RedHill Accelerates its Two Advanced COVID-19 Pill Clinical Programs in Light of their Potential Against Omicron
Acting independently of spike protein mutation, opaganib and RHB-107's unique host-targeted mechanisms of action hold potential versus Omicron and other variants
-- Phase 2/3 study sub-population analysis demonstrated a 62% reduction in mortality in moderately severe hospitalized patients; Data packages submitted in the
-- Top-line data from Part A of the COVID-19 Phase 2/3 study of RHB-107 (upamostat) in non-hospitalized symptomatic COVID-19 patients in the
-- Second consecutive quarter of record net revenues with
-- Strategic investment in
-- Another record quarter for Talicia® revenues, with new prescription volume up 15%, reflecting 117% growth vs. Q3/2020; Movantik® continues to rise with an increase in quarterly new prescriptions of 1.1%
-- Continued prescription volume growth seen into the fourth quarter to date for both Talicia and Movantik, with coverage increase on both commercial and government formularies
-- Management to host webcast today, at
Mr. Ben-Asher added: "Given the recent emergence of the heavily mutated Omicron variant as well as likely emergence of other variants over time, the importance of drug candidates that act independently of the viral spike protein is growing. This makes both opaganib and RHB-107's host-targeted mechanism of action, and expected maintenance of effect against new variants, increasingly more relevant in the battle against COVID-19. This quarter saw significant focus on our opaganib Phase 2/3 COVID-19 study. The initial top-line results demanded further investigation and our rigorous post-hoc analysis provided much greater clarity into the potential of novel, orally-administered opaganib in the underserved hospitalized moderately severe patient group. This is a group of patients for which no novel therapeutic pill has shown a benefit until opaganib, which demonstrated a 62% reduction in mortality, improved return to room air and earlier hospital discharge for opaganib-treated patients. The results of this analysis, in a group of more than half the total study population, were consistent with what we had seen in our Phase 2 study and compassionate use experience. Despite being a post-hoc analysis, the consistency across multiple endpoints and territories provides us with a high degree of confidence in the results showing opaganib's effect in this patient population. This analysis also shed light on key issues of the COVID-19 disease severity classification, suggesting that FiO2 might be an improved method for classifying disease severity and predictor of treatment outcome. We have now provided regulators in various countries with all the necessary data to facilitate discussions on the next steps and we continue to provide the data to regulators in additional countries."
"In parallel, we continue to progress our Phase 2/3 study in the
"With a steep reduction in quarterly operating and net loss and continued commercial business growth, leading to a potential commercial operational breakeven before the end of the year, coupled with advanced, exciting and timely R&D pipeline progress, I believe
Financial highlights for the quarter ended
Net Revenues were
Gross Profit was
Research and Development Expenses were
Selling, Marketing and General and Administrative Expenses were
Operating Loss and Net Loss were
Cash Balance1 as of
Additional Financial Highlights
In
In addition, this month, the Company completed an underwritten public offering of approximately 4.7 million ADSs for gross proceeds of approximately
Commercial Highlights
Movantik® (naloxegol)[4]
The Company's focus on driving Movantik performance and strengthening of market share continues unabated, resulting in another quarter of new prescription growth, increasing by 1.1% compared to the previous quarter.
The Company has achieved significant market access successes with
In July, one of America's largest payors, serving many Blue Cross and Blue Shield Plans and more than 30 million members, had added Movantik as a preferred brand with no restrictions to its Commercial NetResults "A" series formularies and as a preferred brand on its other commercial formularies starting
In
Talicia® (omeprazole magnesium, amoxicillin and rifabutin)[5]
Talicia achieved another record quarter, delivering a 15% increase in new prescriptions, compared to the previous quarter, reflecting 117% growth of Talicia as compared to Q3/2020.
In October,
In July, the Company significantly expanded commercial coverage for Talicia, announcing that
Aemcolo® (rifamycin)[6]
The Company has maintained promotion of Aemcolo in the third quarter of 2021 supporting the initial momentum that Aemcolo was generating pre-COVID-19 travel restrictions.
