Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 10, 2023 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2023 | |
Document Transition Report | false | |
Entity File Number | 001-38150 | |
Entity Registrant Name | KALA BIO, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 27-0604595 | |
Entity Address, Address Line One | 1167 Massachusetts Avenue | |
Entity Address, City or Town | Arlington | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02476 | |
City Area Code | 781 | |
Local Phone Number | 996-5252 | |
Title of 12(b) Security | Common Stock, $0.001 par value per share | |
Trading Symbol | KALA | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 2,693,116 | |
Entity Central Index Key | 0001479419 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 56,063 | $ 70,495 |
Prepaid expenses and other current assets (Note 8) | 1,839 | 7,852 |
Current assets held for sale (Note 4) | 0 | 7,595 |
Total current assets | 57,902 | 85,942 |
Non-current assets: | ||
Property and equipment, net | 802 | 400 |
Right-of-use assets | 2,102 | 16 |
Restricted cash and other long-term assets | 314 | 462 |
Total assets | 61,120 | 86,820 |
Current liabilities: | ||
Accounts payable | 787 | 2,832 |
Accrued expenses and other current liabilities | 6,260 | 8,910 |
Deferred gain on sale of commercial business | 4,189 | |
Deferred grant income | 2,930 | |
Current portion of lease liabilities | 324 | 13 |
Current portion of long-term debt | 5,000 | |
Current portion of contingent consideration | 4,146 | |
Current portion of deferred purchase consideration | 595 | |
Total current liabilities | 10,301 | 25,685 |
Long-term liabilities: | ||
Long-term lease liabilities | 1,880 | |
Long-term debt | 33,878 | 37,937 |
Long-term contingent consideration | 3,838 | 4,224 |
Total long-term liabilities | 39,596 | 42,161 |
Total liabilities | 49,897 | 67,846 |
Commitments and Contingencies (Note 17) | ||
Stockholders' equity: | ||
Common stock, $0.001 par value; 120,000,000 shares authorized as of September 30, 2023 and December 31, 2022; 2,693,116 and 1,706,971 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively | 3 | 2 |
Additional paid-in capital | 632,001 | 606,182 |
Accumulated other comprehensive income | 1 | |
Accumulated deficit | (620,782) | (587,210) |
Total stockholders' equity | 11,223 | 18,974 |
Total liabilities and stockholders' equity | $ 61,120 | $ 86,820 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, authorized | 120,000,000 | 120,000,000 |
Common stock, shares issued | 2,693,116 | 1,706,971 |
Common stock, shares outstanding | 2,693,116 | 1,706,971 |
Series E preferred shares | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 51,246 | 53,144 |
Preferred stock, shares outstanding | 51,246 | 53,144 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||
Revenues, net | $ 420 | $ 3,892 | ||
Costs and expenses: | ||||
Cost of product revenues | 11 | 2,560 | ||
Selling, general and administrative | $ 4,952 | 9,549 | $ 15,944 | 59,204 |
Research and development | 5,554 | 5,391 | 13,868 | 14,330 |
(Gain) loss on fair value remeasurement of deferred purchase consideration | (57) | (230) | 205 | |
Loss (gain) on fair value remeasurement of contingent consideration | (1,744) | 95 | 462 | (952) |
Total costs and expenses | 8,762 | 14,989 | 30,044 | 75,347 |
Loss from operations | (8,762) | (14,569) | (30,044) | (71,455) |
Other income (expense): | ||||
Interest income | 708 | 234 | 2,101 | 310 |
Interest expense | (1,459) | (1,447) | (4,346) | (5,689) |
Grant income | 2,970 | 2,970 | ||
Loss on extinguishment of debt | (2,583) | (2,583) | ||
Gain on sale of commercial business | 46,995 | 46,995 | ||
Other income (expense), net | (2,161) | 443 | (4,253) | 443 |
Total other income (expense) | 58 | 43,642 | (3,528) | 39,476 |
Net (loss) income | $ (8,704) | $ 29,073 | $ (33,572) | $ (31,979) |
Net (loss) income per share attributable to common stockholders-basic (in dollar per share) | $ (3.41) | $ 19.39 | $ (14.36) | $ (21.46) |
Net (loss) income per share attributable to common stockholders-diluted (in dollar per share) | $ (3.41) | $ 19.25 | $ (14.36) | $ (21.46) |
Weighted average shares outstanding-basic (in shares) | 2,550,210 | 1,499,001 | 2,337,492 | 1,490,159 |
Weighted average shares outstanding-diluted (in shares) | 2,550,210 | 1,510,421 | 2,337,492 | 1,490,159 |
Statement of Comprehensive Income (Loss) | ||||
Net (loss) income | $ (8,704) | $ 29,073 | $ (33,572) | $ (31,979) |
Other comprehensive (loss) income: | ||||
Change in unrealized (loss) gain on investments | (8) | 1 | 1 | |
Total other comprehensive (loss) income | (8) | 1 | 1 | |
Total comprehensive (loss) income | $ (8,712) | $ 29,074 | $ (33,571) | $ (31,979) |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN MEZZANINE EQUITY AND STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) $ in Thousands | Preferred Stock Series E preferred shares | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Income | Accumulated Deficit | Series D redeemable preferred stock | Total |
Mezzanine equity: | |||||||
Issuance of redeemable Series D preferred stock (in shares) | 73,208 | ||||||
Balance as of end of period (in shares) at Sep. 30, 2022 | 73,208 | ||||||
Balance as of beginning of period at Dec. 31, 2021 | $ 1 | $ 559,191 | $ (542,388) | $ 16,804 | |||
Balance as of beginning of period (in shares) at Dec. 31, 2021 | 1,322,464 | ||||||
Stockholders' Equity | |||||||
Exercise of stock options | 3 | 3 | |||||
Exercise of stock options (in shares) | 102 | ||||||
Issuance of common stock for vested restricted stock units (in shares) | 3,966 | ||||||
Issuance of common stock to satisfy deferred purchase consideration | 7,936 | 7,936 | |||||
Issuance of common stock to satisfy deferred purchase consideration (in shares) | 136,314 | ||||||
Issuance of common stock under employee stock purchase plan | 298 | 298 | |||||
Issuance of common stock under employee stock purchase plan (in shares) | 13,791 | ||||||
Stock-based compensation expense | 5,970 | 5,970 | |||||
Net income (loss) | (31,979) | (31,979) | |||||
Balance as of end of period at Sep. 30, 2022 | $ 1 | 573,398 | (574,367) | (968) | |||
Balance as of end of period (in shares) at Sep. 30, 2022 | 1,476,637 | ||||||
Mezzanine equity: | |||||||
Issuance of redeemable Series D preferred stock (in shares) | 73,208 | ||||||
Balance as of end of period (in shares) at Sep. 30, 2022 | 73,208 | ||||||
Balance as of beginning of period at Jun. 30, 2022 | $ 1 | 571,886 | $ (1) | (603,440) | (31,554) | ||
Balance as of beginning of period (in shares) at Jun. 30, 2022 | 1,465,949 | ||||||
Stockholders' Equity | |||||||
Issuance of common stock under employee stock purchase plan | 138 | 138 | |||||
Issuance of common stock under employee stock purchase plan (in shares) | 10,688 | ||||||
Stock-based compensation expense | 1,374 | 1,374 | |||||
Change in fair value of investments | 1 | 1 | |||||
Net income (loss) | 29,073 | 29,073 | |||||
Balance as of end of period at Sep. 30, 2022 | $ 1 | 573,398 | (574,367) | (968) | |||
Balance as of end of period (in shares) at Sep. 30, 2022 | 1,476,637 | ||||||
Balance as of beginning of period at Dec. 31, 2022 | $ 2 | 606,182 | (587,210) | 18,974 | |||
Balance as of beginning of period (in shares) at Dec. 31, 2022 | 53,144 | 1,706,971 | |||||
Stockholders' Equity | |||||||
At the market offering, net of offering costs | $ 1 | 17,965 | 17,966 | ||||
At the market offering, net of offering costs (in shares) | 665,265 | ||||||
Issuance of common stock for vested restricted stock units (in shares) | 3,002 | ||||||
Issuance of common stock to satisfy deferred purchase consideration | 365 | 365 | |||||
Issuance of common stock to satisfy deferred purchase consideration (in shares) | 19,350 | ||||||
Issuance of common stock to satisfy contingent consideration | 2,354 | 2,354 | |||||
Issuance of common stock to satisfy contingent consideration (in shares) | 105,038 | ||||||
Issuance of common stock upon conversion of Series E Preferred Stock (in shares) | (1,898) | 189,800 | |||||
Issuance of common stock under employee stock purchase plan | 46 | 46 | |||||
Issuance of common stock under employee stock purchase plan (in shares) | 3,690 | ||||||
Stock-based compensation expense | 5,089 | 5,089 | |||||
Change in fair value of investments | 1 | 1 | |||||
Net income (loss) | (33,572) | (33,572) | |||||
Balance as of end of period at Sep. 30, 2023 | $ 3 | 632,001 | 1 | (620,782) | 11,223 | ||
Balance as of end of period (in shares) at Sep. 30, 2023 | 51,246 | 2,693,116 | |||||
Balance as of beginning of period at Jun. 30, 2023 | $ 3 | 629,558 | 9 | (612,078) | 17,492 | ||
Balance as of beginning of period (in shares) at Jun. 30, 2023 | 52,750 | 2,538,687 | |||||
Stockholders' Equity | |||||||
Issuance of common stock for vested restricted stock units (in shares) | 800 | ||||||
Issuance of common stock upon conversion of Series E Preferred Stock (in shares) | (1,504) | 150,400 | |||||
Issuance of common stock under employee stock purchase plan | 40 | 40 | |||||
Issuance of common stock under employee stock purchase plan (in shares) | 3,229 | ||||||
Stock-based compensation expense | 2,403 | 2,403 | |||||
Change in fair value of investments | (8) | (8) | |||||
Net income (loss) | (8,704) | (8,704) | |||||
Balance as of end of period at Sep. 30, 2023 | $ 3 | $ 632,001 | $ 1 | $ (620,782) | $ 11,223 | ||
Balance as of end of period (in shares) at Sep. 30, 2023 | 51,246 | 2,693,116 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN MEZZANINE EQUITY AND STOCKHOLDERS' EQUITY (DEFICIT) (Parenthetical) $ in Thousands | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN MEZZANINE EQUITY AND STOCKHOLDERS' EQUITY (DEFICIT) | |
Offering costs | $ 446 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Cash flows from operating activities: | |||||
Net loss | $ (33,572) | $ (31,979) | |||
Adjustments to reconcile net loss to cash used in operating activities: | |||||
Depreciation and amortization | 233 | 457 | |||
Non-cash operating lease cost | 94 | 421 | |||
Gain on sale of commercial business | $ (46,995) | (46,995) | |||
Loss on extinguishment of debt | 2,583 | 2,583 | |||
(Gain) loss on fair value remeasurement of deferred purchase consideration | (57) | (230) | 205 | ||
Loss (gain) on fair value remeasurement of contingent consideration | $ (1,744) | 95 | 462 | (952) | |
Amortization of debt discount and other non-cash interest | 941 | 1,130 | |||
Stock-based compensation | 5,089 | 6,048 | |||
Other non-cash (gains) losses, net | (4,322) | 76 | |||
Change in operating assets and liabilities: | |||||
Accounts receivable | 78 | 15,143 | |||
Prepaid expenses and other current assets | 5,892 | (16,928) | |||
Inventory and assets held for sale | 7,544 | (1,011) | |||
Other long-term assets | (143) | ||||
Accounts payable | (2,036) | 2,433 | |||
Accrued expenses and other current liabilities | (319) | 4,531 | |||
Lease liabilities and other long-term liabilities | 58 | (335) | |||
Net cash used in operating activities | (20,231) | (65,173) | |||
Cash flows from investing activities: | |||||
Proceeds from sale of commercial business, net of transaction costs | 62,908 | ||||
Purchases of property and equipment and other assets | (603) | (291) | |||
Proceeds from sale of property and equipment | 47 | 41 | |||
Purchases of short-term investments | (9,866) | (4,992) | |||
Proceeds from sales or maturities of short-term investments | 10,000 | 5,000 | |||
Net cash (used in) provided by investing activities | (422) | 62,666 | |||
Cash flows from financing activities: | |||||
Payment of principal, prepayment premium and final payment fee on debt | (10,000) | (40,000) | |||
Proceeds from common stock offerings, net of offering costs | 17,966 | ||||
Contingent consideration related to Combangio acquisition | (2,041) | ||||
Payment of principal on finance lease | (29) | ||||
Proceeds from exercise of stock options and issuance of common stock under employee stock purchase plan | 46 | 301 | |||
Net cash provided by (used in) financing activities | 5,971 | (39,728) | |||
Net decrease in cash, cash equivalents and restricted cash: | (14,682) | (42,235) | |||
Cash, cash equivalents and restricted cash at beginning of period | 70,745 | 94,878 | $ 94,878 | ||
Cash, cash equivalents and restricted cash at end of period | 56,063 | 52,643 | 56,063 | 52,643 | 70,745 |
Reconciliation of cash, cash equivalents and restricted cash: | |||||
Cash, cash equivalents, and restricted cash at end of period | 56,063 | 52,643 | 56,063 | 52,643 | 70,745 |
Less restricted cash | (250) | (250) | |||
Cash and cash equivalents at end of period | $ 56,063 | $ 52,393 | 56,063 | 52,393 | $ 70,495 |
Non-cash investing and financing activities: | |||||
Purchases of property and equipment in accounts payable and accrued expenses | 16 | ||||
Issuance of common stock to satisfy deferred purchase consideration in additional paid-in capital | 365 | ||||
Issuance of common stock to satisfy contingent consideration in additional paid-in capital | 2,354 | ||||
Supplemental disclosure: | |||||
Cash paid for interest | 3,477 | 4,747 | |||
Right-of-use assets obtained in exchange of operating lease obligations | $ 2,180 | $ 424 |
NATURE OF BUSINESS AND BASIS OF
NATURE OF BUSINESS AND BASIS OF PRESENTATION | 9 Months Ended |
Sep. 30, 2023 | |
NATURE OF BUSINESS AND BASIS OF PRESENTATION | |
NATURE OF BUSINESS AND BASIS OF PRESENTATION | 1. NATURE OF BUSINESS AND BASIS OF PRESENTATION Nature of Business Kala Bio On November 15, 2021, the Company and its newly formed, direct wholly owned subsidiary, Ceres Merger Sub, Inc. (the “Merger Subsidiary”), entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Combangio, Inc. (“Combangio”) and Fortis Advisors LLC, solely in its capacity as Combangio Equityholder Representative in connection with the Merger Agreement, pursuant to which on November 15, 2021, the Merger Subsidiary merged with and into Combangio with Combangio surviving such merger and becoming a direct wholly owned subsidiary of the Company (the “Combangio Acquisition”). In connection with the Combangio Acquisition, the Company acquired Combangio’s mesenchymal stem cell secretomes (“MSC-S”) platform, including its lead product candidate for the treatment of persistent corneal epithelial defects (“PCED”), which the Company refers to as KPI-012. C H A SE The Company expects to commercialize in the United States any of its product candidates that receive marketing approval. In connection with the determination to focus its research and development efforts on KPI-012, in 2022, The Company previously developed and commercialized two marketed products, EYSUVIS ® (loteprednol etabonate ophthalmic suspension) 0.25%, for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease, and INVELTYS ® (loteprednol etabonate ophthalmic suspension) 1%, a topical twice-a-day ocular steroid for the treatment of post-operative inflammation and pain following ocular surgery. Both products applied a proprietary mucus-penetrating particle drug delivery technology, which the Company referred to as the AMPPLIFY ® Drug Delivery Technology. On July 8, 2022, the Company closed the transaction (the “Alcon Transaction”), contemplated by the asset purchase agreement, dated as of May 21, 2022 (the “Asset Purchase Agreement”), by and between the Company, Alcon Pharmaceuticals Ltd. and Alcon Vision, LLC (together referred to as “Alcon”), pursuant to which Alcon purchased the rights to manufacture, sell, distribute, market and commercialize EYSUVIS and INVELTYS and to develop, manufacture, market and otherwise exploit the Company’s AMPPLIFY Drug Delivery Technology (collectively, the “Commercial Business”). Alcon also assumed certain liabilities with respect to the Commercial Business at the closing of the Alcon Transaction. See Note 3, “Sale of Commercial Business to Alcon”, for additional information about the Alcon Transaction. The Company’s success is dependent upon its ability to develop, obtain regulatory approval for and commercialize KPI-012 and any other product candidate it may develop in the future, the success of its research and development efforts, whether it receives any commercial-based sales milestone payments from Alcon, its ability to raise additional capital when needed and, ultimately, attain profitable operations. Reverse Stock Split 1 outstanding outstanding Liquidity including a net loss of $8,704 and $33,572 for the three and nine months ended September 30, 2023, respectively, net income of $29,073 (which includes the gain on the sale of the Company's Commercial Business to Alcon) and a net loss $31,979 for the three and nine months ended September 30, 2022, respectively, and cash used in operating activities of $20,231 and $65,173 , in the nine months ended September 30, 2023 and 2022, respectively an initial $5,900 disbursement from CIRM, and the balance of the total $15,000 award is payable to Combangio upon the achievement of specified milestones (see Note 7, “Grant Income” for further information about the CIRM Award (as defined below)). The Company expects that its cash and cash equivalents as of September 30, 2023, will enable it to fund its operating expenses, lease and debt service obligations and capital expenditure requirements for at least twelve months from the date these condensed consolidated financial statements were issued. This evaluation is based on relevant conditions and events that are known and reasonably knowable at the date that the condensed consolidated financial statements are issued. To the extent these conditions or events change, the Company could deplete its available capital resources sooner than it currently expects. Use of Estimates Net (Loss) Income per Share Attributable to Common Stockholders Basic net loss per share attributable to common stockholders is computed using the weighted-average number of common shares outstanding during the period. Diluted net loss per share attributable to common stockholders is computed using the weighted average number of common shares outstanding during the period and, if dilutive, the weighted average number of potential shares of common stock, including the assumed exercise of stock options and warrants, the issuance of unvested restricted stock units (“RSUs”) and performance-based restricted stock units (“PSUs”) and convertible preferred stock using the if-converted method. The weighted average number of common shares included in the computation of diluted net loss gives effect to all potentially dilutive common equivalent shares, including outstanding stock options, warrants, unvested RSUs and PSUs and Unaudited Interim Financial Information The unaudited condensed consolidated financial statements include the accounts of KALA BIO, Inc. and its wholly owned subsidiaries, Kala Pharmaceuticals Security Corporation and Combangio, Inc. All intercompany transactions and balances have been eliminated in consolidation. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 30, 2023 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES The Company’s significant accounting policies are described in Note 2, “Summary of Significant Accounting Policies,” to the consolidated financial statements included in the Annual Report. There have been no material changes to the significant accounting policies during the three months September 30, 2023, other than as described below: Grant Income Grant income consists of amounts earned from incurring costs to support the CHASE Phase 2b clinical trial of KPI-012 for PCED, as well as product process characterization and analytical development from the program due to the receipt of the CIRM Award. The grant between the Company and CIRM generally provides for the Company to meet certain milestones in order for funds to be provided. The Company accounts for grants received to perform research and development activities in accordance with Accounting Standards Codification (“ASC”) Topic 730-20, Research and Development Arrangements Grant funds received in advance are recorded as deferred grant income on the condensed consolidated balance sheets. Management has determined that the Company is the principal participant under the Company’s CIRM Award, and accordingly, the Company records amounts earned under this arrangement as grant income on the condensed consolidated statements of operations and comprehensive (loss) income. Recent Accounting Pronouncements Management has considered all recent accounting pronouncements issued since the last audit of the Company’s consolidated financial statements. The Company’s management believes that these recent pronouncements will not have a material effect on the Company’s consolidated financial statements. |
SALE OF COMMERCIAL BUSINESS TO
SALE OF COMMERCIAL BUSINESS TO ALCON | 9 Months Ended |
Sep. 30, 2023 | |
SALE OF COMMERCIAL BUSINESS TO ALCON | |
SALE OF COMMERCIAL BUSINESS TO ALCON | 3. SALE OF COMMERCIAL BUSINESS TO ALCON On July 8, 2022, the Company closed the Alcon Transaction contemplated by the Asset Purchase Agreement, pursuant to which Alcon purchased the Commercial Business and assumed certain liabilities with respect to the Commercial Business. Alcon paid to the Company an upfront cash payment of $60,000 upon the closing of the Alcon Transaction. In addition, pursuant to the Asset Purchase Agreement, the Company is eligible to receive from Alcon up to four commercial-based sales milestone payments as follows: (1) $25,000 upon the achievement of $50,000 or more in aggregate worldwide net sales of EYSUVIS and INVELTYS in a calendar year from 2023 to 2028, (2) $65,000 upon the achievement of $100,000 or more in aggregate worldwide net sales of EYSUVIS and INVELTYS in a calendar year from 2023 to 2028, (3) $75,000 upon the achievement of $175,000 or more in aggregate worldwide net sales of EYSUVIS and INVELTYS in a calendar year from 2023 to 2029 and (4) $160,000 upon the achievement of $250,000 or more in aggregate worldwide net sales of EYSUVIS and INVELTYS in a calendar year from 2023 to 2029. Each milestone payment will only become payable once, if at all, upon the first time such milestone is achieved, and only one milestone payment will be paid with respect to a calendar year. In the event that more than one milestone is achieved in a calendar year, the higher milestone payment will become payable and the lower milestone payment will become payable only if the corresponding milestone is achieved again in a subsequent calendar year. Pursuant to the Asset Purchase Agreement, on July 8, 2022, the Company entered into supply and commercial agreements under which the Company agreed to supply EYSUVIS and INVELTYS to Alcon and distribute EYSUVIS and INVELTYS to third-party customers of the Commercial Business on behalf of Alcon for a period of six months following the closing of the Alcon Transaction. In addition, the Company entered into a transition services agreement under which the Company provided certain transition services to Alcon on a cost-plus pricing arrangement for six months following the closing of the Alcon Transaction. Pursuant to the supply agreement, Alcon purchased from the Company, at the closing of the Alcon Transaction, $5,027 of EYSUVIS and INVELTYS inventory on-hand at the Company. Together, the supply, commercial and transition services agreements are referred to herein as the “Transition Agreement.” Gross consideration from the sale of the Commercial Business $ 65,027 Closing and transaction costs 2,119 Net proceeds from the sale of the Commercial Business 62,908 Book value of assets transferred Inventories 8,915 Prepaid expenses and other current assets 556 Property and equipment, net 1,819 Other long-term assets 434 Total book value of assets transferred 11,724 Gain on sale of Commercial Business 51,184 Deferred gain on sale of Commercial Business 4,189 Net gain on sale of Commercial Business $ 46,995 The Company deferred a portion of the gross consideration related to the discounted pricing on any remaining inventory owned by the Company (the “Remaining Inventory”) that Alcon could have purchased. The deferred gain on the sale of the Commercial Business of $4,189 was recorded on the condensed consolidated balance sheet as of the transaction date as deferred gain on sale of Commercial Business. The Remaining Inventory and deferred gain on the sale of the Commercial Business were written off during the three and nine months ended September 30, 2023, and is recorded in the other (expense) income, net line item in the condensed consolidated statements of operations and comprehensive (loss) income. The Company collected cash on behalf of Alcon for revenue generated by sales of EYSUVIS and INVELTYS from July 8, 2022 through the transition period and the Company transferred all cash generated by such sales to Alcon as of December 31, 2022. As of September 30, 2023, the total receivables due from Alcon and from third parties in connection with the Transition Agreement were de minimis As of December 31, 2022, the Company had total receivables due from Alcon and third parties of $5,394 and $26, respectively, and total payables to third parties related to the Transition Agreement of $3,981 of which $1,737 was included in accounts payable and $2,244 within accrued expenses and other current liabilities related to invoices the Company was obligated to pay on Alcon’s behalf. |
ASSETS HELD FOR SALE
ASSETS HELD FOR SALE | 9 Months Ended |
Sep. 30, 2023 | |
ASSETS HELD FOR SALE | |
ASSETS HELD FOR SALE | 4. ASSETS HELD FOR SALE As of December 31, 2022, the Company presented assets to be disposed of that met the criteria as held for sale as a single asset in its condensed consolidated financial statements. The EYSUVIS and INVELTYS product inventory classified as held for sale represented the net realizable value of the Remaining Inventory which Alcon, and solely Alcon, had the right to purchase. As noted in Note 3, “Sale of Commercial Business to Alcon” above, the Company deferred a portion of the gain on the sale of the Commercial Business related to the discounted pricing on the Remaining Inventory of $4,189 . The Remaining Inventory and deferred gain on the sale of the Commercial Business were written off during the three and nine months ended September 30, 2023 and included in other (expense) income, net on the condensed consolidated statements of operations and comprehensive (loss) income. No held for sale assets remained on the condensed consolidated balance sheet as of September 30, 2023. The following is a summary of the major categories of assets that had been reclassified to held for sale on the : December 31, 2022 Inventories $ 7,544 Property and equipment, net 51 Current assets held for sale $ 7,595 See Note 3, “Sale of Commercial Business to Alcon”, for further information on the sale of the Commercial Business. |
FAIR VALUE OF FINANCIAL INSTRUM
FAIR VALUE OF FINANCIAL INSTRUMENTS | 9 Months Ended |
Sep. 30, 2023 | |
FAIR VALUE OF FINANCIAL INSTRUMENTS | |
FAIR VALUE OF FINANCIAL INSTRUMENTS | 5. FAIR VALUE OF FINANCIAL INSTRUMENTS ASC 820, Fair Value Measurements and Disclosures, ● Level 1—Quoted prices in active markets for identical assets or liabilities. ● Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. ● Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The Company’s financial instruments as of September 30, 2023 and December 31, 2022 consisted primarily of cash equivalents and contingent consideration. Cash equivalents and contingent consideration are reported at their respective fair values on the Company’s condensed consolidated balance sheets. T he Company acquired Combangio in November 2021 and in connection with the closing of the Combangio Acquisition, an aggregate of 155,664 shares (the “Deferred Purchase Consideration”) of the Company’s common stock to former Combangio stockholders and other equityholders (the “Combangio Equityholders”) consisting of (i) an aggregate of 136,314 shares of common stock issued on January 3, 2022 (the “Upfront Shares”) and (ii) an aggregate of 19,350 shares of common stock that were held back as partial security for the satisfaction of indemnification obligations and other payment obligations of the Combangio Equityholders and were issued on March 10, 2023 (the “Holdback Shares”). The Company established liabilities for these considerations. T Additionally, the purchase price in connection with the Combangio Acquisition included potential future payments of up to $105,000 that are contingent upon the achievement of specified development, regulatory and commercialization milestones and are required to be recorded at fair value. To date and during the nine months ended September 30, 2023, of the $105,000 in contingent milestone payments, the Company has paid to the Combangio Equityholders an aggregate of $2,500 in cash and $2,354 in shares of the Company’s common stock (representing an aggregate of 105,038 shares of the Company’s common stock) following dosing of the first patient in the Company’s CHASE Phase 2b clinical trial of KPI-012 for PCED in the United States in February 2023 (the “Dosing Milestone”). The Company will pay the remaining amount due in connection with the Dosing Milestone of $146 in cash in January 2024, of which the discounted amount of $140 is included within accrued expenses and other current liabilities on the condensed consolidated balance sheet as of September 30, 2023. Contingent consideration liabilities related to acquisitions are measured at fair value each reporting period using Level 3 unobservable inputs. The fair values of the contingent consideration liabilities were based on a probability-adjusted discounted cash flow calculation using Level 3 fair value measurements. Changes in these estimates and assumptions could have a significant impact on the fair value of the contingent consideration liabilities. Any changes in the fair value of these contingent consideration liabilities are included in loss from operations in the condensed consolidated statements of operations and comprehensive (loss) income. During the three months ended September 30, 2023 and 2022, the change in fair value of the contingent consideration liabilities was a gain of $1,744 and a loss of $95 respectively, and during the nine months ended September 30, 2023 and 2022, the change in the fair value of the contingent consideration liabilities was a loss of $462 and a gain of $952, respectively, primarily due to changes in discount rates, as well as changes in the expected timing and probability of payment, partially offset by the passage of time, and were recognized as a (gain) loss on fair value remeasurement of contingent consideration in the condensed consolidated statements of operations and comprehensive (loss) income for the three and nine months ended September 30, 2023 and 2022. The following tables set forth the fair value of the Company’s financial instruments by level within the fair value hierarchy as of September 30, 2023 and December 31, 2022: September 30, 2023 Fair Value Level 1 Level 2 Level 3 Assets: Cash equivalents $ 49,537 $ 49,537 $ — $ — Total Assets $ 49,537 $ 49,537 $ — $ — Liabilities: Contingent consideration $ 3,838 $ — $ — $ 3,838 Total Liabilities $ 3,838 $ — $ — $ 3,838 December 31, 2022 Fair Value Level 1 Level 2 Level 3 Assets: Cash equivalents $ 31,587 $ 31,587 $ — $ — Total Assets $ 31,587 $ 31,587 $ — $ — Liabilities: Deferred purchase consideration $ 595 $ — $ — $ 595 Contingent consideration 8,370 — — 8,370 Total Liabilities $ 8,965 $ — $ — $ 8,965 The following tables summarize quantitative information and assumptions pertaining to the fair value measurement of the Level 3 inputs as of September 30, 2023 and December 31, 2022: Fair Value at September 30, Range Financial Instrument 2023 Valuation Technique Unobservable Input (Average) Contingent consideration $ 3,838 Probability-adjusted Period of expected milestone achievement 2025 - 2028 (2027) discounted cash flow model Probabilities of achievement 16.6% - 35.5% (23.4%) Discount rate 17.3% Fair Value at December 31, Range Financial Instrument 2022 Valuation Technique Unobservable Input (Average) Deferred purchase consideration $ 595 Option pricing model Discount for lack of marketability 20% Contingent consideration $ 8,370 Probability-adjusted Period of expected milestone achievement 2023 - 2027 (2025) discounted cash flow model Probabilities of achievement 19.9% - 95.0% (44.9%) Discount rate 19.0% Discount for lack of marketability 20.0% The following table summarizes the changes in the Deferred Purchase Consideration and contingent consideration liabilities measured at fair value using Level 3 inputs for the three and nine months ended September 30, 2023 and 2022: Deferred purchase consideration Balance at January 1, 2023 $ 595 Fair value adjustments (230) Settlements (365) Balance at March 31, 2023, June 30, 2023 and September 30, 2023 $ — Contingent consideration Balance at January 1, 2023 $ 8,370 Fair value adjustments 1,847 Settlements (4,854) Reclassification to accrued expenses and other current liabilities (129) Balance at March 31, 2023 $ 5,234 Fair value adjustments 359 Reclassification to accrued expenses and other current liabilities (5) Balance at June 30, 2023 $ 5,588 Fair value adjustments (1,744) Reclassification to accrued expenses and other current liabilities (6) Balance at September 30, 2023 $ 3,838 Deferred purchase consideration Balance at January 1, 2022 $ 7,892 Fair value adjustments 1,051 Settlements (7,935) Balance at March 31, 2022 $ 1,008 Fair value adjustments (789) Balance at June 30, 2022 $ 219 Fair value adjustments (57) Balance at September 30, 2022 $ 162 Contingent consideration Balance at January 1, 2022 $ 8,658 Fair value adjustments (988) Balance at March 31, 2022 $ 7,670 Fair value adjustments (59) Balance at June 30, 2022 $ 7,611 Fair value adjustments 95 Balance at September 30, 2022 $ 7,706 During the three and nine months ended September 30, 2023 and the year ended December 31, 2022, there were no transfers between Level 1 , Level 2 , and Level 3 . |
REVENUE
REVENUE | 9 Months Ended |
Sep. 30, 2023 | |
REVENUE | |
REVENUE | 6. REVENUE Following the sale of its Commercial Business to Alcon in July 2022, the Company no longer has any commercial products in its portfolio. The Company accounted for revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers Product revenues, net The Company sold EYSUVIS and INVELTYS primarily to wholesalers in the United States (collectively, “Customers”). These Customers subsequently resold the Company’s products to specialty and other retail pharmacies. In addition to agreements with Customers, the Company entered into arrangements with third-party payors that provided for government-mandated and/or privately-negotiated rebates, chargebacks and discounts for the purchase of the Company’s products. The goods promised in the Company’s product sales contracts represented a single performance obligation. The Company recognized revenue from product sales at the point the Customer obtained control of the product, which occurred upon delivery. The transaction price (“net sales price”) that was recognized as revenue for product sales included the selling price to the Customer and an estimate of variable consideration. Components of variable consideration included prompt pay and other discounts, product returns, government rebates, third-party payor rebates, coverage gap rebates, incentives such as patient co-pay assistance, and other fees paid to Customers and other third-party payors where a distinct good or service was not received. Variable consideration was recorded on the condensed consolidated balance sheet as either a reduction of accounts receivable, if payable to a Customer, or as a current liability, if payable to a third-party other than a Customer. The Company considered all relevant information when estimating variable consideration such as assessment of its then current and anticipated sales and demand forecasts, actual payment history, information from third parties regarding the payor mix for products, information from third parties regarding the units remaining in the distribution channel, specific known market events and trends, industry data and current contractual and statutory requirements that were reasonably available. The Company included estimated amounts for variable consideration in the net sales price to the extent it was determined probable that a significant reversal of cumulative revenue recognized would not occur when the uncertainty associated with the variable consideration was resolved. Payment terms with Customers did not exceed one year and, therefore, the Company did not account for a significant financing component in its arrangements. The Company expensed the incremental cost of obtaining a contract with a Customer when incurred as the period of benefit was generally less than one year. Reserves for Variable Consideration Trade Discounts and Allowances The Company provided its Customers with certain trade discounts and allowances including discounts for prompt payments and other discounts and fees paid for distribution, data and administrative services. These discounts and fees were based on contractually-determined percentages and were recorded as a reduction of revenue and accounts receivable in the period in which the related product revenue was recognized. Chargebacks Chargebacks for fees and discounts to providers represent the estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to Customers who directly purchased the product from the Company. Customers charged the Company for the difference between what they paid for the product and the ultimate selling price to the qualified healthcare providers. These components of variable consideration were established in the same period that the related revenue was recognized, resulting in a reduction of product revenue and accounts receivable. Reserves for chargebacks consisted of credits the Company expected to issue for units that remained in the distribution channel at the end of each reporting period and that the Company expected would be sold to qualified healthcare providers, as well as chargebacks that Customers had claimed, but for which the Company had not yet issued a credit. Product Returns Consistent with industry practice, the Company has a product returns policy that provides Customers right of return for product purchased within a specified period prior to and subsequent to the product’s expiration date. The Company estimated the amount of its products that may be returned and presented this amount as a reduction of revenue in the period the related product revenue was recognized, in addition to establishing a liability. The Company’s estimates for product returns were based upon available industry data and its own sales information, including its visibility into the inventory remaining in the distribution channel as well as historical returns, which developed over time. Commercial Payor and Medicare Part D Rebates The Company contracted with certain third-party payors, primarily pharmacy benefit managers (“PBMs”) and health plans (“Plans”), for the payment of rebates with respect to utilization of its product. These rebates were based on contractual percentages applied to the amount of product prescribed to patients who were covered by the PBMs or the Plans with which it contracted. The Company estimated the rebates for commercial and Medicare Part D payors based on the contractual discount percentage, the various payor mix for EYSUVIS and INVELTYS as well as future rebates that would be made for product that had been recognized as revenue but remained in the distribution channel at the end of each reporting period. The Company also estimated the number of patients in the prescription drug coverage gap for whom it would owe an additional liability under the Medicare Part D program. Such estimates were recorded in the same period the related revenue was recognized, resulting in a reduction of product revenue and the establishment of a current liability. Government Rebates The Company was subject to discount obligations under Medicaid and other government programs. For Medicaid, reserves were based on actual payment history, and estimates of future Medicaid beneficiary utilization applied to the Medicaid unit rebate formula established by the Centers for Medicaid and Medicare Services. The Company’s liability for these rebates consisted of estimates of claims for the current period and estimated future claims that would be made for product that had been recognized as revenue but remained in the distribution channel at the end of each reporting period. These reserves were recorded in the same period the related revenue was recognized, resulting in a reduction of product revenue and the establishment of a current liability. Co-pay Assistance Programs The Company offered co-pay assistance programs (the “co-pay programs”), which were intended to provide financial assistance to patients who may or may not be covered by commercial insurance or, with respect to INVELTYS, who opt out of Medicare Part D programs. The calculation of accruals for the co-pay programs was based on actual claims processed during the period as well as an estimate of the number and cost per claim that the Company expected to receive associated with product that had been recognized as revenue but remained in the distribution channel at the end of each reporting period. Allowances for estimated co-pay claims were recorded in the same period the related revenue was recognized, resulting in a reduction of product revenue and the establishment of a current liability. The following tables summarize activity in each of the Company’s product revenue provision and allowance categories for the three and nine months ended September 30, 2023 and 2022: Trade Discounts, Allowances and Rebates and Chargebacks (1) Product Returns (2) Incentives (3) Balance as of December 31, 2022 $ 11 $ 518 $ 772 Credit/payments made (2) (49) (484) Balance as of March 31, 2023 $ 9 $ 469 $ 288 Changes in estimate related to prior period sales (9) 249 (240) Credit/payments made — (111) (38) Balance as of June 30, 2023 $ — $ 607 $ 10 Changes in estimate related to prior period sales — 1,106 — Credit/payments made — (64) — Balance as of September 30, 2023 $ — $ 1,649 $ 10 Trade Discounts, Allowances and Rebates and Chargebacks (1) Product Returns (2) Incentives (3) Balance as of December 31, 2021 $ 2,672 $ 1,140 $ 11,280 Provision related to current period sales 2,133 210 13,359 Changes in estimate related to prior period sales (1) (138) (242) Credit/payments made (3,261) (415) (10,108) Balance as of March 31, 2022 $ 1,543 $ 797 $ 14,289 Provision related to current period sales 2,602 214 15,413 Changes in estimate related to prior period sales (41) (199) (107) Credit/payments made (2,041) (112) (14,878) Balance as of June 30, 2022 $ 2,063 $ 700 $ 14,717 Provision related to current period sales 91 4 525 Changes in estimate related to prior period sales 176 150 (680) Credit/payments made (2,310) (263) (9,562) Balance as of September 30, 2022 $ 20 $ 591 $ 5,000 (1) Trade discounts, allowances and chargebacks included fees for distribution service fees, prompt pay and other discounts, and chargebacks. Estimated trade discounts, allowances and chargebacks were deducted from gross revenue at the time revenues were recognized and were recorded as a reduction to accounts receivable on the Company’s condensed consolidated balance sheets. (2) Estimated provisions for product returns were generally deducted from gross revenues at the time revenues were recognized and were included in accrued expenses and other current liabilities on the Company’s condensed consolidated balance sheets. (3) Rebates and incentives included managed care rebates, government rebates, co-pay program incentives, and sales incentives and allowances. Estimated provisions for rebates and discounts were deducted from gross revenues at the time revenues were recognized and were included in accrued expenses and other current liabilities on the Company’s condensed consolidated balance sheets. |
GRANT INCOME
GRANT INCOME | 9 Months Ended |
Sep. 30, 2023 | |
GRANT INCOME | |
GRANT INCOME | 7. GRANT INCOME CIRM Award During each of the three and nine months ended September 30, 2023, the Company recognized $2,970 of grant income related to the CIRM Award on its condensed consolidated statement of operations. As of September 30, 2023, the Company had deferred grant income of $2,930 on its condensed consolidated balance sheet. |
PREPAID EXPENSES AND OTHER CURR
PREPAID EXPENSES AND OTHER CURRENT ASSETS | 9 Months Ended |
Sep. 30, 2023 | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | 8. PREPAID EXPENSES AND OTHER CURRENT ASSETS Prepaid expenses and other current assets, consists of the following: September 30, December 31, 2023 2022 Insurance $ 918 $ 698 Non-trade receivables 143 908 Trade receivables, net 117 195 Due from Alcon 12 5,394 Other 649 657 Prepaid expenses and other current assets $ 1,839 $ 7,852 |
ACCRUED EXPENSES AND OTHER CURR
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | 9 Months Ended |
Sep. 30, 2023 | |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | 9. ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES Accrued expenses and other current liabilities consisted of the following: September 30, December 31, 2023 2022 Compensation and benefits $ 2,783 $ 3,334 Professional services 487 948 Accrued revenue reserves (1) 1,659 807 Development costs 547 446 Contract manufacturing 375 453 Commercial costs 153 271 Due to third parties in connection with Transition Agreement (2) — 2,244 Other 256 407 Accrued expenses and other current liabilities $ 6,260 $ 8,910 (1) There were additional revenue reserves included in accounts payable of $483 as of December 31, 2022. There were no such amounts included in accounts payable as of September 30, 2023. (2) There were additional amounts due to third parties in connection with the Transition Agreement included in accounts payable of $1,737 as of December 31, 2022. There were no such amounts included in accounts payable as of September 30, 2023. |
LEASES
LEASES | 9 Months Ended |
Sep. 30, 2023 | |
LEASES | |
LEASES | 10. LEASES Operating leases Menlo Park, California Office Lease In April 2023, Combangio, a wholly owned subsidiary of the Company, entered into a lease agreement with Menlo Prepi I, LLC, pursuant to which Combangio leases approximately 6,135 square feet of office, laboratory and research and development space in Menlo Park, California. The Company entered into a guaranty of lease agreement guarantying the obligations of Combangio under the lease agreement. The initial term of the lease is for 62 months which commenced on the lease commencement date of July 1, 2023, unless earlier terminated pursuant to the terms of the lease. The lease provides Combangio with an option to extend the lease for an additional five-year term. Combangio was required to make a payment in the amount of $144, as a security deposit pursuant to the lease during the nine months ended September 30, 2023 which is included in other long-term assets on the condensed consolidated balance sheet as of September 30, 2023. Upon the lease commencement, the Company recorded a right-of-use asset of $2.2 million and corresponding $2.1 million of lease liability. As of September 30, 2023, the Company recognized $2.1 million of right-of-use asset and a corresponding $2.2 million of lease liability (current and non-current) by calculating the present value of lease payments, discounted at 13.1% , the Company’s estimated incremental borrowing rate, over the expected term of the lease. As of September 30, 2023, the remaining lease term on the lease was 4.9 years. Variable lease expense for the lease, includes real estate taxes, common area maintenance, and management fees. Terminated Vehicle Fleet Lease During the year ended December 31, 2019, the Company entered into a master fleet lease agreement (the “Vehicle Fleet Lease”), pursuant to which it leased vehicles. The Vehicle Fleet Lease commenced upon the delivery of the initial vehicles in March 2019 and had been subject to modifications as the number of leased vehicles increased or decreased. During the year ended December 31, 2022, in connection with the closing of the Alcon Transaction, the Company terminated the Vehicle Fleet Lease and, as of December 31, 2022, there was no remaining right-of-use asset or corresponding lease liability de minimis. The components of lease expenses and related cash flows were as follows: Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Lease cost Operating lease cost $ 149 $ 9 $ 165 $ 404 Short-term lease cost 20 49 132 143 Variable lease cost 46 114 52 740 Total lease cost $ 215 $ 172 $ 349 $ 1,287 Operating cash outflows from operating leases $ 48 $ 338 $ 61 $ 1,308 The weighted average remaining lease term and weighted average discount rate of operating leases were as follows: September 30, December 31, 2023 2022 Weighted average remaining lease term 4.9 years 0.5 years Weighted average discount rate 13.1% 10.4% As of September 30, 2023, the Company expects that its future minimum lease payments will become due and payable as follows: Years Ending December 31, 2023 (remaining three months) $ 143 2024 581 2025 601 2026 622 2027 644 Thereafter 440 Less: interest (827) Total $ 2,204 |
DEBT
DEBT | 9 Months Ended |
Sep. 30, 2023 | |
DEBT | |
DEBT | 11. DEBT On May 4, 2021, the Company entered into the Loan Agreement with Oxford Finance, in its capacity as lender (in such capacity, the “Lender”), and in its capacity as collateral agent (in such capacity, the “Agent”), pursuant to which a term loan of up to an aggregate principal amount of $125,000 was available to the Company, consisting of a tranche A term loan that was disbursed on the closing date in the aggregate principal amount of $80,000 and additional tranches that are no longer available to the Company. The Company utilized substantially all of the proceeds from the tranche A term loan to repay a prior credit facility. Through June 30, 2023, the term loans bore interest at a floating rate equal to the greater of (i) 30-day LIBOR and (ii) 0.11%, plus 7.89%. Effective July 1, 2023, the term loans bear interest at a floating rate equal to the greater of (i) 8.00% and (ii) the sum of (a) the 1-Month CME Term Secured Overnight Financing Rate, (b) 0.10% and (c) 7.89%. The Loan Agreement, prior to the Second Loan Amendment and Third Loan Amendment (as defined below), provided for interest-only payments until December 1, 2024 if neither the tranche B term loan nor the tranche C term loan are made, and until June 1, 2025 if either the tranche B term loan or the tranche C term loan is made (the “Amortization Date”). The aggregate outstanding principal balance of the term loans were required to be repaid in monthly installments starting on the Amortization Date based on a repayment schedule equal to (i) 18 months if neither the tranche B term loan nor the tranche C term loan is made and (ii) 12 months if either the tranche B term loan or the tranche C term loan is made. All unpaid principal and accrued and unpaid interest with respect to each term loan was due and payable in full on May 1, 2026 (the “Maturity Date”). The Company paid a facility fee of $400 on the closing date of the Loan Agreement and has agreed to pay a facility fee of $100 upon closing of the tranche B term loan and a $125 facility fee upon the closing of the tranche C term loan. The Company will be required to make a final payment fee of 7.00% of the original principal amount of any funded term loan payable on the earlier of (i) the prepayment of the term loan in full or (ii) the Maturity Date. At the Company’s option, the Company may elect to make partial repayments of the term loan to the Lender, subject to specified conditions, including the payment of applicable fees and accrued and unpaid interest on the principal amount of the term loan being repaid. In connection with its entry into the Loan Agreement, the Company granted the Agent a security interest in substantially all of the Company’s personal property owned or later acquired, including intellectual property and the Commercial Business. The Loan Agreement also contains customary representations and warranties and affirmative and negative covenants, as well as customary events of default. Certain of the customary negative covenants limit the ability of the Company and certain of its subsidiaries, among other things, to incur future debt, grant liens, make investments, make acquisitions, distribute dividends, make certain restricted payments and sell assets, subject in each case to certain exceptions. The Loan Agreement includes features requiring (i) additional interest rate upon an event of default accrued at an additional 5% , and (ii) the Lender’s right to declare all outstanding principal and interest immediately payable upon an event of default. These two features were analyzed and determined to be embedded derivatives to be valued as separate financial instruments. These embedded derivatives were bundled and valued as one compound derivative in accordance with the applicable accounting guidance for derivatives and hedging transactions. The Company determined that, due to the unlikely event of default, the embedded derivatives have a de minimis value as of September 30, 2023. The derivative liability will be remeasured at fair value at each reporting date, with changes in fair value being recorded as other income (expense) in the condensed consolidated statements of operations and comprehensive (loss) income. On May 21, 2022, in connection with its entry into the Asset Purchase Agreement with Alcon, the Company entered into an amendment to the Loan Agreement (the “Second Loan Amendment”). Pursuant to the Second Loan Amendment, the Lender and Agent consented to the entry by the Company into the Asset Purchase Agreement and the sale of the Commercial Business to Alcon and agreed to release its liens on the Commercial Business in consideration for the payment by the Company at the closing of the Alcon Transaction of an aggregate amount of $40,000 (the “Second Amendment Prepayment”) to the Lender and Agent, representing a partial prepayment of principal in the amount of $36,697 of the $80,000 principal amount outstanding under the term loan advanced by the Lender under the Loan Agreement, plus a prepayment fee of $734 and a final payment fee of $2,569. In addition, the Company was required to pay all accrued and unpaid interest on the principal amount of the term loan being repaid. In addition, under the Second Loan Amendment, the Lender and Agent agreed that, following the closing of the Alcon Transaction and the Second Amendment Prepayment, the Amortization Date would be extended from December 1, 2024 to January 1, 2026, at which time the aggregate principal balance of the term loan then outstanding under the Loan Agreement is required to be repaid in five monthly installments. Pursuant to the Second Loan Amendment, the Company may also make partial prepayments of the term loan to the Lender, subject to specified conditions, including the payment of applicable fees and accrued and unpaid interest on the principal amount of the term loan being repaid. On July 8, 2022, the Second Amendment Prepayment was paid in connection with the closing of Alcon Transaction, and as such, the Amortization Date was extended to January 1, 2026. The transaction resulted in a loss on extinguishment of debt of $2,583 for the year ended December 31, 2022, consisting of the prepayment premium, a pro-rata portion of the unamortized debt discount and issuance costs and the unaccreted exit fee due upon the Second Amendment Prepayment. On December 27, 2022, the Company entered into an amendment to the Loan Agreement (the “Third Loan Amendment”). Pursuant to the Third Loan Amendment, the Lender and Agent agreed to amend certain provisions of the Loan Agreement to permit the transfer of the listing of the Company’s common stock from The Nasdaq Global Select Market to The Nasdaq Capital Market. Pursuant to the Third Loan Amendment, the Company agreed (A) to make partial prepayments of the principal amount of the term loan outstanding under the Loan Agreement as follows (the “Third Amendment Prepayments”): (1) a payment of $5,000 on or before June 30, 2023, representing a partial prepayment of principal in the amount of $4,673, plus a final payment fee of $327 and (2) a payment of $5,000 on or before January 31, 2024, representing a partial prepayment of principal in the amount of $4,673, plus a final payment fee of $327 and (B) that the Amortization Date under the Loan Agreement shall be changed from January 1, 2026 to January 1, 2025. Pursuant to the Third Loan Amendment, in addition to the Third Amendment Prepayments, if the Company makes an additional prepayment under the Loan Agreement equal to $5,000 (inclusive of the final payment fee) on or prior to December 31, 2024 (the “First Extension Prepayment”), the Amortization Date will be automatically changed to July 1, 2025, and the maturity date of the Loan Agreement will be automatically changed from May 1, 2026 to November 1, 2026. If, in addition to the Third Amendment Prepayments and the First Extension Prepayment, the Company makes an additional prepayment under the Loan Agreement equal to $2,500 (inclusive of the final payment fee) on or prior to June 30, 2025 (the “Second Extension Prepayment”), the Amortization Date will be automatically changed to January 1, 2026, and the maturity date of the Loan Agreement will be automatically changed to May 1, 2027. Under the Third Loan Amendment, the Lender and Agent also agreed to waive the prepayment fees for the Third Amendment Prepayments, the First Extension Prepayment, the Second Extension Prepayment and any other prepayments under the Loan Agreement. Pursuant to the Loan Agreement, the Company also will be required to pay all accrued and unpaid interest on the principal amounts of the term loan being repaid at the time of repayment. The Company paid the Third Amendment Prepayments on January 25, 2023, following which the Company became required to repay the Loan Agreement in monthly installments from January 1, 2025 through May 1, 2026. The principal loan balance under the Loan Agreement following the Third Amendment Prepayments was $33,957. On August 1, 2023, the Company entered into an amendment to the Loan Agreement with Combangio and Oxford Finance (the “Fourth Loan Amendment”). Pursuant to the Fourth Loan Amendment, certain provisions of the Loan Agreement were amended in connection with the change of the Company’s name and the cessation of the U.S. Dollar LIBOR rate. On August 2, 2023, the Company entered into an amendment to the Loan Agreement with Combangio and Oxford Finance (the “Fifth Loan Amendment”). Pursuant to the Fifth Loan Amendment, Oxford Finance consented to the Company’s entry into the CIRM Award and certain provisions of the Loan Agreement were amended in connection therewith. In addition, in connection with the Loan Agreement, the Company paid certain fees to the Lender and other third-party service providers. The fees paid to the Lender were recorded as a debt discount while the fees paid to other third-party service providers were recorded as debt issuance cost. These costs are being amortized using the effective interest method over the term of the Loan Agreement. The amortization of debt discount and debt issuance cost is included in interest expense within the condensed consolidated statements of operations and comprehensive (loss) income. As of September 30, 2023, the effective interest rate was 17.21%, which takes into consideration the non-cash accretion of the exit fee and the amortization of the debt discount and issuance costs. During the three months ended September 30, 2023 and 2022, the Company recognized interest expense of $1,459 and $1,447, respectively, for the This consisted of amortization of debt discount of $68 and $52 for the three months ended , respectively, accretion of the final payment fee of $241 and $206 for the three months ended , respectively, and the contractual coupon interest expense of $1,150 and $1,189 for the three months ended , respectively. for the This consisted of amortization of debt discount of $204 and $281 for the nine months ended , respectively, accretion of the final payment fee of $737 and $849 for the nine months ended , respectively, and the contractual coupon interest expense of $3,405 and $4,573 for the nine months ended , respectively. The components of the carrying value of the debt as of September 30, 2023 and December 31, 2022 are detailed below: September 30, December 31, 2023 2022 Principal loan balance $ 33,957 $ 43,303 Unamortized debt discount and issuance cost (602) (806) Cumulative accretion of exit fee 523 440 Total debt $ 33,878 $ 42,937 Less: current portion of long-term debt — (5,000) Long-term debt, net $ 33,878 $ 37,937 The annual principal payments due under the Loan Agreement as of September 30, 2023 were as follows: Years Ending December 31, 2023 (remaining three months) $ — 2024 — 2025 23,970 2026 9,987 2027 — Total $ 33,957 |
WARRANTS
WARRANTS | 9 Months Ended |
Sep. 30, 2023 | |
WARRANTS. | |
WARRANTS | 12. WARRANTS The following table summarizes the common stock warrants outstanding as of September 30, 2023 and December 31, 2022, each exercisable into the number of shares of common stock set forth below as of the specified dates: Shares Exercisable at Exercise Expiration Exercisable September 30, December 31, Issued Price Per Share Date From 2023 2022 2014 $ 375.00 November 2024 July 2017 320 320 2016 $ 413.50 October 2026 September 2017 290 290 2018 $ 609.23 October 2025 October 2018 3,693 3,693 4,303 4,303 |
EQUITY FINANCINGS
EQUITY FINANCINGS | 9 Months Ended |
Sep. 30, 2023 | |
EQUITY FINANCINGS | |
EQUITY FINANCINGS | 13. EQUITY FINANCINGS Registered Offerings On May 7, 2020, the Company filed a shelf registration statement on Form S-3 with the SEC, which was declared effective on May 19, 2020 (the “2020 Shelf Registration”). Under the 2020 Shelf Registration, the Company may offer and sell up to $350,000 of a variety of securities including common stock, preferred stock, warrants, depositary shares, debt securities or units during the three-year period that commenced upon the 2020 Shelf Registration becoming effective. In connection with the filing of the 2020 Shelf Registration, the Company entered into an amended and restated sales agreement with Jefferies pursuant to which On January 10, 2023, the Amended and Restated Sales Agreement terminated in accordance with its terms when the Company completed the sale of $75,000 of its shares of common stock thereunder. As of the date of termination of the Amended and Restated Sales Agreement, the Company had sold an aggregate of 565,974 shares of its common stock under such agreement for aggregate gross proceeds of $75,000 . On January 19, 2023, the Company entered into an Open Market Sale Agreement with Jefferies (the “Open Market Sale Agreement”), pursuant to which the Company may issue and sell, from time to time, shares its common stock under an at-the-market equity offering. The Company filed a prospectus supplement relating to the Open Market Sale Agreement under its 2020 Shelf Registration (the “2020 Shelf ATM Prospectus Supplement”), pursuant to which the Company could offer and sell shares of common stock having an aggregate offering price of up to $40,000 under the Open Market Sale Agreement. On March 3, 2023, the Company filed a shelf registration statement on Form S-3 with the SEC, which was declared effective on May 11, 2023 (the “2023 Shelf Registration”). Under the 2023 Shelf Registration, the Company may offer and sell up to $350,000 of a variety of securities including common stock, preferred stock, warrants, depositary shares, debt securities, subscription rights or units after such time as the shelf registration statement is declared effective by the SEC. In accordance with the terms of the Open Market Sale Agreement, the Company may issue and sell, from time to time, up to $40,000 of its common stock in an at-the-market equity offering through Jefferies, as sales agent. Upon effectiveness of the 2023 Shelf Registration, the Company ceased any further offers or sales of its common stock pursuant to the 2020 Shelf ATM Prospectus Supplement and the 2020 Shelf Registration. During the nine months ended September 30, 2023, the Company sold 190,000 shares of its common stock under its at-the-market offering pursuant to the 2023 Shelf Registration for total net proceeds of $3,073, none of which were sold during the three months ended September 30, 2023. During the nine months ended September 30, 2023, the Company sold an aggregate of 665,265 shares of its common stock pursuant to (1) the Amended and Restated Sales Agreement and the Open Market Sale Agreement under the 2020 Shelf Registration and (2) the Open Market Sale Agreement under the 2023 Shelf Registration, for total net proceeds of $17,966 . Private Placement On November 28, 2022, the Company entered into a Securities Purchase Agreement (the “Securities Purchase Agreement”) with certain institutional investors named therein (the “Purchasers”), pursuant to which the Company agreed to issue and sell, in a private placement priced at-the-market under Nasdaq rules, shares of common stock and shares of Series E Convertible Non-Redeemable Preferred Stock, par value $0.001 per share, of the Company (the “Series E Preferred Stock”), in two tranches for aggregate gross proceeds of up to $31,000 (collectively, the “Private Placement”). Pursuant to the Securities Purchase Agreement, on December 1, 2022, the Company issued and sold to the Purchasers at the first closing of the Private Placement, (i) 76,813 shares of common stock, at a price per common share equal to $5.75 and (ii) 9,666 shares of Preferred Stock, at a price per share equal to $575.00, for aggregate gross proceeds of approximately $6,000. On December 27, 2022, following the certification by the Chief Executive Officer of the Company that the FDA accepted the Company’s IND for KPI-012, the Company issued and sold to the Purchasers at a second closing of the Private Placement a total of 43,478 Preferred Shares, at a price per share equal to $575.00, for aggregate gross proceeds of approximately $25,000. Costs incurred in connection with the Private Placement were $240, which were recorded as a reduction to additional paid-in capital. |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 9 Months Ended |
Sep. 30, 2023 | |
STOCKBASED COMPENSATION | |
STOCK-BASED COMPENSATION | 14. STOCK‑BASED COMPENSATION On June 22, 2023, the Company’s stockholders approved the Company’s Amended and Restated 2017 Equity Incentive Plan, which amended and restated the Company’s 2017 Equity Incentive Plan, as amended (the “2017 Plan”), to (i) increase the number of shares of common stock authorized for issuance thereunder by 1,250,000 shares; (ii) limit the number of incentive stock options that can be granted under the plan to 7,738,761 shares of common stock; (iii) add an annual limit on non-employee director compensation, including cash and the value of equity awards, of $750,000 for incumbent directors and $1,000,000 in a director’s first year of service; and (iv) extend the term of the plan (including the duration of the evergreen) to 10 years from June 22, 2023, the date that stockholders approved the plan. In addition, the Amended and Restated 2017 Equity Plan provides for an annual increase to be added on the first day of each fiscal year, beginning with the fiscal year ending December 31, 2024 and continuing for each fiscal year until, and including, the fiscal year ending December 31, 2033, equal to the lower of (i) 4% of the sum of (I) the number of outstanding shares of common stock on such date and (II) the number of shares of common stock issuable upon conversion of any outstanding shares of convertible preferred stock of the Company on such date (without giving effect to any restrictions or limitations on conversion) and (ii) an amount determined by the Company’s board of directors. As of September 30, 2023, there were 112,597 shares of common stock available for grant under the Amended and Restated 2017 Equity Incentive Plan. During the nine months ended September In January 2023 and July 2023, employees of the Company purchased an aggregate of 461 shares and 3,229 shares under the Employee Stock Purchase Plan, respectively. The assumptions used in determining fair value of the stock options granted during the nine months ended September 30, 2023 are as follows: Nine Months Ended September 30, 2023 Expected volatility 108.4% – 123.1% Risk-free interest rate 3.55% – 4.43% Expected dividend yield 0% Expected term (in years) 5.50 – 6.10 During the nine months ended September On May 1, 2023, the Company commenced a one-time stock option exchange program (the “Option Exchange Program”), under which the Company’s eligible executive officers, other employees and non-employee directors (collectively, “Eligible Holders”) were given the opportunity to exchange outstanding options to purchase shares of the Company’s common stock held by them for an equal number of RSUs that are subject to vesting conditions. The Option Exchange Program expired on May 30, 2023. A total of 36 Eligible Holders participated in the Option Exchange Program. Pursuant to the terms and conditions of the Option Exchange Program, the Company accepted for exchange options to purchase a total of 182,251 shares of the Company’s common stock. All surrendered options were cancelled effective as of the expiration of the Option Exchange Program, and immediately thereafter, in exchange therefor, the Company granted a total of 182,251 RSUs pursuant to the terms of the Option Exchange Program and the 2017 Plan. A de minimis In January 2022, the Company granted stock options to purchase up to 14,850 shares of common stock to certain executives tied to certain performance criteria. On March 14, 2023, the Compensation Committee of the Company’s Board of Directors determined that certain of the performance conditions were achieved at specific levels of achievement, resulting in vesting of options to purchase an aggregate of 3,960 shares of common stock. All outstanding stock options tied to performance criteria were surrendered in the Option Exchange Program and as such, there were none outstanding as of September 30, 2023. As of September Stock-based compensation expense was classified in the condensed consolidated statements of operations and comprehensive (loss) income as follows for the three and nine months ended September 30, 2023 and 2022: Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Cost of product revenues $ — $ 4 $ — $ 166 Research and development 657 238 1,454 1,085 Selling, general and administrative 1,746 1,085 3,635 4,797 Total $ 2,403 $ 1,327 $ 5,089 $ 6,048 |
(LOSS) INCOME PER SHARE
(LOSS) INCOME PER SHARE | 9 Months Ended |
Sep. 30, 2023 | |
(LOSS) INCOME PER SHARE | |
(LOSS) INCOME PER SHARE | 15. (LOSS) INCOME PER SHARE Basic and diluted net (loss) income per share attributable to common stockholders was calculated as follows for the three and nine months ended : Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Numerator: Net (loss) income attributable to common stockholders $ (8,704) $ 29,073 $ (33,572) $ (31,979) Denominator: Weighted-average common shares outstanding, basic (1) 2,550,210 1,499,001 2,337,492 1,490,159 Effect of dilutive securities — 11,420 — — Weighted-average common shares outstanding, diluted (1) 2,550,210 1,510,421 2,337,492 1,490,159 Net (loss) income per share attributable to common stockholders, basic $ (3.41) $ 19.39 $ (14.36) $ (21.46) Net (loss) income per share attributable to common stockholders, diluted $ (3.41) $ 19.25 $ (14.36) $ (21.46) (1) Included in the weighted-average common shares outstanding, basic and diluted for the three and nine months ended September 30, 2022 is an aggregate of 19,350 shares of common stock that were held back by the Company as partial security for the satisfaction of indemnification obligations and other payment obligations of the Combangio Equityholders and were issued in March 2023. The following potential common stock equivalents, presented based on amounts outstanding at each period end, were excluded from the calculation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect: Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Options to purchase shares of common stock 670,064 221,747 509,914 242,234 Unvested RSUs and PSUs 824,998 — 598,210 11,328 Unexercised warrants 4,303 4,303 4,303 4,303 Convertible preferred stock (as converted to common stock) 5,124,600 — 5,238,000 — 6,623,965 226,050 6,350,427 257,865 |
INCOME TAXES
INCOME TAXES | 9 Months Ended |
Sep. 30, 2023 | |
INCOME TAXES | |
INCOME TAXES | 16. INCOME TAXES The Company did not record a provision or benefit for income taxes during the three and nine months ended September 30, 2023 and 2022. The Company continues to maintain a full valuation allowance for its U.S. federal and state deferred tax assets. The Company has evaluated the positive and negative evidence bearing upon its ability to realize the deferred tax assets. Management has considered the Company’s history of cumulative net losses incurred since inception and its generation of limited revenue from product sales since inception and has concluded that it is more likely than not that the Company will not realize the benefits of the deferred tax assets. Management reevaluates the positive and negative evidence at each reporting period. Realization of the future tax benefits is dependent on many factors, including the Company’s ability to generate taxable income within the net operating loss carryforward period. Under the provisions of Section 382 of the Internal Revenue Code of 1986, as amended, certain substantial changes in the Company’s ownership, including a sale of the Company, or significant changes in ownership due to sales of equity, may have limited, or may limit in the future, the amount of net operating loss carryforwards, which could be used annually to offset future taxable income. The Company previously completed an analysis and determined that an ownership change materially limited the net operating loss carryforwards. During December 2022, an additional ownership change occurred as a result of the Company’s entry into the Securities Purchase Agreement. As a result of the most recent ownership change, the utilization of the Company’s net operating loss carryforwards is subject to an annual limitation of $222. The Company files its corporate income tax returns in the United States and various states. All tax years since the date of incorporation remain open to examination by the major taxing jurisdictions (state and federal) to which the Company is subject, as carryforward attributes generated in years past may still be adjusted upon examination by the Internal Revenue Service (“IRS”) or other authorities if they have or will be used in a future period. The Company is not currently under examination by the IRS or any other jurisdictions for any tax year. As of September 30, 2023 and December 31, 2022, the Company had no uncertain tax positions. The Company’s policy is to recognize interest and penalties related to income tax matters as a component of income tax expense, of which no interest or penalties were recorded for the three and nine months ended September 30, 2023 and 2022. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 9 Months Ended |
Sep. 30, 2023 | |
COMMITMENTS AND CONTINGENCIES | |
COMMITMENTS AND CONTINGENCIES. | 17. COMMITMENTS AND CONTINGENCIES Stanford License Agreement the nine months ended September 30, 2023, the Company paid Stanford a $175 milestone payment which was triggered by the commencement of the CHASE . de minimis Litigation Contingencies related to the Merger Agreement |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Grant Income | Grant Income Grant income consists of amounts earned from incurring costs to support the CHASE Phase 2b clinical trial of KPI-012 for PCED, as well as product process characterization and analytical development from the program due to the receipt of the CIRM Award. The grant between the Company and CIRM generally provides for the Company to meet certain milestones in order for funds to be provided. The Company accounts for grants received to perform research and development activities in accordance with Accounting Standards Codification (“ASC”) Topic 730-20, Research and Development Arrangements Grant funds received in advance are recorded as deferred grant income on the condensed consolidated balance sheets. Management has determined that the Company is the principal participant under the Company’s CIRM Award, and accordingly, the Company records amounts earned under this arrangement as grant income on the condensed consolidated statements of operations and comprehensive (loss) income. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Management has considered all recent accounting pronouncements issued since the last audit of the Company’s consolidated financial statements. The Company’s management believes that these recent pronouncements will not have a material effect on the Company’s consolidated financial statements. |
SALE OF COMMERCIAL BUSINESS T_2
SALE OF COMMERCIAL BUSINESS TO ALCON (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
SALE OF COMMERCIAL BUSINESS TO ALCON | |
Schedule of dispositions of business | Gross consideration from the sale of the Commercial Business $ 65,027 Closing and transaction costs 2,119 Net proceeds from the sale of the Commercial Business 62,908 Book value of assets transferred Inventories 8,915 Prepaid expenses and other current assets 556 Property and equipment, net 1,819 Other long-term assets 434 Total book value of assets transferred 11,724 Gain on sale of Commercial Business 51,184 Deferred gain on sale of Commercial Business 4,189 Net gain on sale of Commercial Business $ 46,995 |
ASSETS HELD FOR SALE (Tables)
ASSETS HELD FOR SALE (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
ASSETS HELD FOR SALE | |
Schedule of the major categories of assets that have been reclassified to held for sale | December 31, 2022 Inventories $ 7,544 Property and equipment, net 51 Current assets held for sale $ 7,595 |
FAIR VALUE OF FINANCIAL INSTR_2
FAIR VALUE OF FINANCIAL INSTRUMENTS (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
FAIR VALUE OF FINANCIAL INSTRUMENTS | |
Schedule of assets and liabilities measured at fair value on a recurring basis | September 30, 2023 Fair Value Level 1 Level 2 Level 3 Assets: Cash equivalents $ 49,537 $ 49,537 $ — $ — Total Assets $ 49,537 $ 49,537 $ — $ — Liabilities: Contingent consideration $ 3,838 $ — $ — $ 3,838 Total Liabilities $ 3,838 $ — $ — $ 3,838 December 31, 2022 Fair Value Level 1 Level 2 Level 3 Assets: Cash equivalents $ 31,587 $ 31,587 $ — $ — Total Assets $ 31,587 $ 31,587 $ — $ — Liabilities: Deferred purchase consideration $ 595 $ — $ — $ 595 Contingent consideration 8,370 — — 8,370 Total Liabilities $ 8,965 $ — $ — $ 8,965 |
Schedule of fair values of warrants, using the Black Scholes option pricing model | Fair Value at September 30, Range Financial Instrument 2023 Valuation Technique Unobservable Input (Average) Contingent consideration $ 3,838 Probability-adjusted Period of expected milestone achievement 2025 - 2028 (2027) discounted cash flow model Probabilities of achievement 16.6% - 35.5% (23.4%) Discount rate 17.3% Fair Value at December 31, Range Financial Instrument 2022 Valuation Technique Unobservable Input (Average) Deferred purchase consideration $ 595 Option pricing model Discount for lack of marketability 20% Contingent consideration $ 8,370 Probability-adjusted Period of expected milestone achievement 2023 - 2027 (2025) discounted cash flow model Probabilities of achievement 19.9% - 95.0% (44.9%) Discount rate 19.0% Discount for lack of marketability 20.0% |
Schedule of changes in Level 3 fair value measurements | Deferred purchase consideration Balance at January 1, 2023 $ 595 Fair value adjustments (230) Settlements (365) Balance at March 31, 2023, June 30, 2023 and September 30, 2023 $ — Contingent consideration Balance at January 1, 2023 $ 8,370 Fair value adjustments 1,847 Settlements (4,854) Reclassification to accrued expenses and other current liabilities (129) Balance at March 31, 2023 $ 5,234 Fair value adjustments 359 Reclassification to accrued expenses and other current liabilities (5) Balance at June 30, 2023 $ 5,588 Fair value adjustments (1,744) Reclassification to accrued expenses and other current liabilities (6) Balance at September 30, 2023 $ 3,838 Deferred purchase consideration Balance at January 1, 2022 $ 7,892 Fair value adjustments 1,051 Settlements (7,935) Balance at March 31, 2022 $ 1,008 Fair value adjustments (789) Balance at June 30, 2022 $ 219 Fair value adjustments (57) Balance at September 30, 2022 $ 162 Contingent consideration Balance at January 1, 2022 $ 8,658 Fair value adjustments (988) Balance at March 31, 2022 $ 7,670 Fair value adjustments (59) Balance at June 30, 2022 $ 7,611 Fair value adjustments 95 Balance at September 30, 2022 $ 7,706 |
REVENUE (Tables)
REVENUE (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
REVENUE | |
Schedule of product revenue provision and allowance categories | Trade Discounts, Allowances and Rebates and Chargebacks (1) Product Returns (2) Incentives (3) Balance as of December 31, 2022 $ 11 $ 518 $ 772 Credit/payments made (2) (49) (484) Balance as of March 31, 2023 $ 9 $ 469 $ 288 Changes in estimate related to prior period sales (9) 249 (240) Credit/payments made — (111) (38) Balance as of June 30, 2023 $ — $ 607 $ 10 Changes in estimate related to prior period sales — 1,106 — Credit/payments made — (64) — Balance as of September 30, 2023 $ — $ 1,649 $ 10 Trade Discounts, Allowances and Rebates and Chargebacks (1) Product Returns (2) Incentives (3) Balance as of December 31, 2021 $ 2,672 $ 1,140 $ 11,280 Provision related to current period sales 2,133 210 13,359 Changes in estimate related to prior period sales (1) (138) (242) Credit/payments made (3,261) (415) (10,108) Balance as of March 31, 2022 $ 1,543 $ 797 $ 14,289 Provision related to current period sales 2,602 214 15,413 Changes in estimate related to prior period sales (41) (199) (107) Credit/payments made (2,041) (112) (14,878) Balance as of June 30, 2022 $ 2,063 $ 700 $ 14,717 Provision related to current period sales 91 4 525 Changes in estimate related to prior period sales 176 150 (680) Credit/payments made (2,310) (263) (9,562) Balance as of September 30, 2022 $ 20 $ 591 $ 5,000 (1) Trade discounts, allowances and chargebacks included fees for distribution service fees, prompt pay and other discounts, and chargebacks. Estimated trade discounts, allowances and chargebacks were deducted from gross revenue at the time revenues were recognized and were recorded as a reduction to accounts receivable on the Company’s condensed consolidated balance sheets. (2) Estimated provisions for product returns were generally deducted from gross revenues at the time revenues were recognized and were included in accrued expenses and other current liabilities on the Company’s condensed consolidated balance sheets. (3) Rebates and incentives included managed care rebates, government rebates, co-pay program incentives, and sales incentives and allowances. Estimated provisions for rebates and discounts were deducted from gross revenues at the time revenues were recognized and were included in accrued expenses and other current liabilities on the Company’s condensed consolidated balance sheets. |
PREPAID EXPENSES AND OTHER CU_2
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | |
Schedule of prepaid expenses and other current assets | September 30, December 31, 2023 2022 Insurance $ 918 $ 698 Non-trade receivables 143 908 Trade receivables, net 117 195 Due from Alcon 12 5,394 Other 649 657 Prepaid expenses and other current assets $ 1,839 $ 7,852 |
ACCRUED EXPENSES AND OTHER CU_2
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES | |
Schedule of accrued expenses and other current liabilities | September 30, December 31, 2023 2022 Compensation and benefits $ 2,783 $ 3,334 Professional services 487 948 Accrued revenue reserves (1) 1,659 807 Development costs 547 446 Contract manufacturing 375 453 Commercial costs 153 271 Due to third parties in connection with Transition Agreement (2) — 2,244 Other 256 407 Accrued expenses and other current liabilities $ 6,260 $ 8,910 (1) There were additional revenue reserves included in accounts payable of $483 as of December 31, 2022. There were no such amounts included in accounts payable as of September 30, 2023. (2) There were additional amounts due to third parties in connection with the Transition Agreement included in accounts payable of $1,737 as of December 31, 2022. There were no such amounts included in accounts payable as of September 30, 2023. |
LEASES (Tables)
LEASES (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
LEASES | |
Schedule of lease cost | Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Lease cost Operating lease cost $ 149 $ 9 $ 165 $ 404 Short-term lease cost 20 49 132 143 Variable lease cost 46 114 52 740 Total lease cost $ 215 $ 172 $ 349 $ 1,287 Operating cash outflows from operating leases $ 48 $ 338 $ 61 $ 1,308 |
Schedule of weighted average remaining lease term and weighted average discount rate of operating leases | September 30, December 31, 2023 2022 Weighted average remaining lease term 4.9 years 0.5 years Weighted average discount rate 13.1% 10.4% |
Schedule of future minimum lease payments | Years Ending December 31, 2023 (remaining three months) $ 143 2024 581 2025 601 2026 622 2027 644 Thereafter 440 Less: interest (827) Total $ 2,204 |
DEBT (Tables)
DEBT (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
DEBT | |
Schedule of carrying value of debt | September 30, December 31, 2023 2022 Principal loan balance $ 33,957 $ 43,303 Unamortized debt discount and issuance cost (602) (806) Cumulative accretion of exit fee 523 440 Total debt $ 33,878 $ 42,937 Less: current portion of long-term debt — (5,000) Long-term debt, net $ 33,878 $ 37,937 |
Schedule of maturities of long-term debt | Years Ending December 31, 2023 (remaining three months) $ — 2024 — 2025 23,970 2026 9,987 2027 — Total $ 33,957 |
WARRANTS (Tables)
WARRANTS (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
WARRANTS. | |
Schedule of outstanding warrants | Shares Exercisable at Exercise Expiration Exercisable September 30, December 31, Issued Price Per Share Date From 2023 2022 2014 $ 375.00 November 2024 July 2017 320 320 2016 $ 413.50 October 2026 September 2017 290 290 2018 $ 609.23 October 2025 October 2018 3,693 3,693 4,303 4,303 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
STOCKBASED COMPENSATION | |
Schedule of assumptions used in determining fair value of the stock options granted | Nine Months Ended September 30, 2023 Expected volatility 108.4% – 123.1% Risk-free interest rate 3.55% – 4.43% Expected dividend yield 0% Expected term (in years) 5.50 – 6.10 |
Schedule of stock based compensation expense | Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Cost of product revenues $ — $ 4 $ — $ 166 Research and development 657 238 1,454 1,085 Selling, general and administrative 1,746 1,085 3,635 4,797 Total $ 2,403 $ 1,327 $ 5,089 $ 6,048 |
(LOSS) INCOME PER SHARE (Tables
(LOSS) INCOME PER SHARE (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
(LOSS) INCOME PER SHARE | |
Schedule of computation of basic and diluted net loss per share | Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Numerator: Net (loss) income attributable to common stockholders $ (8,704) $ 29,073 $ (33,572) $ (31,979) Denominator: Weighted-average common shares outstanding, basic (1) 2,550,210 1,499,001 2,337,492 1,490,159 Effect of dilutive securities — 11,420 — — Weighted-average common shares outstanding, diluted (1) 2,550,210 1,510,421 2,337,492 1,490,159 Net (loss) income per share attributable to common stockholders, basic $ (3.41) $ 19.39 $ (14.36) $ (21.46) Net (loss) income per share attributable to common stockholders, diluted $ (3.41) $ 19.25 $ (14.36) $ (21.46) (1) Included in the weighted-average common shares outstanding, basic and diluted for the three and nine months ended September 30, 2022 is an aggregate of 19,350 shares of common stock that were held back by the Company as partial security for the satisfaction of indemnification obligations and other payment obligations of the Combangio Equityholders and were issued in March 2023. |
Schedule of outstanding securities excluded from the computation of diluted weighted average shares outstanding as they would have been anti-dilutive | Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Options to purchase shares of common stock 670,064 221,747 509,914 242,234 Unvested RSUs and PSUs 824,998 — 598,210 11,328 Unexercised warrants 4,303 4,303 4,303 4,303 Convertible preferred stock (as converted to common stock) 5,124,600 — 5,238,000 — 6,623,965 226,050 6,350,427 257,865 |
NATURE OF BUSINESS AND BASIS _2
NATURE OF BUSINESS AND BASIS OF PRESENTATION (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||
Aug. 02, 2023 USD ($) | Oct. 20, 2022 shares | Sep. 30, 2023 USD ($) shares | Sep. 30, 2022 USD ($) shares | Sep. 30, 2023 USD ($) shares | Sep. 30, 2022 USD ($) shares | Dec. 31, 2022 USD ($) shares | Oct. 19, 2022 shares | Jul. 08, 2022 USD ($) | |
Acquisition of Combangio, Inc | |||||||||
Reverse stock split | 0.02 | ||||||||
Common stock, shares issued | shares | 1 | 2,693,116 | 2,693,116 | 1,706,971 | 50 | ||||
Common stock, shares outstanding | shares | 1 | 2,693,116 | 2,693,116 | 1,706,971 | 50 | ||||
Common stock, authorized | shares | 120,000,000 | 120,000,000 | 120,000,000 | 120,000,000 | |||||
Net (loss) income | $ (8,704) | $ 29,073 | $ (33,572) | $ (31,979) | |||||
Cash used in operations | (20,231) | $ (65,173) | |||||||
Accumulated deficit | $ 620,782 | $ 620,782 | $ 587,210 | ||||||
Proceeds from private placement | $ 31,000 | ||||||||
Combangio, Inc. | Award agreement | California Institute for Regenerative Medicine (CIRM) | |||||||||
Acquisition of Combangio, Inc | |||||||||
Restricted grant | $ 15,000 | ||||||||
Grant disbursement | $ 5,900 | ||||||||
Series D redeemable preferred stock | |||||||||
Acquisition of Combangio, Inc | |||||||||
Shares Outstanding | shares | 73,208 | 73,208 | |||||||
Commercial Business Sale to Alcon | Disposed of by sale not discontinued operations | |||||||||
Acquisition of Combangio, Inc | |||||||||
Amount receivable upon the achievement of specified commercial sales-based milestones | $ 325,000 |
SALE OF COMMERCIAL BUSINESS T_3
SALE OF COMMERCIAL BUSINESS TO ALCON (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Jul. 08, 2022 USD ($) item | Sep. 30, 2023 USD ($) | Sep. 30, 2023 USD ($) | Dec. 31, 2022 USD ($) | |
Dispositions disclosures | ||||
Number of milestone payments | item | 1 | |||
Deferred gain on sale of Commercial Business | $ 4,189 | |||
Due from Alcon | $ 12 | $ 12 | 5,394 | |
Due to third parties | 2,244 | |||
Alcon | ||||
Dispositions disclosures | ||||
Due from third parties | 26 | |||
Accounts payable | ||||
Dispositions disclosures | ||||
Due to third parties | 0 | 0 | 1,737 | |
Transition Service Agreement | ||||
Dispositions disclosures | ||||
Due to third parties | 0 | 0 | 3,981 | |
Net receivables | 1,439 | |||
Transition Service Agreement | Other income | ||||
Dispositions disclosures | ||||
Collaborative arrangement other income | $ 0 | $ 157 | ||
Transition Service Agreement | Accrued expenses and other current liabilities | ||||
Dispositions disclosures | ||||
Due to third parties | 2,244 | |||
Transition Service Agreement | Accounts payable | ||||
Dispositions disclosures | ||||
Due to third parties | 1,737 | |||
Commercial Business Sale to Alcon | ||||
Dispositions disclosures | ||||
Upfront payment | $ 60,000 | |||
Commercial Business Sale to Alcon | Disposed of by sale not discontinued operations | ||||
Dispositions disclosures | ||||
Number of commercial-based sales milestone payments | item | 4 | |||
Amount receivable upon the achievement of specified commercial sales-based milestones | $ 325,000 | |||
Proceeds from inventory transfer | 5,027 | |||
Deferred gain on sale of Commercial Business | $ 4,189 | |||
Commercial Business Sale to Alcon | Disposed of by sale not discontinued operations | Achievement of $50,000 or more in aggregate worldwide net sales | ||||
Dispositions disclosures | ||||
Sales based milestone achievement | 50,000 | |||
Amount receivable upon the achievement of specified commercial sales-based milestones | 25,000 | |||
Commercial Business Sale to Alcon | Disposed of by sale not discontinued operations | Achievement of $100,000 or more in aggregate worldwide net sales | ||||
Dispositions disclosures | ||||
Sales based milestone achievement | 100,000 | |||
Amount receivable upon the achievement of specified commercial sales-based milestones | 65,000 | |||
Commercial Business Sale to Alcon | Disposed of by sale not discontinued operations | Achievement of $175,000 or more in aggregate worldwide net sales | ||||
Dispositions disclosures | ||||
Sales based milestone achievement | 175,000 | |||
Amount receivable upon the achievement of specified commercial sales-based milestones | 75,000 | |||
Commercial Business Sale to Alcon | Disposed of by sale not discontinued operations | Achievement of $250,000 or more in aggregate worldwide net sales | ||||
Dispositions disclosures | ||||
Sales based milestone achievement | 250,000 | |||
Amount receivable upon the achievement of specified commercial sales-based milestones | $ 160,000 |
SALE OF COMMERCIAL BUSINESS T_4
SALE OF COMMERCIAL BUSINESS TO ALCON - Net Gain on Sale of Commercial Business (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Sep. 30, 2022 | Dec. 31, 2022 | |
Book value of assets transferred | |||
Inventories | $ 7,544 | ||
Deferred gain on sale of Commercial Business | 4,189 | ||
Net gain on sale of Commercial Business | $ 46,995 | $ 46,995 | |
Commercial Business Sale to Alcon | Disposed of by sale not discontinued operations | |||
Dispositions disclosures | |||
Gross consideration from the sale of the Commercial Business | 65,027 | ||
Closing and transaction costs | 2,119 | ||
Net proceeds from the sale of the Commercial Business | 62,908 | ||
Book value of assets transferred | |||
Inventories | 8,915 | ||
Prepaid expenses and other current assets | 556 | ||
Property and equipment, net | 1,819 | ||
Other long-term assets | 434 | ||
Total book value of assets transferred | 11,724 | ||
Gain on sale of Commercial Business | 51,184 | ||
Deferred gain on sale of Commercial Business | 4,189 | ||
Net gain on sale of Commercial Business | $ 46,995 |
ASSETS HELD FOR SALE - Major Ca
ASSETS HELD FOR SALE - Major Categories of Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Major categories of assets that have been reclassified to held for sale on the condensed consolidated balance sheet | ||
Inventories | $ 7,544 | |
Property and equipment, net | 51 | |
Deferred gain on sale of Commercial Business | 4,189 | |
Assets held for sale | $ 0 | 7,595 |
Commercial Business Sale to Alcon | Disposed of by sale not discontinued operations | ||
Major categories of assets that have been reclassified to held for sale on the condensed consolidated balance sheet | ||
Inventories | 8,915 | |
Deferred gain on sale of Commercial Business | $ 4,189 |
FAIR VALUE OF FINANCIAL INSTR_3
FAIR VALUE OF FINANCIAL INSTRUMENTS (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||
Nov. 15, 2021 | Mar. 31, 2023 | Feb. 28, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Jan. 31, 2024 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||||||||
Settled liability | $ 365 | $ 7,935 | ||||||
Change in fair value of deferred purchase consideration | $ 0 | |||||||
(Gain) loss on fair value remeasurement of deferred purchase consideration | $ (57) | (230) | $ 205 | |||||
Contingent milestone consideration paid in shares value | 2,354 | |||||||
Contingent consideration | ||||||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||||||||
Reclassification to accrued expenses and other current liabilities | $ 140 | |||||||
Shares not issued until escrow release date of February 15, 2023 | ||||||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||||||||
Number of shares | 19,350 | 19,350 | ||||||
Combangio, Inc. | ||||||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||||||||
Number of shares | 155,664 | |||||||
Combangio, Inc. | Shares Issued on January 3, 2022 | ||||||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||||||||
Number of shares | 136,314 | |||||||
Combangio, Inc. | Shares not issued until escrow release date of March 2023 | ||||||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||||||||
Number of shares | 19,350 | |||||||
Combangio, Inc. | First patient dosed with any product in phase 2 clinical trial, dosing milestone | ||||||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||||||||
Contingent milestone consideration paid | $ 2,500 | |||||||
Contingent milestone consideration paid in shares value | $ 2,354 | |||||||
Contingent milestone consideration paid in shares | 105,038 | 105,038 | ||||||
Combangio, Inc. | First patient dosed with any product in phase 2 clinical trial, dosing milestone | Subsequent Events | ||||||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||||||||
Contingent milestone consideration | $ 146 | |||||||
Combangio, Inc. | Maximum | ||||||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||||||||
Contingent milestone consideration | $ 105,000 |
FAIR VALUE OF FINANCIAL INSTR_4
FAIR VALUE OF FINANCIAL INSTRUMENTS - Recurring and Nonrecurring Fair value Measurements Within Hierarchy (Details) - Fair Value - Recurring - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Fair Value Assets Measured on Recurring and Non recurring Basis | ||
Financial assets by level within fair value hierarchy | $ 49,537 | $ 31,587 |
Fair Value Liabilities Measured on Recurring and Non recurring Basis | ||
Financial liabilities by level within fair value hierarchy | 3,838 | 8,965 |
Deferred purchase consideration | ||
Fair Value Liabilities Measured on Recurring and Non recurring Basis | ||
Financial liabilities by level within fair value hierarchy | 595 | |
Contingent consideration | ||
Fair Value Liabilities Measured on Recurring and Non recurring Basis | ||
Financial liabilities by level within fair value hierarchy | 3,838 | 8,370 |
Cash equivalents | ||
Fair Value Assets Measured on Recurring and Non recurring Basis | ||
Financial assets by level within fair value hierarchy | 49,537 | 31,587 |
Level 1 | ||
Fair Value Assets Measured on Recurring and Non recurring Basis | ||
Financial assets by level within fair value hierarchy | 49,537 | 31,587 |
Level 1 | Cash equivalents | ||
Fair Value Assets Measured on Recurring and Non recurring Basis | ||
Financial assets by level within fair value hierarchy | 49,537 | 31,587 |
Level 3 | ||
Fair Value Liabilities Measured on Recurring and Non recurring Basis | ||
Financial liabilities by level within fair value hierarchy | 3,838 | 8,965 |
Level 3 | Deferred purchase consideration | ||
Fair Value Liabilities Measured on Recurring and Non recurring Basis | ||
Financial liabilities by level within fair value hierarchy | 595 | |
Level 3 | Contingent consideration | ||
Fair Value Liabilities Measured on Recurring and Non recurring Basis | ||
Financial liabilities by level within fair value hierarchy | $ 3,838 | $ 8,370 |
FAIR VALUE OF FINANCIAL INSTR_5
FAIR VALUE OF FINANCIAL INSTRUMENTS - Quantitative Information and Assumptions (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Fair Value Measurements | ||||
(Gain) loss on fair value remeasurement of deferred purchase consideration | $ (57) | $ (230) | $ 205 | |
Level 3 | Deferred purchase consideration | ||||
Fair Value Measurements | ||||
Financial liabilities by level within fair value hierarchy | $ 595 | |||
Business Combination, Contingent Consideration, Liability, Valuation Technique [Extensible Enumeration] | Option pricing model | |||
Business Combination, Contingent Consideration, Liability, Measurement Input [Extensible Enumeration] | Discount for lack of marketability | |||
Level 3 | Deferred purchase consideration | Option pricing model | Discount for lack of marketability | Minimum | ||||
Fair Value Measurements | ||||
Measurement input | 0.20 | |||
Level 3 | Contingent consideration | ||||
Fair Value Measurements | ||||
Financial liabilities by level within fair value hierarchy | $ 3,838 | $ 8,370 | ||
Level 3 | Contingent consideration | Discounted cash flow model | Discount for lack of marketability | ||||
Fair Value Measurements | ||||
Measurement input | 0.200 | |||
Level 3 | Contingent consideration | Discounted cash flow model | Probabilities of achievement | Minimum | ||||
Fair Value Measurements | ||||
Measurement input | 0.166 | 0.199 | ||
Level 3 | Contingent consideration | Discounted cash flow model | Probabilities of achievement | Maximum | ||||
Fair Value Measurements | ||||
Measurement input | 0.355 | 0.950 | ||
Level 3 | Contingent consideration | Discounted cash flow model | Probabilities of achievement | Average | ||||
Fair Value Measurements | ||||
Measurement input | 0.234 | 0.449 | ||
Level 3 | Contingent consideration | Discounted cash flow model | Discount rate | ||||
Fair Value Measurements | ||||
Measurement input | 0.173 | 0.190 |
FAIR VALUE OF FINANCIAL INSTR_6
FAIR VALUE OF FINANCIAL INSTRUMENTS - Fair Value Measurement Levels (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation | ||||||||
Settlements | $ (365) | $ (7,935) | ||||||
Contingent consideration | ||||||||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation | ||||||||
Reclassification to accrued expenses and other current liabilities | (140) | |||||||
Level 3 | Deferred purchase consideration | ||||||||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation | ||||||||
Beginning balance | $ 595 | $ 219 | $ 1,008 | $ 7,892 | 595 | 7,892 | ||
Fair value adjustments | (57) | (789) | 1,051 | (230) | ||||
Settlements | (7,935) | (365) | ||||||
Ending balance | 162 | 219 | 1,008 | 162 | ||||
Level 3 | Contingent consideration | ||||||||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation | ||||||||
Beginning balance | $ 5,588 | $ 5,234 | 8,370 | 7,611 | 7,670 | 8,658 | 8,370 | 8,658 |
Fair value adjustments | (1,744) | 359 | 1,847 | 95 | (59) | (988) | 462 | (952) |
Settlements | (4,854) | |||||||
Reclassification to accrued expenses and other current liabilities | (6) | (5) | (129) | |||||
Ending balance | $ 3,838 | $ 5,588 | $ 5,234 | $ 7,706 | $ 7,611 | $ 7,670 | $ 3,838 | $ 7,706 |
FAIR VALUE OF FINANCIAL INSTR_7
FAIR VALUE OF FINANCIAL INSTRUMENTS - Fair Value Measurement Transfer Levels (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | |
FAIR VALUE OF FINANCIAL INSTRUMENTS | |||
Transfer from level 1 to level 2, Assets | $ 0 | $ 0 | $ 0 |
Transfer from level 2 to level 1, Assets | 0 | 0 | 0 |
Transfer from level 1 to level 2, Liability | 0 | 0 | 0 |
Transfer from level 2 to level 1, Liability | 0 | 0 | 0 |
Transfer into level 3, Assets | 0 | 0 | 0 |
Transfer out of level 3, Assets | 0 | 0 | 0 |
Transfer into level 3, Liability | 0 | 0 | 0 |
Transfer out of level 3, Liability | $ 0 | $ 0 | $ 0 |
REVENUE - Co-pay Assistance Pro
REVENUE - Co-pay Assistance Programs (Details) - USD ($) $ in Thousands | 3 Months Ended | |||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | |
Trade Discounts, Allowances and Chargebacks | ||||||
Disaggregation of Revenue | ||||||
Beginning balance | $ 9 | $ 11 | $ 2,063 | $ 1,543 | $ 2,672 | |
Provision related to current period sales | 91 | 2,602 | 2,133 | |||
Changes in estimate related to prior period sales | (9) | 176 | (41) | (1) | ||
Credit/payments made | (2) | (2,310) | (2,041) | (3,261) | ||
Ending balance | 9 | 20 | 2,063 | 1,543 | ||
Product Returns | ||||||
Disaggregation of Revenue | ||||||
Beginning balance | $ 607 | 469 | 518 | 700 | 797 | 1,140 |
Provision related to current period sales | 4 | 214 | 210 | |||
Changes in estimate related to prior period sales | 1,106 | 249 | 150 | (199) | (138) | |
Credit/payments made | (64) | (111) | (49) | (263) | (112) | (415) |
Ending balance | 1,649 | 607 | 469 | 591 | 700 | 797 |
Rebates and Incentives | ||||||
Disaggregation of Revenue | ||||||
Beginning balance | 10 | 288 | 772 | 14,717 | 14,289 | 11,280 |
Provision related to current period sales | 525 | 15,413 | 13,359 | |||
Changes in estimate related to prior period sales | (240) | (680) | (107) | (242) | ||
Credit/payments made | (38) | (484) | (9,562) | (14,878) | (10,108) | |
Ending balance | $ 10 | $ 10 | $ 288 | $ 5,000 | $ 14,717 | $ 14,289 |
GRANT INCOME (Details)
GRANT INCOME (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |
Aug. 02, 2023 | Sep. 30, 2023 | Sep. 30, 2023 | |
Grant Income [Line Items] | |||
Royalty on net sales (as a percent) | 0.10% | ||
Royalty on net sales based on of funds utilized by the Company | $ 1,000 | ||
Term of royalty from the date of first commercial sale of such product, service or approved drug | 10 years | ||
Grant income | $ 2,970 | $ 2,970 | |
Deferred grant income | 2,930 | 2,930 | |
California Institute for Regenerative Medicine (CIRM) | |||
Grant Income [Line Items] | |||
Threshold period for achievement of specified milestones' | 4 months | ||
Grant income | 2,970 | 2,970 | |
Deferred grant income | $ 2,930 | $ 2,930 | |
Combangio, Inc. | California Institute for Regenerative Medicine (CIRM) | |||
Grant Income [Line Items] | |||
Royalty on net sales (as a percent) | 1% | ||
Threshold sales after which royalty on net sales of funded invention is payable | $ 500,000 | ||
Combangio, Inc. | Award agreement | California Institute for Regenerative Medicine (CIRM) | |||
Grant Income [Line Items] | |||
Restricted grant | 15,000 | ||
Grant disbursement | $ 5,900 |
PREPAID EXPENSES AND OTHER CU_3
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | ||
Non-trade receivables | $ 143 | $ 908 |
Insurance | 918 | 698 |
Trade receivables, net | 117 | 195 |
Due from Alcon | 12 | 5,394 |
Other | 649 | 657 |
Prepaid expenses and other current assets | $ 1,839 | $ 7,852 |
ACCRUED EXPENSES AND OTHER CU_3
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Compensation and benefits | $ 2,783 | $ 3,334 |
Professional services | 487 | 948 |
Accrued revenue reserves | 1,659 | 807 |
Development costs | 547 | 446 |
Contract manufacturing | 375 | 453 |
Commercial costs | 153 | 271 |
Due to third parties in connection with Transition Agreement (2) | 2,244 | |
Other | 256 | 407 |
Accrued expenses and other current liabilities | 6,260 | 8,910 |
Accounts payable | ||
Accrued revenue reserves | 0 | 483 |
Due to third parties in connection with Transition Agreement (2) | $ 0 | $ 1,737 |
LEASES - Menlo Park, CA Office
LEASES - Menlo Park, CA Office Lease (Details) $ in Thousands | 1 Months Ended | |
Apr. 30, 2023 USD ($) ft² | Sep. 30, 2023 USD ($) | |
Leases | ||
Long-term lease liabilities | $ 1,880 | |
Menlo Park, California Office Lease | ||
Leases | ||
Leased square footage | ft² | 6,135 | |
Lease term | 62 months | |
Existence of option to extend | true | |
Renewal term | 5 years | |
Estimated incremental borrowing rate | 13.10% | |
Remaining lease term | 4 years 10 months 24 days | |
Menlo Park, California Office Lease | Restricted cash and other long-term assets | ||
Leases | ||
Security deposit | $ 144 |
LEASES (Details)
LEASES (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Apr. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2019 | |
Leases | |||||||
Right-of-use assets | $ 2,102 | $ 2,102 | $ 16 | ||||
Lease liability | 2,204 | 2,204 | |||||
Lease cost | |||||||
Operating lease cost | 149 | $ 9 | 165 | $ 404 | |||
Short-term lease cost | 20 | 49 | 132 | 143 | |||
Variable lease cost | 46 | 114 | 52 | 740 | |||
Total lease cost | 215 | 172 | 349 | 1,287 | |||
Operating cash outflows from operating leases | $ 48 | $ 338 | $ 61 | $ 1,308 | |||
Weighted average remaining lease term | 4 years 10 months 24 days | 4 years 10 months 24 days | 6 months | ||||
Weighted average discount rate | 10.40% | ||||||
Lessee, Operating Lease, Liability, Payments, Remainder of Fiscal Year | $ 143 | $ 143 | |||||
2019 | 581 | 581 | |||||
Menlo Park, California Office Lease | |||||||
Leases | |||||||
Right-of-use assets | 2,100 | 2,100 | $ 2,200 | ||||
Lease liability | $ 2,200 | $ 2,200 | $ 2,100 | ||||
Lease cost | |||||||
Remaining lease term | 4 years 10 months 24 days | 4 years 10 months 24 days | |||||
Vehicle Fleet Lease | |||||||
Leases | |||||||
Right-of-use assets | $ 0 | ||||||
Lease liability | 0 | ||||||
Amount borrowed | $ 450 | ||||||
Vehicle Fleet Lease | Prepaid expenses and other current assets | |||||||
Leases | |||||||
Due from vendor | $ 775 |
LEASES - Future minimum payment
LEASES - Future minimum payments (Details) $ in Thousands | Sep. 30, 2023 USD ($) |
Future minimum commitments due | |
2023 (remaining three months) | $ 143 |
2024 | 581 |
2025 | 601 |
2026 | 622 |
2027 | 644 |
Thereafter | 440 |
Less: interest | (827) |
Total | $ 2,204 |
DEBT - Oxford Finance Loan and
DEBT - Oxford Finance Loan and Security Agreement (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||
Jul. 01, 2023 | Dec. 27, 2022 USD ($) | May 21, 2022 USD ($) installment | May 04, 2021 USD ($) item | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Debt instruments | |||||||||
Effective interest rate | 17.21% | 17.21% | |||||||
Amount of principal outstanding | $ 33,957 | $ 33,957 | $ 43,303 | ||||||
Loss on extinguishment of debt | $ (2,583) | $ (2,583) | |||||||
Interest expense | 1,459 | 1,447 | 4,346 | 5,689 | |||||
Athyrium Credit Facility | |||||||||
Debt instruments | |||||||||
Amount of principal outstanding | 33,957 | 33,957 | |||||||
Accretion of final prepayment fee | 241 | 206 | 737 | 849 | |||||
Interest expense | 1,459 | 1,447 | 4,346 | 5,703 | |||||
Amortization of debt discount | 68 | 52 | 204 | 281 | |||||
Contractual coupon interest | $ 1,150 | $ 1,189 | $ 3,405 | $ 4,573 | |||||
Athyrium | |||||||||
Debt instruments | |||||||||
Number of derivatives | item | 1 | ||||||||
Athyrium | Athyrium Credit Facility | |||||||||
Debt instruments | |||||||||
Additional interest rate upon an event of default accrued (as a percent) | 5% | ||||||||
Loan Agreement | |||||||||
Debt instruments | |||||||||
Aggregate principal amount | $ 125,000 | ||||||||
Floating interest rate (as a percent) | 0.11% | ||||||||
Facility fees paid | $ 400 | ||||||||
Percentage of final payment fees | 7% | ||||||||
Debt repayments | $ 40,000 | ||||||||
Partial prepayment | 36,697 | ||||||||
Amount of principal outstanding | 80,000 | 33,957 | |||||||
Prepayment fees paid | 734 | ||||||||
Final prepayment fee | $ 2,569 | ||||||||
Number of monthly installments | installment | 5 | ||||||||
Loss on extinguishment of debt | $ (2,583) | ||||||||
Loan Agreement | Neither the tranche B term loan nor the tranche C term loan is made | |||||||||
Debt instruments | |||||||||
Duration of periodic monthly payment installments under a scenario | 18 months | ||||||||
Loan Agreement | Either tranche B term loan nor tranche C term loan is made | |||||||||
Debt instruments | |||||||||
Duration of periodic monthly payment installments under a scenario | 12 months | ||||||||
Loan Agreement | Payment on or before June 30, 2023 | |||||||||
Debt instruments | |||||||||
Debt repayments | $ 5,000 | ||||||||
Partial prepayment | 4,673 | ||||||||
Final prepayment fee | 327 | ||||||||
Loan Agreement | Payment on or before January 31, 2024. | |||||||||
Debt instruments | |||||||||
Debt repayments | 5,000 | ||||||||
Partial prepayment | 4,673 | ||||||||
Final prepayment fee | 327 | ||||||||
Loan Agreement | Payment on or prior to December 31, 2024 | |||||||||
Debt instruments | |||||||||
Debt repayments | 5,000 | ||||||||
Loan Agreement | Payment on or prior to June 30, 2025 | |||||||||
Debt instruments | |||||||||
Debt repayments | $ 2,500 | ||||||||
Loan Agreement | Minimum | |||||||||
Debt instruments | |||||||||
Floating interest rate (as a percent) | 8% | ||||||||
Loan Agreement | 30-day LIBOR | |||||||||
Debt instruments | |||||||||
Spread on variable rate | 7.89% | ||||||||
Loan Agreement | 1- Month CME Term SOFR | |||||||||
Debt instruments | |||||||||
Floating interest rate (as a percent) | 0.10% | ||||||||
Spread on variable rate | 7.89% | ||||||||
Tranche A term loan | |||||||||
Debt instruments | |||||||||
Aggregate principal amount | $ 80,000 | ||||||||
Tranche B term loan | |||||||||
Debt instruments | |||||||||
Facility fees paid | 100 | ||||||||
Tranche C term loan | |||||||||
Debt instruments | |||||||||
Facility fees paid | $ 125 |
DEBT- Carrying Value (Details)
DEBT- Carrying Value (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
DEBT | ||
Principal loan balance | $ 33,957 | $ 43,303 |
Unamortized debt discount and issuance cost | (602) | (806) |
Cumulative accretion of exit fee | 523 | 440 |
Total debt | 33,878 | 42,937 |
Less: current portion of long-term debt | (5,000) | |
Long-term debt, net | $ 33,878 | $ 37,937 |
DEBT - Future Annual Principal
DEBT - Future Annual Principal Payments (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Maturities of long-term debt | ||
Total | $ 33,957 | $ 43,303 |
Athyrium Credit Facility | ||
Maturities of long-term debt | ||
2025 | 23,970 | |
2026 | 9,987 | |
Total | $ 33,957 |
WARRANTS (Details)
WARRANTS (Details) - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Warrants | ||
Shares Exercisable | 4,303 | 4,303 |
Warrants 2014 | ||
Warrants | ||
Exercise Price Per Share | $ 375 | |
Shares Exercisable | 320 | 320 |
Warrants 2016 | ||
Warrants | ||
Exercise Price Per Share | $ 413.50 | |
Shares Exercisable | 290 | 290 |
Warrants 2018 | ||
Warrants | ||
Exercise Price Per Share | $ 609.23 | |
Shares Exercisable | 3,693 | 3,693 |
EQUITY FINANCINGS (Details)
EQUITY FINANCINGS (Details) $ / shares in Units, $ in Thousands | 3 Months Ended | 4 Months Ended | 9 Months Ended | |||||||||
Mar. 03, 2023 USD ($) | Jan. 10, 2023 USD ($) shares | Jan. 10, 2023 USD ($) shares | Dec. 27, 2022 USD ($) $ / shares shares | Dec. 01, 2022 USD ($) $ / shares shares | Nov. 28, 2022 USD ($) tranche $ / shares | May 07, 2020 USD ($) | Sep. 30, 2023 USD ($) $ / shares | May 11, 2023 USD ($) shares | Sep. 30, 2023 USD ($) $ / shares shares | Jan. 19, 2023 USD ($) | Dec. 31, 2022 $ / shares | |
Equity Offerings | ||||||||||||
Stock offering, net of issuance cost and underwriting fees (in shares) | shares | 565,974 | |||||||||||
Stock offering, net of issuance cost and underwriting fees | $ 75,000 | |||||||||||
Maximum | ||||||||||||
Equity Offerings | ||||||||||||
Additional authorized value of securities | $ 350,000 | |||||||||||
Share authorized value (ATM) | $ 40,000 | |||||||||||
Series E preferred shares | ||||||||||||
Equity Offerings | ||||||||||||
Stock offering, net of issuance cost and underwriting fees | $ 31,000 | |||||||||||
Preferred stock, par value | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | ||||||||
Number of tranches | tranche | 2 | |||||||||||
Shelf Registration | ||||||||||||
Equity Offerings | ||||||||||||
Registration period | 3 years | |||||||||||
Shelf Registration | Maximum | ||||||||||||
Equity Offerings | ||||||||||||
Additional authorized value of securities | $ 350,000 | |||||||||||
2020 Shelf Registration | Maximum | ||||||||||||
Equity Offerings | ||||||||||||
Additional authorized value of securities | $ 40,000 | |||||||||||
ATM | ||||||||||||
Equity Offerings | ||||||||||||
Stock offering, net of issuance cost and underwriting fees (in shares) | shares | 245,887 | 190,000 | ||||||||||
Stock offering, net of issuance cost and underwriting fees | $ 9,994 | $ 3,073 | ||||||||||
ATM | Maximum | ||||||||||||
Equity Offerings | ||||||||||||
Additional authorized value of securities | $ 75,000 | |||||||||||
Open Market Sale Agreement | ||||||||||||
Equity Offerings | ||||||||||||
Stock offering, net of issuance cost and underwriting fees (in shares) | shares | 229,378 | |||||||||||
Stock offering, net of issuance cost and underwriting fees | $ 4,899 | |||||||||||
Amended and Restated Sales Agreement and the Open Market Sale Agreement in aggregate | ||||||||||||
Equity Offerings | ||||||||||||
Stock offering, net of issuance cost and underwriting fees (in shares) | shares | 665,265 | |||||||||||
Stock offering, net of issuance cost and underwriting fees | $ 17,966 | |||||||||||
Securities Purchase Agreement, Tranche One | ||||||||||||
Equity Offerings | ||||||||||||
Stock offering, net of issuance cost and underwriting fees | $ 6,000 | |||||||||||
Securities Purchase Agreement, Tranche One | Preferred Stock | ||||||||||||
Equity Offerings | ||||||||||||
Stock offering, net of issuance cost and underwriting fees (in shares) | shares | 9,666 | |||||||||||
Share price (in dollars per share) | $ / shares | $ 575 | |||||||||||
Securities Purchase Agreement, Tranche One | Common Stock | ||||||||||||
Equity Offerings | ||||||||||||
Stock offering, net of issuance cost and underwriting fees (in shares) | shares | 76,813 | |||||||||||
Share price (in dollars per share) | $ / shares | $ 5.75 | |||||||||||
Securities Purchase Agreement Tranche Two | Preferred Stock | ||||||||||||
Equity Offerings | ||||||||||||
Stock offering, net of issuance cost and underwriting fees (in shares) | shares | 43,478 | |||||||||||
Stock offering, net of issuance cost and underwriting fees | $ 25,000 | |||||||||||
Share price (in dollars per share) | $ / shares | $ 575 | |||||||||||
Offering costs | $ 240 |
STOCK-BASED COMPENSATION - Fair
STOCK-BASED COMPENSATION - Fair Value Assumptions (Details) | 9 Months Ended |
Sep. 30, 2023 | |
Assumptions used in determining fair value of the stock options granted | |
Expected volatility (minimum) | 108.40% |
Expected volatility (maximum) | 123.10% |
Risk-free interest rate (minimum) | 3.55% |
Risk-free interest rate (maximum) | 4.43% |
Expected dividend yield | 0% |
Minimum | |
Assumptions used in determining fair value of the stock options granted | |
Expected term (in years) | 5 years 6 months |
Maximum | |
Assumptions used in determining fair value of the stock options granted | |
Expected term (in years) | 6 years 1 month 6 days |
STOCK-BASED COMPENSATION - Indu
STOCK-BASED COMPENSATION - Inducement Stock Option Awards (Details) | 1 Months Ended | 9 Months Ended | |||||
Jun. 22, 2023 USD ($) shares | May 01, 2023 USD ($) person shares | Mar. 14, 2023 shares | Jul. 31, 2023 shares | Jan. 31, 2023 shares | Jan. 31, 2022 shares | Sep. 30, 2023 $ / shares shares | |
Stock-based compensation | |||||||
Number of shares available for future issuance | 112,597 | ||||||
Weighted average grant date fair value of options granted | $ / shares | $ 12.82 | ||||||
Employee stock options | |||||||
Stock-based compensation | |||||||
Granted, options (in shares) | 666,962 | ||||||
Number of shares outstanding | 0 | ||||||
Conditional vesting of shares | 3,960 | ||||||
Employee stock options | Executive Officer | Maximum | |||||||
Stock-based compensation | |||||||
Granted, options (in shares) | 14,850 | ||||||
2017 Equity Incentive Plan | |||||||
Stock-based compensation | |||||||
Options expiry term | 10 years | ||||||
Number of additional shares authorized for issuance under share-based payment arrangement | 1,250,000 | ||||||
Annual limit on non-employee director compensation for incumbent directors | $ | $ 750,000 | ||||||
Annual limit on non-employee director compensation for director's first year of service | $ | $ 1,000,000 | ||||||
Incremental compensation cost as a result of modification | $ | $ 1,210,000 | ||||||
Annual increase in the number of shares (as a percent) | 4% | ||||||
Shares authorized | 7,738,761 | ||||||
ESPP | |||||||
Stock-based compensation | |||||||
Issuance of common stock under employee stock purchase plan (in shares) | 3,229 | 461 | |||||
RSU | |||||||
Stock-based compensation | |||||||
Granted, other than options (in shares) | 824,190 | ||||||
Eligible Holders | Employee stock options | |||||||
Stock-based compensation | |||||||
Number of participants | person | 36 | ||||||
Number of common stock issuable for Option Exchange Program | 182,251 |
STOCK-BASED COMPENSATION - RSUs
STOCK-BASED COMPENSATION - RSUs and PSUs (Details) | 9 Months Ended |
Sep. 30, 2023 USD ($) shares | |
RSU | |
Stock-based compensation | |
Granted, other than options (in shares) | 824,190 |
RSU and PSU | |
Stock-based compensation | |
Outstanding balance at end of period (in shares) | 827,658 |
Unvested outstanding balance at end of period (in shares) | $ | 824,998 |
Vested and deferred (in shares) | 2,660 |
STOCK-BASED COMPENSATION - Stoc
STOCK-BASED COMPENSATION - Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Stock-based compensation | ||||
Stock based compensation expense | $ 2,403 | $ 1,327 | $ 5,089 | $ 6,048 |
Cost of product revenues | ||||
Stock-based compensation | ||||
Stock based compensation expense | 4 | 166 | ||
Research and development | ||||
Stock-based compensation | ||||
Stock based compensation expense | 657 | 238 | 1,454 | 1,085 |
Selling, general and administrative | ||||
Stock-based compensation | ||||
Stock based compensation expense | $ 1,746 | $ 1,085 | $ 3,635 | $ 4,797 |
(LOSS) INCOME PER SHARE (Detail
(LOSS) INCOME PER SHARE (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Numerator: | ||||
Net loss attributable to common stockholders | $ (8,704) | $ 29,073 | $ (33,572) | $ (31,979) |
Denominator: | ||||
Weighted average shares outstanding-basic (in shares) | 2,550,210 | 1,499,001 | 2,337,492 | 1,490,159 |
Effect of dilutive securities | 11,420 | |||
Weighted average shares outstanding-diluted (in shares) | 2,550,210 | 1,510,421 | 2,337,492 | 1,490,159 |
Net income (loss) per share attributable to common stockholders, basic | $ (3.41) | $ 19.39 | $ (14.36) | $ (21.46) |
Net income (loss) per share attributable to common stockholders, diluted | $ (3.41) | $ 19.25 | $ (14.36) | $ (21.46) |
Shares not issued until escrow release date of February 15, 2023 | ||||
Denominator: | ||||
Number of shares | 19,350 | 19,350 |
(LOSS) INCOME PER SHARE - Antid
(LOSS) INCOME PER SHARE - Antidilutive Securities (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Outstanding securities excluded from the computation of diluted weighted average shares outstanding | ||||
Outstanding securities excluded from the computation of diluted weighted average shares outstanding (in shares) | 6,623,965 | 226,050 | 6,350,427 | 257,865 |
Employee stock options | ||||
Outstanding securities excluded from the computation of diluted weighted average shares outstanding | ||||
Outstanding securities excluded from the computation of diluted weighted average shares outstanding (in shares) | 670,064 | 221,747 | 509,914 | 242,234 |
RSU and PSU | ||||
Outstanding securities excluded from the computation of diluted weighted average shares outstanding | ||||
Outstanding securities excluded from the computation of diluted weighted average shares outstanding (in shares) | 824,998 | 598,210 | 11,328 | |
Warrants | ||||
Outstanding securities excluded from the computation of diluted weighted average shares outstanding | ||||
Outstanding securities excluded from the computation of diluted weighted average shares outstanding (in shares) | 4,303 | 4,303 | 4,303 | 4,303 |
Convertible preferred stock | ||||
Outstanding securities excluded from the computation of diluted weighted average shares outstanding | ||||
Outstanding securities excluded from the computation of diluted weighted average shares outstanding (in shares) | 5,124,600 | 5,238,000 |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
INCOME TAXES | ||
Annual limitation amount of tax credit carryforward | $ 222 | |
Uncertain tax positions | $ 0 | 0 |
Interest or penalties recorded | $ 0 | $ 0 |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - Contingencies Related to Stanford and Merger Agreement (Details) - USD ($) $ in Thousands | 1 Months Ended | 9 Months Ended | |||
Mar. 31, 2023 | Feb. 28, 2023 | Sep. 30, 2023 | Jan. 31, 2024 | Nov. 15, 2021 | |
Other Commitments | |||||
Contingent milestone consideration paid in shares value | $ 2,354 | ||||
CHASE Phase 2b clinical trial of KPI-012 | |||||
Other Commitments | |||||
Contingent upon specified development, regulatory and commercialization milestones | $ 175 | ||||
Combangio, Inc. | |||||
Other Commitments | |||||
Contingent upon specified development, regulatory and commercialization milestones | $ 40,000 | ||||
Combangio, Inc. | First patient dosed with any product in phase 2 clinical trial, dosing milestone | |||||
Other Commitments | |||||
Potential maximum payout for contingent consideration | $ 65,000 | ||||
Contingent milestone consideration paid | $ 2,500 | ||||
Contingent milestone consideration paid in shares value | $ 2,354 | ||||
Contingent milestone consideration paid in shares | 105,038 | 105,038 | |||
Combangio, Inc. | First patient dosed with any product in phase 2 clinical trial, dosing milestone | Subsequent Events | |||||
Other Commitments | |||||
Contingent milestone consideration | $ 146 |