Document and Entity Information
Document and Entity Information | 6 Months Ended |
Jun. 30, 2021 | |
Document and Entity Information [Abstract] | |
Document Type | 6-K |
Document Period End Date | Jun. 30, 2021 |
Entity Registrant Name | RedHill Biopharma Ltd. |
Amendment Flag | false |
Entity Central Index Key | 0001553846 |
Current Fiscal Year End Date | --12-31 |
Document Fiscal Year Focus | 2021 |
Document Fiscal Period Focus | Q2 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | ||||
NET REVENUES | $ 21,502 | $ 20,899 | $ 42,077 | $ 21,955 |
COST OF REVENUES | 10,590 | 14,188 | 20,843 | 15,903 |
GROSS PROFIT | 10,912 | 6,711 | 21,234 | 6,052 |
RESEARCH AND DEVELOPMENT EXPENSES | 10,328 | 3,214 | 17,812 | 5,979 |
SELLING AND MARKETING EXPENSES | 15,235 | 9,964 | 29,130 | 18,970 |
GENERAL AND ADMINISTRATIVE EXPENSES | 10,235 | 6,033 | 17,330 | 10,619 |
OPERATING LOSS | 24,886 | 12,500 | 43,038 | 29,516 |
FINANCIAL INCOME | 15 | 108 | 31 | 322 |
FINANCIAL EXPENSES | 4,250 | 3,655 | 8,977 | 4,010 |
FINANCIAL EXPENSES, net | 4,235 | 3,547 | 8,946 | 3,688 |
LOSS AND COMPREHENSIVE LOSS FOR THE PERIOD | $ 29,121 | $ 16,047 | $ 51,984 | $ 33,204 |
LOSS PER ORDINARY SHARE, basic and diluted (U.S. dollars): | $ 0.06 | $ 0.04 | $ 0.12 | $ 0.09 |
WEIGHTED AVERAGE OF ORDINARY SHARES (in thousands) | 466,801 | 357,668 | 448,411 | 355,168 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 51,816 | $ 29,295 |
Bank deposits | 3,521 | 17 |
Financial assets at fair value through profit or loss | 481 | |
Trade receivables | 30,098 | 28,655 |
Prepaid expenses and other receivables | 4,292 | 5,521 |
Inventory | 8,763 | 6,526 |
Total current assets | 98,490 | 70,495 |
NON-CURRENT ASSETS: | ||
Restricted cash | 16,161 | 16,164 |
Fixed assets | 506 | 511 |
Right-of-use assets | 4,294 | 5,192 |
Intangible assets | 84,222 | 87,879 |
Total non-current assets | 105,183 | 109,746 |
TOTAL ASSETS | 203,673 | 180,241 |
CURRENT LIABILITIES: | ||
Accounts payable | 13,306 | 11,553 |
Lease liabilities | 1,692 | 1,710 |
Allowance for deductions from revenue | 26,096 | 18,343 |
Accrued expenses and other current liabilities | 23,162 | 24,082 |
Payable in respect of intangible asset purchase | 14,916 | 17,547 |
Total current liabilities | 79,172 | 73,235 |
NON-CURRENT LIABILITIES: | ||
Borrowing | 83,159 | 81,386 |
Payable in respect of intangible assets purchase | 8,035 | 7,199 |
Lease liabilities | 2,976 | 3,807 |
Royalty obligation | 750 | 750 |
Total non-current liabilities | 94,920 | 93,142 |
TOTAL LIABILITIES | 174,092 | 166,377 |
EQUITY: | ||
Ordinary shares | 1,311 | 1,054 |
Additional paid-in capital | 354,442 | 293,144 |
Accumulated deficit | (326,172) | (280,334) |
TOTAL EQUITY | 29,581 | 13,864 |
TOTAL LIABILITIES AND EQUITY | $ 203,673 | $ 180,241 |
CONDENSED CONSOLIDATED INTERIM
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY - USD ($) $ in Thousands | Ordinary shares | Additional paid-in capital | Accumulated deficit | Total |
Balance at beginning of period at Dec. 31, 2019 | $ 962 | $ 267,403 | $ (208,363) | $ 60,002 |
Share-based compensation to employees and service providers | 1,425 | 1,425 | ||
Issuance of ordinary shares, net of expenses | 24 | 6,339 | 6,363 | |
Comprehensive loss | (33,204) | (33,204) | ||
Balance at end of period at Jun. 30, 2020 | 986 | 273,742 | (240,142) | 34,586 |
Balance at beginning of period at Mar. 31, 2020 | 962 | 267,403 | (224,718) | 43,647 |
Share-based compensation to employees and service providers | 623 | 623 | ||
Issuance of ordinary shares, net of expenses | 24 | 6,339 | 6,363 | |
Comprehensive loss | (16,047) | (16,047) | ||
Balance at end of period at Jun. 30, 2020 | 986 | 273,742 | (240,142) | 34,586 |
Balance at beginning of period at Dec. 31, 2020 | 1,054 | 293,144 | (280,334) | 13,864 |
Share-based compensation to employees and service providers | 6,146 | 6,146 | ||
Issuance of ordinary shares, net of expenses | 243 | 57,971 | 58,214 | |
Exercise of options into ordinary shares | 14 | 3,327 | 3,341 | |
Comprehensive loss | (51,984) | (51,984) | ||
Balance at end of period at Jun. 30, 2021 | 1,311 | 354,442 | (326,172) | 29,581 |
Balance at beginning of period at Mar. 31, 2021 | 1,309 | 354,057 | (302,325) | 53,041 |
