 |
- ????????? 21.5 ?????????????????????????? 2 ????? 2021 ????????? 4.5% ???????????? 1 ????? 2021 ????????????????????????????? ??????????????[1]??? 71.5 ??????????? ? ?????? 30 ???????? 2021
- ??????????????????? Talicia® ?????????????????????? 10% ????????????? Movantik® ?????????????????? 5.6% ????????????????? Talicia ??? Movantik ???????????????????????????????????????????????????????????? 8 ??? 9 ???????? 10 ??????????
- ?? opaganib ???????????????????????????????????? Quantum Leap Healthcare Collaborative ??? BARDA ?????????????????????????? I-SPY COVID-19 ?????????????? BARDA
- ?????????????????????????????????????? opaganib ???????????????????????????-19 ??????????????
- ????????????????????????????????????????? 2/3 ???????????????????-19 ?????????????????????????????????????????????????
- ????????????????? 2 ?????????? opaganib ????????????????????????? ??????????????????????????? ??????????????????????? ??????????????????????????????????????????????????????????????????? ???????????????????????????????????????????????????????????????? ???????? ???????????????
- ????????????????????????????????????????? ???? 8.30 ?. ?????????????????????? (EST)
????????, ???????? ???????, ?????????????
30 ??????? 2564
/PRNewswire/ -- (NASDAQ: RDHL) ("RedHill" ???? "??????") ??????????????????????????? ?????????????????????????????????????????????????????????????????????? 2 ??????????? ? ?????? 30 ???????? 2021
Dror Ben-Asher ?????????????????????????? RedHill ???????? "????????????????????????????????????????? ? ??????????? ?? opaganib ????????????????????????????????????????????????????????????-19 ????????????????? ???????????????????????? opaganib ????????????????? SARS-CoV-2 ???????????????????? ?????????????????????????????????????????????????? ??????????????????????????? 2/3 ???????????????????????????????????????????????????-19 ????????????? ??????????????????????????????????????????????????????????????????????????????????????????" ?????? Ben-Asher ???????????? "?????????????????????? ????????????????????????????????????? ????????????????????????????????????? Talicia ??? Movantik ??????????????????? Talicia ??????????????????????????????????????????????????????????????????????? ????????????????????????????????????????????????????????????????????????????????????????????? H. pylori ??????????????????????????????????????????????????? ???????????????????????????????????????????????"
Micha Ben Chorin ?????????????????????????????????? RedHill ???????? "???????????????????? ???????????????????????????????????????????????????????????????????? ?????????????????????????????????????????????????????????????????? ??????????? 21.5 ???????????????????????????????????????????? 50% ?????????????????????????????????????????????? RedHill ????????????????????????????????????????????????????"
??????????????????????????????????????????????????????????????? ? ?????? 30 ???????? 2021[2]
??????????? (Net Revenues) ?????????? 21.5 ?????????????????????????????????? 2021 ????????? 0.9 ???????????????????????????? 2021 ?????????????????????????????????????????????????????? Talicia® ??? Movantik® ????????????????????????????????????
??????????? (Gross Profit) ?????????? 10.9 ?????????????????????????????????? 2021 ????????????????????????????????????? 51%
?????????????????????????????? ?????????? 10.3 ?????????????????????????????????? 2021 ????????? 2.8 ???????????????????????????? 2021 ???????????????????????????????????????????????????????????????-19 ??????
???????????????????? ??????? ????????????????????????????????? ?????????? 25.5 ?????????????????????????????????? 2021 ????????? 4.5 ???????????????????????????? 2021 ??????????????????????????????????????????????????????????????????????????????????????????????? (share-based compensation) ??????????????????????
????????????????????????????????????????? ????????????? 24.9 ?????????????? 29.1 ?????????????????????????????????????????? 2021 ??? 18.2 ?????????????? 22.9 ??????????????????????????????????? 2021 ????????????????????????????????????????????????????????????????????????????????????????????????????????-19 ?????????????????? ????????????????????????????????????????????????????????????????????????????????????
???????????????????????????????????? ?????????? 18.9 ?????????????????????????????????? 2021 ????????? 6.6 ???????????????????????????? 2021 ?????????????????????????????????????????????????????????????????????????????????
