Country for PR: United Kingdom
Contributor: PR Newswire Europe
Wednesday, December 01 2021 - 00:12
AsiaNet
RedHill Biopharma Reports Operational Highlights and Third Quarter 2021 Financial Results
TEL AVIV, Israel and RALEIGH, NC, Nov 30, 2021 /PRNewswire-AsiaNet/ --

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 U.S., EU (EMA has provided expedited evaluation process timelines), UK 
and other territories, ahead of regulatory advice

- 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 U.S. and 
South Africa expected in Q1/2022

- Second consecutive quarter of record net revenues with $21.6 million for 
Q3/2021 and an increase in gross margin and steep reduction in operating and 
net loss; Cash balance  of $51.5 million as of September 30, 2021 

- Strategic investment in RedHill by South Korea’s Kukbo Co. of up to $10 
million as well as a $15.5 million underwritten public offering in November

- Another record quarter for Talicia (R) revenues, with new prescription volume 
up 15%, reflecting 117% growth vs. Q3/2020; Movantik (R) 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 8:30 a.m. EST

RedHill Biopharma Ltd. [https://www.redhillbio.com/home/default.aspx] (Nasdaq: 
RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, 
today reported its financial results and operational highlights for the third 
quarter ended September 30, 2021. 

Dror Ben-Asher, RedHill’s Chief Executive Officer, said: “Our U.S. commercial 
business continues to drive growth, delivering a second consecutive quarterly 
net revenue record of $21.6 million despite the continuously challenging 
pandemic environment. Talicia generated another record quarter with 15% growth 
in new prescriptions, while Movantik continues to perform adding a 1.1% 
increase to new prescriptions. Both products are also continuing to make 
strides in gaining both commercial and government formulary coverage. In 
addition, gross margin increased from 51% in the second quarter to 57% in the 
third quarter. The Company has successfully attracted a strategic investment 
from South Korea’s Kukbo and continues to demonstrate responsible financial 
discipline across the entire business as we strive to achieve our long-term 
growth aims.” 

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 U.S. and South 
Africa with our other novel, once-daily, oral COVID-19 antiviral drug 
candidate, RHB-107 which has now completed enrollment for Part A of the study, 
with top-line results expected in the first quarter of 2022. Our Phase 3 study 
of RHB-204 in pulmonary nontuberculous mycobacteria (NTM) disease continues to 
enroll patients in the U.S. and progress with Phase 3-stage RHB-104 for Crohn’s 
disease is expected to speed up thanks to recent, much-awaited, potential 
progress in Mycobacterium avium subspecies paratuberculosis (MAP) detection 
research.”

“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 RedHill is well positioned for short, 
medium and long-term success.” 

Financial highlights for the quarter ended September 30, 2021 

Net Revenues were $21.6 million for the third quarter of 2021, as compared with 
$21.5 million for the second quarter of 2021. The increase is attributable to 
an increase in sales of Talicia and Movantik, partially offset by an increase 
in gross-to-net deductions, mainly commercial rebates and Medicare discounts. 

Gross Profit was $12.4 million for the third quarter of 2021, compared to $10.9 
million for the second quarter of 2021 - an increase of 14%. Gross margin 
increased from 51% in the second quarter of 2021 to 57% in the third quarter of 
2021. The increase in gross profit was mainly attributable to a reversal of 
inventory write-off recognized in the third quarter of 2021 following the FDA 
approval of an extension to Talicia stock expiration date.

Research and Development Expenses were $5.8 million for the third quarter of 
2021, a decrease of $4.5 million, a 44% reduction compared to the second 
quarter of 2021, mainly attributable to the completion of our global COVID-19 
Phase 2/3 study with opaganib.

Selling, Marketing and General and Administrative Expenses were $24 million for 
the third quarter of 2021, a decrease of $1.5 million compared to the second 
quarter of 2021. The decrease was mainly attributable to expenses related to 
share-based compensation in the previous quarter.

Operating Loss and Net Loss were $17.4 million and $21.4 million, respectively, 
for the third quarter of 2021 compared to $24.9 million and $29.1 million, 
respectively, in the second quarter of 2021. The decrease was mainly 
attributable to the Talicia inventory expiration date extension, completion of 
our opaganib Phase 2/3 COVID-19 study and a decrease in expenses related to 
share-based compensation, as detailed above. 