Share-based compensation to employees and service providers | 5,274 | 5,274 | ||
Issuance of ordinary shares, net of expenses | 1 | 272 | 273 | |
Exercise of options into ordinary shares | 1 | 113 | 114 | |
Comprehensive loss | (29,121) | (29,121) | ||
Balance at end of period at Jun. 30, 2021 | $ 1,311 | $ 354,442 | $ (326,172) | $ 29,581 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
OPERATING ACTIVITIES: | ||||
Comprehensive loss | $ (29,121) | $ (16,047) | $ (51,984) | $ (33,204) |
Adjustments in respect of income and expenses not involving cash flow: | ||||
Share-based compensation to employees and service providers | 5,274 | 623 | 6,146 | 1,425 |
Depreciation | 465 | 417 | 957 | 767 |
Amortization and impairment of intangible assets | 1,830 | 1,773 | 3,657 | 2,849 |
Non-cash interest expenses related to borrowing and payable in respect of intangible assets purchase | 1,217 | 1,513 | 3,856 | 1,617 |
Fair value losses (gains) on financial assets at fair value through profit or loss | (38) | 6 | 37 | |
Exchange differences and revaluation of bank deposits | 17 | (6) | 63 | (165) |
Total adjustments in respect of income and expenses not involving cash flow | 8,803 | 4,282 | 14,685 | 6,530 |
Changes in assets and liability items: | ||||
Increase in trade receivables | (6,792) | (16,853) | (1,443) | (17,354) |
Decrease (increase) in prepaid expenses and other receivables | (199) | (3,266) | 1,229 | (2,626) |
Decrease (increase) in inventories | 507 | (1,983) | (2,237) | (2,868) |
Increase in accounts payable | 6,770 | 2,123 | 1,753 | 1,124 |
Increase (decrease) in accrued expenses and other liabilities | (2,284) | 17,804 | (920) | 22,123 |
Increase (decrease) in allowance for deductions from revenue | 3,418 | (1,089) | 7,753 | (428) |
Total changes in assets and liability items | 1,420 | (3,264) | 6,135 | (29) |
Net cash used in operating activities | (18,898) | (15,029) | (31,164) | (26,703) |
INVESTING ACTIVITIES: | ||||
Purchase of fixed assets | (3) | (20) | (91) | (191) |
Purchase of intangible assets | (52,500) | (52,633) | ||
Change in investment in current bank deposits | (3,500) | 1,000 | (3,500) | 4,200 |
Proceeds from sale of financial assets at fair value through profit or loss | 1,725 | 475 | 3,950 | |
Net cash (used in) investing activities | (3,503) | (49,795) | (3,116) | (44,674) |
FINANCING ACTIVITIES: | ||||
Proceeds from long-term borrowing, net of transaction costs | (500) | 78,845 | ||
Proceeds from issuance of ordinary shares, net of issuance costs | 273 | 6,363 | 58,214 | 6,363 |
Exercise of options into ordinary shares | 114 | 3,341 | ||
Repayment of payable in respect of intangible asset purchase | (1,754) | (3,879) | ||
Increase in restricted cash | (20,000) | |||
Payment of principal with respect to lease liabilities | (402) | (404) | (785) | (736) |
Net cash (used in) provided by financing activities | (1,769) | 5,459 | 56,891 | 64,472 |
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | (24,170) | (59,365) | 22,612 | (6,905) |
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS | 14 | 23 | (91) | 154 |
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 75,972 | 81,614 | 29,295 | 29,023 |
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD | 51,816 | 22,272 | 51,816 | 22,272 |
SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN CASH | 52 | 71 | 71 | 249 |
SUPPLEMENTARY INFORMATION ON INTEREST PAID IN CASH | $ 3,026 | 2,129 | $ 5,016 | 2,360 |
SUPPLEMENTARY INFORMATION ON NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||||
Acquisition of right-of-use assets by means of lease liabilities | 630 | 2,205 | ||
Purchase of intangible assets posted as payable | $ 12,058 | 12,808 | ||
Long-term borrowing transaction costs | $ 784 |
GENERAL
GENERAL | 6 Months Ended |
Jun. 30, 2021 | |
GENERAL | |
