Redhill Biopharma Ltd (RDHL) 2022 Q1 法說會逐字稿

Good day, and welcome to RedHill Biopharma's First Quarter 2022 Financial Results and Operational Highlights Conference Call. (Operator Instructions) At this time, I would like to introduce to the conference call RedHill's CEO, Dror Ben-Asher; Rick Scruggs, President of RedHill Biopharma, Inc. and Chief Commercial Officer; Guy Goldberg, Chief Business Officer; Gilead Raday, Chief Operating Officer; Micha Ben-Chorin, Chief Financial Officer; Adi Frish, Chief Corporate and Business Development Officer; and Rob Jackson, Senior Vice President of Marketing. Before we begin, we will read from RedHill's safe harbor statement. Please go ahead.

大家好，歡迎參加 RedHill Biopharma 2022 年第一季財務業績和營運亮點電話會議。 （操作員指示）現在，我想向電話會議介紹 RedHill 的首席執行官 Dror Ben-Asher； RedHill Biopharma, Inc. 總裁兼首席商務官 Rick Scruggs；蓋伊·戈德堡 (Guy Goldberg)，首席商務官；吉利德·拉迪 (Gilead Raday)，首席營運官； Micha Ben-Chorin，首席財務官；在我們開始之前，我們先讀一下 RedHill 的安全港聲明。請繼續。

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, financial results, operational cost savings, promotion and other efforts related to RedHill's commercialization activity, potential acquisitions 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 opaganib and RHB-107 for the treatment of COVID-19 and RHB-204 for NTM disease.

本次電話會議可能包含有關未來事件或 RedHill 未來業績的預測或其他前瞻性陳述，包括有關業務、財務業績、營運成本節約、與 RedHill 商業化活動相關的推廣和其他努力、潛在收購以及 RedHill 研究、製造、臨床前研究、臨床試驗、上市申請和批准（如有）的啟動、時間安排、疾病和結果，包括用於治療 COVID-190 的 1990 RHB-204 的臨床試驗。

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 20-F filed with the SEC on March 17, 2022, and its other filings with the Securities and Exchange Commission.

這些聲明只是預測，RedHill 不能保證它們確實會發生。 RedHill 不承擔更新該資訊的任何義務。實際事件、表現、時間、結果或商業化活動可能與 RedHill 今天的預測有重大差異。有關可能導致實際事件、業績、時間、結果或商業化活動與前瞻性陳述中所述內容存在重大差異的因素的更多信息，請參閱公司於 2022 年 3 月 17 日向美國證券交易委員會提交的 20-F 表年度報告以及向美國證券交易委員會提交的其他文件。

I will now turn the call to Dror Ben-Asher, RedHill's CEO.

現在我將把電話轉給 RedHill 執行長 Dror Ben-Asher。

Thank you, Debbie. Good day, everyone, and thank you for joining our first quarter earnings call.

謝謝你，黛比。大家好，感謝大家參加我們的第一季財報電話會議。

To address the current market reality, RedHill is decisive about controlling its own destiny. We are highly focused on achieving earlier profitability, targeting positive cash from operations to start during the second half of 2022. Our comprehensive cost-reduction plan is expected to generate operational cost savings of approximately $50 million over the next 18 months. We are already seeing a significant positive impact of our disciplined cost control approach, with a reduction of over 70% in cash used in operating activities in the first quarter.

針對當前的市場現實，RedHill 果斷掌握自己的命運。我們高度重視實現更早的獲利，目標是從 2022 年下半年開始實現營運現金流為正。我們的全面成本削減計畫預計將在未來 18 個月內節省約 5,000 萬美元的營運成本。我們已經看到了嚴格的成本控制方法帶來的顯著正面影響，第一季經營活動所用的現金減少了 70% 以上。

The majority of our cost-reduction plan, the savings, results from an approximately 1/3 reduction of the U.S. commercial team workforce. We have also streamlined operational expenditure, including SG&A expenses and also refined the company's R&D strategy to rely mostly on external funding sources for now, based on the promising clinical data generated to date. Our excellent R&D progress will be discussed shortly by Gilead, our Chief Operating Officer.

我們的成本削減計劃，即節省的大部分資金，來自美國商業團隊員工約三分之一的裁減。我們也精簡了營運支出，包括銷售、一般和行政費用，並根據迄今為止產生的有希望的臨床數據，改善了公司的研發策略，目前主要依靠外部資金來源。我們的營運長吉利德將很快討論我們出色的研發進度。

On behalf of the company, I would like to express my profound and respectful gratitude to the colleagues who have departed RedHill. While difficult, the changes we have made as part of our cost-reduction plan were necessary, given the current reality. I would also like to thank our resilient and highly driven team as well as various stakeholders for their patience and support as we continue to diligently and decisively grow the business against various headwinds.

我謹代表公司向離開RedHill的同事們表示深切而崇高的謝意。儘管很困難，但考慮到當前的現實，我們作為成本削減計劃的一部分所做的改變是必要的。我還要感謝我們堅韌而又積極進取的團隊以及各利益相關者的耐心和支持，我們將繼續勤奮而果斷地克服各種不利因素來發展業務。

In summary, RedHill significantly improved financial stability results from major cost savings, a robust commercial portfolio with 3 FDA-approved proprietary drugs, continued prescription growth, expanded managed care coverage and the recently improved credit agreement with HealthCare Royalty. RedHill is, therefore, well positioned for further growth, both organically from our own pipeline and nonorganically through potential acquisitions of additional revenue-generating synergistic products to expedite and increase cash generation, both in the short term and the longer term.

總而言之，RedHill 的財務穩定性顯著提高，這得益於大幅的成本節約、擁有 3 種 FDA 批准的專利藥物的強大商業組合、處方藥的持續增長、管理式醫療覆蓋範圍的擴大以及最近與 HealthCare Royalty 達成的改進的信貸協議。因此，RedHill 已做好進一步成長的準備，既可以透過我們自己的產品線實現有機成長，也可以透過潛在收購額外的創收協同產品實現非有機成長，以加快和增加短期和長期的現金產生。

I will now be turning to our Chief Business Officer, Guy Goldberg, and the rest of the team for our detailed commercial R&D financial presentation to be followed by a Q&A session.

現在，我將向我們的首席商務官 Guy Goldberg 和團隊的其他成員進行詳細的商業研發財務演示，然後進行問答環節。

Unfortunately, we have a slight technical problem. We will be with you in just one moment.

不幸的是，我們遇到了一點技術問題。我們馬上就會來找您。

(technical difficulty)

（技術難度）

Thank you, Dror. And apologies to our listeners who had to bear with us while we had some technical challenges. I will start at the beginning of Slide 4. This is Guy, and I'll walk through an overview on my section, and then we'll continue the presentation. So Dror just made his remarks, and I'll be now on Slide 5.

謝謝你，德羅爾。並向我們的聽眾表示歉意，因為當我們遇到一些技術挑戰時，他們必須忍受我們。我將從投影片 4 的開頭開始。這是 Guy，我將概述我的部分，然後我們將繼續演示。德羅爾剛剛發表了講話，我現在講的是第 5 張幻燈片。

So RedHill is going through an important transformational process to achieve financial independence. This is one of the longest and deepest downturns that the biotech sector has ever been through. Only resilient companies will emerge stronger at the end of the tunnel. In this new reality, RedHill implemented important cost-control measures to weather the storm. In other words, as can be seen in the illustration at the bottom of the slide, by investing less, we're able to conserve cash and speed up the point where we achieve breakeven.

因此，RedHill 正在經歷一個重要的轉型過程，以實現財務獨立。這是生技產業經歷的最長、最嚴重的衰退之一。只有具有韌性的公司才能在隧道的盡頭變得更強大。面對這個新現實，RedHill 實施了重要的成本控制措施來度過難關。換句話說，正如幻燈片底部的插圖所示，透過減少投資，我們能夠節省現金並加快實現收支平衡的速度。

We have been implementing a comprehensive cost-reduction program that aims to make us cash flow positive from operations during the second half of 2022. By focusing on achieving operational profitability earlier, we expect savings of approximately $50 million over the next 18 months. In conjunction, we have completed other complementary initiatives to support this strategy, including improving the terms of key covenants in our credit agreement with our partner, HealthCare Royalties. We're also continuing discussions on various BD opportunities that fit the strategic goal that is commercial-stage products that match our current call points and are accretive in terms of revenue and return on investment.

