RedHill Biopharma Ltd. (NASDAQ:RDHL) Q1 2021 Earnings Conference Call May 27, 2021 8:30 AM ET Â Company Participants Alexandra Okmian - Senior Business Development and Investor Relations Manager Dror Ben-Asher - Chief Executive Officer Micha Ben-Chorin - Chief Financial Officer Rick Scruggs - Chief Commercial Officer Gilead Raday - Chief Operating Officer Guy Goldberg - Chief Business Officer Adi Frish - Chief Corporate and Business Development Officer Rob Jackson - Senior Vice President, Sales and Marketin ...

Financial Performance - Net revenues for the three months ended March 31, 2021, were $20.575 million, a significant increase from $1.056 million in the same period of 2020, representing a growth of approximately 1,846%[6] - Gross profit for the same period was $10.322 million, compared to a gross loss of $0.659 million in Q1 2020, indicating a turnaround in profitability[6] - The company reported a comprehensive loss of $22.863 million for the three months ended March 31, 2021, compared to a loss of $17.157 million in the same period of 2020, reflecting ongoing investment in growth despite increased revenues[6] - Movantik® revenues for the three months ended March 31, 2021, were $18.898 million, with other products contributing $1.677 million[33] - The operating loss for the Commercial Operations segment was $8.515 million, while the Research and Development segment incurred an operating loss of $9.637 million, leading to a consolidated operating loss of $18.152 million for the three months ended March 31, 2021[36] Expenses and Investments - Research and development expenses increased to $7.484 million from $2.765 million year-over-year, reflecting a rise of approximately 171% as the company continues to invest in its therapeutic candidates[6] - Selling and marketing expenses rose to $13.895 million from $9.006 million, an increase of about 54% year-over-year, indicating a focus on expanding market presence[6] Assets and Cash Position - The total assets as of March 31, 2021, were $220.123 million, up from $180.241 million at the end of 2020, marking an increase of approximately 22%[10] - Cash and cash equivalents increased to $75.972 million from $29.295 million year-over-year, representing a growth of approximately 159%[10] - The accumulated deficit as of March 31, 2021, was $302.325 million, up from $280.334 million at the end of 2020, indicating ongoing financial challenges despite revenue growth[10] Future Plans and Financing - The company plans to fund future operations through commercialization and out-licensing of therapeutic candidates, as well as raising additional capital through equity or debt financing[17] - The company issued 7,836,209 ADSs for net proceeds of approximately $58 million and 428,421 ADSs from options exercises for about $3 million during the reporting period[29] Legal and Regulatory Matters - The company plans to vigorously defend itself against a patent infringement complaint filed by Aether Therapeutics Inc. regarding the Movantik® product[29] - RedHill Biopharma amended its License Agreement with AstraZeneca, adjusting a payment of $15.5 million due in December 2021 to gradual payments totaling $16 million from March 2021 to December 2022[29] COVID-19 Impact - The company continues to assess the impact of the COVID-19 pandemic on its operations, with some commercial activities affected, particularly sales of Aemcolo® for travelers' diarrhea[22] Fair Value Measurements - The fair value of the borrowing as of March 31, 2021, was approximately $103 million, while the payable in respect of intangible assets purchase was about $27 million[34] - The company’s financial assets as of December 31, 2020, were measured at fair value at level 1, with no liabilities measured at fair value during the reported periods[34] - The estimated fair value of options granted on April 28, 2021, was approximately $8.5 million, with a total of 2,121,296 ADSs granted to employees and consultants[37] Revenue Allowance - The allowance for deductions from revenue increased to $22.677 million as of March 31, 2021, up from $18.343 million at the beginning of the year, reflecting a rise of approximately 23%[30]

RedHill Biopharma Ltd. (NASDAQ:RDHL) Q4 2020 Earnings Conference Call March 18, 2021 8:30 AM ET Company Participants Alexandra Okmian - Senior Business Development and Investor Relations Manager Dror Ben-Asher - CEO Micha Chorin - CFO Rick Scruggs - Chief Commercial Officer Gilead Raday - COO Guy Goldberg - Chief Business Officer Adi Frish - Chief Corporate and Business Development Officer Rob Jackson - SVP, Sales and Marketing Conference Call Participants Scott Henry - ROTH Capital Ram Selvaraju - H.C. Wai ...

