RedHill Biopharma

RedHill Biopharma Ltd. develops medicines for gastrointestinal and infectious diseases. It operates through Commercial Operations, and the Research and Development segments. The Commercial Operations segment covers all areas relating to the commercial sales and is being performed by the subsidiary in the U.S. The Research and Development segment includes the study and licensing of therapeutic candidates. Its products include Talicia, Movantik, and Aemcolo. The company was founded by Dror Ben-Asher and Ori Shilo on August 3, 2009 and is headquartered in Tel Aviv, Israel.

Earnings data Q4 2019

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RedHill obtains Israel rights to Movantik ® from AstraZeneca , giv ing RedHill global rights, excluding Europe and Canada -- Movantik approved for opioid-induced constipation in Israel under the brand name Mov e ntig ® -- RedHill to evaluate partnering opportunities for commercialization of Movantik in Israel -- RedHill maintains sole and exclusive U.S. commercialization responsibility for Movantik , which generated approximately $2 0 million in net revenue in Q2 / 2020, the first quarter of sales as a RedHill product

RedHill Biopharma Adds Israel Rights to Movantik® From AstraZeneca

Second pre-scheduled independent Safety Monitoring Committee (SMC) review unanimously recommends continuation without change of the U.S. Phase 2 study with opaganib in COVID-19  -- The U.S. Phase 2 study is 75% enrolled with data expected later this quarter -- In parallel, e nrollment advancing rapidly in the g lobal COVID-19 P hase 2/3 study with opaganib  -- Global emergency use authorization applications are planned, subject to positive clinical results

RedHill Biopharma’s Opaganib COVID-19 Study Passes Second Independent Committee Review

TEL AVIV, Israel and RALEIGH, N.C., Oct. 06, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that it will present at the following virtual conferences in October:

RedHill Biopharma to Present at BIO Investor and BIO-Europe 2020 Virtual Conferences

Veeva Systems

RedHill has adopted Veeva's (VEEV) Vault CDMS platform for the opaganib study.

Veeva Collaborates With RedHill for Coronavirus Clinical Study

The Brazilian Health Regulatory Agency okays RedHill's (RDHL) to conduct a phase II/III study on opaganib for treating patients with severe COVID-19 infection and pneumonia. Stock up.

RedHill Gets Nod in Brazil for Coronavirus Study on Opaganib

The  ongoing global  Phase 2/3 study  with  orally-administered opaganib in  patients with  severe COVID-19  is  approved  in Italy,  the  UK, Russia , Israel ,  Mexico  and Brazil ;  16 clinical sites initiated  globally  to date  --  In  parallel , the opaganib  U.S.  Phase 2  study , with 8 active clinical sites, is  approximately  75%  enrolled and  expected to  be  complete d  in the coming weeks  --  O paganib completely inhibited SARS-CoV-2  viral replication in  a n in vitro human lung cell model , c omparing favorably with remdesivir, the positive control in the study  --  Opaganib demonstrated dual anti-inflammatory and antiviral activity  and  targets a host cell component, unaffected by viral mutation, thus minimizing the likelihood of resistance  --  G lobal  e mergency  u se  authorization  application s planned ,  subject to positive  clinical  results

Brazil Approves RedHill Biopharma’s Phase 2/3 COVID-19 Study with Opaganib

Opaganib completely inhibited SARS-CoV-2 viral replication as measured after three days incubation in an in vitro model of human bronchial tissue, comparing favorably with remdesivir, the positive control in the study  --  Opaganib is uniquely positioned as an orally-administered potential COVID-19 treatment  combining potent antiviral and anti-inflammatory mechanisms of actio n, targeting a host cell component and minimizing likelihood of resistance  --  Global Phase 2/3 and U.S. Phase 2 clinical studies ongoing with opaganib for severe COVID-19 pneumonia   --  RedHill’s second COVID-19 drug candidate, RHB-107 (upamostat), a novel serine protease inhibitor, strongly inhibited SARS-CoV-2 viral replication in the same model, further supporting planned initiation of a Phase 2/3 U.S. outpatient study later this year

RedHill Biopharma’s Opaganib Demonstrates Complete Inhibition of SARS-CoV-2

A global Phase 2/3 study in up to 270 patients hospitalized with severe COVID-19 pneumonia, and a U.S. Phase 2 study in up to 40 patients, are ongoing with opaganib, a novel, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with dual anti-inflammatory and anti-viral properties

