BioLine RX Ltd (BLRX) 2023 Q1 法說會逐字稿

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx first-quarter 2023 financial results conference call. (Operator Instructions)

女士們先生們，感謝你們的支持。歡迎參加 BioLineRx 2023 年第一季度財務業績電話會議。 （操作員說明）

I would now like to turn over the call to John Lacey, Head of Investor Relations and Corporate Communications, BioLineRx. Please go ahead.

我現在想將電話轉給 BioLineRx 投資者關係和企業傳播主管 John Lacey。請繼續。

Thank you, operator. Before turning the call over to management, I would like to make the following remarks concerning forward-looking statements. All statements in this conference call other than historical facts are indeed forward-looking statements. The words anticipate, believe, estimate, expect, intend, guidance, confidence, target, project, and other similar expressions are used typically to identify such forward-looking statements.

謝謝你，接線員。在將電話轉交給管理層之前，我想就前瞻性陳述發表以下評論。本次電話會議中除歷史事實外的所有陳述均屬前瞻性陳述。預期、相信、估計、期望、打算、指導、信心、目標、項目和其他類似表達方式通常用於識別此類前瞻性陳述。

These forward-looking statements are not guarantees of future performance and may involve and are subject to certain risks and uncertainties and other factors that may affect BioLineRx's business, financial condition, and other operating results. These include but are not limited to the risk factors and other qualifications contained in BioLineRx's annual report on Form 20-F, quarterly reports filed in a 6-K, and other reports filed by BioLineRx with the SEC to which your attention is directed.

這些前瞻性陳述不是對未來業績的保證，可能涉及並受到某些風險和不確定性以及可能影響 BioLineRx 業務、財務狀況和其他經營業績的其他因素的影響。其中包括但不限於 BioLineRx 以 20-F 表格形式提交的年度報告、以 6-K 形式提交的季度報告以及 BioLineRx 向 SEC 提交的其他您應注意的報告中包含的風險因素和其他資格。

Actual outcomes and results may differ materially from what is expressed or implied by these forward-looking statements. BioLineRx expressly disclaims any intent or obligation to update these forward-looking statements.

實際結果和結果可能與這些前瞻性陳述所明示或暗示的內容存在重大差異。 BioLineRx 明確否認有任何更新這些前瞻性陳述的意圖或義務。

At this time, it is now my pleasure to turn the call over to Phil Serlin, Chief Executive Officer of BioLineRx.

此時此刻，我很高興將電話轉給 BioLineRx 首席執行官 Phil Serlin。

Thank you, John, and good morning, everyone. Thank you for joining us on our first-quarter 2023 results conference call today. Earlier this morning, we issued a press release, a copy of which is available in the Investor Relations section of our website. It was also filed as a 6-K.

謝謝約翰，大家早上好。感謝您今天參加我們的 2023 年第一季度業績電話會議。今天早上早些時候，我們發布了一份新聞稿，您可以在我們網站的投資者關係部分找到該新聞稿的副本。它也被歸檔為 6-K。

As is our practice, I will begin with an overview then Mali Zeevi, our Chief Financial Officer, will provide a discussion of our financial results. We will then open the call and are looking forward to your questions.

按照我們的慣例，我將首先進行概述，然後我們的首席財務官 Mali Zeevi 將討論我們的財務業績。然後我們將開始通話並期待您的提問。

Also joining the call for Q&A are Ella Sorani, our Chief Development Officer; Holly May, President of BioLineRx USA; and Tami Rachmilewitz, MD, our Chief Medical Officer.

我們的首席開發官 Ella Sorani 也加入了問答環節。 Holly May，BioLineRx USA 總裁；以及我們的首席醫療官 Tami Rachmilewitz 醫學博士。

Beginning with our lead program, motixafortide, the stem cell mobilization in patients with multiple myeloma. We announced in November of last year that the FDA accepted our new drug application and assigned a PDUFA target action date of September 9, 2023. We continue to be on track.

從我們的主導項目 motixafortide 開始，該項目是多發性骨髓瘤患者的干細胞動員。我們去年 11 月宣布，FDA 接受了我們的新藥申請，並將 PDUFA 目標行動日期指定為 2023 年 9 月 9 日。我們繼續走在正軌上。

In anticipation of potential FDA approval, we have had a very productive quarter across each of our commercial readiness activities, including completing the hiring of an experienced sales force, most of whom have particular expertise in relevant transplant centers across the US. We have also substantially advanced supply chain, market access, and medical affairs activities.

考慮到 FDA 可能會批准，我們的每項商業準備活動都取得了非常富有成效的季度，包括完成了經驗豐富的銷售人員的招聘，其中大多數人在美國相關移植中心擁有特殊的專業知識。我們還大幅推進了供應鏈、市場准入和醫療事務活動。

We previously talked about our US leadership, including Holly May, who heads all of our US activities and has led 14 product launches throughout her career. And Kevin Campbell, our new Head of US sales and market development, whose prior experience includes serving as head of transplant at Sanofi, where he led a 23-person commercial team whose portfolio included plerixafor, known by its brand name, Mozobil for stem cell mobilization.