COVID-19 Treatments and Impact - The company is pursuing the study of opaganib and RHB-107 as potential treatments for COVID-19, but has conducted limited testing and cannot assure their safety and efficacy[26]. - The short-term capacity for finished drug product opaganib is anticipated to be 155,000 patient treatments, with plans to scale up to treat an estimated 2.8 million patients[37]. - The ongoing COVID-19 pandemic has caused significant volatility and uncertainty in global markets, adversely affecting the company's business, revenues, and results of operations[41]. - The pandemic has led to decreased commercial activities, negatively impacting sales of products like Movantik®, Aemcolo®, and Talicia® due to reduced in-clinic patient visits[42]. - The initiation of the Phase 3 study with RHB-204 in first-line pulmonary NTM infections was deferred by two quarters to Q4 2020 due to pandemic-related delays[43]. - The company may face challenges in scaling up manufacturing processes for COVID-19 treatments, which could impact the ability to meet demand following potential emergency use authorization[27]. - The biotechnology sector is highly competitive, with numerous companies pursuing COVID-19 treatments, which may limit the commercial opportunity for the company's therapeutic candidates[29]. - Government involvement may limit the commercial success of the company's COVID-19 therapeutic candidates, potentially affecting their competitive position[30]. Financial Performance and Capital Resources - The company recorded net losses of approximately $76.2 million in 2020, $42.3 million in 2019, and $38.8 million in 2018, with an accumulated deficit of approximately $280.3 million as of December 31, 2020[48]. - As of December 31, 2020, the company had cash, cash equivalents, short-term investments, and restricted cash of approximately $46.0 million, down from $48.0 million in 2019[53]. - The company plans to fund future operations through commercialization of Movantik®, Talicia®, and Aemcolo®, out-licensing of therapeutic candidates, and raising additional capital through equity or debt financing[54]. - The company has a term loan facility of up to $115 million, with $30 million already borrowed to support commercial operations and an additional $50 million for the acquisition of Movantik®[58]. - The company may continue to incur significant losses in the coming years as it focuses on the development and commercialization of therapeutic candidates[46]. - The company’s ability to generate sufficient revenues to sustain operations and achieve profitability depends on successful commercialization of current and future products[50]. - The company may face challenges in raising additional capital or securing development partners due to inherent business risks and market conditions[56]. - The company’s term loan facility imposes significant operating and financial restrictions, which may limit its ability to capitalize on business opportunities[57]. Commercialization and Market Challenges - The company has increased its sales force to support the commercialization of Movantik®, Talicia®, and Aemcolo®[89]. - Commercialization of products may face challenges such as low market acceptance and insufficient reimbursement levels[92]. - The company may need to expand its commercial capabilities to successfully market and sell its products[89]. - A substantial portion of revenues for the twelve-month period ended December 31, 2020, was attributed to Movantik®, indicating its critical role in future success[126]. - The company faces competitive pressures from other drugs in the PAMORA class and non-PAMORA alternatives, which could impact sales of Movantik®[126]. - The company has limited experience in independently commercializing products, which may hinder the successful commercialization of Movantik®, Talicia®, and Aemcolo®[134]. - Market uncertainty complicates demand forecasting for commercial products, risking excess inventory or shortages that could adversely affect revenues[139]. - The company relies on third-party data for sales volume and product acquisition assessments, which may be inaccurate and affect reported revenues[141]. - The company does not own manufacturing facilities and relies on third parties for production, which poses risks to the timely supply of products[142]. - The company may face challenges in establishing and expanding its commercial infrastructure, which is essential for maximizing sales of its products[131]. Regulatory and Compliance Issues - Regulatory delays or failures could significantly impact revenue generation and overall financial condition[75]. - Changes in regulatory requirements could directly impact the commercialization of products[93]. - The company must ensure compliance with regulatory standards to avoid adverse effects on its reputation and financial condition[172]. - The company may face delays in obtaining FDA approval for therapeutic candidates due to issues related to manufacturing standards or clinical studies[166]. - The company is responsible for managing the global safety database for Movantik®, which may increase regulatory scrutiny[158]. - The company may face regulatory challenges requiring new approvals for modifications to marketed products, which could lead to recalls or suspensions[189]. Clinical Trials and Development - The company faces various risks in clinical trials, including delays in securing clinical investigators, obtaining regulatory approvals, and potential negative results from trials[170]. - The FDA granted orphan drug designation for RHB-104 for the treatment of Crohn's disease in the pediatric population, which provides financial incentives and exclusivity for seven years upon approval[184][185]. - RHB-204 received QIDP designation by the FDA for the treatment of pulmonary NTM infections, allowing for a total exclusivity period of twelve years when combined with orphan drug designation[187]. - The company relies on contract research organizations for clinical data management, which may lead to risks regarding the accuracy and integrity of clinical data[180]. - The company may need to alter its development and commercialization plans if it fails to establish collaborations or raise substantial additional capital[174]. Product-Specific Challenges - Aemcolo® received FDA approval on November 16, 2018, for the treatment of travelers' diarrhea, but its market success is contingent on the completion of two pediatric postmarketing studies[98]. - The pediatric studies for Aemcolo® must be completed by June 2022 and June 2021, respectively, but COVID-19 may impact these timelines[100]. - Movantik® was approved by the FDA on September 16, 2014, for the treatment of opioid-induced constipation (OIC) but requires an additional postmarketing safety study to maintain its approval[104]. - The MACE study for Movantik® must be completed by December 2021, with the final report due by December 2023, but slow patient enrollment may delay this[105]. - Non-compliance with pediatric postmarketing requirements for Aemcolo® could result in civil monetary penalties of up to $250,000 per violation, totaling up to $10 million for all violations in a single proceeding[103]. - Failure to complete the required studies for Aemcolo® or Movantik® could lead to FDA enforcement actions, including withdrawal of marketing approval, adversely affecting the company's reputation and financial condition[106]. Competitive Landscape - The company faces intense competition in the pharmaceutical industry, particularly for its products Movantik®, Talicia®, and Aemcolo®, from both branded and generic alternatives[205]. - Movantik® competes with other approved PAMORA drugs and various branded therapies for opioid-induced constipation (OIC)[207]. - Talicia® faces competition from established therapies for H. pylori, including a new treatment under development by Phathom Pharmaceuticals[208]. - Aemcolo® competes with several marketed drugs for travelers' diarrhea, including Xifaxan® and various generic antibiotics[209]. - The company competes for in-license and acquisition opportunities with well-capitalized firms, which may hinder its ability to grow its therapeutic candidate portfolio[193]. Management and Operational Risks - Future growth may impose significant responsibilities on management, diverting attention from day-to-day operations[91]. - The inability to find satisfactory replacements for key executives could trigger immediate repayment obligations under the term loan facility[70]. - The integration of acquired products or technologies may lead to operational difficulties and additional costs, impacting overall business performance[120]. - The company’s growth is contingent on attracting and retaining key personnel, which is challenging due to high demand in the pharmaceutical industry[199]. - Increased scrutiny on opioid-related products may affect the company's ability to commercialize Movantik® and could reduce its market size[218]. - The company is at risk of adverse effects from healthcare reform measures that could change the market for medical care and coverage in the U.S.[219].