我們一直在實施一項全面的成本削減計劃，旨在使我們在 2022 年下半年的營運現金流為正。透過專注於儘早實現營運獲利，我們預計未來 18 個月將節省約 5,000 萬美元。同時，我們也完成了其他補充措施來支持這項策略，包括改善與我們的合作夥伴 HealthCare Royalties 簽訂的信貸協議中的關鍵契約條款。我們也持續討論符合策略目標的各種 BD 機會，即符合我們目前呼叫點的商業階段產品，並在收入和投資回報方面實現增值。

We have a top-tier commercial organization in place, and any additional product would benefit from our excellent commercial team drive, talent and experience and would also see the benefit company-wise of economies of scale.

我們擁有頂尖的商業組織，任何附加產品都將受益於我們優秀的商業團隊的推動、人才和經驗，同時也將使公司獲得規模經濟的好處。

Next on R&D, while RHB-204 continues to progress as before, for our other programs, including our 2 COVID drug candidates, we are currently expecting to advance those programs through external funding. We are committed to our COVID programs and believe the data we have generated is highly promising and justifies continued development. In this funding environment, we are in discussions for other nondilutive sources of capital, including public and private grants, largely in the U.S. and Europe, COVID-19 platform studies and industry partnerships.

接下來在研發方面，雖然 RHB-204 繼續像以前一樣取得進展，但對於我們的其他項目，包括我們的 2 種 COVID 候選藥物，我們目前希望透過外部資金推進這些項目。我們致力於我們的 COVID 計劃，並相信我們產生的數據非常有前景，值得繼續發展。在這種融資環境下，我們正在討論其他非稀釋性資本來源，包括公共和私人撥款（主要在美國和歐洲）、COVID-19 平台研究和產業合作夥伴關係。

This slide shows our R&D activities. I want to emphasize that our COVID-19 programs, opaganib and upamostat, are core programs for RedHill, and we will continue to move forward. The need for oral therapeutics in this space is still acute. Research indicates that the new subvariants of Omicron show substantial resistance to vaccine-induced and infection-induced serum-neutralizing activity.

這張投影片展示了我們的研發活動。我想強調的是，我們的 COVID-19 項目 opaganib 和 upamostat 是 RedHill 的核心項目，我們將繼續向前發展。該領域對口服治療的需求仍然很迫切。研究表明，Omicron 的新亞變體對疫苗誘導和感染誘導的血清中和活性表現出顯著的抵抗力。

COVID continues to be an important field of drug development for 2 reasons: First, it is an ongoing and future public health threat with a huge unmet medical need; and second, it has shown to be a very large, relatively undeveloped market opportunity. We are firm believers in our COVID programs, and we think are -- their unique host-directed mechanism of action puts us at the forefront of development in this field. In fact, the broad-acting antiviral nature of our programs could be very important with the growing general interest in pandemic preparedness. Gilead will provide more updates on our COVID programs and other development programs later.

COVID 仍然是藥物開發的重要領域，原因有二：首先，它是一個持續的和未來的公共衛生威脅，具有巨大的未滿足的醫療需求；其次，它已被證明是一個非常大的、相對尚未開發的市場機會。我們堅信我們的 COVID 項目，我們認為——其獨特的宿主導向機制使我們處於該領域發展的前沿。事實上，隨著人們對流行病防範的普遍興趣日益濃厚，我們計畫的廣泛抗病毒特性可能非常重要。吉利德稍後將提供有關我們的 COVID 計劃和其他開發計劃的更多更新。

I will now turn it over to Rob to discuss our commercial progress.

現在我將把話題交給 Rob 來討論我們的商業進展。

Thank you, Guy, and good morning. Over the next few minutes, I'm going to summarize the progress we made during the first quarter with our sales, marketing and market access activities so that you can understand why we continue to feel confident about where the business is heading this year. Our clear corporate priorities are to drive revenue growth and manage expenses as we continue to progress towards operational profitability in the second half of 2022.

謝謝你，蓋伊，早安。在接下來的幾分鐘裡，我將總結我們在第一季在銷售、行銷和市場准入活動方面取得的進展，以便您理解為什麼我們對今年的業務發展方向仍然充滿信心。我們明確的企業重點是推動營收成長和管理費用，同時我們將繼續努力在 2022 年下半年實現營運獲利。

I'd like to begin my presentation by recognizing the efforts of our RedHill colleagues, especially our sales team, as we all strive to deliver consistent profitable growth. Thank you to everybody for your contributions.

在演講的開始，我想先表彰 RedHill 同事，特別是銷售團隊的努力，我們都致力於實現持續的獲利成長。感謝大家的貢獻。

During the first quarter, RedHill achieved record quarterly prescription volume. In the first quarter, RedHill delivered our second best quarterly performance of Movantik, since we added Movantik to our portfolio. We maintained a very strong prescribing trend during the always challenging start of a new deductible season, and Movantik continues to maintain clear market leadership with the PAMORA class with nearly 74% market share.

第一季度，RedHill 的季度處方量創下了歷史新高。自從我們將 Movantik 納入投資組合以來，RedHill 在第一季為 Movantik 帶來了第二好的季度表現。在新的免賠額季節開始時，我們保持了非常強勁的處方趨勢，而 Movantik 憑藉近 74% 的市場份額，繼續憑藉 PAMORA 類產品保持明顯的市場領先地位。

During the first quarter, RedHill grew to lift the prescription volume by 12.8% over the fourth quarter of 2021, a significant achievement following our very strong record close to last year. Talicia prescription volume has surpassed Pylera, establishing Talicia as the most prescribed branded H. pylori therapy in the United States.

在第一季度，RedHill 的處方量較 2021 年第四季成長了 12.8%，這是去年同期非常強勁的業績之後取得的重大成就。 Talicia 的處方量已超過 Pylera，成為美國處方量最大的品牌幽門螺旋桿菌治療藥物。

This is strong evidence that payers and prescribers increasingly and rapidly recognize Talicia's ability to overcome the combined challenges of clarithromycin resistance, a poor regimen tolerability and diminished efficacy. And these are the issues that frustrate prescribers and patients every day, consuming valuable health care resources and forcing patients to endure multiple rounds of a 14-day antibiotic regimen while searching for an effective therapy such as Talicia.

這有力地表明，付款人和處方者越來越迅速地認識到 Talicia 能夠克服克拉黴素抗藥性、方案耐受性差和療效降低等綜合挑戰。這些問題每天都讓開藥者和患者感到沮喪，消耗了寶貴的醫療資源，並迫使患者在尋找像 Talicia 這樣的有效療法的同時忍受多輪 14 天的抗生素治療。

Our 2 lead brands are well positioned to continue the performance trends into the second half of the year. In the month of June, we've already achieved new weekly prescription volume records for both Movantik and Talicia. We're closing the second quarter with a trend of growing volume and are entering the third quarter with positive momentum.

我們的兩大領導品牌已做好準備，在下半年持續保持良好的業績趨勢。六月份，我們的 Movantik 和 Talicia 的每週處方量均創下了新高。我們以銷售成長的趨勢結束第二季度，並以積極的勢頭進入第三季度。

During the first quarter, RedHill delivered Movantik prescription volume that was within 1% of our record fourth quarter results. And our first quarter volume represented an 8.6% improvement over what we achieved in the first quarter of 2021. We achieved this by continuing to take a disciplined approach and focusing on target prescribers in the pain specialty segment. In tandem, we also executed marketing strategies focused on growing the PAMORA market. This is a key objective for Movantik as the established market leader, and we invested to raise opioid-induced constipation awareness with patients and prescribers and also to educate these potential customers about how Movantik can provide relief from the symptoms of opioid-induced constipation.

