Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2021 | Nov. 12, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2021 | |
Entity File Number | 001-38709 | |
Entity Registrant Name | Osmotica Pharmaceuticals plc | |
Entity Incorporation, State or Country Code | L2 | |
Entity Tax Identification Number | 00-0000000 | |
Entity Address, Address Line One | 400 Crossing Boulevard | |
Entity Address, City or Town | Bridgewater | |
Entity Address, State or Province | NJ | |
Entity Address, Postal Zip Code | 08807 | |
City Area Code | 908 | |
Local Phone Number | 809-1300 | |
Title of 12(b) Security | Ordinary Shares | |
Trading Symbol | OSMT | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 83,280,591 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q3 | |
Entity Central Index Key | 0001739426 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 8,352 | $ 114,053 |
Accounts receivable, net | 4,190 | 3,149 |
Inventories, net | 824 | 1,831 |
Prepaid expenses and other current assets | 10,019 | 12,592 |
Assets held for sale | 41,529 | |
Total current assets | 23,385 | 173,154 |
Property, plant and equipment, net | 851 | 2,391 |
Operating lease assets | 1,651 | 1,953 |
Intangibles, net | 27,210 | 35,090 |
Goodwill | 55,847 | 55,847 |
Other non-current assets | 603 | 373 |
Assets held for sale | 102,141 | |
Total assets | 109,547 | 370,949 |
Current liabilities: | ||
Trade accounts payable | 4,449 | 3,128 |
Accrued liabilities | 18,521 | 16,951 |
Current portion of debt, net of deferred financing costs | 29,925 | |
Current portion of obligation under finance leases | 6 | 20 |
Current portion of lease liability | 1,029 | 1,199 |
Income taxes payable - current portion | 2 | |
Liabilities held for sale | 34,484 | |
Total current liabilities | 53,930 | 55,784 |
Long-term debt, net of non-current deferred financing costs | 219,525 | |
Long-term portion of lease liability | 701 | 871 |
Income taxes payable - long term portion | 1 | |
Deferred taxes | 165 | 345 |
Liabilities held for sale | 568 | |
Total liabilities | 54,797 | 277,093 |
Commitments and contingencies (See Note 12) | ||
Shareholders' equity: | ||
Ordinary shares ($0.01 nominal value 400,000,000 shares authorized, 63,127,288 and 62,545,832 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively) | 631 | 625 |
Preferred shares ($0.01 nominal value 40,000,000 shares authorized, no shares issued and outstanding) | 0 | 0 |
Euro deferred shares (1.00 nominal value 25,000 shares authorized, no shares issued and outstanding) | 0 | 0 |
Additional paid in capital | 554,156 | 548,070 |
Accumulated deficit | (497,808) | (452,610) |
Accumulated other comprehensive loss | (2,229) | (2,229) |
Total shareholders' equity | 54,750 | 93,856 |
Total liabilities and shareholders' equity | $ 109,547 | $ 370,949 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parentheticals) | Sep. 30, 2021$ / sharesshares | Sep. 30, 2021€ / sharesshares | Dec. 31, 2020$ / sharesshares | Dec. 31, 2020€ / sharesshares |
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||
Ordinary shares, nominal value (in dollars per share) | $ / shares | $ 0.01 | $ 0.01 | ||
Ordinary shares, number of shares authorized | 400,000,000 | 400,000,000 | 400,000,000 | 400,000,000 |
Ordinary shares, number of shares issued | 63,127,288 | 63,127,288 | 62,545,832 | 62,545,832 |
Ordinary shares, number of shares outstanding | 63,127,288 | 63,127,288 | 62,545,832 | 62,545,832 |
Preferred shares, nominal value (in dollars per share) | $ / shares | $ 0.01 | $ 0.01 | ||
Preferred shares, number of shares authorized | 40,000,000 | 40,000,000 | 40,000,000 | 40,000,000 |
Preferred shares, number of shares issued | 0 | 0 | 0 | 0 |
Preferred shares, number of shares outstanding | 0 | 0 | 0 | 0 |
Euro deferred shares, nominal value (in euros per share) | € / shares | € 1 | € 1 | ||
Euro deferred shares, number of shares authorized | 25,000 | 25,000 | 25,000 | 25,000 |
Euro deferred shares, number of shares issued | 0 | 0 | 0 | 0 |
Euro deferred shares, number of shares outstanding | 0 | 0 | 0 | 0 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Revenues | $ 2,196 | $ 25,751 | $ 14,641 | $ 26,627 |
Cost of goods sold | 1,147 | 1,185 | 2,535 | 1,794 |
Gross profit | 1,049 | 24,566 | 12,106 | 24,833 |
Selling, general and administrative expenses | 24,841 | 21,360 | 63,769 | 54,028 |
Research and development expenses | 1,376 | 1,779 | 5,789 | 9,264 |
Impairment of intangibles | 7,880 | |||
Total operating expenses | 26,217 | 23,139 | 77,438 | 63,292 |
Operating income (loss) | (25,168) | 1,427 | (65,332) | (38,459) |
Gain on sales of product rights, net | 5,636 | |||
Operating income (loss) | (25,168) | 1,427 | (59,696) | (38,459) |
Interest expense and amortization of debt discount | 735 | 1,071 | 1,750 | 3,560 |
Other non-operating (gain) loss | 120 | (51) | 1,312 | 246 |
Total other non-operating expense | (855) | (1,020) | (3,062) | (3,806) |
Income (loss) before income taxes | (26,023) | 407 | (62,758) | (42,265) |
Income tax expense (benefit) | 324 | (1,308) | 415 | (5,042) |
Income (loss) from continuing operations | (26,347) | 1,715 | (63,173) | (37,223) |
Gain on sales of discontinued operations, net | 4,373 | 4,373 | ||
Income (loss) from discontinued operations before income tax expense | 3,983 | (10,171) | 14,219 | 17,571 |
Income tax expense (benefit) - discontinued operations | (132) | 177 | 617 | 5,063 |
Income (loss) from discontinued operations, net of tax | 8,488 | (10,348) | 17,975 | 12,508 |
Net and other comprehensive loss | $ (17,859) | $ (8,633) | $ (45,198) | $ (24,715) |
(Loss) income per share attributable to shareholders: | ||||
(Loss) income per share attributable to shareholders, Continuing operations, basic | $ (0.42) | $ 0.03 | $ (1.01) | $ (0.62) |
(Loss) income per share attributable to shareholders, Discontinued operations, Basic | 0.13 | (0.16) | 0.29 | 0.21 |
(Loss) income per share attributable to shareholders, Continuing operations, Diluted | (0.42) | 0.03 | (1.01) | (0.62) |
(Loss) income per share attributable to shareholders, Discontinued operations, Diluted | 0.13 | (0.16) | 0.29 | 0.21 |
(Loss) income per share attributable to shareholders, basic | (0.28) | (0.14) | (0.72) | (0.41) |
(Loss) income per share attributable to shareholders, diluted | $ (0.28) | $ (0.14) | $ (0.72) | $ (0.41) |
Weighted average shares basic and diluted | ||||
Weighted average shares, basic | 62,945,898 | 62,785,866 | 62,798,123 | 59,979,834 |
Weighted average shares, diluted | 62,945,898 | 63,285,258 | 62,798,123 | 59,979,834 |
Product Revenue | ||||
Revenues | $ 2,196 | $ 586 | $ 4,451 | $ 998 |
Royalty Revenue | ||||
Revenues | 165 | 190 | 629 | |
Licensing and Contract Revenue | ||||
Revenues | $ 25,000 | $ 10,000 | $ 25,000 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN SHAREHOLDERS EQUITY - USD ($) $ in Thousands | Ordinary shares | Additional Paid-in Capital [Member] | Accumulated deficit | Accumulated other comprehensive loss | Total |
Stockholders' equity, beginning balance at Dec. 31, 2019 | $ 518 | $ 489,440 | $ (373,021) | $ (2,229) | $ 114,708 |
Shares, Outstanding, Beginning Balance at Dec. 31, 2019 | 51,845,742 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (3,083) | (3,083) | |||
Share compensation, value | $ 2 | 1,107 | 1,109 | ||
Share compensation, shares | 181,966 | ||||
Payments for taxes related to the net share settlement of equity awards | (616) | (616) | |||
Issuance of ordinary shares, net of offering costs | $ 69 | 31,720 | 31,789 | ||
Issuance of ordinary shares in initial public offering and private placement, shares | 6,900,000 | ||||
Repurchase of ordinary shares, value | (167) | (167) | |||
Repurchase of ordinary shares, shares | (29,000) | ||||
Stockholders' equity, ending balance at Mar. 31, 2020 | $ 589 | 521,484 | (376,104) | (2,229) | 143,740 |
Shares, Outstanding, Ending Balance at Mar. 31, 2020 | 58,898,708 | ||||
Stockholders' equity, beginning balance at Dec. 31, 2019 | $ 518 | 489,440 | (373,021) | (2,229) | 114,708 |
Shares, Outstanding, Beginning Balance at Dec. 31, 2019 | 51,845,742 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (24,715) | ||||
Stockholders' equity, ending balance at Sep. 30, 2020 | $ 631 | 550,020 | (397,736) | (2,229) | 150,686 |
Shares, Outstanding, Ending Balance at Sep. 30, 2020 | 63,105,832 | ||||
Stockholders' equity, beginning balance at Mar. 31, 2020 | $ 589 | 521,484 | (376,104) | (2,229) | 143,740 |
Shares, Outstanding, Beginning Balance at Mar. 31, 2020 | 58,898,708 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (12,999) | (12,999) | |||
Share compensation, value | $ 1 | 1,221 | 1,222 | ||
Share compensation, shares | 31,295 | ||||
Payments for taxes related to the net share settlement of equity awards | (133) | (133) | |||
Repurchase of ordinary shares, value | $ (2) | (917) | (919) | ||
Repurchase of ordinary shares, shares | (169,257) | ||||
Stockholders' equity, ending balance at Jun. 30, 2020 | $ 588 | 521,655 | (389,103) | (2,229) | 130,911 |
Shares, Outstanding, Ending Balance at Jun. 30, 2020 | 58,760,746 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (8,633) | (8,633) | |||
Share compensation, value | 1,508 | 1,508 | |||
Share compensation, shares | 22,554 | ||||
Issuance of ordinary shares, net of offering costs | $ 50 | 30,599 | 30,649 | ||
Issuance of ordinary shares in initial public offering and private placement, shares | 5,000,000 | ||||
Repurchase of ordinary shares, value | $ (7) | (3,742) | (3,749) | ||
Repurchase of ordinary shares, shares | (677,468) | ||||
Stockholders' equity, ending balance at Sep. 30, 2020 | $ 631 | 550,020 | (397,736) | (2,229) | 150,686 |
Shares, Outstanding, Ending Balance at Sep. 30, 2020 | 63,105,832 | ||||
Stockholders' equity, beginning balance at Dec. 31, 2020 | $ 625 | 548,070 | (452,610) | (2,229) | 93,856 |
Shares, Outstanding, Beginning Balance at Dec. 31, 2020 | 62,545,832 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (9,612) | (9,612) | |||
Share compensation, value | $ 2 | 1,309 | 1,311 | ||
Share compensation, shares | 173,299 | ||||
Payments for taxes related to the net share settlement of equity awards | (358) | (358) | |||
Stockholders' equity, ending balance at Mar. 31, 2021 | $ 627 | 549,021 | (462,222) | (2,229) | 85,197 |
Shares, Outstanding, Ending Balance at Mar. 31, 2021 | 62,719,131 | ||||
Stockholders' equity, beginning balance at Dec. 31, 2020 | $ 625 | 548,070 | (452,610) | (2,229) | 93,856 |
Shares, Outstanding, Beginning Balance at Dec. 31, 2020 | 62,545,832 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ (45,198) | ||||
Repurchase of ordinary shares, shares | 0 | ||||
Stockholders' equity, ending balance at Sep. 30, 2021 | $ 631 | 554,156 | (497,808) | (2,229) | $ 54,750 |
Shares, Outstanding, Ending Balance at Sep. 30, 2021 | 63,127,288 | ||||
Stockholders' equity, beginning balance at Mar. 31, 2021 | $ 627 | 549,021 | (462,222) | (2,229) | 85,197 |
Shares, Outstanding, Beginning Balance at Mar. 31, 2021 | 62,719,131 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (17,727) | (17,727) | |||
Share compensation, value | $ 1 | 1,232 | 1,233 | ||
Share compensation, shares | 128,931 | ||||
Payments for taxes related to the net share settlement of equity awards | (249) | (249) | |||
Stockholders' equity, ending balance at Jun. 30, 2021 | $ 628 | 550,004 | (479,949) | (2,229) | 68,454 |
Shares, Outstanding, Ending Balance at Jun. 30, 2021 | 62,848,062 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (17,859) | (17,859) | |||
Share compensation, value | $ 2 | 4,277 | 4,279 | ||
Share compensation, shares | 133,064 | ||||
Payments for taxes related to the net share settlement of equity awards | (160) | (160) | |||
Issuance of ordinary shares, net of offering costs | $ 1 | 35 | 36 | ||
Issuance of ordinary shares in initial public offering and private placement, shares | 146,162 | ||||
Stockholders' equity, ending balance at Sep. 30, 2021 | $ 631 | $ 554,156 | $ (497,808) | $ (2,229) | $ 54,750 |
Shares, Outstanding, Ending Balance at Sep. 30, 2021 | 63,127,288 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Cash Flows from Operating Activities: | ||
Net loss from continuing operations | $ (63,173) | $ (37,223) |
Net income from discontinued operations | 17,975 | 12,508 |
Net loss | (45,198) | (24,715) |
Adjustments to reconcile net loss to net cash provided by operating activities: | ||
Depreciation and amortization | 8,068 | 16,589 |
Share compensation | 6,592 | 3,836 |
Impairment of intangibles | 7,880 | |
Impairment of intangibles | 23,157 | |
Deferred income tax benefit | (180) | (974) |
Gain on sale of product rights, net | (5,636) | |
Gain on sale of discontinued operations, net | (4,373) | |
Loss on sale of fixed and leased assets | 1,229 | 281 |
Bad debt provision | 6 | |
Amortization of deferred financing and loan origination fees | 746 | 985 |
Write off of deferred financing and loan origination fees in connection with prepayment | 1,387 | 496 |
Change in operating assets and liabilities: | ||
Accounts receivable, net | 4,643 | 22,339 |
Inventories, net | 2,256 | (398) |
