Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2020 | Oct. 30, 2020 | |
DOCUMENT AND ENTITY INFORMATION [Abstract] | ||
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2020 | |
Document Quarterly Report | true | |
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 | 755-7936 | |
Entity Information, Former Legal or Registered Name | Menlo Therapeutics Inc. | |
Title of 12(b) Security | Common Stock, par value $0.0001 | |
Trading Symbol | VYNE | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Shell Company | false | |
Entity Central Index Key | 0001566044 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false | |
Entity Ex Transition Period | true | |
Entity Common Stock, Shares Outstanding | 167,878,646 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 72,956 | $ 43,759 |
Restricted cash | 855 | 825 |
Short-term bank deposits | 0 | 12,102 |
Investment in marketable securities (Note 6) | 3,046 | 16,246 |
Restricted investment in marketable securities (Note 6) | 0 | 434 |
Trade receivables, net of allowances | 11,189 | 135 |
Prepaid and other assets | 3,466 | 1,557 |
Inventory (Note 7) | 6,650 | 1,356 |
TOTAL CURRENT ASSETS | 98,162 | 76,414 |
NON-CURRENT ASSETS: | ||
Property and equipment, net | 2,744 | 2,885 |
Operating lease right-of-use assets (Note 10) | 2,191 | 1,694 |
Prepaid and other assets | 4,586 | 166 |
TOTAL NON-CURRENT ASSETS | 9,521 | 4,745 |
TOTAL ASSETS | 107,683 | 81,159 |
CURRENT LIABILITIES: | ||
Trade payables | 4,622 | 19,352 |
Accrued expenses (Note 4) | 12,132 | 3,381 |
Employee related obligations | 5,294 | 5,231 |
Operating lease liabilities (Note 10) | 1,098 | 1,092 |
Other | 46 | 270 |
TOTAL CURRENT LIABILITIES | 23,192 | 29,326 |
LONG-TERM LIABILITIES: | ||
Liability for employee severance benefits | 409 | 424 |
Operating lease liabilities (Note 10) | 1,092 | 653 |
Long-term debt (Note 8) | 33,017 | 32,725 |
Other liabilities | 457 | 456 |
TOTAL LONG-TERM LIABILITIES | 34,975 | 34,258 |
TOTAL LIABILITIES | 58,167 | 63,584 |
COMMITMENTS AND CONTINGENCIES (Note 11) | 0 | 0 |
STOCKHOLDERS' EQUITY: | ||
Preferred stock: $0.0001 par value; 20,000,000 shares authorized at September 30, 2020 and December 31, 2019, respectively; no shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively | 0 | 0 |
Common stock: $0.0001 par value; 300,000,000 shares authorized at September 30, 2020 and December 31, 2019, respectively; 167,859,461 and 36,480,314 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively | 17 | 3 |
Additional paid-in capital | 592,514 | 328,154 |
Accumulated deficit | (543,015) | (310,587) |
Accumulated other comprehensive income | 0 | 5 |
TOTAL SHAREHOLDERS' EQUITY | 49,516 | 17,575 |
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ 107,683 | $ 81,159 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2020 | Dec. 31, 2019 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (USD/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 (USD/share) | $ 0.0001 | $ 0.0001 |
Common stock shares authorized (in shares) | 300,000,000 | 300,000,000 |
Common stock shares issued (in shares) | 167,859,461 | 36,480,314 |
Common stock shares outstanding (in shares) | 167,859,461 | 36,480,314 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
TOTAL REVENUES | $ 3,269,000 | $ 0 | $ 16,707,000 | $ 308,000 |
EXPENSES | ||||
Cost of goods sold | 371,000 | 0 | 858,000 | 0 |
Research and development | 6,623,000 | 12,452,000 | 35,695,000 | 35,856,000 |
Selling, general and administrative | 19,766,000 | 10,747,000 | 71,640,000 | 22,894,000 |
Goodwill and in-process research & development impairments | 0 | 0 | 54,345,000 | 0 |
Contingent Stock Right Remeasurement | 0 | 0 | 84,726,000 | 0 |
TOTAL EXPENSES | 26,760,000 | 23,199,000 | 247,264,000 | 58,750,000 |
OPERATING LOSS | 23,491,000 | 23,199,000 | 230,557,000 | 58,442,000 |
FINANCE INCOME | (4,000) | (381,000) | (1,218,000) | (1,385,000) |
FINANCE EXPENSES | 1,226,000 | 343,000 | 3,306,000 | 477,000 |
LOSS BEFORE INCOME TAX | 24,713,000 | 23,161,000 | 232,645,000 | 57,534,000 |
INCOME TAX | 1,000 | 0 | (258,000) | (176,000) |
NET LOSS FOR THE PERIOD | $ 24,714,000 | $ 23,161,000 | $ 232,387,000 | $ 57,358,000 |
LOSS PER SHARE BASIC AND DILUTED (in dollars per share) | $ 0.15 | $ 0.23 | $ 1.99 | $ 0.59 |
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE (in shares) | 167,737 | 100,805 | 116,530 | 97,989 |
Product sales | ||||
TOTAL REVENUES | $ 2,863,000 | $ 0 | $ 6,096,000 | $ 0 |
License revenues | ||||
TOTAL REVENUES | 0 | 0 | 10,000,000 | 0 |
Royalty revenues | ||||
TOTAL REVENUES | $ 406,000 | $ 0 | $ 611,000 | $ 308,000 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ 24,714 | $ 23,161 | $ 232,387 | $ 57,358 |
OTHER COMPREHENSIVE LOSS (INCOME): | ||||
Net unrealized gains from marketable securities | (2) | (1) | (1) | (41) |
Losses on marketable securities reclassified into net loss | 2 | 0 | 6 | 0 |
Net unrealized gains on derivative financial instruments | 0 | (1) | 0 | (3) |
TOTAL OTHER COMPREHENSIVE (INCOME) LOSS | 0 | (2) | 5 | (44) |
TOTAL COMPREHENSIVE LOSS | $ 24,714 | $ 23,159 | $ 232,392 | $ 57,314 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common stock | Additional paid-in capital | Accumulated deficit | Accumulated other comprehensive income (loss) |
Balance at Dec. 31, 2018 | $ 92,182 | $ 10 | $ 307,624 | $ (215,409) | $ (43) |
Balance (shares) at Dec. 31, 2018 | 97,864,663 | ||||
CHANGES DURING THE PERIOD: | |||||
Comprehensive (loss) income | (57,314) | (57,358) | 44 | ||
Exercise of options and vesting of restricted stock units | 44 | 44 | |||
Exercise of options, vesting of restricted stock units and shares issued under employee stock purchase plan (in shares) | 410,339 | ||||
Stock-based compensation | 3,606 | 3,606 | |||
Issuance of Ordinary Shares through a public offering, net of $3,903 issuance costs | 15,011 | $ 1 | 15,010 | ||
Issuance of Ordinary Shares through public offering, net of $3,903 issuance costs (in shares) | 11,779,628 | ||||
Balance at Sep. 30, 2019 | 53,529 | $ 11 | 326,284 | (272,767) | 1 |
Balance (shares) at Sep. 30, 2019 | 110,054,630 | ||||
CHANGES DURING THE PERIOD: | |||||
Payments of stock issuance costs | 359 | ||||
Balance at Jun. 30, 2019 | 60,382 | $ 10 | 309,979 | (249,606) | (1) |
Balance (shares) at Jun. 30, 2019 | 98,053,418 | ||||
CHANGES DURING THE PERIOD: | |||||
Comprehensive (loss) income | (23,159) | (23,161) | 2 | ||
Exercise of options and vesting of restricted stock units | 26 | 26 | |||
Exercise of options, vesting of restricted stock units and shares issued under employee stock purchase plan (in shares) | 221,584 | ||||
Stock-based compensation | 1,269 | 1,269 | |||
Issuance of Ordinary Shares through a public offering, net of $3,903 issuance costs | 15,011 | $ 1 | 15,010 | ||
Issuance of Ordinary Shares through public offering, net of $3,903 issuance costs (in shares) | 11,779,628 | ||||
Balance at Sep. 30, 2019 | 53,529 | $ 11 | 326,284 | (272,767) | 1 |
Balance (shares) at Sep. 30, 2019 | 110,054,630 | ||||
CHANGES DURING THE PERIOD: | |||||
Payments of stock issuance costs | 359 | ||||
Balance at Dec. 31, 2019 | $ 17,575 | $ 3 | 328,154 | (310,587) | 5 |
Balance (shares) at Dec. 31, 2019 | 36,480,314 | 36,480,314 | |||
CHANGES DURING THE PERIOD: | |||||
Comprehensive (loss) income | $ (232,392) | (232,387) | (5) | ||
Exercise of options and vesting of restricted stock units | 342 | 342 | |||
Exercise of options, vesting of restricted stock units and shares issued under employee stock purchase plan (in shares) | 1,207,650 | ||||
Stock-based compensation | 15,147 | 15,147 | |||
Deemed dividend to warrants holders due to warrant modification | 0 | 41 | (41) | ||
Classification of stock awards to derivative liability | (975) | (975) | |||
Issuance of Ordinary Shares through a public offering, net of $3,903 issuance costs | 53,649 | $ 3 | 53,646 | ||
Issuance of Ordinary Shares through public offering, net of $3,903 issuance costs (in shares) | 31,107,500 | ||||
Issuance of stock related to merger | 196,170 | $ 11 | 196,159 | ||
Issuance of stock related to merger (in shares) | 99,063,997 | ||||
Balance at Sep. 30, 2020 | $ 49,516 | $ 17 | 592,514 | (543,015) | 0 |
Balance (shares) at Sep. 30, 2020 | 167,859,461 | 167,859,461 | |||
CHANGES DURING THE PERIOD: | |||||
Payments of stock issuance costs | $ 3,903 | ||||
Balance at Jun. 30, 2020 | 71,528 | $ 17 | 589,812 | (518,301) | 0 |
Balance (shares) at Jun. 30, 2020 | 167,683,814 | ||||
CHANGES DURING THE PERIOD: | |||||
Comprehensive (loss) income | (24,714) | (24,714) | 0 | ||
Exercise of options and vesting of restricted stock units | 82 | 82 | |||
Exercise of options, vesting of restricted stock units and shares issued under employee stock purchase plan (in shares) | 175,647 | ||||
Stock-based compensation | 2,620 | 2,620 | |||
Balance at Sep. 30, 2020 | $ 49,516 | $ 17 | $ 592,514 | $ (543,015) | $ 0 |
Balance (shares) at Sep. 30, 2020 | 167,859,461 | 167,859,461 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Statement of Stockholders' Equity [Abstract] | |||
Payments of stock issuance costs | $ 359 | $ 3,903 | $ 359 |
Issuance of Ordinary Shares through a public offering, net of $3,903 issuance costs | $ 15,011 | $ 53,649 | $ 15,011 |
CONDENSED CONSOLIDATED STATEM_5
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net Loss | $ 232,387 | $ 57,358 |
Adjustments required to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 254 | 256 |
Goodwill and in-process research & development impairments | 54,345 | 0 |
Contingent stock right remeasurement | 84,726 | 0 |
Loss from disposal and sale of fixed assets | 0 | 7 |
Changes in marketable securities and bank deposits, net | (142) | (269) |
Changes in accrued liability for employee severance benefits, net of retirement fund profit | (15) | 52 |
Stock-based compensation | 15,147 | 3,606 |
Non-cash finance (income) expenses, net | (727) | 85 |
Changes in operating assets and liabilities, net of effects of businesses acquired: | ||
(Increase) decrease in trade receivables, prepaid and other assets | (11,383) | 1,086 |
Increase in other non-current assets | (4,430) | (124) |
(Decrease) increase in accounts payable and accruals | (11,801) | 1,511 |
Increase in inventory | (5,294) | 0 |
Net cash used in operating activities | (111,707) | (51,148) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of fixed assets | (113) | (861) |
Proceeds from sale of fixed assets | 0 | 24 |
Investment in marketable securities | 0 | (48,001) |
Cash acquired through merger | 38,641 | 0 |
Proceeds from sale and maturity of marketable securities | 48,577 | 84,673 |
Net cash provided by investing activities | 87,105 | 35,835 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds related to issuance of ordinary shares through offerings, net of issuance costs | 53,646 | 13,714 |
Proceeds from debt financing and issuance of warrants, net of issuance costs | 0 | 14,196 |
Proceeds related to issuance of stock for stock-based compensation arrangements, net | 182 | 44 |
Net cash provided by financing activities | 53,828 | 27,954 |
INCREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | 29,226 | 12,641 |
EFFECT OF EXCHANGE RATE ON CASH, CASH EQUIVALENTS AND RESTRICTED CASH | 1 | 25 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT BEGINNING OF THE PERIOD | 44,584 | 28,118 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT END OF THE PERIOD | 73,811 | 40,784 |
TOTAL CASH, CASH EQUIVALENTS AND RESTRICTED CASH SHOWN IN STATEMENT OF CASH FLOWS | 73,811 | 40,784 |
SUPPLEMENTARY INFORMATION ON INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS - | ||
Cashless exercise of warrants and restricted stock units | 7 | |
Issuance of shares under employee stock purchase plan | 163 | 0 |
Additions to operating lease right of use assets | 1,120 | 1,193 |
Additions to operating lease liabilities | 1,120 | 1,175 |
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION: | ||
Interest received | 232 | 1,125 |
Interest paid | 2,936 | 289 |
Fair value of assets acquired | 117,270 | 0 |
Less liabilities assumed | 5,827 | 0 |
Net acquired (See “Note 3- Business combination”) | 111,443 | 0 |
Less cash acquired | 38,641 | 0 |
Merger net of cash acquired | $ 72,802 | $ 0 |
NATURE OF OPERATIONS
NATURE OF OPERATIONS | 9 Months Ended |
Sep. 30, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
NATURE OF OPERATIONS | NATURE OF OPERATIONS On September 4, 2020, we changed our corporate name from "Menlo Therapeutics Inc." ("Menlo") to “VYNE Therapeutics Inc.” (the “Company,” “VYNE” or the “combined company”) and changed our ticker symbol on the Nasdaq Global Select Market from "MNLO" to "VYNE." VYNE is a specialty pharmaceutical company focused on developing and commercializing proprietary, innovative and differentiated therapies in dermatology and beyond. The Company is a Delaware corporation, has its principal executive offices in Bridgewater, New Jersey and operates as one business segment. Reverse Merger On November 10, 2019, Menlo, Foamix Pharmaceuticals Ltd. (“Foamix”) and Giants Merger Subsidiary Ltd. (“Merger Sub”), a wholly-owned subsidiary of Menlo, entered into an Agreement and Plan of Merger (as amended by Amendment No. 1 to the Agreement and Plan of Merger, dated as of December 4, 2019, the “Merger Agreement”). Pursuant to the terms of the Merger Agreement, Merger Sub merged with and into Foamix, with Foamix surviving as a wholly-owned subsidiary of Menlo (the “Merger”) on March 9, 2020 (the “Effective Date”). For accounting purposes, the Merger is treated as a “reverse acquisition” under generally accepted accounting principles in the United States (“U.S. GAAP”) and Foamix is considered the accounting acquirer. Accordingly, upon consummation of the Merger, the historical financial statements of Foamix became the Company’s historical financial statements, and the historical financial statements of Foamix are included in the comparative prior periods. See “Note 3 – Business Combination” for more information on the Merger. Products, Product Candidates and Licenses Prior to the Merger, in January 2020, Foamix launched AMZEEQ ® (minocycline) topical foam, 4% (“AMZEEQ”), a once-daily topical antibiotic for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients 9 years of age and older. On May 28, 2020, the U.S. Food and Drug Administration (the "FDA") approved ZILXI ™ (minocycline) topical foam, 1.5% (formerly FMX103, "ZILXI"), for the treatment of inflammatory lesions of rosacea in adults. ZILXI became available in pharmacies nationwide on October 1, 2020. AMZEEQ and ZILXI are the first topical minocycline products approved by the FDA for any condition. AMZEEQ and ZILXI utilize the Company’s proprietary Molecule Stabilizing Technology (MST) ™ that is also being used in the development of the Company’s product candidate FCD105, a topical foam comprising minocycline and adapalene for the treatment of acne vulgaris. On June 2, 2020, the Company announced positive results from a Phase II clinical trial evaluating the preliminary safety and efficacy of FCD105 (3% minocycline / 0.3% adapalene foam), the first ever topical minocycline-based combination product, for the treatment of moderate-to-severe acne vulgaris. The Company has scheduled an end-of-Phase 2 meeting with the FDA in the fourth quarter of 2020. Additionally, the Company was developing serlopitant, a small molecule inhibitor of the neurokinin 1 receptor, or NK1-R, given as a once-daily, oral tablet, for the treatment of pruritus, or itch, associated with various conditions including prurigo nodularis, or PN. On April 6, 2020, the Company announced top line results from two Phase III clinical trials evaluating the safety and efficacy of once-daily oral serlopitant for the treatment of pruritus (itch) associated with PN, studies MTI-105 and MTI-106. Neither study met their respective primary endpoint of demonstrating statistically significant reduction in pruritus in patients treated with serlopitant compared to placebo based on a 4-point improvement responder analysis. The Company does not currently intend to further pursue the development of serlopitant. As a result, in the second quarter of 2020, the Company recorded a full impairment charge related to the IPR&D and Goodwill assets in its unaudited condensed consolidated statement of operations and comprehensive loss. See "Note 3 - Business Combination" for more information. The Company is actively pursuing opportunities to out-license its products and product candidates to third parties for development and commercialization outside the United States, and recently entered into a license agreement with Cutia Therapeutics (HK) Limited (“Cutia”). See "Note 4 - Revenue