RedHill Biopharma's Opaganib Awarded COVID-19 Grant by State of Pennsylvania

A pre-scheduled independent Safety Monitoring Committee (SMC) has recommended that the U.S. Phase 2 COVID-19 study with opaganib continue with no changes; the study is more than 50% enrolled and enrollment is planned to be completed in the coming weeks--  The global Phase 2/3 COVID-19 study with opaganib, being conducted in parallel to the U.S. Phase 2 study, received approval in Italy; this study has also been approved in the UK, Russia and Mexico, and is under review in additional countries  --  The first patients have been enrolled in the global Phase 2/3 study with opaganib, which is set to enroll up to 270 patients hospitalized with severe COVID-19 pneumonia across up to 40 clinical sites  --  Potential submission of global emergency use applications as early as Q4/2020

RedHill Biopharma Announces Positive Recommendation from Independent Committee to Continue U.S. Phase 2 COVID-19 Study, and Approval of COVID-19 Phase 2/3 Study in Italy

RedHill Biopharma Ltd (RDHL) CEO Dror Ben-Asher on Q2 2020 Results - Earnings Call Transcript

Q2 / 2020 net revenues of approximately $21 million, up from $1.1 million in Q1/2020 and $1.6 million in Q2/2019, an increase of approximately 1,900% and 1,200%, respectively

RedHill Biopharma Provides Q2/2020 Financial Results and Operational Highlights

TEL-AVIV, Israel and RALEIGH, N.C., Aug.  13, 2020  (GLOBE NEWSWIRE) --  RedHill Biopharma Ltd.  (Nasdaq:  RDHL ) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that it has entered into a binding term sheet with Cosmo Pharmaceuticals N.V. (SIX: COPN) (“Cosmo”) for an exclusive licensing and manufacturing agreement for multiple products. The transaction is expected to close in the coming weeks.

RedHill Biopharma and Cosmo Pharmaceuticals to Expand Strategic Partnership with Exclusive Licensing Agreement and Manufacturing Agreement for Multiple Products

The global Phase 2/3 study with opaganib is set to enroll up to 270 patients with severe  COVID-19 across 40 clinical sites  --  The global Phase 2/3 study has been approved in Mexico, the UK and Russia and is also under review in Italy, Brazil and additional countries  --  Enrollment in a parallel U.S. Phase 2 study in patients with severe COVID-19 is approximately 50% complete and is expected to be completed this month  --  Potential submission of global emergency use applications planned as early as Q4/2020

RedHill Biopharma’s Phase 2/3 COVID-19 Study Approved in Mexico

TEL-AVIV, Israel and RALEIGH, N.C., Aug.  07, 2020  (GLOBE NEWSWIRE) --  RedHill Biopharma Ltd.  (Nasdaq:  RDHL ) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that it will report its second quarter 2020 financial results and business highlights on Thursday, August 13, 2020.

RedHill Biopharma to Host Second Quarter Financial Results and Business Highlights Conference Call and Webcast on August 13, 2020

TEL-AVIV, Israel and RALEIGH, N.C., Aug.  05, 2020  (GLOBE NEWSWIRE) --  RedHill Biopharma Ltd.  (Nasdaq:  RDHL ) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that it will participate in the following virtual conferences in August:

RedHill Biopharma to Participate in Upcoming BTIG and Intellisight Conferences

RHB-204 is a potential first-line oral treatment for pulmonary nontuberculous mycobacteria (NTM) infections, a rare disease with no FDA-approved first-line therapy   --  The pivotal Phase 3 study aims to enroll 125 patients at 50 clinical sites across the U.S.  --  RHB-204 was granted QIDP designation and is eligible for Fast-Track development, NDA priority review and a total of eight years of U.S. market exclusivity, if approved   --  RedHill has also submitted to the FDA an Orphan Drug Designation application for  RHB-204, which, if granted, will extend U.S. market exclusivity to a total of 12 years

RedHill Biopharma Announces FDA Clearance for Pivotal Phase 3 Study with RHB-204 for NTM Infections

The global Phase 2/3 study will enroll up to 270 patients with severe COVID-19 across 40 clinical sites; The study has been approved in the UK and Russia and is under review in Italy, Brazil and Mexico

RedHill Biopharma Initiates Global Phase 2/3 Study for COVID-19

Publication of the Phase 2 U.S. study data show that RHB-102 (Bekinda®) 12mg delivers a clinically meaningful improvement in overall stool consistency response versus placebo in patients with diarrhea-predominant irritable bowel syndrome (IBS-D), meeting the study’s primary endpoint  --  In addition, the publication highlights that elevated baseline C-reactive protein (CRP) may be used to identify treatment responders in this complex disease, which lacks reliable predictive markers  --   The 126-patient study was conducted in 16 sites across the U.S.  --  RHB-102, a novel, proprietary, once-daily bimodal release formulation of ondansetron that allows for both immediate relief and 24-hour maintenance of effect, is also in Phase 3 development for acute gastroenteritis and gastritis

RedHill Biopharma Publishes Positive IBS-D Phase 2 Study Data in The American Journal of Gastroenterology

TEL-AVIV, Israel and RALEIGH, N.C., July  21, 2020  (GLOBE NEWSWIRE) --  RedHill Biopharma Ltd.  (Nasdaq:  RDHL ) (“RedHill” or the “Company”), a specialty biopharmaceutical company, announced today it is seeking regulatory review by the Securities and Exchange Commission (“SEC”), and intends to approach the Financial Industry Regulatory Authority, Inc. (“FINRA”), regarding suspicious trading activity including potential naked short selling of the Company’s stock.

RedHill Biopharma Seeks SEC Review of Suspicious Trading Activity

Clinical Trial Application approved in Russia for the Phase 2/3 study with opaganib in severe COVID-19 patients following recent approval in the UK and similar submission in Italy  --  The Phase 2/3 study aims to enroll 270 subjects in up to 40 clinical sites; enrollment planned to be initiated later this month with potential submission of Emergency Use Authorization application planned for Q4/2020  --  In parallel, the U.S. Phase 2a study with opaganib in patients with severe COVID-19 is advancing rapidly with more than 25% of patients enrolled  --  Approval also received for a clinical study with opaganib in Israel in up to 50 patients with severe COVID-19  --  Treatment of patients with severe COVID-19 under compassionate use showed substantial benefit to such patients compared to a matched case-control group

RedHill Biopharma Receives Approval for Phase 2/3  COVID-19 Study in Russia

﻿TEL-AVIV, Israel and RALEIGH, N.C., July  01, 2020  (GLOBE NEWSWIRE) --  RedHill Biopharma Ltd.  (Nasdaq:  RDHL ) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that Mr. Gilead Raday, RedHill's Chief Operating Officer, will present the Company’s ongoing Phase 2/3 development programs with opaganib (Yeliva®, ABC294640)1 and RHB-107 (upamostat, WX-671)2 for COVID-19 at the Sachs Digital Novel Coronavirus Investment Forum, taking place July 7-9, 2020.

RedHill Biopharma to Present at the Sachs Novel Coronavirus Investment Forum

RedHill's (RDHL) CTA gets approval in the United Kingdom to start a phase II/III study on opaganib for patients hospitalized with severe COVID-19 infection and pneumonia.

RedHill (RDHL) to Study Opaganib for Severe Coronavirus in UK

The Phase 2/3 multi-center, randomized, double-blind, parallel-arm, placebo-controlled study with opaganib aims to enroll 270 severe COVID-19 patients in up to 40 clinical sites across the UK, Italy, Russia and additional countries 

RedHill Biopharma Receives Approval for COVID-19 Phase 2/3 Study with Opaganib in the UK

Analysis of treatment outcomes in five severe COVID-19 patients showed substantial benefit to patients treated with opaganib under compassionate use in both clinical outcomes and inflammatory markers as compared to a matched case-control group from the same hospital  --  All patients in the opaganib-treated group were discharged from hospital without requiring mechanical ventilation whereas 33% of the matched case-control group required mechanical ventilation  --  Median time to weaning from high-flow nasal cannula was reduced to 10 days in the opaganib-treated group, as compared to 15 days in the matched case-control group  --  Phase 2/3 Clinical Trial Applications submitted for a multi-center, randomized, double-blind, parallel-arm, placebo-controlled study with opaganib in 270 patients with severe COVID-19 to be conducted in up to 40 clinical sites across Russia, Italy, the UK and additional countries  --  A randomized, double-blind, placebo-controlled study with opaganib in up to 40 patients with  severe COVID-19 initiated at leading medical centers across the U.S.

Publication of Data from Severe COVID-19 Patients Shows Substantial Benefit to Patients Treated with RedHill’s Opaganib Compared to Matched Case-Control Group

The multi-center, randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 clinical study with opaganib in 270 severe COVID-19 patients is planned to be conducted in up to 40 clinical sites across Russia, Italy, the UK and additional countries

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