Prepaid expenses and other current assets | (3,316) | 4,741 |
Other non-current assets | (603) | |
Trade accounts payable | 515 | (586) |
Accrued and other current liabilities | (4,347) | (19,915) |
Net cash provided by (used in) operating activities | (30,337) | 25,842 |
Cash Flows from Investing Activities: | ||
Proceeds from sale of fixed and leased assets | 40 | 50 |
Payments on disposal of leased assets | (209) | |
Proceeds from product rights disposal | 7,300 | |
Proceeds from discontinued operations | 110,845 | |
Purchase of property, plant and equipment | (1,657) | (2,213) |
Net cash provided by (used in) investing activities | 116,528 | (2,372) |
Cash flows from Financing Activities: | ||
Payments on finance lease obligations | (35) | (98) |
Proceeds from public offering, net of issuance costs | 36 | 62,440 |
Proceeds from purchases of stock under ESPP | 234 | |
Debt repayment | (191,360) | (50,000) |
Repurchases of ordinary shares | (4,835) | |
Payments for taxes related to net share settlement of equity awards | (767) | (749) |
Net cash provided by (used in) financing activities | (191,892) | 6,758 |
Net change in cash and cash equivalents | (105,701) | 30,228 |
Cash and cash equivalents, beginning of period | 114,053 | 95,865 |
Cash and cash equivalents, end of period | 8,352 | 126,093 |
Supplemental disclosure of cash and non-cash transactions: | ||
Cash paid for interest | 7,166 | 12,014 |
Cash paid for taxes | $ 2,060 | $ 1,439 |
Organization and Nature of Oper
Organization and Nature of Operations | 9 Months Ended |
Sep. 30, 2021 | |
Organization and Nature of Operations | |
Organization and Nature of Operations | Note 1. Organization and Nature of Operations Osmotica Pharmaceuticals plc, an Irish public limited company (the “Company”), together with its subsidiaries, is a specialty pharmaceutical company focused on the commercialization and development of products that target markets with underserved patient populations. In July 2020, the Company received regulatory approval from the FDA for RVL-1201, or Upneeq, (oxymetazoline hydrocholoride ophthalmic solution, 0.1%), for the treatment of acquired blepharoptosis, or droopy eyelid, in adults. Upneeq was commercially launched September 2020 to a limited number of eye care professionals with commercialization operations expanded in 2021 among ophthalmology, optometry and oculoplastic specialties. On August 27, 2021, the Company closed the divestiture of its portfolio of branded and non-promoted products and its Marietta, Georgia manufacturing facility, (the “Legacy Business”) to certain affiliates of Alora Pharmaceuticals, or Alora, for $111 million in cash upon closing, subject to certain adjustments, and up to $60 million in contingent milestone payments. Pursuant to the agreement the Company post-closing retained the rights to Upneeq and to arbaclofen extended release tablets which is under development for the treatment of spasticity in multiple sclerosis. With the divestiture of the Legacy Business the primary focus of the Company will be on the commercialization and development of specialty pharmaceuticals in the ocular and medical aesthetics therapeutic areas. With the divestiture of the Legacy Business the Company’s commercial operations would be conducted by its wholly-owned subsidiaries, RVL Pharmaceuticals, Inc. and RVL Pharmacy, LLC, or RVL. RVL operates pharmacy operations dedicated to the processing and fulfillment of prescriptions for Upneeq. Unless otherwise indicated or required by the context, references throughout to “Osmotica,” or the “Company”, refer to our continuing operations following the sale or the Legacy Business to Alora. A description of our business prior to the consummation of the transaction is included in Item 1. “Business”, in Part I of the Annual Report on Form 10-K for the year ended December 31, 2020 that was previously filed with the Securities and Exchange Commission (“SEC”) on March 30, 2021. |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2021 | |
Basis of Presentation and Summary of Significant Accounting Policies | |
Basis of Presentation and Summary of Significant Accounting Policies | Note 2. Basis of Presentation and Summary of Significant Accounting Policies Going Concern Evaluation As of September 30, 2021, the Company’s cash and cash equivalents totaled $8.4 million. For the fiscal year ended December 31, 2020 and the three and nine months ended September 30, 2021 the Company incurred net losses of $79.6 million, $17.9 million and $45.2 million, respectively. On August 27, 2021, the Company announced the closing of the divestiture of the Company’s portfolio of branded and non-promoted products and its Marietta, Georgia manufacturing facility, or the Legacy Business, to certain affiliates of Alora Pharmaceuticals for $111 million in cash upon closing, subject to certain post-closing adjustments, and up to $60 million in contingent milestone payments, or the Transaction. Pursuant to the Transaction the Company retained the rights to Upneeq and to arbaclofen extended release tablets, which is under development for the treatment of spasticity in multiple sclerosis. Proceeds from the divestiture of the Legacy business, together with cash on hand were used to repay $186.1 million of debt. As of September 30, 2021, the Company had interest bearing debt of $29.9 million, net of deferred financing fees, with a maturity date of November 21, 2021. On October 12, 2021 the Company issued $55.0 million of senior secured notes to a lender, a portion of the proceeds of which, together with the proceeds from the underwritten offering described below, were used to repay $30.7 million of outstanding term loans, accrued interest and related fees and expenses. Also on October 12, 2021 the Company issued 14,000,000 ordinary shares and warrants to purchase 16,100,000 shares in an underwritten offering, raising net proceeds of approximately $32.5 million. The remaining net proceeds from the issuance of the senior notes and ordinary shares is being used for general corporate purposes. The divestiture of the Legacy Business resulted in the loss of substantially all the Company’s revenue generating assets and the Company’s business plan is focused on the launch of its commercial product, Upneeq, which diminished the Company’s cash flows in at least the near term, in particular cash inflows from product sales. The Company will require additional capital to fund its operating needs, including the commercialization of Upneeq and other activities. Accordingly, the Company expects to incur significant expenditures and increasing operating losses in the future. As a result, the Company’s current sources of liquidity will not be sufficient to meet its obligations for the 12 months following the date the unaudited condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q are issued. These conditions give rise to substantial doubt as to our ability to operate as a going concern. Our ability to continue as a going concern will require us to obtain additional funding, generate positive cash flow from operations and/or enter into strategic alliances or sell assets. The Company’s plans to address these conditions include pursuing one or more of the following options to secure additional funding, none of which can be guaranteed or are entirely within our control: • raise funds through additional sales of our ordinary shares, through equity sales agreements with broker/dealers or other public or private equity financings. • • There can be no assurance the Company will receive cash proceeds from any of these potential resources or, to the extent cash proceeds are received, such proceeds would be sufficient to support the Company’s current operating plan for at least the next 12 months from the date the condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q are issued. The sale of additional equity or convertible debt securities may result in additional dilution to the Company’s stockholders. If we raise additional funds through the issuance of debt securities or preferred stock or through additional credit facilities, these securities and/or the loans under credit facilities could provide for rights senior to those of the Company’s ordinary shares and could contain covenants that would restrict the Company’s operations. Additional funds may not be available when needed, on terms that are acceptable to the Company, or at all. The unaudited condensed consolidated financial statements have been prepared on a going concern basis, which assumes the realization of assets and settlement of liabilities in the normal course of business. The Company’s ability to continue as a going concern is dependent on the Company’s ability to obtain the necessary financing to meet its obligations and repay liabilities arising from the normal business operations when they become due. The outcome of these matters cannot be predicted with any certainty at this time and raise substantial doubt that the Company will be able to continue as a going concern. The unaudited condensed consolidated financial statements do not include any adjustments to the amount and classification of assets and liabilities that may be necessary should the Company be unable to continue as a going concern. Basis of Presentation nine months ended September 30, 2021, are not necessarily indicative of the results that may be expected for any future period or for the year ending December 31, 2021 or any period thereafter. The accompanying Condensed Consolidated Balance Sheet data as of December 31, 2020 was derived from the audited consolidated financial statements. These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2020. The Company accounted for the sale of the Legacy Business in accordance with Accounting Standards Codification, ASC, 205 Discontinued Operations and Accounting Standards Update, ASU, No. 2014-08, Reporting of Discontinued Operations and Disclosures of Disposals of Components of an Entity. The Company followed the held-for-sale criteria as defined in ASC 360 and ASC 205. ASC 205 requires that a component of an entity that has been disposed of or is classified as held for sale and has operations and cash flows that can be clearly distinguished from the rest of the entity be reported as assets held for sale and discontinued operations. In the period a component of an entity has been disposed of or classified as held for sale, the results of operations for the periods presented are reclassified into separate line items, net of tax, in the unaudited condensed consolidated statements of operations. Assets and liabilities are also reclassified into separate line items on the related condensed consolidated balance sheets for the periods presented. The statements of cash flows for the periods presented are also reclassified to reflect the results of discontinued operations as separate line items. ASU 2014-08 requires that only a disposal of a component of an entity, or a group of components of an entity, that represents a strategic shift that has, or will have, a major effect on the reporting entity’s operations and financial results be reported in the financial statements as discontinued operations. ASU 2014-08 also provides guidance on the financial statement presentations and disclosures of discontinued operations. Due to the sale of the Legacy Business during the third quarter of 2021, in accordance with ASC 205, Discontinued Operations, the Company has classified the results of the Legacy Business as discontinued operations in our unaudited condensed consolidated statements of operations and cash flows for all periods presented. All assets and liabilities associated with our Legacy Business were therefore classified as assets and liabilities of discontinued operations in our condensed consolidated balance sheets as of December 31, 2020. All amounts included in the notes to the unaudited condensed consolidated financial statements relate to continuing operations unless otherwise noted. For additional information, see Note 3, Discontinued Operations. Basic and Diluted Loss per Share The following potentially dilutive securities have been excluded from the computation of diluted weighted average shares outstanding as they would be anti-dilutive as of September 30, 2021 and 2020: Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Performance and restricted stock units 1,456,910 2,092,419 1,456,910 2,591,811 Options to purchase ordinary shares 2,650,946 2,772,805 2,650,946 2,772,805 Shares to be purchased through employee stock purchase plan 79,919 — 79,919 — Fair Value of Financial Instrument receivable, accounts payable and debt approximate book value because of the short maturity of these financial instruments. The valuation hierarchy is composed of three levels. The classification within the valuation hierarchy is based on the lowest level of input that is significant to the fair value measurement. The levels within the valuation hierarchy are described below: Level 1 — Assets and liabilities with unadjusted, quoted prices listed on active market exchanges. Inputs to the fair value measurement are observable inputs, such as quoted prices in active markets for identical assets or liabilities. Level 2 — Inputs to the fair value measurement are determined using prices for recently traded assets and liabilities with similar underlying terms, as well as direct or indirect observable inputs, such as interest rates and yield curves that are observable at commonly quoted intervals. Level 3 — Inputs to the fair value measurement are unobservable inputs, such as estimates, assumptions, and valuation techniques when little or no market data exists for the assets or liabilities. Segment Reporting |