Recognition." The Company has also licensed certain technology under development and licensing agreements to various pharmaceutical companies for development of certain products combining the Company’s foam technology with the licensee’s proprietary drugs. Liquidity and Capital Resources The Company launched AMZEEQ in the United States in January 2020 and commenced generating product revenues in the first quarter of 2020. The Company’s activities prior to the commercial launch of AMZEEQ had primarily consisted of developing product candidates, raising capital and performing research and development activities. Since inception, the Company has incurred losses and negative cash flows from operations. For the nine months ended September 30, 2020, the Company incurred a net loss of $232.4 million and used $111.7 million of cash in operations. As of September 30, 2020, the Company had cash, cash equivalents and investments of $76.9 million and an accumulated deficit of $543.0 million. If the Company does not successfully commercialize AMZEEQ, ZILXI or any of its future product candidates, it may be unable to achieve profitability. Accordingly, the Company may be required to obtain further funding through public or private debt or equity offerings, or other arrangements. Adequate additional funding may not be available to the Company on acceptable terms, or at all. If the Company is unable to raise capital when needed or on acceptable terms, it may be forced to delay, reduce or eliminate its research and development programs or commercialization and manufacturing efforts. Prior to the Merger, the Company was focused on the development and commercialization of serlopitant. Following the receipt of the results of the Phase 3 clinical trials evaluating serlopitant for the treatment of PN and the impact of the COVID-19 pandemic, the Company revised its operating plan to focus on the commercialization of AMZEEQ, ZILXI and its current product candidates. The Company does not currently intend to further pursue the development of serlopitant. In addition, the revised operating plan reflects prudent resource prioritization and allocation management, including the rationalization of research and development spend to focus on existing product candidates. The Company believes that its existing cash, cash equivalents and investments as of September 30, 2020 and projected cash flows from revenues will provide sufficient resources to fund its current ongoing needs through December 31, 2021. However, the Company may seek additional financing in order to achieve its longer-term strategic plans. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 30, 2020 | |
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 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 consolidated financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. These unaudited interim condensed consolidated financial statements should be read in conjunction with Foamix’s audited consolidated financial statements for the year ended December 31, 2019, included in the Company’s Current Report on Form 8-K/A filed with the Securities and Exchange Commission ("SEC") on May 7, 2020, and the Company's unaudited consolidated financial statements included in the Company's Quarterly Reports on Form 10-Q for the quarters ended March 31, 2020 and June 30, 2020, filed with the SEC on May 11, 2020 and August 6, 2020, respectively. The results for the three and nine months ended September 30, 2020 are not necessarily indicative of the results expected for the year ending December 31, 2020. b. Principles of Consolidation The 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 condensed consolidated financial statements and reported amounts of income and expenses during the reporting periods. Significant items subject to such estimates and assumptions include accounting for business combinations, impairments of goodwill and intangible assets and revenue recognition. Actual results could differ from the Company’s estimates. The extent to which the COVID-19 pandemic impacts the Company’s business and financial results will depend on numerous evolving factors including, but not limited to: the magnitude and duration of the pandemic; the extent to which patients and our sales representatives are able to access healthcare provider offices; the impact on worldwide macroeconomic conditions, including interest rates, employment rates and health insurance coverage; the speed of the anticipated recovery; and governmental and business reactions to the pandemic. While the Company’s product sales for AMZEEQ have experienced a modest recovery during the three months ended September 30, 2020, our sales of AMZEEQ were negatively impacted by office closures due to the pandemic during the six months ended June 30, 2020. No assurance can be given that such office closures will not occur again in future periods, and if such closures do occur, or any other circumstance arises such that patients or our sales representatives are restricted in their ability to connect with healthcare providers, our product sales would be negatively impacted. 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 September 30, 2020 and through the date of this report. The accounting matters assessed included, but were not limited to, the Company’s allowance for doubtful accounts and credit losses, inventory and related reserves, impairments of long-lived assets and revenue recognition. The Company recorded impairments of goodwill and certain indefinite-lived intangible assets; however, these were unrelated to the impact of COVID-19 (See "Note 3 - Business Combination" for more information). The Company’s future assessment of the magnitude and duration of COVID-19, as well as other factors, could result in material impacts to the Company’s consolidated financial statements in future reporting periods. d. Business Acquisition The Company’s unaudited interim condensed consolidated financial statements include the operations of an acquired business after the completion of the acquisition. The Company accounts for acquired businesses using the acquisition method of accounting, which requires, among other things, that most assets acquired and liabilities assumed be recognized at their estimated fair values as of the acquisition date and that the fair value of In-Process Research and Development and Goodwill be recorded on the balance sheet. Transaction costs are expensed as incurred. Amounts recorded in connection with an acquisition can result from a complex series of judgments about future events and uncertainties and can rely heavily on estimates and assumptions. The Company is required to measure certain assets and liabilities at fair value, either upon initial recognition or for subsequent accounting or reporting. For example, the Company uses fair value in the initial recognition of net assets acquired in a business combination and when measuring impairment losses. The Company estimates fair value using an exit price approach, which requires, among other things, that Company determine the price that would be received to sell an asset or paid to transfer a liability in an orderly market. The determination of an exit price is considered from the perspective of market participants, considering the highest and best use of non-financial assets and, for liabilities, assuming that the risk of non-performance will be the same before and after the transfer. When estimating fair value, depending on the nature and complexity of the asset or liability, the Company may use one or all of the following techniques: • Income approach, which is based on the present value of a future stream of net cash flows. • Market approach, which is based on market prices and other information from market transactions involving identical or comparable assets or liabilities. • Cost approach, which is based on the cost to acquire or construct comparable assets, less an allowance for functional and/or economic obsolescence. Our fair value methodologies depend on the following types of inputs: • Quoted prices for identical assets or liabilities in active markets (Level 1 inputs). • Quoted prices for similar assets or liabilities in active markets, or quoted prices for identical or similar assets or liabilities in markets that are not active, or inputs other than quoted prices that are directly or indirectly observable, or inputs that are derived principally from, or corroborated by, observable market data by correlation or other means (Level 2 inputs). • Unobservable inputs that reflect estimates and assumptions (Level 3 inputs). A single estimate of fair value can result from a complex series of judgments about future events and uncertainties and can rely heavily on estimates and assumptions. Asset Impairment The Company reviews all of its long-lived assets for impairment indicators throughout the year. Impairment testing is performed for indefinite-lived intangible assets annually (or sooner if warranted) and for all other long-lived assets whenever impairment indicators are present. When necessary, the Company records charges for impairments of long-lived assets for the amount by which the fair value is less than the carrying value of these assets. e. Revenue Recognition The Company accounts for its revenue transactions under FASB 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 include a limited number of national and select regional wholesalers (the “distributors”). These distributors subsequently resell the product, primarily to retail pharmacies that dispense the product to patients. Net product revenue is typically recognized when distributors obtain control of the Company’s products, which occurs at a point in time, typically upon delivery of product to the distributors. The Company evaluates the creditworthiness of each of its distributors to determine whether it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur. The Company does not assess whether a contract has a significant financing component if the expectation is such that the period between the transfer of the promised goods to the customer and the receipt of payment will be less than one year. Standard credit terms do not exceed 90 days. The Company expenses 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 are included in selling, general and administrative expenses. The Company’s net product revenues through September 30, 2020 were primarily 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. 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. See “Note 4 – Revenue Recognition” for more information. On April 23, 2020, the Company announced that it entered into a license agreement with Cutia for AMZEEQ as well as certain of the Company's other topical minocycline product candidates, once approved, on an exclusive basis in Greater China. Under the terms of the agreement, Cutia will have an exclusive license to obtain regulatory approval of and commercialize AMZEEQ, ZILXI and, if approved in the U.S., FCD105 in the Greater China territory. The Company will supply the finished licensed products to Cutia for clinical and commercial use. The Company received an upfront cash payment of $10.0 million ($4.0 million received in the three months ended September 30, 2020 and $6.0 million received in the three months ended June 30, 2020) and will be eligible to receive an additional $1.0 million payment upon the receipt of marketing approval in China of the first licensed product. The Company will also receive royalties on net sales of any licensed products. The license is determined to be a distinct performance obligation of the arrangement, therefore the Company recognizes the revenues from the upfront license fee when the license is transferred to the licensee and the licensee is able to use and benefit from the license. See "Note 4 - Revenue Recognition" for more information. f. Allowance for credit losses 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 and nine months ended September 30, 2020. g. Derivative instruments The Company recognizes all derivative instruments as either assets or liabilities in the unaudited condensed consolidated balance sheet at their respective fair values. All gains and losses associated with derivatives are reported as a finance expense (income) in the accompanying condensed consolidated statements of operations. As of September 30, 2020, the Company had no derivative instruments. h. 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. i. Loss per share The calculation of the weighted-average number of common stock outstanding during the period in which the reverse merger occurs was based on: a. The number of common stock outstanding from the beginning of that period to the merge date was computed on the basis of the weighted-average number of common stock of the legal acquiree (accounting acquirer) outstanding during the period multiplied by the exchange ratio established in the merger agreement b. The number of common outstanding common stock outstanding from the merge date to the end of that period was the actual number of common stock of the legal acquirer (the accounting acquiree) outstanding during that period. The basic and diluted loss per share for each comparative period before the acquisition date presented in the consolidated financial statements following the reverse merger was calculated by dividing (a) by (b): a. The loss of the legal acquiree attributable to common stockholders in each of those periods. b. The legal acquiree's historical weighted-average number of common stock outstanding multiplied by the exchange ratio established in the merge agreement Net loss per share, basic and diluted, is computed on the basis of the net loss for the period divided by the weighted average number of Ordinary 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 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 Nine months ended 2020 2019 2020 2019 Outstanding stock options, RSUs and shares under the ESPP 20,765,196 11,488,993 15,024,198 10,903,631 Warrants 1,980,660 1,371,225 1,510,168 457,075 In addition to the above, the CSR was excluded from the calculation of the diluted net loss per share because its effect would have been anti-dilutive for the periods presented. On April 6, 2020, the Company announced that each of Menlo’s Phase III PN Trials (study MTI-105 and study MTI-106) did not meet their respective primary endpoint of demonstrating statistically significant reduction in pruritus in patients treated with serlopitant compared to placebo based upon a 4-point improvement responder analysis. Each CSR was converted into 1.2082 shares of Menlo common stock, resulting in an effective exchange ratio (the "Exchange Ratio") in the Merger of 1.8006 shares of Menlo common stock for each Foamix ordinary share. The conversion of the CSR also affected the Exchange Ratio of the pre-Merger Foamix equity awards and warrants outstanding as of March 9, 2020. See "Note 3 - Business Combination" for more information. j. Newly issued and recently adopted accounting pronouncements Recent Accounting Guidance Issued: In March 2020, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update No. 2020-4, "Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting" (ASU 2020-4), 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 2020-4 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 2020-4 are optional and are effective from March 12, 2020 through December 31, 2022. The Company is currently evaluating the impact of ASU 2020-4 on its consolidated financial statements. In June 2016, the FASB issued Accounting Standards Update 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 Accounting Standard Updates 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. |
BUSINESS COMBINATION
BUSINESS COMBINATION | 9 Months Ended |
Sep. 30, 2020 | |
Business Combinations [Abstract] | |