Net Cash Used in Operating Activities was $19 million for the third quarter of 
2021, similar to the second quarter of 2021.

Net Cash Used in Financing Activities was $1 million for the third quarter of 
2021, comprised primarily of payables with respect to the Movantik acquisition, 
partially offset by proceeds from utilization of ATM and from exercise of 
options. 

Cash Balance as of September 30, 2021, was $51.5 million. 

Additional Financial Highlights

In November 2021, the Company announced that it had entered into a strategic 
agreement with Kukbo Co. Ltd., a South Korean corporation, for the sale of 
RedHill's American Depositary Shares (ADSs) in a private placement of up to $10 
million, of which the first tranche of $5 million has been paid. As part of the 
agreement, the Company granted Kukbo a six month right of first offer for a 
license with respect to one or more of opaganib, RHB-107 (upamostat) and 
Talicia® for South Korea and other Asian territories.

In addition, this month, the Company completed an underwritten public offering 
of approximately 4.7 million ADSs for gross proceeds of approximately $15.5 
million, led by Cantor Fitzgerald.

Commercial Highlights

Movantik® (naloxegol)
 
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 U.S. major 
payors, continuing to increase the levels of payor coverage.

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 July 1, 2021. In April, Movantik was also included on the Part D 
formulary of another major payor with no restrictions. Almost 9 out of 10 U.S. 
commercial lives are now covered, and we continue to work toward additional 
formulary coverage for the remaining patients.

In September 2021 RedHill Biopharma Inc., AstraZeneca AB, AstraZeneca 
Pharmaceuticals LP and Nektar Therapeutics entered into a settlement and 
license agreement with Aurobindo Pharma USA, Inc. resolving their patent 
litigation in the U.S. in response to Aurobindo's Abbreviated New Drug 
Application (ANDA) seeking approval by the FDA to market a generic version of 
Movantik. This follows the previously announced resolution of the Apotex 
litigation and brings to a close all presently pending Movantik patent 
litigation brought pursuant to The Drug Price Competition and Patent Term 
Restoration Act (the Hatch-Waxman Act). The earliest licensed entry date of any 
generic naloxegol in the U.S. is October 1, 2030.

Talicia® (omeprazole magnesium, amoxicillin and rifabutin) 
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, Medi-Cal - California's Medicaid Health Care program covering two 
million beneficiaries - had added Talicia to its Contract Drug List (CDL) for 
H. pylori treatment, with no prior authorization required. This coverage is 
expected to expand to 14 million beneficiaries on January 1, 2022. During the 
same month, a new U.S. Patent covering Talicia was granted. This patent 
reinforces the protection for Talicia through 2034, and the Company has listed 
this patent in the FDA's Approved Drug Products with Therapeutic Equivalence 
Evaluations, or Orange Book. 

In July, the Company significantly expanded commercial coverage for Talicia, 
announcing that OptumRx, part of the UnitedHealth Group, a leader in healthcare 
coverage, partnered with more than 1.3 million healthcare professionals and 
6,500 hospitals, had added Talicia to its Commercial Formulary as an 
unrestricted brand for H. pylori treatment, effective July 1, 2021. This 
agreement expanded access to Talicia to 26 million additional Americans and 
increased overall patient access to Talicia to greater than 8 out of 10 covered 
U.S. Commercial lives. 

Aemcolo® (rifamycin) 
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. RedHill and Cosmo Pharmaceuticals N.V are currently in 
discussions with respect to the amendment of the Aemcolo License Agreement. 

R&D Highlights 

COVID-19 Program: Opaganib (ABC294640)  
In September 2021, the Company announced top-line results from the global 
475-patient Phase 2/3 study in hospitalized patients with severe COVID-19 
pneumonia (NCT04467840). 
[https://clinicaltrials.gov/ct2/show/NCT04467840?term=NCT04467840&draw=2&rank=1]
. Whilst results showed consistent trends in favor of the opaganib arm, the 
study endpoints did not achieve statistical significance. 