Discontinued Operations
Discontinued Operations | 9 Months Ended |
Sep. 30, 2021 | |
Discontinued Operations | |
Discontinued Operations | Note 3. Discontinued Operations On August 27, 2021, we closed the divestiture of the Company’s Legacy Business, to certain affiliates of Alora Pharmaceuticals for $111 million in cash upon closing, subject to certain post-closing adjustments, and up to $60 million in contingent milestone payments. We have determined the divestiture of the Legacy Business represents a Discontinued Operations The following table presents the results of the discontinued operations for the three- and nine -month periods ended September 30, 2021 and 2020: Three months ended Nine months ended September 30, September 30, 2021 2020 2021 2020 Total revenues $ 15,551 $ 31,421 $ 61,785 $ 116,726 Cost of goods sold (exclusive of depreciation and amortization shown separately below) 4,973 10,938 23,435 41,583 Selling, general and administrative expense 740 2,185 4,209 7,247 Depreciation and amortization — 4,592 6,583 13,925 Impairment of intangibles — 19,539 — 23,157 Research and development expenses 3,189 1,947 5,882 5,921 Income (loss) from operations 6,649 (7,780) 21,676 24,893 Interest expense 1,495 2,493 6,399 7,808 Other income (loss), net 1,171 (102) 1,058 (486) Income (loss) from discontinued operations before costs of disposal and provision for income taxes 3,983 (10,171) 14,219 17,571 Income tax expense (benefit) (132) 177 617 5,063 Income (loss) from discontinued operations before gain on disposal 4,115 (10,348) 13,602 12,508 Gain on sales of discontinued operations 4,373 — 4,373 — Income (loss) from discontinued operations, net of tax $ 8,488 $ (10,348) $ 17,975 $ 12,508 The following table presents the significant non-cash items and purchases of property, plant and equipment for the discontinued operations for the Legacy Business that are included in the accompanying consolidated statements of cash flows. Nine months ended September 30, Cash flows from operating activities: 2021 2020 Depreciation and amortization $ 6,583 $ 13,925 Share compensation 619 260 Impairment of intangibles — 23,157 Cash flows from investing activities: Purchase of property, plant and equipment $ (1,335) $ (1,707) The following table summarizes the carrying amounts of major classes of assets and liabilities of discontinued operations as of December 31, 2020. December 31, 2020 Cash and cash equivalents $ — Accounts receivable, net 23,263 Inventories 16,103 Prepaid expenses and other current assets 2,163 Total current assets of discontinued operations 41,529 Property, plant and equipment, net 25,663 Operating lease right-of-use assets 803 Goodwill 45,008 Intangible assets, net 30,667 Total non-current assets of discontinued operations 102,141 Total assets of discontinued operations $ 143,670 Accounts payable $ 3,640 Accrued liabilities 30,566 Current portion of operating lease liabilities 278 Total current liabilities of discontinued operations 34,484 Operating lease liabilities, net of current portion 568 Total non-current liabilities of discontinued operations 568 Total liabilities of discontinued operations 35,052 Net assets of discontinued operations $ 108,618 The following table presents the gain on the sale for the quarter ended September 30, 2021: September 30, 2021 Cash proceeds $ 111,848 Less: transaction costs (6,335) Less: net assets transferred (101,140) Gain on sale, pre-tax $ 4,373 |
Revenues
Revenues | 9 Months Ended |
Sep. 30, 2021 | |
Revenues | |
Revenues | Note 4. Revenues The Company’s performance obligations are to provide its pharmaceutical products based upon purchase orders from customers. The performance obligation is satisfied at a point in time, typically upon delivery, when the customer obtains control of the pharmaceutical product. The Company collects payments in advance from its customers. The following table disaggregates revenue with customers by pharmaceutical products (dollars in thousands): Three Months Ended September 30, Nine Months Ended September 30, Pharmaceutical Products 2021 2020 2021 2020 Upneeq $ 2,196 $ 52 $ 4,451 $ 52 Osmolex — 534 — 946 Net product sales 2,196 586 4,451 998 Royalty revenue — 165 190 629 Licensing revenue — 25,000 10,000 25,000 Total revenues $ 2,196 $ 25,751 $ 14,641 $ 26,627 On July 28, 2020, the Company entered into a License Agreement with Santen Pharmaceutical Co. Ltd, granting Santen exclusive development, registration, and commercialization rights to RVL-1201 in Japan, China, and other Asian countries as well as Europe, the Middle East and Africa (“EMEA”) countries. Under the agreement the Company is entitled to certain development and regulatory milestone payments. The Company is also entitled to royalty payments on net sales of RVL-1201 in Santen commercialization territories. During the three and nine months ended September 30, 2021, the Company received $0.0 million and $10.0 million, respectively, which were recognized as license revenue in the periods as all performance obligations were met. When the Company receives consideration from a customer, or such consideration is unconditionally due from a customer prior to the transfer of products to the customer under the terms of a contract, the Company records a contract liability. The Company classifies contract liabilities as deferred revenue. The Company had deferred revenue of $0.2 million for the nine months ended September 30, 2021. Contract assets primarily relate to rights to consideration for goods or services transferred to the customer when the right is conditional on something other than the passage of time. Contract assets are transferred to accounts receivable when the rights become unconditional. The Company had no contract assets as of September 30, 2021. The Company has no costs to obtain or fulfill contracts meeting the capitalization criteria under ASC Topic 340, Other Assets and Deferred Costs. |
Accounts Receivable
Accounts Receivable | 9 Months Ended |
Sep. 30, 2021 | |
Accounts Receivable | |
Accounts Receivable | Note 5. Accounts Receivable Accounts receivable result primarily from amounts due under revenue sharing, license and royalty arrangements. Trade accounts receivable, net consisted of the following (dollars in thousands): September 30, December 31, 2021 2020 Gross accounts receivable: Accounts receivable $ — $ 196 Royalty accounts receivable — 55 Other receivable 4,190 2,903 Less reserves for: Commercial rebates — (4) Discounts and allowances — (1) Total accounts receivable, net $ 4,190 $ 3,149 The Company recorded the following adjustments to gross product sales (dollars in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Gross product sales $ 2,355 $ 647 $ 4,611 $ 1,497 Less provisions for: Chargebacks (1) — (2) — Government and managed care rebates — (57) — (96) Commercial rebates — 2 — (50) Product returns — (3) — (67) Discounts and allowances (158) (1) (158) (12) Advertising and promotions — (2) — (274) Net product sales $ 2,196 $ 586 $ 4,451 $ 998 The activity in the Company’s allowance for customer deductions against trade accounts receivable was as follows (dollars in thousands): Discounts Commercial and Rebates Allowances Total Balance at January 1, 2020 $ 7 $ 2 $ 9 Provision 56 14 70 Charges processed (59) (15) (74) Balance at December 31, 2020 $ 4 $ 1 $ 5 Provision — 158 158 Charges processed (4) (159) (163) Balance at September 30, 2021 $ — $ — $ — |
Inventories
Inventories | 9 Months Ended |
Sep. 30, 2021 | |
Inventories | |
Inventories | Note 6. Inventories The components of inventories, net of allowances, were as follows (dollars in thousands): September 30, December 31, 2021 2020 Finished goods $ 824 $ 1,593 Work in process — 90 Raw materials and supplies — 148 $ 824 $ 1,831 The Company maintains an allowance for excess and obsolete inventory, as well as inventory where its cost is in excess of its net realizable value. There was no allowance for excess, obsolete, and net realizable value inventory in the nine months ended September 30, 2021 or year ended December 31, 2020. |
Goodwill and Other Intangible A
Goodwill and Other Intangible Assets | 9 Months Ended |
Sep. 30, 2021 | |
Goodwill and Other Intangible Assets | |
Goodwill and Other Intangible Assets | Note 7. Goodwill and Other Intangible Assets The Company tests goodwill and indefinite-lived intangible assets for impairment annually as of October 1 st were no indications that the fair value of goodwill was less than its carrying value. The following table sets forth the carrying value of goodwill as of September 30, 2021 and December 31, 2020. Goodwill January 1, 2020 $ 55,847 Impairments — December 31, 2020 55,847 Impairments — September 30, 2021 $ 55,847 Impairments of indefinite-lived In-Process R&D assets for the nine months ended September 30, 2021 and year ended December 31, 2020, were $7.9 million and $28.9 million, respectively, related to arbaclofen ER due to delay in anticipated commercialization of the product candidate, if approved. As part of the Company’s intangible asset impairment assessment, the Company estimates the fair value of the intangible asset using an income approach that utilizes a discounted cash flow model, or, where appropriate, a market approach. The discounted cash flow models are dependent upon our estimates of future cash flows and other factors. These estimates of future cash flows involve assumptions concerning (i) future operating performance, including future sales, long-term growth rates, operating margins, variations in the amounts, allocation and timing of cash flows and the probability of achieving the estimated cash flows and (ii) future economic conditions. These assumptions are based on significant inputs not observable in the market and thus represent Level 3 measurements within the fair value hierarchy. Indefinite-lived intangible assets classified as in-process research and development, or IPRD, are subject to adjustments reducing their anticipated revenues and costs by a probability of success, or POS, factor based upon empirical research of probabilities a new drug candidate would be approved based on the candidate’s stage of clinical development. The POS factor applied to the IPRD asset on the impairment assessment for the nine months ended September 30, 2021 and for the year ended December 31, 2020 was 69.6% and the discount rate was 12.5%. The Company believes the discount rates and other inputs and assumptions are consistent with those that a market participant would use. The following table sets forth the major categories of the Company’s intangible assets and the weighted-average remaining amortization period for those assets that were not already fully amortized (dollars in thousands): September 30, 2021 Weighted Average Remaining Gross Net Amortization Carrying Accumulated Carrying Period Amount Amortization Impairment Amount (Years) IPR&D $ 35,090 $ — $ (7,880) $ 27,210 Indefinite Lived $ 35,090 $ — $ (7,880) $ 27,210 December 31, 2020 Weighted Average Gross Net Remaining Carrying Accumulated Carrying Amortization Amount Amortization Impairment Amount Period (Years) IPR&D $ 64,000 $ — $ (28,910) $ 35,090 Indefinite Lived $ 64,000 $ — $ (28,910) $ 35,090 Changes in the net carrying amount of intangible assets were as follows (dollars in thousands): Intangible Assets Total January 1, 2020 $ 64,000 $ 64,000 Amortization — — Impairments (28,910) (28,910) December 31, 2020 35,090 35,090 Amortization — — Impairments (7,880) (7,880) September 30, 2021 $ 27,210 $ 27,210 There was no amortization expense for the nine months ended September 30, 2021 or 2020. |
Accrued Liabilities
Accrued Liabilities | 9 Months Ended |
Sep. 30, 2021 | |
Accrued Liabilities | |
Accrued Liabilities | Note 8. Accrued Liabilities Accrued liabilities consist of the following (dollars in thousands): September 30, December 31, 2021 2020 Accrued chargeback $ — $ 1,376 Accrued product returns — 88 Accrued royalties 144 29 Accrued compensation 6,570 6,232 Accrued government and managed care rebates — 46 Accrued research and development 312 721 Accrued expenses and other liabilities 11,289 8,455 Customer coupons — 4 Deferred revenue 206 — Total $ 18,521 $ 16,951 |
Financing Arrangements
Financing Arrangements | 9 Months Ended |
Sep. 30, 2021 | |
Financing Arrangements | |