BUSINESS COMBINATION | BUSINESS COMBINATION On November 10, 2019, Menlo entered into the Merger Agreement with Foamix, and Merger Sub, a direct and wholly-owned Israeli subsidiary of Menlo. On March 9, 2020, the Merger was completed and Foamix is now a wholly-owned subsidiary of the Company. On the Effective Date, each ordinary share of Foamix was exchanged for 0.5924 shares of common stock of Menlo. In addition, on the Effective Date, Foamix shareholders received one contingent stock right (a “CSR”) for each Foamix ordinary share held by them. The CSRs were issued pursuant to the Contingent Stock Rights Agreement (the “CSR Agreement”), dated as of March 9, 2020, by and between Menlo and American Stock Transfer & Trust Company, LLC, and represented the non-transferable contractual right to receive shares of common stock of Menlo depending on the results of Menlo’s phase III clinical trials evaluating the safety and efficacy of once daily oral serlopitant for the treatment of prurigo nodularis (the “Phase III PN Trials”). On April 6, 2020, the Company announced that each of Menlo’s Phase III PN Trials (study MTI-105 and study MTI-106) did not meet their respective primary endpoint of demonstrating statistically significant reduction in pruritus in patients treated with serlopitant compared to placebo based upon a 4-point improvement responder analysis. Accordingly, on April 6, 2020, pursuant to the terms of the CSR Agreement, each CSR was converted into 1.2082 additional shares of Menlo common stock, resulting in an effective Exchange Ratio in the Merger of 1.8006 shares of Menlo common stock for each Foamix ordinary share. The CSR conversion resulted in the issuance and delivery of 74,544,413 additional shares of Menlo common stock underlying the CSRs. Following the conversion of the CSRs, pre-Merger Foamix shareholders and pre-Merger Menlo stockholders owned approximately 82% and 18% of post-Merger Menlo, respectively, each calculated on a fully diluted basis. For accounting purposes, the Merger is treated as a “reverse acquisition” under U.S. GAAP and Foamix is considered the accounting acquirer. Accordingly, upon consummation of the Merger, the historical financial statements of Foamix became the Company’s historical financial statements, and the historical financial statements of Foamix are included in the comparative prior periods. Under reverse acquisition accounting, the U.S. dollar amount for common stock in the financial statements is based on the value and number of shares issued by Menlo (reflecting the legal structure of Menlo as the legal acquirer) on the Merger date plus subsequent shares issued by the Company. The amounts in additional paid-in capital represent that of Foamix and include the fair value of shares deemed for accounting purposes to have been issued by Foamix on the merger date and the fair value of the Menlo equity awards included in the purchase price calculation. The Foamix additional paid-in capital was also adjusted for the difference between the number of common stock and the historical number of shares of Foamix’s ordinary shares. During the nine months ended September 30, 2020, the Company incurred transaction costs of approximately $11.7 million, which are recorded in the consolidated statements of operations and comprehensive income. This amount includes $8.1 million of severance benefits for employees terminated after the Effective Date. The total transaction costs and other non-recurring costs related to the Merger were $21.8 million. Purchase Price The following is the Merger Consideration (as defined in the Merger Agreement) was transferred to effect the Merger: (in thousands) Total Deemed (for accounting purposes only) issuance of Foamix shares to Menlo stockholders $ 123,757 Deemed (for accounting purposes only) conversion of Menlo equity awards 7,322 Total consideration* $ 131,079 * This amount reflects total consideration prior to reduction in respect of the CSRs (which had a fair value of $19.6 million as of the Merger Date) that were issued to Foamix shareholders and that reduced the Menlo stockholders’ relative ownership in the combined company. If the effect of the CSRs is included, the total consideration deemed paid by Foamix, as the accounting acquirer, to Menlo stockholders and equity award holders in the Merger would be reduced to approximately $111.4 million, as shown in the purchase price allocation table below. Based on Foamix’s closing share price of $2.99 as of March 9, 2020, the Merger Consideration under reverse acquisition accounting was approximately $131.1 million, consisting of $123.8 million for the deemed (for accounting purposes only) issuance of 41.4 million Foamix shares assuming that no upwards adjustment was made to the Exchange Ratio relating to the CSR, and $7.3 million for the fair value of Menlo equity awards deemed (for accounting purposes only) to be converted into Foamix equity awards. The converted stock options represent the fair value of such options attributable to service prior to the Merger date using the Foamix closing share price of $2.99 as of March 9, 2020 as an input to the Black Scholes valuation model to determine the fair value of the options. Purchase Price Allocation The Company completed its analysis of the allocation of the purchase price to the fair values of assets acquired and liabilities assumed as follows: (in thousands) March 9, 2020 Cash and cash equivalents $ 38,641 Investment in marketable securities 22,703 Prepaid expenses and other current assets 1,581 In-process research and development 50,300 Goodwill 4,045 Total assets 117,270 Current liabilities (5,827) Total liabilities (5,827) Estimated purchase price* $ 111,443 * Reflects reduction in the purchase price deemed paid to Menlo stockholders in the Merger on the assumption that the CSRs, in an aggregate value of $19.6 million, convert into additional shares of the combined company for the Foamix shareholders, thereby resulting in a lower percentage of the combined company’s outstanding shares being owned by Menlo stockholders following the Merger. Goodwill Goodwill is recorded with the acquisition of a business and is calculated as the difference between the acquisition date fair value of the consideration transferred and the values assigned to the assets acquired and liabilities assumed. Goodwill is not amortized but is tested for impairment at least annually. None of the Goodwill recognized is expected to be deductible for income tax purposes . The purchase price of the transaction and the excess purchase price over the fair value of the identifiable net assets acquired, are calculated as follows: (in thousands) March 9, 2020 Purchase price $ 111,443 Less: fair value of net assets acquired, including other identifiable intangibles (107,398) Goodwill $ 4,045 On April 6, 2020, the Company announced that each of Menlo’s Phase III PN Trials (study MTI-105 and study MTI-106) did not meet their respective primary endpoint of demonstrating statistically significant reduction in pruritus in patients treated with serlopitant compared to placebo based upon a 4-point improvement responder analysis. The Company does not intend to further pursue the development of serlopitant. As such, the Company recorded a full impairment charge of $4.0 million related to goodwill in its unaudited condensed consolidated statements of operations and comprehensive loss for the nine months ended September 30, 2020. There was no impairment charge in the three months ended September 30, 2020. In-Process Research and Development (“IPR&D") The IPR&D recognized relates to Menlo’s once - daily oral serlopitant for the treatment of pruritus (itch) associated with PN that has not reached technological feasibility as follows: (in thousands) Intangible asset Estimated Fair Value Acquired indefinite life intangible assets* $ 50,300 Fair value of identified intangible assets $ 50,300 * Represents acquired IPR&D assets which are initially recognized at fair value and are classified as indefinite-lived assets until the successful completion or abandonment of the associated research and development efforts. Accordingly, during the research and development period, these assets will not be amortized into earnings; instead these assets will be subject to periodic impairment testing. The fair value of IPR&D has been estimated utilizing a multi-period excess earnings method under the income approach, which reflects the present value of the projected cash flows that are expected to be generated, less charges representing the contribution of other assets to those cash flows that use projected cash flows with and without the intangible asset in place. On April 6, 2020, the Company announced that each of Menlo’s Phase III PN Trials (study MTI-105 and study MTI-106) did not meet their respective primary endpoint of demonstrating statistically significant reduction in pruritus in patients treated with serlopitant compared to placebo based upon a 4-point improvement responder analysis. The Company does not intend to further pursue the development of serlopitant. As such, the Company recorded a full impairment charge of $50.3 million related to the IPR&D asset in its unaudited condensed consolidated statements of operations and comprehensive loss for the nine months ended September 30, 2020. There was no impairment charge in the three months ended September 30, 2020. CSR The CSR was issued pursuant to the CSR Agreement, dated as of March 9, 2020, by and between Menlo and American Stock Transfer & Trust Company, LLC, and represented the non-transferable contractual right to receive shares of common stock of Menlo depending on the results of Menlo’s Phase III PN Trials. The Company recognized a liability of $19.6 million in the unaudited condensed consolidated balance sheet as of March 31, 2020. The liability was measured at fair value and categorized as level 3 as of the acquisition date in accordance with ASC 805-31-25-5 and subsequently at each reporting date thereafter. The fair value of the CSR was estimated as the incremental value that Foamix would be able to achieve on a probability weighted basis assuming three different potential probabilities of the following scenarios: (a) serlopitant significance was achieved in both Phase III PN Trials (b) serlopitant significance was achieved in only one Phase III PN Trial and (c) serlopitant significance was not achieved or was not determined on or before May 31, 2020. On April 6, 2020, the Company announced that each of Menlo’s Phase III PN Trials (study MTI-105 and study MTI-106) did not meet their respective primary endpoint of demonstrating statistically significant reduction in pruritus in patients treated with serlopitant compared to placebo based upon a 4-point improvement responder analysis. Accordingly, on April 6, 2020, pursuant to the terms of the CSR Agreement, each CSR was converted into 1.2082 additional shares of Menlo common stock, resulting in an effective Exchange Ratio in the Merger of 1.8006 shares of Menlo common stock for each Foamix ordinary share. The CSR conversion resulted in the issuance and delivery of 74,544,413 additional shares of Menlo common stock underlying the CSRs. Following the conversion of the CSRs, pre-Merger Foamix shareholders and pre-Merger Menlo stockholders own approximately 82% and 18% of post-Merger Menlo, respectively, each calculated on a fully diluted basis. The conversion of the CSR also affected the Exchange Ratio of the pre-Merger Foamix equity awards and warrants outstanding as of March 9, 2020 and increased the awards available for grant under the Company's equity plan. The contingent consideration associated with the CSR was recognized and measured at fair value as of the acquisition date in accordance with ASC 805-30-25-5. An acquirer's obligation to pay contingent consideration should be classified as a liability or equity in accordance with ASC 480, Distinguishing Liabilities from Equity, ASC 815 Derivatives and Hedging, and other applicable U.S. GAAP. The contingent consideration associated with the CSR was initially measured at fair value and will subsequently be measured at fair value at each reporting date. The CSR was classified as a liability, as it is settled by issuing a variable number of the Company's common stock. On April 6, 2020, the Company recorded $84.7 million of expense in its unaudited condensed consolidated statements of operations and comprehensive loss to remeasure the CSR liability in its consolidated balance sheet to its fair value of $104.4 million (calculated based on 74,544,413 shares issued and a share price of $1.40 on April 6, 2020) and then settled in connection with the issuance of shares. Pro Forma The actual Menlo net loss included in the Company’s consolidated statements of operations and comprehensive income for the three and nine months ended September 30, 2020 (for the period from the March 9, 2020, the Effective Date, through September 30, 2020, which are not indicative of the results to be expected for a full year) and the supplemental unaudited pro forma revenue and net loss of the combined entity had the acquisition been completed on January 1, 2019 are as follows: Actual Menlo results of operations included in the condensed consolidated statement of operation for the three and nine months ended September 30, 2020: (in thousands) Three months ended September 30, 2020 Nine months ended September 30, 2020 (Unaudited) Revenues $ — $ — Loss attributable to Menlo $ 4,100 $ 23,737 Three months ended Nine months ended 2020 2019 2020 2019 (in thousands, except per share data) (Unaudited) (Unaudited) SUPPLEMENTAL PRO FORMA COMBINED RESULTS OF OPERATIONS: Revenues $ 3,269 $ — $ 16,707 $ 308 Net loss $ 24,912 $ 40,016 $ 229,994 $ 109,563 Loss per share - basic and diluted $ 0.15 $ 0.66 $ 1.88 $ 1.82 Adjustments to the supplemental pro forma combined results of operations, included in the above, are as follows: Transaction costs $ — $ — $ (14,931) $ — Acceleration of stock based compensation — — (7,199) — Total Adjustments $ — $ — $ (22,130) $ — These unaudited pro forma condensed consolidated financial results have been prepared for illustrative purposes only and do not purport to be indicative of the results of operations that actually would have resulted had the acquisition occurred on the first day of the earliest period presented, or of future results of the consolidated entities. The unaudited pro forma condensed consolidated financial information does not reflect any operating efficiencies and cost savings that may be realized from the integration of the Merger. |
REVENUE RECOGNITION
REVENUE RECOGNITION | 9 Months Ended |
Sep. 30, 2020 | |
Revenue from Contract with Customer [Abstract] | |
REVENUE RECOGNITION | REVENUE RECOGNITION Product Sales Product revenues for the three and nine months ended September 30, 2020 were primarily generated from sales of AMZEEQ which was commercially launched in the United States in January 2020. ZILXI became available in pharmacies nationwide on October 1, 2020 and therefore the Company did not generate any revenue from sales of ZILXI during the period. The Company’s customers include a limited number of national and select regional distributors. These distributors subsequently resell the product, primarily to retail pharmacies that dispense the product to patients. Net product revenue is typically recognized when distributors obtain control of the Company’s products, which occurs at a point in time, typically upon delivery of product to the distributors. For the three months ended September 30, 2020, three distributors accounted for 41%, 43% and 16% of product revenue, respectively. For the nine months ended September 30, 2020, three distributors accounted for 43%, 41% and 15% of product revenue, respectively. Product Sales Provisions Product revenue is recorded net of distribution fees, trade discounts, allowances, rebates, chargebacks, estimated returns and other incentives, described below. The Company calculates its net product revenue based on the wholesale acquisition cost that the Company charges its distributors less provisions for (i) trade discounts and allowances, such as distributor fees and discounts for prompt payment, (ii) estimated rebates to third-party payers, patient co-pay assistance programs, chargebacks and other discount programs and (iii) reserves for expected product returns. Provisions for distribution fees, trade discounts and chargebacks are reflected as a reduction to trade receivables, net on the condensed consolidated balance sheet. All other provisions, including rebates, other discounts and return provisions are reflected as a liability within accrued expenses on the condensed consolidated balance sheet. Provisions for revenue reserves described below reduced product revenues by $11.0 million and $25.1 million for the three and nine months ended September 30, 2020, respectively. The revenue reserve accrual at September 30, 2020 was $5.6 million reflected in accrued expense in the consolidated balance sheet. Distribution Fees and Trade Discounts and Allowances : The Company pays fees for distribution services and for certain data that distributors provide to the Company and generally provides discounts on sales to its distributors for prompt payment. These fees and discounts are contractual in nature and the Company expects its distributors to earn these fees and discounts, and accordingly deducts the full amount of these fees and discounts from its gross product revenues at the time such revenues are recognized. Rebates, Chargebacks and Other Discounts : Product sales made under managed-care and governmental pricing programs in the U.S. are subject to rebates. Managed Care rebates relate to contractual agreements to sell products to managed care organizations and pharmacy benefit managers at contractual rebate percentages in exchange for volume and/or market share. Chargebacks relate to contractual agreements to sell products to government agencies and other indirect customers at contractual prices that are lower than the list prices the Company charges wholesalers. When these government agencies or other indirect customers purchase products through wholesalers at these reduced prices, the wholesaler charges the Company for the difference between the prices they paid the Company and the prices at which they sold the products to the indirect customers. The Company estimates the rebates and chargebacks it expects to be obligated to provide and deducts these estimated amounts from its gross product revenue at the time the revenue is recognized. The Company estimates the rebates and chargebacks that it expects to be obligated to provide based upon (i) the Company's current contracts and negotiations, (ii) estimates regarding the payer mix based on third-party data and utilization, (iii) inventory held by distributors and (iv) estimates of inventory held at the retail channel. Other discounts include the Company’s co-pay assistance coupon programs for commercially-insured patients meeting certain eligibility requirements. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to pay associated with product that has been recognized as revenue. Product Returns : Consistent with industry practice, customers are generally allowed to return products within a specified period of time before and after its expiration date. The Company estimates the amount of product that will be returned and deducts these estimated amounts from its gross revenue at the time the revenue is recognized. T he information utilized to estimate the returns provision includes: (i) historical industry information regarding rates for comparable pharmaceutical products and product portfolios , (ii) external data with respect to inventory levels in the wholesale distribution channel, (iii) external data with respect to prescription demand for products and (iv) remaining shelf lives of products at the date of sale. The Company estimates that approximately 2% to 3% of product will be returned. License Revenues On April 23, 2020, the Company announced that it entered into a license agreement with Cutia for AMZEEQ as well as certain of the Company's other topical minocycline product candidates, once approved, on an exclusive basis in Greater China. Under the terms of the agreement, Cutia will have an exclusive license to obtain regulatory approval of and commercialize AMZEEQ, ZILXI and, if approved in the U.S., FCD105 in the Greater China territory. The Company will supply the finished licensed products to Cutia for clinical and commercial use. Outside of the license transferred, the Company does not have any additional performance obligations under the arrangement. In exchange for the license, the Company received an upfront cash payment of $10.0 million ($4.0 million received in the three months ended September 30, 2020 and $6.0 million and received in the three months ended June 30, 2020) and will be eligible to receive an additional $1.0 million payment upon the receipt of marketing approval in China of the first licensed product. The license is considered functional IP as the licensee is able to use and benefit from the license without the continued involvement of the Company. The Company recorded $10.0 million of license revenue in the nine months ended September 30, 2020. There was no license revenue in the three months ended September 30, 2020. The Company will also receive royalties on net sales of any licensed products, such royalties will be recognized in the period the sales or usage occurs under the royalties sales-and usage based exception. The Company has not recorded revenue related to the $1.0 million payment due upon receipt of marketing approval for the licensed product as such amount is constrained under the variable consideration guidance under ASC 606, Revenue from Contracts with Customers. Contract Assets and Contract Liabilities The Company did not have any contract assets (unbilled receivables) related to product sales or as of September 30, 2020, as customer invoicing generally occurs before or at the time of revenue recognition. The Company received a $4.0 million payment from Cutia related to its license agreement in the three months ended September 30, 2020. The Company did not have any contract assets (unbilled receivables) related to its license revenues as of September 30, 2020. The Company did not have any contract liabilities as of September 30, 2020, as the Company did not receive payments in advance of fulfilling its performance obligations to its customers. Sales Commissions Sales commissions are generally attributed to periods shorter than one year and therefore are expensed when incurred. Sales commissions are included in selling, general and administrative expenses. Financing Component The Company has elected not to adjust consideration for the effects of a significant financing component when the period between the transfer of a promised good or service to the customer and when the customer pays for that good or service will be one year or less. Standard credit terms do not exceed 90 days. Royalty Revenues The Company is entitled to royalty payments with respect to sales of a product developed by a customer in collaboration with the Company. Revenues in the amount of $0.4 million and $0.6 million were recorded during the three and nine months ending September 30, 2020, respectively, and revenues in the amount of $0.3 million were recorded during the nine months ending September 30, 2019. There was no revenue for the three months ending September 30, 2019. |
FAIR VALUE MEASUREMENT
FAIR VALUE MEASUREMENT | 9 Months Ended |
Sep. 30, 2020 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENT | FAIR VALUE MEASUREMENT The Company’s assets and liabilities that are measured at fair value as of September 30, 2020 and December 31, 2019, are classified in the tables below in one of the three categories described in "Note 2 - Fair value measurement" above: September 30, 2020 (in thousands) Level 1 Level 2 Level 3 Total Marketable securities (1) $ 1,027 $ 2,019 $ — $ 3,046 December 31, 2019 Level 1 Level 2 Level 3 Total Marketable securities (1) $ 1,020 $ 15,660 $ — $ 16,680 (1) The Company’s debt securities are traded in markets that are not considered to be active, but are valued based on quoted market prices, broker or dealer quotations, or alternative pricing sources with reasonable levels of price transparency. Accordingly, these assets are categorized as Level 2. Foreign exchange risk management Occasionally, the Company purchases and writes non-functional currency options in order to hedge the currency exposure on the Company’s cash flow. The currency hedged items are denominated in New Israeli Shekels (“NIS”). The purchasing and writing of options is part of a comprehensive currency hedging strategy with respect to salary and rent expenses denominated in NIS. These transactions are at zero cost for periods of up to one year. The counterparties to the derivatives are major banks in Israel. As of September 30, 2020, there were no hedged amounts. As of September 30, 2020, the Company has a lien in the amount of $0.3 million on the Company’s checking account, in respect of bank guarantees granted in order to secure the hedging transactions. |
MARKETABLE SECURITIES
MARKETABLE SECURITIES | 9 Months Ended |
Sep. 30, 2020 | |
Investments, Debt and Equity Securities [Abstract] | |
MARKETABLE SECURITIES | MARKETABLE SECURITIES Marketable securities as of September 30, 2020 and December 31, 2019 consist mainly of debt and mutual funds securities. The debt securities are classified as available-for-sale and are recorded at fair value. Changes in fair value, net of taxes (if applicable), are reflected in other comprehensive loss. Realized gains and losses on sales of the securities, as well as premium or discount amortization, are included in the consolidated statement of operations as finance income or expenses. Equity securities with readily determinable fair value are measured at fair value. The changes in the fair value of equity investments are recognized through finance (income) expense in the condensed consolidated statements of operations. The following table sets forth the Company’s marketable securities: September 30 December 31 (in thousands) 2020 2019 Israeli mutual funds $ 1,027 $ 1,020 Certificates of deposit — 151 U.S Government — 6,031 U.S Treasury bills — 9,478 Corporate notes 2,019 — Total $ 3,046 $ 16,680 As of September 30, 2020 and December 31, 2019 the fair value, cost and gross unrealized holding gains and losses of the debt marketable securities owned by the Company were as follows: September 30, 2020 (in thousands) Fair Cost or Gross Gross unrealized Corporate notes 2,019 2,019 — — Total $ 2,019 $ 2,019 $ — $ — December 31, 2019 (in thousands) Fair Cost or Gross Gross Certificates of deposit $ 151 $ 151 $ — $ — U.S Government and agency bonds 6,031 6,030 — 1 U.S Treasury bills 9,478 9,475 — 3 Total $ 15,660 $ 15,656 $ — $ 4 The Company has considered factors regarding other than temporary impaired securities and determined that there are no securities with impairment that is other than temporary as of September 30, 2020 and December 31, 2019. As of September 30, 2020 and December 31, 2019, all of the Company’s debt securities were due within one year. During the nine months ended September 30, 2020 and September 30, 2019 the Company received aggregate proceeds of $36.4 million and $45.7 million, respectively, upon sale and maturity of marketable securities. As of September 30, 2020, there were no restricted marketable securities. As of December 31, 2019, the Company’s restricted marketable securities were $0.4 million due to a lien in respect of bank guarantees granted to secure hedging transactions and the Company’s rent agreements. See “Note 5 - Fair Value Measurement” and “Note 10 - Operating Lease” for more information. |
INVENTORY
INVENTORY | 9 Months Ended |
Sep. 30, 2020 | |
Inventory Disclosure [Abstract] | |
INVENTORY | INVENTORY Inventories are stated at the lower of cost and net realizable value with cost determined on a first-in, first-out basis by product. The Company capitalizes inventory costs associated with products following regulatory approval when future commercialization is considered probable and the future economic benefit is expected to be realized. The Company commenced capitalizing inventory for AMZEEQ upon FDA approval of AMZEEQ on October 18, 2019 and ZILXI on May 29, 2020. The Company periodically reviews its inventory levels and, if necessary, writes down inventory that is expected to expire prior to being sold, inventory in excess of expected sales requirements and inventory that fails to meet commercial sale specifications, with a corresponding charge to cost of goods sold. There were no inventory write-downs during the three and nine months ended September 30, 2020. The following table sets forth the Company’s inventory: September 30 December 31 (in thousands) 2020 2019 Raw materials $ 4,293 $ 500 Work-in-process — — Finished goods 2,357 856 Total $ 6,650 $ 1,356 |
LONG-TERM DEBT
LONG-TERM DEBT | 9 Months Ended |
Sep. 30, 2020 | |
Debt Disclosure [Abstract] | |
LONG-TERM DEBT | LONG-TERM DEBTOn July 29, 2019, Foamix entered into a Credit Agreement (the "Credit Agreement") to secure up to $50 million from two lenders, one of which is a significant stockholder of the Company and is considered a related party, and a Securities Purchase Agreement with one of the lenders for gross proceeds of approximately $14 million, before deducting offering expenses (see “Note 9- Share Capital” for more information). On March 9, 2020, the Company entered into an Amended and Restated Credit Agreement and Guaranty (the “Amended and Restated Credit Agreement”), whereby the Company has guaranteed the indebtedness obligations of the borrower and granted a first priority security interest in substantially all of our assets for the benefit of the lenders. As of September 30, 2020 and December 31, 2019, $35.0 million was drawn under the Amended and Restated Credit Agreement. The Company did not, and does not expect to, incur the remaining $15.0 million under the Credit Agreement. The term loans available under the Amended and Restated Credit Agreement are comprised as follows: (a) $15 million that was funded on July 29, 2019 (the “Tranche 1 Loan”), (b) $20 million that was funded on December 17, 2019 (the “Tranche 2 Loan”) and (c) up to $15 million that was available prior to September 30, 2020 (the “Tranche 3 Loan”). The Tranche 2 Loan was borrowed following the FDA’s approval of the Company’s NDA for AMZEEQ and listing of AMZEEQ in the FDA’s “Orange Book,” in addition to maintaining arrangements with a third party for the commercial supply and manufacture of AMZEEQ. The Company did not, and does not expect to, incur the Tranche 3 Loan. Subject to any acceleration as provided in the Amended and Restated Credit Agreement, including upon an event of default (as defined in the Amended and Restated Credit Agreement), the loans will mature on July 29, 2024 and bear interest equal to the sum of (A) 8.25% (subject to increase in accordance with the terms of the Amended and Restated Credit Agreement) plus (B) the greater of (x) the one-month LIBOR as of the second business day immediately preceding the first day of the calendar month or the date of borrowing (if such loan is not outstanding as of the first day of the calendar month), as applicable, and (y) 2.75%. A fee in an amount equal to 1.0% of the aggregate principal amount of all loans made on any given borrowing date shall be payable to the lenders. The Amended and Restated Credit Agreement contains certain financial covenants, including that the Company maintain a minimum aggregate compensating cash balance of $2.5 million. In addition, the parties entered into Amendment No. 1 to Amended and Restated Credit Agreement (the "Amendment") on August 5, 2020. The Amendment provides for a covenant "holiday" with respect to the minimum net revenue covenant such that the compliance with such covenant will commence with the fiscal quarter ending on December 31, 2020, rather than September 30, 2020. Accordingly, as of the last day of each fiscal quarter commencing with the fiscal quarter ending December 31, 2020, the Company must generate consolidated net product revenue for the trailing 12-month period in amounts set forth in the Amendment, which range from $6.0 million for the fiscal quarter ending December 31, 2020 to $97.0 million for the fiscal quarter ending June 30, 2024. As of September 30, 2020, the Company is in compliance with all covenants, including maintaining a minimum aggregate compensating cash balance as mentioned above. In the event where the Company fails to observe or perform any of the financial covenants the lenders may, by notice to the Company, declare the loans then outstanding to be due and payable in whole, together with accrued interest and a Prepayment Premium (as defined in the Amended and Restated Credit Agreement ). Additionally, the Company will continue to monitor ongoing developments in connection with the COVID-19 pandemic, which may have an adverse impact on the Company’s commercial prospects, projected cash position and ability to remain in compliance with these covenants. Under the Amended and Restated Credit Agreement, there are no required payments of principal amounts until July 2023. Afterwards, the Company will pay 1.5% of the aggregate principal amount each month. The outstanding amount will be paid in full in July 2024. In addition, on July 29, 2019, the lenders under the Credit Agreement were issued warrants to purchase up to an aggregate of 1,100,000 of Foamix ordinary shares, at an exercise price of $2.09 per share (the “Warrants”), which represented the five-day volume weighted average price of the Foamix ordinary shares as of the trading day immediately prior to the issuance of the Warrants. In connection with the completion of the Merger, the exchange ratio was applied to the Warrants such that they became exercisable for 651,640 shares of the Company’s common stock, and the exercise price was adjusted to $3.53. Following the Phase 3 PN Trial results, the Warrants were further adjusted and they are currently exercisable for 1,980,660 shares of our common stock with an exercise price of $1.1607 per share. Payment of the exercise price will be made, at the option of the holder, either in cash or as a reduction of common stock issuable upon exercise of the Warrant, with an aggregate fair value equal to the aggregate exercise price ("cashless exercise"), or any combination of the foregoing. The Warrants are exercisable pursuant to the terms, and subject to the conditions, thereof and expire on July 29, 2026. Any Warrants left outstanding will be cashless exercised on the Warrants' expiration date, if in the money. The Warrants issued were classified as equity in accordance with ASC 815-40. Proceeds received under the Tranche 1 Loan were allocated to the Warrants and the Tranche 1 Loan on a relative fair value basis. The Company incurred offering expenses of $1.1 million in connection with transactions contemplated by the Credit Agreement and the Securities Purchase Agreement, which were allocated to the Warrants, shares and debt consistently with the allocation of proceeds. The Company incurred additional expenses in the amount of $0.3 million from the borrowing of Tranche 2 Loan, allocated only to the debt. Debt issuance costs are recorded on the consolidated balance sheet as a reduction of liabilities. Amounts allocated to the debt, net of issuance cost, are subsequently recognized at amortized cost using the effective interest method. The fair value of the debt as of September 30, 2020 was $36.3 million and is categorized as Level 3. The valuation was performed by applying the income approach, under which the contractual present value method was used. The estimation of risk adjusted discount curve was based on public information reported in the financial statements of publicly traded venture lending companies. During the three months ended September 30, 2020, the Company recorded interest expense of $1.0 million and $0.1 million relating to the interest and discount cost. During the nine months ended September 30, 2020, the Company recorded interest expense of $2.9 million and $0.3 million relating to the interest and discount cost. |
