Geron Corp (GERN) 2024 Q3 法說會逐字稿

Hello and welcome to the Geron third quarter, 2024 earnings call. (Operator Instructions) I would now like to turn the conference over to Aron Feingold, Vice President of Investor Relations and corporate communications. You may begin.

大家好，歡迎參加 Geron 2024 年第三季財報電話會議。（操作員指示）我現在想將會議轉交給投資者關係和企業傳播副總裁 Aron Feingold。你可以開始了。

Good morning, everyone. Welcome to the Geron Corporation third quarter, 2024 earnings conference call. I am Aron Feingold, Geron's Vice President of Investor relations and corporate communications. I'm joined today by several members of Geron's management team.

大家早安。歡迎參加 Geron Corporation 2024 年第三季財報電話會議。我是 Aron Feingold，Geron 負責投資者關係和企業傳播的副總裁。今天，Geron 管理團隊的幾位成員也加入了我的行列。

Dr. John Scarlett, Chairman and Chief Executive Officer; Michelle Robertson, executive Vice President and Chief Financial Officer; Jim Ziegler, executive Vice President and Chief Commercial Officer; Dr. Faye Feller, executive Vice President and Chief Medical Officer and Dr. Andrew Grethlein, executive Vice President and Chief Operating Officer.

約翰‧史嘉莉博士，董事長兼執行長；米歇爾·羅伯遜，執行副總裁兼財務長； Jim Ziegler，執行副總裁兼首席商務官； Faye Feller 博士，執行副總裁兼首席醫療官；Andrew Grethlein 博士，執行副總裁兼營運長。

Before we begin. Please note that during the course of this presentation and question and answer session, we will be making forward-looking statements regarding future events, performance plans, expectations and other projections including those relating to the launch commercial opportunity and therapeutic potential of Rytelo anticipated clinical and commercial events and related timelines.

在我們開始之前。請注意，在本次演示和問答環節中，我們將就未來事件、業績計劃、期望和其他預測做出前瞻性陳述，包括與 Rytelo 預期臨床和治療的啟動商業機會和治療潛力相關的預測。活動和相關時間表。

The sufficiency of Jon financial resources and other statements that are not historical fact, actual events or results could differ materially. Therefore, I refer you to the discussion under the heading risk factors in Geron's most recent periodic report filed with the SEC which identifies important factors that could cause actual results to differ materially from those contained in the forward-looking statements and our future updates to those risk factors.

喬恩財務資源的充足性和其他不屬於歷史事實、實際事件或結果的陳述可能存在重大差異。因此，我建議您參閱Geron 向SEC 提交的最新定期報告中風險因素標題下的討論，其中確定了可能導致實際結果與前瞻性聲明中包含的內容存在重大差異的重要因素以及我們未來對這些聲明的更新風險因素。

Geron undertakes no duty or obligation to update our forward-looking statements with that. I'll turn the call over to chip.

Geron 不承擔更新我們的前瞻性聲明的責任或義務。我會把電話轉給晶片。

Thanks Aron, good morning to everybody on the call. Thanks for joining us today following FDA approval and the commercial launch of Rytelo our first-in-class telomerase inhibitor. This has been a transformative year for Geron.

謝謝阿倫，大家早安。感謝您今天加入我們，我們一流的端粒酶抑制劑 Rytelo 獲得 FDA 批准並商業化上市。對 Geron 來說，今年是改變的一年。

As a result, We believe we're well positioned to build long term commercial value with this product. In our first full quarter on the market in the United States, we achieved $28.2 million in Rytelo net product revenue which exceeded our expectations.

因此，我們相信我們有能力利用該產品建立長期商業價值。在美國市場上市的第一個完整季度，我們的 Rytelo 產品淨收入達到了 2,820 萬美元，超出了我們的預期。

The initial quarter of product revenue speaks to our execution as a commercial company as well as the high on that need in lower risk MDS and the compelling value proposition of Rytelo for hematologists and patients. This gives us confidence in future continued demand and momentum for Rytelo.

第一季的產品收入證明了我們作為商業公司的執行力、對低風險 MDS 的高需求以及 Rytelo 對血液學家和患者的令人信服的價值主張。這讓我們對 Rytelo 未來的持續需求和動力充滿信心。

Our strong IP position underlies the long-term commercial value proposition for Rytelo. we believe this IP position including specific claims and our patents covering the indication that's in our FDA label. And buttressed by the FDA's grant of orphan drug exclusivity for lower risk MDS into June of 2031 will provide exclusivity in the United States through August of 2037.

我們強大的智慧財產權地位是 Rytelo 長期商業價值主張的基礎。我們相信這項智慧財產權立場包括具體聲明和我們的專利，涵蓋了 FDA 標籤中的適應症。在 FDA 授予低風險 MDS 孤兒藥獨佔權的支持下，該藥物將在 2031 年 6 月之前在美國獲得獨佔權，直至 2037 年 8 月。

Today, our primary focus is on continuing to deliver on the initial success we achieved in the third quarter, getting Rytelo to more eligible lower-risk MDS patients and maximizing our opportunity in the US market.

今天，我們的主要重點是繼續實現我們在第三季度取得的初步成功，將 Rytelo 帶給更多符合資格的低風險 MDS 患者，並最大限度地提高我們在美國市場的機會。

In Europe, we believe that the CHMP review of our Rytelo marketing authorization application in lower-risk MDS could be completed in late 2024 or early 2025 with potential EU approval in the first half of 2025. Subject to receiving this approval.

在歐洲，我們相信 CHMP 對低風險 MDS 的 Rytelo 行銷授權申請的審查可能會在 2024 年底或 2025 年初完成，歐盟可能在 2025 年上半年獲得批准。須獲得此批准。

We're continuing to prepare for the potential launch of Rytelo in the EU and are planning to marshal Rytelo and select EU markets beginning in 2026. As all of you know, Jim Ziegler joined us as Chief Commercial Officer in early September.

我們正在繼續為 Rytelo 在歐盟的潛在推出做準備，並計劃從 2026 年開始整合 Rytelo 並選擇歐盟市場。眾所周知，吉姆·齊格勒 (Jim Ziegler) 於 9 月初加入我們，擔任首席商務官。

Jim hit the ground running, and, on this call, we'll provide more color on the third quarter US commercial launch performance, key imperatives for our continued success and our next steps in preparing for potential EU commercialization.

吉姆立即發言，在這次電話會議上，我們將提供更多關於第三季美國商業發布業績的資訊、我們持續成功的關鍵要素以及我們為潛在的歐盟商業化做準備的下一步措施。

In addition to this quarter's strong commercial performance, we were pleased to announce this morning, a completion of both the synthetic royalty transaction and a debt financing transaction that together generated $250 million in gross proceeds.

除了本季強勁的商業表現外，我們今天早上還很高興地宣布，合成特許權使用費交易和債務融資交易均已完成，總收益達 2.5 億美元。

These transactions were comprised of $125 million capped synthetic royalty with royalty, Pharma and a $250 million committed senior secured debt facility with funds managed by Pharmakon Advisors under which we've borrowed $125 million allowing us to retire existing debt.

這些交易包括 1.25 億美元的上限合成特許權使用費、Pharma 以及由 Pharmakon Advisors 管理的 2.5 億美元承諾高級擔保債務融資，根據該融資，我們藉入了 1.25 億美元，使我們能夠償還現有債務。

With this new debt facility. We also have access to an additional $125 million. We believe that the favorable terms we achieved in these transactions reflect the significant commercial potential of Rytelo and coming off a successful first quarter of commercial launch, provide us with critical flexibility to fuel continued growth and investment in our future.

有了這個新的債務便利。我們還可以獲得額外的 1.25 億美元。我們相信，我們在這些交易中實現的優惠條款反映了 Rytelo 的巨大商業潛力，並且第一季商業發布的成功，為我們提供了關鍵的靈活性，以推動未來的持續成長和投資。

Michelle will provide more details on these transactions and on our Q3 results later on this call, let's move on to our commercial development programs starting with our pivotal imetelstat phase 3 IMpactMF trial and JAK inhibitor relapsed/refractory myelofibrosis. This trial was approximately 70% enrolled as of August 2024.