Financing Arrangements | Note 9. Financing Arrangements The composition of the Company’s debt and financing obligations were as follows (dollars in thousands): September 30, December 31, 2021 2020 CIT Bank, N.A. Term Loan, net of deferred financing costs of $0.1 million and $1.8 million as of September 30, 2021 and December 31, 2020, respectively $ 29,925 $ 219,525 Total debt 29,925 219,525 Less: current portion (29,925) — Long-term debt $ — $ 219,525 Term Loan As of September 30, 2021, the interest rate was 4.75% for the Company’s Term A Loan and 5.25% for the Term B Loan. As of December 31, 2020, the interest rate was 4.75% for the Term A Loan and 5.25% for the Term B Loan. The Company was in compliance with all covenants of the Term Loan Agreement as of September 30, 2021. Revolving Facility In connection with the Fifth Amendment to the credit agreement with CIT Bank, N.A. which became effective on August 27, 2021 the Company terminated its revolving credit facility. Additionally, the Company prepaid $186.1 million in aggregate of the outstanding principal amount of its term loans. The prepayments consisted of $157.4 million of Term A Loan outstanding principal and $28.7 million of Term B Loan outstanding principal. The prepayments were made on a pro-rata basis between the Term A Loan and the Term B Loan. In accordance with ASC 470, when debt is prepaid within its contractual terms and the terms of the remaining debt are not modified, the prepayment should be treated as a partial extinguishment rather than a modification. During the second quarter, pursuant to the terms of Fourth Amendment to the Credit Agreement, the Company exercised its right to cure a shortfall in the financial covenants which resulted in the mandatory prepayment of $5.3 million of term loans. As a result of the partial extinguishment, the Company has elected, as an accounting policy in accordance with ASC 470-50-40-2, to write off a proportionate amount of the unamortized fees at the time that the financing was partially settled in accordance with the terms of the Third Amendment. The unamortized debt issuance costs are allocated between the remaining original loan balance and the portion of the loan paid down on a pro-rata basis. During the three and nine months ended September 30, 2021, the Company wrote off $1.4 million and $1.4 million of debt issuance costs, respectively, relating to the prepayments and recorded the expense in the accompanying Condensed Consolidated Statement of Operations and Comprehensive Loss. On October 12, 2021 the Company issued $55 million of senior secured notes and completed an equity follow-on offering of 14,000,000 ordinary shares and warrants to purchase 16,100,000 shares. A portion of the proceeds from these transactions was used to fully repay term loans outstanding under the credit agreement as of September 30, 2021, see Note 17, Subsequent Events. |
Concentrations and Credit Risk
Concentrations and Credit Risk | 9 Months Ended |
Sep. 30, 2021 | |
Concentrations and Credit Risk | |
Concentrations and Credit Risk | Note 10. Concentrations and Credit Risk The Company does not have significant concentrations of credit risk with its customers. Purchasing The Company does not have significant purchase agreements with third parties. |
Incentive Plans
Incentive Plans | 9 Months Ended |
Sep. 30, 2021 | |
Incentive Plans | |
Incentive Plans | Note 11. Incentive Plans The Company recognized share-based compensation expense of $5.9 million and $3.3 million during the nine months ended September 30, 2021 and 2020, respectively. In connection with the divestiture of the Company’s Legacy Business, we accelerated the vesting of certain options, restricted stock units and performance stock units under our incentive plans during the quarter. As of September 30, 2021, the total remaining unrecognized compensation cost related to non-vested share-based compensation awards, amounted to |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2021 | |
Commitments and Contingencies | |
Commitments and Contingencies | Note 12. Commitments and Contingencies Contingent Milestone Payments Upon closing of the Legacy Business divestiture, the only strategic business agreements remaining with the Company are those related to the acquisition of Upneeq and its related intellectual property. The amount of future contingent milestone payments under the intellectual property license agreement, based on certain levels of US and ex-US sales of Upneeq, was $1.3 million in the aggregate as of September 30, 2021, in addition to royalties paid to the licensor on net sales of Upneeq. The Company is also obligated to pay earn out payments pursuant to the acquisition of RevtitaLid, Inc., the original owner of Upneeq, as a percentage of US and ex-US sales of Upneeq. The Company believes the earn-out payments are currently immaterial to its financial statements. Supply Agreement Obligations The only supply agreement remaining with the Company after the divestiture of the Legacy Business is that related to the supply of Upneeq, which contains no minimum purchase obligations. Legal Proceedings The Company is a party in legal proceedings and potential claims arising from time to time in the ordinary course of its business. The amount, if any, of ultimate liability with respect to such matters cannot be determined. Despite the inherent uncertainties of litigation, management of the Company believes that the ultimate disposition of such proceedings and exposures will not have a material adverse impact on the financial condition, results of operations, or cash flows of the Company. On February 16, 2018, the Company received FDA approval for its amantadine extended release tablets under the trade name Osmolex ER. On that same date the Company filed in the Federal District Court for the District of Delaware a Complaint for Declaratory Judgment of Noninfringement of certain patents owned by Adamas Pharmaceuticals, Inc. (Osmotica Pharmaceutical US LLC and Vertical Pharmaceuticals, LLC vs. Adamas Pharmaceuticals, Inc. and Adamas Pharma, LLC). Adamas was served with the Complaint on February 21, 2018. Adamas filed an answer on April 13, 2018 denying the allegations in the Complaint and reserving the ability to raise counterclaims as the litigation progresses. On September 20, 2018, Adamas filed an amended answer to the Company’s Complaint for Declaratory Judgment of Noninfringement, with counterclaims alleging infringement of certain patents included in the Company’s Complaint and requesting that the court grant Adamas damages, injunctive relief and attorneys’ fees. On December 2, 2020, we entered into an agreement to settle the litigation with Adamas. Under the terms of the agreement, both parties agreed to drop their respective claims relating to the patent litigation, and Adamas agreed to acquire the global rights to Osmolex ER from the Company for $7.5 million. The sale of the global rights to Osmolex ER closed in January 2021 at which time the related gain was recorded. The sale of the global rights to Osmolex ER closed in January 2021 and a gain of $5.6 million was recorded in the condensed consolidated statements of operations and comprehensive loss under gain on sale of product rights, net. Additionally, in connection with the settlement and the sale of the global rights to Osmolex ER, the parties entered into a supply agreement pursuant to which the Company agreed to supply Adamas with amantadine extended release tablets for a six-year term, subject to possible two-year extensions and customary closing conditions at market rates. The supply agreement transferred to Alora as part of the divestiture of the Legacy Business. On April 30, 2019, the Company was served with a complaint in an action entitled Leo Shumacher, et al., v. Osmotica Pharmaceuticals plc, et al., Superior Court of New Jersey, Somerset County No. SOM-L-000540-19. On May 10, 2019, a Complaint entitled Jeffrey Tello, et al., v. Osmotica Pharmaceuticals plc, et al., Superior Court of New Jersey, Somerset County No. SOM-L-000617-19 was filed in the same court as the Shumacher action. The complaints named the Company, certain of the Company’s directors and officers and the underwriters of the Company’s initial public offering as defendants in putative class actions alleging violations of Sections 11 and 15 of the Securities Act of 1933 related to the disclosures contained in the registration statement and prospectus used for the Company’s initial public offering of ordinary shares. On July 22, 2019, the plaintiffs filed an amended complaint consolidating the two actions, reiterating the previously pled allegations and adding an additional individual defendant. The parties participated in a mediation and reached an agreement in principle to settle the litigation on December 15, 2020. The parties subsequently negotiated a settlement agreement setting forth the terms of the settlement. On May 18, 2021, plaintiffs filed an unopposed motion for preliminary approval of the settlement and notice to the proposed settlement class, which motion was granted by the court on June 11, 2021. The settlement, which was finally approved by the Court on November 10, 2021, calls for a payment by the Company of $5.25 million (a portion of which was covered by applicable insurance) and which fully resolves all claims asserted in the litigation against all defendants named in the litigation, including the Company. No party admitted any wrongdoing as part of the settlement, which was reached to avoid the further cost and distraction of litigation. On April 19, 2021, Vertical Pharmaceuticals, LLC (“Vertical”) was served with a complaint in an action entitled United States ex rel. Lupinetti, et al. v. Exeltis USA, Inc., et al., Northern District of Illinois, No. 1:19-cv-00825. The complaint named Vertical and four other pharmaceutical manufacturers as defendants in a suit alleging violations of the federal False Claims Act and state corollary statutory schemes related to the labelling, marketing, and reimbursement of several prenatal vitamins. The United States government declined to intervene in the action and the plaintiff has chosen to proceed with the litigation as a qui tam relator on behalf of the federal government and 29 individual states seeking monetary damages, statutory civil penalties, and costs and fees. We have retained outside counsel to defend us against the claims. On June 18, 2021, we and the other defendants in the action filed a Joint Motion to Dismiss, and on August 2, 2021, Plaintiff filed an Opposition to the Joint Motion to Dismiss. The Company disputes the allegations in the complaint and intends to vigorously defend against the action. However, this litigation matter is still in an early stage and there is no assurance that the Company will be successful in its defense or that insurance will be available or adequate to fund any settlement or judgment or the litigation costs of the action, which could adversely affect the Company’s results of operations and financial condition. There was not a loss that is probable or reasonably estimatable as of September 30, 2021. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2021 | |
Income Taxes | |
Income Taxes | Note 13. Income Taxes During the nine months ended September 30, 2021, the Company recognized an income tax expense on continuing operations of $0.4 million on $62.8 million of loss before income tax, compared to $5.0 million of income tax benefit on $42.3 million of loss before income tax during the comparable 2020 period. Income taxes for the interim periods have been based on an estimated annual worldwide effective tax rate. Income tax (expense) benefit differs from the statutory income tax rate primarily due to the occurrence of orphan drug and research development credits, movement in a valuation allowance and the addition of state and foreign taxes. The Company provides reserves for potential payments of income tax to various tax authorities or does not recognize income tax benefits related to uncertain tax positions and other issues. Tax benefits for uncertain tax positions are based on a determination of whether a tax benefit taken by the Company in its tax filings or positions is more likely than not to be realized, assuming that the matter in question will be decided based on its technical merits. The Company’s policy is to record interest and penalties in the provision for income taxes. Valuation Allowance Net deferred tax assets arise due to the recognition of income and expense items for tax purposes, which differ from those used for financial statement purposes. ASC 740, Income Taxes, provides for the recognition of deferred tax assets if the realization of such assets is more likely than not. In assessing the need for a valuation allowance in the nine months ended September 30, 2021, the Company considered all available objective and verifiable evidence both positive and negative, including historical levels of pre-tax income (loss) both on a consolidated basis and tax reporting entity basis, legislative developments, expectations and risks associated with estimates of future pre-tax income, and prudent and feasible tax planning strategies. The Company assesses the realizability of the deferred tax assets at each balance sheet date based on actuals and forecasted operating results in order to determine the proper amount, if any, of a valuation allowance. As a result of this analysis, the Company determined that it is more likely than not that it will not realize the benefits of its net deferred tax assets and therefore has recorded a valuation allowance to reduce the carrying value of its net deferred tax assets. The Company continues to maintain valuation allowances on deferred tax assets applicable to entities in foreign jurisdictions for which separate income tax returns are filed, where realization of the related deferred tax assets from future profitable operations is not reasonably assured. |