SHARE CAPITAL
SHARE CAPITAL | 9 Months Ended |
Sep. 30, 2020 | |
Stockholders' Equity Note [Abstract] | |
SHARE CAPITAL | SHARE CAPITAL Preferred stock As of September 30, 2020, the Company's Certificate of Incorporation, as amended, authorizes the Company to issue 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 September 30, 2020 and December 31, 2019. 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. Common stock As of September 30, 2020, the Company’s Certificate of Incorporation, as amended, authorizes the Company to issue 300,000,000 shares of common stock, par value $0.0001 per share. In connection with the corporate name change, we changed our ticker symbol from "MNLO" to "VYNE" on September 8, 2020. At the Company's annual meeting of stockholders held on August 3, 2020, the Company's stockholders voted to approve a proposal to adopt an amendment to the Company’s Amended and Restated Certificate of Incorporation to effect (a) a reverse stock split of the Company’s outstanding shares of common stock, at a reverse stock split ratio ranging from 1-for-2 shares to 1-for-7 shares, which may be determined by the Board at a later date, and (b) a reduction in the number of authorized shares of the Company’s common stock by a corresponding ratio. The exact timing for selection of the reverse stock split ratio and the effective date of the reverse stock split will be determined by the Board based upon its evaluation as to when such action will be most advantageous to the Company and its stockholders. The Board may delay or abandon the reverse stock split at any time prior to the effective time of the reverse stock split, if the Board determines that the reverse stock split is no longer in the best interests of the Company or its stockholders. The reverse stock split, if implemented, would become effective upon the filing of a Certificate of Amendment with the Delaware Secretary of State. 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 July 29, 2019, pursuant to the Credit Agreement and Securities Purchase Agreement, Foamix issued and sold, in a registered offering, an aggregate of 6,542,057 ordinary shares at a purchase price of $2.14 per share, later exchanged to 3,875,514 Menlo common stock at the closing of the Merger. The aggregate gross proceeds of approximately $14 million, before deducting issuance costs allocated as described in Note 8-Long Term Debt, in the amount of $0.3 million. Pursuant to the completion of the merger, on March 9, 2020, the Company issued 36,550,335 shares to Foamix shareholders. On April 6, 2020, pursuant to the terms of the CSR Agreement, the Company issued 74,544,413 shares to Foamix shareholders. On June 9, 2020, the Company completed an underwritten public offering of 31,107,500 shares of common stock at a price to the public of $1.85 per share. The net proceeds of the offering were approximately $53.6 million, after deducting underwriting discounts and commissions and other offering expenses. Warrants In connection with entering into the Credit Agreement on July 29, 2019, Foamix issued to the lenders Warrants to purchase up to an aggregate of 1,100,000 of its ordinary shares, later exchanged to Warrants to purchase up to 1,980,660 shares of Menlo’s common stock. Upon the closing of the Merger, each Warrant received one CSR as described in Note 3- Business Combinations. The Warrants may be exercised by the holders pursuant to the terms thereof and any Warrants left outstanding will be cashless exercised on the Warrants’ expiration date, subject to certain conditions. The exchange of Warrants from Foamix warrants to Menlo warrants and the additional CSR was accounted for as a modification, by analogy, from the modification’s guidance under ASC 260-10-S99-2. The Company assessed the significance of the modification of the Warrants by comparing the fair value of the Warrants immediately before and after the amendments. In its assessment, it also considered additional qualitative factors. The Company concluded that the change of terms was not significant. Therefore, the incremental fair value, in the amount of $41,000, of the modified Warrants over the original ones (as of modification date) was recognized in retained earnings as a deemed dividend to the Warrants holders in the nine months ended September 30, 2020. Share-based compensation Equity incentive plans: Upon closing of the Merger, the Company adopted Foamix’s 2019 Equity incentive plan (the “2019 Plan”). As of September 30, 2020, 2,650,213 shares remain issuable under the 2019 Plan. In addition, the Company adopted the 2018 Omnibus Incentive Plan (the "2018 Plan") in January 2018. In January 2020, the number of shares reserved under the 2018 Plan automatically increased by 976,105 shares of common stock pursuant to the terms thereof. As of September 30, 2020, 2,237,869 shares remain issuable under the 2018 Plan. Employee Share Purchase Plan: Upon closing of the Merger, the Company adopted Foamix’s 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 September 30, 2020, 9,371,258 shares remain available for grant under the ESPP. During the nine months ended September 30, 2020, 61,031 Foamix ordinary shares were purchased by Foamix employees pursuant to the ESPP prior to the Merger. Such shares were later exchanged for 109,892 shares of the Company's common stock in the Merger. Options and RSUs granted to employees and directors: In the nine months ended September 30, 2020 and 2019, the Company granted options and RSU as follows: Nine months ended September 30, 2020 Award Exercise price Vesting period Expiration Employees and Directors: Options 5,266,548 $1.46-$3.13 1 year -4 years 10 years RSUs 2,589,710 — 1 year -4 years — Nine months ended September 30, 2019 Award Exercise price Vesting period Expiration Employees and Directors: Options 2,570,889 $1.31-$2.12 1 year -4 years 10 years RSUs 766,343 — 1 year -4 years — * All amounts and exercise prices for pre-Merger grants are presented following the exchange to Menlo options and RSUs at the Exchange Ratio described in Note 3-Business Combination. The fair value of options and RSUs granted to employees and directors during the nine months ended September 30, 2020, and the nine months ended September 30, 2019 was $11.8 million and $4.0 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: Nine months ended 2020 2019 Dividend yield 0 % 0 % Expected volatility 60.44%-69.83% 59.35%-61.40% Risk-free interest rate 0.31%-1.26% 1.42%-2.62% Expected term 6 years 6 years Pursuant to the Merger, all outstanding options and RSUs granted by Foamix were exchanged for stock options and RSUs of Menlo’s common stock according to the Exchange Ratio. In addition, for each option and RSU the holder received a CSR as described in Note 3- Business Combination. This transaction was considered by the company to be a modification under ASC 718, Compensation - Stock Compensation. The modification did not affect the remaining requisite service period. As a result of the modification, for outstanding options and RSUs granted to Foamix employees and consultants, the Company recorded incremental compensation expense of $60,000 related to the modification in the consolidated statement of operations for the three months ended March 31, 2020. As described in Note 3 - Business Combination, on April 6, 2020, pursuant to the terms of the CSR Agreement, each CSR was converted into 1.2082 shares of Menlo common stock, resulting in an effective Exchange Ratio in the Merger of 1.8006 shares of Menlo common stock for each Foamix ordinary share. The conversion was considered by the company to be a modification under ASC 718. As a result of the modification, for outstanding options and RSUs granted to Foamix employees and consultants, the Company recorded incremental compensation of $1.1 million and $10.4 million for the three and nine months ended September 30, 2020. As of September 30, 2020 there is $4.9 million of unrecognized incremental compensation expense related to the modification which will primarily be amortized using a graded vesting method over the next 2 years. Awards granted to holders who are no longer employed or providing services to the Company are accounted for in accordance with ASC 815-40, Derivatives and Hedging. Under this guidance, the awards are classified as a derivative liability because the award no longer exchanges a fixed amount of cash for a fixed number of shares. Accordingly, as of March 9, 2020 the Company reclassified $1.6 million from additional paid-in capital to derivative liability on the unaudited condensed consolidated balance sheet. Prior to the reclassification of these awards as a liability instrument, the Company recorded an incremental compensation expense of $0.6 million due to the above mentioned modification in accordance with ASC 718. Subsequent to the reclassification of these awards as a liability instrument, the Company recorded incremental compensation expense of $1.0 million for the nine months ended September 30, 2020. There was no incremental compensation expense for the three months ended September 30, 2020. As described in Note 3 - Business Combination, on April 6, 2020, the Company announced that study MTI-105 and study MTI-106 did not meet their respective primary endpoint of demonstrating statistically significant reduction in pruritus in patients treated with serlopitant compared to placebo based upon a 4-point improvement responder analysis. Accordingly, on April 6, 2020, pursuant to the terms of the CSR Agreement, each CSR was converted into 1.2082 shares of Menlo common stock, resulting in an effective Exchange Ratio in the Merger of 1.8006 shares of Menlo common stock for each Foamix ordinary share. On April 6, 2020, the awards are exchangeable for a fixed amount of cash for a fixed number of shares and were remeasured to fair value and reclassified from derivative liability to additional paid-in capital. Prior to the Merger, Menlo recognized all expenses relating to awards outstanding as of the Effective Date. These awards were subject to acceleration upon the change of control per the previous Menlo stock option plan. The following table illustrates the effect of share-based compensation on the statements of operations: Three months ended September 30 Nine months ended September 30 (in thousands) 2020 2019 2020 2019 Research and development expenses $ 361 $ 389 $ 3,927 $ 1,127 Selling, general and administrative 2,259 880 11,220 2,479 Total $ 2,620 $ 1,269 $ 15,147 $ 3,606 |
OPERATING LEASE
OPERATING LEASE | 9 Months Ended |
Sep. 30, 2020 | |
Leases [Abstract] | |
OPERATING LEASE | OPERATING LEASE Operating lease agreements The Company has operating leases for corporate offices, research and development facilities, and vehicles. The properties primarily relate to the Company’s principal executive office in Bridgewater, New Jersey, corporate offices in Redwood City, California and research and development facility 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 Amendment”). The 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 Amendment is due to expire on August 31, 2022. Pursuant to The Amendment of the lease on the Current Space, 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 Company’s corporate offices in Redwood City, California are under lease through December 31, 2020 with a base rent of approximately $60,000 per month. Given the short-term nature of the remaining lease period, the combined company did not recognize a right-of-use asset and liability and expects to recognize the lease payments in its statements of operations and comprehensive loss on a straight-line basis over the remaining lease term. The lease agreement for the research and development facility in Israel is linked to the Israeli consumer price index (“CPI”) and due to expire in December 2020. Additionally, the Company has entered into operating lease agreements in connection with the leasing of vehicles. The lease periods are generally for three-year terms. To secure the terms of certain of the vehicle lease agreements, the Company has made prepayments to the leasing company, representing approximately 3 months of lease payments. These amounts have been recorded as part of the operating lease right-of-use assets. Maturities of lease liabilities are as follows: (in thousands) 2020 $ 423 2021 1,002 2022 777 2023 94 Total lease payments 2,296 Less imputed interest 106 Total lease liability $ 2,190 As of September 30, 2020, the Company has a lien in the amount of $0.6 million on the Company’s cash and marketable securities in respect of bank guarantees granted in order to secure the lease agreements. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 9 Months Ended |