R&D Highlights
COVID-19 Program: Opaganib (ABC294640)[7]
In
A post-hoc analysis of data from 251 study participants requiring a Fraction of inspired Oxygen (FiO2) up to 60% at baseline (54% of the study participants), was subsequently reported in
The results provide a strong rationale for opaganib's potential efficacy in hospitalized patients in need of oxygen supplementation up to 60% FiO2, a large proportion of hospitalized COVID-19 patients. The Phase 2/3 study results are also consistent with opaganib's earlier
Additional new preclinical results demonstrating opaganib's efficacy in significantly decreasing renal fibrosis in a unilateral ureteral obstruction-induced renal interstitial fibrosis mode were also reported by the Company in
The Company has submitted data packages for opaganib to the regulatory agencies in the
The Company also continues its discussions with
COVID-19 Program: RHB-107 (upamostat)[8]
Further to announcing in
RHB-204 - Pulmonary Nontuberculous Mycobacteria (NTM) Disease
A
The Company previously announced that the FDA granted Fast Track designation for RHB-204, providing early and frequent communications and a rolling review of any New Drug Application (NDA). RHB-204 is also eligible for NDA Priority Review and Accelerated Approval.
RHB-204 was granted FDA Orphan Drug designation and Qualified Infectious Disease Product designation, extending its U.S. market exclusivity to a potential total of 12 years upon potential FDA approval.
RHB-104 - Crohn's Disease
Based on recent published research, potential progress in Mycobacterium avium subspecies paratuberculosis (MAP) diagnostic technology may enable us to advance the program towards a confirmatory study in approximately 150 MAP positive moderate-severe Crohn's patients, subject to required regulatory input.
Opaganib - Prostate Cancer and Cholangiocarcinoma
In
The Phase 2a study evaluating the activity of opaganib in advanced cholangiocarcinoma (bile duct cancer) is ongoing at
Conference Call and Webcast Information:
The Company will host a webcast today,
The webcast including slides will be broadcast live on the Company's website, https://ir.redhillbio.com/events, and will be available for replay for 30 days.
To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call:
+972-3-530-8845; the access code for the call is: 9753927.
About
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements include statements regarding the timing of top-line results of Part A of the Phase 2/3 study of once-daily oral RHB-107 in non-hospitalized patients with symptomatic COVID-19. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the risk of a delay in top-line data from Part A of the Phase 2/3 study of once-daily oral RHB-107 in non-hospitalized patients with symptomatic COVID-19, that the Phase 2/3 COVID-19 study for RHB-107 may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib and RHB-107 are likely to be required, as well as risks and uncertainties associated with the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®, and Aemcolo® and Movantik®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the
Company contact: Chief Corporate and Business Development Officer +972-54-6543-112 adi@redhillbio.com |
Media contacts: +1 212 529 2236 bryan.gibbs@finnpartners.com +44 (0) 7739 658 783 fennell@consilium-comms.com |
| ||||||||
Three Months Ended | Nine Months Ended | |||||||
2021 | 2020 | 2021 | 2020 | |||||
U.S. dollars in thousands | ||||||||
NET REVENUES | 21,609 | 20,943 | 63,686 | 42,898 | ||||