米歇爾將在稍後的電話會議上提供有關這些交易和我們第三季度結果的更多詳細信息，讓我們繼續我們的商業開發計劃，從我們關鍵的imetelstat 3 期IMpactMF 試驗和JAK 抑製劑復發/難治性骨髓纖維化開始。截至 2024 年 8 月，該試驗的入組人數約為 70%。

Based on the most recent planning assumptions for enrollment and death rates in the trial, we continue to expect an interim analysis in early 2026 as well as the final analysis in early '27 as the first myelofibrosis phase 3 trial with overall survival as the primary end point. We believe that if the trial is positive imetelstat could transform the treatment landscape for this high unmet need. Patient population with dismal survival representing a substantial commercial opportunity.

根據試驗中入組率和死亡率的最新計劃假設，我們繼續預計2026 年初將進行中期分析，並預計27 年初將進行最終分析，作為第一個以總生存期為主要終點的骨髓纖維化3 期試驗觀點。我們相信，如果試驗結果積極，imetelstat 可能會改變這種未滿足的高需求的治療模式。存活率低的患者群代表著巨大的商業機會。

In addition to IMpactMF, we are exploring the potential of imetelstat across multiple different myeloid hematologic malignancies which were highlighted in ASH abstracts that were released earlier this week. Faye will speak to the new data and to our earlier clinical programs later in the call. Finally, I'd like to highlight the very significant contributions from our colleagues across the company.

除了 IMpactMF 之外，我們還在探索 imetelstat 在多種不同的骨髓血液惡性腫瘤中的潛力，本週早些時候發布的 ASH 摘要中強調了這一點。費耶將在稍後的電話會議中談到新數據和我們早期的臨床項目。最後，我想強調整個公司同事所做的非常重要的貢獻。

In these first four months of our launch, they executed against our key business objectives with focus and a sense of urgency to deliver, Rytelo to the patients. We're committed to help. We deeply appreciate this commitment as we continue our evolution as a commercial company, looking forward to the future. With that, I'll hand the call over to Jim for a commercial update. Jim?

在我們推出的前四個月裡，他們以專注和緊迫感來執行我們的關鍵業務目標，為患者提供 Rytelo。我們致力於提供協助。在我們作為一家商業公司不斷發展並展望未來的過程中，我們深深感謝這項承諾。這樣，我會將電話轉給吉姆以獲取商業更新。吉姆？

Thank you, Chip and good morning everyone. I am honored to join Geron at this important time for the company with the U.S. launch of Rytelo. We have an exciting opportunity to improve the lives of patients with lower-risk MDS with transfusion dependent anemia.

謝謝你，奇普，大家早安。我很榮幸能在 Geron 公司在美國推出 Rytelo 的這個重要時刻加入該公司。我們有一個令人興奮的機會來改善患有輸血依賴性貧血的低風險 MDS 患者的生活。

As Chip highlighted, we achieved $28.2 million in Rytelo net product revenues in our first full quarter of U.S sales in the first few months of launch demand has increased month-over-month with Q3 performance exceeding our expectations, demand from launch through Q3 has come from 388 ordering centers which represents approximately 45% of our key targeted accounts.

正如Chip 所強調的那樣，我們在美國銷售的第一個完整季度中實現了2820 萬美元的Rytelo 產品淨收入。的預期，從發佈到第三季的需求已達到來自 388 個訂購中心，約占我們主要目標客戶的 45%。

this strong start reinforces the high unmet need in Rytelo's clinical profile. In first-line ESA ineligible and second line plus lower-risk MDS. Our market research indicates treating physicians appreciate Rytelo's differentiated clinical profile in 24 weeks and one year. Red blood cell transfusion, independent rates, median duration of red blood cell transfusion, independence and hemoglobin rise.

這一強勁的開端強化了 Rytelo 臨床概況中尚未滿足的高度需求。一線 ESA 不合格，二線加低風險 MDS。我們的市場研究表明，治療醫生欣賞 Rytelo 在 24 週和一年內的差異化臨床特徵。紅血球輸注、獨立率、紅血球輸注的中位數持續時間、獨立性和血紅素升高。

We believe Rytelo's strong clinical data support broad utilization across treatment eligible patient sub-groups in both community and academic settings. Patient access is also critical for adoption and update. And we have achieved significant payer coverage since approval Payers responsible for approximately 70% of US covered lives have implemented medical coverage policies for Rytelo that are consistent with its FDA label clinical trials and or NCCN guidelines.

我們相信 Rytelo 強大的臨床數據支持在社區和學術環境中符合治療資格的患者亞群中廣泛使用。患者的訪問對於採用和更新也至關重要。自批准以來，我們已經實現了顯著的付款人承保範圍，負責約 70% 的美國承保生命的付款人已經為 Rytelo 實施了符合其 FDA 標籤臨床試驗和/或 NCCN 指南的醫療承保政策。

Additionally, our permanent J-code was issued in October 2024 and becomes effective on 1 January 2025. We believe the permanent J-code will streamline billing and reimbursement for standards treating patients with Rytelo. I also want to acknowledge questions from investors regarding the trajectory of weekly Rytelo.

此外，我們的永久 J 代碼於 2024 年 10 月發布，並於 2025 年 1 月 1 日生效。我們相信永久 J 代碼將簡化 Rytelo 患者治療標準的計費和報銷。我還想回答投資者關於每週 Rytelo 發展軌跡的問題。

sales as reflected in third party claims data, we believe that while these claims data may reflect trends and demands that are directionally consistent with what we see internally. There are caveats around this data when we compare them to our own insights, including incomplete weekly data capture.

第三方索賠數據中反映的銷售情況，我們認為，雖然這些索賠數據可能反映的趨勢和需求與我們內部看到的方向一致。當我們將這些數據與我們自己的見解進行比較時，存在一些警告，包括不完整的每週資料擷取。

Also we remain in the early stages of launch and continue to expect week to week fluctuations regardless of the source of sales data. We believe HCPs will continue to utilize Rytelo based on our strong label and NCCN guidelines, positive payer coverage observations from the field and ongoing market research including chart reviews to deliver steady growth.

此外，我們仍處於發布的早期階段，無論銷售數據的來源為何，我們仍預計每週都會出現波動。我們相信，基於我們強大的標籤和 NCCN 指南、來自現場的積極付款人覆蓋觀察以及持續的市場研究（包括圖表審查），HCP 將繼續使用 Rytelo 以實現穩定增長。

We must execute on several key imperatives including driving new patients across all eligible segments, particularly in second line, reinforcing the value of an appropriate duration of treatment with HCPs, educating HCPs on appropriate cytopenia management and leveraging strong payer access supported by the NCCN guidelines and the newly approved J-code from our own internal demand sales data.

我們必須執行幾項關鍵任務，包括在所有符合條件的細分市場（特別是二線）推動新患者的出現、加強HCP 適當治療持續時間的價值、對HCP 進行適當的血細胞減少管理教育以及利用NCCN 指南支援的強大支付者准入管道和新批准的 J 代碼來自我們自己的內部需求銷售數據。

So far, the Rytelo sales growth trajectory in the fourth quarter continues to be promising overall, we remain confident in our launch progress to date. Continued demand for Rytelo expected momentum into 2025 and the projected long-term growth of the brand.

到目前為止，Rytelo 第四季的銷售成長軌跡總體上仍然充滿希望，我們對迄今為止的上市進度仍然充滿信心。對 Rytelo 的持續需求預計將持續到 2025 年，並​​且預計該品牌將實現長期成長。

Our number one commercial priority is to deliver a strong US launch. We are committed to keeping laser focused on that objective. We plan to leverage our us launch experience to also prepare for commercialization in select EU countries in 2026. And beyond, our goal in Europe is to optimize patient access and revenues for imetelstat in prioritized countries.