Sep. 30, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIES The Company may periodically become subject to legal proceedings and claims arising in connection with its business. As of September 30, 2020, no claims or actions pending against the Company that, in the opinion of management, are likely to have a material adverse effect on the Company. IPO Lawsuits On November 8, 2018 and January 28, 2019, two purported class actions were filed in the Superior Court of California, San Mateo County, against the Company and certain of our officers and directors. The actions were entitled Silvestrov v. Menlo Therapeutics Inc., et al., and McKay v. Menlo Therapeutics Inc., et al. The underwriters for our initial public offering were also named as defendants in these lawsuits. The complaints contained identical allegations against the same defendants. Both complaints alleged that the Registration Statement and prospectus for Menlo's initial public offering contained false and misleading statements in violation of Sections 11, 12(a)(2) and 15 of the Securities Act of 1933 due to allegedly false and misleading statements in connection with Menlo's initial public offering. The complaints sought, among other things, an award of damages in an amount to be proven at trial, along with reimbursement of reasonable costs and expenses, including attorneys’ fees and expert fees. The McKay action was consolidated with the Silvestrov action and the claim for violations of Section 12(a)(2) was dismissed. The parties mediated the consolidated lawsuit and reached a settlement, providing for payment to the class of plaintiffs in the amount of $9.5 million, the vast majority of which was paid by the Company's insurance carriers, in return for a release of all claims against the defendants, including the Company and its current and former officers and directors. The Court granted final approval of the settlement at a hearing on August 14, 2020. Accordingly, the Company considers the matter concluded. Menlo accrued for the remaining settlement amount that is not covered by insurance carriers as of December 31, 2019, which did not have a material impact on its financial statements. Merger Lawsuits Seven lawsuits (collectively, the “Merger Lawsuits”) were filed in various U.S. federal district courts against Foamix and certain other defendants in connection with the Merger. The lawsuits generally alleged that the registration statement on Form S-4 and the prospectus/joint proxy statement included therein included false or misleading information regarding the Merger in violations of Section 14(a) and Section 20(a) of the Exchange Act and/or Rule 14a 9 promulgated under the Exchange Act. In addition, one of the lawsuits alleged that the members of Foamix’s board of directors breached their fiduciary duties in connection with the Merger. The plaintiffs sought, among other things, to enjoin consummation of the Merger, or alternatively rescission or rescissory damages; to compel the individual defendants to disseminate a joint proxy statement/prospectus that does not contain any untrue statements of material fact and that states all material facts required in it or necessary to make the statements contained therein not misleading; a declaration that defendants violated Sections 14(a) and/or 20(a) of the Exchange Act; a declaration that the Merger Agreement was entered into in breach of fiduciary duty and is therefore invalid and unenforceable; an order directing the individual defendants to commence a sale process for Foamix and obtain a transaction; and an award of costs, including attorneys’ and experts’ fees and expenses, as well as an accounting of damages allegedly suffered by the plaintiffs. The plaintiffs have agreed the Lawsuits were rendered moot by subsequent disclosure, and on April 22, 2020, each of the plaintiffs and defendants named in the Merger Lawsuits entered into a mootness resolution agreement pursuant to which the plaintiffs agreed to dismiss their lawsuits with prejudice as to the named plaintiff and Foamix agreed to pay a de minimis |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Sep. 30, 2020 | |
Accounting Policies [Abstract] | |
Reverse Merger | Reverse Merger On November 10, 2019, Menlo, Foamix Pharmaceuticals Ltd. (“Foamix”) and Giants Merger Subsidiary Ltd. (“Merger Sub”), a wholly-owned subsidiary of Menlo, entered into an Agreement and Plan of Merger (as amended by Amendment No. 1 to the Agreement and Plan of Merger, dated as of December 4, 2019, the “Merger Agreement”). Pursuant to the terms of the Merger Agreement, Merger Sub merged with and into Foamix, with Foamix surviving as a wholly-owned subsidiary of Menlo (the “Merger”) on March 9, 2020 (the “Effective Date”). For accounting purposes, the Merger is treated as a “reverse acquisition” under generally accepted accounting principles in the United States (“U.S. GAAP”) and Foamix is considered the accounting acquirer. Accordingly, upon consummation of the Merger, the historical financial statements of Foamix became the Company’s historical financial statements, and the historical financial statements of Foamix are included in the comparative prior periods. See “Note 3 – Business Combination” for more information on the Merger. |
Liquidity and Capital Resources | Liquidity and Capital Resources The Company launched AMZEEQ in the United States in January 2020 and commenced generating product revenues in the first quarter of 2020. The Company’s activities prior to the commercial launch of AMZEEQ had primarily consisted of developing product candidates, raising capital and performing research and development activities. Since inception, the Company has incurred losses and negative cash flows from operations. For the nine months ended September 30, 2020, the Company incurred a net loss of $232.4 million and used $111.7 million of cash in operations. As of September 30, 2020, the Company had cash, cash equivalents and investments of $76.9 million and an accumulated deficit of $543.0 million. If the Company does not successfully commercialize AMZEEQ, ZILXI or any of its future product candidates, it may be unable to achieve profitability. Accordingly, the Company may be required to obtain further funding through public or private debt or equity offerings, or other arrangements. Adequate additional funding may not be available to the Company on acceptable terms, or at all. If the Company is unable to raise capital when needed or on acceptable terms, it may be forced to delay, reduce or eliminate its research and development programs or commercialization and manufacturing efforts. Prior to the Merger, the Company was focused on the development and commercialization of serlopitant. Following the receipt of the results of the Phase 3 clinical trials evaluating serlopitant for the treatment of PN and the impact of the COVID-19 pandemic, the Company revised its operating plan to focus on the commercialization of AMZEEQ, ZILXI and its current product candidates. The Company does not currently intend to further pursue the development of serlopitant. In addition, the revised operating plan reflects prudent resource prioritization and allocation management, including the rationalization of research and development spend to focus on existing product candidates. The Company believes that its existing cash, cash equivalents and investments as of September 30, 2020 and projected cash flows from revenues will provide sufficient resources to fund its current ongoing needs through December 31, 2021. However, the Company may seek additional financing in order to achieve its longer-term strategic plans. |
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 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 consolidated financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. These unaudited interim condensed consolidated financial statements should be read in conjunction with Foamix’s audited consolidated financial statements for the year ended December 31, 2019, included in the Company’s Current Report on Form 8-K/A filed with the Securities and Exchange Commission ("SEC") on May 7, 2020, and the Company's unaudited consolidated financial statements included in the Company's Quarterly Reports on Form 10-Q for the quarters ended March 31, 2020 and June 30, 2020, filed with the SEC on May 11, 2020 and August 6, 2020, respectively. The results for the three and nine months ended September 30, 2020 are not necessarily indicative of the results expected for the year ending December 31, 2020. |
Principles of Consolidation | Principles of ConsolidationThe 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 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 condensed consolidated financial statements and reported amounts of income and expenses during the reporting periods. Significant items subject to such estimates and assumptions include accounting for business combinations, impairments of goodwill and intangible assets and revenue recognition. Actual results could differ from the Company’s estimates. The extent to which the COVID-19 pandemic impacts the Company’s business and financial results will depend on numerous evolving factors including, but not limited to: the magnitude and duration of the pandemic; the extent to which patients and our sales representatives are able to access healthcare provider offices; the impact on worldwide macroeconomic conditions, including interest rates, employment rates and health insurance coverage; the speed of the anticipated recovery; and governmental and business reactions to the pandemic. While the Company’s product sales for AMZEEQ have experienced a modest recovery during the three months ended September 30, 2020, our sales of AMZEEQ were negatively impacted by office closures due to the pandemic during the six months ended June 30, 2020. No assurance can be given that such office closures will not occur again in future periods, and if such closures do occur, or any other circumstance arises such that patients or our sales representatives are restricted in their ability to connect with healthcare providers, our product sales would be negatively impacted. 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 September 30, 2020 and through the date of this report. The accounting matters assessed included, but were not limited to, the Company’s allowance for doubtful accounts and credit losses, inventory and related reserves, impairments of long-lived assets and revenue recognition. The Company recorded impairments of goodwill and certain indefinite-lived intangible assets; however, these were unrelated to the impact of COVID-19 (See "Note 3 - Business Combination" for more information). The Company’s future assessment of the magnitude and duration of COVID-19, as well as other factors, could result in material impacts to the Company’s consolidated financial statements in future reporting periods. |
Business Acquisition | Business Acquisition The Company’s unaudited interim condensed consolidated financial statements include the operations of an acquired business after the completion of the acquisition. The Company accounts for acquired businesses using the acquisition method of accounting, which requires, among other things, that most assets acquired and liabilities assumed be recognized at their estimated fair values as of the acquisition date and that the fair value of In-Process Research and Development and Goodwill be recorded on the balance sheet. Transaction costs are expensed as incurred. Amounts recorded in connection with an acquisition can result from a complex series of judgments about future events and uncertainties and can rely heavily on estimates and assumptions. The Company is required to measure certain assets and liabilities at fair value, either upon initial recognition or for subsequent accounting or reporting. For example, the Company uses fair value in the initial recognition of net assets acquired in a business combination and when measuring impairment losses. The Company estimates fair value using an exit price approach, which requires, among other things, that Company determine the price that would be received to sell an asset or paid to transfer a liability in an orderly market. The determination of an exit price is considered from the perspective of market participants, considering the highest and best use of non-financial assets and, for liabilities, assuming that the risk of non-performance will be the same before and after the transfer. When estimating fair value, depending on the nature and complexity of the asset or liability, the Company may use one or all of the following techniques: • Income approach, which is based on the present value of a future stream of net cash flows. • Market approach, which is based on market prices and other information from market transactions involving identical or comparable assets or liabilities. • Cost approach, which is based on the cost to acquire or construct comparable assets, less an allowance for functional and/or economic obsolescence. Our fair value methodologies depend on the following types of inputs: • Quoted prices for identical assets or liabilities in active markets (Level 1 inputs). • Quoted prices for similar assets or liabilities in active markets, or quoted prices for identical or similar assets or liabilities in markets that are not active, or inputs other than quoted prices that are directly or indirectly observable, or inputs that are derived principally from, or corroborated by, observable market data by correlation or other means (Level 2 inputs). • Unobservable inputs that reflect estimates and assumptions (Level 3 inputs). A single estimate of fair value can result from a complex series of judgments about future events and uncertainties and can rely heavily on estimates and assumptions. Asset Impairment The Company reviews all of its long-lived assets for impairment indicators throughout the year. Impairment testing is performed for indefinite-lived intangible assets annually (or sooner if warranted) and for all other long-lived assets whenever impairment indicators are present. When necessary, the Company records charges for impairments of long-lived assets for the amount by which the fair value is less than the carrying value of these assets. |
Revenue Recognition | Revenue Recognition The Company accounts for its revenue transactions under FASB 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 include a limited number of national and select regional wholesalers (the “distributors”). These distributors subsequently resell the product, primarily to retail pharmacies that dispense the product to patients. Net product revenue is typically recognized when distributors obtain control of the Company’s products, which occurs at a point in time, typically upon delivery of product to the distributors. The Company evaluates the creditworthiness of each of its distributors to determine whether it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur. The Company does not assess whether a contract has a significant financing component if the expectation is such that the period between the transfer of the promised goods to the customer and the receipt of payment will be less than one year. Standard credit terms do not exceed 90 days. The Company expenses 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 are included in selling, general and administrative expenses. The Company’s net product revenues through September 30, 2020 were primarily 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. 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. See “Note 4 – Revenue Recognition” for more information. |
Allowance for credit losses | Allowance for credit lossesAn 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 and nine months ended September 30, 2020. |
Derivative instruments | Derivative instrumentsThe Company recognizes all derivative instruments as either assets or liabilities in the unaudited condensed consolidated balance sheet at their respective fair values. All gains and losses associated with derivatives are reported as a finance expense (income) in the accompanying condensed consolidated statements of operations. As of September 30, 2020, the Company had no derivative instruments. |
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. |
Loss per share | Loss per share The calculation of the weighted-average number of common stock outstanding during the period in which the reverse merger occurs was based on: a. The number of common stock outstanding from the beginning of that period to the merge date was computed on the basis of the weighted-average number of common stock of the legal acquiree (accounting acquirer) outstanding during the period multiplied by the exchange ratio established in the merger agreement b. The number of common outstanding common stock outstanding from the merge date to the end of that period was the actual number of common stock of the legal acquirer (the accounting acquiree) outstanding during that period. The basic and diluted loss per share for each comparative period before the acquisition date presented in the consolidated financial statements following the reverse merger was calculated by dividing (a) by (b): a. The loss of the legal acquiree attributable to common stockholders in each of those periods. b. The legal acquiree's historical weighted-average number of common stock outstanding multiplied by the exchange ratio established in the merge agreement Net loss per share, basic and diluted, is computed on the basis of the net loss for the period divided by the weighted average number of Ordinary 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 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 Nine months ended 2020 2019 2020 2019 Outstanding stock options, RSUs and shares under the ESPP 20,765,196 11,488,993 15,024,198 10,903,631 Warrants 1,980,660 1,371,225 1,510,168 457,075 In addition to the above, the CSR was excluded from the calculation of the diluted net loss per share because its effect would have been anti-dilutive for the periods presented. On April 6, 2020, the Company announced that each of Menlo’s Phase III PN Trials (study MTI-105 and study MTI-106) did not meet their respective primary endpoint of demonstrating statistically significant reduction in pruritus in patients treated with serlopitant compared to placebo based upon a 4-point improvement responder analysis. Each CSR was converted into 1.2082 shares of Menlo common stock, resulting in an effective exchange ratio (the "Exchange Ratio") in the Merger of 1.8006 shares of Menlo common stock for each Foamix ordinary share. The conversion of the CSR also affected the Exchange Ratio of the pre-Merger Foamix equity awards and warrants outstanding as of March 9, 2020. See "Note 3 - Business Combination" for more information. |