我們之前談到了我們的美國領導層，包括 Holly May，她負責我們所有美國活動，並在她的職業生涯中領導了 14 次產品發布。 Kevin Campbell，我們新任美國銷售和市場開發主管，他之前的經驗包括在賽諾菲擔任移植主管，領導了一支 23 人的商業團隊，其產品組合包括普樂沙福（因其品牌名稱 Mozobil 幹細胞而聞名）動員。

Kevin helped to grow and expand the use of Mozobil, and we believe he is the ideal person to help make motixafortide the new standard of care mobilization agent. As we have said several times in the past, but it is worth repeating, based on proprietary market research that we commissioned the stem cell mobilization market continues to grow and is worth some $360 million in the US and more than $500 million globally.

Kevin 幫助發展和擴大了 Mozobil 的使用，我們相信他是幫助使 motixafortide 成為護理動員劑新標準的理想人選。正如我們過去多次說過的那樣，但值得重複的是，根據我們委託進行的專有市場研究，幹細胞動員市場持續增長，在美國價值約 3.6 億美元，在全球價值超過 5 億美元。

With the team that we have assembled, I believe we are very well positioned to capture a significant share of this market over time. Further validating the potential benefits of motixafortide in stem cell mobilization, we were pleased during the quarter to announce the publication of our GENESIS Phase 3 clinical trial data, which supports our pending new drug application in the highly regarded peer-reviewed journal Nature Medicine. Of particular note, the publication describes how the GENESIS trial included patients representative of the current multiple myeloma population undergoing autologous stem cell mobilization, including older patients and those who received lenalidomide-containing induction therapies, both factors associated with impaired mobilization.

憑藉我們組建的團隊，我相信我們完全有能力隨著時間的推移佔領這個市場的重要份額。為了進一步驗證 motixafortide 在幹細胞動員方面的潛在益處，我們很高興在本季度宣布發布 GENESIS 3 期臨床試驗數據，該數據支持我們在備受推崇的同行評審期刊《自然醫學》上即將進行的新藥申請。特別值得注意的是，該出版物描述了 GENESIS 試驗如何納入當前接受自體幹細胞動員的多發性骨髓瘤群體的代表患者，包括老年患者和接受含來那度胺誘導治療的患者，這兩種因素都與動員受損有關。

Multiple myeloma is the second most common hematologic malignancy and stem cell transplantation has been shown to improve survival and as such plays a central role in the treatment of these patients. A meaningful number of patients, however, are unable to collect the target number of peripheral blood CD34-positive hematopoietic stem and progenitor cells with the current standard of care in stem cell mobilization.

多發性骨髓瘤是第二常見的血液惡性腫瘤，幹細胞移植已被證明可以提高生存率，因此在這些患者的治療中發揮著核心作用。然而，相當多的患者無法利用目前的干細胞動員護理標準收集目標數量的外周血 CD34 陽性造血幹細胞和祖細胞。

The primary objective of this study was to demonstrate that one dose of motixafortide with G-CSF compared to placebo with G-CSF allowed more patients to mobilize 6 million CD34 positive cells or more per kilogram of body weight in up to two apheresis sessions. A secondary objective of the study was to demonstrate that one dose of motixafortide with G-CSF was superior to placebo with G-CSF in its ability to mobilize 6 million CD34-positive cells or more per kilogram of body weight in just one apheresis session.

本研究的主要目的是證明，與安慰劑加 G-CSF 相比，一劑莫替沙福肽加 G-CSF 可以讓更多患者在最多兩次血漿分離術中每公斤體重動員 600 萬個或更多 CD34 陽性細胞。該研究的第二個目標是證明一劑莫替沙福肽聯合 G-CSF 優於安慰劑聯合 G-CSF，因為它能夠在一次血漿分離術中動員每公斤體重 600 萬個或更多的 CD34 陽性細胞。

The clinical trial found that all primary and secondary endpoints were achieved with statistical significance, a p-value of less than 0.0001. If approved, motixafortide would be the first true advancement in stem cell mobilization in over a decade. In parallel with our development work in stem cell mobilization for multiple myeloma, we believe there are additional therapeutic areas with the demonstrated benefits of motixafortide can be beneficial.