第一季度，RedHill 的 Movantik 處方量與我們創紀錄的第四季業績相比，僅相差 1% 以內。我們第一季的銷量比 2021 年第一季成長了 8.6%。我們透過繼續採取嚴謹的方法並專注於疼痛專科領域的目標處方者來實現這一目標。同時，我們也實施了專注於擴大 PAMORA 市場的行銷策略。這是 Movantik 作為市場領導者的關鍵目標，我們投資提高患者和處方者對阿片類藥物引起的便秘的認識，並教育這些潛在客戶如何 Movantik 緩解阿片類藥物引起的便秘症狀。

The positive impact of these investments in market development can be seen in the next slide. Looking at the 12-month moving annual total of PAMORA prescriptions, a clear trend of market growth has developed over the past 3 quarters. This is a significant change for the PAMORA class, reflecting RedHill's investment in building awareness of opioid-induced constipation and encouraging provider-patient conversations. Many believe the PAMORA class would decline in tandem with the opioid market. In fact, the opposite is happening, and we expect that opioid prescribing may flatten or even increase in the near future, providing further support for the PAMORA market. Movantik is the clear market leader and Movantik will disproportionately benefit from more patients being treated with PAMORA agents.

這些投資對市場開發的正面影響可以在下一張投影片中看到。綜觀 PAMORA 處方的 12 個月移動年度總數，過去 3 個季度市場呈現明顯的成長趨勢。對於 PAMORA 課程來說，這是一個重大變化，反映了 RedHill 在提高人們對阿片類藥物引起的便秘的認識和鼓勵醫患對話方面的投資。許多人認為 PAMORA 類藥物將隨著鴉片類藥物市場的衰落而衰退。事實上，情況恰恰相反，我們預計阿片類藥物處方量在不久的將來可能會趨於平穩甚至增加，從而為 PAMORA 市場提供進一步的支持。 Movantik 是明顯的市場領導者，隨著更多患者接受 PAMORA 藥物治療，Movantik 將從中受益匪淺。

Recently, CDC announced draft revisions to their 2016 opioid prescribing guideline, and this new guideline is expected to provide further support for opioid use in patients experiencing chronic pain. In fact, one of the reported intents of the revised guideline is to address the misapplication of the 2016 guideline and CDC expects to publish their final guidance by the end of this year. It remains to be seen, but the new guideline may relax some portions of the 2016 guideline resulting in a potential increase in responsible opioid prescribing and a subsequent increase in demand for PAMORA agents.

近日，美國疾病管制與預防中心（CDC）公佈了2016年阿片類藥物處方指南修訂草案，預計該新指南將為慢性疼痛患者使用鴉片類藥物提供進一步支持。事實上，修訂指南的目的之一就是解決 2016 年指南的誤用問題，CDC 預計將在今年年底前發布最終指南。雖然仍有待觀察，但新指南可能會放寬 2016 年指南的某些部分，這可能會增加負責任的鴉片類藥物處方，並隨之增加對 PAMORA 藥物的需求。

An alternative view of Movantik prescribing data, the 13-week moving annual total trend also shows robust growth as we move into the second quarter of 2022. After facing the challenge of the COVID-19 pandemic and the allocation of corporate focus on Talicia launch in 2020, we successfully developed a positive growth trend for Movantik that continues to improve. To summarize, Movantik continues to achieve new milestones. Movantik delivered 8.6% growth versus first quarter of 2021 and Movantik maintains its competitive advantage of having best-in-class payer coverage with nearly 92% of insurance plans providing access from Movantik. And since original launch, more than 3 million Movantik prescriptions have been dispensed.

從 Movantik 處方數據的另一個角度來看，隨著我們進入 2022 年第二季度，13 週移動年度整體趨勢也顯示出強勁增長。在面臨 COVID-19 大流行的挑戰以及 2020 年將公司重點放在 Talicia 推出上之後，我們成功地為 Movantik 創造了積極的成長趨勢，而這種趨勢還在繼續改善。總而言之，Movantik 不斷取得新的里程碑。與 2021 年第一季相比，Movantik 實現了 8.6% 的成長，並且 Movantik 保持了其擁有一流付款人覆蓋範圍的競爭優勢，近 92% 的保險計劃都提供 Movantik 的服務。自首次推出以來，Movantik 已發放了 300 多萬張處方。

Simultaneously, Talicia continued to achieve new milestones. And as you can see in this graph, monthly prescription volume continues to increase consistently. In the first quarter, Talicia achieved its best ever performance in terms of prescription volume and market share, and our March volume represented a strong finish to the first quarter. In the first quarter, Talicia achieved 12.8% quarter-on-quarter growth and record prescription volume building on the record volume previously achieved in the fourth quarter of last year.

與此同時，塔利西亞繼續取得新的里程碑。正如您在圖表中所看到的，每月處方量持續穩定增加。在第一季度，Talicia 在處方量和市場份額方面取得了有史以來最好的表現，而我們三月份的處方量為第一季度畫上了圓滿的句號。第一季度，Talicia 的處方量較上季成長 12.8%，創下歷史新高，而去年第四季的處方量也創下了歷史新高。

And additionally, when we compare first quarter of 2022 to first quarter of 2021, Talicia's first quarter results represented an 80% growth in prescription volume, and we expect this trend to continue.

此外，當我們將 2022 年第一季與 2021 年第一季進行比較時，Talicia 第一季的業績顯示處方量增加了 80%，我們預計這一趨勢將持續下去。

On the payer front, our market access team has continued to improve our already competitive position with payers. Effective January 1 of this year, Talicia became available to 14 million Medi-Cal beneficiaries as a preferred brand with no restrictions. This has helped RedHill accelerate Talicia uptake in what is the second largest individual state for each H. pylori infections and treatments. Effective April 1, Talicia gained similar coverage on Florida Medicaid, Additionally, another large Part D plan per coverage became effective earlier this quarter. And effective July 1, another national PBM will improve access to Talicia on its commercial formulary, improving Talicia's position from restricted, not preferred to preferred. We expect to see a further prescription volume lift from this win during the second half of 2022, carrying into 2023.

在付款人方面，我們的市場准入團隊繼續提高我們與付款人的競爭地位。從今年 1 月 1 日起，Talicia 成為 1,400 萬 Medi-Cal 受益人的首選品牌，不受任何限制。這有助於 RedHill 加速 Talicia 在印度的普及，印度是幽門螺旋桿菌感染和治療數量第二大的州。自 4 月 1 日起，Talicia 獲得了佛羅裡達州醫療補助計劃 (Florida Medicaid) 的類似保險，此外，另一項大型 D 部分計劃也於本季度初生效。從 7 月 1 日起，另一個國家 PBM 將在其商業處方集中改善 Talicia 的取得途徑，將 Talicia 的地位從受限、不優先提升到優先。我們預計，2022 年下半年的處方量將因此次勝利而進一步提升，並持續到 2023 年。

These wins are consistent signs that healthcare providers and payers are increasingly recognizing, first, the challenge of clarithromycin resistance. These challenges are clearly outlined by the American College of Gastroenterology's 2017 guidelines. Secondly, the pitfalls of continuing to persist using clarithromycin-based therapy as a first-line treatment of choice and third, the clinical benefits of prescribing Talicia.

這些勝利一致表明，醫療保健提供者和付款人越來越認識到克拉黴素抗藥性的挑戰。美國胃腸病學會 2017 年指南明確概述了這些挑戰。其次，繼續堅持使用克拉黴素療法作為第一線治療的弊端；第三，開立 Talicia 的臨床益處。

To summarize, Talicia continues to achieve new milestones. We achieved record prescription volume driven by 12.8% volume growth over the fourth quarter of 2021 and 80% growth over what we had in the first quarter of last year. We've generated significant improvements in payer coverage and we currently have the highest level of payer coverage compared to any of the other branded H. pylori therapies.

總而言之，Talicia 不斷取得新的里程碑。我們的處方量創下了歷史新高，比 2021 年第四季成長了 12.8%，比去年第一季成長了 80%。我們在付款人覆蓋率方面取得了顯著的進步，與任何其他品牌的幽門螺旋桿菌療法相比，我們目前擁有最高水準的付款人覆蓋率。

In summary, we finished the first quarter with a consistent growth trend for our two lead brands: Movantik and Talicia. We remain focused on our corporate priorities of driving revenue growth and managing expenses as we continue to progress toward positive cash from operations and increase independence in the second half of this year. As a market leader in the PAMORA class, we demonstrated our ability to continue to grow new Movantik prescriptions, grow prescription volume in the PAMORA class and further improve on already strong Movantik payer coverage. We continue to build the case for Talicia with payers, emphasizing the known shortcomings of clarithromycin-based therapies and the clinical benefits of prescribing Talicia. And we continue to advance new ways to grow Aemcolo volume in the primary care segment. We look forward to further growing our business during the remainder of the year. And thank you, and I'll turn the call back to our COO, Gilead Raday.

