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RedHill Biopharma Ltd. (NASDAQ: RDHL) is a specialty biopharmaceutical company centered on gastrointestinal and infectious diseases. The company is headquartered in Israel and operates internationally, with teams in the U.S., Canada, and Europe. RedHill's primary focus is the development and commercialization of late-stage clinical therapeutics and patented reformulations of existing drugs.
Core Business and Products
RedHill's flagship commercial products in the U.S. include Talicia® (omeprazole, amoxicillin, and rifabutin) for treating Helicobacter pylori (H. pylori) infection in adults, and Aemcolo® (rifamycin) for treating travelers' diarrhea. Talicia® is unique as the only FDA-approved rifabutin-containing therapy optimized for H. pylori eradication, addressing the rising concern of antibiotic resistance.
Key Development Programs
- Opaganib (ABC294640): A first-in-class oral SPHK2 inhibitor with applications in pandemic preparedness, oncology, and radioprotection. It is undergoing trials for multiple indications including Acute Radiation Syndrome (ARS) and COVID-19, and has shown promising results in pre-clinical studies against Ebola.
- RHB-107 (upamostat): An oral broad-acting, host-directed serine protease inhibitor targeting non-hospitalized symptomatic COVID-19, supported by U.S. Department of Defense funding in a 300-patient Phase 2 trial. It also shows potential for cancer and inflammatory gastrointestinal diseases.
- RHB-102: A novel therapy for chemotherapy and radiotherapy-induced nausea and vomiting, with positive Phase 3 results for acute gastroenteritis.
- RHB-104: Demonstrated efficacy in a Phase 3 study for Crohn's disease.
- RHB-204: In Phase 3 development for pulmonary nontuberculous mycobacteria (NTM) disease.
Recent Achievements
Recent publications highlight Opaganib's efficacy in enhancing long-term survival in radiation exposure models, and its selection by the U.S. NIH for the Radiation and Nuclear Countermeasures Program. Additionally, the company secured a new U.S. patent for Talicia®, extending its protection until 2034, and obtained a new Chinese patent for Opaganib in combination with immune checkpoint inhibitors, valid through 2040.
Financial Performance
For the year ending December 31, 2023, RedHill reported net revenues of $6.5 million, primarily from Talicia®, with a gross profit of $3.1 million. The company has reduced its liabilities significantly following the divestiture of Movantik, and its financial health is bolstered by ongoing U.S. government funding for key R&D programs.
Strategic Direction
RedHill is focused on leveraging its solid pipeline and partnerships to address unmet medical needs in gastrointestinal and infectious diseases. The company is strategically positioned to benefit from growing geopolitical and health threats, aiming to provide innovative solutions in challenging healthcare environments.
RedHill Biopharma (Nasdaq: RDHL) announced that Chief Business Officer Guy Goldberg will present a corporate overview and participate in 1-on-1 investor meetings at the German Equity Forum 2020 on November 17, 2020, at 9:30 a.m. CET. The event is among Europe’s largest investor gatherings. A replay of the presentation will be available for 30 days on the Company's website. RedHill focuses on gastrointestinal and infectious diseases, promoting drugs such as Movantik and Talicia.
RedHill Biopharma reported Q3 2020 net revenues of approximately $21 million with a gross profit of $10.6 million, representing a 51% gross margin, up from 32% in Q2 2020. Talicia® saw exceptional growth with a 300% quarter-over-quarter increase in prescriptions. Movantik® also reversed its declining trend with two consecutive quarters of prescription growth. The Company is advancing studies for opaganib in COVID-19, nearing 50% enrollment for global trials. As of September 30, 2020, RedHill's cash balance was approximately $51 million.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced it will report its third-quarter 2020 financial results on November 12, 2020. A conference call will be held at 8:30 a.m. EST, covering financial performance, commercial activities, and progress in its late-stage development program for opaganib targeting COVID-19, along with advancements in its pipeline, including the Phase 3 study for RHB-204 for pulmonary infections.
RedHill Biopharma (RDHL) has received a Notice of Allowance from the USPTO for a patent covering the combination of its investigational drugs, opaganib and RHB-107, for treating solid tumors, extending IP protection until 2036. A pre-clinical study on cholangiocarcinoma showed that both drugs individually and together induced tumor regression, with the combination being particularly effective. RedHill plans to introduce a third cohort in its Phase 2a study to evaluate this combination, pending FDA discussions, following preliminary positive results from the ongoing trial.
RedHill Biopharma presented compelling data on Talicia, its FDA-approved rifabutin-based therapy for H. pylori, at the ACG 2020 meeting. The Phase 3 trial revealed low eradication rates with clarithromycin-based regimens due to rising antibiotic resistance, highlighting the need for first-line treatments like Talicia. Importantly, Talicia's efficacy remained consistent across varying BMI levels, unlike traditional therapies, which saw a significant drop in effectiveness in obese patients. This positions Talicia as a superior option amid declining standard treatment success rates.
RedHill Biopharma (RDHL) announced that the FDA granted Orphan Drug Designation for RHB-204, aimed at treating pulmonary nontuberculous mycobacteria (NTM) disease. This designation extends U.S. market exclusivity for RHB-204 to 12 years, enhancing the urgency for new treatment options in a market lacking FDA-approved therapies. A Phase 3 study to evaluate RHB-204's safety and efficacy is set to begin soon, targeting 125 patients across 40 U.S. sites. The study will compare RHB-204 with a placebo, focusing on patient-reported outcomes and sputum culture conversion by Month 6.
RedHill Biopharma (RDHL) announced collaborations with European and Canadian pharmaceutical manufacturers to enhance opaganib production, a treatment for severe COVID-19 pneumonia. The global Phase 2/3 study is progressing rapidly with enrollments expected to reach 270 patients by year-end. The U.S. Phase 2 study is nearing completion and has passed a second independent review. Opaganib, an SK2 selective inhibitor, shows promising antiviral activity against SARS-CoV-2, which could support emergency use applications and address imminent demand.
RedHill Biopharma (RDHL) announced it has acquired the rights to Movantik (naloxegol) in Israel from AstraZeneca, securing global rights outside Europe and Canada. Movantik, approved for treating opioid-induced constipation, is not yet commercialized in Israel. RedHill is exploring local partnerships to bring the drug to market. In the U.S., RedHill holds exclusive commercialization rights and reported approximately $20 million in net revenue for Movantik in Q2 2020. RedHill aims to enhance margins and brand strategy for Movantik through recent agreements.
The independent Safety Monitoring Committee has recommended continuing the U.S. Phase 2 study of opaganib in COVID-19 without changes, as it is 75% enrolled. The study focuses on safety and will provide data later this quarter. Concurrently, a global Phase 2/3 study is rapidly enrolling in 15 sites, aiming for up to 270 patients and focusing on efficacy. The company is also seeking U.S. government funding to expedite opaganib's advancement towards potential emergency use authorization.
TEL AVIV, Israel and RALEIGH, N.C., Oct. 6, 2020 – RedHill Biopharma (Nasdaq: RDHL) announced its participation in two upcoming virtual conferences in October. The BIO Investor Forum will be held from Oct. 13-15, featuring Guy Goldberg, Chief Business Officer. Subsequently, the BIO-Europe 2020 conference will run from Oct. 26-29 with Adi Frish, Senior VP Business Development, as the speaker. Presentations will be accessible on the company's website for 30 days following each event.
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