我們的首要商業任務是在美國推出強勁的產品。我們致力於始終專注於此目標。我們計劃利用我們在美國的上市經驗，為 2026 年在部分歐盟國家的商業化做好準備。除此之外，我們在歐洲的目標是在優先國家優化 imetelstat 的患者使用和收入。

As chip mentioned subject to receiving regulatory approval. We are preparing to commercialize Rytelo in select EU countries in 2026. This includes working with experienced third parties who can provide contracted services including essential critical path activities such as reimbursement, HTA assessment market access and distribution.

正如提到的晶片需要獲得監管部門的批准。我們準備在 2026 年在部分歐盟國家將 Rytelo 商業化。這包括與經驗豐富的第三方合作，他們可以提供合約服務，包括報銷、HTA 評估市場准入和分銷等基本關鍵路徑活動。

In summary, I want to acknowledge the dedicated cross functional teams at Geron for all their hard work to ensure that eligible US patients have broad and timely access to Rytelo I am inspired by how we have remained focused during this time of transition and I am optimistic in the future. We are very pleased with the strong demand for Rytelo across community and academic settings, favorable payer coverage policies and broad utilization across patient segments.

總之，我要感謝Geron 的跨職能團隊為確保符合條件的美國患者能夠廣泛且及時地獲得Rytelo 所做的辛勤工作，我們在這段過渡時期保持專注的方式讓我深受鼓舞，我對此感到樂觀將來。我們對 Rytelo 在社區和學術環境中的強勁需求、有利的付款人覆蓋政策以及在患者群體中的廣泛使用感到非常高興。

These early launch dynamics reinforce our expectations for continued demand and promising growth. With that. I'll turn the call over to Michelle for a financial update Michelle?

這些早期的推出動態增強了我們對持續需求和有希望的成長的預期。就這樣。我會把電話轉給米歇爾，了解最新財務狀況 米歇爾？

Thanks Jim and good morning everyone for detailed Q3 2024 financial results. Please refer to the press release we issued this morning, which is available on our website. We are pleased with our commercial performance this quarter and with securing the synthetic royalty and debt financing announced this morning. I'll bring your attention to key Q3 financial results and then discuss the new royalty and senior term loan agreement.

感謝吉姆，大家早安，了解詳細的 2024 年第三季財務業績。請參閱我們今天早上發布的新聞稿，該新聞稿可在我們的網站上找到。我們對本季的商業表現以及今天上午宣布的合成特許權使用費和債務融資感到滿意。我將提請您注意第三季的關鍵財務業績，然後討論新的特許權使用費和高級定期貸款協議。

As of September 30, 2024, we had approximately $378.9 million in cash, cash equivalents, restricted cash and marketable securities on a pro forma basis including gross proceeds from the upfront payment under the royalty pharma agreement and the first tranche of the Pharmakon loan and after repayment of our existing debt, we had approximately $542.4 million in cash, cash equivalents, restricted cash and marketable securities.

截至2024 年9 月30 日，我們預計持有約3.789 億美元的現金、現金等價物、限制性現金和有價證券，包括特許權使用費藥品協議下的預付款和Pharmakon 貸款的第一筆及之後的總收益。

As of September 30, 2024, total product revenue net for the three and nine months ended September 30, was $28.2 million and $29 million respectively. Total net revenue for the three months and the nine months ended September 30, 2024, was $28.3 million and $29.5 million respectively. Compared to $164,000 and $214,000 for the same period. In 2023 the increase in revenue is due to product revenue from US.

截至 2024 年 9 月 30 日，截至 9 月 30 日的三個月和九個月的產品淨收入總額分別為 2,820 萬美元和 2,900 萬美元。截至 2024 年 9 月 30 日的三個月和九個月的淨收入總額分別為 2,830 萬美元和 2,950 萬美元。同期為 164,000 美元和 214,000 美元。2023年收入的成長是由於來自美國的產品收入。

sales of Rytelo which was available for prescribers to order from specialty distributors as of June 27, 2024 total operating expenses for the three and nine months ended September 30 were $56.5 million and $183.1 million respectively.

截至 2024 年 6 月 27 日，處方醫生可以向專業經銷商訂購 Rytelo 的銷售額。

Compared to $47.8 million and $139.9 million for the same periods. In 2023 cost of goods sold was approximately $450,000 and $473,000 for the three and nine months ended September 30, 2024, respectively, which consisted of cost to manufacture and distribute Rytelo research and development expenses for the three months and nine months ended September 30, 2024, were $20.2 million and $80.3 million respectively. And $29.4 million and $92.1 million for the same period.

同期為 4,780 萬美元和 1.399 億美元。2023年，截至2024年9月30日的三個月和九個月的銷售成本分別約為450,000美元和473,000美元，其中包括截至2024年9月30日的三個月和九個月的製造和分銷Rytelo 研發費用，分別為 2,020 萬美元和 8,030 萬美元。同期分別為 2,940 萬美元和 9,210 萬美元。

In 2023 the decrease is primarily due to manufacturing and quality costs that were capitalized in the current period due to FDA approval of Rytelo compared to being expensed in the prior period. Selling general and administrative expenses for the three and nine months ended September 30, 2024, or $35.9 million and $102.4 million respectively and $18.4 million and $47.7 million for the same period.

2023 年的下降主要是由於 Rytelo 獲得 FDA 批准而在本期資本化的製造和品質成本，而上一期則被費用化。截至2024年9月30日的三個月和九個月的銷售一般和管理費用分別為3590萬美元和1.024億美元，同期分別為1840萬美元和4770萬美元。

In 2023 the increase in selling general and administrative expenses primarily reflects higher commercial launch expenses, increases in head count and related expenses in connection with the US launch of Rytelo. for fiscal year 2024. We expect total operating expenses to be in the range of approximately $260 million to $270 million.

2023 年，銷售一般和管理費用的增加主要反映了商業上市費用的增加、員工人數的增加以及與 Rytelo 在美國上市相關的相關費用。 2024 財年。我們預計總營運費用約為 2.6 億至 2.7 億美元。

Finally, we are pleased to announce this morning the closing of synthetic royalty and debt financing with two exceptional long-term partners, royalty, pharma and Pharmakon advisors that provide us with access up to $375 million in capital of which we have received $250 million in gross proceeds. For a detailed overview of the terms of the financing.

最後，我們很高興地宣布今天早上與兩位傑出的長期合作夥伴（即特許權使用費、製藥公司和Pharmakon 顧問）完成了合成特許權使用費和債務融資，這為我們提供了高達3.75 億美元的資本，其中我們已收到2.5 億美元的資金。有關融資條款的詳細概述。

Please review the press release and the form 8-K we issued this morning available on our website, this financing strengthened our cash position and further solidify our balance sheet. it provide flexibility to invest in our future and reduce considerably our dependence on the equity capital markets.

請查看我們今天早上在我們網站上發布的新聞稿和 8-K 表格，這筆融資增強了我們的現金狀況，並進一步鞏固了我們的資產負債表。它為我們的未來投資提供了靈活性，並大大減少了我們對股權資本市場的依賴。

First, we have entered into a synthetic royalty agreement with royalty farmer which we believe prioritizes cost of capital and maximizes operating flexibility. Importantly, our royalties to royalty Pharma are capped at 1.65 times the closing payment of $125 million if royalty Pharma receives that amount by June 30, 2031, or two times after that date.

首先，我們與特許權使用費農民簽訂了綜合特許權使用費協議，我們認為該協議優先考慮資本成本並最大限度地提高營運彈性。重要的是，如果 Pharma 在 2031 年 6 月 30 日之前或之後兩次收到特許權使用費，我們向 Pharma 收取的特許權使用費上限為 1.25 億美元成交額的 1.65 倍。

In other words, we retain all sales after the hard cap is reached, our royalty payments will be 7.75% of net annual US sales of right up to $500 million dropping to 3% for sales between $500 million and $1 billion and 1% over $1 billion, which we believe are competitive terms for capped royalty agreement.