臨床試驗發現，所有主要和次要終點均達到統計學顯著性，p 值小於 0.0001。如果獲得批准，motixafortide 將成為十多年來幹細胞動員方面的第一個真正進步。在我們針對多發性骨髓瘤幹細胞動員的開發工作的同時，我們相信，莫替沙福肽已被證實的益處還可以在其他治療領域發揮作用。

One of these is autologous hematopoietic stem cell-based gene therapy for patients suffering from sickle cell disease, one of the most common genetic diseases globally. To that end, in March, we announced a clinical trial collaboration with Washington University School of Medicine to evaluate motixafortide in this indication. Unlike multiple myeloma patients, one of the current standard-of-care mobilization agents, G-CSF carries significant risks and potential severe side effects for patients suffering from sickle cell disease

其中之一是針對鐮狀細胞病患者進行基於自體造血幹細胞的基因治療，鐮狀細胞病是全球最常見的遺傳病之一。為此，三月份，我們宣布與華盛頓大學醫學院開展臨床試驗合作，以評估莫替沙福肽在這一適應症中的作用。與多發性骨髓瘤患者（當前標準護理動員劑之一）不同，G-CSF 對於患有鐮狀細胞病的患者俱有顯著的風險和潛在的嚴重副作用

Furthermore, in many cases, the other current mobilization treatments fail to reliably yield optimal numbers of stem cells to facilitate gene therapy. As such, this patient population is in urgent need of an effective new mobilization regimen.

此外，在許多情況下，當前的其他動員治療無法可靠地產生最佳數量的干細胞來促進基因治療。因此，該患者群體迫切需要有效的新動員方案。

Through this collaboration, we plan to conduct a proof-of-concept trial that will study motixafortide as both a single agent and in combination with the immunomodulator, natalizumab. This study will assess the safety and tolerability of the two regimens as mobilization agents and CD34-positive hematopoietic stem cells in patients with sickle cell disease and is anticipated to begin enrollment in the second half of 2023.

通過此次合作，我們計劃進行一項概念驗證試驗，研究莫替沙福肽作為單一藥物以及與免疫調節劑那他珠單抗的聯合用藥。這項研究將評估兩種方案作為動員劑和 CD34 陽性造血幹細胞治療鐮狀細胞病患者的安全性和耐受性，預計將於 2023 年下半年開始入組。

Let's turn now to our clinical programs in metastatic pancreatic cancer. Recall that motixafortide is being evaluated in an investigator-initiated metastatic pancreatic cancer trial in collaboration with Columbia University. This Phase 2 study is evaluating motixafortide in combination with the anti-PD-1 cemiplimab and standard-of-care chemotherapy in first-line metastatic pancreatic cancer patients.

現在讓我們轉向轉移性胰腺癌的臨床項目。回想一下，motixafortide 正在與哥倫比亞大學合作進行的一項由研究者發起的轉移性胰腺癌試驗中進行評估。這項 2 期研究正在評估 motixafortide 與抗 PD-1 cemiplimab 和標準化療聯合治療一線轉移性胰腺癌患者的情況。

This study continues to progress, and we anticipate data from the first cohort of patients this year. We also previously announced a collaboration with GenFleet Therapeutics, pursuant to which GenFleet will execute a rigorously designed, randomized Phase 2b clinical study assessing motixafortide in combination with a PD-1 inhibitor and standard-of-care chemotherapy in approximately 200 first-line metastatic pancreatic cancer patients in China.

這項研究仍在繼續取得進展，我們預計今年第一批患者的數據。我們之前還宣布與 GenFleet Therapeutics 合作，根據該合作，GenFleet 將執行一項嚴格設計的隨機 2b 期臨床研究，評估 motixafortide 與 PD-1 抑製劑和標準護理化療聯合治療約 200 名一線轉移性胰腺癌患者中國的癌症患者。

This collaboration follows the positive results that we reported from our Phase 2a COMBAT/KEYNOTE-202 triple combination study of motixafortide in combination with the anti-PD-1 pembrolizumab and chemotherapy in second-line patients. As a reminder, data from that Phase 2a study demonstrated a substantial improvement across all study endpoints as compared to historical data, including median overall survival, median progression-free survival, confirmed overall response rate, overall response rate, and disease control rate. We anticipate that the GenFleet Phase 2b trial will initiate by the end of this year.

此次合作是在我們的 2a 期 COMBAT/KEYNOTE-202 三聯組合研究中報告的積極結果之後進行的，該研究將莫替沙福肽與抗 PD-1 派姆單抗和化療聯合用於二線患者。提醒一下，該 2a 期研究的數據表明，與歷史數據相比，所有研究終點都有顯著改善，包括中位總生存期、中位無進展生存期、確認的總體緩解率、總體緩解率和疾病控制率。我們預計 GenFleet 2b 期試驗將於今年年底啟動。

Turning now to our second clinical candidate, the investigational intra-tumoral anticancer vaccine, AGI-134. We believe AGI-134 coach tumor cells with alpha-gal to make them look like foreign tissue in order to evoke an immune response that both destroys existing tumors and also provides a vaccine-like effect.

現在轉向我們的第二個臨床候選疫苗，即研究中的腫瘤內抗癌疫苗 AGI-134。我們相信 AGI-134 用 α-gal 訓練腫瘤細胞，使它們看起來像外來組織，以激發免疫反應，既破壞現有腫瘤，又提供類似疫苗的效果。

In December, we announced results from a Phase 1/2a study of AGI-134 in metastatic solid tumors. The first-in-human single-agent study met its primary endpoint for safety and tolerability and demonstrated immune activity across multiple biomarkers. At this time, we are evaluating potential development program pathways in consultation with the program scientific advisory board, and we will provide further updates as appropriate.