????????????????????????????????????? ?????????? 18.9 ?????????????????????????????????? 2021 ?????????????????????????????????????????? Movantik
?????????[1] ? ?????? 30 ???????? 2021 ?????????? 71.5 ???????????
?????????????????????
Movantik ® (naloxegol)[3]
??????????????????????????????????????????????????????????????????????????? Movantik ??????????????????????????????????????????????????? ?????????????????????????????? 5.6%
????????????????????????????????????????????????????????????????????????????????????? ???????????????????????????????????????????????????????????????????????? ?????????????? ??????????????????????????????????????????????????????? ? ?????????? ??????????????????????????????????? Blue Cross ??? Blue Shield ??????? ??????????????????? 30 ??????? ???????? Movantik ????????????????????????????????????????????????????? Commercial NetResults "A" ??????????????? 1 ??????? 2021 ????????? ???????????????? Movantik ??????????????????????????? Part D ????????????????????????????????????????????????????? ??????????? 9 ?? 10 ???????????????????????????????????????????????????????????????? ???????????????????????????????????????????????????????????????????
?????????????? 2021 ?????????????????? RedHill Biopharma Inc., AstraZeneca AB, AstraZeneca Pharmaceuticals LP ??? Nektar Therapeutics ?????????????????????????????????????? Apotex, Inc. ??? Apotex Corp. (Apotex) ??????????????????????????????????????? ???????? Apotex ?????????????????????????? Abbreviated New Drug Application (ANDA) ????????????????????????????????????????????????????? (FDA) ?????????????????? Movantik ????????????? ???????????????????????????????? Apotex ?????????????????? Movantik ?????????????????????????? 1 ?????? 2030 (???????????????????????? FDA) ???????????????????????????
Talicia® (omeprazole magnesium, amoxicillin ??? rifabutin)[4]
Talicia ????????????????????????????????? ????????????????????????????????? 10% ???????????????????????????
?????????????? ???????????????????????????????????????? Talicia ??????????????? ???????????? OptumRx ????????????? UnitedHealth Group ???????????????????????????????????????????????????????????????????????????????? 1.3 ??????????????????????? 6,500 ???? ???????? Talicia ????????????????????? Commercial Formulary ????????????????????????????????????????????????????????????????????????????? H. pylori ?????????????? 1 ??????? 2021 ????????????????????????????? Talicia ??????????????????????? 26 ?????? ???????????????????? Talicia ???????????????????????? 8 ?? 10 ??????????????????????????????????????????
Aemcolo® (rifamycin)[5]
??????????????????????????? Aemcolo ??????????????????? 2021 ????????????????????????????????????????? ???????????????????????????????????????????????????????????????? Aemcolo ??????????????????????????????-19 ?????????????????????????????????????????????? Aemcolo ??????????????????????????????????????????????????????????????????
????????????????????????????????????
????????????-19: Opaganib (ABC294640)[6]
?????????????????????????????????????????????????????????? opaganib ???????????? 2/3 ??????????????????????????????????????????-19 ?????????????????????????? 475 ?? () ?????????????????????????????????????? ?????????????? opaganib ???????????????????????????????????????????????????????????????????????????????????????-19 ????????????????????????????????????????????????????????????????-19 ??????????
????????????????????????????????????????????? Quantum Leap Healthcare Collaborative ??? Biomedical Advanced Research and Development Authority (BARDA) ?????????????? ???????????????? opaganib ???????????????????????????? I-SPY COVID-19 Trial ??? BARDA ??????????????????????? opaganib ??????? ??????? I-SPY ?????????????????????????????????????????????????????????-19 ??????????
opaganib ???????????????????????????????????????????????????? sphingosine kinase-2 (SK2) ???????????????????????????????????????????????????????????? ?????????????????????????????????????????? ??????????????????????????????????? ? ???????????????????????????????????????????????????????????????????????????????? opaganib ????????????????????????????????-19 ??????????????????????????????????????? ????????????????????????????????????????????????????????????????????? ??????????????????????????????????????????????????????????????????????? ??????????????????????????????????????????????? opaganib ??????????????????????????????????????????????????????????? (spike protein) ??????????????????????????????????????