Related Parties
Related Parties | 9 Months Ended |
Sep. 30, 2021 | |
Related Parties | |
Related Parties | Note 14. Related Parties There were no related party transactions during the three months ended September 30, 2021 and had recognized no related expenses for the nine months ended September 30, 2021. |
Shareholders' Equity
Shareholders' Equity | 9 Months Ended |
Sep. 30, 2021 | |
Stockholders' Equity | |
Shareholders' Equity | Note 15. Shareholders’ Equity Ordinary Share Repurchase Program In September 2019, the Company’s Board of Directors authorized the repurchase of up to 5,251,892 ordinary shares pursuant to a share repurchase program. Purchases under the ordinary share repurchase program can be made on the open market or in privately negotiated transactions, with the size and timing of these purchases based on a number of factors, including the price and business and market conditions. The Company expects to retire ordinary shares acquired under the repurchase program. In the nine months ended September 30, 2021, the Company did not repurchase ordinary shares. 2019 Employee Share Purchase Plan In September 2019, the Company’s board of directors adopted and approved, the Employee Share Purchase Plan (the “ESPP”). The ESPP allows each eligible employee who is participating in the plan to purchase shares by authorizing payroll deductions of up to $2,000 per payroll period. Unless the participating employee has previously withdrawn from the offering, accumulated payroll deductions will be used to purchase shares on the last business day of the offering period at a price equal to 85 percent of the fair market value of the shares on the first business day or the last business day of the offering period, whichever is lower. Under applicable tax rules, an employee may purchase no more than $25,000 worth of ordinary shares, valued at the start of the purchase period, under the ESPP in any calendar year. There is no minimum holding period associated with shares purchased pursuant to this plan. An employee’s purchase rights terminate immediately upon termination of employment. The Company accounts for employee stock purchases made under its ESPP using the estimate grant date fair value of accounting in accordance with ASC 718, Stock Compensation. The purchase price discount and the look-back feature cause the ESPP to be compensatory and the Company to recognize compensation expense. The compensation cost is recognized on a straight-line basis over the requisite service period. The Company recognized less than $0.1 million of compensation expense for the nine months ended September 30, 2021. The Company values ESPP shares using the Black-Scholes model. As of September 30, 2021, there was less than $0.1 million of unrecognized ordinary share compensation expense related to the ESPP, which is expected to be recognized over a weighted-average period of 0.50 years. On July 2, 2021, the Company issued 37,111 ordinary shares to the employees who participated in the ESPP during the offering period ended September 30, 2021. 2020 Equity Offering On January 13, 2020 we completed an equity offering and allotted 6.9 million ordinary shares at a public offering price of $5.00 per share. The number of shares issued in this offering reflected the exercise in full of the underwriters option to purchase 900,000 ordinary shares. The aggregate proceeds from the follow-on offering were approximately $31.8 million after deducting underwriter discounts and commissions and offering expenses. On July 16, 2020 we completed a follow-on equity offering and allotted 5.0 million ordinary shares. The aggregate proceeds from the follow-on offering were approximately $30.6 million after deducting offering expenses. |
Restructuring Expenses
Restructuring Expenses | 9 Months Ended |
Sep. 30, 2021 | |
Restructuring Expenses | |
Restructuring Expenses | Note 16. Restructuring Expenses In April 2021, the Company curtailed operations and implemented workforce reductions in its research and development subsidiary in Buenos Aires, Argentina. These restructuring activities were associated with the Company’s plans to reduce expenses and better align business activities with the Company’s corporate strategy. As a result, the Company recognized $4.5 million of restructuring expenses in operating expenses which were incurred in the nine month period ending on September 30, 2021. The restructuring expenses consisted of $3.2 million one-time employee related termination benefits, and $1.3 million of asset disposal costs related to leasehold improvements at the Buenos Aires location. Of the $4.5 million of restructuring expenses, $2.0 million were recognized in Selling, General and Administrative expenses, $1.2 million were recognized in Research and Development expenses, and $1.3 million of asset disposal costs were recognized in non-operating expenses. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2021 | |
Subsequent Events. | |
Subsequent Events | Note 17. Subsequent Events On October 1, 2021, the Company entered into a Note Purchase Agreement (the “Note Purchase Agreement”) with, among others, Athyrium Opportunities IV Acquisition LP, as administrative agent, and certain purchasers party thereto from time to time (the “Purchaser”). The Note Purchase Agreement provides for the issuance of senior secured notes (the “Notes”) to Purchaser in an aggregate principal amount of up to $100 million in three separate tranches. The first tranche of Notes was issued in an aggregate principle amount equal to $55,000,000 on October 12, 2021. At any time after October 12, 2021 but prior to the first anniversary thereof, upon the satisfaction of certain conditions, including a minimum net product sales target for Upneeq over a specified period of time, the Company may request the issuance of second tranche Notes in an aggregate principal amount of up to $20,000,000. At any time after October 12, 2021 but prior to the second anniversary thereof, the Company may request the issuance of third tranche Notes in an aggregate principal amount of up to $25,000,000, which shall be funded in the sole discretion of the Purchasers. The Notes are guaranteed on a senior secured basis by certain of the Company’s subsidiaries. The Notes and guarantees are secured by substantially all of the assets of the Company and its U.S. subsidiaries, including a security interest in substantially all of the tangible and intangible assets of the Issuer and each guarantor, including intellectual property rights and personal property consisting of inventory, related accounts, cash and deposit accounts. The Notes bear interest at a rate of 9.0% plus adjusted three-month LIBOR, with a LIBOR floor of 1.50% and LIBOR cap of 3.00%, payable in cash quarterly arrears, and will mature five The Notes may be voluntarily prepaid upon the satisfaction of certain conditions and with each such prepayment being accompanied by, as applicable, (1) a make-whole premium, (2) an exit fee of 2.0% of the principal amount of the Notes prepaid, (3) certain other fees, indemnities and expenses and (4) all accrued interest on the principal amount of the Notes being so prepaid. The exit fee described in (2) above is payable on the principal amount of all Notes prepaid or repaid, including upon the repayment of the Notes upon maturity. Subject to certain exceptions and qualifications, the Note Purchase Agreement contains covenants that, among other things, limit the Issuer’s ability and the ability of its restricted subsidiaries, including the guarantors, to: · · · · · engage in consolidations, amalgamations or mergers, or sell, transfer or otherwise dispose of all or substantially all of their assets; and · The Note Purchase Agreement also provides for events of default which, if any of them occurs and is continuing, would require or permit (x) the principal of, premium, if any, exit fee and accrued interest on the Notes to become or to be declared due and payable and (y) the termination of the commitments (if any) of each purchaser to purchase Notes. As a condition to the effectiveness of the Note Purchase Agreement, on October 1, 2021, the Company entered into a share subscription agreement with the Purchaser for the issuance and sale of 6,148,832 ordinary shares for a price of $0.01 per share. The Company issued the shares to the Purchaser on October 12, 2021. On October 12, 2021,a portion of the proceeds of the first tranche notes, together with the proceeds from the underwritten offering described below, were used to repay in full the $29.9 million, net of deferred financing fees, outstanding under the Credit Agreement dated as of February 3, 2016 (as amended) between the Company, CIT Bank, N.A., and the other parties thereto (the “Credit Agreement”) together with $0.7 million in fees and accrued interest. The remainder of the proceeds from the first tranche notes and the issuance of ordinary shares will be used for working capital and general corporate purposes, including the launch of Upneeq. Further, on October 12, 2021 the Company completed a follow-on offering and issued and allotted 14,000,000 ordinary shares of the Company and warrants to purchase up to 14,000,000 ordinary shares, at a public offering price of $2.50 per share and accompanying warrant. In addition, the Company granted the underwriter a 30-day option to purchase up to an additional 2,100,000 ordinary shares and/or warrants to purchase additional 2,100,000 ordinary shares at the public offering price, less the underwriting discounts and commissions. On October 11, 2021 the underwriter exercised its option to purchase additional warrants to purchase up to 2,100,000 ordinary shares. The warrants have an exercise price of $3.10 per share, were immediately exercisable and will expire 3.5 years from the date of issuance. The aggregate net proceeds from the follow-on offering were approximately $32.5 million after deducting underwriting commissions and offering expenses. |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
Basis of Presentation and Summary of Significant Accounting Policies | |
Going Concern | Going Concern Evaluation As of September 30, 2021, the Company’s cash and cash equivalents totaled $8.4 million. For the fiscal year ended December 31, 2020 and the three and nine months ended September 30, 2021 the Company incurred net losses of $79.6 million, $17.9 million and $45.2 million, respectively. On August 27, 2021, the Company announced the closing of the divestiture of the Company’s portfolio of branded and non-promoted products and its Marietta, Georgia manufacturing facility, or the Legacy Business, to certain affiliates of Alora Pharmaceuticals for $111 million in cash upon closing, subject to certain post-closing adjustments, and up to $60 million in contingent milestone payments, or the Transaction. Pursuant to the Transaction the Company retained the rights to Upneeq and to arbaclofen extended release tablets, which is under development for the treatment of spasticity in multiple sclerosis. Proceeds from the divestiture of the Legacy business, together with cash on hand were used to repay $186.1 million of debt. As of September 30, 2021, the Company had interest bearing debt of $29.9 million, net of deferred financing fees, with a maturity date of November 21, 2021. On October 12, 2021 the Company issued $55.0 million of senior secured notes to a lender, a portion of the proceeds of which, together with the proceeds from the underwritten offering described below, were used to repay $30.7 million of outstanding term loans, accrued interest and related fees and expenses. Also on October 12, 2021 the Company issued 14,000,000 ordinary shares and warrants to purchase 16,100,000 shares in an underwritten offering, raising net proceeds of approximately $32.5 million. The remaining net proceeds from the issuance of the senior notes and ordinary shares is being used for general corporate purposes. The divestiture of the Legacy Business resulted in the loss of substantially all the Company’s revenue generating assets and the Company’s business plan is focused on the launch of its commercial product, Upneeq, which diminished the Company’s cash flows in at least the near term, in particular cash inflows from product sales. The Company will require additional capital to fund its operating needs, including the commercialization of Upneeq and other activities. Accordingly, the Company expects to incur