換句話說，我們在達到硬上限後保留所有銷售額，我們的特許權使用費將為美國年淨銷售額不超過5 億美元的7.75%，對於5 億至10 億美元的銷售額，我們的特許權使用費將降至3%，對於超過1 美元的銷售額，我們的特許權使用費將降至1%。

Additionally, the agreement allows for optional prepayment of the royalties upon a change in control. We believe this royalty agreement is a very clean and flexible structure with no maturity date, mandatory repayments or economic ratchets.

此外，該協議允許在控制權發生變化時可選擇預付特許權使用費。我們認為，該特許權使用費協議是一個非常乾淨和靈活的結構，沒有到期日、強制還款或經濟棘輪。

In addition to the transaction with Royalty Pharma, we have entered into a five-year senior secured term loan with funds managed by Pharmakon advisors for up to $250 million at closing. We drew $125 million under this loan of which we used $86.5 million to fully repay our existing loan with Hercules and Silicon Valley Bank, which has now been terminated.

除了與Royalty Pharma 的交易外，我們還簽訂了為期五年的高級擔保定期貸款，資金由Pharmakon 顧問管理，交易結束時金額高達2.5 億美元。我們在這筆貸款下提取了 1.25 億美元，其中 8,650 萬美元用於全額償還我們與 Hercules 和矽谷銀行的現有貸款，該貸款現已終止。

We have the ability to draw another $125 million by the end of 2025 of which $75 million will be available at our option and the remaining $50 million available at our option subject to reaching a specified revenue threshold. The facility contains no scheduled amortization payments with all outstanding principal due at maturity in 2029 and there are no financial covenants.

到 2025 年底，我們有能力再提取 1.25 億美元，其中 7,500 萬美元將由我們選擇提供，其餘 5,000 萬美元將在達到指定收入門檻的情況下由我們選擇提供。該融資不包含 2029 年到期的所有未償還本金的計畫攤銷付款，且不存在任何財務契約。

The loan bears interest at a variable rate per year equals 5.75% plus the three month secured overnight financing rate or SOFR, subject to a SOFR floor of 3%. We are very pleased with the completion of these non equity financing transactions on favorable terms based on our current operating plans and assumptions.

該貸款的年利率為 5.75%，加上三個月擔保隔夜融資利率（SOFR），但 SOFR 下限為 3%。我們對根據我們目前的營運計劃和假設以優惠條件完成這些非股權融資交易感到非常高興。

We believe our existing cash, cash equivalents and marketable securities including the upfront payments received under these agreements and the anticipated revenues from US sales of Rytelo will be sufficient to fund our projected operating requirements for at least the next 12 months from today, allowing us to continue supporting commercial launch Rytelo in the US

我們相信，我們現有的現金、現金等價物和有價證券，包括根據這些協議收到的預付款以及Rytelo 在美國銷售的預期收入將足以滿足我們從今天起至少未來12 個月的預計營運需求，使我們能夠繼續支持 Rytelo 在美國的商業發布

and potential launch in the EU complete the phase three impact MF trial and relapse refractory MF. Invest in supply chain redundancy for righto and fund our general working capital requirements. We believe there are scenarios where these financing can take us to profitability without raising future equity capital overall, we believe we're in a very strong capital position to fuel continued growth of us sales and support critical value drivers for our business. With that. I'll turn the call over to Faye for a medical and clinical update. Okay.

並可能在歐盟推出，完成第三階段影響 MF 試驗和復發難治性 MF 試驗。投資 righto 的供應鏈冗餘並滿足我們的一般營運資金需求。我們相信，在某些情況下，這些融資可以使我們在無需籌集未來整體股本的情況下實現盈利，我們相信我們擁有非常強大的資本地位，可以推動美國銷售的持續增長並支持我們業務的關鍵價值驅動因素。就這樣。我會將電話轉給 Faye，以了解醫療和臨床最新情況。好的。

Thanks Michelle and hello everyone. I'd like to start by sharing how meaningful it has been for me and my entire team to hear feedback about the impact of Rytelo in the commercial setting. This further motivates our team to develop and deliver imetelstat for patients with myeloid hematologic malignancies.

謝謝米歇爾，大家好。首先，我想分享一下，對於我和我的整個團隊來說，聽到有關 Rytelo 在商業環境中的影響的回饋是多麼有意義。這進一步激勵我們的團隊為骨髓血液惡性腫瘤患者開發和提供 imetelstat。

The field medical team has been responding to information requests that support HCPs as they use Rytelo in a commercial setting, in particular around education on site management and sequencing with other lower risk MDS treatments.

現場醫療團隊一直在回應支持 HCP 在商業環境中使用 Rytelo 的資訊請求，特別是圍繞現場管理和其他低風險 MDS 治療測序的教育。

Today, I will focus on our ASH abstracts released earlier this week which we believe continue to highlight telomere inhibition with imetelstat as an important and powerful approach to treating myeloid hematological malignancies.

今天，我將重點關注本週早些時候發布的 ASH 摘要，我們相信摘要將繼續強調 imetelstat 的端粒抑製作用，作為治療骨髓血液惡性腫瘤的重要而有力的方法。

For detailed information on the data abstract, please view the press release we issued on Tuesday available on our website or visit the website to view the abstract. First, I will cover new analysis from the IMerge clinical trial suggesting that imetelstat demonstrates clinical activity in patients with lower risk MDS with transfusion dependent anemia regardless of prior therapy.

有關數據摘要的詳細信息，請查看我們網站上週二發布的新聞稿或訪問網站查看摘要。首先，我將介紹 IMerge 臨床試驗的新分析，該分析表明 imetelstat 在患有輸血依賴性貧血的低風險 MDS 患者中表現出臨床活性，無論先前的治療如何。

Abstract. 352 accepted as an oral presentation, [pooled thea] from IMerge phase 2, phase 3, and the QTc substudy and evaluate the effect of prior treatments including [ESAs, luspatercept, lenalidomide] and HMA on the clinical activity across these patients.

抽象的。 352 份報告被接受為口頭報告，來自 IMerge 第 2 期、第 3 期和 QTc 子研究，並評估了先前治療（包括 [ESA、luspatercept、lenalidomide] 和 HMA）對這些患者臨床活動的影響。

Although we have small numbers in some cases and limited data on outcomes in later lines of treatment. We believe these data have important clinical implications suggesting that these patients experience an RBC transfusion related clinical benefits and improvements in hemoglobin with imetelstat regardless of their prior treatment history.

儘管我們在某些​​病例中的數量很少，且有關後續治療結果的數據也有限。我們相信這些數據具有重要的臨床意義，顯示這些患者無論先前的治療史如何，都可以透過伊美司他獲得紅血球輸注相關的臨床益處和血紅蛋白的改善。

Abstract 4,590 accepted as opposed to presentation reports. The first efficacy and safety results from the ventricular repolarization IMerge QTc substudy conducted per FDA guidance. As of the day, the cutoff on May 10, 2024 no clinically meaningful effects of imetelstat on cardiac repolarization or other ECG parameters were observed and no new safety signals emerged.

摘要 4,590 份被接受，而非示範報告。第一個療效和安全性結果來自根據 FDA 指導進行的心室復極 IMerge QTc 亞研究。截至 2024 年 5 月 10 日截止，沒有觀察到伊美司他對心臟復極或其他心電圖參數有臨床意義的影響，也沒有出現新的安全訊號。

In this QTC sub study, efficacy and safety of intel that were comparable to that shown in the overall population of the emerged phase three trial and notably response to state health that we're seeing in patients receiving prior treatments, including luspatercept, lenalidomide and HMA. The third emerge abstract 3210, accepted as a poster presentation reports on post hoc analysis of the patient reported outcomes or PRO population as assessed by validated measures, the functional assessment of chronic illness therapy or facet fatigue, functional assessment of cancer therapy, anemia or [FACT-An and the quality ] of life in Myelodysplasia Scale or [QUALMS] questionnaires.