RedHill Biopharma Ltd. ("RDHL") Corporate Presentation December 2020 Forward Looking Statement This presentation does not constitute an offer or invitation to sell or issue, or any solicitation of an offer to subscribe for or acquire any of the Company's securities or to participate in any investment in the Company. No representation or warranty is made to the accuracy or completeness of this presentation. You must make your own investigation and assessment of the matters contained herein. In particular, no ...

RedHill Biopharma Ltd. (NASDAQ:RDHL) Q3 2020 Earnings Conference Call November 12, 2020 8:30 AM ET Company Participants Alexandra Okmian - Senior Business Development and Investor Relations Manager Dror Ben-Asher - Chief Executive Officer Micha Chorin - Chief Financial Officer Rick Scruggs - Chief Commercial Officer Gilead Raday - Chief Operating Officer Guy Goldberg - Chief Business Officer Conference Call Participants Matt Kaplan - Ladenburg David Hoang - SMBC Scott Henry - ROTH Capital Operator Good day ...

RedHill Biopharma Ltd. ("RDHL") Corporate Presentation November 2020 Forward Looking Statement This presentation does not constitute an offer or invitation to sell or issue, or any solicitation of an offer to subscribe for or acquire any of the Company's securities or to participate in any investment in the Company. No representation or warranty is made to the accuracy or completeness of this presentation. You must make your own investigation and assessment of the matters contained herein. In particular, no ...

RedHill Biopharma Ltd. ("RDHL") Corporate Presentation October 2020 Forward Looking Statement This presentation does not constitute an offer or invitation to sell or issue, or any solicitation of an offer to subscribe for or acquire any of the Company's securities or to participate in any investment in the Company. No representation or warranty is made to the accuracy or completeness of this presentation. You must make your own investigation and assessment of the matters contained herein. In particular, no ...

RedHill Biopharma Ltd. ("RDHL") Corporate Presentation September 2020 Forward Looking Statement This presentation does not constitute an offer or invitation to sell or issue, or any solicitation of an offer to subscribe for or acquire any of the Company's securities or to participate in any investment in the Company. No representation or warranty is made to the accuracy or completeness of this presentation. You must make your own investigation and assessment of the matters contained herein. In particular, n ...

RedHill Biopharma Ltd. ("RDHL") Corporate Presentation August 2020 Forward Looking Statement This presentation does not constitute an offer or invitation to sell or issue, or any solicitation of an offer to subscribe for or acquire any of the Company's securities or to participate in any investment in the Company. No representation or warranty is made to the accuracy or completeness of this presentation. You must make your own investigation and assessment of the matters contained herein. In particular, no r ...