12 月，我們公佈了 AGI-134 在轉移性實體瘤中的 1/2a 期研究結果。這項首次人體單藥研究達到了安全性和耐受性的主要終點，並證明了多種生物標誌物的免疫活性。目前，我們正在與項目科學顧問委員會協商評估潛在的開發項目路徑，我們將酌情提供進一步的更新。

I would now like to turn the call over to Mali Zeevi, our CFO, who will give a brief overview of our main financial results. Mali, please go ahead.

我現在想將電話轉給我們的首席財務官 Mali Zeevi，他將簡要概述我們的主要財務業績。馬里，請繼續。

Thank you, Phil. As is our practice, in our financial discussion, we will only go over a few significant items on this call, research and development expenses and cash. Therefore, let me invite you to review the 6-K filing we made this morning, which contains our financials and press release.

謝謝你，菲爾。按照我們的慣例，在我們的財務討論中，我們只會討論本次電話會議中的幾個重要項目，即研發費用和現金。因此，我邀請您查看我們今天早上提交的 6-K 文件，其中包含我們的財務數據和新聞稿。

Research and development expenses for the three months ended March 31, 2023, were $3.7 million, a decrease of $0.7 million or 16.9% compared to $4.4 million for the three months ended March 31, 2022. The decrease resulted primarily from lower expenses related to NDA-supporting activities related to motixafortide as well as lower expenses associated with the completed AGI-134 clinical trial.

截至2023年3月31日止三個月的研發費用為370萬美元，與截至2022年3月31日止三個月的440萬美元相比，減少70萬美元或16.9%。減少的主要原因是與NDA相關的費用減少-支持與motixafortide相關的活動以及與已完成的AGI-134臨床試驗相關的較低費用。

Turning to cash, the company held $43.3 million of cash, cash equivalents, and short-term bank deposits as of March 31, 2023. This does not include $30 million available to us under the debt agreement with Kreos Capital, which is tied to the attainment of certain milestones. We believe we are well financed to fund our operations and as currently planned into the first half of 2024.

至於現金，截至 2023 年 3 月 31 日，該公司持有 4,330 萬美元的現金、現金等價物和短期銀行存款。這不包括我們根據與 Kreos Capital 的債務協議可用的 3,000 萬美元，該協議與達到某些里程碑。我們相信，我們有充足的資金來支持我們的運營，並按照目前的計劃持續到 2024 年上半年。

And with that, I'll turn the call back over to Phil.

然後，我會將電話轉回給菲爾。

Thank you, Mali. In closing, as is our custom, I would like to take a few moments to summarize our key upcoming milestones: first, potential FDA approval of APHEXDA this coming September; potential US launch of APHEXDA shortly after approval; initiation of a clinical trial in collaboration with Washington University School of Medicine to evaluate motixafortide as monotherapy and in combination for CD34-positive hematopoietic stem cell mobilization for gene therapies in sickle cell disease, which is expected to begin in the second half of 2023 of this year; initiation of a Phase 2b randomized clinical trial with 200 patients assessing motixafortide in combination with a PD-1 inhibitor and standard of care chemotherapy as a first-line metastatic pancreatic cancer therapy with collaboration partner, GenFleet also by the end of this year; and finally, initial cohort data from the ongoing Columbia University investigator-initiated study evaluating motixafortide in combination with the PD-1 inhibitor cemiplimab and standard of care chemotherapy in first-line metastatic patients with pancreatic cancer also in the second half of this year.

謝謝你，馬里。最後，按照我們的慣例，我想花一些時間總結一下我們即將到來的關鍵里程碑：首先，FDA 可能會在今年 9 月批准 APHEXDA； APHEXDA 可能在獲得批准後不久在美國啟動；與華盛頓大學醫學院合作啟動一項臨床試驗，評估 motixafortide 作為單一療法和聯合療法用於 CD34 陽性造血幹細胞動員的鐮狀細胞病基因療法，預計將於 2023 年下半年開始年;也在今年年底與合作夥伴 GenFleet 啟動了一項 2b 期隨機臨床試驗，該試驗有 200 名患者參與，評估 motixafortide 聯合 PD-1 抑製劑和標準護理化療作為一線轉移性胰腺癌治療；最後，哥倫比亞大學研究者發起的一項研究的初步隊列數據也在今年下半年評估了莫替沙福肽與 PD-1 抑製劑西米普利單抗和標準護理化療聯合治療一線轉移性胰腺癌患者的效果。

With that, we have now concluded the formal part of our presentation. Operator, we will now open up the call to questions.

至此，我們現在結束了演示的正式部分。接線員，我們現在開始提問。

(Operator Instructions) Joe Pantginis, HC Wainwright.