在這項QTC 子研究中，英特爾的療效和安全性與出現的第三階段試驗的總體人群中顯示的結果相當，尤其是我們在接受先前治療（包括luspatercept、來那度胺和HMA）的患者中看到的對狀態健康的反應。第三個出現摘要 3210，被接受為海報演示報告，內容涉及透過有效措施評估的患者報告結果或 PRO 群體的事後分析、慢性病治療或面部疲勞的功能評估、癌症治療的功能評估、貧血或 [骨髓增生異常量表或[QUALMS] 問卷中的FACT-An 和生活品質。

The sustained improvement in fatigue and maintenance of quality of life and anemia. Symptoms within the [telstat] shown in these analyses are meaningful and very encouraging as we aim to improve outcomes for these patients. Abstract 998, accepted as an oral presentation reports.

持續改善疲勞並維持生活品質和貧血。這些分析中顯示的 [telstat] 中的症狀是有意義且非常令人鼓舞的，因為我們的目標是改善這些患者的治療結果。摘要 998，被接受為口頭報告。

The first safety results from the dose escalation part 1 of the phase 1 IMproveMF clinical trial in which 13 patients were enrolled. As of July 10, 2024 at least three patients received each dose level of imetelstat and doses of ruxolitinib were individualized per patient. No dose emitting toxicities were observed and adverse events were consistent with those observed in other clinical trials of imetelstat.

第一個安全性來自 IMproveMF 1 期臨床試驗的劑量遞增第 1 部分，該試驗招募了 13 名患者。截至 2024 年 7 月 10 日，至少有 3 名患者接受了每個劑量等級的 imetelstat，且每位患者的魯索替尼劑量都是個別化的。未觀察到劑量發射毒性，不良事件與伊美司他其他臨床試驗中觀察到的情況一致。

The pharmacokinetic profiles within the [telsta] and lignin in this combination study were similar to previous monotherapy studies. These early results support the potential tolerability of imetelstat as a combination therapy and could inform our future development efforts also with regards to improve IMproveMF based on the study's safety evaluation team review of the dose finding data from part 1 of the study,

此聯合研究中 telsta 和木質素的藥物動力學特徵與先前的單一療法研究相似。這些早期結果支持 imetelstat 作為聯合療法的潛在耐受性，並且可以為我們未來的開發工作提供信息，也可以根據該研究的安全性評估小組對研究第 1 部分的劑量發現數據的審查來改進 IMproveMF，

we adopted the set unanimous recommendation and progressed to part 2 of the study which is designed to confirm the safety profile of the imetelstat 9.4 mg per kilogram in combination with [Rruxolitinib]. Abstract 3222 submitted by Geron collaborators and accepted as a poster presentation provides an interim analysis from the phase 2 IMpress trial evaluating the health stat in patients with high risk MDS or AML refractory relapsing or intolerant to either Azacytidine or Decitabine or [Vne Oclock plus AYO].

我們採納了一致建議，並進入研究的第 2 部分，該部分旨在確認 imetelstat 9.4 mg/kg 與[魯索替尼]。由Geron 合作者提交並被接受為海報展示的摘要3222 提供了2 期IMpress 試驗的中期分析，該試驗評估了高風險MDS 或AML 難治性複發或對阿扎胞苷或地西他濱或不耐受的患者的健康狀況[Vne Oclock 加 AYO]。

In the first part of the trial, none of the six high risk MDS or 17 AML treated patients reached the primary endpoint visit which was scheduled after four cycles of treatment, short-term transient improvement in hematological values was observed in individual cases and patients on the lower risk MDS dosing schedule of every four weeks. And we tell that showed some anti proliferative effects including a decline in blast and [leuc] overall, no new safety signals occurred beyond those already known for imetelstat.

在試驗的第一部分中，6 名高風險MDS 或17 名AML 治療患者均未達到在四個治療週期後安排的主要終點訪視，在個別病例和接受治療的患者中觀察到血液學值的短期短暫改善。我們告訴我們，這顯示出一些抗增殖作用，包括原始細胞和[白血球]總體下降，除了已知的 imetelstat 之外，沒有出現新的安全訊號。

Based on the observations in this first cohort, the protocol was amended to a more frequent dosing schedule for a second cohort of patients that is now being enrolled and treated with a modified schedule starting in August 2024.

根據第一組患者的觀察結果，該方案被修改為第二組患者的更頻繁的給藥時間表，第二組患者目前正在入組，並從2024 年8 月開始按照修改後的時間表進行治療。

Lastly abstract 52 submitted by general and collaborators and accepted as an oral presentation shares pre clinical data identifying imetelstat [dated CTOS associated lipi domic alterations] and AML cells that correlate with the [metalstat] treatment responses. In vivo.

最後，由一般人士和合作者提交並被接受為口頭報告的摘要 52 分享了識別 imetelstat [日期 CTOS 相關脂瘤改變] 和與 [metalstat] 治療反應相關的 AML 細胞的臨床前數據。體內。

These mechanistic insights may be leveraged to develop an optimized therapeutic strategy using a [metalstat] to target the neta is [cyto] resistant AML sub chrome. I look forward to keeping you updated on our clinical development progress, and I will now turn the call back over to chip.

這些機制見解可用於開發優化的治療策略，使用 [metalstat] 來靶向 neta 具有 [細胞] 抗性的 AML 亞鉻。我期待著向您通報我們的臨床開發進展，現在我將把電話轉回給晶片。

Thanks, Faye to close, we're obviously very pleased with this quarter's performance and the feedback we're receiving from customers and payers. We're confident in our launch trajectory and opportunity for long term growth. While recognizing we're only four months into this launch.

謝謝，Faye，最後，我們顯然對本季度的業績以及從客戶和付款人那裡收到的反饋感到非常滿意。我們對我們的發布軌跡和長期成長機會充滿信心。雖然我們意識到我們的發布才剛剛四個月。

we have conviction that righto can become part of the standard of care for eligible patients in this high unmet need, low risk MDS treatment paradigm and that it can bring differentiated benefits to patients both in the US and subject to regulatory approval in the EU.

我們堅信，righto 可以成為這種高未滿足需求、低風險 MDS 治療模式中合格患者護理標準的一部分，並且它可以為美國患者和歐盟監管部門批准的患者帶來差異化的益處。

In addition to lower risk MDS, we're also looking forward to the readout of our pivotal phase 3 impact MF trial in relapse refractory MF. We believe that approval of righto and lower risk MDS in the EU and a positive outcome in this MF trial are key milestones that contribute very significantly to the commercial value proposition for Rytelo. In the future, we'll now open the line for questions, operator.

除了風險較低的 MDS 之外，我們還期待著針對復發難治性 MF 的關鍵 3 期影響 MF 試驗的結果。我們相信，righto 和低風險 MDS 在歐盟的批准以及 MF 試驗的積極成果是關鍵的里程碑，對 Rytelo 的商業價值主張做出了非常重大的貢獻。將來，我們將開通提問熱線，接線員。

(Operator Instructions)

（操作員說明）

Tara Bancroft, TD Cowen.

塔拉·班克羅夫特，TD·考恩。

Hi, good morning and congrats on the great quarter. So given what you have seen this quarter we were hoping you could give us a better idea of how you think growth cadence could look over the next few quarters or over the next year. But I'm especially curious how your growth assumptions and even the ultimate market for Vitello factored into the terms of the royalty deal. Thanks.

你好，早上好，恭喜這個偉大的季度。因此，考慮到您本季所看到的情況，我們希望您能讓我們更了解您認為未來幾季或明年的成長節奏會如何。但我特別好奇你們的成長假設，甚至 Vitello 的最終市場是如何納入特許權使用費交易條款的。謝謝。

Tara. This chip. Could you explain a little bit more what you mean by what factored into the royalty do? Just for the avoidance of doubt?

塔拉.這個晶片。您能否進一步解釋一下您所說的特許權使用費的影響因素是什麼？只是為了避免疑慮嗎？

when you were negotiating the deal, how were your assumptions for the ultimate market and our growth over the next couple of years kind of factored into that?