Newly issued and recently adopted accounting pronouncements | Newly issued and recently adopted accounting pronouncements Recent Accounting Guidance Issued: In March 2020, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update No. 2020-4, "Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting" (ASU 2020-4), 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 2020-4 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 2020-4 are optional and are effective from March 12, 2020 through December 31, 2022. The Company is currently evaluating the impact of ASU 2020-4 on its consolidated financial statements. In June 2016, the FASB issued Accounting Standards Update 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 Accounting Standard Updates 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. |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Accounting Policies [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The following 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 Nine months ended 2020 2019 2020 2019 Outstanding stock options, RSUs and shares under the ESPP 20,765,196 11,488,993 15,024,198 10,903,631 Warrants 1,980,660 1,371,225 1,510,168 457,075 |
BUSINESS COMBINATION (Tables)
BUSINESS COMBINATION (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Business Combinations [Abstract] | |
Schedule of Merger Consideration to be transferred | The following is the Merger Consideration (as defined in the Merger Agreement) was transferred to effect the Merger: (in thousands) Total Deemed (for accounting purposes only) issuance of Foamix shares to Menlo stockholders $ 123,757 Deemed (for accounting purposes only) conversion of Menlo equity awards 7,322 Total consideration* $ 131,079 * This amount reflects total consideration prior to reduction in respect of the CSRs (which had a fair value of $19.6 million as of the Merger Date) that were issued to Foamix shareholders and that reduced the Menlo stockholders’ relative ownership in the combined company. If the effect of the CSRs is included, the total consideration deemed paid by Foamix, as the accounting acquirer, to Menlo stockholders and equity award holders in the Merger would be reduced to approximately $111.4 million, as shown in the purchase price allocation table below. |
Schedule of allocation of the purchase price to the fair values of assets acquired and liabilities assumed | The Company completed its analysis of the allocation of the purchase price to the fair values of assets acquired and liabilities assumed as follows: (in thousands) March 9, 2020 Cash and cash equivalents $ 38,641 Investment in marketable securities 22,703 Prepaid expenses and other current assets 1,581 In-process research and development 50,300 Goodwill 4,045 Total assets 117,270 Current liabilities (5,827) Total liabilities (5,827) Estimated purchase price* $ 111,443 * Reflects reduction in the purchase price deemed paid to Menlo stockholders in the Merger on the assumption that the CSRs, in an aggregate value of $19.6 million, convert into additional shares of the combined company for the Foamix shareholders, thereby resulting in a lower percentage of the combined company’s outstanding shares being owned by Menlo stockholders following the Merger. |
Schedule of the calculation of goodwill from the merger | The purchase price of the transaction and the excess purchase price over the fair value of the identifiable net assets acquired, are calculated as follows: (in thousands) March 9, 2020 Purchase price $ 111,443 Less: fair value of net assets acquired, including other identifiable intangibles (107,398) Goodwill $ 4,045 |
Schedule of indefinite-lived intangible IPRD assets acquired in the merger | The IPR&D recognized relates to Menlo’s once - daily oral serlopitant for the treatment of pruritus (itch) associated with PN that has not reached technological feasibility as follows: (in thousands) Intangible asset Estimated Fair Value Acquired indefinite life intangible assets* $ 50,300 Fair value of identified intangible assets $ 50,300 |
Schedule of pro forma | Actual Menlo results of operations included in the condensed consolidated statement of operation for the three and nine months ended September 30, 2020: (in thousands) Three months ended September 30, 2020 Nine months ended September 30, 2020 (Unaudited) Revenues $ — $ — Loss attributable to Menlo $ 4,100 $ 23,737 Three months ended Nine months ended 2020 2019 2020 2019 (in thousands, except per share data) (Unaudited) (Unaudited) SUPPLEMENTAL PRO FORMA COMBINED RESULTS OF OPERATIONS: Revenues $ 3,269 $ — $ 16,707 $ 308 Net loss $ 24,912 $ 40,016 $ 229,994 $ 109,563 Loss per share - basic and diluted $ 0.15 $ 0.66 $ 1.88 $ 1.82 Adjustments to the supplemental pro forma combined results of operations, included in the above, are as follows: Transaction costs $ — $ — $ (14,931) $ — Acceleration of stock based compensation — — (7,199) — Total Adjustments $ — $ — $ (22,130) $ — |
FAIR VALUE MEASUREMENT (Tables)
FAIR VALUE MEASUREMENT (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements, Recurring and Nonrecurring | The Company’s assets and liabilities that are measured at fair value as of September 30, 2020 and December 31, 2019, are classified in the tables below in one of the three categories described in "Note 2 - Fair value measurement" above: September 30, 2020 (in thousands) Level 1 Level 2 Level 3 Total Marketable securities (1) $ 1,027 $ 2,019 $ — $ 3,046 December 31, 2019 Level 1 Level 2 Level 3 Total Marketable securities (1) $ 1,020 $ 15,660 $ — $ 16,680 (1) The Company’s debt securities are traded in markets that are not considered to be active, but are valued based on quoted market prices, broker or dealer quotations, or alternative pricing sources with reasonable levels of price transparency. Accordingly, these assets are categorized as Level 2. |
MARKETABLE SECURITIES (Tables)
MARKETABLE SECURITIES (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | The following table sets forth the Company’s marketable securities: September 30 December 31 (in thousands) 2020 2019 Israeli mutual funds $ 1,027 $ 1,020 Certificates of deposit — 151 U.S Government — 6,031 U.S Treasury bills — 9,478 Corporate notes 2,019 — Total $ 3,046 $ 16,680 |
Gain (Loss) on Securities | As of September 30, 2020 and December 31, 2019 the fair value, cost and gross unrealized holding gains and losses of the debt marketable securities owned by the Company were as follows: September 30, 2020 (in thousands) Fair Cost or Gross Gross unrealized Corporate notes 2,019 2,019 — — Total $ 2,019 $ 2,019 $ — $ — December 31, 2019 (in thousands) Fair Cost or Gross Gross Certificates of deposit $ 151 $ 151 $ — $ — U.S Government and agency bonds 6,031 6,030 — 1 U.S Treasury bills 9,478 9,475 — 3 Total $ 15,660 $ 15,656 $ — $ 4 |
INVENTORY (Tables)
INVENTORY (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Inventory Disclosure [Abstract] | |
Schedule of inventories | The following table sets forth the Company’s inventory: September 30 December 31 (in thousands) 2020 2019 Raw materials $ 4,293 $ 500 Work-in-process — — Finished goods 2,357 856 Total $ 6,650 $ 1,356 |
SHARE CAPITAL (Tables)
SHARE CAPITAL (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Stockholders' Equity Note [Abstract] | |
Schedule of share-based compensation awards granted for options and RSUs during the period | In the nine months ended September 30, 2020 and 2019, the Company granted options and RSU as follows: Nine months ended September 30, 2020 Award Exercise price Vesting period Expiration Employees and Directors: Options 5,266,548 $1.46-$3.13 1 year -4 years 10 years RSUs 2,589,710 — 1 year -4 years — Nine months ended September 30, 2019 Award Exercise price Vesting period Expiration Employees and Directors: Options 2,570,889 $1.31-$2.12 1 year -4 years 10 years RSUs 766,343 — 1 year -4 years — * All amounts and exercise prices for pre-Merger grants are presented following the exchange to Menlo options and RSUs at the Exchange Ratio described in Note 3-Business Combination. |
Summary of underlying data used for computing the fair value of the options | 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: Nine months ended 2020 2019 Dividend yield 0 % 0 % Expected volatility 60.44%-69.83% 59.35%-61.40% Risk-free interest rate 0.31%-1.26% 1.42%-2.62% Expected term 6 years 6 years |
Share-based Payment Arrangement, Expensed and Capitalized, Amount | The following table illustrates the effect of share-based compensation on the statements of operations: Three months ended September 30 Nine months ended September 30 (in thousands) 2020 2019 2020 2019 Research and development expenses $ 361 $ 389 $ 3,927 $ 1,127 Selling, general and administrative 2,259 880 11,220 2,479 Total $ 2,620 $ 1,269 $ 15,147 $ 3,606 |
OPERATING LEASE (Tables)
OPERATING LEASE (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Leases [Abstract] | |
Lessee, Operating Lease, Liability, Maturity | Maturities of lease liabilities are as follows: (in thousands) 2020 $ 423 2021 1,002 2022 777 2023 94 Total lease payments 2,296 Less imputed interest 106 Total lease liability $ 2,190 |
NATURE OF OPERATIONS (Details)
NATURE OF OPERATIONS (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2020USD ($)segment | Sep. 30, 2019USD ($) | Dec. 31, 2019USD ($) | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||||
Number of segments | segment | 1 | ||||
Net loss | $ 24,714 | $ 23,161 | $ 232,387 | $ 57,358 | |
Cash used in operations | (111,707) | $ (51,148) | |||
Cash and investments | 76,900 | 76,900 | |||
Accumulated deficit | $ (543,015) | $ (543,015) | $ (310,587) |
SIGNIFICANT ACCOUNTING POLICI_4
SIGNIFICANT ACCOUNTING POLICIES (Details) $ in Millions | Apr. 23, 2020USD ($) | Sep. 30, 2020USD ($)derivativeInstruments | Jun. 30, 2020USD ($) | Apr. 06, 2020 |
Loss per share | ||||
Number of derivative instruments held | derivativeInstruments | 0 | |||
Number of common stock shares issued per CSR (in shares) | 1.2082 | |||
Effective exchange ratio of Foamix ordinary shares into Menlo common stock (share/share) | 1.8006 | |||
Foamix | ||||
Loss per share | ||||
Proceeds from royalties | $ 10 | $ 4 | $ 6 | |
Additional royalty upon receipt of marketing approval in China | $ 1 |
SIGNIFICANT ACCOUNTING POLICI_5
SIGNIFICANT ACCOUNTING POLICIES - Schedule of AntiDilutive Equity Awards Not Included in the Calculation of EPS (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Outstanding stock options, RSUs and shares under the ESPP | ||||
Loss per share | ||||
Antidilutive securities (in shares) | 20,765,196 | 11,488,993 | 15,024,198 | 10,903,631 |
Warrants | ||||
Loss per share | ||||
Antidilutive securities (in shares) | 1,980,660 | 1,371,225 | 1,510,168 | 457,075 |
BUSINESS COMBINATION - Narrativ
BUSINESS COMBINATION - Narrative (Details) | Apr. 06, 2020USD ($)$ / sharesshares | Mar. 09, 2020USD ($)$ / sharesshares | Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | May 11, 2020USD ($) |
Business Acquisition [Line Items] | |||||||
Number of common stock shares issued per CSR (in shares) | 1.2082 | ||||||
Effective exchange ratio (CSR per share) | 1.8006 | ||||||
Share issued and delivered upon CSR conversion (in shares) | shares | 74,544,413 | ||||||
Ownership percentage of parent by subsidiary stockholders | 82.00% | ||||||
Ownership percentage of parent by parent stockholders | 18.00% | ||||||
Closing share price (in usd per share) | $ / shares | $ 1.40 | ||||||
Goodwill impairment loss | $ 0 | $ 4,000,000 | |||||
Value of CSR converted into additional shares of the combined company | $ 19,600,000 | ||||||
Contingent Stock Right Remeasurement | $ 84,700,000 | 0 | $ 0 | 84,726,000 | $ 0 | ||
Contingent consideration, fair value of liability | $ 104,400,000 | ||||||
In Process Research and Development | |||||||
Business Acquisition [Line Items] | |||||||
In process research and development impairment | $ 0 | 50,300,000 | |||||
Foamix | |||||||
Business Acquisition [Line Items] | |||||||
Number of contingent stock rights issued (in CSR) | 1 | ||||||
Transaction costs | $ 21,800,000 | ||||||
Closing share price (in usd per share) | $ / shares | $ 2.99 | ||||||
Consideration transferred | $ 131,079,000 | ||||||
Deemed (for accounting purposes only) issuance of Foamix shares to Menlo stockholders | $ 123,757,000 | ||||||
Number of shares deemed (for accounting purposes only) issued (in shares) | shares | 41,400,000 | ||||||
Deemed (for accounting purposes only) conversion of Menlo equity awards | $ 7,322,000 | ||||||
Value of CSR converted into additional shares of the combined company | 19,600,000 | ||||||
Contingent consideration, fair value of liability | $ 19,600,000 | ||||||
Foamix | Employee benefits | |||||||
Business Acquisition [Line Items] | |||||||
Acquisition related costs | 8,100,000 | ||||||
Foamix | Selling, general and administrative | |||||||
Business Acquisition [Line Items] | |||||||
Acquisition related costs | $ 11,700,000 | ||||||
Common stock | Foamix | |||||||
Business Acquisition [Line Items] | |||||||
Exchange ratio per ordinary share for common stock (share per share) | 0.5924 |
BUSINESS COMBINATION - Consider
BUSINESS COMBINATION - Consideration Transferred in Merger (Details) - USD ($) $ in Thousands | Mar. 09, 2020 | Apr. 06, 2020 |
Business Acquisition [Line Items] | ||
Contingent consideration, fair value of liability | $ 104,400 | |
Foamix | ||
Business Acquisition [Line Items] | ||
Deemed (for accounting purposes only) issuance of Foamix shares to Menlo stockholders | $ 123,757 | |
Deemed (for accounting purposes only) conversion of Menlo equity awards | 7,322 | |
Total consideration | 131,079 | |
Contingent consideration, fair value of liability | 19,600 | |
Consideration net of the effect of CSRs | $ 111,400 |
BUSINESS COMBINATION - Purchase
BUSINESS COMBINATION - Purchase Price Allocation (Details) $ in Thousands | Mar. 09, 2020USD ($) |
Allocations of purchase price | |
Value of CSR converted into additional shares of the combined company | $ 19,600 |
Foamix | |
Allocations of purchase price | |
Cash and cash equivalents | 38,641 |
Investment in marketable securities | 22,703 |
Prepaid expenses and other current assets | 1,581 |
In-process research and development | 50,300 |
Goodwill | 4,045 |
Total assets | 117,270 |
Current liabilities | (5,827) |
Total liabilities | (5,827) |
Purchase price | 111,443 |
Value of CSR converted into additional shares of the combined company | $ 19,600 |
BUSINESS COMBINATION - Goodwill
BUSINESS COMBINATION - Goodwill (Details) - Foamix | Mar. 09, 2020USD ($) |
Business Combination, Goodwill [Abstract] | |
Goodwill deductible for income tax purposes | $ 0 |
Purchase price | 111,443,000 |
Less: fair value of net assets acquired, including other identifiable intangibles | (107,398,000) |
Goodwill | $ 4,045,000 |
BUSINESS COMBINATION - IPRD and
BUSINESS COMBINATION - IPRD and CSR (Details) - Foamix $ in Thousands | Mar. 09, 2020USD ($) |
In-Process Research and Development | |
Acquired indefinite life intangible assets | $ 50,300 |
Fair value of identified intangible assets | $ 50,300 |
BUSINESS COMBINATION - Pro Form
BUSINESS COMBINATION - Pro Forma (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Business Combinations [Abstract] | ||||
Revenues | $ 0 | $ 0 | ||
Loss attributable to Menlo | 4,100 | 23,737 | ||
SUPPLEMENTAL PRO FORMA COMBINED RESULTS OF OPERATIONS: | ||||
Revenues | 3,269 | $ 0 | 16,707 | $ 308 |
Net loss | $ 24,912 | $ 40,016 | $ 229,994 | $ 109,563 |
Loss per share - basic (in USD per share) | $ 0.15 | $ 0.66 | $ 1.88 | $ 1.82 |
Loss per share - diluted (in dollars per share) | $ 0.15 | $ 0.66 | $ 1.88 | $ 1.82 |
Adjustments to the supplemental pro forma combined results of operations, included in the above, are as follows: | ||||
Transaction costs | $ 0 | $ 0 | $ (14,931) | $ 0 |
Acceleration of stock based compensation | 0 | 0 | (7,199) | 0 |
Total Adjustments | $ 0 | $ 0 | $ (22,130) | $ 0 |
REVENUE RECOGNITION (Details)
REVENUE RECOGNITION (Details) - USD ($) | Apr. 23, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 |
Product Sales | ||||||