總而言之，我們在第一季結束時，兩大主力品牌 Movantik 和 Talicia 都保持了持續的成長趨勢。我們將繼續專注於推動收入成長和管理費用的企業優先事項，並在今年下半年繼續實現營運現金流正成長並提高獨立性。作為 PAMORA 類市場的領導者，我們展示了我們繼續增加新的 Movantik 處方、增加 PAMORA 類處方量以及進一步改善已經很強大的 Movantik 付款人覆蓋範圍的能力。我們繼續向付款人宣傳 Talicia，強調克拉黴素療法的已知缺點以及開立 Talicia 的臨床益處。我們將繼續推進新方法來擴大 Aemcolo 在初級保健領域的銷售。我們期待在今年剩餘時間內進一步發展我們的業務。謝謝您，我會將電話轉回給我們的營運長 Gilead Raday。

Thank you, Rob. I will provide a brief update on our R&D activities. Opaganib is our orally administered, first-in-class selective sphingosine kinase-2 inhibitor in advanced clinical development. Opaganib has broad antiviral activity and inhibits viral replication of multiple types of viruses, including COVID-19. Opaganib also reduces the body's excess immune response, providing a dual-action benefit to patients with severe inflammatory response to viral infection. Opaganib development is also being continued in oncology indications with cholangiocarcinoma Phase II top line data expected in Q3 2022.

謝謝你，羅布。我將簡要介紹我們的研發活動。 Opaganib 是我們首創的口服選擇性鞘氨醇激酶 2 抑制劑，目前處於晚期臨床開發階段。奧加尼具有廣泛的抗病毒活性，可抑制包括 COVID-19 在內的多種病毒的複製。 Opaganib 還能減少人體過度的免疫反應，為對病毒感染有嚴重發炎反應的患者提供雙重益處。 Opaganib 在腫瘤學適應症領域的發展也持續，預計膽管癌 II 期頂線數據將於 2022 年第三季公佈。

With promising data from the Phase II/III study in hospitalized COVID patients and with new data confirming opaganib's antiviral activity also against influenza, which I will discuss in the coming slides, opaganib is a highly promising therapeutic candidate for viral pandemic preparedness, which is the current spotlight of public health efforts.

鑑於住院 COVID 患者的 II/III 期研究數據令人鼓舞，並且有新數據證實了奧帕加尼對流感也有抗病毒活性（我將在接下來的幻燈片中討論），奧帕加尼是一種非常有希望的病毒大流行防範治療候選藥物，這是當前公共衛生工作的重點。

RHB-107 is our second clinical-stage novel COVID-19 oral field candidate. RHB-107 is well positioned to treat early-stage mild to moderate COVID-19 infection, through targeting human serine proteases, which are (inaudible) both in viral replication. We announced positive and promising results from Part A of a Phase II/III study in nonhospitalized symptomatic COVID-19 patients that show upamostat potential capacity to prevent the deterioration with excellent safety and tolerability and are progressing towards potential participation in COVID-19 outpatient platform study.

RHB-107 是我們第二個臨床階段的新型 COVID-19 口服領域候選藥物。 RHB-107 非常適合治療早期輕度至中度 COVID-19 感染，透過靶向人類絲氨酸蛋白酶，這兩種蛋白酶都參與病毒複​​製。我們宣布了針對非住院症狀性 COVID-19 患者的 II/III 期研究 A 部分的積極和有希望的結果，這些結果表明 upamostat 具有防止病情惡化的潛在能力，並且具有出色的安全性和耐受性，並且正在朝著參與 COVID-19 門診平台研究的方向發展。

With opaganib and RHB-107, RedHill holds 2 promising products that could serve as important tools in responding to future pandemic waves, whether caused by SARS-CoV-2 variants or by other viruses.

憑藉 opaganib 和 RHB-107，RedHill 擁有兩種前景光明的產品，它們可以作為應對未來大流行浪潮的重要工具，無論是由 SARS-CoV-2 變體還是其他病毒引起。

In fact, we are seeing a shift in focus of government funding sources, public health experts, institutions and industry towards looking for broad antiviral mechanisms of action that could address emerging new variants of SARS-CoV-2 and also combat other viruses that might create future pandemic waves. This is a more sustainable long-term approach than having to rediscover and reinvent very specific antiviral therapeutics, which quickly become obsolete in the face of rapidly mutating viruses.

事實上，我們看到政府資金來源、公共衛生專家、機構和產業的重點正在轉向尋找廣泛的抗病毒作用機制，以應對新出現的 SARS-CoV-2 變種，並對抗可能引發未來大流行的其他病毒。這是一種更永續的長期方法，無需重新發​​現和發明非常特定的抗病毒療法，因為面對快速變異的病毒，這些療法很快就會過時。

The novel host-targeting antiviral mechanisms of RedHill's opaganib and RHB-107 are highly suitable to meet the demand of this long-term pandemic preparedness approach. RHB-204 is the most clinically advanced stand-alone oral therapy in development for first-line treatment of pulmonary nontuberculous mycobacteria. The ongoing Phase III study is progressing. Overall, in line with our strategy to support operational profitability in the second half of 2022 and in view of the highly promising clinical and preclinical data generated to date, we anticipate external funding for much of our promising R&D programs through grants, industry partnerships and participation in platform study. I will highlight some further details regarding each program in the next few slides.

RedHill 的 opaganib 和 RHB-107 的新型宿主標靶抗病毒機制非常適合滿足這種長期大流行防範方法的需求。 RHB-204 是臨床上最先進的獨立口服療法，用於治療肺部非結核分枝桿菌的第一線治療。正在進行的第三階段研究正在取得進展。總體而言，根據我們支持 2022 年下半年營運獲利的策略，並鑑於迄今為止產生的極具前景的臨床和臨床前數據，我們預計我們的許多有前景的研發項目將透過撥款、產業合作夥伴關係和參與平台研究獲得外部資金。我將在接下來的幾張投影片中重點介紹有關每個程式的一些細節。

Opaganib's clinical data package has been submitted to several regulatory agencies. Based on regulatory input, a positive confirmatory study constitutes the likely pathway to potential opaganib's submissions for approval in the U.S., EU and multiple other territories. As a reminder, the global Phase II/III data met part of its prespecified endpoints. The study showed a 70% reduction in mortality for opaganib when given on top of remdesivir and corticosteroids, with less than 7% mortality in opaganib arm versus over 23% mortality in the placebo control arm with a p-value of 0.034. Opaganib also provided a 34% benefit in time to recovery by Day 14 with a p-value of 0.013. Additionally, opaganib improved the median time to viral RNA clearance by at least 4 days, with a hazard ratio of 1.34, a nominal p-value of 0.043.

Opaganib的臨床資料包已經提交給多個監管機構。根據監管部門的意見，積極的確認性研究可能為 opaganib 在美國、歐盟和其他多個地區提交批准提供途徑。提醒一下，全球 II/III 期資料滿足了部分預定終點。研究表明，在瑞德西韋和皮質類固醇的基礎上聯合使用奧帕加尼，死亡率降低了 70%，奧帕加尼組的死亡率不到 7%，而安慰劑對照組的死亡率超過 23%，p 值為 0.034。 Opaganib 還提供了 14 天的恢復時間效益 34%，p 值為 0.013。此外，opaganib 將病毒 RNA 清除的中位數時間縮短了至少 4 天，風險比為 1.34，名目 p 值為 0.043。

Seeing an improvement in viral clearance at such a late stage of the viral infection in patients with a median of 11 days from onset of symptoms is a unique clinical finding, which is indicated opaganib's antiviral effects in the most challenging clinical setting of advanced and severe viral infection. Further post hoc analysis also showed the marked benefit in reducing mortality, a 62% reduction in large subpopulation of over half of the study participants, which consisted of moderately severe hospitalized COVID-19 patients. Data from the global Phase II/III study has recently been published on Medarex ID and is in submission processes to peer-reviewed scientific journal. The results will also be subject of a late-breaker oral presentation at the International Conference on emerging infectious diseases, which is hosted by the CDC in collaboration with the task force for global health to be held this August in Atlanta. Adding to opaganib's expanding patent suite on June 21, 2022, RedHill was granted an additional U.S. patent, covering a method for the treatment of patients with moderate to severe COVID-19 using opaganib.