???????????????????????????????????????????????? University of Louisville ??????????????????? IL-6 ?? basal supernatants ??????????????????????????????????????????????? SARS-CoV-2 ????????????????????????? opaganib ????????? opaganib ??????????????????????????????????????? (thrombosis) ?????????????????????????????????????????? (ARDS) ?????????????? ??????????????????????????????????????????????????? opaganib ???????????????????????????????
????????????? opaganib ????????????????????????????????????? 2 ??????????????????????-19 ?????????? ????????????????????????????????? World Microbe Forum (WMF) 2021 ??????????????????????????????? compassionate use ????????????????????????????????????????????? ??????????????????????????????????-19 ????????????????????????????? ??????????????? opaganib ???? 2/3 ????????????????????????????????????????????????????????????????????????? 4 ????? ??????????????????????????????????????????? ??????????????????????????????????????? opaganib ??????????????????????? 460 ???
????????????????????????????????????????????????????????????????????? ????? ???????????????? ?????????? Cosmo Pharmaceuticals ??????????????????? opaganib ??????????? ?????????????????????????????????????????? opaganib ??????????????
??????????????????? FDA, EMA ???????????????????????? ? ???????? ???????????????????????????????????????? opaganib ????????????????????????? ?????????????????????????????????????????????????? ??????????????????????????? opaganib ??????????????????????????????????????????????????? ????????????????????????????????????? 2/3 ?????????????????????????????????????????????????????????????????????????????? ??????????????????????????????????? ?????????????????????????????????????????????????????????????????????? ?????????????????????????????????????? opaganib ?????????????? FDA ????????????????????????????????????????????????????????????????????????? ???????????????????????????????????????????????????????????????????????????? opaganib ????????????????????????????????????? ?????????????????????????????????????????????????? FDA, EMA ???????????????????????????????? ?
????????????????????????????????????????????????????????????????????????????????? ? ???????????????????????????????????????????????????????? opaganib ????????????????????????????????????????????????????????????????? opaganib ???????????? ? ????
????????????-19: RHB-107 (upamostat)[7]
RedHill ??????????????????????????????????????-19 ???? 2/3 ?????????? RHB-107 (upamostat) ??????????????????????????????????????????????????????????????? ???????????????? RHB-107 ?????????????????????????????????????????????-19 ???????????????????????????????????????????????????????????????????????????? ???????????????????????????????-19
?? RHB-107 ?????????????????? serine proteases ?????????????????????????????????????????????????????????????????????????????????? RHB-107 ???????????????????????????????? ??????????????????????????????????????????????????????? ? ??????????????????????????????????
RHB-204 - ?????????????????????????????????????????????????? (NTM)
????????????????? 3 ?????????????????????????????? ???????????????????????????????????????????????? RHB-204 ??????????????????????????????????????????????????????????? (NTM) ????? ?????????????????????? Mycobacterium avium Complex (MAC)
????????????????????????????? FDA ??????????? Fast Track ?????? RHB-204 ??????????????????????????????????????????????????????????? (rolling review) ?????????????????????????? New Drug Application (NDA) ????????? RHB-204 ???????????????????????????????????????????????????????????????????? NDA Priority Review ????????????????????????? Accelerated Approval
RHB-204 ??????????? Orphan Drug ??? FDA ??? Qualified Infectious Disease Product ??????????????????????????????????????????????????????????????????????? 12 ?? ??????????????????????????????? FDA
Opaganib – ??????????????????????????????????
??????????????????????????????????????????????????????????????????????????????????? 2 ?????????????????????????????????????????????????????? opaganib ??????????????????????????????????????????????????????????????????? Medical University of South Carolina (MUSC) ??? Emory University ?????? ??????????????????????????????????????????????????????????????????????????????? 6 ???????????????????????? (????????????????????????????????????????????????????? 16 ???????) ????????????????????????????????????????????????? 27 ??? ????????????????????????????????????????????????????????????????????? ???????? opaganib ????????????????????????????????????????????????????? ????????????????????????????????????????????? ??????????????????????????????????????????????????????? ??????????????????????????????????????????????????????????????????????????????????????????????? 2022 ????