GENERAL | NOTE 1 - GENERAL: a. General 1) The Company’s ordinary shares were traded on the Tel-Aviv Stock Exchange (“TASE”) from February 2011 to February 2020, after which the Company voluntarily delisted from trading on the TASE, effective February 13, 2020. The Company’s American Depositary Shares (“ADSs”) were traded on the Nasdaq Capital Market from December 27, 2012 and have been listed on the Nasdaq Global Market (“Nasdaq”) since July 20, 2018. The Company’s registered address is 21 Ha’arba’a St, Tel-Aviv, Israel. 2) Since the Company established its commercial presence in the U.S. in 2017, it has promoted or commercialized various GI-related products that were either developed internally or acquired through in-licensing agreements. As of the date of approval of these condensed consolidated interim financial statements, the Company commercializes in the U.S., Talicia ® , for the treatment of Helicobacter pylori infection in adults , the first product approved by the U .S. Food and Drug Administration (“FDA”) being developed primarily internally by the Company, Movantik ® , for the treatment of opioid-induced constipation, and Aemcolo ® (rifamycin) , for traveler’s diarrhea. Effective April 1, 2020, RedHill Inc. entered into an exclusive license agreement (the “License Agreement”) with AstraZeneca AB (“AstraZeneca”), granting RedHill Inc. exclusive, worldwide (excluding Europe, Canada) commercialization and development rights to Movantik ® 3) The Company plans to further fund its future operations through commercialization and out-licensing of its therapeutic candidates, commercialization of in-licensed or acquired products and raising additional capital through equity or debt financing or through non-dilutive financing. The Company’s current cash resources are not sufficient to complete the research and development of all of its therapeutic candidates and to fully support its commercial operations until generation of sustainable positive cash flows. Management expects that the Company will incur additional losses as it continues to focus its resources on advancing the development of its therapeutic candidates, as well as advancing its commercial operations, based on a prioritized plan that will result in negative cash flows from operating activities. The Company believes its existing capital resources should be sufficient to fund its current and planned operations for at least the next 12 months. If the Company is unable to out-license, sell or commercialize its therapeutic candidates, generate sufficient and sustainable revenues from its commercial operations, or obtain future financing, the Company may be forced to delay, reduce the scope of, or eliminate one or more of its research and development or commercialization programs, any of which may have a material adverse effect on the Company’s business, financial condition or results of operations. The current COVID-19 pandemic has presented substantial public health and economic challenges around the world and specifically in the Company’s target markets in the U.S., affecting employees, patients, medical clinics, medical diagnosis, communities and business operations. The full extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations and financial condition will depend on future developments that are highly uncertain and cannot be accurately predicted at this stage. The Company took actions designed to mitigate the potential impact of the COVID-19 pandemic on its business operations and to date, the COVID-19 pandemic has not caused significant disruptions to the supply chain and the Company has sufficient supply on hand to meet U.S. commercial demand and clinical studies needs. A number of the Company’s commercial activities have been impacted by the COVID-19 pandemic, including some launch sales and marketing activities for Talicia ® H. pylori ® Although no major disruptions, other than manageable impact on its development and commercial activities, the Company continues to assess the potential impact of the COVID-19 pandemic on its business and operations, including on its sales, expenses, supply chain, financial resources, and clinical trials. b. Approval of the condensed consolidated interim financial statements: These condensed consolidated interim financial statements were approved by the Board of Directors (the "BoD") on August 25, 2021. |
BASIS OF PREPARATION OF THE CON
BASIS OF PREPARATION OF THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS | 6 Months Ended |
Jun. 30, 2021 | |
BASIS OF PREPARATION OF THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS | |
BASIS OF PREPARATION OF THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS | NOTE 2 - BASIS OF PREPARATION OF THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS: The accounting policies applied in the preparation of the Condensed Consolidated Interim Financial Statements are consistent with those applied in the preparation of the annual financial statements as of December 31, 2020. |
SIGNIFICANT EVENTS DURING THE C
SIGNIFICANT EVENTS DURING THE CURRENT REPORTING PERIOD | 6 Months Ended |
Jun. 30, 2021 | |
SIGNIFICANT EVENTS DURING THE CURRENT REPORTING PERIOD | |
SIGNIFICANT EVENTS DURING THE CURRENT REPORTING PERIOD | NOTE 3 - SIGNIFICANT EVENTS DURING THE CURRENT REPORTING PERIOD: a. Movantik ® License Agreement amendment In connection with the agreements mentioned in 1a(2), in April 2020, RedHill Inc. made an upfront payment of $52.5 million to AstraZeneca. Under the terms of the License Agreement, as amended on July 14, 2020, RedHill Inc. agreed to pay a further noncontingent payment of $15.5 million in December 2021. On March 11, 2021, RedHill Inc and AstraZeneca signed an amendment to the License Agreement. Pursuant to which, the $15.5 million payment due in December 2021 will be adjusted to gradual payments starting in March 2021 and ending in December 2022, totaling $16 million. The amendment is not considered a substantial modification of the terms and resulted in an adjustment of approximately $0.5 million in the carrying amount of the payable in respect of intangible assets purchase and a corresponding charge in the statements of comprehensive loss, under financial expenses. b. During the six months ended June 30, 2021, the Company issued 7,836,209 and 428,421 ADSs for net proceeds of approximately $58 million from underwritten offerings and $3 million from options exercises, respectively. c. On February 22, 2021, Aether Therapeutics Inc., filed a complaint against the Company in the United States District Court for the District of Delaware ("Aether Litigation"). The complaint asserts that the Company's marketing of the Movantik® product infringes U.S. Patent No’s. 6,713,488, 8,748,448, 8,883,817 and 9,061,024 held by Aether Therapeutics Inc., or the Aether Patents. Aether has asserted the Aether Patents against other entities previously involved in the marketing of the Movantik® product. The complaint requests customary remedies for patent infringement, including (i) a judgment that the Company has infringed, contributed to and induced infringement of the Aether patents, (ii) damages, (iii) attorneys’ fees and (iv) costs and expenses. the Company intends to vigorously defend itself against these claims. Given the early stage of the Aether Litigation, the Company is unable to predict the likelihood of success of the claims of Aether Therapeutics Inc. or to quantify any risk of loss. d. Write-downs of inventories to net realizable value amounted to $1.2 million in the six months ended June 30, 2021. These were recognized as an expense, included in cost of revenues in the statement of comprehensive loss. |
ALLOWANCE FOR DEDUCTIONS FROM R
ALLOWANCE FOR DEDUCTIONS FROM REVENUES | 6 Months Ended |
Jun. 30, 2021 | |
ALLOWANCE FOR DEDUCTIONS FROM REVENUES | |
ALLOWANCE FOR DEDUCTIONS FROM REVENUES | NOTE 4 : - ALLOWANCE FOR DEDUCTIONS FROM REVENUES: The following table shows the movement of the allowance for deductions from revenues: Rebates and patient discount programs Product returns Total U.S. dollars in thousands As of January 1, 2021 16,380 1,963 18,343 Increases 41,679 956 42,635 Decreases (utilized) (33,643) (576) (34,219) Adjustments (692) 29 (663) As of June 30, 2021 23,724 2,372 26,096 (0) — — (0) Rebates and patient discount programs Product returns Total U.S. dollars in thousands As of January 1, 2020 1,001 266 1,267 Increases 252 392 644 Decreases (utilized) (372) (28) (400) Adjustments (698) 26 (672) As of June 30, 2020 183 656 839 Rebates and patient discount programs Product returns Total U.S. dollars in thousands As of April 1, 2021 20,497 2,180 22,677 Increases 23,873 495 24,368 Decreases (utilized) (20,614) (333) (20,947) Adjustments (32) 30 (2) As of June 30, 2021 23,724 2,372 26,096 (0) (0) — (0) Rebates and patient discount programs Product returns Total U.S. dollars in thousands As of April 1, 2020 948 650 1,598 Increases — — — Decreases (utilized) (149) (20) (169) Adjustments (616) 26 (590) As of June 30, 2020 183 656 839 |