在病毒感染的晚期階段，從症狀出現到痊癒的平均時間為 11 天的患者中，病毒清除率有所改善，這是一個獨特的臨床發現，表明奧帕加尼在晚期和嚴重病毒感染這一最具挑戰性的臨床環境中具有抗病毒作用。進一步的事後分析也表明，死亡率降低有顯著優勢，超過一半的研究參與者的大群體（由中度嚴重的住院 COVID-19 患者組成）的死亡率減少了 62%。全球 II/III 期研究的數據最近已在 Medarex ID 上發表，並正在提交給同行評審的科學期刊。研究結果也將在新興傳染病國際會議上進行口頭報告，該會議由美國疾病管制與預防中心與全球衛生工作小組合作主辦，將於今年 8 月在亞特蘭大舉行。 2022 年 6 月 21 日，RedHill 獲得了額外的美國專利，涵蓋使用 opaganib 治療中度至重度 COVID-19 患者的方法，這為 opaganib 不斷擴大的專利套件增添了新的內容。

Given its broad antiviral activity, opaganib is continuing to be developed for treating additional viral infections, including RSV, Ebola and influenza. Previous data has indicated opaganib's capacity to inhibit Ebola virus application. Recent new data utilizing preclinical services from the National Institute of Allergy and Infectious Diseases, which is part of the National Institute of Health, demonstrates opaganib's potent activity against influenza H1N1 strain. The results were obtained in human bronchial epithelial cells, which are the natural human target of the virus, making the test assay a realistic model of the infection.

鑑於其廣泛的抗病毒活性，奧帕加尼正在繼續開發用於治療其他病毒感染，包括呼吸道合胞病毒、伊波拉病毒和流感。先前的數據顯示opaganib具有抑制伊波拉病毒的能力。最近利用美國國立衛生研究院下屬的國家過敏和傳染病研究所的臨床前服務獲得的新數據證明了奧帕加尼對 H1N1 流感病毒株的強效活性。該結果是在人類支氣管上皮細胞中獲得的，該細胞是該病毒的天然人類目標，這使得測試分析成為感染的現實模型。

Opaganib achieved potent inhibition of viral replication at low concentrations with no evidence of toxicity at dose level. As can be seen from the results, opaganib inhibited 90% of viral replication at concentration which was over 60x lower than the concentration that reduces cell viability by 50%. This markedly exceeds the target threshold for indicating potent antiviral activity in this assay and provides further evidence of opaganib's potential broad-spectrum antiviral activity.

Opaganib 在低濃度下就能有效抑制病毒複製，且在劑量水平下沒有毒性的證據。從結果可以看出，opaganib 抑制了 90% 的病毒複製，其濃度比降低細胞活力 50% 的濃度低 60 倍以上。這明顯超過了該檢測中顯示強效抗病毒活性的目標閾值，並進一步證明了奧帕加尼的潛在廣譜抗病毒活性。

We are also continuing to advance opaganib's development program in oncology and inflammatory indications with cholangiocarcinoma Phase II study top line analysis expected in Q3 2020.

我們也將繼續推進 opaganib 在腫瘤學和發炎適應症方面的開發計劃，預計在 2020 年第三季進行膽管癌 II 期研究的頂線分析。

As previously announced, RHB-107, also called upamostat, provided positive top line results from Part A of the Phase II/III study in outpatients in the U.S. Part A met the primary endpoint of safety and tolerability. Moreover, Part A provided highly promising efficacy results despite its small sample size of 61 subjects. We saw a 100% reduction in COVID-19-related hospitalization with 0 out of 41 patients who were treated with RHB-107 versus 15% on the placebo control arm requiring hospitalization. There was also an 88% reduction in reported new severe COVID-19 symptoms after treatment initiation. Only one RHB-107 patients out of 41, equating 22.4%, reported new severe COVID-19 symptoms versus 20% of patients reporting new severe COVID symptoms in the placebo control arm. Importantly, for early-stage COVID-19-infected patients, RHB-107 presents a highly favorable profile. It is taken orally once a day as a stand-alone treatment with excellent safety and with no major drug-drug interactions limiting its potential use.

如前所述，RHB-107（也稱為 upamostat）在美國門診患者 II/III 期研究的 A 部分中獲得了積極的頂線結果。 A 部分達到了安全性和耐受性的主要終點。此外，儘管 A 部分的樣本量很小，只有 61 名受試者，但其療效結果卻非常有希望。我們發現與 COVID-19 相關的住院率減少了 100%，在接受 RHB-107 治療的 41 名患者中，0 例需要住院，而安慰劑對照組中，有 15% 的患者需要住院。開始治療後，報告的新的嚴重 COVID-19 症狀也減少了 88%。在 41 名 RHB-107 患者中，只有 1 名（佔 22.4%）報告了新的嚴重 COVID-19 症狀，而安慰劑對照組中有 20% 的患者報告了新的嚴重 COVID 症狀。重要的是，對於早期 COVID-19 感染患者，RHB-107 表現出非常有利的療效。它每天口服一次，作為獨立治療方法，具有極好的安全性，並且沒有限制其潛在用途的重大藥物交互作用。

Given the promising outcomes, work is underway to complete data analysis and submit to regulatory agencies for moving into Phase III studies. Further, we anticipate potential participation in a platform study, which is in advanced regulatory preparations with FDA. RHB-204 is the only first-line stand-alone oral treatment in late-stage clinical development for pulmonary NTM disease caused by Mycobacterium avium complex, MAC, a rare condition with no FDA-approved first-line therapy. We continue to advance the ongoing Phase III study in first-line pulmonary nontuberculous mycobacteria towards potential NDA submission for this indication. We are expecting enrollment to pick up with the raining of COVID-19 in the U.S. and with expansion of study participating sites. As a reminder, the study is a randomized placebo-controlled study and has a 6-month co-primary endpoint sputum culture conversion and clinical benefit using patient-reported outcomes. After the first 6 months, study subjects cross over to open-label active treatment with RHB-204 for an additional 12 months from conversion in accordance with clinical practice.

鑑於良好的結果，目前正在進行數據分析並提交給監管機構以進入第三階段研究。此外，我們預計將參與平台研究，該研究正在與 FDA 進行高級監管準備。 RHB-204 是目前處於後期臨床開發階段的唯一一線獨立口服治療藥物，用於治療由鳥分枝桿菌複合體 (MAC) 引起的肺部 NTM 疾病，這是一種罕見疾病，目前尚無 FDA 批准的一線療法。我們繼續推進正在進行的一線肺部非結核分枝桿菌 III 期研究，以便針對該適應症提交潛在 NDA。我們預計，隨著美國 COVID-19 疫情的蔓延以及研究參與地點的擴大，入學人數將會增加。提醒一下，該研究是一項隨機安慰劑對照研究，並使用患者報告的結果實現了 6 個月的共同主要終點痰培養轉化和臨床益處。在前 6 個月後，研究對象將根據臨床實踐轉為接受 RHB-204 開放標籤活性治療，為期 12 個月。

Of note, RHB-204 has been granted orphan drug designation and QIDP status. Together, these designations provide for expedited development, priority review of the NDA and a total of 12 years market exclusivity from potential approval in the U.S. We see a lot of interest from industry in this program and are in discussions with several potential industry partners to further support and accelerate. I will now turn it over to Micha for reviewing the Q1 2022 financial results.

值得注意的是，RHB-204 已被授予孤兒藥稱號和 QIDP 地位。總之，這些指定提供了加速開發、NDA 的優先審查以及自美國潛在批准以來總共 12 年的市場獨佔權。我們看到業界對這個項目很感興趣，並且正在與幾個潛在的行業合作夥伴進行討論，以進一步支持和加速。現在我將把審查 2022 年第一季財務業績的任務交給 Micha。

Thank you, Gilead. RedHill is now focusing on cash flow and financial independence. This facilitated the achievement of positive contribution from our commercial operations segment for the first time in Q4 of last year. And we are now targeting positive cash flow from operations before interest payment for the whole company to start during half 2 of this year. This follows recently implemented comprehensive cost reduction plan, which expected operational cost savings of approximately $50 million over the next 18 months. Importantly, looking at Q1, continuous implementation of cash optimization measures, reduced cash used in operating activities by more than 70%, to approximately $4 million compared to approximately $15 million in Q4 of last year, signaling a clear path towards our stated goal of achieving financial independence.

