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

Earnings data Q1 2020

Earnings data Q2 2020

Earnings data Q3 2020

Earnings data Q4 2020

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Earnings data Q3 2021

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Earnings data Q3 2022

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Earnings data Q2 2023

Earnings data Q4 2023

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RedHill Biopharma Ltd. (RDHL) CEO Dror Ben-Asher on Q3 2020 Results - Earnings Call Transcript

Shares of Redhill Biopharma (NASDAQ:RDHL) remained unaffected after the company reported Q3 results. Quarterly Results Earnings per share fell 66.67% year over year to ($0.05), which beat the estimate of ($0.16).

Recap: Redhill Biopharma Q3 Earnings

Q3/2020 net revenues of approximately $21 million , with gross profit of $10.6 million , or approximately 51% , up from $6.7 million and approximately 32% in Q2/2020 -- 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 -- T wo 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 U.S. Phase 2 stud y over 90% enrolled ; Initiated manufacturing ramp-up in preparation for potential e mergency u se applications as early as Q1/2021 -- Commencing Phase 3 study with RHB-204 for first-line treatment of pulmonary NTM infection s -- Cash balance of approximately $ 51 million as of September 30 , 2020 -- Management to host webcast today, at 8:30 a.m. EST

RedHill Biopharma Provides Q3/2020 Results and Highlights, Including 300% Talicia Prescription Growth

Notice of Allowance received for combination of RedHill's novel orally-administered investigational drugs, opaganib and RHB-107, for treatment of solid tumor cancers; patent expected to extend IP protection until 2036

RedHill Biopharma Receives U.S. Patent Allowance Covering Opaganib and RHB-107 Combination

  H. pylori e radication rates with clarithromycin-based triple therapy were found to be predictably low in the Phase 3 trial , with antibiotic resistance a contributing factor . D espite declining efficacy, physicians are still prescribing these regimens counter to ACG guidelines , which advocat e for us ing first-line regimens that provid e the highest likelihood of eradication success -- Talicia 's efficacy in the Phase 3 study was unaffected by patient body mass index ( BMI ) , while published data suggest that BMI may be associated with the failure of clarithromycin-based H. pylori treatments , further supporting the use of Talicia as a first-line therapy i n all populations -- Talicia is the first and only FDA-approved rifabutin-based therapy for the treatment of H. pylori infection , designed as a first-line option to address the high and growing resistance of H. pylori to commonly used antibiotics

RedHill Biopharma Presents New Data from Talicia®'s Phase 3 Studies at ACG 2020 Focused on Achieving Successful First-Line Treatment in H. pylori Eradication

RedHill (RDHL) gets Orphan Drug status from the FDA for the treatment of nontuberculous mycobacteria (NTM) disease.

RedHill's (RDHL) RHB-204 Gets FDA Orphan Drug Designation

RHB-204 Phase 3 study in pulmonary NTM infections is planned to be initiated in the coming weeks -- Orphan Drug Designation , along with RHB-204’s FDA QIDP priority designation, will extend U.S. potential market exclusivity to a total of 12 years

RedHill Biopharma Announces FDA Orphan Drug Designation for RHB-204 for the Treatment of NTM Infections

        Collaborations with European and Canadian suppliers for large-scale ramp-up of opaganib manufacturing further strengthen s manufacturing capabilities and capacity , in preparation for potential emergency use applications 

RedHill Biopharma Announces Partnerships to Expand Manufacturing for COVID-19 Therapeutic Candidate Opaganib

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

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