????????????????? 2a ?????????????????????????? opaganib ????????????????????????????????????? ?????????????????????????? Mayo Clinic ??????????????????????, Emory University ??? Huntsman Cancer Institute ??? University of Utah ?????????????????????????????????????????????????????????????????? 39 ?? ?????????????????????? opaganib ????????????????????????????????????? ??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? ?????????????????????????????????????????????????????????????? ?????????????????????? opaganib ????????? hydroxychloroquine ???????????????????????????????????? (autophagy)
????????????????????????????????????????:
?????????????????????????????????????? ????????????????? 26 ??????? 2021 ???? 8.30 ?. (EDT) ?????????????????????????????????????????????????????? 2021
???????????????????????????????????????????????????????????? ???????????????????????????? 30 ???
??????????????????????????? ???????????????????? 15 ??????????????????? ????????????: +1-877-870-9135; ????????: +1-646-741-3167 ???????????: +972-3-530-8845; ???????????????????????????????? 5554521
????????? RedHill Biopharma
RedHill Biopharma Ltd. (NASDAQ: RDHL) ??????????????????????????????????????????????????????????????????????????? RedHill ?????????????????????????? Movantik® ??????????????????????????????????????????, Talicia® ????????????????????????? Helicobacter pylori (H. pylori) ????????? ??? Aemcolo® ?????????????????????????????????? ???????????????????????????????????????????? RedHill ?????????? (i) RHB-204 ?????????????????????????? 3 ??????????????????????????????????????????????????? (pulmonary nontuberculous mycobacteria - NTM) (ii) opaganib (ABC294640) ??????????????? selective inhibitor ????? sphingosine kinase 2 (SK2) ?????????????????????????????? ????????????????????????????? 2/3 ???????????????????-19 ?????????????????? 2 ???????????????????????????????????????????????? (iii) RHB-107 (upamostat) ?????????? serine protease ???????????? ??????????????????????????? 2/3 ?????????????????????-19 ???????????????????????????????????????????????????????????????????? ? (iv) RHB-104 ?????????????????????????????????????? 3 ??????????????? (v) RHB-102 ?????????????????????????????????????? 3 ???????????????????????????????????????????????? ????????????????????? 2 ????????????????????? IBS-D ??? (vi) RHB-106 ?????????????????????? ?????????????????????????????????????? /
????????: ??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? ????????????????????????????????? ??????????????????????????????????????????????????????????????????????
??????????????????: |
??????????????????????: |
REDHILL BIOPHARMA LTD. |
||||||||
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS |
||||||||
(Unaudited) |
||||||||
Three Months Ended |
Six Months Ended |
|||||||
June 30, |
June 30, |
|||||||
2021 |
2020 |
2021 |
2020 |
|||||
U.S. dollars in thousands |
||||||||
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 |
||||
REDHILL BIOPHARMA LTD. |
||||
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION |
||||
June 30, |
December 31, |
|||
2021 |
2020 |
|||
Unaudited Audited |
||||
U.S. dollars in thousands |
||||
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 |
||
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 |
||
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 revenues |
26,096 |
18,343 |
||
Accrued expenses and other current liabilities |
23,162 |
24,082 |
||
Payable in respect of intangible assets purchase |
14,916 |
17,547 |
||
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 |
||
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 |
||
REDHILL BIOPHARMA LTD. |
||||||||
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS |
||||||||
(Unaudited) |
||||||||
Three Months Ended |
Six Months Ended |
|||||||
June 30, |
June 30, |
|||||||
2021 |
2020 |
2021 |
2020 |
|||||
U.S. dollars in thousands |
||||||||
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) |
||||
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 revenues |
3,418 |
(1,089) |
7,753 |
(428) |
||||
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 borrowings, 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 borrowings transaction costs |
— |
— |
— |
784 |
||||
1 ???????????????? ???????????????????? ????????????? ???????????????????? |
2 ??????????????????????????????????????????????????????????????? |
3 Movantik® (naloxegol) ?????????????????????????????????????????????? (OIC) ???????????????????????????: |
4 Talicia® (omeprazole magnesium, amoxicillin ??? rifabutin) ???????????????????????????????????????????????????????? H. pylori ????????? ???????????????????????????: |
5 Aemcolo® (rifamycin) ??????????????????????????????????????????????????? (travelers' diarrhea) ???????? Escherichia coli ?????????????????????????????????????????????? ???????????????????????????: |
6 Opaganib (ABC294640, Yeliva®) ????????????????????????????????????? ?????????????????????????????? |
7 RHB-107 (upamostat) ????????????????????????????????????? ?????????????????????????????? |
?????:
