PR93358

 

TEL AVIV, Israel and RALEIGH, NC, Nov 30, 2021 /PRNewswire=KYODO JBN/ --

 

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.