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REDHILL BIOPHARMA LTD.
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(the "Registrant")
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Date: March 17, 2022
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By:
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/s/ Dror Ben-Asher
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Dror Ben-Asher
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Chief Executive Officer
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Press Release
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• |
A prespecified mortality analysis, undertaken for all patients from the Phase 2/3 study who were receiving remdesivir and corticosteroids at baseline, demonstrated a significant 70.2% mortality benefit for opaganib-treated patients, with
a mortality rate of 6.98% (n=3/43) for the opaganib arm + SoC versus 23.4% (n=11/47) for placebo + SoC by Day 42 (p-value=0.034).
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A second prespecified analysis showed that opaganib delivered a significant 34% benefit in time to recovery, defined as achieving a score of 1 or less on the WHO Ordinal Scale by Day 14, with 37.4% of opaganib-treated patients (n=86/230)
reaching this event versus 27.9% of patients (n=65/233) treated with placebo + SoC (p-value=0.013, Hazard Ratio 1.49).
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A third prespecified analysis, of all oral opaganib's Phase 2/3 study patients with positive PCR at screening, demonstrated that opaganib improved the median time to viral RNA clearance by at least 4 days. Treatment with opaganib
resulted in viral RNA clearance in a median of 10 days while the median for clearance in the placebo arm was not reached by the end of 14-days treatment for placebo (Hazard Ratio 1.34; nominal p-value=0.043, N=437/463)
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Company contact:
Adi Frish
Chief Corporate and Business Development Officer
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
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Media contacts:
U.S.: Bryan Gibbs, Finn Partners
+1 212 529 2236
bryan.gibbs@finnpartners.com
UK: Amber Fennell, Consilium
+44 (0) 7739 658 783
fennell@consilium-comms.com
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Year Ended December 31,
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||||||||||||
2021
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2020
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2019
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U.S. dollars in thousands
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||||||||||||
NET REVENUES
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85,757
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64,359
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6,291
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COST OF REVENUES
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49,406
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36,892
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2,259
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GROSS PROFIT
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36,351
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27,467
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4,032
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RESEARCH AND DEVELOPMENT EXPENSES
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29,498
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16,491
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17,419
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SELLING AND MARKETING EXPENSES
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55,623
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49,285
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18,333
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GENERAL AND ADMINISTRATIVE EXPENSES
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32,365
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25,375
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11,481
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OPERATING LOSS
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81,135
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63,684
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43,201
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FINANCIAL INCOME
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51
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270
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1,335
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FINANCIAL EXPENSES
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16,660
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12,759
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438
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FINANCIAL EXPENSES (INCOME), net
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16,609
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12,489
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(897
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)
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LOSS AND COMPREHENSIVE LOSS FOR THE YEAR
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97,744
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76,173
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42,304
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LOSS PER ORDINARY SHARE, basic and diluted (U.S. dollars)
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0.21
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0.21
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0.14
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Year Ended December 31,
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2021
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2020
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2019
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U.S. dollars in thousands
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OPERATING ACTIVITIES:
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Comprehensive loss
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(97,744
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)
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(76,173
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)
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(42,304
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)
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Adjustments in respect of income and expenses not involving cash flow:
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Share-based compensation to employees and service providers
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10,212
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4,202
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3,027
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Depreciation
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1,914
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1,710
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997
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Amortization and impairment of intangible assets
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16,235
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7,035
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216
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Non-cash interest expenses related to borrowing and payable in respect of intangible assets purchase
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5,366
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6,032
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—
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Fair value adjustments on derivative financial instruments
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—
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—
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(344
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)
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Fair value (gains) losses on financial assets at fair value through profit or loss
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5
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94
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(27
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)
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Exchange differences and revaluation of bank deposits
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118
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101
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24
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33,850
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19,174
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3,893
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Changes in assets and liability items:
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Increase in trade receivables
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(3,021
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)
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(27,439
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)
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(258
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Decrease (increase) in prepaid expenses and other receivables
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860
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(3,277
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)
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(368
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Increase in inventories
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(8,285
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)
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(4,644
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(1,113
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Increase in accounts payable
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111
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7,369
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860
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Increase (decrease) in accrued expenses and other liabilities
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(3,186
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)
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19,335
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(2,726
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)
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Increase in allowance for deductions from revenue
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12,368
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17,076
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1,267
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(1,153
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8,420
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(2,338
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Net cash used in operating activities
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(65,047
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(48,579
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(40,749
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INVESTING ACTIVITIES:
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Purchase of fixed assets
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(115
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(406
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(168
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Purchase of intangible assets
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—
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(53,368
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(35
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Change in investment in current bank deposits
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(8,500
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)
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10,200
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(2,069
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)
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Purchase of financial assets at fair value through profit or loss
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—
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—
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(4,325
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)
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Proceeds from sale of financial assets at fair value through profit or loss
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475
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7,925
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11,761
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Net cash provided by (used in) investing activities
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(8,140
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)
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(35,649
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)
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5,164
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FINANCING ACTIVITIES:
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Proceeds from long-term borrowings, net of transaction costs
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—
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78,061
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—
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Proceeds from issuance of ordinary shares, net of issuance costs
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78,536
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23,867
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36,300
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Exercise of options into ordinary shares
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4,006
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52
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5
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Repayment of payable in respect of intangible asset purchase
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(7,397
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—
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—
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Increase in restricted cash
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—
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(20,000
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—
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Decrease in restricted cash
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—
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4,000
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—
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Payment of principal with respect to lease liabilities
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(1,683
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(1,610
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(796
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Net cash provided by financing activities
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73,462
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84,370
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35,509
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INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
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275
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142
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(76
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EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
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(96
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)
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130
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94
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BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
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29,295
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29,023
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29,005
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BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD
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29,474
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29,295
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29,023
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SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN CASH
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47
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414
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753
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SUPPLEMENTARY INFORMATION ON INTEREST PAID IN CASH
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11,280
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6,654
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251
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SUPPLEMENTARY INFORMATION ON NON-CASH INVESTING AND FINANCING ACTIVITIES:
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Acquisition of right-of-use assets by means of lease liabilities
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303
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2,930
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2,805
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Purchase of intangible assets posted as payable
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—
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24,619
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—
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|||||||||
Purchase of an intangible asset in consideration for issuance of shares
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—
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1,914
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11,788
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