（操作員說明）Joe Pantginis，HC Wainwright。

Hey, everybody. Good morning and good afternoon. Thanks for taking the question and continued good luck wishes ahead of the PDUFA date.

嘿，大家。早上好，下午好。感謝您提出問題，並在 PDUFA 日期之前繼續祝您好運。

So a couple of questions, Phil, first on as you're preparing for the potential approval, I guess one of the things I wanted to get more color on, how have your, I guess, let's call it, pre-discussions with payers been ongoing?

菲爾，有幾個問題，首先，當你正在為潛在的批准做準備時，我想我想了解更多的事情之一，我想，讓我們稱之為與付款人的預先討論如何一直在進行嗎？

Yeah. So first of all, good morning, Joe. Thanks for joining the call. Let me turn that question over to Holly. She can provide a little color on that.

是的。首先，早上好，喬。感謝您加入通話。讓我把這個問題轉給霍莉。她可以對此提供一些色彩。

Thank you, Phil. I thank Joe for the question. So I would say it's going quite well. We have since, I think, the last time we spoke, solidified more of our market access plan, and that includes the full complement of national accounts representative executives in the field being able to really understand the marketplace and understand where the payers are.

謝謝你，菲爾。我感謝喬提出的問題。所以我想說一切進展順利。我認為，自上次談話以來，我們已經進一步鞏固了我們的市場准入計劃，其中包括該領域國民賬戶代表高管的全面補充，使他們能夠真正了解市場並了解付款人在哪裡。

Obviously, we aren't talking anything at this point in time, specifically about product, but we are -- we do have a very experienced international custom account executive team that is really starting to understand what we need to do to be successful around market access in the marketplace. We also are engaging with external stakeholders. As time goes on, we will be having a steering committee to help -- to continue to advise us in the future.

顯然，我們目前沒有談論任何事情，特別是關於產品，但我們確實擁有一支經驗豐富的國際定制客戶執行團隊，他們真正開始了解我們需要做什麼才能在市場上取得成功進入市場。我們還與外部利益相關者進行接觸。隨著時間的推移，我們將成立一個指導委員會來提供幫助——未來繼續為我們提供建議。

Got it. No, that's helpful. Thank you. And then I guess I'll just stick with motixafortide for just a second here. And of course, it's my obligatory question on status of BD discussions, but I want to approach it this way today in the sense that it's a bit of a hybrid approach here where going into September, you might have an approved drug for a particular therapeutic approach. And then, of course, you have the long-standing oncology approach as well. So how do you think that impacts your potential BD discussions going forward? And if you just focus on the oncology standpoint, do you think it might fit into the category of -- or long-standing category of, a partner would be interested once they see the randomized Phase 2b data? Thanks a lot.

知道了。不，這很有幫助。謝謝。然後我想我會在這裡堅持使用 motixafortide 一秒鐘。當然，這是我關於 BD 討論狀況的強制性問題，但我今天想以這種方式處理它，因為它有點混合方法，進入 9 月份，你可能會有一種針對特定治療的批准藥物方法。當然，還有長期存在的腫瘤學方法。那麼您認為這對您未來潛在的 BD 討論有何影響？如果您只關注腫瘤學的觀點，您認為它是否可能屬於合作夥伴在看到隨機 2b 期數據後會感興趣的類別或長期的類別？多謝。

Yeah. So on, I mean, we've had that approach for quite a while. So I mean, we are fully focused right now on the commercialization of stem cell mobilization to self-commercialization in the US, and we're moving forward on that as Holly mentioned and as we've disclosed in our public filings. Of course, we do have the PDAC and the oncology, the solid tumor area that we're developing, and our idea is with the randomized data, both from the study that we're doing in collaboration in China as well as the data that we have and that we're -- that is being produced in the Columbia University collaboration. We're hoping the two together would provide us with the type of data that would -- we would be able to initiate discussions with a potential partner with. And so that's what we're doing. And I think that we haven't veered from that approach for several quarters already.

是的。等等，我的意思是，我們採用這種方法已經有一段時間了。所以我的意思是，我們現在完全專注於乾細胞動員的商業化，以及在美國的自我商業化，正如霍莉提到的以及我們在公開文件中披露的那樣，我們正在推進這一目標。當然，我們確實有 PDAC 和腫瘤學，即我們正在開發的實體瘤領域，我們的想法是使用隨機數據，這些數據既來自我們在中國合作進行的研究，也來自我們已經有了，並且正在與哥倫比亞大學合作製作。我們希望兩者共同為我們提供數據類型，以便我們能夠與潛在合作夥伴展開討論。這就是我們正在做的事情。我認為我們已經有幾個季度沒有改變這種方法了。

No, I appreciate that. Thanks. And if you would just indulge me a little bit of a shift question on 134. Obviously, things are developing. You're very resource-focused on motixafortide, but any potential broad strokes you can take with regard to the design of next steps?

