Redhill Biopharma Ltd.

Good day, and welcome to the Redhill Biopharma Second Quarter 2021 Financial Results Conference Call. The presentation will be followed by a question and answer session, at which time, if you wish to ask a question, you have to press star 1 on your telephone keypad. At this time, I would like to introduce to the conference call Redhill CEO, Dror Ben Asher, Mika Ben-Korin, Chief Financial Officer, Rick Scruggs, Chief Commercial Officer, Kiliad Radai, Chief Operating Officer. Guy Goldberg, Chief Business Officer. Adi Frisch, Chief Corporate and Business Development Officer. Rob Jackson, Senior Vice President, Sales and Marketing. And Bob Gilkin, Senior VP, Market Access and Trade Relations. Before we begin, we will read from the Red Hill Safe Harbor Statement. Please go ahead.

Thank you, Andrea. This conference call may contain projections or other forward-looking statements regarding future events or the future performance of Redhill, including statements with respect to the business promotion and other efforts related to Redhill's commercialization activities and the initiation, timing, progress, and results of Redhill's research, manufacturing, preclinical studies, clinical trials, marketing applications, and approvals, if any, including the clinical trials of Opagonib and RHP107 for the treatment of COVID-19. These statements are only predictions and Redhill cannot guarantee that they will in fact occur. Redhill does not assume any obligation to update that information. Actual events, performance, timing, results, or commercialization activities may differ materially from what Redhill projects today. Additional information concerning factors that could cause actual events, performance, timing, results, or commercialization activities to materially differ from those contained in the forward-looking statements can be found in the company's annual report. report on Form 20-F filed with the SEC on March 18th, 2021, and then its other filings with the Securities and Exchange Commission. I will now transfer the call to Jorob and Asher Redil's CEO.

Thank you, Alexandra. Good day, everyone, and thank you for joining our second quarter earnings call. We hope that this call finds you and your loved ones safe and well despite the challenging times. Today, we will be presenting detailed R&D commercial and financial highlights. Starting with R&D, COVID-19 is a devastating disease. Delta and other variants of concern continue to rapidly spread havoc across the U.S. and the globe, along with rising COVID-19 new cases, hospitalizations, and unfortunately, death. There's a clear and immediate need for an effective COVID-19 therapeutic in an oral field form, as outlined by many public health experts, including recently by the director of the NIA. I'm proud of Fred Hill's small but agile and resilient team that rose to the challenge and remained relentlessly execution-focused. This morning, we announced data from the University of Louisville showing strong inhibition of the Delta variant with Opaginib. Also this morning, we announced important potential support by QuantumLib and BARDA, an arm of the U.S. government, for Opaginib to be included in the iSpy COVID-19 clinical trial as a promising drug candidate for severe COVID-19 patients. In parallel, our team and our partners are doing everything humanly possible to get to the finish line with Apaganiv's global 475-patient Phase 2-3 study in severe COVID-19. With last patient out announced last month, we are nearly there. Remarkably, this study only commenced about a year ago, It was planned and executed by Redhill and its partners at the speed of light in pharma terms, and it was driven by the urgent medical need all around. To put things in perspective, Opacanib is probably the most advanced novel dual mode of action oral pill candidate of its kind in development currently for hospitalized COVID-19 patients. Opaginib demonstrates strong antiviral activity, including key variants of concern, such as Delta, and as well as strong anti-inflammatory activity, including very recently data about interleukin-6 IL-6 inhibition. This is an important inflammatory cytokine target, highly relevant for COVID-19 disease. From an even broader perspective, It is important to note that fighting viruses that lead to devastating epidemics or pandemics in a globalized and interconnected world does not stop with COVID-19. Apogonids' potential goes way beyond COVID-19, and it is therefore being explored in additional infectious diseases and models such as Ebola and others. A lot more is happening here at Red Hill on the R&D front. For example, this morning we reported that the primary endpoint was met in the ongoing phase two study of opaginib in prostate cancer, based on our preliminary review. Our second COVID-19 drug candidate, the antiviral and once daily oral drug, RGB107, or Rupamostat, continues its Phase 2-3 study in non-hospitalized COVID-19 patients early in the course of the disease. For RGB204, the Phase 3 study in the U.S. for NTM infection is also ongoing. Our chief operating officer, Gilad, will add more color about select R&D programs shortly. Moving on to the commercial front. Earlier today, we announced the achievement of record quarterly revenues despite the challenging pandemic environment, particularly so for new drug launches such as Thalysia. Thalysia prescription volume continues to grow, and new prescription growth from Avantik during the quarter has been strong, even beating pre-pandemic levels. New formulary wins with several of the nation's largest pairs translate into an impressive 8 out of 10 commercially insured Americans now being covered for Talisia, and 9 out of 10 commercially insured Americans now being covered for Movantik. Plans are also in place to build on the initial momentum that M-Colo was generating pre-COVID travel restrictions. Rob, our head of sales and marketing, will provide additional details in a moment. I will now turn to our chief business officer, Guy, and the rest of the team for our presentation to be followed by a Q&A session.