當您談判交易時，您對最終市場和我們未來幾年成長的假設是如何考慮的？

Sure. Michelle, would you like to take that?

當然。米歇爾，你願意接受嗎？

Sure. Well, I think Jim, why don't we have Jim answer her first question, which is just about how we're thinking about growth over the coming quarters and then I can comment on the structure.

當然。好吧，我想吉姆，為什麼我們不讓吉姆回答她的第一個問題，即我們如何考慮未來幾季的成長，然後我可以對結構發表評論。

Good morning, Tim here. So what we're looking at is and expecting is steady, consistent, growth across all of the patient segments, specifically second line in both RS negative and RS positive. First line ESA ineligible and then of course, the relapse for factory third line plus patients. We're not giving guidance at this point, but we are expecting steady and consistent growth going forward. Thank you.

早上好，提姆在這裡。因此，我們正在關注並期望所有患者群體都能實現穩定、一致的成長，特別是 RS 陰性和 RS 陽性的第二線患者。第一線 ESA 不合格，當然還有工廠三線加病患的復發。我們目前不提供指導，但我們預計未來將實現穩定、持續的成長。謝謝。

Great. Sure. And I'll take the second one, first of all, I just want to say that this was an extremely competitive process and we're very happy with the outcome. We used our current internal forecast and to determine and negotiate the terms which we're very, again, just very pleased with.

偉大的。當然。我要談第二個，首先，我只想說這是一個競爭極為激烈的過程，我們對結果非常滿意。我們使用目前的內部預測來確定和協商我們非常滿意的條款。

Faisal Khurshid, Leerink Partners.

費薩爾‧庫希德 (Faisal Khurshid)，Leerink 合夥人。

Hey, guys, just two questions if you don't mind first, just on the royalty percentage rates, can you just clarify, sort of, how you think investors should be thinking about the royalty rate as well as the kind of cap multiplier on that. I think the rate seems like it starts out a little bit higher than your typical royalty deals, but then kind of comes lower. And then if you could just clarify your cash flow expectations.

嘿，夥計們，如果您不介意的話，首先有兩個問題，只是關於特許權使用費百分比率，您能否澄清一下，您認為投資者應該如何考慮特許權使用費率以及上限乘數的類型那。我認為該費率一開始似乎比典型的特許權使用費交易高一點，但隨後會降低。然後您能否澄清一下您的現金流預期。

Sure. Thanks. So, I mean, I'm not going to comment on other transactions that have been done with royalty farmer again, very competitive. We're very happy that it is a cap royalty deal at the [1.65] it's achieved by a certain date. And so we think that the rate is competitive from what we've seen.

當然。謝謝。所以，我的意思是，我不會再對與特許權農民進行的其他交易發表評論，這些交易非常有競爭力。我們很高興這是一項上限特許權使用費交易，在某個日期之前實現了[1.65]。因此，從我們所看到的情況來看，我們認為該費率具有競爭力。

But again, I think that our focus is on that cap of [1.65] and based on our current plans and meeting our internal revenue projections, we feel pretty confident that we can reach that prior to peak sales on the cash runway.

但我再次認為，我們的重點是 [1.65] 的上限，並且根據我們目前的計劃和滿足我們的內部收入預測，我們非常有信心能夠在現金跑道上的銷售高峰之前達到這一目標。

Yeah, on the cash runway. As I mentioned in my script, there are scenarios where we feel that these two transactions can take us to break even again based on our current plan, that would mean meeting our internal revenue, our [OpEx] projections over the next several years.

是的，在現金跑道上。正如我在腳本中提到的，在某些情況下，我們認為根據我們當前的計劃，這兩支交易可以使我們再次實現收支平衡，這意味著滿足我們的內部收入，以及我們在未來幾年的[OpEx] 預測。

And we feel that we could reach break-even without needing additional financing. One of our goals of this, of these transactions was to not fall below 12 months of cash. As I said in Q2, and just to clarify these two transactions allow us to maintain 12 months of cash going forward. Again, based on our current revenue expectations and [OpEx] projections.

我們認為我們可以在不需要額外融資的情況下實現收支平衡。我們的目標之一是這些交易的現金金額不低於 12 個月。正如我在第二季所說，為了澄清這兩筆交易，我們可以維持未來 12 個月的現金。同樣，基於我們目前的收入預期和 [OpEx] 預測。

So we're not saying we have 12 months of cash because I know previously we talked about cash into Q2 of 2026. What we're saying is that we can maintain that 12 months of cash, which was, has always been one of our goals not to fall below 12 months.

因此，我們並不是說我們有 12 個月的現金，因為我知道之前我們談到 2026 年第二季的現金。我們想說的是，我們可以維持 12 個月的現金，這一直是我們的目標之一，不低於 12 個月。

Yeah, it makes sense. And then just to clarify your comments. So you, you're saying that your kind of internal assumptions are that you kind of trip the multiple on like on the earlier side.

是的，這是有道理的。然後只是為了澄清你的評論。所以你，你是說你的內部假設是你像之前那樣將倍數絆倒了。

Yes, if we meet our current internal revenue projections, yes.

是的，如果我們達到目前的內部收入預測，是的。

Sounds good. Thank you.

聽起來不錯。謝謝。

Corinne Johnson, Goldman Sachs.

科琳·約翰遜，高盛。

Hey, thanks, good morning. You did mention that you expect to see kind of steady growth over the coming quarters. But could you clarify a little bit about what that means to you? Is that in terms of like absolute number of patient growth or the growth rate? Just a little clarification would be helpful there. And then in terms of the patients that you're seeing come on to therapy, are these primarily second line or third line patients? And what portion of them have previously seen? [Revil] at this Stage?

嘿，謝謝，早安。您確實提到，您預計未來幾季會穩定成長。但你能澄清一下這對你意味著什麼嗎？是指患者成長的絕對數量還是成長率？只要稍微澄清一下就會有所幫助。然後就您看到的接受治療的患者而言，這些患者主要是第二線還是三線患者？他們中的哪一部分以前見過？[Revil]現階段？

Go ahead, Jim

來吧，吉姆

Hi, Corinne, this is Jim Ziegler. Then we're not providing guidance, but in terms of our growth, what we expect is growth across all patient segments in both the academic and community setting. And what we provided on this earnings call is that 388 of our targeted accounts have ordered.

嗨，科琳娜，我是吉姆·齊格勒。然後，我們不提供指導，但就我們的成長而言，我們期望的是學術和社區環境中所有患者群體的成長。我們在本次財報電話會議上提供的資訊是，我們的目標客戶中有 388 個已訂購。

So that's the breadth over time. What we're expecting is obviously to increase the breadth and depth of prescriptions are prescribing right. Tell it for patients across these accounts. So I'll just reinforce that we're seeing uptake and utilization across all patient segments including first line ESA ineligible second line and then third line patients at this point.

這就是隨著時間的推移的廣度。我們期望的顯然是增加正確處方的廣度和深度。透過這些帳戶告訴患者。因此，我要強調的是，我們看到所有患者群體的吸收和利用，包括第一線 ESA 不合格的二線患者，然後是三線患者。

Okay.

好的。

Carter Gould, Barclays.

卡特·古爾德，巴克萊銀行。

Great. Good morning. Thanks for taking the questions. Maybe start off just one or two housekeeping questions. Can you spell out any impacts from inventory in the quarter? And as well, if you're providing patient starts numbers, that would be helpful. And then maybe just to follow up on the prior question, the breadth of centers with ordering is is impressive.

偉大的。早安.感謝您提出問題。也許可以從一兩個內務問題開始。您能否說明本季庫存的影響？同樣，如果您提供患者的起始號碼，那也會很有幫助。也許只是為了跟進先前的問題，訂購中心的廣度令人印象深刻。

And I guess what I'm but I guess with our back of the envelope math, it does suggest that the depth of prescribing is still very much in its early stages. Can you talk a little bit about what this implies around how centers are sort of experimenting with the product and then adopting and maybe if that argues against [a Bolis] and any commentary that would be helpful.