SHARE-BASED PAYMENTS
SHARE-BASED PAYMENTS | 6 Months Ended |
Jun. 30, 2021 | |
SHARE-BASED PAYMENTS | |
SHARE-BASED PAYMENTS | NOTE 5 - SHARE-BASED PAYMENTS: Number of options granted According to the Award Plan Exercise Fair value of of the Company price for 1 options on date of Other than ADS ($) grant in U.S. dollars Date of BoD directors (1) To directors (1)(2) Total in thousands (1)(2)(3) March 2021 40,500 — 40,500 9.44 151 April 2021 2,036,096 310,341 2,346,437 7.08 9,584 May 2021 22,500 — 22,500 7.05 90 2,099,096 310,341 2,409,437 9,825 1) 1/4 2) 3) 4) Exchange of options to purchase the Company’s ADSs: a. On April 26, 2021, the Company made an o ffer ( the “Exchange Offer”) to eligible option holders (as defined in the offer), subject to specified conditions, to exchange some or all of their outstanding options to purchase ADSs ( the “Exchanged Options”) for new options to purchase ADSs ( the “New Options” ). On May 26, 2021, concurrently with the expiration of the Exchange Offer, the Company granted New Options to purchase 2,805,281 ADSs of the Company, pursuant to the terms of the Exchange Offer and the Company’s Amended and Restated Award Plan (2010). The New Options have lower exercise price per ADS than the Exchanged Options and subject to meeting certain performance conditions, specified in the Exchange Offer, may be further lowered. Other than the exercise price, each New Option has the same expiration date, vesting schedule and other terms as the Exchanged Options . b. The incremental compensation expense recognized by the Company has been measured as the excess of the fair value of each New Option granted, as of the date the New Options were granted, over the fair value of the Exchanged Options, measured immediately prior to the exchange. The total incremental value measured by the Company is approximately $3.5 million, of which $2.9 million were recognized as expense in the six months ended June 30, 2021. The remaining incremental value will be recognized over the remaining vesting period of the New Options. c. 58.8% |
NET REVENUES
NET REVENUES | 6 Months Ended |
Jun. 30, 2021 | |
NET REVENUES | |
NET REVENUES | NOTE 6 - NET REVENUES: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 U.S dollars in thousands U.S dollars in thousands Movantik® revenues 19,212 19,951 38,113 19,951 Other products 2,290 948 3,964 2,004 21,502 20,899 42,077 21,955 |
FINANCIAL INSTRUMENTS
FINANCIAL INSTRUMENTS | 6 Months Ended |
Jun. 30, 2021 | |
FINANCIAL INSTRUMENTS | |
FINANCIAL INSTRUMENTS | NOTE 7 - FINANCIAL INSTRUMENTS: a. Fair value hierarchy The Company's financial assets as of December 31, 2020, measured at fair value, are at level 1. The Company has no liabilities measured at fair value in the reported periods. During the reported periods, there were no transfers of financial assets between Levels 1, 2, or 3 fair value measurements. b. The fair value of the borrowing and Payable in respect of intangible assets purchase is approximately $104 million and $25 million as of June 30, 2021, respectively . |
SEGMENT INFORMATION
SEGMENT INFORMATION | 6 Months Ended |
Jun. 30, 2021 | |
SEGMENT INFORMATION | |
SEGMENT INFORMATION | NOTE 8 - SEGMENT INFORMATION: The Company has two segments, Commercial Operations and Research and Development. The following table presents net revenues and operating loss for the Company's segments for the three and six months ended June 2021 and 2020: Three Months Ended June 30, Six Months Ended June 30, 2021 2021 June 30, 2021: Commercial Operations Research and Development Consolidated Commercial Operations Research and Development Consolidated U.S. dollars in thousands U.S. dollars in thousands Net revenues 21,502 — 21,502 42,077 — 42,077 Operating loss 10,081 14,805 24,886 18,596 24,442 43,038 2020 2020 Commercial Operations Research and Development Consolidated Commercial Operations Research and Development Consolidated U.S. dollars in thousands U.S. dollars in thousands Net revenues 20,899 — 20,899 21,955 — 21,955 Operating loss 8,029 4,471 12,500 20,332 9,184 29,516 |