COST OF REVENUES | 9,229 | 10,337 | 30,072 | 26,240 | ||||
GROSS PROFIT | 12,380 | 10,606 | 33,614 | 16,658 | ||||
RESEARCH AND DEVELOPMENT EXPENSES | 5,818 | 4,323 | 23,630 | 10,302 | ||||
SELLING AND MARKETING EXPENSES | 15,525 | 13,414 | 44,655 | 32,384 | ||||
GENERAL AND ADMINISTRATIVE EXPENSES | 8,435 | 7,329 | 25,765 | 17,948 | ||||
OPERATING LOSS | 17,398 | 14,460 | 60,436 | 43,976 | ||||
FINANCIAL INCOME | 17 | 42 | 39 | 339 | ||||
FINANCIAL EXPENSES | 4,006 | 4,220 | 12,974 | 8,205 | ||||
FINANCIAL EXPENSES, net | 3,989 | 4,178 | 12,935 | 7,866 | ||||
LOSS AND COMPREHENSIVE LOSS FOR THE PERIOD | 21,387 | 18,638 | 73,371 | 51,842 | ||||
LOSS PER ORDINARY SHARE, basic and diluted ( | 0.05 | 0.05 | 0.16 | 0.14 | ||||
WEIGHTED AVERAGE OF ORDINARY SHARES (in thousands) | 467,908 | 372,893 | 454,995 | 359,428 |
| ||||
2021 | 2020 | |||
U.S. dollars in thousands | ||||
CURRENT ASSETS: | ||||
Cash and cash equivalents | 23,254 | 29,295 | ||
Bank deposits | 12,028 | 17 | ||
Financial assets at fair value through profit or loss | — | 481 | ||
Trade receivables | 30,036 | 28,655 | ||
Prepaid expenses and other receivables | 4,682 | 5,521 | ||
Inventory | 13,115 | 6,526 | ||
83,115 | 70,495 | |||
NON-CURRENT ASSETS: | ||||
Restricted cash | 16,163 | 16,164 | ||
Fixed assets | 477 | 511 | ||
Right-of-use assets | 4,193 | 5,192 | ||
Intangible assets | 82,388 | 87,879 | ||
103,221 | 109,746 | |||
TOTAL ASSETS | 186,336 | 180,241 | ||
CURRENT LIABILITIES: | ||||
Account payable | 15,245 | 11,553 | ||
Lease liabilities | 1,743 | 1,710 | ||
Allowance for deductions from revenue | 28,356 | 18,343 | ||
Accrued expenses and other current liabilities | 20,587 | 24,082 | ||
Payable in respect of intangible assets purchase | 15,731 | 17,547 | ||
81,662 | 73,235 | |||
NON-CURRENT LIABILITIES: | ||||
Borrowing | 83,516 | 81,386 | ||
Payable in respect of intangible assets purchase | 6,010 | 7,199 | ||
Lease liabilities | 2,849 | 3,807 | ||
Royalty obligation | 750 | 750 | ||
93,125 | 93,142 | |||
TOTAL LIABILITIES | 174,787 | 166,377 | ||
EQUITY: | ||||
Ordinary shares | 1,316 | 1,054 | ||
Additional paid-in capital | 355,601 | 293,144 | ||
Accumulated deficit | (345,368) | (280,334) | ||
TOTAL EQUITY | 11,549 | 13,864 | ||
TOTAL LIABILITIES AND EQUITY | 186,336 | 180,241 |
| ||||||||
Three Months Ended | Nine Months Ended | |||||||
2021 | 2020 | 2021 | 2020 | |||||
U.S. dollars in thousands | ||||||||
OPERATING ACTIVITIES: | ||||||||
Comprehensive loss | (21,387) | (18,638) | (73,371) | (51,842) | ||||
Adjustments in respect of income and expenses not involving cash flow: | ||||||||
Share-based compensation to employees and service providers | 2,191 | 1,695 | 8,337 | 3,120 | ||||
Depreciation | 507 | 470 | 1,465 | 1,237 | ||||
Amortization and impairment of intangible assets | 1,834 | 2,109 | 5,491 | 4,958 | ||||
Non-cash interest expenses related to borrowing and payable in respect of intangible assets purchase | 869 | 2,039 | 4,725 | 3,656 | ||||
Fair value losses on financial assets at fair value through profit or loss | — | 31 | 6 | 68 | ||||
Exchange differences and revaluation of bank deposits | 17 | 5 | 80 | (160) | ||||
5,418 | 6,349 | 20,104 | 12,879 | |||||
Changes in assets and liability items: | ||||||||
Decrease (increase) in trade receivables | 62 | 6,146 | (1,381) | (11,208) | ||||
Decrease (increase) in prepaid expenses and other receivables | (390) | 235 | 839 | (2,391) | ||||
Increase in inventories | (4,352) | (350) | (6,589) | (3,218) | ||||
