REDHILL BIOPHARMA LTD. | |||
(the "Registrant") | |||
Date: June 12, 2023
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By:
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/s/ Dror Ben-Asher | |
Name: | Dror Ben-Asher | ||
Title: | Chief Executive Officer | ||
Press Release
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Q1/23 saw Talicia recording a 9.6% increase in new prescriptions compared to the same period last year, maintaining its place as the leading prescribed branded H. pylori therapy by U.S.
gastroenterologists6.
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• |
On May 9, 2023, the Company announced new Talicia PBPK modeling data, published in AP&T Journal7, showing that generically substituted regimens are non-bioequivalent to Talicia. Separately, new Talicia PBPK
modeling data, presented at Digestive Diseases Week (DDW) 2023, supports bioequivalence between TID and Q8H dosing regimens for Helicobacter pylori (H. pylori)
eradication therapy; TID dosing is thought to promote patient adherence without impacting efficacy.
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On March 21, 2023, the Company announced the establishment of a warranty program for Talicia, in which RedHill committed to reimburse patient out of pocket costs should Talicia not work. This warranty commitment extends to all
commercially insured and non-insured Talicia patients who complete the full 14-day treatment course and whose infection is not eradicated based on post-treatment confirmation testing8. It is believed that this is the first time
a warranty program has been offered for a widespread community (non-hospital) treated condition, lowering the bar for patient access.
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• |
Total Talicia coverage stood at more than 202 million American lives as of March 31, 2023.
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On December 5, 2022, the Company announced that the FDA Exclusivity Board has granted Aemcolo five years’ exclusivity under the FDA’s Qualified Infectious Disease Product (QIDP) designation in addition to the five years NCE data
exclusivity, extending regulatory exclusivity through to 2028.
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• |
On February 6, 2023, the ownership of Movantik was transitioned to Movantik Acquisition Co., an affiliate of HCR, in exchange for extinguishment of all RedHill’s debt obligations with HCR. Movantik is no longer a RedHill product.
Revenues for Movantik were recorded up to and including February 1, 2023.
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• |
As part of the agreement, and to ensure continuous patient care, RedHill is providing HCR with transition services for up to 12 months, paid for by HCR.
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On February 28, 2023, the Company announced that the Radiation and Nuclear Countermeasures Program (RNCP), of the National Institute of Allergy and Infectious
Diseases, part of the National Institutes of Health, has selected opaganib for the nuclear medical countermeasures product development pipeline as a potential treatment for Acute Radiation Syndrome (ARS). As part of this collaboration,
contractors directed and supported by the RNCP will undertake studies, designed in collaboration with RedHill, to test opaganib in established ARS models. This follows the February 15, 2023, announcement that the FDA provided guidance on
the use of the Animal Rule for opaganib's developmental pathway for Acute Radiation Syndrome (ARS), utilizing pivotal animal model efficacy studies instead of human clinical trials. Sponsors of approved medical countermeasures are
eligible for a Priority Review Voucher. These announcements followed publication of data from eight U.S. government-funded in vivo studies, and additional experiments, indicating that opaganib was associated with:
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Protection of normal tissue, including gastrointestinal, from radiation damage due to ionizing radiation exposure or cancer radiotherapy.
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o |
Improvement of antitumor activity, response to chemoradiation, and enhancement of tolerability and survival.
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• |
Additional collaboration discussions with U.S. and other governments are ongoing.
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Preclinical development of opaganib, in collaboration with the US Army and NIAID, for various antiviral indications is ongoing.
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On May 1, 2023, the Company announced that the U.S. Patent and Trademark Office (USPTO) had granted a new patent for opaganib in respect to combination compositions for treatment of cancer, extending protection to October 2036.
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On January 3, 2023, the Company announced publication of positive data from a Phase 2 study of once-daily oral investigational RHB-107 (upamostat) in non-hospitalized symptomatic COVID-19 patients, in the peer-reviewed International
Journal of Infectious Diseases13. The study showed that RHB-107 successfully met the primary endpoint of safety and tolerability and delivered promising efficacy results, despite the small number of patients in each
treatment group, including faster recovery from severe COVID-19 symptoms and 100% reduction in hospitalization due to COVID-19.