ALLOWANCE FOR DEDUCTIONS FROM_2
ALLOWANCE FOR DEDUCTIONS FROM REVENUES (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
ALLOWANCE FOR DEDUCTIONS FROM REVENUES | |
Schedule of movement of allowance for deductions from revenue | Rebates and patient discount programs Product returns Total U.S. dollars in thousands As of January 1, 2021 16,380 1,963 18,343 Increases 41,679 956 42,635 Decreases (utilized) (33,643) (576) (34,219) Adjustments (692) 29 (663) As of June 30, 2021 23,724 2,372 26,096 (0) — — (0) Rebates and patient discount programs Product returns Total U.S. dollars in thousands As of January 1, 2020 1,001 266 1,267 Increases 252 392 644 Decreases (utilized) (372) (28) (400) Adjustments (698) 26 (672) As of June 30, 2020 183 656 839 Rebates and patient discount programs Product returns Total U.S. dollars in thousands As of April 1, 2021 20,497 2,180 22,677 Increases 23,873 495 24,368 Decreases (utilized) (20,614) (333) (20,947) Adjustments (32) 30 (2) As of June 30, 2021 23,724 2,372 26,096 (0) (0) — (0) Rebates and patient discount programs Product returns Total U.S. dollars in thousands As of April 1, 2020 948 650 1,598 Increases — — — Decreases (utilized) (149) (20) (169) Adjustments (616) 26 (590) As of June 30, 2020 183 656 839 |
SHARE-BASED PAYMENTS (Tables)
SHARE-BASED PAYMENTS (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
SHARE-BASED PAYMENTS | |
Schedule of information on options granted | Number of options granted According to the Award Plan Exercise Fair value of of the Company price for 1 options on date of Other than ADS ($) grant in U.S. dollars Date of BoD directors (1) To directors (1)(2) Total in thousands (1)(2)(3) March 2021 40,500 — 40,500 9.44 151 April 2021 2,036,096 310,341 2,346,437 7.08 9,584 May 2021 22,500 — 22,500 7.05 90 2,099,096 310,341 2,409,437 9,825 1) 1/4 2) 3) 4) Exchange of options to purchase the Company’s ADSs: a. On April 26, 2021, the Company made an o ffer ( the “Exchange Offer”) to eligible option holders (as defined in the offer), subject to specified conditions, to exchange some or all of their outstanding options to purchase ADSs ( the “Exchanged Options”) for new options to purchase ADSs ( the “New Options” ). On May 26, 2021, concurrently with the expiration of the Exchange Offer, the Company granted New Options to purchase 2,805,281 ADSs of the Company, pursuant to the terms of the Exchange Offer and the Company’s Amended and Restated Award Plan (2010). The New Options have lower exercise price per ADS than the Exchanged Options and subject to meeting certain performance conditions, specified in the Exchange Offer, may be further lowered. Other than the exercise price, each New Option has the same expiration date, vesting schedule and other terms as the Exchanged Options . b. The incremental compensation expense recognized by the Company has been measured as the excess of the fair value of each New Option granted, as of the date the New Options were granted, over the fair value of the Exchanged Options, measured immediately prior to the exchange. The total incremental value measured by the Company is approximately $3.5 million, of which $2.9 million were recognized as expense in the six months ended June 30, 2021. The remaining incremental value will be recognized over the remaining vesting period of the New Options. c. 58.8% |
NET REVENUES (Tables)
NET REVENUES (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
NET REVENUES | |
Schedule of net revenues | Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 U.S dollars in thousands U.S dollars in thousands Movantik® revenues 19,212 19,951 38,113 19,951 Other products 2,290 948 3,964 2,004 21,502 20,899 42,077 21,955 |
SEGMENT INFORMATION (Tables)
SEGMENT INFORMATION (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
SEGMENT INFORMATION | |
Schedule of segment information | Three Months Ended June 30, Six Months Ended June 30, 2021 2021 June 30, 2021: Commercial Operations Research and Development Consolidated Commercial Operations Research and Development Consolidated U.S. dollars in thousands U.S. dollars in thousands Net revenues 21,502 — 21,502 42,077 — 42,077 Operating loss 10,081 14,805 24,886 18,596 24,442 43,038 2020 2020 Commercial Operations Research and Development Consolidated Commercial Operations Research and Development Consolidated U.S. dollars in thousands U.S. dollars in thousands Net revenues 20,899 — 20,899 21,955 — 21,955 Operating loss 8,029 4,471 12,500 20,332 9,184 29,516 |
SIGNIFICANT EVENTS DURING THE_2
SIGNIFICANT EVENTS DURING THE CURRENT REPORTING PERIOD - Movantik Transaction (Details) - USD ($) $ in Thousands | Apr. 01, 2020 | Jun. 30, 2020 | Jun. 30, 2020 | Mar. 11, 2021 |
Disclosure of detailed information about intangible assets [line items] | ||||
Upfront payment for acquisition of rights | $ 52,500 | $ 52,633 | ||
AstraZeneca AB | Movantik | ||||
Disclosure of detailed information about intangible assets [line items] | ||||
Upfront payment for acquisition of rights | $ 52,500 | |||
Agreement amount payable for acquisition of rights | $ 15,500 | $ 16,000 | ||
Increase in agreement amount payable for acquisition of rights | $ 500 |
SIGNIFICANT EVENTS DURING THE_3
SIGNIFICANT EVENTS DURING THE CURRENT REPORTING PERIOD - Equity Offering (Details) $ in Millions | 6 Months Ended |
Jun. 30, 2021USD ($)shares | |
At-the-market equity offering program | |
Disclosure of classes of share capital [line items] | |
Net proceeds from issuing shares | $ | $ 58 |
Proceeds from exercise of options | $ | $ 3 |
ADSs | Issuance tranche one | |
Disclosure of classes of share capital [line items] | |
Number of shares issued | shares | 7,836,209 |
ADSs | Issuance tranche two | |
Disclosure of classes of share capital [line items] | |
Number of shares issued | shares | 428,421 |
SIGNIFICANT EVENTS DURING THE_4
SIGNIFICANT EVENTS DURING THE CURRENT REPORTING PERIOD - Inventories (Details) $ in Millions | 6 Months Ended |
Jun. 30, 2021USD ($) | |
SIGNIFICANT EVENTS DURING THE CURRENT REPORTING PERIOD | |
Inventory write-down | $ 1.2 |
ALLOWANCE FOR DEDUCTIONS FROM_3
ALLOWANCE FOR DEDUCTIONS FROM REVENUES (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Disclosure of other provisions [line items] | ||||
Balance at beginning of the period | $ 22,677 | $ 1,598 | $ 18,343 | $ 1,267 |
Increases | 24,368 | 42,635 | 644 | |
Decreases (utilized) | (20,947) | (169) | (34,219) | (400) |
Adjustments | (2) | (590) | (663) | (672) |
Balance at end of the period | 26,096 | 839 | 26,096 | 839 |
Rebates and Patient Discount Programs | ||||
Disclosure of other provisions [line items] | ||||
Balance at beginning of the period | 20,497 | 948 | 16,380 | 1,001 |
Increases | 23,873 | 41,679 | 252 | |
Decreases (utilized) | (20,614) | (149) | (33,643) | (372) |
Adjustments | (32) | (616) | (692) | (698) |
Balance at end of the period | 23,724 | 183 | 23,724 | 183 |
Product returns | ||||
Disclosure of other provisions [line items] | ||||
Balance at beginning of the period | 2,180 | 650 | 1,963 | 266 |
Increases | 495 | 956 | 392 | |
Decreases (utilized) | (333) | (20) | (576) | (28) |
Adjustments | 30 | 26 | 29 | 26 |
Balance at end of the period | $ 2,372 | $ 656 | $ 2,372 | $ 656 |
SHARE-BASED PAYMENTS (Details)
SHARE-BASED PAYMENTS (Details) | Jul. 26, 2021USD ($) | Jun. 30, 2021USD ($)$ / shares | Jun. 30, 2021USD ($)installment$ / shares |
2021 | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Number of options granted | 2,409,437 | ||
Fair value of options on date of grant in U.S. dollars in thousands | $ 9,825,000 | $ 9,825,000 | |
March 2021 | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Number of options granted | 40,500 | ||
Exercise price for 1 ADS ($) | $ / shares | $ 9.44 | ||
Fair value of options on date of grant in U.S. dollars in thousands | 151,000 | $ 151,000 | |
April 2021 | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Number of options granted | 2,346,437 | ||
Exercise price for 1 ADS ($) | $ / shares | $ 7.08 | ||
Fair value of options on date of grant in U.S. dollars in thousands | 9,584,000 | $ 9,584,000 | |
May 2021 | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Number of options granted | 22,500 | ||
Exercise price for 1 ADS ($) | $ / shares | $ 7.05 | ||
Fair value of options on date of grant in U.S. dollars in thousands | $ 90,000 | $ 90,000 | |
