employee Stock Option [Member] | Vesting upon achievement of corporate performance-based milestones | |
Number of Shares | |
Options outstanding | 132,250 |
Additional disclosures | |
Total unrecognized compensation costs | $ | $ 2.5 |
RSUs | |
Number of Shares | |
Granted (in shares) | 291,373 |
Vested (in shares) | 66,408 |
Outstanding (in shares) | 387,729 |
Weighted-Average Grant Date Fair Value | |
Grant-date weighted-average fair value (in dollars per share) | $ / shares | $ 12.52 |
Additional disclosures | |
Vesting period | 3 years |
STOCK-BASED COMPENSATION - Assu
STOCK-BASED COMPENSATION - Assumptions (Details) - Employee Stock Option [Member] | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Weighted-average assumptions | ||||
Risk-free interest rate (as a percent) | 4.50% | 3.70% | 4.20% | 3.70% |
Expected term (in years) | 6 years | 6 years 8 months 12 days | 6 years 2 months 12 days | 7 years |
Dividend yield (as a percent) | 0% | 0% | 0% | 0% |
Expected volatility (as a percent) | 88.10% | 86% | 87.40% | 83.10% |
STOCK-BASED COMPENSATION - Plan
STOCK-BASED COMPENSATION - Plans (Details) | 1 Months Ended | 6 Months Ended | ||
Jul. 01, 2024 | May 31, 2024 shares | Mar. 31, 2024 shares | Jun. 30, 2024 USD ($) item shares | |
Additional disclosures | ||||
Additional shares approved | 650,000 | 78,232 | ||
Shares of common stock available for grant | 1,412,669 | |||
Purchase Plan | ||||
Additional disclosures | ||||
Award offering period | 24 months | |||
Purchase price expressed as a percentage of fair market value of common stock on the first day of the offering period | 85% | |||
Number of purchase periods per award offering period | item | 4 | |||
Award purchase period | 6 months | |||
Purchase price expressed as a percentage of fair market value of common stock on the purchase date | 85% | |||
Shares purchased | 35,902 | |||
Shares reserved for future issuance | 213,681 | |||
Unrecognized compensation cost related to purchase plan | $ | $ 0 | |||
Purchase Plan | Subsequent event | ||||
Additional disclosures | ||||
Award offering period | 24 months |
OTHER BALANCE SHEET COMPONENT_2
OTHER BALANCE SHEET COMPONENTS - Inventories (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
OTHER BALANCE SHEET COMPONENTS | ||
Raw Materials | $ 2,145 | $ 4,609 |
Work in process | 6,006 | 1,876 |
Finished goods | 4,368 | 1,508 |
Reported as: | ||
Inventories | 8,059 | 5,522 |
Other assets | 4,460 | 2,471 |
Total | 12,519 | 7,993 |
Advance payments for raw materials | $ 2,200 | $ 0 |
OTHER BALANCE SHEET COMPONENT_3
OTHER BALANCE SHEET COMPONENTS - Intangible Assets (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
OTHER BALANCE SHEET COMPONENTS | |||||
Intangible asset cost | $ 30,360 | $ 30,360 | $ 15,000 | ||
Accumulated amortization | (2,085) | (2,085) | (1,122) | ||
Intangible asset, net | 28,275 | 28,275 | $ 13,878 | ||
Amortization expense | $ 600 | $ 300 | $ 1,000 | $ 500 |
OTHER BALANCE SHEET COMPONENT_4
OTHER BALANCE SHEET COMPONENTS - Estimated Future Amortization Expense Of Intangible Assets (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
OTHER BALANCE SHEET COMPONENTS | ||
Remainder of 2024 | $ 1,176 | |
2025 | 2,351 | |
2026 | 2,351 | |
2027 | 2,351 | |
2028 | 2,351 | |
Thereafter | 17,695 | |
Intangible asset, net | $ 28,275 | $ 13,878 |
CASH, CASH EQUIVALENTS AND SH_3
CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Cash, cash equivalent and short term investments | ||
Cash and cash equivalents | $ 36,053 | $ 32,786 |
Short-term investments | 13,049 | 24,147 |
Cash, cash equivalents and short-term investments | 49,102 | 56,933 |
Money market funds | ||
Cash, cash equivalent and short term investments | ||
Cash, cash equivalents and short-term investments | 13,805 | 9,685 |
US treasury bills | ||
Cash, cash equivalent and short term investments | ||
Cash, cash equivalents and short-term investments | 4,963 | 12,594 |
Government-sponsored enterprise securities | ||
Cash, cash equivalent and short term investments | ||
Cash, cash equivalents and short-term investments | 10,444 | 11,233 |
Corporate bonds and commercial paper | ||
Cash, cash equivalent and short term investments | ||
Cash, cash equivalents and short-term investments | 13,764 | 15,174 |
Cash | ||
Cash, cash equivalent and short term investments | ||
Cash, cash equivalents and short-term investments | $ 6,126 | $ 8,247 |