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Discussions are ongoing for external non-dilutive funding for additional late-stage COVID-19 clinical development.
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RHB-107 is also the subject of several cooperative research projects with government and non-government bodies, evaluating RHB-107 against multiple viral targets, including influenza and Ebola (amongst others).
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On May 1, 2023, the Company announced that the European Patent Office granted RHB-102 (BEKINDA), a 24-hr bimodal release, once-daily oral tablet formulation of ondansetron, a patent covering antiemetic extended-release solid dosage forms
for the prevention of nausea and vomiting (CINV/RINV). The patent provides the potential for UK and EU protection of RHB-102 to March 2034.
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On February 16, 2023, the Company announced that it held a positive pre-Marketing Authorisation Application meeting with the UK Medicines & Healthcare products Regulatory Agency (MHRA) with regard to seeking marketing approval for
RHB-102 (BEKINDA) for oncology support (management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, also referred to as CINV and RINV).
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Discussions for potential commercialization partners are ongoing.
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On May 22, 2023, the Company announced the termination of RHB-204's U.S. Phase 3 study for non-tuberculosis mycobacteria (NTM) disease due to a very low accrual rate. This decision is intended to enable the Company to better focus its
resources on key pipeline catalysts and revenue-generating product acquisition, while searching for out-licensing partners for RHB-204.
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Three Months Ended
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||||||||
March 31,
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||||||||
2023
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2022
|
|||||||
U.S. dollars in thousands
|
||||||||
NET REVENUES
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3,599
|
13,104
|
||||||
COST OF REVENUES
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1,612
|
6,293
|
||||||
GROSS PROFIT
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1,987
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6,811
|
||||||
RESEARCH AND DEVELOPMENT EXPENSES
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1,084
|
3,062
|
||||||
SELLING AND MARKETING EXPENSES
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5,110
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12,560
|
||||||
GENERAL AND ADMINISTRATIVE EXPENSES
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5,797
|
7,818
|
||||||
OTHER INCOME
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(39,084
|
)
|
—
|
|||||
OPERATING (INCOME) LOSS
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(29,080
|
)
|
16,629
|
|||||
FINANCIAL INCOME
|
21,582
|
10
|
||||||
FINANCIAL EXPENSES
|
421
|
3,909
|
||||||
FINANCIAL (INCOME) EXPENSES, net
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(21,161
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)
|
3,899
|
|||||
(INCOME) LOSS AND COMPREHENSIVE (INCOME) LOSS FOR THE PERIOD
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(50,241
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)
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20,528
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|||||
(INCOME) LOSS PER ORDINARY SHARE, basic and diluted (U.S. dollars):
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(0.05
|
)
|
0.04
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March 31,
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December 31,
|
|||||||
2023
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2022
|
|||||||
U.S. dollars in thousands
|
||||||||
CURRENT ASSETS:
|
||||||||
Cash and cash equivalents
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17,571
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19,968
|
||||||
Bank deposits
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15
|
15
|
||||||
Restricted cash
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11,047
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16,000
|
||||||
Trade receivables
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6,854
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34,521
|
||||||
Prepaid expenses and other receivables
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5,170
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4,387
|
||||||
Inventory
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5,859
|
11,009
|
||||||
46,516
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85,900
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|||||||
NON-CURRENT ASSETS:
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||||||||
Restricted cash
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146
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150
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||||||
Fixed assets
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444
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502
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||||||
Right-of-use assets
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6,127
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6,692
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||||||
Intangible assets
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5,601
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65,626
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||||||
12,318
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72,970
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TOTAL ASSETS
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58,834
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158,870
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||||||
CURRENT LIABILITIES:
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||||||||
Account payable
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4,366
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4,230
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||||||
Lease liabilities
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979
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1,032
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||||||
Allowance for deductions from revenue
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25,967
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47,870
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||||||
Accrued expenses and other current liabilities