謝謝你，吉利德。 RedHill 目前專注於現金流和財務獨立。這促使我們的商業營運部門在去年第四季首次實現了正貢獻。我們目前的目標是，從今年下半年開始，整個公司在支付利息之前的營運現金流量將達到正數。這是最近實施的全面成本削減計劃的一部分，預計未來 18 個月內可節省約 5,000 萬美元的營運成本。重要的是，縱觀第一季度，持續實施現金優化措施，將經營活動所用現金減少了 70% 以上，至約 400 萬美元，而去年第四季度約為 1500 萬美元，這標誌著我們朝著實現財務獨立的既定目標邁出了明確的步伐。

Net revenues of $18.2 million in Q1 compared to $22.1 million in Q4 of last year reduced revenues are due to typical cyclical trends in Movantik sales, which remains on track in Q2 with the last week measured earlier this month, showing record scripts of both Talicia and Movantik.

第一季淨收入為 1820 萬美元，而去年第四季為 2210 萬美元，收入減少是由於 Movantik 銷售的典型週期性趨勢，該趨勢在第二季度保持正常，本月早些時候測量的最後一周顯示 Talicia 和 Movantik 的腳本均創下了紀錄。

Gross profit was $10.2 million in Q1, representing 56% gross margin, which is expected to continue to improve as Talicia scripts continue to grow. Research and development expenses for the quarter were $3.1 million as compared to $5.9 million in the fourth quarter of 2021. This decrease was attributed to the ongoing optimization of R&D costs and completion of elements of the opaganib and RHB-107 development programs.

第一季毛利為 1,020 萬美元，毛利率為 56%，隨著 Talicia 處方藥的持續成長，預計毛利率將繼續提高。本季研發費用為 310 萬美元，而 2021 年第四季為 590 萬美元。這一下降歸因於研發成本的持續優化以及 opaganib 和 RHB-107 開發計劃部分內容的完成。

As compared with previous quarter, we had lower operating loss, lower net loss and lower cash used in operating activities. This led to cash position of approximately $45 million as of March 31 of this year, prior to the $15 million of gross proceeds from our registered direct offering in May. To summarize, our projected organic sales growth potential in-licensing and synergies FDA-approved revenue-generating products and out-licensing activities together with our vigorous cost reduction plan, position us really well to achieve our target of positive cash flow from operations before interest payments expected to start during the second half of this year. I'll now turn the discussion back to Dror, to Q&A.

與上一季相比，我們的營業虧損、淨虧損和經營活動所用現金均有所減少。這使得截至今年 3 月 31 日的現金狀況約為 4,500 萬美元，而我們在 5 月註冊的直接發行總收益為 1,500 萬美元。總而言之，我們預計的有機銷售成長潛力、許可和協同效應、FDA 批准的創收產品和許可活動，加上我們強有力的成本削減計劃，使我們能夠很好地實現預計在今年下半年開始支付利息之前的經營現金流為正的目標。現在我將討論轉回 Dror 的問答環節。

Thank you, Micha. We are happy to take questions.

謝謝你，米查。我們很樂意回答問題。

(Operator Instructions) Our first question today comes from the line of Brandon Folkes from Cantor Fitzgerald.

（操作員指示）我們今天的第一個問題來自 Cantor Fitzgerald 的 Brandon Folkes。

Maybe just firstly, can you talk about the reduction of the commercial team and any impact on overall sales? Maybe just some color in terms of will those territories be covered by the remaining reps or will they remain uncovered? And then secondly, maybe just staying on the commercial portfolio. How do we think about gross to net in 2022 compared to 2021?

首先，您能談談商業團隊的縮減以及對整體銷售的影響嗎？也許只是一些顏色，這些地區是否會被剩餘的代表覆蓋，或者是否仍未被覆蓋？其次，也許只是保留商業投資組合。與 2021 年相比，我們如何看待 2022 年的毛利率與淨利率？

Thank you, Brandon. As far as gross to net, starting from your second question, I refer to Micha. And the first question thereafter will be taken by Rick, our Chief Commercial Officer. Micha, please.

謝謝你，布蘭登。至於總額與淨額，從您的第二個問題開始，我指的是 Micha。隨後第一個問題將由我們的首席商務官里克 (Rick) 回答。米查，請。

So we believe we stabilized on a gross to net, and we will continue in more or less where we are now.

因此，我們相信，我們的總收入與淨收入已經穩定下來，並且我們將繼續保持目前的水平。

I'm sorry. And how does that compare to last year?

對不起。與去年相比如何？

The comparison of last year is a little bit more gross to net because of the coverage increase.

由於覆蓋範圍擴大，與去年相比，總額略高於淨額。

Brandon, are you okay on gross to net? Should we continue?

布蘭登，你的總成績和淨成績還好嗎？我們應該繼續嗎？

Yes, please.

是的，請。

Thank you. Well, gross to net had to do with increased coverage. Rick, please.

謝謝。嗯，總額與淨額的比率與覆蓋範圍的擴大有關。瑞克，請。

Oh, yes, sure. So this is Rick. I will just briefly mention or answer your question. We did do a comprehensive analysis of our commercial operation. We did a comprehensive analysis of all the territories, the territories that were profitable, the territories have had opportunities for growth, the territories that could be merged. We did merge territories. We did line up with a few territories going to white space. We do employ in our commercial organization, a group called Customer Engagement Specialists. They answer questions from physicians, also reach out to physicians and the white space. So we have consolidated. We have consolidated sales leadership as well. So we did a lot of consolidation. And we did this with the eye to hit our revenue targets for this year and into 2023. It was a tough reorganization, but it was something we need to do, and we have successfully completed that operation, and we feel poised to go forward right now.

噢，是的，當然。這就是里克。我只是簡單地提及或回答你的問題。我們確實對我們的商業營運做了全面的分析。我們對所有地區進行了全面的分析，包括獲利的地區、有成長機會的地區、可以合併的地區。我們確實合併了領土。我們確實與一些進入空白地區的地區達成了一致。我們的商業組織確實僱用了一個名為「客戶參與專家」的團隊。他們回答醫生的問題，也與醫生和空白處進行交流。因此我們已經合併。我們也鞏固了銷售領導地位。因此我們做了很多合併工作。我們這樣做是為了實現今年和 2023 年的收入目標。這是一次艱難的重組，但這是我們需要做的事情，我們已經成功完成了這項操作，現在我們感到準備好繼續前進了。

And maybe just one more, if I may. On the $50 million OpEx savings over the next 18 months. Any color in terms of how quickly you expect that to be achieved? Or how we should at least think about modeling that over the 18 months?

如果可以的話，也許我還可以再說一個。未來 18 個月內可節省 5,000 萬美元的營運支出。您預計多快能實現這一目標？或者我們至少應該如何考慮在未來 18 個月內對此進行建模？

Yes. So we prepared a very detailed plan, which shows that in the next coming 6 quarters, more or less on the same pace, we will save those $50 million.

是的。因此，我們制定了一個非常詳細的計劃，該計劃表明，在接下來的 6 個季度中，我們將以大致相同的速度節省這 5000 萬美元。

The next question today comes from the line of Boobalan Pachaiyappan from H.C. Wainwright.

今天的下一個問題來自 H.C. 的 Boobalan Pachaiyappan。溫賴特。

This is Boobalan. Can you hear me okay?

這是 Boobalan。你聽見我說話嗎？

Very well. Thank you.

很好。謝謝。

All right. Great. A few questions from our end. So I wanted to start off our discussion first by focusing on potassium-competitive acid blockers. So obviously, one of your competitors recently received FDA approval. So just to kind of hear your thoughts on this -- on the kind of upward pressure these agents can put on Talicia sales. And also, how do you see the evolution of H. pylori treatment in the wake of potassium channel blocker approval?