CASH, CASH EQUIVALENTS AND SH_4
CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS - Gross Unrealized Gains and Losses (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Cash equivalents and available-for-sale securities | ||
Amortized Cost | $ 29,180 | $ 38,993 |
Fair Value | 29,171 | 39,001 |
Gross Unrealized Gains | ||
Cash equivalents and available-for-sale securities | ||
Gross Unrealized Gains (Losses) | 15 | |
Gross Unrealized Losses | ||
Cash equivalents and available-for-sale securities | ||
Gross Unrealized Gains (Losses) | (9) | (7) |
US treasury bills | ||
Cash equivalents and available-for-sale securities | ||
Amortized Cost | 4,963 | 12,591 |
Fair Value | 4,963 | 12,594 |
US treasury bills | Gross Unrealized Gains | ||
Cash equivalents and available-for-sale securities | ||
Gross Unrealized Gains (Losses) | 3 | |
Government-sponsored enterprise securities | ||
Cash equivalents and available-for-sale securities | ||
Amortized Cost | 10,446 | 11,230 |
Fair Value | 10,444 | 11,233 |
Government-sponsored enterprise securities | Gross Unrealized Gains | ||
Cash equivalents and available-for-sale securities | ||
Gross Unrealized Gains (Losses) | 7 | |
Government-sponsored enterprise securities | Gross Unrealized Losses | ||
Cash equivalents and available-for-sale securities | ||
Gross Unrealized Gains (Losses) | (2) | (4) |
Corporate bonds and commercial paper | ||
Cash equivalents and available-for-sale securities | ||
Amortized Cost | 13,771 | 15,172 |
Fair Value | 13,764 | 15,174 |
Corporate bonds and commercial paper | Gross Unrealized Gains | ||
Cash equivalents and available-for-sale securities | ||
Gross Unrealized Gains (Losses) | 5 | |
Corporate bonds and commercial paper | Gross Unrealized Losses | ||
Cash equivalents and available-for-sale securities | ||
Gross Unrealized Gains (Losses) | $ (7) | $ (3) |
CASH, CASH EQUIVALENTS AND SH_5
CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS - Unrealized Loss Position (Details) $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2024 USD ($) position | Dec. 31, 2023 USD ($) | |
Fair value and gross unrealized losses of investments in individual securities in unrealized loss position | ||
Weighted-average time to maturity of cash equivalents and available-for-sale securities | 68 days | 82 days |
Number of investments in continuous unrealized loss position for more than 12 months | position | 0 | |
Number of individual securities in unrealized loss position for 12 months or less | position | 26 | |
Credit losses recognized | $ 0 | $ 0 |
Fair Value | 22,959 | |
Unrealized Losses | (9) | |
Government-sponsored enterprise securities | ||
Fair value and gross unrealized losses of investments in individual securities in unrealized loss position | ||
Fair Value | 9,694 | |
Unrealized Losses | (2) | |
Corporate bonds and commercial paper | ||
Fair value and gross unrealized losses of investments in individual securities in unrealized loss position | ||
Fair Value | 13,265 | |
Unrealized Losses | $ (7) |
FAIR VALUE (Details)
FAIR VALUE (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Fair Value | ||
Investments at fair value | $ 29,171 | $ 39,001 |
Fair Value Measurements Recurring | Estimate Of Fair Value Fair Value Disclosure | ||
Fair Value | ||
Investments at fair value | 42,976 | 48,686 |
Fair Value Measurements Recurring | Money market funds | Estimate Of Fair Value Fair Value Disclosure | ||
Fair Value | ||
Investments at fair value | 13,805 | 9,685 |
Fair Value Measurements Recurring | US treasury bills | Estimate Of Fair Value Fair Value Disclosure | ||
Fair Value | ||
Investments at fair value | 4,963 | 12,594 |
Fair Value Measurements Recurring | Government-sponsored enterprise securities | Estimate Of Fair Value Fair Value Disclosure | ||
Fair Value | ||
Investments at fair value | 10,444 | 11,233 |
Fair Value Measurements Recurring | Corporate bonds and commercial paper | Estimate Of Fair Value Fair Value Disclosure | ||
Fair Value | ||
Investments at fair value | 13,764 | 15,174 |
Fair Value Measurements Recurring | Level 1 | ||
Fair Value | ||
Investments at fair value | 13,805 | 9,685 |
Fair Value Measurements Recurring | Level 1 | Money market funds | ||
Fair Value | ||
Investments at fair value | 13,805 | 9,685 |
Fair Value Measurements Recurring | Level 2 | ||
Fair Value | ||