Product sales provisions | $ 11,000,000 | $ 25,100,000 | ||||
Minimum estimate product return (as a percent) | 2.00% | 2.00% | ||||
Maximum estimate product return (as a percent) | 3.00% | 3.00% | ||||
Revenues | $ 3,269,000 | $ 0 | $ 16,707,000 | $ 308,000 | ||
Royalty revenues | ||||||
Product Sales | ||||||
Revenues | 406,000 | $ 0 | 611,000 | $ 308,000 | ||
Allowance For Sales Returns | ||||||
Product Sales | ||||||
Revenue reserve accrual | 5,600,000 | 5,600,000 | ||||
Foamix | ||||||
Product Sales | ||||||
Proceeds from royalties | $ 10,000,000 | 4,000,000 | $ 6,000,000 | |||
Upfront royalty receipt | $ 0 | $ 10,000,000 | ||||
Additional royalty upon receipt of marketing approval in China | $ 1,000,000 | |||||
Customers | Revenue from Contract with Customer, Product and Service Benchmark | Distributor One | ||||||
Product Sales | ||||||
Concentration risk, percentage | 41.00% | 43.00% | ||||
Customers | Revenue from Contract with Customer, Product and Service Benchmark | Distributor Two | ||||||
Product Sales | ||||||
Concentration risk, percentage | 43.00% | 41.00% | ||||
Customers | Revenue from Contract with Customer, Product and Service Benchmark | Distributor Three | ||||||
Product Sales | ||||||
Concentration risk, percentage | 16.00% | 15.00% |
FAIR VALUE MEASUREMENT - Assets
FAIR VALUE MEASUREMENT - Assets and Liabilities Measured at Fair Value (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | $ 3,046 | $ 16,680 |
Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 1,027 | 1,020 |
Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 2,019 | 15,660 |
Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | $ 0 | $ 0 |
FAIR VALUE MEASUREMENT - Narrat
FAIR VALUE MEASUREMENT - Narrative (Details) | 9 Months Ended |
Sep. 30, 2020USD ($) | |
FAIR VALUE MEASURMENTS [Abstract] | |
Currency hedging cost for a year | $ 0 |
Currency hedging transactions, maximum term | 1 year |
Derivative, amount of hedged items | $ 0 |
Foreign exchange risk lien on checking account for bank guarantees granted to secure hedging transactions | $ 300,000 |
MARKETABLE SECURITIES - Marketa
MARKETABLE SECURITIES - Marketable Securities (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Debt Securities, Available-for-sale [Line Items] | ||
Marketable securities | $ 3,046 | $ 16,680 |
Israeli mutual funds | ||
Debt Securities, Available-for-sale [Line Items] | ||
Marketable securities | 1,027 | 1,020 |
Certificates of deposit | ||
Debt Securities, Available-for-sale [Line Items] | ||
Marketable securities | 0 | 151 |
U.S Government | ||
Debt Securities, Available-for-sale [Line Items] | ||
Marketable securities | 0 | 6,031 |
U.S Treasury bills | ||
Debt Securities, Available-for-sale [Line Items] | ||
Marketable securities | 0 | 9,478 |
Corporate notes | ||
Debt Securities, Available-for-sale [Line Items] | ||
Marketable securities | $ 2,019 | $ 0 |
MARKETABLE SECURITIES - Fair Va
MARKETABLE SECURITIES - Fair Value, Cost and Gross Unrealized Holding Gains of Securities Owned (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Debt Securities, Available-for-sale [Line Items] | ||
Fair value | $ 2,019 | $ 15,660 |
Cost or amortized cost | 2,019 | 15,656 |
Gross unrealized holding losses | 0 | 0 |
Gross unrealized holding gains | 0 | 4 |
Corporate notes | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair value | 2,019 | |
Cost or amortized cost | 2,019 | |
Gross unrealized holding losses | 0 | |
Gross unrealized holding gains | $ 0 | |
Certificates of deposit | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair value | 151 | |
Cost or amortized cost | 151 | |
Gross unrealized holding losses | 0 | |
Gross unrealized holding gains | 0 | |
U.S Government | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair value | 6,031 | |
Cost or amortized cost | 6,030 | |
Gross unrealized holding losses | 0 | |
Gross unrealized holding gains | 1 | |
U.S Treasury bills | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair value | 9,478 | |
Cost or amortized cost | 9,475 | |
Gross unrealized holding losses | 0 | |
Gross unrealized holding gains | $ 3 |
MARKETABLE SECURITIES - Narrati
MARKETABLE SECURITIES - Narrative (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2020 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | |
Investments, Debt and Equity Securities [Abstract] | ||||
Permanent impairment loss, debt securities, available for sale | $ 0 | $ 0 | ||
Proceeds from sale and maturity of marketable securities | 36,400,000 | $ 45,700,000 | ||
Restricted Investments | $ 0 | $ 400,000 |
INVENTORY - Narrative (Details)
INVENTORY - Narrative (Details) - USD ($) | 3 Months Ended | 9 Months Ended |
Sep. 30, 2020 | Sep. 30, 2020 | |
Inventory Disclosure [Abstract] | ||
Inventory write-down | $ 0 | $ 0 |
INVENTORY - Schedule of Invento
INVENTORY - Schedule of Inventory Components (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 4,293 | $ 500 |
Work-in-process | 0 | 0 |
Finished goods | 2,357 | 856 |
Total | $ 6,650 | $ 1,356 |
LONG-TERM DEBT - Narrative (Det
LONG-TERM DEBT - Narrative (Details) | Mar. 09, 2020USD ($)$ / sharesshares | Jul. 29, 2019USD ($)lender$ / sharesshares | Dec. 31, 2020USD ($) | Jun. 30, 2024USD ($) | Sep. 30, 2020USD ($)$ / sharesshares | Sep. 30, 2020USD ($)$ / sharesshares | Dec. 31, 2019USD ($) | Dec. 17, 2019USD ($) |
Debt offering expenses | ||||||||
Incurred expenses related to Credit Agreement and Securities Purchase Agreement | $ 1,100,000 | $ 300,000 | ||||||
Interest expense | $ 1,000,000 | 2,900,000 | ||||||
Discount cost | 100,000 | 300,000 | ||||||
Credit Agreement | Level 3 | ||||||||
Debt offering expenses | ||||||||
Debt instrument, fair value | 36,300,000 | 36,300,000 | ||||||
Amended And Restated Credit Agreement | ||||||||
Debt instrument information | ||||||||
Long-term debt, gross | 35,000,000 | 35,000,000 | $ 35,000,000 | |||||
Remaining borrowing capacity | 15,000,000 | 15,000,000 | ||||||
Base interest rate | 8.25% | |||||||
Debt instrument fee as a percent of the aggregate principal amount | 1.00% | |||||||
Minimum aggregate cash balance to maintain after FDA approval | $ 2,500,000 | |||||||
Monthly payment as a percent of the aggregate principal amount beginning July 2023 | 1.50% | |||||||
Amended And Restated Credit Agreement | Forecast | Subsequent Event | ||||||||
Debt instrument information | ||||||||
Debt covenant, minimum quarterly revenue compliance | $ 6,000,000 | $ 97,000,000 | ||||||
Amended And Restated Credit Agreement | One-month LIBOR | ||||||||
Debt instrument information | ||||||||
Basis spread on variable rate | 2.75% | |||||||
Amended and Restated Credit Agreement, Trench 1 Loan | ||||||||
Debt instrument information | ||||||||
Debt instrument, face amount | 15,000,000 | |||||||
Amended and Restated Credit Agreement, Trench 2 Loan | ||||||||
Debt instrument information | ||||||||
Debt instrument, face amount | $ 20,000,000 | |||||||
Debt offering expenses | ||||||||
Incurred expenses related to Credit Agreement and Securities Purchase Agreement | $ 300,000 | |||||||
Amended and Restated Credit Agreement, Trench 3 Loan | ||||||||
Debt instrument information | ||||||||
Borrowing capacity | $ 15,000,000 | $ 15,000,000 | ||||||
Shareholder Lender | Foamix | ||||||||
Warrants issued | ||||||||
Number of ordinary shares that may be purchased by exercise of warrants (in shares) | shares | 651,640 | 1,100,000 | 1,980,660 | 1,980,660 | ||||
Warrant exercise price (in dollars per share) | $ / shares | $ 3.53 | $ 2.09 | $ 1.1607 | $ 1.1607 | ||||
Shareholder Lender | Credit Agreement | ||||||||
Debt instrument information | ||||||||
Borrowing capacity | $ 50,000,000 | |||||||
Registered offering per securities purchase agreement | Shareholder Lender | ||||||||
Debt instrument information | ||||||||
Number of lenders involved | lender | 1 | |||||||
Gross proceeds from issuance of common stock | $ 14,000,000 |
SHARE CAPITAL - Common Stock, P
SHARE CAPITAL - Common Stock, Preferred Stock, and Warrants Narrative (Details) $ / shares in Units, $ in Thousands | Aug. 03, 2020 | Jun. 09, 2020USD ($)$ / sharesshares | Mar. 09, 2020USD ($)shares | Jul. 29, 2019USD ($)$ / sharesshares | Sep. 30, 2019shares | Sep. 30, 2020USD ($)vote$ / sharesshares | Sep. 30, 2019shares | Dec. 31, 2019$ / sharesshares |
Class of Stock [Line Items] | ||||||||
Preferred stock, shares authorized (in shares) | 20,000,000 | 20,000,000 | ||||||
Preferred stock, par value (USD/share) | $ / shares | $ 0.0001 | $ 0.0001 | ||||||
Preferred stock, shares issued (in shares) | 0 | 0 | ||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | ||||||
Common stock shares authorized (in shares) | 300,000,000 | 300,000,000 | ||||||
Common stock par value (USD/share) | $ / shares | $ 0.0001 | $ 0.0001 | ||||||
Payments of financing and stock issuance costs | $ | $ 1,100 | $ 300 | ||||||
Deemed dividend to warrants holders due to warrant modification | $ | $ 0 | |||||||
Maximum | ||||||||
Class of Stock [Line Items] | ||||||||
Reverse stock split, conversion ratio (share/share) | 7 | |||||||
Minimum | ||||||||
Class of Stock [Line Items] | ||||||||
Reverse stock split, conversion ratio (share/share) | 2 | |||||||
Foamix | ||||||||
Class of Stock [Line Items] | ||||||||
Number of shares issued pursuant to the merger (in shares) | 74,544,413 | |||||||
Number of contingent stock rights issued (in CSR) | 1 | |||||||
Deemed dividend to warrants holders due to warrant modification | $ | $ 41 | |||||||
Foamix | CSR Agreement | ||||||||
Class of Stock [Line Items] | ||||||||
Number of shares issued pursuant to the merger (in shares) | 36,550,335 | |||||||
Initial Public Offering | ||||||||
Class of Stock [Line Items] | ||||||||
Sale of stock (USD/share) | $ / shares | $ 1.85 | |||||||
Number of shares issued in transaction (in shares) | 31,107,500 | |||||||
Consideration received in a transaction | $ | $ 53,600 | |||||||
Common stock | ||||||||
Class of Stock [Line Items] | ||||||||
Number of votes entitled to each ordinary share | vote | 1 | |||||||
Number of shares issued (in shares) | 3,875,514 | 11,779,628 | 31,107,500 | 11,779,628 | ||||
Gross proceeds from issuance of common stock | $ | $ 14,000 | |||||||
Ordinary Shares | Registered offering per securities purchase agreement | Foamix | ||||||||
Class of Stock [Line Items] | ||||||||
Number of shares issued (in shares) | 6,542,057 | |||||||
Sale of stock (USD/share) | $ / shares | $ 2.14 | |||||||
Warrants | Foamix | Maximum | ||||||||
Class of Stock [Line Items] | ||||||||
Number of ordinary shares that may be purchased by exercise of warrants (in shares) | 1,100,000 | |||||||
Number of shares issued for warrants exercised | 1,980,660 |
SHARE CAPITAL - Share-based Com
SHARE CAPITAL - Share-based Compensation Narrative (Details) | Apr. 06, 2020 | Mar. 09, 2020USD ($) | Sep. 30, 2020USD ($)shares | Jun. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2020USD ($)shares | Sep. 30, 2019USD ($) |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Fair value of options and RSUs granted | $ 11,800,000 | $ 4,000,000 | |||||
Share-based compensation | $ 2,620,000 | $ 1,269,000 | 15,147,000 | $ 3,606,000 | |||
Number of common stock shares issued per CSR (in shares) | 1.2082 | ||||||
Effective exchange ratio (CSR per share) | 1.8006 | ||||||
Additional paid in capital reclassified to derivate liabilities | 975,000 | ||||||
Foamix | Employees and consultants | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Share-based compensation | $ 60,000 | ||||||
Incremental compensation costs incurred | 1,100,000 | 10,400,000 | |||||
Incremental compensation costs incurred | $ 4,900,000 | ||||||
Incremental compensation costs, recognition period | 2 years | ||||||
Foamix | No longer employed or providing services | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Incremental compensation costs incurred | $ 0 | $ 1,000,000 | |||||
Additional paid in capital reclassified to derivate liabilities | $ 1,600,000 | ||||||
Incremental compensation cost | $ 600,000 | ||||||
Common stock | Foamix | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Shares issued during the period (in shares) | shares | 61,031 | ||||||
2019 Plan | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Shares reserved for future issuance (in shares) | shares | 2,650,213 | 2,650,213 | |||||
2018 Plan | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Shares reserved for future issuance (in shares) | shares | 2,237,869 | 2,237,869 | |||||
Increase in shares reserved for future issuance (in shares) | shares | 976,105 | 976,105 | |||||
ESPP | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Shares reserved for future issuance (in shares) | shares | 9,371,258 | 9,371,258 | |||||
Percentage of fair market value used as purchase price | 85.00% | ||||||
Percent of annual earnings that may be used to purchase shares | 15.00% | ||||||
ESPP | Common stock | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Stock issued during period, conversion of units (in shares) | shares | 109,892 |
SHARE CAPITAL - Options and RSU
SHARE CAPITAL - Options and RSU Grants (Details) - $ / shares | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Option, award amount (in shares) | 5,266,548 | 2,570,889 |
Exercise price range, minimum (in usd per share) | $ 1.46 | $ 1.31 |
Exercise price range, maximum (in usd per share) | $ 3.13 | $ 2.12 |
Expiration | 10 years | 10 years |
Options | Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting period | 1 year | 1 year |
Options | Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting period | 4 years | 4 years |
RSUs | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
RSU, award amount (in shares) | 2,589,710 | 766,343 |
RSUs | Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting period | 1 year | 1 year |
RSUs | Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting period | 4 years | 4 years |
SHARE CAPITAL - Fair value assu
SHARE CAPITAL - Fair value assumptions (Details) - Options | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Share-based payment assumptions for computing fair value | ||
Dividend yield | 0.00% | 0.00% |
Expected volatility, minimum | 60.44% | 59.35% |
Expected volatility, maximum | 69.83% | 61.40% |
Risk-free interest rate, minimum | 0.31% | 1.42% |
Risk-free interest rate, maximum | 1.26% | 2.62% |
Expected term | 6 years | 6 years |
SHARE CAPITAL - Schedule of Sha
SHARE CAPITAL - Schedule of Share-based Compensation (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Expense | ||||
Share-based compensation | $ 2,620 | $ 1,269 | $ 15,147 | $ 3,606 |
Research and development expenses | ||||
Expense | ||||
Share-based compensation | 361 | 389 | 3,927 | 1,127 |
Selling, general and administrative | ||||
Expense | ||||
Share-based compensation | $ 2,259 | $ 880 | $ 11,220 | $ 2,479 |
OPERATING LEASE - Narrative (De
OPERATING LEASE - Narrative (Details) $ in Thousands | Mar. 13, 2019USD ($)ft² | Sep. 30, 2020USD ($) | Dec. 31, 2019USD ($) |
Operating Lease | |||
Operating lease right-of-use assets | $ 2,191 | $ 1,694 | |
Operating lease terms | 3 years | ||
Vehicles lease prepaid period | 3 months | ||
Lien on marketable securities to secure lease agreements | $ 600 | ||
Building [Member] | Redwood City, California | |||
Operating Lease | |||
Monthly base rent | $ 60 | ||
Original Space | Bridgewater, New Jersey | |||
Operating Lease | |||
Facility space leased | ft² | 10,000 | ||
Operating lease right-of-use assets | $ 700 | ||
Additional Space | Bridgewater, New Jersey | |||
Operating Lease | |||
Facility space leased | ft² | 4,639 | ||
Operating lease right-of-use assets | $ 300 |
OPERATING LEASE - Maturities of
OPERATING LEASE - Maturities of Lease Liabilities (Details) $ in Thousands | Sep. 30, 2020USD ($) |
Leases [Abstract] | |
2020 | $ 423 |
2021 | 1,002 |
2022 | 777 |
2023 | 94 |
Total lease payments | 2,296 |
Less imputed interest | 106 |
Total lease liability | $ 2,190 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details) $ in Millions | 9 Months Ended | |
Sep. 30, 2020USD ($)lawsuit | Nov. 08, 2018lawsuit | |
IPO Lawsuits | ||
Loss Contingencies [Line Items] | ||
Number of class actions | 2 | |
Merger Lawsuits | ||
Loss Contingencies [Line Items] | ||
Number of class actions | 7 | |
Merger Lawsuits, Breach of Fiduciary Duties Of BOD | ||
Loss Contingencies [Line Items] | ||
Number of class actions | 1 | |
Current and Former Officers and Directors | ||
Loss Contingencies [Line Items] | ||
Payments for settlement | $ | $ 9.5 |
Uncategorized Items - vyne-2020
Label | Element | Value |
Restricted Cash and Cash Equivalents | us-gaap_RestrictedCashAndCashEquivalents | $ 855,000 |
Restricted Cash and Cash Equivalents | us-gaap_RestrictedCashAndCashEquivalents | $ 250,000 |