significant expenditures and increasing operating losses in the future. As a result, the Company’s current sources of liquidity will not be sufficient to meet its obligations for the 12 months following the date the unaudited condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q are issued. These conditions give rise to substantial doubt as to our ability to operate as a going concern. Our ability to continue as a going concern will require us to obtain additional funding, generate positive cash flow from operations and/or enter into strategic alliances or sell assets. The Company’s plans to address these conditions include pursuing one or more of the following options to secure additional funding, none of which can be guaranteed or are entirely within our control: • raise funds through additional sales of our ordinary shares, through equity sales agreements with broker/dealers or other public or private equity financings. • • There can be no assurance the Company will receive cash proceeds from any of these potential resources or, to the extent cash proceeds are received, such proceeds would be sufficient to support the Company’s current operating plan for at least the next 12 months from the date the condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q are issued. The sale of additional equity or convertible debt securities may result in additional dilution to the Company’s stockholders. If we raise additional funds through the issuance of debt securities or preferred stock or through additional credit facilities, these securities and/or the loans under credit facilities could provide for rights senior to those of the Company’s ordinary shares and could contain covenants that would restrict the Company’s operations. Additional funds may not be available when needed, on terms that are acceptable to the Company, or at all. The unaudited condensed consolidated financial statements have been prepared on a going concern basis, which assumes the realization of assets and settlement of liabilities in the normal course of business. The Company’s ability to continue as a going concern is dependent on the Company’s ability to obtain the necessary financing to meet its obligations and repay liabilities arising from the normal business operations when they become due. The outcome of these matters cannot be predicted with any certainty at this time and raise substantial doubt that the Company will be able to continue as a going concern. The unaudited condensed consolidated financial statements do not include any adjustments to the amount and classification of assets and liabilities that may be necessary should the Company be unable to continue as a going concern. |
Basis of Presentation | Basis of Presentation nine months ended September 30, 2021, are not necessarily indicative of the results that may be expected for any future period or for the year ending December 31, 2021 or any period thereafter. The accompanying Condensed Consolidated Balance Sheet data as of December 31, 2020 was derived from the audited consolidated financial statements. These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2020. The Company accounted for the sale of the Legacy Business in accordance with Accounting Standards Codification, ASC, 205 Discontinued Operations and Accounting Standards Update, ASU, No. 2014-08, Reporting of Discontinued Operations and Disclosures of Disposals of Components of an Entity. The Company followed the held-for-sale criteria as defined in ASC 360 and ASC 205. ASC 205 requires that a component of an entity that has been disposed of or is classified as held for sale and has operations and cash flows that can be clearly distinguished from the rest of the entity be reported as assets held for sale and discontinued operations. In the period a component of an entity has been disposed of or classified as held for sale, the results of operations for the periods presented are reclassified into separate line items, net of tax, in the unaudited condensed consolidated statements of operations. Assets and liabilities are also reclassified into separate line items on the related condensed consolidated balance sheets for the periods presented. The statements of cash flows for the periods presented are also reclassified to reflect the results of discontinued operations as separate line items. ASU 2014-08 requires that only a disposal of a component of an entity, or a group of components of an entity, that represents a strategic shift that has, or will have, a major effect on the reporting entity’s operations and financial results be reported in the financial statements as discontinued operations. ASU 2014-08 also provides guidance on the financial statement presentations and disclosures of discontinued operations. Due to the sale of the Legacy Business during the third quarter of 2021, in accordance with ASC 205, Discontinued Operations, the Company has classified the results of the Legacy Business as discontinued operations in our unaudited condensed consolidated statements of operations and cash flows for all periods presented. All assets and liabilities associated with our Legacy Business were therefore classified as assets and liabilities of discontinued operations in our condensed consolidated balance sheets as of December 31, 2020. All amounts included in the notes to the unaudited condensed consolidated financial statements relate to continuing operations unless otherwise noted. For additional information, see Note 3, Discontinued Operations. |
Basic and Diluted Loss per Share | Basic and Diluted Loss per Share The following potentially dilutive securities have been excluded from the computation of diluted weighted average shares outstanding as they would be anti-dilutive as of September 30, 2021 and 2020: Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Performance and restricted stock units 1,456,910 2,092,419 1,456,910 2,591,811 Options to purchase ordinary shares 2,650,946 2,772,805 2,650,946 2,772,805 Shares to be purchased through employee stock purchase plan 79,919 — 79,919 — |
Fair Value of Financial Instruments | Fair Value of Financial Instrument receivable, accounts payable and debt approximate book value because of the short maturity of these financial instruments. The valuation hierarchy is composed of three levels. The classification within the valuation hierarchy is based on the lowest level of input that is significant to the fair value measurement. The levels within the valuation hierarchy are described below: Level 1 — Assets and liabilities with unadjusted, quoted prices listed on active market exchanges. Inputs to the fair value measurement are observable inputs, such as quoted prices in active markets for identical assets or liabilities. Level 2 — Inputs to the fair value measurement are determined using prices for recently traded assets and liabilities with similar underlying terms, as well as direct or indirect observable inputs, such as interest rates and yield curves that are observable at commonly quoted intervals. Level 3 — Inputs to the fair value measurement are unobservable inputs, such as estimates, assumptions, and valuation techniques when little or no market data exists for the assets or liabilities. |
Segment Reporting | Segment Reporting |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Basis of Presentation and Summary of Significant Accounting Policies | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Performance and restricted stock units 1,456,910 2,092,419 1,456,910 2,591,811 Options to purchase ordinary shares 2,650,946 2,772,805 2,650,946 2,772,805 Shares to be purchased through employee stock purchase plan 79,919 — 79,919 — |
Discontinued Operations (Tables
Discontinued Operations (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Legacy Products And Manufacturing Facility [Member] | Discontinued Operations, Held-for-sale or Disposed of by Sale [Member] | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |
Schedule of results of operations and carrying amounts of assets and liabilities of discontinued operations | Three months ended Nine months ended September 30, September 30, 2021 2020 2021 2020 Total revenues $ 15,551 $ 31,421 $ 61,785 $ 116,726 Cost of goods sold (exclusive of depreciation and amortization shown separately below) 4,973 10,938 23,435 41,583 Selling, general and administrative expense 740 2,185 4,209 7,247 Depreciation and amortization — 4,592 6,583 13,925 Impairment of intangibles — 19,539 — 23,157 Research and development expenses 3,189 1,947 5,882 5,921 Income (loss) from operations 6,649 (7,780) 21,676 24,893 Interest expense 1,495 2,493 6,399 7,808 Other income (loss), net 1,171 (102) 1,058 (486) Income (loss) from discontinued operations before costs of disposal and provision for income taxes 3,983 (10,171) 14,219 17,571 Income tax expense (benefit) (132) 177 617 5,063 Income (loss) from discontinued operations before gain on disposal 4,115 (10,348) 13,602 12,508 Gain on sales of discontinued operations 4,373 — 4,373 — Income (loss) from discontinued operations, net of tax $ 8,488 $ (10,348) $ 17,975 $ 12,508 Nine months ended September 30, Cash flows from operating activities: 2021 2020 Depreciation and amortization $ 6,583 $ 13,925 Share compensation 619 260 Impairment of intangibles — 23,157 Cash flows from investing activities: Purchase of property, plant and equipment $ (1,335) $ (1,707) December 31, 2020 Cash and cash equivalents $ — Accounts receivable, net 23,263 Inventories 16,103 Prepaid expenses and other current assets 2,163 Total current assets of discontinued operations 41,529 Property, plant and equipment, net 25,663 Operating lease right-of-use assets 803 Goodwill 45,008 Intangible assets, net 30,667 Total non-current assets of discontinued operations 102,141 Total assets of discontinued operations $ 143,670 Accounts payable $ 3,640 Accrued liabilities 30,566 Current portion of operating lease liabilities 278 Total current liabilities of discontinued operations 34,484 Operating lease liabilities, net of current portion 568 Total non-current liabilities of discontinued operations 568 Total liabilities of discontinued operations 35,052 Net assets of discontinued operations $ 108,618 September 30, 2021 Cash proceeds $ 111,848 Less: transaction costs (6,335) Less: net assets transferred (101,140) Gain on sale, pre-tax $ 4,373 |
Revenues (Tables)
Revenues (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Revenues | |
Schedule of disaggregation of revenue from contracts with customers | The following table disaggregates revenue with customers by pharmaceutical products (dollars in thousands): Three Months Ended September 30, Nine Months Ended September 30, Pharmaceutical Products 2021 2020 2021 2020 Upneeq $ 2,196 $ 52 $ 4,451 $ 52 Osmolex — 534 — 946 Net product sales 2,196 586 4,451 998 Royalty revenue — 165 190 629 Licensing revenue — 25,000 10,000 25,000 Total revenues $ 2,196 $ 25,751 $ 14,641 $ 26,627 |
Accounts Receivable (Tables)
Accounts Receivable (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Accounts, Notes, Loans and Financing Receivable [Line Items] | |
Schedule of components of accounts receivable | Trade accounts receivable, net consisted of the following (dollars in thousands): September 30, December 31, 2021 2020 Gross accounts receivable: Accounts receivable $ — $ 196 Royalty accounts receivable — 55 Other receivable 4,190 2,903 Less reserves for: Commercial rebates — (4) Discounts and allowances — (1) Total accounts receivable, net $ 4,190 $ 3,149 |
Schedule of adjustments to gross product sales | The Company recorded the following adjustments to gross product sales (dollars in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Gross product sales $ 2,355 $ 647 $ 4,611 $ 1,497 Less provisions for: Chargebacks (1) — (2) — Government and managed care rebates — (57) — (96) Commercial rebates — 2 — (50) Product returns — (3) — (67) Discounts and allowances (158) (1) (158) (12) Advertising and promotions — (2) — (274) Net product sales $ 2,196 $ 586 $ 4,451 $ 998 |
Trade accounts receivable | |
Accounts, Notes, Loans and Financing Receivable [Line Items] | |
Schedule of activity in allowance/liability for customer deductions | The activity in the Company’s allowance for customer deductions against trade accounts receivable was as follows (dollars in thousands): Discounts Commercial and Rebates Allowances Total Balance at January 1, 2020 $ 7 $ 2 $ 9 Provision 56 14 70 Charges processed (59) (15) (74) Balance at December 31, 2020 $ 4 $ 1 $ 5 Provision — 158 158 Charges processed (4) (159) (163) Balance at September 30, 2021 $ — $ — $ — |
Inventories (Tables)
Inventories (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Inventories | |
Summary of components of inventories, net of allowances | The components of inventories, net of allowances, were as follows (dollars in thousands): September 30, December 31, 2021 2020 Finished goods $ 824 $ 1,593 Work in process — 90 Raw materials and supplies — 148 $ 824 $ 1,831 |
Goodwill and Other Intangible_2