好的。偉大的。我們有幾個問題。因此，我想先從鉀競爭性酸阻滯劑開始我們的討論。顯然，您的一個競爭對手最近獲得了 FDA 的批准。所以只是想聽聽你對此的看法——這些代理商可以給 Talicia 的銷售帶來多大的壓力。此外，您如何看待鉀通道阻斷劑核准後幽門螺旋桿菌治療的發展？

Thank you, Boobalan, and Gilead will answer the first aspect. And Rob Jackson, our Head of Marketing and Sales, will discuss about the evolving landscape. We'll start with Gilead.

謝謝Boobalan，Gilead會回答第一個面向。我們的行銷和銷售主管 Rob Jackson 將討論不斷變化的情況。我們將從吉利德開始。

Thank you. So Talicia, to put it simply, has best-in-class on-label efficacy, especially in addressing the clari-resistant population, which is the major issue for empirical first-line treatment of the H. pylori infection. So we're highly confident in Talicia continuing to be the leading brand for H. pylori treatment going forward.

謝謝。因此，簡而言之，Talicia 具有同類最佳的標籤功效，特別是在解決對克拉黴素抗藥性的人群方面，這是幽門螺旋桿菌感染經驗性一線治療的主要問題。因此，我們非常有信心 Talicia 將繼續成為未來幽門螺旋桿菌治療的領導品牌。

Thank you, Gilead. Rob, would you like to speak about how we see the landscape evolving?

謝謝你，吉利德。羅布，您願意談談我們如何看待景觀的演變嗎？

Absolutely. Thank you, Dror. I think as a company, we certainly welcome the increased focus on H. pylori infections and the need for new treatments. So we think any additional noise that comes into the category from a new entrant will be a positive. In terms of how we'll stand up against the new competition, how this impacts the competitive landscape, to Gilead's point, I think resistance is really the key issue here. And what we've identified with Talicia in our clinical studies is we have 90% efficacy, really, regardless of the patient's resistant status.

絕對地。謝謝你，德羅爾。我認為，作為一家公司，我們當然歡迎人們更多地關注幽門螺旋桿菌感染和新療法的需要。因此，我們認為，新進入者為該類別帶來的任何額外影響都將是正面的。關於我們如何應對新的競爭，以及這將如何影響競爭格局，就吉利德的觀點而言，我認為抵抗才是真正的關鍵問題。我們在臨床研究中發現，Talicia 的有效率高達 90%，無論患者的抗藥性狀況如何。

And that's a true differentiator for Talicia, it's going to stand strong for the brand in the long term. And I think that's going to really play into our favor as the market grows, I think we'll continue to capture a disproportionate share of that business.

這對 Talicia 來說是一個真正的差異化因素，它將為該品牌的長期發展奠定堅實的基礎。我認為，隨著市場的成長，這將真正對我們有利，我認為我們將繼續佔據該業務的不成比例的份額。

Okay. And then the next one. So it appears you're doing two things at once, which are cost reduction and achieving profitability. So what's interesting is that the cost reduction comes in the backdrop of a rising momentum in Movantik and Talicia sales.

好的。然後是下一個。因此看起來你同時在做兩件事，也就是降低成本和獲利。有趣的是，成本降低是在 Movantik 和 Talicia 銷量上升的背景下發生的。

So Guy presented an interesting graph, and I believe the slopes are communicating some value. Just curious whether the priority here is to achieve early profitability, but grow at a slow pace rather than grow fast, but admission profitability at a later stage.

因此，蓋伊展示了一個有趣的圖表，我相信斜率傳達了一些價值。只是好奇這裡的優先事項是否是實現早期盈利，但以緩慢的速度增長而不是快速增長，但在後期實現盈利。

Excellent question. We have a very clear priority to preserve cash and generate as much cash as possible and turn breakeven during the second half when it comes to cash from operations. This is the clear goal. Longer term, we want to achieve the whole company P&L profitability, and we are heading there. As far as sacrificing growth, as Rick outlined, we have done a lot of analysis, and we are confident that we can continue to grow given the cost optimization and shifting resources inside the company together.

非常好的問題。我們的首要任務非常明確，就是保留現金、產生盡可能多的現金，並在下半年達到經營現金的收支平衡。這是一個明確的目標。從長遠來看，我們希望實現整個公司的獲利，並且我們正在朝著這個目標努力。至於犧牲成長，正如 Rick 所概述的，我們已經做了大量分析，我們相信，透過成本優化和公司內部資源的共同轉移，我們能夠繼續成長。

Okay. Great. Just 2 more, if I may. So today's press release mentioned that you are engaged in a nonbinding discussion to acquire a GI drug. Just curious what has to happen in order for the process to complete? And how do you expect to fund the transaction?

好的。偉大的。如果可以的話，我再說 2 個。今天的新聞稿提到，你們正在進行一項非約束性討論，以收購一種胃腸道藥物。只是好奇為了完成這個過程需要發生什麼事？您預計如何為該交易籌資？

Thank you. Unfortunately, we cannot provide additional color on this one beyond what we already stated.

謝謝。不幸的是，除了我們已經提到的內容之外，我們無法提供更多詳細資訊。

Understood. Just one last question. What are your thoughts on the commercial outlook for COVID-19 therapeutics targeting more severely ill patients given the evolving nature of the pandemic.

明白了。最後一個問題。鑑於疫情的不斷演變，您對重症患者的 COVID-19 療法的商業前景有何看法？

We see COVID-19 remain a problem, very dynamic evolving problem with variants and mutations arising continuously. So the landscape is shifting, and it's very hard to predict exactly what comes next in terms of the waves of COVID-19 infection. Certainly, the public health focus and spotlight is on pandemic preparedness for waves of infection from SARS-CoV-2 variants or from other sources of pandemics outside of the SARS-CoV-2 family line. So in the long term and in the short term, we see our antiviral programs as very much in the focus of public health interest, both for COVID-19 future potential waves both for early-stage and late-stage infections and also for other potential viruses that are lying in the wake.

我們看到 COVID-19 仍然是一個問題，而且是一個不斷演變的問題，其變種和突變不斷出現。因此，情況正在發生變化，很難準確預測下一波 COVID-19 感染將如何發展。當然，公共衛生的重點和焦點是針對 SARS-CoV-2 變種或 SARS-CoV-2 家族以外的其他流行病源的感染浪潮的防範。因此，從長遠和短期來看，我們認為我們的抗病毒計畫是公共衛生關注的焦點，這既針對 COVID-19 未來的潛在浪潮，也針對早期和晚期感染，也針對隨後出現的其他潛在病毒。

The next question today comes from the line of Scott Henry from ROTH Capital.

今天的下一個問題來自 ROTH Capital 的 Scott Henry。

I guess for starters, it seemed like the call was later in the calendar year this year. Was there a reason for that?

我想首先，這個電話似乎是在今年晚些時候打來的。有什麼原因嗎？

There are several reasons for that. For example, you saw that we just announced an improved credit agreement. That was important. We also had other reasons for delay, but the results are announced already over a month ago in a public filing, so there was nothing that was particularly extreme in doing so.

造成這種情況的原因有幾個。例如，您看到我們剛剛宣布了一項改進的信用協議。這很重要。我們還有其他延遲的原因，但結果已經在一個多月前透過公開文件公佈，因此這樣做並沒有什麼特別極端的原因。

Okay. Fair enough. I just wanted to ask. And then I guess the other thing, I just wanted to understand the cash flow positive from operations and how you define that. Gross profit is about $10 million, SG&A is $20 million. It's hard to see how those numbers will match, but I think you're probably pulling some things out. So I just wanted to get a better understanding of the way you define cash flow positive from operations?

好的。很公平。我只是想問一下。然後我想另一件事是，我只是想了解營運產生的正現金流以及如何定義它。毛利約 1,000 萬美元，銷售、一般及行政費用為 2,000 萬美元。很難看出這些數字如何匹配，但我認為你可能會得出一些東西。所以我只是想更能理解您對經營活動產生的現金流量正值的定義？

So obviously, we will need to do -- and we are doing a vigorous action on expenses -- on the expense side, and this is going to go down very substantially in all terms, whether it is the sales and marketing, G&A and mainly R&D. And we also see our revenues continue to grow and even faster and that will allow us to achieve cash from operations before interest payment starting from the second half of the year, whether it's going to be Q3 or Q4, we shall see.

