Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2022 | May 05, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2022 | |
Document Transition Report | false | |
Entity File Number | 001-38356 | |
Entity Registrant Name | VYNE THERAPEUTICS INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 45-3757789 | |
Entity Address, Address Line One | 520 U.S. Highway 22, Suite 204 | |
Entity Address, City or Town | Bridgewater | |
Entity Address, State or Province | NJ | |
Entity Address, Postal Zip Code | 08807 | |
City Area Code | 800 | |
Local Phone Number | 775-7936 | |
Title of 12(b) Security | Common Stock, par value $0.0001 | |
Trading Symbol | VYNE | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Shell Company | true | |
Entity Common Stock, Shares Outstanding (in shares) | 57,908,489 | |
Entity Central Index Key | 0001566044 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Current Assets: | ||
Cash and cash equivalents | $ 50,495 | $ 42,250 |
Restricted cash | 605 | 605 |
Trade receivables, net of allowances | 535 | 7,583 |
Amount due from sale of MST Franchise | 5,000 | 0 |
Prepaid expenses and other assets | 3,895 | 4,565 |
Operating lease right of use assets | 124 | 338 |
Discontinued operations - current assets | 0 | 7,845 |
Total Current Assets | 60,654 | 63,186 |
Property and equipment, net | 310 | 354 |
Non-current prepaid expenses and other assets | 3,355 | 3,506 |
Total Assets | 64,319 | 67,046 |
Current Liabilities: | ||
Trade payables | 3,612 | 6,510 |
Accrued expenses | 3,312 | 8,593 |
Employee related obligations | 1,331 | 2,752 |
Liability for employee severance benefits | 216 | 206 |
Operating lease liabilities | 117 | 349 |
Total Liabilities | 8,588 | 18,410 |
Commitments and Contingencies (Note 7) | ||
Stockholders' Equity: | ||
Preferred stock: $0.0001 par value; 20,000,000 shares authorized at March 31, 2022 and December 31, 2021; no shares issued and outstanding at March 31, 2022 and December 31, 2021 | 0 | 0 |
Common stock: $0.0001 par value; 150,000,000 shares authorized at March 31, 2022 and December 31, 2021; 57,908,489 and 53,577,744 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively | 6 | 5 |
Additional paid-in capital | 690,580 | 688,156 |
Accumulated deficit | (634,855) | (639,525) |
Total Stockholders' Equity | 55,731 | 48,636 |
Total Liabilities and Stockholders’ Equity | $ 64,319 | $ 67,046 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 20,000,000 | 20,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock shares authorized (in shares) | 150,000,000 | 150,000,000 |
Common stock shares issued (in shares) | 57,908,489 | 53,577,744 |
Common stock shares outstanding (in shares) | 57,908,489 | 53,577,744 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Total Revenues | $ 178 | $ 230 |
Operating expenses: | ||
Research and development | 4,452 | 4,255 |
Selling, general and administrative | 4,417 | 5,732 |
Total operating expenses | 8,869 | 9,987 |
Operating loss | (8,691) | (9,757) |
Interest expense | 0 | (1,062) |
Other expense | (3) | (57) |
Loss from continuing operations before income taxes | (8,694) | (10,876) |
Income tax expense | 0 | 0 |
Loss from continuing operations | (8,694) | (10,876) |
Income (loss) from discontinued operations, net of income taxes | 13,364 | (9,674) |
Net income (loss) | $ 4,670 | $ (20,550) |
Loss per share from continuing operations, basic (in dollars per share) | $ (0.16) | $ (0.22) |
Loss per share from continuing operations, diluted (in dollars per share) | (0.16) | (0.22) |
Income (Loss) per share from discontinuing operations, basic (in dollars per share) | 0.24 | (0.20) |
Income (Loss) per share from discontinuing operations, diluted (in dollars per share) | 0.24 | (0.20) |
Income (Loss) per share basic (in dollars per share) | 0.08 | (0.42) |
Income (Loss) per share diluted (in dollars per share) | $ 0.08 | $ (0.42) |
Weighted average shares outstanding - basic (in shares) | 55,386 | 48,868 |
Weighted average shares outstanding - diluted (in shares) | 55,386 | 48,868 |
Royalty revenues | ||
Total Revenues | $ 178 | $ 230 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common stock | Additional paid-in capital | Accumulated deficit |
Beginning balance (shares) at Dec. 31, 2020 | 43,205,221 | |||
Beginning balance at Dec. 31, 2020 | $ 37,493 | $ 4 | $ 603,685 | $ (566,196) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Net income (loss) | (20,550) | (20,550) | ||
Exercise of options, vesting of restricted stock units and shares issued under employee stock purchase plan (in shares) | 129,102 | |||
Exercise of options, vesting of restricted stock units and shares issued under employee stock purchase plan | 388 | 388 | ||
Stock-based compensation | 2,442 | 2,442 | ||
Issuance of common stock, net of issuance costs (in shares) | 8,052,273 | |||
Issuance of common stock, net of issuance costs | 73,128 | $ 1 | 73,127 | |
Ending balance (shares) at Mar. 31, 2021 | 51,386,596 | |||
Ending balance at Mar. 31, 2021 | $ 92,901 | $ 5 | 679,642 | (586,746) |
Beginning balance (shares) at Dec. 31, 2021 | 53,577,744 | 53,577,744 | ||
Beginning balance at Dec. 31, 2021 | $ 48,636 | $ 5 | 688,156 | (639,525) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Net income (loss) | 4,670 | 4,670 | ||
Stock-based compensation | 893 | 893 | ||
Vesting of restricted stock units, net of witholding tax (in shares) | 75,297 | |||
Vesting of restricted stock units, net of withholding tax | $ (25) | (25) | ||
Issuance of commitment shares (in shares) | 1,667,593 | |||
Issuance of common stock, net of issuance costs (in shares) | 2,587,855 | |||
Issuance of common stock, net of issuance costs | $ 1,557 | $ 1 | 1,556 | |
Ending balance (shares) at Mar. 31, 2022 | 57,908,489 | 57,908,489 | ||
Ending balance at Mar. 31, 2022 | $ 55,731 | $ 6 | $ 690,580 | $ (634,855) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Statement of Stockholders' Equity [Abstract] | ||
Payments of stock issuance costs | $ 48 | $ 3,991 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Cash Flows From Operating Activities: | ||
Net income (loss) | $ 4,670 | $ (20,550) |
Adjustments required to reconcile net income (loss) to net cash used in operating activities: | ||
Depreciation and amortization | 44 | 27 |
Changes in accrued liability for employee severance benefits, net of retirement fund profit | 10 | (108) |
Stock-based compensation | 893 | 2,442 |
Non-cash finance income, net | 0 | (66) |
Gain on the disposition of the MST Franchise | (13,005) | 0 |
Changes in operating assets and liabilities: | ||
Decrease in trade receivables | 7,048 | 5,064 |
Decrease (increase) in inventory | 97 | (688) |
Decrease in prepaid expenses and other assets and operating lease right of use asset | 100 | 719 |
Decrease in other non-current assets | 0 | 404 |
(Decrease) increase in trade payables, accrued expenses and liability for employee related obligations | (9,600) | 205 |
Decrease in operating lease liabilities | (232) | 0 |
Net cash used in operating activities | (9,975) | (12,551) |
Cash Flows From Investing Activities: | ||
Net proceeds from the sale of the MST Franchise | 16,688 | 0 |
Net cash provided by investing activities | 16,688 | 0 |
Cash Flows From Financing Activities: | ||
Proceeds related to issuance of common shares through offerings, net of issuance costs | 1,557 | 73,127 |
(Payments) proceeds related to issuance of stock for stock-based compensation arrangements, net | (25) | 376 |
Net cash provided by financing activities | 1,532 | 73,503 |
Increase in cash, cash equivalents and restricted cash | 8,245 | 60,952 |
Effect of exchange rate on cash, cash equivalents and restricted cash | 0 | 1 |
Cash, cash equivalents and restricted cash at beginning of the period | 42,855 | 58,418 |
Cash, cash equivalents and restricted cash at end of the period | 51,100 | 119,371 |
Cash and cash equivalents | 50,495 | 118,516 |
Restricted cash | 605 | 855 |
Total cash, cash equivalents and restricted cash shown in statement of cash flows | 51,100 | 119,371 |
Supplemental disclosure of cash flow information: | ||
Amount due from sale of MST Franchise | 5,000 | 0 |
Interest paid | $ 0 | $ 963 |
NATURE OF OPERATIONS
NATURE OF OPERATIONS | 3 Months Ended |
Mar. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
NATURE OF OPERATIONS | NATURE OF OPERATIONS VYNE Therapeutics Inc. ("VYNE" or the "Company") is a biopharmaceutical company focused on developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions. The Company's most advanced product candidate, FMX114, which is in a Phase 2a clinical trial, is being evaluated for the potential treatment of mild-to-moderate atopic dermatitis ("AD"). The Company is also in the preclinical stages of developing products containing bromodomain and extra-terminal domain ("BET") inhibitor compounds. The Company's initial BET inhibitor candidate in development is VYN201, a locally administered pan-BET inhibitor, which the Company is exploring in various immuno-inflammatory diseases, including skin diseases. In addition, the Company continues to explore opportunistic transactions that may enhance its pipeline portfolio, as well as support its current operations and fund its future growth. The Company is a Delaware corporation, has its principal executive offices in Bridgewater, New Jersey and operates as one business segment. Strategic Business Review and Sale of the MST Franchise Beginning in the second quarter of 2021, the Company conducted a review of its commercial and research and development portfolio to determine how to optimally deploy capital and drive shareholder value. During the course of this review, the Company carefully considered the revenues received from the commercialization of AMZEEQ and ZILXI and the associated costs to drive those revenues, the protracted negative impact of the COVID-19 pandemic during the commercial launches of both AMZEEQ and ZILXI, the payor landscape, as well as the costs to develop each of its pipeline products. During this process, the Company evaluated several strategic options including the acquisition of marketed assets, out-licensing its approved products