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 October 2021, demonstrating that treatment with 
oral opaganib resulted in a 62% reduction in mortality as well as improved 
outcomes in time to room air and median time to hospital discharge, in this 
large group of hospitalized, moderately severe COVID-19 patients. 

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 U.S Phase 2 study results and the 
demonstrated potent antiviral inhibition of SARS-CoV-2 variants in human 
bronchial epithelial cells, providing further support for its potential in 
earlier stages of disease where viral load is higher.

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 September 2021.

The Company has submitted data packages for opaganib to the regulatory agencies 
in the U.S., EU, UK and other territories, ahead of planned regulatory advice, 
with the European Medicines Agency (EMA) having provided expedited evaluation 
process timelines. As previously stated, additional studies to support the 
potential of such applications and the use or marketing of opaganib are likely 
to be required. For example, the FDA has previously indicated that we will need 
to complete additional studies to support applications in the U.S. The strength 
of the safety and efficacy data generated from the opaganib studies will be key 
to regulatory applications. 

The Company also continues its discussions with U.S. and other government 
agencies and non-governmental organizations around potential funding to support 
the ongoing development of opaganib. Discussions are also ongoing with 
potential partners who are interested in the rights to opaganib in various 
territories. 

COVID-19 Program: RHB-107 (upamostat) 
RedHill continues to advance the Phase 2/3 study of novel, once-daily, 
orally-administered, antiviral drug candidate, RHB-107, in the treatment of 
non-hospitalized patients with symptomatic COVID-19 in the early course of the 
disease who do not require supplemental oxygen - the vast majority of COVID-19 
patients. The study plans to test for the Omicron variant.

Further to announcing in September 2021 that South Africa had joined the U.S. 
in approving the Phase 2/3 study, along with the expansion to additional U.S. 
sites, the Company announced this month that the last patient had been enrolled 
in Part A of the Phase 2/3 study. The study is a 2-part trial designed to 
evaluate time to sustained recovery from illness as the primary endpoint and 
for dose selection. A total of 61 patients have been enrolled in Part A and 
based on safety and tolerability results of part A, a dose for part B will be 
selected. Top-line results from Part A of the study are expected in the first 
quarter of 2022, with Part B of the study expected to follow subsequent to 
discussions with regulators.

RHB-204 - Pulmonary Nontuberculous Mycobacteria (NTM) Disease       
A U.S. Phase 3 study is ongoing to evaluate the efficacy and safety of RHB-204 
in adults with pulmonary NTM disease caused by Mycobacterium avium Complex 
(MAC) infection. The Company is also assessing potential expansion of the 
RHB-204 Phase 3 study to additional territories.

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 August 2021, we announced that, based on a preliminary review of partial and 
unaudited data, the ongoing Phase 2 study for prostate cancer had met its 
primary endpoint of at least six subjects demonstrating disease control 
(defined as stable disease or better after 16 weeks on treatment) among at 
least 27 evaluable subjects. Upon further review and analysis of the unaudited 
data, the Company reported that the study did not meet its primary endpoint in 
the study arm evaluating opaganib in combination with enzalutamide. Patient 
enrolment continues for the study’s other arm, evaluating a combination of 
opaganib and abiraterone. Accrual and data entry are ongoing and results for 
the study remain subject to further review and analysis.

The Phase 2a study evaluating the activity of opaganib in advanced 
cholangiocarcinoma (bile duct cancer) is ongoing at Mayo Clinics in Arizona and 
Minnesota, Emory University and the Huntsman Cancer Institute at the University 
of Utah. 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. Enrollment is ongoing 
for a second cohort, evaluating opaganib in combination with 
hydroxychloroquine, an anti-autophagy agent.

Conference Call and Webcast Information:
The Company will host a webcast today, Tuesday, November 30, 2021, at 8:30 a.m. 
EST, during which it will present key highlights for the third quarter of 2021.

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: United States: +1-877-870-9135; 
International: +1-646-741-3167 and Israel: 
+972-3-530-8845; the access code for the call is: 9753927.