不，我很欣賞這一點。謝謝。如果您願意請我回答一下 134 上的問題。顯然，事情正在發展。您非常注重 motixafortide 的資源，但是您可以對後續步驟的設計採取任何潛在的大綱嗎？

Yeah. So let me turn that over to Ella. Ella, you want to take that question?

是的。所以讓我把這個交給艾拉。艾拉，你想回答這個問題嗎？

Yes, sure. Hi. Hi, Joe. This is Ella. So with regard to AGI, we are currently assessing the development program forward. We are discussing it with our Scientific Advisory Board. And I cannot give too much -- go into too much specifics, however, it's probably fair to say that going forward, we would probably consider to do a combination study.

是的，當然。你好。嗨，喬。這是艾拉。因此，關於 AGI，我們目前正在評估未來的開發計劃。我們正在與我們的科學顧問委員會討論這個問題。我不能給出太多的細節，但是，可以公平地說，展望未來，我們可能會考慮進行一項組合研究。

Okay. Thanks for all the answers, and good luck with your background discussions.

好的。感謝您的所有回答，祝您的背景討論順利。

Thanks so much, Joe. Have a great day.

非常感謝，喬。祝你有美好的一天。

Mark Breidenbach, Oppenheimer.

馬克·布雷登巴赫，奧本海默。

Hey, guys. Congrats on the progress this quarter, and thanks for taking our questions. Just a couple of quick ones for me. First, just with respect to the upcoming expiry date of the Genzyme Sanofi patent on plerixafor. How quickly after that expiration do you expect generics to enter US market? Is it going to be an immediate thing? Or is it maybe we'll see a little bit of lag or gap before generics are approved here?

大家好。祝賀本季度取得的進展，並感謝您提出我們的問題。對我來說只有幾個快速的。首先，關於健贊賽諾菲的普樂沙福專利即將到期。您預計仿製藥在到期後多久會進入美國市場？這會是立竿見影的事情嗎？或者，在仿製藥在這裡獲得批准之前，我們是否會看到一些滯後或差距？

And then the second question, just, I think, Mali was clear with regard to the financial guidance and cash runway guidance. But operational runway extending into the first half of 2024, that is exclusive of the $30 million in debt tranches from Kreos, is that correct? Thanks for taking the questions.

然後是第二個問題，我認為，馬里在財務指導和現金跑道指導方面是明確的。但運營跑道延伸至 2024 年上半年，這不包括 Kreos 的 3000 萬美元債務部分，這是正確的嗎？感謝您提出問題。

Okay. So first of all, good morning, and thanks for joining the call. I'll take the second question, and then the first part of the question, I'll hand over to Holly. Regarding our financial resources, our guidance does not take into account the $30 million of the framework of the Kreos loan. Okay, so that's with regard to your second part of your question.

好的。首先，早上好，感謝您加入通話。我將回答第二個問題，然後問題的第一部分將交給Holly。關於我們的財務資源，我們的指導沒有考慮 Kreos 貸款框架的 3000 萬美元。好的，這就是您問題的第二部分。

Regarding generics, I will just say, overall, the exclusivity runs out at the end of July. For plerixafor, I think, we do expect a couple of generics. There are some ANDAs that have filed, and so we do expect a couple of generics, but it's really hard to say. I think maybe Holly can provide a little more color on that. Go ahead, Holly.

關於仿製藥，我只想說，總體而言，獨占權將在七月底到期。我認為，對於 Plerixafor，我們確實期望有一些仿製藥。有一些 ANDA 已經提交，所以我們確實預計會有一些仿製藥，但這真的很難說。我想也許霍莉可以為此提供更多的色彩。繼續吧，霍莉。

Yeah, okay. I would just say basically that -- in some ways, if anyone guess as to what the generic manufacturers are going to do. That said, we have, through our research, we've not uncovered anything that would say they are not coming to the market. I know that is a little bit of a different situation just because Sanofi Genzyme did defend their patents, so it's been kind of a longer time to market for these manufacturers, but we are keeping a key eye on it. This is all part of our ongoing market research is to have some intelligence around marketplace and landscape, and we are taking that into consideration.

好的。我只想基本上說——在某些方面，如果有人猜測仿製藥製造商會做什麼。也就是說，通過我們的研究，我們沒有發現任何表明它們不會進入市場的信息。我知道情況有點不同，因為賽諾菲健贊確實捍衛了他們的專利，所以這些製造商的上市時間有點長，但我們正在密切關注。這是我們正在進行的市場研究的一部分，旨在了解有關市場和格局的一些情報，我們正在考慮這一點。

That said, our discovery research really suggests that motixafortide is well positioned to take a significant share of the market over time despite generic competitors to the first-generation mobilizer that's currently in the marketplace. So we are still -- we still have great confidence.