我猜我是什麼，但我想透過我們的粗略數學計算，它確實表明處方的深度仍處於早期階段。您能否談談這意味著中心如何對產品進行試驗然後採用，也許這是否反對 [a Bolis] 以及任何有幫助的評論。

Great, thanks Carter. Jim Ziegler. So in terms of inventory, typically in buy and bill, what we see is between two and four weeks of inventory and we're right in that range. So that's consistent with what we would expect. In terms of the breadth and depth questions, we're still relatively early in launch, this is our first full quarter. And so your observations are correct early on.

太好了，謝謝卡特。吉姆·齊格勒。因此，就庫存而言，通常是在購買和帳單方面，我們看到的庫存量在兩到四個星期之間，而我們正好在這個範圍內。所以這與我們的預期是一致的。就廣度和深度問題而言，我們的發布還相對較早，這是我們的第一個完整季度。所以你的觀察很早就正確的。

We're seeing the breadth, physicians are getting experience. And then over time, we expect to see depth in these accounts and continued breadth going forward in terms of bolus, the way we think about it is there's still a high end met need, righto gives patients another treatment option. We expect consistent steady growth. We within Geron did not model [ABS]. we expected steady and consistent growth and early in launch, that's what we're seeing.

我們看到了廣度，醫生們正在獲得經驗。然後隨著時間的推移，我們預計會看到這些帳戶的深度和推注方面的持續廣度，我們認為仍然存在高端滿足需求，righto 為患者提供了另一種治療選擇。我們預計持續穩定成長。我們 Geron 內部並沒有建模 [ABS]。我們預計在發布初期會出現穩定、持續的成長，這就是我們所看到的。

And the patient starts number. Are you guys providing that?

病人開始編號。你們提供那個嗎？

Oh yeah, carter on the patient starts in the buy and bill market. We don't get that hard data in the way you might with other markets. So the way to think about it is if you take the total milligrams that were sold divided by your assumption on average patient wait times 7.1 a starting dose that would give you the range of patients.

哦，是的，卡特對病人的研究始於購買和帳單市場。我們無法像其他市場一樣獲得硬數據。因此，考慮這個問題的方法是，如果您將銷售的總毫克數除以您假設的平均患者等待時間 7.1，即為起始劑量，即可得出患者範圍。

But what it doesn't account for specifically is new patients versus continuing patients or dose interruptions or you know, dose reduction. So, that's why we're not going to give that going forward because it's not a clean number. It's a calculated number.

但它沒有具體考慮新患者與持續患者或劑量中斷或劑量減少。所以，這就是為什麼我們不會繼續給出這個數字，因為它不是一個乾淨的數字。這是一個計算出來的數字。

Emily Bodnar, H.C. Wainwright.

艾米莉·博德納爾，H.C.溫賴特。

Hi, good morning. Thanks for taking the questions and congrats on the good quarter. I guess maybe if you can discuss some of the initial real world experience in terms of benefit on transfusion reductions and also on the safety profile. Are you kind of seeing the data in line with the [meg] study? And then curious how loose batter steps kind of transitioning more into the first line setting has impacted the launch if at all. And if you're seeing more patients previously treated with this batter set in the first line. Thanks.

嗨，早安。感謝您提出問題，並祝賀本季表現良好。我想也許您可以討論一些關於減少輸血的益處和安全性方面的最初的現實經驗。您看到的數據與 [meg] 研究相符嗎？然後好奇鬆散的擊球手步驟更多地過渡到第一線設置對發射是否有影響（如果有的話）。如果您看到更多以前接受過這種麵糊治療的患者，請將其放在第一線。謝謝。

Hi, it's Jim again. I'll take the 1st part of the question and maybe they can also jump in. It's still relatively early in launch. And much of the insights that we get are from the field and from market research, like our patient chart audits, what I would share right now is that performance and real world sort of experiences are consistent with clinical trials. But again, it's still relatively early on in launch. And then in terms of loose patter step in the first line.

嗨，又是吉姆。我將回答問題的第一部分，也許他們也可以介入。目前還處於發布相對早期的階段。我們獲得的許多見解都來自現場和市場研究，例如我們的患者圖表審核，我現在要分享的是，性能和現實世界的經驗與臨床試驗一致。但同樣，它的發布仍處於相對早期的階段。然後在第一行中採用鬆散的模式步驟。

Yes. Based upon their label and the commands, I expect that trial that they will compete and compete for that first line patient against ESA as you know. And regardless of whether that first line patient is on ESA or at least powder set, we expect that our differentiated product profile will allow us to become standard of care in second line. And we still have that first line ESA ineligible patient population, which is about 10% that we expect to compete for as well.

是的。根據他們的標籤和命令，我預計他們將在試驗中與 ESA 競爭第一線患者，正如你所知。無論第一線患者是否使用 ESA 或至少使用粉末組，我們預計我們的差異化產品概況將使我們成為二線護理標準。我們仍然擁有不符合 ESA 資格的第一線患者群體，這大約是我們希望競爭的 10%。

Yes. And hi, this is Faye just to add and reinforce what I was saying, it's still early. But an totally what we are hearing from the field is the community of providers are comfortable managing these type of team and are [ex] overall enthusiastic and excited to use right for their and have this option for their patients.

是的。嗨，我是 Faye，我只是來補充和強化我所說的話，現在還為時過早。但我們從該領域聽到的完全是，提供者社群能夠輕鬆地管理此類團隊，並且總體上充滿熱情並興奮地為他們使用正確的方法，並為他們的患者提供這種選擇。

Stephen Willey, Stifel.

史蒂芬威利，斯蒂菲爾。

Yeah, good morning. Thanks for taking the questions and congrats on the progress. I was wondering if you could just maybe talk a little bit about the split that you're seeing. I know it's early in terms of in terms of data that you guys are getting, but just in terms of the utilization split between academics and community prescribers.

是的，早安。感謝您提出問題並祝賀取得的進展。我想知道你是否可以談談你所看到的分裂。我知道就你們獲得的數據而言還為時過早，但就學術界和社區處方者之間的利用情況而言。

And then you mentioned your review of chart audits in terms of informing how current utilization trends are looking. Can you talk about just how the dose management to address the side opinions that occurred typically during the first few cycles is playing out in the real world data just relative to IMerge. And then I just have a follow up from a show.

然後您提到了您對圖表審計的審查，以了解當前利用率趨勢的情況。您能否談談劑量管理是如何在與 IMerge 相關的現實世界數據中發揮作用的，以解決最初幾個週期中通常出現的側面意見。然後我就收到了一場演出的後續報導。

Sure. Hi Stephen Jim Ziegler. Again, the split between community and academic is 65/35 or roughly two- thirds, one-third. And then right now, what we're hearing from our physicians in both the field observations as well as our market research is that cytopenia management is well understood.

當然。嗨，史蒂芬·吉姆·齊格勒。同樣，社區和學術界之間的比例為 65/35，即大約三分之二、三分之一。現在，我們從醫生的現場觀察和市場研究中聽到的是，血球減少症的管理已被很好的理解。

There aren't major concerns and I would expect that the real world cytopenia management is at least as good as it is in the clinical trials. And we have a lot of personal, non personal efforts to help support appropriate side opinion management associated with. Right?

沒有什麼大問題，我希望現實世界的血球減少症管理至少與臨床試驗中的一樣好。我們有很多個人的、非個人的努力來幫助支持與之相關的適當的側面意見管理。正確的？

Okay. And then maybe for Michelle, I know you've kind of given kind of longer term gross to net guidance in the mid 10s range, just curious if you could give us a gross to net number for the quarter. And then also obviously the royalty transaction will impact cost of goods going forward. But just curious if you can kind of give us a steady state cost of goods assumption that excludes the impact of the royalty. Thank you.