Investments at fair value | 29,171 | 39,001 |
Fair Value Measurements Recurring | Level 2 | US treasury bills | ||
Fair Value | ||
Investments at fair value | 4,963 | 12,594 |
Fair Value Measurements Recurring | Level 2 | Government-sponsored enterprise securities | ||
Fair Value | ||
Investments at fair value | 10,444 | 11,233 |
Fair Value Measurements Recurring | Level 2 | Corporate bonds and commercial paper | ||
Fair Value | ||
Investments at fair value | $ 13,764 | $ 15,174 |
DEBT (Summary of Loans Payable)
DEBT (Summary of Loans Payable) (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
DEBT | ||
Principal outstanding | $ 60,000 | $ 60,000 |
Unamortized debt issuance costs | (308) | (398) |
Principal outstanding, net of unamortized debt issuance costs | 59,692 | 59,602 |
Reported as: | ||
Loans payable, net, current portion | 7,229 | |
Long-term portion of loans payable, net | 59,692 | 52,373 |
Total | $ 59,692 | $ 59,602 |
DEBT (Narrative) (Details)
DEBT (Narrative) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Mar. 28, 2023 | May 31, 2022 | May 31, 2020 | |
Debt Instrument [Line Items] | |||||||
Interest expense | $ 2,029 | $ 1,862 | $ 3,903 | $ 3,066 | |||
Following Fourth Amendment | |||||||
Debt Instrument [Line Items] | |||||||
Final payment fee, percentage of principal | 4.25% | ||||||
SOFR | Following Fourth Amendment | |||||||
Debt Instrument [Line Items] | |||||||
Rate adjustment | 0.11448% | ||||||
Basis spread on variable rate | 6.50% | ||||||
Floor rate | 4% | 4% | |||||
Credit Facility with MidCap | |||||||
Debt Instrument [Line Items] | |||||||
Maximum borrowing capacity | $ 60,000 | $ 60,000 | |||||
Remaining borrowing capacity | 0 | 0 | |||||
Outstanding balance | 60,000 | 60,000 | |||||
Interest expense | $ 2,000 | $ 1,900 | 3,900 | $ 3,100 | |||
Accrued interest | $ 1,800 | ||||||
Credit Facility with MidCap | Following Third Amendment | |||||||
Debt Instrument [Line Items] | |||||||
Final payment fee, percentage of principal | 2.50% | ||||||
Credit Facility with MidCap | SOFR | Following Third Amendment | |||||||
Debt Instrument [Line Items] | |||||||
Rate adjustment | 0.11448% | ||||||
Basis spread on variable rate | 5.65% | ||||||
Floor rate | 1.50% | 1.50% | |||||
Credit Facility with MidCap | Tranche 1 | |||||||
Debt Instrument [Line Items] | |||||||
Outstanding balance | $ 10,000 | $ 10,000 | |||||
Credit Facility with MidCap | Tranche 2 | |||||||
Debt Instrument [Line Items] | |||||||
Outstanding balance | $ 10,000 | ||||||
Credit Facility with MidCap | Tranche 3 | |||||||
Debt Instrument [Line Items] | |||||||
Outstanding balance | $ 10,000 | ||||||
Credit Facility with MidCap | Tranche 4 | |||||||
Debt Instrument [Line Items] | |||||||
Outstanding balance | $ 10,000 | ||||||
Credit Facility with MidCap | Tranche 5 | |||||||
Debt Instrument [Line Items] | |||||||
Outstanding balance | $ 20,000 |
DEBT - Future Minimum Payments
DEBT - Future Minimum Payments (Details) $ in Thousands | Jun. 30, 2024 USD ($) |
Future minimum payments | |
2025 | $ 7,500 |
2026 | 30,000 |
2027 | 22,500 |
Principal amount (Tranches 1, 2, 3 and 4) | $ 60,000 |
LEASES (Details)
LEASES (Details) | Jun. 30, 2024 |
Headquarters office space sublease, South San Francisco, California | |
Sublease Agreement | |
Weighted average remaining lease term | 11 months 1 day |
LEASES - Lease Expense (Details
LEASES - Lease Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
LEASES | ||||
Fixed operating lease expense | $ 166 | $ 166 | $ 332 | $ 778 |
Variable operating lease expense (net credit) | 28 | 56 | 30 | |
Variable operating lease expense (net credit) | (42) | |||
Total operating lease expense | $ 194 | $ 124 | $ 388 | $ 808 |
LEASES - Cash Flow Information
LEASES - Cash Flow Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
LEASES | ||||
Cash payments included in the measurement of operating lease liabilities | $ 184 | $ 178 | $ 368 | $ 1,174 |
LEASES - Sublease Information (
LEASES - Sublease Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Operating sublease information | ||||
Fixed sublease expense | $ 365 | |||
Variable sublease expense | 77 | |||
Sublease income | (442) | |||
Net |
LEASES - Future Lease Payments
LEASES - Future Lease Payments (Details) $ in Thousands | Jun. 30, 2024 USD ($) |
Operating Lease | |
Remainder of 2024 | $ 371 |
2025 | 301 |
Total minimum payments required | $ 672 |