因此，顯然我們需要採取行動——我們正在大力削減開支——在開支方面，所有方面的開支都將大幅下降，無論是銷售和行銷、一般及行政費用還是主要的研發費用。我們也看到我們的收入持續成長，甚至更快，這將使我們能夠從今年下半年開始實現利息支付前的經營現金流，無論是第三季還是第四季度，我們拭目以待。

Okay. So you are including all G&A and selling expenses in that calculation?

好的。所以你在計算中包括了所有 G&A 和銷售費用嗎？

Correct.

正確的。

I assume you're backing out stock comp, maybe you are, maybe you're not, but just for clarity.

我假設您正在退出股票補償，也許您是，也許您不是，但只是為了清楚起見。

Sorry. Sorry, can you repeat the question?

對不起。抱歉，您能重複這個問題嗎？

So I guess by cash flow from operations, are you including G&A and selling expenses in that?

所以我猜，經營活動現金流是否包含了一般行政費用和銷售費用？

Yes, we do.

是的，我們有。

Okay. So -- and are you including stock compensation?

好的。那麼—您包括股票薪酬嗎？

No, because we are talking about cash flow, so the equity compensation will be in the P&L, and we are referring to cash flows.

不，因為我們談論的是現金流，所以股權補償將在損益表中，我們指的是現金流。

Okay. Okay. And approximately how much is that on a quarterly basis? I'm just trying to get a sense of what levers need to happen to close that, I mean, basically, to close that $10 million gap.

好的。好的。每季大約是多少？我只是想知道需要採取什麼措施來彌補這一差距，我的意思是，基本上彌補 1000 萬美元的差距。

We referred in the conference call to the percentage of the workforce that we are using. This will give you the answer of how this is going to look like. And on the R&D, since we completed the programs of COVID, you can assume that our R&D expenses will continue to go even lower than the levels that we presented and will also support the -- achieving positive cash from operations before interest payments.

我們在電話會議中提到了我們正在使用的勞動力百分比。這將告訴你它將會是什麼樣子。在研發方面，自從我們完成了 COVID 專案以來，你可以假設我們的研發費用將繼續低於我們提出的水平，並且還將支持在支付利息之前實現經營活動產生的正現金。

The next question today comes from the line of Matt Kaplan from Ladenburg Thalmann.

今天的下一個問題來自拉登堡塔爾曼公司的馬特卡普蘭 (Matt Kaplan)。

Just wanted to kind of follow up on Scott's question. I guess, given the implementation of your cost-cutting plan, what's your current cash runway given your current cash levels of, I guess, $45 million at the end of the quarter plus the registered direct. What's your, I guess, cash runway?

只是想跟進一下斯科特的問題。我想，考慮到您實施的成本削減計劃，考慮到您目前的現金水平，我猜，本季末的現金水平為 4500 萬美元加上註冊直接現金，您目前的現金儲備是多少。我想，你的現金儲備是多少？

This is Dror. We have no going concern remark, as you probably noticed, and we feel confident not only in the next month, which are covered by the now going concern remark, but well beyond that.

這是德羅爾。您可能已經注意到，我們沒有持續經營備註，我們不僅在下個月（現在的持續經營備註涵蓋了下個月）充滿信心，而且遠不止於此。

And just to add to that, according to the plan that we put together, we will be able to -- with the current cash that we have, as we said, to reach operational profitability in terms of cash flows and later on also to support our overall debt service. So we have enough cash in hand for the next coming quarters.

補充一點，根據我們制定的計劃，正如我們所說，我們將能夠利用現有現金在現金流方面實現營運盈利，並在以後支持我們的整體債務償還。因此，我們手頭上有足夠的現金來滿足接下來幾季的需求。

Okay. That's helpful. And can you break out the revenue contribution performance for Talicia and Movantik for the first quarter?

好的。這很有幫助。您能否透露一下 Talicia 和 Movantik 第一季的營收貢獻表現？

So in this quarter, we had three main components, Movantik with a little over $14 million. We had an out-licensing deal for Talicia for $2 million and the rest commercial sales of Talicia.

因此，在本季度，我們有三個主要組成部分，Movantik 的價值略高於 1400 萬美元。我們與 Talicia 簽訂了一項價值 200 萬美元的對外授權協議，並負責 Talicia 其餘部分的商業銷售。

Okay. And then regarding the pathway for opaganib from a regulatory point of view, can you give us some detail in terms of your thoughts for that pathway in COVID-19? I guess the question is, will it include use authorization? Or is that off the table, you have to do a full clinical development plan right now?

好的。然後從監管角度考慮奧帕加尼的治療途徑，您能否詳細介紹一下您對 COVID-19 中該治療途徑的看法？我想問題是，它是否包括使用授權？或者這是不可能的，你現在必須制定一個完整的臨床開發計畫？

So for COVID-19, the current expectation is that a confirmatory -- a positive confirmatory study for either opaganib or also upamostat can, depending on the situation of the pandemic, support month use approvals, potentially also full applications depending on the outcome of the study. But that remains to be seen. And also depending on the state of the pandemic at the time of submission. I hope that answers.

因此，對於 COVID-19，目前的預期是，對奧帕尼或烏帕莫司進行確認性——根據疫情情況，對奧帕尼或烏帕莫司進行積極的確認性研究可以支持月度使用批准，並可能根據研究結果支持全面應用。但這還有待觀察。並且還取決於提交時的疫情狀況。我希望這能解答你的疑問。

Yes, yes. And then last question in terms of RHB-204 and NTM. You're talking about potentially getting some external funding for that. I guess, can you plot out the two pathways there if you have to fund it yourself, the ongoing Phase III? Where are you in enrollment there? And what does that look like if you fund it yourself? And then secondly, if you bring on some external funding, what's the timing of that program in both scenarios?

是的，是的。最後一個問題是關於 RHB-204 和 NTM 的。您談到了可能為此獲得一些外部資金。我想，如果您必須自己資助正在進行的第三階段，您能否規劃出兩條路徑？你在那裡報名的？如果您自己出資，情況會如何？其次，如果您引入一些外部資金，那麼在兩種情況下該計劃的實施時間是怎樣的？

We haven't provided exact guidance on time lines, but of course, with additional sources of capital and resources, which could be provided by interested partners that could accelerate the time frame of enrolling the patients, increasing the number of sites, possibly expanding the study also out of the U.S. to U.K. and Japan, for instance, which are very interesting territories with high unmet need and the potential market for NTM.

我們尚未提供關於時間表的確切指導，但當然，如果有其他資金和資源來源，可以由感興趣的合作夥伴提供，從而加快招募患者的時間，增加站點數量，並可能將研究範圍從美國擴展到英國和日本等，這些地區非常有趣，具有大量未滿足的需求和 NTM 的潛在市場。

So we see a lot of benefit in finding co-development partners, and there's a lot of interest in that respect and ongoing discussions. That's where we think the benefit to accelerating the study can come in. We hope to be able to enroll the study, I would say, within 1.5 years. And that could put 6 months accelerated review of an NDA and 6-month primary endpoint allow for a pretty rapid completion of the study and proceeding towards NDA filing.

因此，我們認為尋找共同開發夥伴有很多好處，而且大家對此很感興趣，並且正在進行討論。我們認為這就是加速研究的好處。我們希望能夠在 1.5 年內完成這項研究。這樣就可以對 NDA 進行 6 個月的加速審查，並在 6 個月內完成主要終點，從而可以相當快速地完成研究並提交 NDA 申請。

That concludes today's question-and-answer session. So I'd like to pass the conference back over to Dror Ben-Asher for closing remarks.

今天的問答環節到此結束。因此，我想將會議交還給 Dror Ben-Asher 做閉幕發言。

Thank you. Thanks all for joining the call. Please reach out to us if you have any additional questions. Keep safe, and have a pleasant day.

謝謝。感謝大家參加電話會議。如果您還有其他問題，請與我們聯絡。注意安全，祝您有個愉快的一天。

That concludes today's conference call. Thank you all for your participation. You may now disconnect your lines.

今天的電話會議到此結束。謝謝大家的參與。現在您可以斷開線路了。