Goodwill and Other Intangible Assets (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Goodwill and Other Intangible Assets | |
Schedule of carrying value of goodwill | Goodwill January 1, 2020 $ 55,847 Impairments — December 31, 2020 55,847 Impairments — September 30, 2021 $ 55,847 |
Schedule of major categories of the Company's intangible assets and the weighted average remaining amortization period | September 30, 2021 Weighted Average Remaining Gross Net Amortization Carrying Accumulated Carrying Period Amount Amortization Impairment Amount (Years) IPR&D $ 35,090 $ — $ (7,880) $ 27,210 Indefinite Lived $ 35,090 $ — $ (7,880) $ 27,210 December 31, 2020 Weighted Average Gross Net Remaining Carrying Accumulated Carrying Amortization Amount Amortization Impairment Amount Period (Years) IPR&D $ 64,000 $ — $ (28,910) $ 35,090 Indefinite Lived $ 64,000 $ — $ (28,910) $ 35,090 |
Schedule of changes in the net carrying amount of intangible assets | Changes in the net carrying amount of intangible assets were as follows (dollars in thousands): Intangible Assets Total January 1, 2020 $ 64,000 $ 64,000 Amortization — — Impairments (28,910) (28,910) December 31, 2020 35,090 35,090 Amortization — — Impairments (7,880) (7,880) September 30, 2021 $ 27,210 $ 27,210 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Accrued Liabilities | |
Schedule of accrued liabilities | Accrued liabilities consist of the following (dollars in thousands): September 30, December 31, 2021 2020 Accrued chargeback $ — $ 1,376 Accrued product returns — 88 Accrued royalties 144 29 Accrued compensation 6,570 6,232 Accrued government and managed care rebates — 46 Accrued research and development 312 721 Accrued expenses and other liabilities 11,289 8,455 Customer coupons — 4 Deferred revenue 206 — Total $ 18,521 $ 16,951 |
Financing Arrangements (Tables)
Financing Arrangements (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Financing Arrangements | |
Schedule of Composition of Company's Debt and Financing Obligations | The composition of the Company’s debt and financing obligations were as follows (dollars in thousands): September 30, December 31, 2021 2020 CIT Bank, N.A. Term Loan, net of deferred financing costs of $0.1 million and $1.8 million as of September 30, 2021 and December 31, 2020, respectively $ 29,925 $ 219,525 Total debt 29,925 219,525 Less: current portion (29,925) — Long-term debt $ — $ 219,525 |
Organization and Nature of Op_2
Organization and Nature of Operations (Details) $ in Millions | Aug. 27, 2021USD ($) |
Stock transactions | |
Consideration | $ 111 |
Additional milestone payments | 60 |
Legacy Products And Manufacturing Facility [Member] | Discontinued Operations, Held-for-sale or Disposed of by Sale [Member] | |
Stock transactions | |
Consideration | 111 |
Additional milestone payments | $ 60 |
Basis of Presentation - Going C
Basis of Presentation - Going Concern Evaluation (Details) - USD ($) $ in Thousands, shares in Millions | Oct. 12, 2021 | Aug. 27, 2021 | Jul. 16, 2020 | Jan. 13, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 |
Debt Instrument [Line Items] | |||||||||||
Cash and cash equivalents | $ 8,352 | $ 126,093 | $ 8,352 | $ 126,093 | $ 114,053 | $ 95,865 | |||||
Net losses | 17,859 | 8,633 | 45,198 | $ 24,715 | $ 79,600 | ||||||
Consideration | $ 111,000 | ||||||||||
Additional milestone payments | 60,000 | ||||||||||
Debt reduction | $ 186,100 | ||||||||||
Current portion of debt, net of deferred financing costs | 29,925 | $ 29,925 | |||||||||
Number of ordinary shares issued | 5 | 6.9 | |||||||||
Issuance of ordinary shares, net of offering costs | $ 30,600 | $ 31,800 | $ 36 | $ 30,649 | $ 31,789 | ||||||
Subsequent Events | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Debt reduction | $ 30,700 | ||||||||||
Face amount of debt | $ 55,000 | ||||||||||
Number of ordinary shares issued | 14 | ||||||||||
Number of shares attributable to warrants | 16.1 | ||||||||||
Issuance of ordinary shares, net of offering costs | $ 32,500 |
Basis of Presentation - Anti-di
Basis of Presentation - Anti-dilutive shares (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Restricted Stock Units (RSUs) [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Potentially dilutive securities | 1,456,910 | 2,092,419 | 1,456,910 | 2,591,811 |
Options | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Potentially dilutive securities | 2,650,946 | 2,772,805 | 2,650,946 | 2,772,805 |
Shares to be purchased through employee stock purchase plan | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Potentially dilutive securities | 79,919 | 79,919 |
Basis of Presentation - Segment
Basis of Presentation - Segments (Details) | 9 Months Ended |
Sep. 30, 2021segment | |
Basis of Presentation and Summary of Significant Accounting Policies | |
Number of operating segments | 1 |
Number of reportable operating segments | 1 |
Discontinued Operations (Detail
Discontinued Operations (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Aug. 27, 2021 | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||
Consideration | $ 111,000 | ||||
Additional milestone payments | 60,000 | ||||
Disposal Group, Including Discontinued Operation, Income Statement Disclosures [Abstract] | |||||
Impairment of intangibles | $ 23,157 | ||||
Gain on sales of discontinued operations, net | $ 4,373 | $ 4,373 | |||
Income (loss) from discontinued operations, net of tax | 8,488 | $ (10,348) | 17,975 | 12,508 | |
Legacy Products And Manufacturing Facility [Member] | Discontinued Operations, Held-for-sale or Disposed of by Sale [Member] | |||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||
Consideration | 111,000 | ||||
Additional milestone payments | $ 60,000 | ||||
Disposal Group, Including Discontinued Operation, Income Statement Disclosures [Abstract] | |||||
Total revenues | 15,551 | 31,421 | 61,785 | 116,726 | |
Cost of goods sold (exclusive of depreciation and amortization shown separately below) | 4,973 | 10,938 | 23,435 | 41,583 | |
Selling, general and administrative expenses | 740 | 2,185 | 4,209 | 7,247 | |
Depreciation and amortization | 4,592 | 6,583 | 13,925 | ||
Impairment of intangibles | 19,539 | 23,157 | |||
Research and development expenses | 3,189 | 1,947 | 5,882 | 5,921 | |
Income (loss) from operations | 6,649 | (7,780) | 21,676 | 24,893 | |
Interest expense | 1,495 | 2,493 | 6,399 | 7,808 | |
Other income (loss), net | 1,171 | (102) | 1,058 | (486) | |
Income (loss) from discontinued operations before costs of disposal and provision for income taxes | 3,983 | (10,171) | 14,219 | 17,571 | |
Income tax expense (benefit) | (132) | 177 | 617 | 5,063 | |
Income (loss) from discontinued operations before gain on disposal | 4,115 | (10,348) | 13,602 | 12,508 | |
Gain on sales of discontinued operations, net | 4,373 | 4,373 | |||
Income (loss) from discontinued operations, net of tax | $ 8,488 | $ (10,348) | $ 17,975 | $ 12,508 |
Discontinued Operations - Cash
Discontinued Operations - Cash flows (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Cash Flows from Operating Activities: | |||
Impairment of intangibles | $ 23,157 | ||
Legacy Products And Manufacturing Facility [Member] | Discontinued Operations, Held-for-sale or Disposed of by Sale [Member] | |||
Cash Flows from Operating Activities: | |||
Depreciation and amortization | $ 4,592 | $ 6,583 | 13,925 |
Share compensation | 619 | 260 | |
Impairment of intangibles | $ 19,539 | 23,157 | |
Cash flows from Financing Activities: | |||
Purchase of property, plant and equipment | $ (1,335) | $ (1,707) |
Discontinued Operations - Balan
Discontinued Operations - Balance Sheet (Details) $ in Thousands | Dec. 31, 2020USD ($) |
Disposal Group, Including Discontinued Operation, Balance Sheet Disclosures [Abstract] | |
Total current assets of discontinued operations | $ 41,529 |
Total non-current assets of discontinued operations | 102,141 |
Total current liabilities of discontinued operations | 34,484 |
Total non-current liabilities of discontinued operations | 568 |
Legacy Products And Manufacturing Facility [Member] | Discontinued Operations, Held-for-sale or Disposed of by Sale [Member] | |
Disposal Group, Including Discontinued Operation, Balance Sheet Disclosures [Abstract] | |
Accounts receivable, net | 23,263 |
Inventories | 16,103 |
Prepaid expenses and other current assets | 2,163 |
Total current assets of discontinued operations | 41,529 |
Property, plant and equipment, net | 25,663 |
Operating lease right-of-use assets | 803 |
Goodwill | 45,008 |
Intangible assets, net | 30,667 |
Total non-current assets of discontinued operations | 102,141 |
Total assets of discontinued operations | 143,670 |
Accounts payable | 3,640 |
Accrued liabilities | 30,566 |
Current portion of operating lease liabilities | 278 |
Total current liabilities of discontinued operations | 34,484 |
Operating lease liabilities, net of current portion | 568 |
Total non-current liabilities of discontinued operations | 568 |
Total liabilities of discontinued operations | 35,052 |
Net assets of discontinued operations | $ 108,618 |
Discontinued Operations - Gain
Discontinued Operations - Gain on Sale (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2021 | Sep. 30, 2021 | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Proceeds from discontinued operations | $ 110,845 | |
Gain on sale, pre-tax | $ 4,373 | 4,373 |
Legacy Products And Manufacturing Facility [Member] | Discontinued Operations, Held-for-sale or Disposed of by Sale [Member] | ||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Proceeds from discontinued operations | 111,848 | |
Less: Transaction costs | (6,335) | |
Less: Net assets transferred | (101,140) | |
Gain on sale, pre-tax | $ 4,373 | $ 4,373 |
Revenues (Details)
Revenues (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Disaggregation of Revenue [Line Items] | ||||
Revenues | $ 2,196,000 | $ 25,751,000 | $ 14,641,000 | $ 26,627,000 |
Contract with customer, asset and liability | ||||
Deferred revenue | 200,000 | 200,000 | ||
Contract assets | 0 | 0 | ||
Cost to obtain or fulfill contracts | 0 | 0 | ||
Product Revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | 2,196,000 | 586,000 | 4,451,000 | 998,000 |
Osmolex [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | 534,000 | 946,000 | ||
Upneeq | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | 2,196,000 | 52,000 | 4,451,000 | 52,000 |
Royalty Revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | 165,000 | 190,000 | 629,000 | |
License and contract revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | $ 0 | $ 25,000,000 | $ 10,000,000 | $ 25,000,000 |
Accounts Receivable - Trade acc
Accounts Receivable - Trade accounts receivable, net (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||
Reserves | $ (5) | $ (9) | |
Total trade accounts receivable, net | $ 4,190 | 3,149 | |
Commercial rebates | |||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||
Reserves | (4) | (7) | |
Discounts and allowances | |||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||
Reserves | (1) | $ (2) | |
Trade accounts receivable | |||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||
Gross trade accounts receivable | 196 | ||
Royalty accounts receivable | |||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||
Gross trade accounts receivable | 55 | ||
Other receivable | |||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||
Gross trade accounts receivable | $ 4,190 | $ 2,903 |
Accounts Receivable - Adjustmen
Accounts Receivable - Adjustment to gross product sales (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||
Revenues | $ 2,196 | $ 25,751 | $ 14,641 | $ 26,627 |
Product Revenue | ||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||
Gross product sales | 2,355 | 647 | 4,611 | 1,497 |
Revenues | 2,196 | 586 | 4,451 | 998 |
Product Revenue | Chargebacks | ||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||
Adjustments to gross products sales | (1) | (2) | ||
Product Revenue | Government And Managed Care Rebates [Member] | ||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||
Adjustments to gross products sales | (57) | (96) | ||
Product Revenue | Commercial rebates | ||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||
Adjustments to gross products sales | 2 | (50) | ||
Product Revenue | Product returns | ||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||
Adjustments to gross products sales | (3) | (67) | ||
Product Revenue | Discounts and allowances | ||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||
Adjustments to gross products sales | $ (158) | $ (1) | $ (158) | $ (12) |
Accounts Receivable - Allowance
Accounts Receivable - Allowance for customer deduction (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | ||
Balance at beginning of period | $ 5 | $ 9 |
Provision | 158 | 70 |
Charges processed | (163) | (74) |
Balance at end of period | 5 | |
Commercial rebates | ||
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | ||
Balance at beginning of period | 4 | 7 |
Provision | 56 | |
Charges processed | (4) | (59) |
Balance at end of period | 4 | |
Discounts and allowances | ||