好的。然後，也許對於米歇爾來說，我知道您已經給出了 10 左右範圍內的長期毛淨值指引，只是好奇您能否給我們一個本季度毛淨值的數字。顯然，特許權使用費交易將影響未來的商品成本。但只是好奇你是否可以給我們一個排除特許權使用費影響的穩態商品成本假設。謝謝。

Yeah, sure. So, we have continued to guide on the gross to net and kind of the mid double digits. and that's what it was. That's what we ended in the third quarter, I believe it was you can do the math around 14%. So we expect that to slightly go up as we the volume increases. And we review the next, the [340 B] next.

是的，當然。因此，我們繼續將毛收入和淨收入引導為中兩位數。就是這樣。這就是我們第三季的結果，我相信你可以算一下，大約是 14%。因此，我們預計隨著交易量的增加，這一數字會略有上升。我們回顧下一個，下一個[340 B]。

But we, we continue to guide on the mid double digits. And then on COGS, I mean, obviously we're, we're not guiding on a specific cog but once we get out of sort of this inventory that had already been expensed, we anticipate our fully loaded COGS to be a middle, mid-single digits going forward.

但我們繼續以中兩位數為指導。然後，關於銷貨成本，我的意思是，顯然我們不會對特定的齒輪進行指導，但一旦我們擺脫了已經支出的庫存，我們預計滿載的銷貨成本將是中等、中等水平- 未來將是一個位數。

All very helpful. Thanks for taking the questions.

一切都非常有幫助。感謝您提出問題。

Kalpit Patel, B. Riley Securities

卡爾皮特‧帕特爾 (Kalpit Patel)，B. 萊利證券

Yeah. Hey, good morning and thanks for taking the questions. Maybe. First for Michelle. I guess. Can you. Elaborate. On why the royalty and debt structure was chosen over maybe a simpler equity raise, especially given the current market cap of the company. You know what specific considerations made this approach more preferable?

是的。嘿，早上好，感謝您提出問題。或許。首先是米歇爾。我猜。你可以嗎。精心製作的。關於為什麼選擇特許權使用費和債務結構而不是更簡單的股權融資，特別是考慮到公司目前的市值。您知道哪些具體考慮因素使這種方法更可取嗎？

Oh, sure, thanks Calbert. So again, the transaction, this is a result of an extremely competitive process. We had options across both debt and royalty structures and those ranged in various sizes. And terms, based on the terms that were available to us, we thought carefully about how much debt to take on so that we could pay off our current debt that we have with Hercules SVB that had unfavorable terms which we did pay off.

哦，當然，謝謝卡爾伯特。再說一遍，這筆交易，這是一個極其競爭過程的結果。我們在債務和特許權使用費結構上都有不同規模的選擇。條款方面，根據我們可以獲得的條款，我們仔細考慮了要承擔多少債務，以便我們能夠償還我們與 Hercules SVB 的當前債務，這些債務的條款不利，但我們確實還清了。

Once we received the funds from Pharmakon, and then just the amount of sales to retain in the early launch period and we felt that this struck the right balance. And again this reduces our dependency on the equity markets, which was a goal of ours was to not further dilute the stock.

一旦我們收到了 Pharmakon 的資金，然後就是在發布初期保留的銷售額，我們認為這達到了正確的平衡。這再次減少了我們對股票市場的依賴，我們的目標是不進一步稀釋股票。

Okay. Got it. And then maybe. In the data that you're seeing so far. Do we have an early sense of what. The Month-over-month adherence rates or continuation rates are for these patients who started treatment? how consistent is that with the clinical trials?

好的。知道了。然後也許。在您目前看到的數據中。我們是否對什麼有早期的認知？這些開始治療的患者的逐月遵從率或繼續率是多少？與臨床試驗的一致性如何？

Hi Kalpit, this is Jim again. It's still relatively early, I'm not comfortable given, any data at this point, but obviously, it's something that we're trying to assess through a number of different mechanisms. But for right now, anecdotally, what I would say is that we expect month-over-month treatment to be more consistent with clinical trials. And then over time, we're obviously aspiring to have better management over time.

嗨，卡爾皮特，我又是吉姆。現在還相對較早，我對目前的任何數據感到不舒服，但顯然，我們正在嘗試透過許多不同的機制來評估這一點。但就目前而言，我想說的是，我們預期逐月治療將與臨床試驗更一致。隨著時間的推移，我們顯然渴望擁有更好的管理。

Okay. Got it. Thank you. Very much.

好的。知道了。謝謝。非常。

Gil Blum, Needham and Company.

吉爾布魯姆，李約瑟公司。

Good morning. And thanks for squeezing our question and congrats on a very impressive first quarter of sales. So just a couple from us. now that you have the additional capital, is there a plan on, further investing on expanding sales in the US, for example, or really, this is just about keeping that 12 months buffer. And my other question regarding assumptions on profitability, which you've mentioned, Do you think that includes a potential in [myelofibrosis]? Thank you.

早安.感謝您提出我們的問題，並祝賀第一季的銷售業績非常令人印象深刻。所以只有我們幾個。現在您有了額外的資金，是否有計劃進一步投資以擴大在美國的銷售，例如，或者實際上，這只是為了保留 12 個月的緩衝。我的另一個問題是關於你提到的獲利能力假設，你認為這包括潛力嗎？[骨髓纖維化]？謝謝。

Michelle, why don't you go ahead and restart?

米歇爾，你為什麼不繼續重新開始呢？

Sure. Yeah, thanks you. So the reason why we chose this hybrid structure is for the flexibility. So, as you recall, we took down the first $250 million, we still have access to another $125 million. Really, we looked at our strategy around redundancy and second supplier for Rytelo and that has always been extremely important to us.

當然。是的，謝謝你。所以我們選擇這種混合結構的原因是為了靈活性。所以，正如你所記得的，我們拿走了第一筆 2.5 億美元，但我們仍然可以獲得另外 1.25 億美元。確實，我們研究了關於 Rytelo 的冗餘和第二供應商的策略，這對我們來說一直非常重要。

This now allows us to invest and get ready for a second supplier and for redundancy on our drug substance, It also allows us to continue to support the US commercialization of Rytelo. And but all those costs, for commercialization are in our current plans in the US.

現在，這使我們能夠投資並為第二家供應商和我們的原料藥冗餘做好準備，這也使我們能夠繼續支持 Rytelo 在美國的商業化。但所有這些商業化成本都在我們目前在美國的計畫中。

But it allows us to, to also start spending, you know, some capital on preparing for a potential EU launch. And as you mentioned, it's, we retain more than 12 months of cash going forward -- and then just maybe your second question.

但它也使我們能夠開始花費一些資金，為潛在的歐盟啟動做準備。正如您所提到的，我們未來保留超過 12 個月的現金——這可能是您的第二個問題。

Regarding assumptions on profitability and if they include myelofibrosis. Thanks.

關於獲利能力的假設以及是否包括骨髓纖維化。謝謝。

Well there are scenarios where the financing takes us to break even with just low risk [MDF] and with myelofibrosis, again, based on our current plans and our internal revenue and [OpEx] projections. But yes, we do include you know, [MF] in our internal revenue projections.

好吧，根據我們目前的計劃以及我們的內部收入和 [OpEx] 預測，在某些情況下，融資會讓我們在低風險 [MDF] 和骨髓纖維化的情況下實現收支平衡。但是，是的，我們確實將 [MF] 納入我們的內部收入預測中。

Thank you.

謝謝。

(Operator Instructions) This will conclude the question-and-answer session. I will turn the call to Aron for closing remarks.

（操作員說明）問答環節就此結束。我將請阿倫致閉幕詞。

Thanks so much everyone for joining us today. We appreciate your interest in Geron and look forward to keeping you updated during this very exciting time. Exciting time for our company. Thank you.

非常感謝大家今天加入我們。我們感謝您對 Geron 的興趣，並期待在這個激動人心的時刻為您提供最新資訊。對我們公司來說這是一個令人興奮的時刻。謝謝。

This concludes today's conference call. Thank you for joining you. May now.

今天的電話會議到此結束。感謝您的加入。現在可以了。