RedHill Biopharma Provides Q3/2020 Results and Highlights, Including 300% Talicia Prescription Growth
Q3/2020 net revenues of approximately
Strong growth for Talicia® with approximately 300% quarter-over-quarter prescription growth and rapid expansion of the prescriber base; Talicia achieved national coverage for 167 million lives since launch, with additional coverage expected
Two consecutive quarters of Movantik® prescription (TRx) growth, reversing the trend of prescription decline prior to RedHill acquisition
Opaganib’s COVID-19 global Phase 2/3 study advancing rapidly with nearly 50% of patients enrolled and
Commencing Phase 3 study with RHB-204 for first-line treatment of pulmonary NTM infections
Cash balance of approximately $51 million as of
Management to host webcast today, at
Financial highlights for the third quarter ended September 30, 20201
Net Revenues of
Cost of Revenues of
Gross Profit of
Research and Development Expenses were
Selling, Marketing and Business Development Expenses were
General and Administrative Expenses were
Operating Loss was
Net Loss was
Net Cash Provided by Financing Activities was
Liquidity and Capital Resources
Cash Balance2 as of
The Company has completed the transition of Movantik from AstraZeneca and achieved two consecutive full quarters of RedHill-led prescription. Additionally, the Company has targeted a larger prescriber base that has driven a 2.1% increase in unique prescribers of Movantik. This growth reverses a steady decline in prescriptions prior to RedHill acquiring the rights to Movantik, representing a shift in the trend and pointing to both a successful transition by RedHill and the prospects for continuing growth for Movantik.
RedHill acquired the global rights to Movantik from AstraZeneca, excluding
Talicia® (omeprazole magnesium, amoxicillin and rifabutin)4
Since RedHill launched Talicia in the
COVID-19 (SARS-CoV-2) Program: Opaganib (ABC294640, Yeliva®)5
Following encouraging compassionate use results published6 last quarter, the late-stage development program for opaganib in patients with severe COVID-19 pneumonia has progressed rapidly. The Company is currently enrolling patients in two randomized, double-blind, parallel-arm, placebo-controlled studies with opaganib in patients with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen:
- Enrollment in the
U.S.Phase 2 study (NCT04414618) is over 90% complete and top-line data is expected before the end of this year, subject to recruitment completion. The study has passed two pre-scheduled safety reviews by an independent Safety Monitoring Committee (SMC) with unanimous recommendations to continue the study without change.
- A global Phase 2/3 study (NCT04467840) is advancing rapidly and is approaching 50% enrollment. Approved in six countries and active across 20 clinical sites to date, the study is on track to enroll up to 270 patients.
- The studies are intended to support potential emergency use applications as early as the first quarter of 2021, subject to positive results.
The Company also entered into collaborations with European and Canadian suppliers for large-scale ramp-up of opaganib manufacturing in preparation for potential emergency use authorizations, further strengthening manufacturing capabilities and capacity for opaganib. RedHill continues to expand manufacturing capacity with additional supply agreements expected to be finalized in the coming weeks.
The Company continues its discussions with
COVID-19 (SARS-CoV-2) Program: RHB-107 (upamostat)7
In recently released in vitro results, RedHill’s second COVID-19 drug candidate, RHB-107, a novel, orally-administered serine protease inhibitor, strongly inhibited SARS-CoV-2 viral replication. The Company has submitted an Investigational New Drug (IND) application to the FDA for a
RHB-204 - Pulmonary Nontuberculous Mycobacteria (NTM) Infections
RedHill announced in
The Company recently announced that RHB-204 had been granted FDA Orphan Drug Designation. This, along with RHB-204’s previously granted QIDP designation, extends U.S. market exclusivity for RHB-204 to a potential total of 12 years upon FDA approval.
Opaganib - Cholangiocarcinoma and prostate cancer
The Phase 2a study evaluating the activity of opaganib in advanced cholangiocarcinoma (bile duct cancer) is ongoing. Enrollment has been completed for the first cohort of 39 patients, evaluating the activity of orally-administered opaganib as a stand-alone treatment. Preliminary data from this cohort indicated a signal of activity in a number of subjects with advanced cholangiocarcinoma, and in light of these data, input from key opinion leaders and preclinical research that had been conducted at
In light of preclinical findings demonstrating that treatment with opaganib and RHB-107 (upamostat, WX-671) in combination resulted in tumor regression, RedHill plans to add an additional cohort to the ongoing Phase 2a study, evaluating opaganib in combination with RHB-107, subject to discussions with the FDA.
RedHill recently announced that it had received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a new patent application related to the use of opaganib and RHB-107 for the treatment of solid tumor cancers. The patent is expected to extend IP protection for the combination until 2036.
An additional Phase 2 study with opaganib in prostate cancer is ongoing at the
RedHill announced in
COVID-19 Impact Update
RedHill’s primary concern during the COVID-19 pandemic continues to be the safety and protection of its employees, patients, colleagues, and the communities to which we belong.
Operationally, the actions the Company took to mitigate the impact of the COVID-19 pandemic continue to serve us well, with minimal effect on our ongoing operational and supply chain activities. Promotional activity has now been largely re-instated where safe to do so, and in adherence to social distancing and other public health guidelines. RedHill will continue to assess the potential impact of COVID-19 on its business and operations.