也就是說，我們的發現研究確實表明，儘管目前市場上的第一代動員劑存在通用競爭對手，但 motixafortide 仍處於有利位置，隨著時間的推移，將佔據重要的市場份額。所以我們仍然——我們仍然有很大的信心。

Yeah, I mean, I'd like to just to add to that, I mean, it's very important for -- I think that we've emphasized that we believe that we are highly differentiated from plerixafor and obviously any generics that are coming in once the [loss] of exclusivity happens. And so therefore, we believe that obviously it may affect us, but we think that we are still moving forward and are confident that we can, as Holly said, take a significant share of the market.

是的，我的意思是，我想補充一點，我的意思是，這非常重要——我認為我們已經強調，我們相信我們與普樂沙福以及顯然任何即將上市的仿製藥有很大不同一旦[喪失]排他性發生。因此，我們認為這顯然可能會影響我們，但我們認為我們仍在前進，並且有信心我們可以像霍莉所說的那樣，佔據重要的市場份額。

And I think Phil and I are tag-teaming on this answer. Just to add on to what Phil said, yes, well positioned, our research has shown both on the clinical side as well as on the value -- and economic side of that value proposition.

我認為菲爾和我正在就這個答案進行合作。只是補充一下菲爾所說的，是的，我們的研究已經表明了該價值主張的臨床方面以及價值和經濟方面。

Thanks, Holly.

謝謝，霍莉。

Thank you, guys.

感謝你們。

Okay. Have a great day, Mark.

好的。祝你有美好的一天，馬克。

John Vandermosten, Zacks.

約翰·范德莫斯坦，扎克斯。

Thank you, and hello, everyone. Phil, you've mentioned the $500 million global market for APHEXDA and what are the trends outside the US for growth and the structure of the market? Is it similar to the US where there are few sites responsible for most of the procedures or is it -- or does it have a different structure?

謝謝大家，大家好。 Phil，您提到了 APHEXDA 價值 5 億美元的全球市場，美國以外的增長趨勢和市場結構是什麼？它是否類似於美國，只有很少的站點負責大部分程序？或者它有不同的結構嗎？

I think, overall, there are certain -- there are large transplantation centers that are handling transplantations, both in the US and also around the world. But of course, I think that we've mentioned in Europe, the pricing is different, the regulation is different, the payer is different, the way our reimbursement happens is different. In certain areas, the standard of care is different than the US.

我認為，總體而言，美國和世界各地都有大型移植中心正在處理移植手術。但當然，我認為我們在歐洲提到過，定價不同，監管不同，付款人不同，我們報銷的方式也不同。在某些地區，護理標準與美國不同。

So there are a lot of -- there are question marks regarding the rest of the world. And obviously, we're focusing right now on the US because that's the key market and that's where we're initiating our commercialization steps. And I think that we've said this several times in the past, once we get approval in launch, we will certainly look to maximize the value outside of the US.

因此，關於世界其他地區，還有很多問號。顯然，我們現在關注的是美國，因為這是關鍵市場，也是我們啟動商業化步驟的地方。我認為我們過去已經多次說過這一點，一旦我們獲得啟動批准，我們肯定會尋求在美國以外實現價值最大化。

Okay, and as you look at your other motixafortide programs as the two PDAC programs in the sickle cell gene therapy program, how do you look at those in terms of opportunity? I mean, you have some geographical expansion partners there, what do you see when you see those in terms of opportunities? And how do you rank them?

好的，當您將其他 motixafortide 項目視為鐮狀細胞基因治療項目中的兩個 PDAC 項目時，您如何看待這些項目的機會？我的意思是，您在那裡有一些地域擴張合作夥伴，當您看到這些機會時您會看到什麼？你如何對它們進行排名？

Yeah. So I mean, pancreatic cancer is a huge market. It would open up if we have successful data, both in the study that's going to be initiating in China as well as the one that's happening at Columbia University. We believe that the next steps would be something much more significant, much more global. And that's obviously not only in pancreatic cancer, we think that if it works in pancreatic cancer, it's likely to work in several other indications. And so we look that as a huge potential market. Of course, pancreatic cancer is a difficult indication and it's a high-risk indication, but also very, very high reward.

是的。所以我的意思是，胰腺癌是一個巨大的市場。如果我們有成功的數據，無論是在中國啟動的研究還是在哥倫比亞大學正在進行的研究，一切都會開放。我們相信接下來的舉措將更加重要、更加全球化。顯然，這不僅適用於胰腺癌，我們認為，如果它適用於胰腺癌，它也可能適用於其他幾種適應症。因此，我們認為這是一個巨大的潛在市場。當然，胰腺癌是一個困難的適應症，也是一個高風險的適應症，但回報也非常非常高。

So I think that would be obviously -- if we do see the results that we're hoping to see, that could be obviously a very, very significant opportunity for us. In gene therapy, I think that's also something that we look at as a high potential. There are a lot of -- there are new therapies that are being developed that -- and we hope that they're going to be several gene therapies in the next 18 to 24 months that will receive approval. We think they all require a substantial number of cells. And we believe that we are very well positioned to move into that market because of what we believe to be -- we believe that we are a highly differentiated and very robust mobilization agent. So we think that that will also be a key area of growth for us in the future.