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17,126
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17,949
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||||||
Borrowing
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—
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115,216
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||||||
Payable in respect of intangible assets purchase
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—
|
11,157
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||||||
48,438
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197,454
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|||||||
NON-CURRENT LIABILITIES:
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||||||||
Lease liabilities
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6,015
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6,443
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||||||
Derivative financial instruments
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1,627
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2,623
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||||||
Royalty obligation
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750
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750
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||||||
8,392
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9,816
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|||||||
TOTAL LIABILITIES
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56,830
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207,270
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||||||
EQUITY (Capital Deficiency):
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||||||||
Ordinary shares
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2,845
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2,835
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||||||
Additional paid-in capital
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382,634
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382,625
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||||||
Accumulated deficit
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(383,475
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)
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(433,860
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)
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||||
TOTAL EQUITY (Capital Deficiency)
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2,004
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(48,400
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)
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|||||
TOTAL LIABILITIES AND EQUITY (Capital Deficiency)
|
58,834
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158,870
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Three Months Ended
|
||||||||
March 31,
|
||||||||
2023
|
2022
|
|||||||
OPERATING ACTIVITIES:
|
||||||||
Comprehensive income (loss)
|
50,241
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(20,528
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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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144
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2,306
|
||||||
Depreciation
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460
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537
|
||||||
Amortization and impairment of intangible assets
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60,025
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1,601
|
||||||
Non-cash expenses related to borrowing and payable in respect of intangible assets purchase
|
(119,818
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)
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3,123
|
|||||
Fair value (gains) on derivative financial instruments
|
(996
|
)
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—
|
|||||
Exchange differences and revaluation of bank deposits
|
2
|
4
|
||||||
(60,183
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)
|
7,571
|
||||||
Changes in assets and liability items:
|
||||||||
Decrease (increase) in trade receivables
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27,667
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5,743
|
||||||
Decrease (increase) in prepaid expenses and other receivables
|
(783
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)
|
1,154
|
|||||
Decrease in inventories
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5,150
|
538
|
||||||
Increase (decrease) in accounts payable
|
136
|
(5,958
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)
|
|||||
Increase (decrease) in accrued expenses and other liabilities
|
(7,511
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)
|
1,514
|
|||||
Increase (decrease) in allowance for deductions from revenue
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(21,903
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)
|
5,811
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|||||
2,756
|
8,802
|
|||||||
Net cash used in operating activities
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(7,186
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)
|
(4,155
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)
|
||||
INVESTING ACTIVITIES:
|
||||||||
Purchase of fixed assets
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—
|
(13
|
)
|
|||||
Change in investment in current bank deposits
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—
|
8,500
|
||||||
Net cash provided by investing activities
|
—
|
8,487
|
||||||
FINANCING ACTIVITIES:
|
||||||||
Advance proceeds from issuance of ordinary shares and warrants
|
6,708
|
713
|
||||||
Repayment of payable in respect of intangible asset purchase
|
(6,555
|
)
|
(5,542
|
)
|
||||
Decrease in restricted cash
|
4,953
|
—
|
||||||
Payment of principal with respect to lease liabilities
|
(296
|
)
|
(115
|
)
|
||||
Net cash (used in) provided by financing activities
|
4,810
|
(4,944
|
)
|
|||||
DECREASE IN CASH AND CASH EQUIVALENTS
|
(2,376
|
)
|
(612
|
)
|
||||
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
|
(21
|
)
|
(15
|
)
|
||||
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
|
19,968
|
29,474
|
||||||
BALANCE OF CASH AND CASH EQUIVALENTS AT THE END OF PERIOD
|
17,571
|
28,847
|
||||||
SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN CASH
|
54
|
11
|
||||||
SUPPLEMENTARY INFORMATION ON INTEREST PAID IN CASH
|
158
|
772
|
||||||
SUPPLEMENTARY INFORMATION ON NON-CASH INVESTING AND FINANCING ACTIVITIES:
|
||||||||
Acquisition of right-of-use assets by means of lease liabilities
|
—
|
4,767
|
||||||
Settlement of borrowings through the transfer of rights of an asset.
|
115,216
|
—
|