outside of the United States, and possible partnering or co-development relationships with interested parties. Following its review, the Company determined to initiate a process to explore a possible sale or license of its topical minocycline franchise, including AMZEEQ, ZILXI, FCD105 (the Company’s former Phase 3 proprietary novel topical combination foam formulation of minocycline and adapalene for the treatment of moderate-to-severe acne vulgaris) and the underlying Molecule Stabilizing Technology ("MST") platform. On January 12, 2022, the Company entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Journey Medical Corporation (”Journey”) pursuant to which the Company sold its Molecule Stabilizing Technology franchise, including AMZEEQ, ZILXI, and FCD105 (the “MST Franchise”), to Journey. The assets include certain contracts, including the license agreement with Cutia Therapeutics (HK) Limited, inventory and intellectual property related to the MST Franchise (together, the “Assets”). Pursuant to the Purchase Agreement, Journey assumed certain liabilities of the MST Franchise including, among others, those arising from the Company's patent infringement suit initiated against Padagis Israel Pharmaceuticals Ltd. There were no current or long-term liabilities recorded by the Company which were transferred to Journey. Pursuant to the Purchase Agreement, the Company received an upfront payment of $20.0 million and will receive an additional $5.0 million on the one-year anniversary of the closing of the transaction. The Company is also eligible to receive sales milestone payments of up to $450.0 million in the aggregate upon the achievement of specified levels of net sales on a product-by-product basis, beginning with annual net sales exceeding $100.0 million (with products covered in three categories (1) AMZEEQ (and certain modifications), (2) ZILXI (and certain modifications), and (3) FCD105 and other products covered by the patents being transferred, including certain modifications). In addition, the Company is entitled to receive certain payments from any licensing or sublicensing of the assets by Journey outside of the United States. See "Note 3 - Discontinued Operations" for additional discussion of the disposition. In addition, on August 12, 2021, the Company announced a transaction with In4Derm Limited, a company incorporated and registered in Scotland (“In4Derm”). In4Derm is a spin-out of the University of Dundee’s School of Life Sciences which has discovered and is developing proprietary BET inhibitors for the treatment of immunology and oncology conditions. On April 30, 2021, the parties entered into an Evaluation and Option Agreement (the “Option Agreement”) pursuant to which In4Derm granted the Company an exclusive option to obtain exclusive worldwide rights to research, develop and commercialize products containing In4Derm’s BET inhibitor compounds, which are new chemical entities for treatments in all fields for any disease, disorder or condition in humans. On August 6, 2021, the parties entered into a License Agreement granting the Company a worldwide, exclusive license that is sublicensable through multiple tiers to exploit certain of In4Derm’s pan-BD BET inhibitor compounds in all fields. The Company paid a $1.0 million cash payment to In4Derm upon the execution of the Option Agreement and $0.5 million in connection with entering into the License Agreement. Pursuant to the License Agreement, the Company has agreed to make cash payments to In4Derm upon the achievement of specified clinical development and regulatory approval milestones with respect to each licensed topical product in the United States of up to $15.75 million for all indications. In addition, the Company currently expects to exercise the Oral BETi Option following the selection of a lead candidate for the program. Upon exercise of the exclusive Oral BETi Option, the parties will sign a license agreement (the “Oral License Agreement”), and the Company will be required to pay In4Derm a $4.0 million cash payment. The Oral License Agreement will include cash payments of up to $43.75 million payable to In4Derm upon the achievement of specified clinical development and regulatory approval milestones with respect to each licensed oral product in the United States for all indications. The license agreements also provide for tiered royalty payments of up to 10% of net annual sales across licensed BET inhibitor products by the Company. In4Derm is entitled to additional milestones upon the achievement of regulatory approvals in certain jurisdictions outside the United States. As the Company transitioned from a commercial organization to one focused on research and development, the Company streamlined operations by eliminating the vast majority of planned expenditures supporting its commercial operations Furthermore, following its decision to divest the MST Franchise, the Company reduced its workforce to approximately 28 employees by the completion of the sale of the MST Franchise. The Company does not expect to incur any material expenses in 2022 as a result of the restructuring plan. Reverse stock split and recasting of per-share amounts On February 10, 2021, the Company's Board of Directors approved a one-for-four reverse stock split of its outstanding shares of common stock. The reverse stock split was effected on February 12, 2021, at 5:00 p.m. Eastern time. At the effective time, every four issued and outstanding shares of the Company's common stock were converted into one share of common stock. No fractional shares were issued in connection with the reverse stock split, and in lieu thereof, each stockholder holding fractional shares was entitled to receive a cash payment (without interest or deduction) from the Company's transfer agent in an amount equal to such stockholder's respective pro rata shares of the total net proceeds from the Company's transfer agent sale of all fractional shares at the then-prevailing prices on the open market. In connection with the reverse stock split, the number of authorized shares of the Company's common stock was also reduced on a one-for-four basis, from 300 million shares to 75 million shares. The par value of each share of common stock remained unchanged. A proportionate adjustment was also made to the maximum number of shares issuable under the Company's 2019 Equity Incentive Plan, 2019 Employee Share Purchase Plan and 2018 Omnibus Incentive Plan. Unless otherwise noted, all common shares and per share amounts contained in the unaudited condensed consolidated financial statements have been retroactively adjusted to reflect the reverse stock split. Liquidity and Capital Resources Since inception, the Company has funded operations primarily through private and public placements of its equity, debt and warrants and through fees, cost reimbursements and payments received from its licensees. The Company commenced generating product revenues related to sales of AMZEEQ and ZILXI in January 2020 and October 2020, respectively. AMZEEQ and ZILXI were sold as part of the sale of the MST Franchise on January 12, 2022 and, as such, the Company no longer generates revenue from the sale of these products. The Company has incurred losses from continuing operations and experienced negative operating cash flows since its inception and anticipates that it will continue to incur losses until such a time when its product candidates, if approved, are commercially successful, if at all. The Company will not generate any revenue from any current or future product candidates unless and until it obtains regulatory approval and commercializes such products. For the three months ended March 31, 2022, the Company generated net income of $4.7 million and used $10.0 million of cash in operations. Net income was the result of income from discontinued operations of $13.4 million and loss from continuing operations of $8.7 million As of March 31, 2022, the Company had cash, cash equivalents and restricted cash of $51.1 million and an accumulated deficit of $634.9 million. The Company received gross proceeds of $20.0 million from the sale of the MST Franchise in January 2022 and will receive an additional payment of $5.0 million on the one-year anniversary of the sale. The Company had no outstanding debt as of March 31, 2022. The Company has taken a number of actions to support its operations and meet its liquidity needs. Beginning in the second quarter of 2021, the Company conducted a review of its commercial and research and development portfolio to determine how to optimally deploy capital and drive shareholder value. Following its review, the Company initiated a process to explore a possible sale or license of its MST Franchise, including AMZEEQ, ZILXI, FCD105 and the underlying Molecule Stabilizing Technology platform and refocus its resources on its immuno-inflammatory development programs. As a result of this decision, the Company restructured its operations and reduced its workforce, which lowered operating costs. In January 2022, the Company sold its MST Franchise. In March 2022, the Company entered into an equity purchase agreement (the “Equity Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”) which provides that, upon the terms and subject to the conditions and limitations set forth therein, the Company may sell to Lincoln Park up to $30.0 million of shares of its common stock over the 36-month term of the Equity Purchase Agreement. The Company has not made any sales pursuant to the Equity Purchase Agreement to date. As described above, the Company has refocused its limited resources on its immuno-inflammatory pipeline including FMX114 and the BET inhibitor development programs. Research and development activities for these programs, including preclinical and clinical testing of the Company's product candidates, will require significant additional financing. The future viability of the Company and its ability to continue as a going concern is dependent on its ability to raise sufficient working capital through either debt or equity financings to fund its operations and successfully develop commercially viable product candidates. There is no assurance the Company will be able to achieve these objectives under acceptable terms or at all. In accordance with Accounting Standards Update (“ASU”) 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40), the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about its ability to continue as a going concern within one year after the date that its unaudited interim condensed consolidated financial statements are issued. The accompanying unaudited condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern and contemplate the realization of assets and the satisfaction of liabilities in the normal course of business. The Company's ability to continue as a going concern is expected to be impacted by the outcome of the plans outlined above, including the Company's ability to raise additional capital to fund its operations, results from clinical trials for FMX114, and the development and results from clinical trials for the BET inhibitor programs. Based on its current plans and assumptions, the Company believes that absent sufficient proceeds received from financing transactions or business development transactions, the Company will not have sufficient cash and cash equivalents to fund its operations beyond one year from the issuance of these financial statements. This assumption does not include proceeds that can be drawn from Lincoln Park. Accordingly, the Company will, over the course of the next twelve months, require significant additional financing to continue its operations, including potentially selling a significant amount of shares pursuant to the Equity Purchase Agreement. In addition, the amount of proceeds the Company may be able to raise pursuant to its existing shelf registration statement on Form S-3 may be limited. As of the filing of this Quarterly Report on Form 10-Q, the Company is subject to the general instructions of Form S-3 known as the "baby shelf rules." Under these instructions, the amount of funds the Company can raise through primary public offerings of securities in any 12-month period using its registration statement on Form S-3 is limited to one-third of the aggregate market value of the shares of its common stock held by non-affiliates of the Company. Therefore, the Company will be limited in the amount of proceeds it is able to raise by selling shares of its common stock using its Form S-3 until such time as its public float exceeds $75.0 million. These factors raise substantial doubt about the Company's ability to continue as a going concern. Failure to successfully receive additional financing will require the Company to delay, scale back or otherwise modify its business and its research and development activities and other operations. The accompanying financial statements do not include any adjustments related to the recoverability and classification of assets or the amounts and classification of liabilities or any other adjustments that might be necessary should the Company be unable to continue as a going concern. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | SIGNIFICANT ACCOUNTING POLICIES a. Basis of Presentation The unaudited interim condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America ("U.S. GAAP") for interim financial statements. In the opinion of management, the Company has made all necessary adjustments, which include normal recurring adjustments necessary for a fair statement of the Company’s unaudited condensed consolidated financial position, results of operations, cash flow and statement of stockholders' equity for the interim periods presented. Certain information and disclosures normally included in the annual audited consolidated financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. Certain prior period amounts have been reclassified to conform to current year presentation. These unaudited interim condensed consolidated financial statements should be read in conjunction with the Company's audited consolidated financial statements contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the SEC on March 17, 2022. The results for the three months ended March 31, 2022 are not necessarily indicative of the results expected for the year ending December 31, 2022. b. Principles of Consolidation The unaudited interim condensed consolidated financial statements include the accounts of the Company and its subsidiaries. Intercompany balances and transactions have been eliminated upon consolidation. c. Use of Estimates The preparation of unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements and reported amounts of income and expenses during the reporting periods. Significant items subject to such estimates and assumptions include research and development accruals and valuation assumptions for share based compensation. Actual results could differ from the Company’s estimates. The COVID-19 pandemic and government measures taken in response to the pandemic had a negative impact on the Company's commercial operations in 2021. Access to healthcare providers was limited, which negatively impacted sales and the Company's ability to execute its commercial strategy with respect to AMZEEQ and ZILXI prior to the sale of the assets to Journey in January 2022. In addition, the Company further assessed certain accounting matters that generally require consideration of forecasted financial information in context with the information reasonably available to the Company and the unknown future impacts of COVID-19 as of March 31, 2022 and through the issuance of the condensed consolidated financial statements. d. Inventories As of December 31, 2021 and January 12, 2022, the date the inventory was sold as part of the sale of the MST franchise, inventories were stated at the lower of cost and net realizable value with cost determined on a first-in, first-out basis by product. The Company capitalized inventory costs associated with products following regulatory approval when future commercialization is considered probable and the future economic benefit was expected to be realized. The Company periodically reviewed its inventory levels and, if necessary, wrote down inventory that was expected to expire prior to being sold, inventory in excess of expected sales requirements and inventory that failed to meet commercial sale specifications, with a corresponding charge to cost of goods sold. There were no material write-downs during the three months ended March 31, 2021 or in the period from December 31, 2021 and January 12, 2022. As a result of the sale of the MST Franchise there were no inventory balances at March 31, 2022. e. Revenue Recognition As a result of the disposition of the MST Franchise in January 2022, the Company no longer has any revenue generating products; however, it still receives certain royalty revenues (see Note 3 Discontinued Operations). The Company accounts for its revenue transactions under Financial Accounting Standards Board ("FASB") Accounting Standards Codification ("ASC") Topic 606, Revenue from Contracts with Customers . In accordance with ASC Topic 606, the Company recognizes revenues when its customers obtain control of its product for an amount that reflects the consideration it expects to receive from its customers in exchange for that product. To determine revenue recognition for contracts that are determined to be in scope of ASC Topic 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies the performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. Once the contract is determined to be within the scope of ASC Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when such performance obligation is satisfied. The Company’s customers were a limited number of national and select regional wholesalers (the “distributors”) and certain independent and specialty pharmacies (together, the “customers”). These distributors would subsequently resell the product, primarily to retail pharmacies that dispense the product to patients. Net product revenue was typically recognized when customers obtained control of the Company’s products, which occurred at a point in time, typically upon delivery of product to the customers. The Company evaluated the creditworthiness of its customers to determine whether it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur. The Company did not assess whether a contract had a significant financing component if the expectation was such that the period between the transfer of the promised goods to the customer and the receipt of payment would be less than one year. Standard credit terms did not exceed 75 days. The Company expensed incremental costs of obtaining a contract as and when incurred if the expected amortization period of the asset that would have been recognized is one year or less or the amount is immaterial. Shipping and handling costs related to the Company’s product sales were included in selling, general and administrative expenses. The Company’s net product revenues were generated through sales of AMZEEQ, which was approved by the FDA in October 2019 and was commercially launched in the United States in January 2020, and ZILXI, which was approved by the FDA in May 2020 and was commercially launched in the United States in October 2020. The Company sold the MST Franchise on January 12, 2022 and, as such, the Company no longer generates revenue from the sale of these products. Product revenue is recorded net of distribution fees, trade discounts, allowances, rebates, copay program coupons, chargebacks, estimated returns and other incentives. These reserves are classified as either reductions of accounts receivable or as current liabilities. The estimates of reserves established for variable consideration reflect current contractual and statutory requirements, known market events and trends, industry data and forecasted customer mix. The transaction price, which includes variable consideration reflecting the impact of discounts and allowances, may be subject to constraint and is included in the net product revenues only to the extent that it is probable that a significant reversal of the amount of the cumulative revenues recognized will not occur in a future period. Actual amounts may ultimately differ from these estimates. If actual results vary, estimates may be adjusted in the period such change in estimate becomes known, which could have an impact on earnings in the period of adjustment. The Company is entitled to royalty payments with respect to sales of a product developed by a customer in collaboration with the Company. Royalties are recognized as the products developed by a customer in collaboration with the Company are sold. f. Allowance for doubtful accounts An allowance for doubtful accounts is maintained for potential credit losses based on the aging of trade receivables, historical bad debts experience and changes in customer payment patterns. Trade receivable balances are written off against the allowance when it is deemed probable that the receivable will not be collected. Trade receivables, net are stated net of reserves for certain sales allowances and provisions for doubtful accounts. Provisions for doubtful accounts were not material for the three months ended March 31, 2022 or March 31, 2021. g. Fair value measurement Fair value is based on the price that would be received from the sale of an asset or that would be paid to transfer a liability in an orderly transaction between market participants at the measurement date. In order to increase consistency and comparability in fair value measurements, the guidance establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described as follows: Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. Level 2: Observable prices that are based on inputs not quoted on active markets, but corroborated by market data or active market data of similar or identical assets or liabilities. Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and considers counterparty credit risk in its assessment of fair value. The Company did not have any assets or liabilities which were required to be measured at fair value as of March 31, 2022 or December 31, 2021. h. Income (loss) per share Net income (loss) per share, basic and diluted, is computed on the basis of the net loss from continuing operations for the period divided by the weighted average number of common shares outstanding during the period. Diluted net loss per share is based upon the weighted average number of common stock and of common stock equivalents outstanding when dilutive. Common stock equivalents include outstanding stock options and warrants which are included under the treasury share method when dilutive. The following weighted average stock options, restricted stock units (“RSUs”), warrants and incremental shares to be issued under the employee stock purchase plan (“ESPP”) were excluded from the calculation of diluted net loss per share because their effect would have been anti-dilutive for the periods presented (share data): Three months ended March 31 2022 2021 Outstanding stock options, RSUs and shares under the ESPP 6,346,175 5,321,517 Warrants 495,165 495,165 j. Discontinued operations The Company accounted for the sale of the MST Franchise in accordance with ASC 205, Discontinued Operations, and ASU No. 2014-08, Reporting of Discontinued Operations and Disclosures of Disposals of Components of an Entity . The Company followed the held-for-sale criteria as defined in ASC 360 Property, Plant and Equipment and ASC 205. ASC 205 requires that a component of an entity that has been disposed of or is classified as held for sale and has operations and cash flows that can be clearly distinguished from the rest of the entity be reported as assets held for sale and discontinued operations. In the period a component of an entity has been disposed of or classified as held for sale, the results of operations for the periods presented are reclassified into separate line items in the consolidated statements of operations. Assets and liabilities are also reclassified into separate line items on the related unaudited condensed consolidated balance sheets for the periods presented. Non-cash items presented in the statement of cash flows and related to discontinued operations are presented in Note 3 - Discontinued Operations. ASU 2014-08 requires that only a disposal of a component of an entity, or a group of components of an entity, that represents a strategic shift that has, or will have, a major effect on the reporting entity’s operations and financial results be reported in the financial statements as discontinued operations. ASU 2014-08 also provides guidance on the financial statement presentations and disclosures of discontinued operations. Due to the sale of the MST Franchise during the first quarter of 2022, in accordance with ASC 205, the Company has classified the results of the MST Franchise as discontinued operations in its unaudited condensed consolidated statements of operations and cash flows for all periods presented, see Note 3, Discontinued Operations. All disposed assets and liabilities associated with the MST Franchise were therefore classified as assets and liabilities of discontinued operations in the Company's unaudited condensed consolidated balance sheets for the periods presented. All amounts included in the notes to the unaudited condensed consolidated financial statements relate to continuing operations unless otherwise noted. k. Newly issued and recently adopted accounting pronouncements Recent Accounting Guidance Issued: In March 2020, the FASB issued ASU No. 2020-04, Reference Rate Reform : Facilitation of the Effects of Reference Rate Reform on Financial Reporting (Topic 848)", which provides guidance to alleviate the burden in accounting for reference rate reform by allowing certain expedients and exceptions in applying generally accepted accounting principles to contracts, hedging relationships, and other transactions impacted by reference rate reform. The provisions of ASU 2020-04 apply only to those transactions that reference LIBOR or another reference rate expected to be discontinued due to reference rate reform. Adoption of the provisions of ASU 2020-04 are optional and are effective from March 12, 2020 through December 31, 2022. The Company is currently evaluating the impact of ASU 2020-04 on its consolidated financial statements. Currently, the Company does not expect the adoption of the new standard to have a material impact to the consolidated financial statements. In June 2016, the FASB issued ASU No. 2016-13, “ Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments” (ASU 2016-13), which requires companies to measure credit losses of financial instruments, including customer accounts receivable, utilizing a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. Subsequent to the issuance of ASU 2016-13, the FASB issued several additional ASUs to clarify implementation guidance, provide narrow-scope improvements and provide additional disclosure guidance. As a smaller reporting company, the Company will adopt ASU 2016-13 effective January 1, 2023 or at such time where it is no longer a smaller reporting company. Currently, the Company does not expect the adoption of the new standard to have a material impact to the consolidated financial statements. |
DISCONTINUED OPERATIONS
DISCONTINUED OPERATIONS | 3 Months Ended |
Mar. 31, 2022 | |
Discontinued Operations and Disposal Groups [Abstract] | |
DISCONTINUED OPERATIONS | DISCONTINUED OPERATIONSOn January 12, 2022, the Company entered into the Purchase Agreement with Journey pursuant to which the Company sold its MST Franchise to Journey. The Company has determined that the sale of the MST Franchise represents a strategic shift that had a major effect on the business and therefore the MST Franchise met the criteria for classification as discontinued operations at March 31, 2022. Accordingly the MST Franchise is reported as discontinued operations in accordance with ASC 205-20, Discontinued Operations . Amounts applicable to prior years have been recast to conform to the discontinued operations presentation. The Company recognized a gain on the sale of the MST Franchise upon closing. The following table presents the combined results of discontinued operations of the MST Franchise: (in thousands) Three months ended March 31, 2022 Three months ended March 31, 2021 Product sales $ 106 $ 3,889 Cost of goods sold 80 601 Operating expenses: Research and development — 2,078 Selling, general and administrative (333) 10,884 Total operating expenses (333) 12,962 Income (loss) from discontinued operations 359 (9,674) Gain on the sale of the MST Franchise 13,005 — Income (loss) from discontinued operations, before income taxes 13,364 (9,674) Income tax expense — — Net income (loss) from discontinued operations $ 13,364 $ (9,674) The following table presents the carrying amounts of the classes of assets and liabilities related to the discontinued operations of the MST Franchise as of March 31, 2022 and December 31, 2021: (in thousands) March 31, 2022 December 31, 2021 Current assets: Inventory $ — $ 7,291 Prepaid expenses and other assets — 554 Total current assets of discontinued operations $ — $ 7,845 The following table presents non-cash items related to discontinued operations, which are included in the Company's unaudited condensed consolidated statement of cash flows for the three months ended March 31, 2022 and 2021: (in thousands) Three months ended March 31, 2022 Three months ended March 31, 2021 Cash Flows From Operating Activities: Stock-based compensation (income) expense* $ (352) $ 382 (Gain) on the sale of the MST Franchise (13,005) — Total non-cash items of discontinued operations $ (13,357) $ 382 Supplemental disclosure of cash flow information: Amount due from sale of MST Franchise $ 5,000 $ — *Income from stock based compensation is related to forfeitures. The following table presents the gain on the sale of the MST Franchise: (in thousands) March 31, 2022 Cash proceeds $ 20,000 Proceeds to be paid in January 2023 5,000 25,000 Less transaction costs: (4,247) Less book value of sold assets (7,748) Gain on sale, before income taxes 13,005 Income tax expense — Gain on sale net of tax $ 13,005 In accordance with ASC 205-20, only expenses specifically identifiable and related to a business to be disposed may be presented in discontinued operations. As such, the research and development, marketing, selling and general and administrative expenses in discontinued operations include corporate costs incurred directly to solely support the MST Franchise. The Company has also entered into a Transition Services Agreement ("TSA") with Journey, through which the Company will provide transitional services related to discovery, clinical development, technical operations, commercial and general and administrative related activities into early 2023. Amounts to be earned under the TSA are anticipated to be immaterial. The milestone payment for sales of ZILXI, AMZEEQ and FCD105 represent contingent consideration. Contingent consideration has been accounted for as a gain contingency in accordance with ASC 450, Contingencies , and will be recognized in earnings in the period when realizable. |
SHARE CAPITAL
SHARE CAPITAL | 3 Months Ended |
Mar. 31, 2022 | |
Equity [Abstract] | |
SHARE CAPITAL | SHARE CAPITAL Common stock and preferred stock As of March 31, 2022, the Company's Certificate of Incorporation, as amended, authorizes the Company to issue 150,000,000 shares of common stock and 20,000,000 shares of preferred stock, par value $0.0001 per share. There were no shares of preferred stock issued and outstanding as of March 31, 2022 and December 31, 2021. Shares of preferred stock may be issued from time to time in one or more series. The voting powers (if any), preferences and relative, participating, optional or other special rights, and the qualifications, limitations and restrictions of any series of preferred stock will be set forth in a Certificate of Designation filed pursuant to the Delaware General Corporation Law, as determined by the Company's Board of Directors. Each share of common stock is entitled to one vote. The holders of common stock are also entitled to receive dividends whenever funds are legally available and when and if declared by the board of directors, subject to the prior rights of holders of all classes of preferred stock outstanding. The Company has never declared any dividends on common stock. Issuance of stock On February 1, 2019, the Company entered into a Sales Agreement (the "2019 Sales Agreement") with Cantor Fitzgerald & Co. ("Cantor Fitzgerald") to sell shares of the Company's common stock, from time to time, with aggregate gross sales proceeds of up to $50.0 million through an at-the-market ("ATM") equity offering program under which Cantor Fitzgerald acted as the Company's sales agent. Cantor Fitzgerald was entitled to compensation for its services equal to up to 3.0% of the gross proceeds of any shares of common stock sold under the 2019 Sales Agreement. From January 1, 2021 through January 25, 2021, the Company issued and sold 2,778,012 shares of common stock at a weighted average price per share of $9.76 pursuant to the 2019 Sales Agreement for $26.3 million in net proceeds. Effective as of January 25, 2021, the Company terminated the 2019 Sales Agreement. On January 26, 2021, the Company entered into a Securities Purchase Agreement with certain institutional and accredited investors for the sale of an aggregate of 5,274,261 shares of common stock of the Company, at a purchase price of $9.48 per share in a registered direct offering. The offering was completed on January 28, 2021 and the Company received approximately $46.8 million in net proceeds, after deducting placement agent fees and other offering expenses. On August 12, 2021, the Company entered into a Sales Agreement (the "2021 Sales Agreement") with Cantor Fitzgerald to sell shares of the Company's common stock, from time to time, with aggregate gross sales proceeds of up to $50.0 million through an at-the-market equity offering program under which Cantor Fitzgerald will act as the Company's sales agent. Cantor Fitzgerald is entitled to compensation for its services equal to up to 3.0% of the gross proceeds of any shares of common stock sold under the 2021 Sales Agreement. During the three months ended March 31, 2022, the Company issued and sold 2,587,855 shares of common stock at a weighted average per share price of $0.62 pursuant to the 2021 Sales Agreement for $1.6 million in net proceeds. On March 15, 2022, the Company entered into the Equity Purchase Agreement, with Lincoln Park which provides that, upon the terms and subject to the conditions and limitations set forth therein, the Company may sell to Lincoln Park, at the Company's discretion, up to $30.0 million of shares of its common stock over the 36-month term of the Equity Purchase Agreement. Upon execution of the Equity Purchase Agreement, the Company issued 1,667,593 shares of its common stock to Lincoln Park as commitment shares in accordance with the closing conditions contained within the Equity Purchase Agreement. The issuance of these shares were specific incremental costs directly attributable to the proposed offering. The commitment shares were valued at $0.9 million and recorded as an addition to equity for the issuance of common stock and treated as a reduction to equity as a cost of capital to be raised under the Equity Purchase Agreement. Lincoln Park has covenanted not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of the Company’s common stock. The Equity Purchase Agreement may be terminated by the Company at any time, at its sole discretion, without any additional cost or penalty. As of March 31, 2022, the Company had not sold any shares of its common stock to Lincoln Park under the Equity Purchase Agreement. |
SHARE BASED COMPENSATION
SHARE BASED COMPENSATION | 3 Months Ended |
Mar. 31, 2022 | |
Share-based Payment Arrangement [Abstract] | |
SHARE BASED COMPENSATION | SHARE BASED COMPENSATION Equity incentive plans: As of March 31, 2022, 724,589 shares remain issuable under the 2019 Equity Incentive Plan (the "2019 Plan"). In addition, the Company maintains the 2018 Omnibus Incentive Plan (the "2018 Plan"). In January 2022, the number of shares reserved under the 2018 Plan automatically increased by 750,000 shares of common stock pursuant to the terms of the 2018 Plan. As of March 31, 2022, 6,566 shares remain issuable under the 2018 Plan. Employee Share Purchase Plan: The Company also has an Employee Share Purchase Plan ("ESPP") pursuant to which qualified employees (as defined in the ESPP) may elect to purchase designated shares of the Company’s common stock at a price equal to 85% of the lesser of the fair market value of the common stock at the beginning or end of each semi-annual share purchase period (“Purchase Period”). Employees are permitted to purchase the number of shares purchasable with up to 15% of the earnings paid (as such term is defined in the ESPP) to each of the participating employees during the Purchase Period, subject to certain limitations under Section 423 of the U.S. Internal Revenue Code. As of March 31, 2022, 2,232,207 shares remain available for grant under the ESPP. There were no shares of common stock purchased by employees pursuant to the ESPP during the three months ended March 31, 2022 or March 31, 2021. Options and RSUs granted to employees and directors: In the three months ended March 31, 2022, the Company granted options and RSUs as follows: Three months ended March 31, 2022 Award Exercise price Vesting period Expiration Employees and Directors: Options 774,503 $0.61 2 years - 4 years 10 years RSUs 726,102 — 4 years - 4 years — The fair value of options and RSUs granted to employees and directors during the three months ended March 31, 2022 and the three months ended March 31, 2021 was $0.8 million and $7.5 million, respectively. The fair value of RSUs granted is based on the share price on the grant date. The fair value of options granted was computed using the Black-Scholes model. The underlying data used for computing the fair value of the options are as follows: Three months ended March 31 2022 2021 Dividend yield 0 % 0 % Expected volatility 74.40 % 68.38% - 69.12% Risk-free interest rate 2.2% 0.50% - 1.05% Expected term 6 years 6 years Stock-based compensation expense is reflected in the unaudited condensed consolidated statements of operations as follows: Three months ended March 31 (in thousands) 2022 2021 Research and development expenses $ 229 $ 458 Selling, general and administrative 1,016 1,602 Discontinued operations (352) 382 Total $ 893 $ 2,442 |
OPERATING LEASES
OPERATING LEASES | 3 Months Ended |
Mar. 31, 2022 | |
Leases [Abstract] | |
OPERATING LEASES | OPERATING LEASES Operating lease agreements As of March 31, 2022, the Company has operating leases for corporate offices. The properties primarily relate to the Company’s principal executive office in Bridgewater, New Jersey and office space in Israel. On March 13, 2019, the Company signed an amendment to the original lease agreement for its principal executive office in Bridgewater, New Jersey (the “Lease Amendment”). The Lease Amendment includes an extension of the lease period of the 10,000 square feet previously leased under the original agreement (the “Original Space”) and an addition of 4,639 square feet (the “Additional Space”). The Company entered the Additional Space following a period of preparation by the lessor completed during September 2019 (the “Commencement Date”). The Lease Amendment is due to expire on September 30, 2022. Pursuant to the Lease Amendment, the Company recognized an additional right of use asset and liability in the amount of $0.7 million. The Additional Space was considered a new lease agreement and was recognized as a right of use asset and liability, in the amount of $0.3 million, on the Commencement Date. The lease liability matures September 30, 2022. The remaining lease liability of $0.1 million is reflective of the remaining principal payments with an immaterial amount of imputed interest. The lease agreement for the office space in Israel is a one year lease that expires in December 2022. Given the short-term nature of the lease term, the Company did not recognize a right-of-use asset and liability. As of March 31, 2022, the Company had a lien in the amount of $0.6 million related to a letter of credit on the Company’s cash in respect of bank guarantees granted in order to secure the lease agreements. This amount is presented as restricted cash in the Company's unaudited condensed consolidated balance sheet. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 3 Months Ended |