Stock Options | Exchange Offer | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Number of options granted | 2,805,281 | ||
Incremental value measured | 3,500,000 | ||
Expense recognized | $ 2,900,000 | ||
Stock Options | Minimum | Exchange Offer | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Exercise price for 1 ADS ($) | $ / shares | $ 4.3 | ||
Expected volatility | 58.80% | ||
Risk free interest rate | 0.01% | ||
Stock Options | Maximum | Exchange Offer | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Exercise price for 1 ADS ($) | $ / shares | $ 7 | ||
Expected volatility | 65.28% | ||
Risk free interest rate | 2.31% | ||
Stock Options | 2021 | Minimum | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Price of the Company's ordinary shares | $ / shares | $ 7.05 | ||
Expected volatility | 64.05% | ||
Risk free interest rate | 1.58% | ||
Stock Options | 2021 | Maximum | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Price of the Company's ordinary shares | $ / shares | $ 9.44 | ||
Expected volatility | 64.06% | ||
Risk free interest rate | 1.73% | ||
Stock Options | 2021 | Vesting, services exceeding one year | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Number of equal quarterly vesting installments | installment | 16 | ||
Vesting period | 4 years | ||
Stock Options | 2021 | Vesting, services exceeding one year | Minimum | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Service period | 1 year | ||
Stock Options | 2021 | Vesting, services not exceeding one year | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Number of equal quarterly vesting installments | installment | 12 | ||
Vesting period | 1 year | ||
Percentage of options vesting | 0.25% | ||
Option term | 10 years | ||
Stock Options | 2021 | Vesting, services not exceeding one year | Maximum | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Service period | 1 year | ||
Other than directors | 2021 | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Number of options granted | 2,099,096 | ||
Other than directors | March 2021 | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Number of options granted | 40,500 | ||
Other than directors | April 2021 | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Number of options granted | 2,036,096 | ||
Other than directors | May 2021 | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Number of options granted | 22,500 | ||
To directors | 2021 | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Number of options granted | 310,341 | ||
To directors | April 2021 | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Number of options granted | 310,341 | ||
Event subsequent to reporting period | To directors | Stock Options | |||
Disclosure of terms and conditions of share-based payment arrangement [line items] | |||
Number of options granted | 310,341 |
NET REVENUES (Details)
NET REVENUES (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Revenues | ||||
Other products | $ 2,290 | $ 948 | $ 3,964 | $ 2,004 |
Revenue | 21,502 | 20,899 | 42,077 | 21,955 |
Movantik | ||||
Revenues | ||||
Revenue | $ 19,212 | $ 19,951 | $ 38,113 | $ 19,951 |
FINANCIAL INSTRUMENTS (Details)
FINANCIAL INSTRUMENTS (Details) - USD ($) $ in Millions | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
Financial instruments | ||
Transfers between levels 1, 2 or 3 fair value measurements | $ 0 | $ 0 |
Borrowing | ||
Financial instruments | ||
Fair value | 104 | |
Payable in respect of intangible asset purchase | ||
Financial instruments | ||
Fair value | $ 25 |
SEGMENT INFORMATION (Details)
SEGMENT INFORMATION (Details) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($)segment | Jun. 30, 2020USD ($) | |
Disclosure of operating segments [line items] | ||||
Number of segments | segment | 2 | |||
Net revenues | $ 21,502 | $ 20,899 | $ 42,077 | $ 21,955 |
Operating loss | 24,886 | 12,500 | 43,038 | 29,516 |
Commercial Operations | ||||
Disclosure of operating segments [line items] | ||||
Net revenues | 21,502 | 20,899 | 42,077 | 21,955 |
Operating loss | 10,081 | 8,029 | 18,596 | 20,332 |
Research and Development | ||||
Disclosure of operating segments [line items] | ||||
Operating loss | $ 14,805 | $ 4,471 | $ 24,442 | $ 9,184 |