所以我認為這顯然是——如果我們確實看到了我們希望看到的結果，那對我們來說顯然是一個非常非常重要的機會。在基因治療方面，我認為這也是我們認為具有很高潛力的領域。有很多新療法正在開發中，我們希望在未來 18 到 24 個月內有幾種基因療法能夠獲得批准。我們認為它們都需要大量的細胞。我們相信，我們處於進入該市場的有利位置，因為我們相信我們是一個高度差異化且非常強大的動員機構。所以我們認為這也將是我們未來增長的一個關鍵領域。

Okay, great. Yeah, lots of opportunities for that market. And the last one for me on the manufacturing and CMC side, I guess those efforts are progressing as expected and there will be sufficient quantities. And I believe you have those arrangements with Biokine, I think that's still current. Do you look for perhaps another partner as you expand further perhaps geographically to have another manufacturer to support global operations?

好的，太好了。是的，這個市場有很多機會。最後一個對我來說是在製造和 CMC 方面，我想這些努力正在按預期進行，並且會有足夠的數量。我相信你們與 Biokine 有這些安排，我認為這仍然是最新的。當您進一步擴大地域範圍以擁有另一家製造商來支持全球運營時，您是否正在尋找另一家合作夥伴？

Yeah, so Biokine is the licensor for motixafortide, but they are not the manufacturer, they are just simply -- they were the original licensor to us of the product. Our manufacturers are larger, well-established manufacturers, for the API in the US and for the drug product in Europe. And we don't see any problems meeting our current demand over the next number of years, so that really isn't an issue from our perspective at this point.

是的，Biokine 是 motixafortide 的許可方，但他們不是製造商，他們只是簡單地 - 他們是我們該產品的原始許可方。我們的製造商是規模較大、實力雄厚的製造商，在美國生產原料藥，在歐洲生產藥品。我們認為在未來幾年內滿足我們當前的需求不會有任何問題，因此從我們的角度來看，目前這確實不是問題。

Okay, great. Thank you, Phil. Appreciate it.

好的，太好了。謝謝你，菲爾。欣賞它。

All right. Thanks, John. Have a great day.

好的。謝謝，約翰。祝你有美好的一天。

There are no further questions at this time. Before I ask Mr. Phil Serlin to go ahead with his closing statement, I would like to remind participants that a replay of this call is scheduled to begin two hours after the conference. In the US, please call 1-888-295-2634. In Israel, please call 03-9255-904. Internationally, please call 972-392-55904.

目前沒有其他問題。在我請 Phil Serlin 先生繼續他的結束語之前，我想提醒與會者，本次電話會議的重播計劃在會議結束後兩小時開始。在美國，請致電 1-888-295-2634。在以色列，請致電 03-9255-904。國際請致電 972-392-55904。

Mr. Serlin, would you like to make your concluding statement?

Serlin先生，您願意做一下總結髮言嗎？

Yes, thank you. Thank you, operator. In closing, we are progressing through 2023 with significant momentum. We are preparing for the potential US approval of our first therapy in stem cell mobilization and our commercial organization is readying for a robust launch with a highly experienced team.

是的，謝謝。謝謝你，接線員。最後，我們正以強勁的勢頭邁向 2023 年。我們正在為我們的第一個乾細胞動員療法可能在美國獲得批准做準備，我們的商業組織也正準備與經驗豐富的團隊一起大力推出。

We have initiated a new program and an additional and important transplant area by entering into a collaboration to execute a clinical trial with motixafortide as a mobilization agent in gene therapies. We are also making notable progress in our pancreatic cancer program and anticipate important data from our first-line investigator-initiated study later this year as well as the initiation of our GenFleet collaboration study.

我們通過合作開展一項以莫替沙福肽作為基因治療動員劑的臨床試驗，啟動了一項新計劃和一個額外且重要的移植領域。我們的胰腺癌項目也取得了顯著進展，預計今年晚些時候我們的一線研究者發起的研究以及 GenFleet 合作研究的啟動將提供重要數據。

I am very pleased with our progress during the first quarter, and I'm very excited about what we are in the process of achieving this year. Thank you all very much for your continued interest in BioLineRx, and we look forward to providing our next comprehensive update in August.

我對我們第一季度取得的進展感到非常滿意，我對我們今年取得的成就感到非常興奮。非常感謝大家對 BioLineRx 的持續關注，我們期待在 8 月份提供下一次全面更新。

Be safe and have a great day. Thank you.

請注意安全，祝您度過愉快的一天。謝謝。

Thank you. This concludes the BioLineRx first-quarter 2023 conference call. Thank you for your participation. You may go ahead and disconnect.

謝謝。 BioLineRx 2023 年第一季度電話會議到此結束。感謝您的參與。您可以繼續並斷開連接。