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | ||
Balance at beginning of period | 1 | 2 |
Provision | 158 | 14 |
Charges processed | $ (159) | (15) |
Balance at end of period | $ 1 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Inventories | ||
Finished goods | $ 824 | $ 1,593 |
Work in process | 90 | |
Raw materials and supplies | 148 | |
Total | 824 | 1,831 |
Summary of activity in the allowance for excess, obsolete, and net realizable value inventory account | ||
Balance at beginning of period | 5 | 9 |
Provision | 158 | 70 |
Charges processed | (163) | (74) |
Balance at end of period | 5 | |
Allowance for excess and obsolete inventory | ||
Summary of activity in the allowance for excess, obsolete, and net realizable value inventory account | ||
Provision | 0 | 0 |
Charges processed | $ 0 | $ 0 |
Goodwill and Other Intangible_3
Goodwill and Other Intangible Assets - Goodwill (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Goodwill [Roll Forward] | ||
Goodwill, Beginning Balance | $ 55,847 | $ 55,847 |
Goodwill impairment | 0 | 0 |
Goodwill, Ending Balance | $ 55,847 | $ 55,847 |
Goodwill and Other Intangible_4
Goodwill and Other Intangible Assets - Major Categories (Details) $ in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | |
Schedule of major categories of the Company's intangible assets and the weighted average remaining amortization period | |||
Impairment of intangibles | $ 7,880 | $ 28,910 | |
Impairment | (7,880) | (28,910) | |
Gross carrying amount | 35,090 | 64,000 | |
Net carrying amount | 27,210 | 35,090 | $ 64,000 |
IPR&D | |||
Schedule of major categories of the Company's intangible assets and the weighted average remaining amortization period | |||
Impairment of intangibles | 7,880 | 28,910 | |
Gross carrying amount, Indefinite-lived | 35,090 | 64,000 | |
Impairment | (7,880) | (28,910) | |
Indefinite-lived intangible assets | 27,210 | 35,090 | |
Net carrying amount | $ 27,210 | $ 35,090 | $ 64,000 |
IPR&D | Measurement Input, Discount Rate [Member] | |||
Schedule of major categories of the Company's intangible assets and the weighted average remaining amortization period | |||
Intangible Asset Measurement Input | 0.125 | 0.125 | |
IPR&D | Measurement Input, Discount for Lack of Marketability [Member] | |||
Schedule of major categories of the Company's intangible assets and the weighted average remaining amortization period | |||
Intangible Asset Measurement Input | 0.696 | 0.696 |
Goodwill and Other Intangible_5
Goodwill and Other Intangible Assets - Changes in Net Carrying Amount of Intangible Assets (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Schedule of major categories of the Company's intangible assets and the weighted average remaining amortization period | |||
Balance at the beginning of the period | $ 35,090 | $ 64,000 | $ 64,000 |
Amortization | 0 | 0 | |
Impairments | (7,880) | (28,910) | |
Balance at the end of the period | 27,210 | 35,090 | |
Amortization expense | 0 | 0 | |
IPR&D | |||
Schedule of major categories of the Company's intangible assets and the weighted average remaining amortization period | |||
Balance at the beginning of the period | 35,090 | $ 64,000 | 64,000 |
Impairments | (7,880) | (28,910) | |
Balance at the end of the period | $ 27,210 | $ 35,090 |
Accrued Liabilities (Details)
Accrued Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Accrued Liabilities | ||
Accrued Chargeback | $ 1,376 | |
Accrued product returns | 88 | |
Accrued royalties | $ 144 | 29 |
Accrued compensation | 6,570 | 6,232 |
Accrued government and managed care rebates | 46 | |
Accrued research and development | 312 | 721 |
Accrued expenses and other liabilities | 11,289 | 8,455 |
Customer coupons | 4 | |
Deferred revenue | 206 | |
Accrued Liabilities | $ 18,521 | $ 16,951 |
Financing Arrangements - Compon
Financing Arrangements - Components (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Financing Arrangements | ||
Long-term debt | $ 29,925 | $ 219,525 |
Less current portion | (29,925) | |
Long-term debt, net of non-current deferred financing costs | 219,525 | |
Deferred financing costs | 100 | 1,800 |
CIT Bank, N.A. Term Loan | ||
Financing Arrangements | ||
Long-term debt | $ 29,925 | $ 219,525 |
Financing Arrangements - Term l
Financing Arrangements - Term loan (Details) | Sep. 30, 2021 | Dec. 31, 2020 |
Term A Loan | ||
Financing Arrangements | ||
Effective interest rate (as percent) | 4.75% | 4.75% |
Term B Loan | ||
Financing Arrangements | ||
Effective interest rate (as percent) | 5.25% | 5.25% |
Financing Arrangements - Revolv
Financing Arrangements - Revolving credit facility (Details) - USD ($) $ in Thousands, shares in Millions | Oct. 12, 2021 | Aug. 27, 2021 | Jul. 16, 2020 | Jan. 13, 2020 | Sep. 30, 2021 | Jun. 30, 2021 | Sep. 30, 2021 | Sep. 30, 2020 |
Financing Arrangements | ||||||||
Debt issuance costs written off | $ 1,400 | $ 1,387 | $ 496 | |||||
Number of ordinary shares issued | 5 | 6.9 | ||||||
Subsequent Events | ||||||||
Financing Arrangements | ||||||||
Face amount of debt | $ 55,000 | |||||||
Number of ordinary shares issued | 14 | |||||||
Number of shares attributable to warrants | 16.1 | |||||||
CIT Bank, N.A. Term Loan | ||||||||
Financing Arrangements | ||||||||
Repayment Of Debt, Principal Portion | $ 186,100 | $ 5,300 | ||||||
CIT Bank, N.A. Term Loan | Subsequent Events | ||||||||
Financing Arrangements | ||||||||
Repayment Of Debt, Principal Portion | $ 29,900 | |||||||
Term A Loan | ||||||||
Financing Arrangements | ||||||||
Repayment Of Debt, Principal Portion | 157,400 | |||||||
Term B Loan | ||||||||
Financing Arrangements | ||||||||
Repayment Of Debt, Principal Portion | $ 28,700 |
Incentive Plans - (Details)
Incentive Plans - (Details) - USD ($) $ in Millions | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based compensation expense | $ 5.9 | $ 3.3 |
Unrecognized compensation cost | $ 5.4 | |
Unrecognized compensation cost, recognition period | 6 months | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | ||
Granted | 150,188 | 1,644,778 |
Outstanding at end of period, shares | 1,456,910 | |
Number of shares that vested during the period | 451,061 | 280,381 |
Options outstanding, weighted average contractual term | 1 year 18 days | |
Remaining contractual term | 2 years 3 months 25 days |
Commitments and Contingencies -
Commitments and Contingencies - Legal (Details) $ in Thousands | Jun. 11, 2021USD ($) | Apr. 19, 2021item | Jan. 31, 2021USD ($) | Sep. 30, 2021USD ($) | Jul. 22, 2019item |
Commitments and Contingencies | |||||
Aggregate milestones payable | $ 1,300 | ||||
Proceeds from product rights disposal | $ 7,500 | 7,300 | |||
Gain on sales of product rights, net | $ 5,600 | $ 5,636 | |||
Agreement Term | 6 years | ||||
Agreement Extension Period | 2 years | ||||
Number of claims | item | 2 | ||||
Settlement to be paid | $ 5,250 | ||||
Number of defendants | item | 4 | ||||
Number of states seeking damages | item | 29 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Income Taxes | ||||
Income tax expense (benefit) | $ 324 | $ (1,308) | $ 415 | $ (5,042) |
Loss before income tax | $ 26,023 | $ (407) | $ 62,758 | $ 42,265 |
Related Parties (Details)
Related Parties (Details) - Avista | 9 Months Ended |
Sep. 30, 2021USD ($) | |
Related Party Transaction [Line Items] | |
Accrued liability | $ 0 |
Related party expenses | $ 0 |
Shareholders' Equity - Share re
Shareholders' Equity - Share repurchase program, ESPP, SBC (Details) - USD ($) | Jul. 02, 2021 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2019 |
Equity, Class of Treasury Stock [Line Items] | ||||
Repurchase authorization, number of shares | 5,251,892 | |||
Shares repurchased, in shares | 0 | |||
Maximum deduction per pay period | $ 2,000 | |||
Share price, as percentage of fair market value | 85.00% | |||
Unrecognized compensation cost | $ 5,400,000 | |||
ESPP, shares issued during the period | 37,111 | |||
Share-based compensation expense | $ 5,900,000 | $ 3,300,000 | ||
Unrecognized compensation cost, recognition period | 6 months | |||
Maximum | ||||
Equity, Class of Treasury Stock [Line Items] | ||||
ESPP expense recognized | $ 100,000 | |||
Employee Share Purchase Plan 2019 [Member] | Maximum | ||||
Equity, Class of Treasury Stock [Line Items] | ||||
Unrecognized compensation cost | $ 100,000 |
Shareholders' Equity - Equity o
Shareholders' Equity - Equity offering (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | Jul. 16, 2020 | Jan. 13, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Mar. 31, 2020 |
Subsidiary, Sale of Stock [Line Items] | |||||
Number of ordinary shares issued | 5,000 | 6,900 | |||
Sale of Stock, Price Per Share | $ 5 | ||||
Issuance of ordinary shares, net of offering costs | $ 30,600 | $ 31,800 | $ 36 | $ 30,649 | $ 31,789 |
Over-Allotment Option [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Number of ordinary shares issued | 900 |
Restructuring Expenses (Details
Restructuring Expenses (Details) $ in Millions | 9 Months Ended |
Sep. 30, 2021USD ($) | |
Restructuring Cost and Reserve [Line Items] | |
Restructuring expenses | $ 4.5 |
Selling, general and administrative expenses | |
Restructuring Cost and Reserve [Line Items] | |
Restructuring expenses | 2 |
Research and development | |
Restructuring Cost and Reserve [Line Items] | |
Restructuring expenses | 1.2 |
Nonoperating Income (Expense) [Member] | |
Restructuring Cost and Reserve [Line Items] | |
Restructuring expenses | 1.3 |
Special Termination Benefits [Member] | |
Restructuring Cost and Reserve [Line Items] | |
Restructuring expenses | 3.2 |
Facility Closing [Member] | |
Restructuring Cost and Reserve [Line Items] | |
Restructuring expenses | $ 1.3 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) $ / shares in Units, $ in Thousands | Oct. 12, 2021 | Oct. 11, 2021 | Oct. 01, 2021 | Aug. 27, 2021 | Jul. 16, 2020 | Jan. 13, 2020 | Jun. 30, 2021 | Sep. 30, 2021 | Sep. 30, 2020 |
Subsequent Events | |||||||||
Number of ordinary shares issued | 5,000,000 | 6,900,000 | |||||||
Proceeds from public offering, net of issuance costs | $ 36 | $ 62,440 | |||||||
Over-Allotment Option [Member] | |||||||||
Subsequent Events | |||||||||
Number of ordinary shares issued | 900,000 | ||||||||
CIT Bank, N.A. Term Loan | |||||||||
Subsequent Events | |||||||||
Repayment of principal | $ 186,100 | $ 5,300 | |||||||
Term A Loan | |||||||||
Subsequent Events | |||||||||
Repayment of principal | 157,400 | ||||||||
Term B Loan | |||||||||
Subsequent Events | |||||||||
Repayment of principal | $ 28,700 | ||||||||
Subsequent Events | |||||||||
Subsequent Events | |||||||||
Face amount of debt | $ 55,000 | ||||||||
Number of ordinary shares issued | 14,000,000 | ||||||||
Number of shares attributable to warrants | 16,100,000 | ||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 3.10 | ||||||||
Warrants and Rights Outstanding, Term | 3 years 6 months | ||||||||
Proceeds from public offering, net of issuance costs | $ 32,500 | ||||||||
Subsequent Events | Share subscription agreement | |||||||||
Subsequent Events | |||||||||
Number of ordinary shares issued | 6,148,832 | ||||||||
Share Price | $ 0.01 | ||||||||
Subsequent Events | Over-Allotment Option [Member] | |||||||||
Subsequent Events | |||||||||
Number of ordinary shares issued | 2,100,000 | 2,100,000 | |||||||
Number of shares attributable to warrants | 2,100,000 | ||||||||
Subsequent Events | Follow On Offering [Member] | |||||||||
Subsequent Events | |||||||||
Number of ordinary shares issued | 14,000,000 | ||||||||
Share Price | $ 2.50 | ||||||||
Number of shares attributable to warrants | 14,000,000 | ||||||||
Subsequent Events | Senior Secured Notes Under Note Purchase Agreement [Member] | |||||||||
Subsequent Events | |||||||||
Interest rate | 9.00% | ||||||||
Debt instrument term | 5 years | ||||||||
Exit fee (as a percent) | 2.00% | ||||||||
Subsequent Events | Senior Secured Notes Under Note Purchase Agreement [Member] | Minimum | |||||||||
Subsequent Events | |||||||||
Margin rate, as a percent | 1.50% | ||||||||
Subsequent Events | Senior Secured Notes Under Note Purchase Agreement [Member] | Maximum | |||||||||
Subsequent Events | |||||||||
Margin rate, as a percent | 3.00% | ||||||||
Subsequent Events | Senior Secured Notes Under Note Purchase Agreement, Tranche One [Member] | |||||||||
Subsequent Events | |||||||||
Face amount of debt | $ 55,000 | ||||||||
Subsequent Events | CIT Bank, N.A. Term Loan | |||||||||
Subsequent Events | |||||||||
Repayment of principal | 29,900 | ||||||||
Repayment of accrued interest | $ 700 | ||||||||
Subsequent Events | Scenario, Plan [Member] | Senior Secured Notes Under Note Purchase Agreement [Member] | |||||||||
Subsequent Events | |||||||||
Face amount of debt | $ 100,000 | ||||||||
Subsequent Events | Scenario, Plan [Member] | Senior Secured Notes Under Note Purchase Agreement, Tranche Two [Member] | |||||||||
Subsequent Events | |||||||||
Face amount of debt | 20,000 | ||||||||
Subsequent Events | Scenario, Plan [Member] | Senior Secured Notes Under Note Purchase Agreement, Tranche Three [Member] | |||||||||
Subsequent Events | |||||||||
Face amount of debt | $ 25,000 |