Conference Call and Webcast Information:
The Company will host a conference call and live webcast today, Thursday, November 12, 2020, at
The webcast and accompanying slides will be broadcast live on the Company's website: http://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:
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 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 the closing of the exclusive licensing and manufacturing agreement with Cosmo, the risk that the transaction with Cosmo will close on different terms than the terms of the binding term sheet, if it will close at all; the risk that the
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
|Three Months Ended||Nine Months Ended|
|U.S. dollars in thousands|
|COST OF REVENUES||10,337||629||26,240||1,471|
|RESEARCH AND DEVELOPMENT EXPENSES, net||4,323||2,799||10,302||15,143|
|SELLING, MARKETING AND BUSINESS DEVELOPMENT EXPENSES||13,414||4,892||32,384||12,175|
|GENERAL AND ADMINISTRATIVE EXPENSES||7,329||2,925||17,948||7,349|
|FINANCIAL EXPENSES (INCOME), net||4,178||(9||)||7,866||(824||)|
|LOSS AND COMPREHENSIVE LOSS FOR THE PERIOD||18,638||9,835||51,842||30,613|
|LOSS PER ORDINARY SHARE, basic and diluted (
|WEIGHTED AVERAGE OF ORDINARY SHARES (in thousands)||372,893||283,687||359,428||283,687|
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
|U.S. dollars in thousands|
|Cash and cash equivalents||26,198||29,023|
|Financial assets at fair value through profit or loss||2,407||8,500|
|Prepaid expenses and other receivables||4,635||2,244|
|Accrued expenses and other current liabilities||23,536||5,598|
|Payable in respect of intangible assets purchase||23,739||—|
|Additional paid-in capital||284,806||267,403|
|TOTAL LIABILITIES AND EQUITY||168,981||74,099|
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS
|Three Months Ended||Nine Months Ended|
|U.S. dollars in thousands|
|Adjustments in respect of income and expenses not involving cash flow:|
|Share-based compensation to employees and service providers||1,695||782||3,120||2,278|
|Amortization and impairment of intangible assets||2,109||—||4,958||—|
|Unpaid interest expenses related to borrowing and payable in respect of intangible assets purchase||2,039||—||3,656||—|
|Fair value adjustments on derivative financial instruments||—||(5||)||—||(336||)|
|Fair value losses (gains) on financial assets at fair value through profit or loss||31||14||68||(73||)|
|Exchange differences and revaluation of bank deposits||5||180||(160||)||112|
|Changes in assets and liability items:|
|Decrease (increase) in trade receivables||6,146||110||(11,208||)||105|
|Decrease (increase) in prepaid expenses and other receivables||235||(23||)||(2,391||)||(462||)|
|Increase in inventories||(350||)||(135||)||(3,218||)||(1,192||)|
|Increase (decrease) in accounts payable||1,261||51||2,385||1,470|
|Increase (decrease) in accrued expenses and other current liabilities||(4,174||)||(321||)||17,521||1,087|
|Net cash used in operating activities||(9,171||)||(8,894||)||(35,874||)||(26,880||)|
|Purchase of fixed assets||(166||)||(1||)||(357||)||(135||)|
|Purchase of intangible assets||(735||)||—||(53,368||)||—|
|Change in investment in current bank deposits||—||6,000||4,200||4,931|
|Purchase of financial assets at fair value through profit or loss||—||(9||)||—||(2,584||)|
|Proceeds from sale of financial assets at fair value through profit or loss||2,075||5,748||6,025||7,848|
|Net cash provided by (used in) investing activities||1,174||11,738||(43,500||)||10,060|
|Proceeds from issuance of ordinary shares, net of issuance costs||9,137||—||15,500||—|
|Exercise of options into ordinary shares||53||—||53||—|
|Proceeds from long-term borrowings, net of transaction costs||(784||)||—||78,061||—|
|Increase in restricted cash||—||—||(20,000||)||—|
|Decrease in restricted cash||4,000||4,000|
|Payment of principal with respect to lease liabilities||(450||)||(206||)||(1,186||)||(591||)|
|Net cash provided by (used in) financing activities||11,956||(206||)||76,428||(591||)|
|INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS||3,959||2,638||(2,946||)||(17,411||)|
|EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS||(33||)||1||121||40|
|BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD||22,272||8,995||29,023||29,005|
|BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD||26,198||11,634||26,198||11,634|
|SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN CASH||71||284||320||609|
|SUPPLEMENTARY INFORMATION ON INTEREST PAID IN CASH||2,147||48||4,507||71|
|SUPPLEMENTARY INFORMATION ON NON-CASH INVESTING AND FINANCING ACTIVITIES:|
|Acquisition of right-of-use assets by means of lease liabilities||533||—||2,738||2,681|
|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||—|
1All financial highlights are approximate and are rounded to the nearest hundreds of thousands.
2Including cash, short-term investments (bank deposits and financial assets at fair value) and restricted cash.
3Movantik® (naloxegol) is indicated for opioid-induced constipation (OIC). Full prescribing information see: www.movantik.com.
4Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: www.Talicia.com.
5Opaganib (ABC294640, Yeliva®) is an investigational new drug, not available for commercial distribution.
6The article was authored by
7RHB-107 (upamostat) is an investigational new drug, not available for commercial distribution.
8Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.
9Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.
10Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.
Adi FrishChief Corporate and Business Development Officer RedHill Biopharma+972-54-6543-112 firstname.lastname@example.org Media contact ( U.S.): Bryan GibbsVice President Finn Partners+1 212 529 2236 email@example.com
Source: RedHill Biopharma Ltd.