Mar. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIESThe Company may periodically become subject to legal proceedings and claims arising in connection with its business. As of March 31, 2022, no claims or actions are pending against the Company that, in the opinion of management, are likely to have a material adverse effect on the Company. |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The unaudited interim condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America ("U.S. GAAP") for interim financial statements. In the opinion of management, the Company has made all necessary adjustments, which include normal recurring adjustments necessary for a fair statement of the Company’s unaudited condensed consolidated financial position, results of operations, cash flow and statement of stockholders' equity for the interim periods presented. Certain information and disclosures normally included in the annual audited consolidated financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. Certain prior period amounts have been reclassified to conform to current year presentation. These unaudited interim condensed consolidated financial statements should be read in conjunction with the Company's audited consolidated financial statements contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the SEC on March 17, 2022. The results for the three months ended March 31, 2022 are not necessarily indicative of the results expected for the year ending December 31, 2022. |
Principles of Consolidation | Principles of ConsolidationThe unaudited interim condensed consolidated financial statements include the accounts of the Company and its subsidiaries. Intercompany balances and transactions have been eliminated upon consolidation. |
Use of Estimates | Use of EstimatesThe preparation of unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements and reported amounts of income and expenses during the reporting periods. Significant items subject to such estimates and assumptions include research and development accruals and valuation assumptions for share based compensation. Actual results could differ from the Company’s estimates.The COVID-19 pandemic and government measures taken in response to the pandemic had a negative impact on the Company's commercial operations in 2021. Access to healthcare providers was limited, which negatively impacted sales and the Company's ability to execute its commercial strategy with respect to AMZEEQ and ZILXI prior to the sale of the assets to Journey in January 2022. In addition, the Company further assessed certain accounting matters that generally require consideration of forecasted financial information in context with the information reasonably available to the Company and the unknown future impacts of COVID-19 as of March 31, 2022 and through the issuance of the condensed consolidated financial statements. |
Inventories | InventoriesAs of December 31, 2021 and January 12, 2022, the date the inventory was sold as part of the sale of the MST franchise, inventories were stated at the lower of cost and net realizable value with cost determined on a first-in, first-out basis by product. The Company capitalized inventory costs associated with products following regulatory approval when future commercialization is considered probable and the future economic benefit was expected to be realized. The Company periodically reviewed its inventory levels and, if necessary, wrote down inventory that was expected to expire prior to being sold, inventory in excess of expected sales requirements and inventory that failed to meet commercial sale specifications, with a corresponding charge to cost of goods sold. |
Revenue Recognition | Revenue Recognition As a result of the disposition of the MST Franchise in January 2022, the Company no longer has any revenue generating products; however, it still receives certain royalty revenues (see Note 3 Discontinued Operations). The Company accounts for its revenue transactions under Financial Accounting Standards Board ("FASB") Accounting Standards Codification ("ASC") Topic 606, Revenue from Contracts with Customers . In accordance with ASC Topic 606, the Company recognizes revenues when its customers obtain control of its product for an amount that reflects the consideration it expects to receive from its customers in exchange for that product. To determine revenue recognition for contracts that are determined to be in scope of ASC Topic 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies the performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. Once the contract is determined to be within the scope of ASC Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when such performance obligation is satisfied. The Company’s customers were a limited number of national and select regional wholesalers (the “distributors”) and certain independent and specialty pharmacies (together, the “customers”). These distributors would subsequently resell the product, primarily to retail pharmacies that dispense the product to patients. Net product revenue was typically recognized when customers obtained control of the Company’s products, which occurred at a point in time, typically upon delivery of product to the customers. The Company evaluated the creditworthiness of its customers to determine whether it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur. The Company did not assess whether a contract had a significant financing component if the expectation was such that the period between the transfer of the promised goods to the customer and the receipt of payment would be less than one year. Standard credit terms did not exceed 75 days. The Company expensed incremental costs of obtaining a contract as and when incurred if the expected amortization period of the asset that would have been recognized is one year or less or the amount is immaterial. Shipping and handling costs related to the Company’s product sales were included in selling, general and administrative expenses. The Company’s net product revenues were generated through sales of AMZEEQ, which was approved by the FDA in October 2019 and was commercially launched in the United States in January 2020, and ZILXI, which was approved by the FDA in May 2020 and was commercially launched in the United States in October 2020. The Company sold the MST Franchise on January 12, 2022 and, as such, the Company no longer generates revenue from the sale of these products. Product revenue is recorded net of distribution fees, trade discounts, allowances, rebates, copay program coupons, chargebacks, estimated returns and other incentives. These reserves are classified as either reductions of accounts receivable or as current liabilities. The estimates of reserves established for variable consideration reflect current contractual and statutory requirements, known market events and trends, industry data and forecasted customer mix. The transaction price, which includes variable consideration reflecting the impact of discounts and allowances, may be subject to constraint and is included in the net product revenues only to the extent that it is probable that a significant reversal of the amount of the cumulative revenues recognized will not occur in a future period. Actual amounts may ultimately differ from these estimates. If actual results vary, estimates may be adjusted in the period such change in estimate becomes known, which could have an impact on earnings in the period of adjustment. The Company is entitled to royalty payments with respect to sales of a product developed by a customer in collaboration with the Company. Royalties are recognized as the products developed by a customer in collaboration with the Company are sold. |
Allowance for doubtful accounts | Allowance for doubtful accountsAn allowance for doubtful accounts is maintained for potential credit losses based on the aging of trade receivables, historical bad debts experience and changes in customer payment patterns. Trade receivable balances are written off against the allowance when it is deemed probable that the receivable will not be collected. Trade receivables, net are stated net of reserves for certain sales allowances and provisions for doubtful accounts. |
Fair value measurement | Fair value measurement Fair value is based on the price that would be received from the sale of an asset or that would be paid to transfer a liability in an orderly transaction between market participants at the measurement date. In order to increase consistency and comparability in fair value measurements, the guidance establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described as follows: Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. Level 2: Observable prices that are based on inputs not quoted on active markets, but corroborated by market data or active market data of similar or identical assets or liabilities. Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and considers counterparty credit risk in its assessment of fair value. The Company did not have any assets or liabilities which were required to be measured at fair value as of March 31, 2022 or December 31, 2021. |
Income (loss) per share | Income (loss) per share Net income (loss) per share, basic and diluted, is computed on the basis of the net loss from continuing operations for the period divided by the weighted average number of common shares outstanding during the period. Diluted net loss per share is based upon the weighted average number of common stock and of common stock equivalents outstanding when dilutive. Common stock equivalents include outstanding stock options and warrants which are included under the treasury share method when dilutive. The following weighted average stock options, restricted stock units (“RSUs”), warrants and incremental shares to be issued under the employee stock purchase plan (“ESPP”) were excluded from the calculation of diluted net loss per share because their effect would have been anti-dilutive for the periods presented (share data): Three months ended March 31 2022 2021 Outstanding stock options, RSUs and shares under the ESPP 6,346,175 5,321,517 Warrants 495,165 495,165 |