Increase in accounts payable | 1,939 | 1,261 | 3,692 | 2,385 | ||||
Increase (decrease) in accrued expenses and other liabilities | (2,575) | (4,687) | (3,495) | 17,437 | ||||
Increase in allowance for deductions from revenue | 2,260 | 513 | 10,013 | 84 | ||||
(3,056) | 3,118 | 3,079 | 3,089 | |||||
Net cash used in operating activities | (19,025) | (9,171) | (50,188) | (35,874) | ||||
INVESTING ACTIVITIES: | ||||||||
Purchase of fixed assets | (21) | (166) | (112) | (357) | ||||
Purchase of intangible assets | — | (735) | — | (53,368) | ||||
Change in investment in current bank deposits | (8,500) | — | (12,000) | 4,200 | ||||
Proceeds from sale of financial assets at fair value through profit or loss | — | 2,075 | 475 | 6,025 | ||||
Net cash provided by (used in) investing activities | (8,521) | 1,174 | (11,637) | (43,500) | ||||
FINANCING ACTIVITIES: | ||||||||
Proceeds from long-term borrowings, net of transaction costs | — | (784) | — | 78,061 | ||||
Proceeds from issuance of ordinary shares, net of issuance costs | 499 | 9,137 | 58,713 | 15,500 | ||||
Exercise of options into ordinary shares | 665 | 53 | 4,006 | 53 | ||||
Repayment of payable in respect of intangible asset purchase | (1,721) | — | (5,600) | — | ||||
Increase in restricted cash | — | — | — | (20,000) | ||||
Decrease in restricted cash | — | 4,000 | — | 4,000 | ||||
Payment of principal with respect to lease liabilities | (442) | (450) | (1,229) | (1,186) | ||||
Net cash provided by (used in) financing activities | (999) | 11,956 | 55,890 | 76,428 | ||||
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | (28,545) | 3,959 | (5,936) | (2,946) | ||||
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS | (17) | (33) | (105) | 121 | ||||
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 51,816 | 22,272 | 29,295 | 29,023 | ||||
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD | 23,254 | 26,198 | 23,254 | 26,198 | ||||
SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN CASH | 11 | 71 | 36 | 320 | ||||
SUPPLEMENTARY INFORMATION ON INTEREST PAID IN CASH | 3,250 | 2,147 | 8,266 | 4,507 | ||||
SUPPLEMENTARY INFORMATION ON NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||||||||
Acquisition of right-of-use assets by means of lease liabilities | 385 | 533 | 385 | 2,738 | ||||
Purchase of intangible assets posted as payable | — | 12,511 | — | 24,619 | ||||
Purchase of an intangible asset in consideration for issuance of shares | — | 1,914 | — | 1,914 |
[1] Including cash, cash equivalents, bank deposits and restricted cash
[2]
[3] All financial highlights are approximate and are rounded to the nearest hundreds of thousands.
[4] Movantik® (naloxegol) is indicated for opioid-induced constipation (OIC). Full prescribing information see: www.movantik.com.
[5] Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: www.Talicia.com.
[6] Aemcolo® (rifamycin) is indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coli in adults. For full prescribing information see: www.aemcolo.com
[7] Opaganib (ABC294640, Yeliva®) is an investigational new drug, not available for commercial distribution.
[8] RHB-107 (upamostat) is an investigational new drug, not available for commercial distribution.
Logo - https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg
View original content:https://www.prnewswire.com/news-releases/redhill-biopharma-reports-operational-highlights-and-third-quarter-2021-financial-results-301433750.html
SOURCE
© Canada Newswire, source