Redhill Biopharma Ltd.

Good day and thank you for standing by. Welcome to the Red Hill Biopharmers 3rd Quarter 2021 Results Financial Conference Call. If you wish to ask a question, please press star 1 on your telephone keypad. At this time, I would like to introduce to the conference call Red Hill's CEO, Dror Ben Asher, Micah Ben Corrine, Chief Financial Officer, Gilid Rade, Chief Operating Officer, Guy Goldberg, Chief Business Officer. Adi Frisch, Chief Corporate and Business Development Officer. Rob Jackson, Senior Vice President, Sales and Marketing. Bob Gilkin, Senior VP Market Access and Trade Relations. And Dr. June Almanoff, Chief Medical Officer. Before we begin, we will read from Red Hills Safe Harbor Statement. Please go ahead.

Thank you, Brian. 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 Opaginib 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 on Form 20F, filed with the SEC on March 18, 2021, and in its other filings with the Securities and Exchange Commission.

Thank you, Alexandra. Good day, everyone, and thank you for joining our third quarter earnings call. Today, we'll be presenting detailed R&D commercial and financial highlights. In light of the recent emergence of the Omicron variant, and the risk presented by future variants of concern, we will elaborate on Red Hill's strategy with Opaganib and RHB107, and there are increasingly relevant mechanisms of action potential against the emerging variants. Our U.S. commercial business continues to drive growth, delivering a second consecutive quarterly net revenue record of $21.6 million. despite continuously challenging pandemic environments. Felicia generated another record quarter with 15% growth in new prescriptions, while Movanti 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. Rob Jackson, who is heading our marketing and sales will further elaborate shortly. Turning to R&D. Given the recent emergence of the heavily mutated Omicron or South African variant, as well as likely emergence of other variants of concern over time, the importance of drug candidates that act independently of the viral spike protein is growing. This makes both Opaginib and RHB107 host-targeted mechanism of action and expected maintenance of effects against new variants increasingly more relevant in the battle against COVID-19. The third quarter saw significant focus on completing Opaginib's global phase 2.3 COVID-19 study in hospitalized patients. specifically in the currently underserved, hospitalized, moderately severe patient group, which the Pfizer and Merck pills do not address, a subpopulation comprising more than 50% of our total study population. Opaginib demonstrated a 62% reduction in mortality, as well as improved return to room air and earlier hospital discharge. This is consistent with what we have seen in our phase two study and compassionate use experience. The consistency across multiple endpoints and territories provides us with a high degree of confidence in the results showing a positive effect in this patient population. We have now provided regulators in various countries with robust data packages to facilitate discussions on next steps. and will continue to provide data to regulators in additional countries. Expedited review of the Opaginib data has already been granted by EMA, the European Union's regulatory body, equivalent to the FDA in the United States. In parallel, we continue to progress our Phase 2-3 program in non-hospitalized patients in the United States and South Africa with our other novel once daily oral COVID-19 drug candidate, RHB107, with Part A topline results expected in the first quarter of 2022. Gilad, our chief operating officer, will elaborate about the status of our COVID-19 programs shortly. Our Phase III study of RHB204 in pulmonary NTM disease continues to enroll patients in the United States. Importantly, progress with phase 3 stage RGB104 for Crohn's disease is expected to speed up thanks to a recent, much-awaited potential progress in mycobacterium avium subspecies paratypoclosis, or in short, MAP detection research. We are very excited about that. With steep reduction in quarterly operating and net loss, a quarterly record gross profit of $12.4 million, with improved gross margin from net revenues, and a potential commercial non-GAAP EBITDA break-even before the end of the year, along with advanced, exciting, and timely R&D pipeline. We are well positioned for short, medium, and long-term success as an emerging specialty pharma company. Before turning to our Chief Business Officer, Guy Goldberg, and the rest of the team for our presentation. Please remember to press the link in order to view our detailed slides to be followed by a Q&A session.