Discontinued operations | Discontinued operations The Company accounted for the sale of the MST Franchise in accordance with ASC 205, Discontinued Operations, and ASU No. 2014-08, Reporting of Discontinued Operations and Disclosures of Disposals of Components of an Entity . The Company followed the held-for-sale criteria as defined in ASC 360 Property, Plant and Equipment and ASC 205. ASC 205 requires that a component of an entity that has been disposed of or is classified as held for sale and has operations and cash flows that can be clearly distinguished from the rest of the entity be reported as assets held for sale and discontinued operations. In the period a component of an entity has been disposed of or classified as held for sale, the results of operations for the periods presented are reclassified into separate line items in the consolidated statements of operations. Assets and liabilities are also reclassified into separate line items on the related unaudited condensed consolidated balance sheets for the periods presented. Non-cash items presented in the statement of cash flows and related to discontinued operations are presented in Note 3 - Discontinued Operations. ASU 2014-08 requires that only a disposal of a component of an entity, or a group of components of an entity, that represents a strategic shift that has, or will have, a major effect on the reporting entity’s operations and financial results be reported in the financial statements as discontinued operations. ASU 2014-08 also provides guidance on the financial statement presentations and disclosures of discontinued operations. Due to the sale of the MST Franchise during the first quarter of 2022, in accordance with ASC 205, the Company has classified the results of the MST Franchise as discontinued operations in its unaudited condensed consolidated statements of operations and cash flows for all periods presented, see Note 3, Discontinued Operations. All disposed assets and liabilities associated with the MST Franchise were therefore classified as assets and liabilities of discontinued operations in the Company's unaudited condensed consolidated balance sheets for the periods presented. All amounts included in the notes to the unaudited condensed consolidated financial statements relate to continuing operations unless otherwise noted. |
Newly issued and recently adopted accounting pronouncements | Newly issued and recently adopted accounting pronouncements Recent Accounting Guidance Issued: In March 2020, the FASB issued ASU No. 2020-04, Reference Rate Reform : Facilitation of the Effects of Reference Rate Reform on Financial Reporting (Topic 848)", which provides guidance to alleviate the burden in accounting for reference rate reform by allowing certain expedients and exceptions in applying generally accepted accounting principles to contracts, hedging relationships, and other transactions impacted by reference rate reform. The provisions of ASU 2020-04 apply only to those transactions that reference LIBOR or another reference rate expected to be discontinued due to reference rate reform. Adoption of the provisions of ASU 2020-04 are optional and are effective from March 12, 2020 through December 31, 2022. The Company is currently evaluating the impact of ASU 2020-04 on its consolidated financial statements. Currently, the Company does not expect the adoption of the new standard to have a material impact to the consolidated financial statements. In June 2016, the FASB issued ASU No. 2016-13, “ Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The following weighted average stock options, restricted stock units (“RSUs”), warrants and incremental shares to be issued under the employee stock purchase plan (“ESPP”) were excluded from the calculation of diluted net loss per share because their effect would have been anti-dilutive for the periods presented (share data): Three months ended March 31 2022 2021 Outstanding stock options, RSUs and shares under the ESPP 6,346,175 5,321,517 Warrants 495,165 495,165 |
DISCONTINUED OPERATIONS (Tables
DISCONTINUED OPERATIONS (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Schedule of Discontinued Operations of the MST Franchise | The following table presents the combined results of discontinued operations of the MST Franchise: (in thousands) Three months ended March 31, 2022 Three months ended March 31, 2021 Product sales $ 106 $ 3,889 Cost of goods sold 80 601 Operating expenses: Research and development — 2,078 Selling, general and administrative (333) 10,884 Total operating expenses (333) 12,962 Income (loss) from discontinued operations 359 (9,674) Gain on the sale of the MST Franchise 13,005 — Income (loss) from discontinued operations, before income taxes 13,364 (9,674) Income tax expense — — Net income (loss) from discontinued operations $ 13,364 $ (9,674) The following table presents the carrying amounts of the classes of assets and liabilities related to the discontinued operations of the MST Franchise as of March 31, 2022 and December 31, 2021: (in thousands) March 31, 2022 December 31, 2021 Current assets: Inventory $ — $ 7,291 Prepaid expenses and other assets — 554 Total current assets of discontinued operations $ — $ 7,845 The following table presents non-cash items related to discontinued operations, which are included in the Company's unaudited condensed consolidated statement of cash flows for the three months ended March 31, 2022 and 2021: (in thousands) Three months ended March 31, 2022 Three months ended March 31, 2021 Cash Flows From Operating Activities: Stock-based compensation (income) expense* $ (352) $ 382 (Gain) on the sale of the MST Franchise (13,005) — Total non-cash items of discontinued operations $ (13,357) $ 382 Supplemental disclosure of cash flow information: Amount due from sale of MST Franchise $ 5,000 $ — *Income from stock based compensation is related to forfeitures. The following table presents the gain on the sale of the MST Franchise: (in thousands) March 31, 2022 Cash proceeds $ 20,000 Proceeds to be paid in January 2023 5,000 25,000 Less transaction costs: (4,247) Less book value of sold assets (7,748) Gain on sale, before income taxes 13,005 Income tax expense — Gain on sale net of tax $ 13,005 |
SHARE BASED COMPENSATION (Table
SHARE BASED COMPENSATION (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Equity [Abstract] | |
Schedule of Share Based Compensation by Share Based Payment Award Grants in Period | In the three months ended March 31, 2022, the Company granted options and RSUs as follows: Three months ended March 31, 2022 Award Exercise price Vesting period Expiration Employees and Directors: Options 774,503 $0.61 2 years - 4 years 10 years RSUs 726,102 — 4 years - 4 years — |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions | The underlying data used for computing the fair value of the options are as follows: Three months ended March 31 2022 2021 Dividend yield 0 % 0 % Expected volatility 74.40 % 68.38% - 69.12% Risk-free interest rate 2.2% 0.50% - 1.05% Expected term 6 years 6 years |
Schedule of Share-based Payment Arrangement, Expensed and Capitalized, Amount | Stock-based compensation expense is reflected in the unaudited condensed consolidated statements of operations as follows: Three months ended March 31 (in thousands) 2022 2021 Research and development expenses $ 229 $ 458 Selling, general and administrative 1,016 1,602 Discontinued operations (352) 382 Total $ 893 $ 2,442 |
NATURE OF OPERATIONS (Details)
NATURE OF OPERATIONS (Details) | Mar. 31, 2022USD ($)shares | Mar. 15, 2022USD ($) | Jan. 12, 2022USD ($) | Aug. 06, 2021USD ($) | Feb. 12, 2021shares | Mar. 31, 2022USD ($)segmentshares | Mar. 31, 2021USD ($) | Dec. 31, 2021USD ($)employeeshares | Feb. 11, 2021shares |
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | |||||||||
Number of segments | segment | 1 | ||||||||
Period of closing transaction | 1 year | ||||||||
Disposal group, milestone payments receivable upon achievement of net sales | $ 450,000,000 | ||||||||
Milestone payments upon achieving certain criteria, exceeding annual net sales | $ 100,000,000 | ||||||||
Reverse stock split, conversion ratio (share/share) | 0.25 | ||||||||
Restructuring and related cost, number of positions eliminated | employee | 28 | ||||||||
Common stock shares authorized (in shares) | shares | 150,000,000 | 75,000,000 | 150,000,000 | 150,000,000 | |||||
Net income (loss) | $ 4,670,000 | $ (20,550,000) | |||||||
Cash used in operations | (9,975,000) | (12,551,000) | |||||||
Income (loss) from discontinued operations, net of income taxes | 13,364,000 | (9,674,000) | |||||||
Net income (loss) | (8,694,000) | $ (10,876,000) | |||||||
Cash and investments | $ 51,100,000 | 51,100,000 | |||||||
Accumulated deficit | (634,855,000) | (634,855,000) | $ (639,525,000) | ||||||
Additional paid-in capital | 690,580,000 | 690,580,000 | $ 688,156,000 | ||||||
Outstanding debt | 0 | 0 | |||||||
Sale of stock, public float threshold | 75,000,000 | 75,000,000 | |||||||
Lincoln Park Equity Purchase Agreement | |||||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | |||||||||
Consideration receivable on transaction | $ 30,000,000 | $ 30,000,000 | 30,000,000 | ||||||
Term of equity purchase agreement | 36 months | 36 months | |||||||
Menlo - Premerger | |||||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | |||||||||
Common stock shares authorized (in shares) | shares | 300,000,000 | ||||||||
MST Franchise | Discontinued Operations, Disposed of by Sale | |||||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | |||||||||
Cash proceeds | $ 20,000,000 | 20,000,000 | |||||||