About RedHill Biopharma	    
RedHill Biopharma Ltd. (Nasdaq: RDHL) 
[https://finance.yahoo.com/quote/RDHL?p=RDHL&.tsrc=fin-srch&guccounter=1] is a 
specialty biopharmaceutical company primarily focused on gastrointestinal and 
infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik (R) 
for opioid-induced constipation in adults, Talicia (R) for the treatment of 
Helicobacter pylori (H. pylori) infection in adults, and Aemcolo (R) for the 
treatment of travelers’ diarrhea in adults. RedHill’s key clinical late-stage 
development programs include: (i) RHB-204, with an ongoing Phase 3 study for 
pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib ( 
ABC294640), a first-in-class, oral SK2 selective inhibitor targeting multiple 
indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for 
prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), an 
oral serine protease inhibitor in a U.S. Phase 2/3 study as treatment for 
symptomatic COVID-19, and targeting multiple other cancer and inflammatory 
gastrointestinal diseases; (iv) RHB-104, with positive results from a first 
Phase 3 study for Crohn's disease; (v) RHB-102, with positive results from a 
Phase 3 study for acute gastroenteritis and gastritis and positive results from 
a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. 
More information about the Company is available at www.redhillbio.com / 
https://twitter.com/RedHillBio.

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 (R); (v) the Company’s 
ability to successfully commercialize and promote Talicia (R), and Aemcolo (R) 
and Movantik (R); (vi) the Company’s ability to establish and maintain 
corporate collaborations; (vii) the Company's ability to acquire products 
approved for marketing in the U.S. that achieve commercial success and build 
its own marketing and commercialization capabilities; (viii) the interpretation 
of the properties and characteristics of the Company’s therapeutic candidates 
and the results obtained with its therapeutic candidates in research, 
pre-clinical studies or clinical trials; (ix) the implementation of the 
Company’s business model, strategic plans for its business and therapeutic 
candidates; (x) the scope of protection the Company is able to establish and 
maintain for intellectual property rights covering its therapeutic candidates 
and its ability to operate its business without infringing the intellectual 
property rights of others; (xi) parties from whom the Company licenses its 
intellectual property defaulting in their obligations to the Company; (xii) 
estimates of the Company’s expenses, future revenues, capital requirements and 
needs for additional financing; (xiii) the effect of patients suffering adverse 
experiences using investigative drugs under the Company's Expanded Access 
Program; (xiv) competition from other companies and technologies within the 
Company’s industry; and (xv) the hiring and employment commencement date of 
executive managers. More detailed information about the Company and the risk 
factors that may affect the realization of forward-looking statements is set 
forth in the Company's filings with the Securities and Exchange Commission 
(SEC), including the Company's Annual Report on Form 20-F filed with the SEC on 
March 18, 2021. All forward-looking statements included in this press release 
are made only as of the date of this press release. The Company assumes no 
obligation to update any written or oral forward-looking statement, whether as 
a result of new information, future events or otherwise unless required by law.

Company contact:
Adi Frish
Chief Corporate and Business Development Officer
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com

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












REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
(Unaudited)
								
		Three Months Ended 		Nine Months Ended 
		September 30, 		September 30, 
	  	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 (U.S. dollars):		 0.05	 	 0.05		 
0.16	 	 0.14
WEIGHTED AVERAGE OF ORDINARY SHARES (in thousands)		 467,908	 	 372,893		 
454,995	 	 359,428






REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
				
				
		September 30, 		December 31, 
	    	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



REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS
(Unaudited)

								
		Three Months Ended 		Nine Months Ended 
		September 30, 		September 30, 
	  	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 John M. Aitken, Khoi Phan, Samantha E. Bodman, Sowmya Sharma, Anthony Watt, 
Peter M. George, Gaurav Agrawal, Andrew B.M. Tie: A Mycobacterium species for 
Crohn's disease? Pathology, 2021 Dec;53(7):818-823
3 All financial highlights are approximate and are rounded to the nearest 
hundreds of thousands.
4 Movantik (R) (naloxegol) is indicated for opioid-induced constipation (OIC). 
Full prescribing information see: www.movantik.com.
5 Talicia (R) (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 (R) (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 (R)) is an investigational new drug, not 
available for commercial distribution.
8 RHB-107 (upamostat) is an investigational new drug, not available for 
commercial distribution.

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Source: RedHill Biopharma Ltd.




Translations

Japanese