Additional paid-in capital | $ 5,000,000 | $ 5,000,000 | |||||||
Licensing Agreements | |||||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | |||||||||
Payments for licensing agreements | $ 1,000,000 | ||||||||
Royalty percent, maximum | 10.00% | ||||||||
Topical BETi Option Agreement | |||||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | |||||||||
Payments for licensing agreements | $ 500,000 | ||||||||
Milestone payments upon achieving certain criteria, maximum | 15,750,000 | ||||||||
Oral BETi Option Agreement | |||||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | |||||||||
Payments for licensing agreements | 4,000,000 | ||||||||
Milestone payments upon achieving certain criteria, maximum | $ 43,750,000 |
SIGNIFICANT ACCOUNTING POLICI_4
SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | |
Accounting Policies [Abstract] | |||
Accounts receivable, credit loss expense (reversal) | $ 0 | $ 0 | |
Inventory write-down | $ 0 | $ 0 | |
Inventory | $ 0 |
SIGNIFICANT ACCOUNTING POLICI_5
SIGNIFICANT ACCOUNTING POLICIES - Schedule of AntiDilutive Equity Awards Not Included in the Calculation of EPS (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Fair value, net asset (liability) | $ 0 | $ 0 | |
Outstanding stock options, RSUs and shares under the ESPP | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities (in shares) | 6,346,175 | 5,321,517 | |
Warrants | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities (in shares) | 495,165 | 495,165 |
DISCONTINUED OPERATIONS - Disco
DISCONTINUED OPERATIONS - Discontinued Operations of the MST Franchise (Details) - Discontinued Operations, Disposed of by Sale - MST Franchise - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Cost of goods sold | $ 80 | $ 601 |
Research and development | 0 | 2,078 |
Selling, general and administrative | (333) | 10,884 |
Total operating expenses | (333) | 12,962 |
Income (loss) from discontinued operations | 359 | (9,674) |
Gain on the sale of the MST Franchise | 13,005 | 0 |
Income (loss) from discontinued operations, before income taxes | 13,364 | (9,674) |
Income tax expense | 0 | 0 |
Net income (loss) from discontinued operations | 13,364 | (9,674) |
Product sales | ||
Total Revenues | $ 106 | $ 3,889 |
DISCONTINUED OPERATIONS - Asset
DISCONTINUED OPERATIONS - Assets and Liabilities Related to discontinued operations of the MST Franchise (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Total current assets of discontinued operations | $ 0 | $ 7,845 |
Discontinued Operations, Disposed of by Sale | MST Franchise | ||
Current assets: | ||
Inventory | 0 | 7,291 |
Prepaid expenses and other assets | 0 | 554 |
Total current assets of discontinued operations | $ 0 | $ 7,845 |
DISCONTINUED OPERATIONS - Non-C
DISCONTINUED OPERATIONS - Non-Cash Items Related to Discontinued Operations (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Cash Flows From Operating Activities: | ||
Stock-based compensation (income) expense* | $ (893) | $ (2,442) |
(Gain) on the sale of the MST Franchise | 13,005 | 0 |
Supplemental disclosure of cash flow information: | ||
Amount due from sale of MST Franchise | 5,000 | 0 |
Discontinued Operations, Disposed of by Sale | MST Franchise | ||
Cash Flows From Operating Activities: | ||
Stock-based compensation (income) expense* | (352) | 382 |
(Gain) on the sale of the MST Franchise | (13,005) | 0 |
Total non-cash items of discontinued operations | $ (13,357) | $ 382 |
DISCONTINUED OPERATIONS - Gain
DISCONTINUED OPERATIONS - Gain on the Sale of the MST Franchise (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Proceeds to be paid in January 2023 | $ 690,580 | $ 688,156 | |
Discontinued Operations, Disposed of by Sale | MST Franchise | |||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Cash proceeds | 20,000 | ||
Proceeds to be paid in January 2023 | 5,000 | ||
Total cash proceeds net | 25,000 | ||
Less transaction costs: | (4,247) | ||
Less book value of sold assets | (7,748) | ||
Gain on sale, before income taxes | 13,005 | $ 0 | |
Income tax expense | 0 | ||
Gain on sale net of tax | $ 13,005 |
SHARE CAPITAL - Common Stock, P
SHARE CAPITAL - Common Stock, Preferred Stock, and Warrants Narrative (Details) | Mar. 31, 2022USD ($)vote$ / sharesshares | Mar. 15, 2022USD ($)shares | Aug. 12, 2021USD ($) | Jan. 28, 2021USD ($)$ / sharesshares | Feb. 01, 2019USD ($) | Jan. 25, 2021USD ($)$ / sharesshares | Mar. 31, 2022USD ($)vote$ / sharesshares | Mar. 31, 2021USD ($) | Dec. 31, 2021$ / sharesshares | Feb. 12, 2021shares |
Class of Stock [Line Items] | ||||||||||
Common stock shares authorized (in shares) | shares | 150,000,000 | 150,000,000 | 150,000,000 | 75,000,000 | ||||||
Preferred stock, shares authorized (in shares) | shares | 20,000,000 | 20,000,000 | 20,000,000 | |||||||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||||||
Preferred stock, shares issued (in shares) | shares | 0 | 0 | 0 | |||||||
Preferred stock, shares outstanding (in shares) | shares | 0 | 0 | 0 | |||||||
Proceeds related to issuance of common shares through offerings, net of issuance costs | $ | $ 1,557,000 | $ 73,127,000 | ||||||||
Cantor Sales Agreement | ||||||||||
Class of Stock [Line Items] | ||||||||||
Consideration received in a transaction | $ | $ 50,000,000 | $ 26,300,000 | ||||||||
Commission from gross proceeds from issuance of common stock | 3000.00% | 3000.00% | ||||||||
Number of shares issued in transaction (in shares) | shares | 2,778,012 | 2,587,855 | ||||||||
Sale of stock (USD/share) | $ / shares | $ 0.62 | $ 9.76 | $ 0.62 | |||||||
Payments of financing and stock issuance costs | $ | $ 50,000,000 | |||||||||
Proceeds related to issuance of common shares through offerings, net of issuance costs | $ | $ 1,600,000 | |||||||||
Registered Direct Offering | ||||||||||
Class of Stock [Line Items] | ||||||||||
Consideration received in a transaction | $ | $ 46,800,000 | |||||||||
Number of shares issued in transaction (in shares) | shares | 5,274,261 | |||||||||
Sale of stock (USD/share) | $ / shares | $ 9.48 | |||||||||
Lincoln Park Equity Purchase Agreement | ||||||||||
Class of Stock [Line Items] | ||||||||||
Number of shares issued in transaction (in shares) | shares | 1,667,593 | 0 | ||||||||
Consideration receivable on transaction | $ | $ 30,000,000 | $ 30,000,000 | $ 30,000,000 | |||||||
Term of equity purchase agreement | 36 months | 36 months | ||||||||
Consideration receivable on additional transaction | $ | $ 900,000 | |||||||||
Common stock | ||||||||||
Class of Stock [Line Items] | ||||||||||
Number of votes entitled to each ordinary share | vote | 1 | 1 |
SHARE BASED COMPENSATION - Narr
SHARE BASED COMPENSATION - Narrative (Details) - USD ($) $ in Millions | Mar. 09, 2020 | Mar. 31, 2022 | Mar. 31, 2021 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Fair value of options and RSUs granted | $ 0.8 | $ 7.5 | |
2019 Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Shares reserved for future issuance (in shares) | 724,589 | ||
2018 Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Shares reserved for future issuance (in shares) | 6,566 | ||
Increase in shares reserved for future issuance (in shares) | 750,000 | ||
ESPP | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Shares reserved for future issuance (in shares) | 2,232,207 | ||
Percentage of fair market value used as purchase price | 85.00% | ||
Percent of annual earnings that may be used to purchase shares | 15.00% |
SHARE BASED COMPENSATION - Opti
SHARE BASED COMPENSATION - Options and RSU Grants (Details) | 3 Months Ended |
Mar. 31, 2022$ / sharesshares | |
Options | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Granted (in shares) | 774,503 |
Exercise price range, minimum (in dollar per share) | $ / shares | $ 0.61 |
Expiration | 10 years |
Options | Minimum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Vesting period | 2 years |
Options | Maximum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Vesting period | 4 years |
RSUs | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
RSU, award amount (in shares) | 726,102 |
RSUs | Minimum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Vesting period | 4 years |
RSUs | Maximum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Vesting period | 4 years |
SHARE BASED COMPENSATION - Fair
SHARE BASED COMPENSATION - Fair value assumptions (Details) - Options | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Share-based payment assumptions for computing fair value | ||
Dividend yield | 0.00% | 0.00% |
Expected volatility, minimum | 74.40% | 68.38% |
Expected volatility, maximum | 69.12% | |
Risk-free interest rate, minimum | 2.20% | 0.50% |
Risk-free interest rate, maximum | 1.05% | |
Expected term | 6 years | 6 years |
SHARE BASED COMPENSATION - Sche
SHARE BASED COMPENSATION - Schedule of Share-based Compensation (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Expense | ||
Share-based compensation | $ 893 | $ 2,442 |
Research and development expenses | ||
Expense | ||
Share-based compensation | 229 | 458 |
Selling, general and administrative | ||
Expense | ||
Share-based compensation | 1,016 | 1,602 |
Discontinued operations | ||
Expense | ||
Share-based compensation | $ (352) | $ 382 |
OPERATING LEASES - Narrative (D
OPERATING LEASES - Narrative (Details) | Mar. 13, 2019USD ($)ft² | Mar. 31, 2022USD ($) | Dec. 31, 2021USD ($) |
Operating Lease | |||
Operating lease, right-of-use asset | $ 0 | ||
Operating lease, liability | 0 | ||
Operating lease, liability, current | 117,000 | $ 349,000 | |
Lien on marketable securities to secure lease agreements | $ 600,000 | ||
ISRAEL | |||
Operating Lease | |||
Operating lease terms | 1 year | ||
Original Space | Bridgewater, New Jersey | |||
Operating Lease | |||
Facility space leased | ft² | 10,000 | ||
Operating lease, right-of-use asset | $ 700,000 | ||
Additional Space | Bridgewater, New Jersey | |||
Operating Lease | |||
Facility space leased | ft² | 4,639 | ||
Operating lease, right-of-use asset | $ 300,000 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details) | Mar. 31, 2022claim |
Commitments and Contingencies Disclosure [Abstract] | |
Number of claims | 0 |