Coherus Oncology Inc (CHRS) 2024 Q1 法說會逐字稿

Ladies and gentlemen, thank you for standing by. At this time, I would like to welcome everyone to Coherus BioSciences Inc. first-quarter 2024 earnings conference call. (Operator Instructions) I would now like to turn the conference over to Jami Taylor, Head of Investor Relations. Please go ahead.

女士們先生們，謝謝你們的支持。此時此刻，我歡迎大家參加 Coherus BioSciences Inc. 2024 年第一季財報電話會議。（操作員指示）我現在想將會議轉交給投資者關係主管 Jami Taylor。請繼續。

Thank you, operator. Good afternoon, and welcome to Coherus BioSciences first-quarter 2024 earnings conference call. Joining me today to discuss our results are Denny Lanfear, Chief Executive Officer of Coherus; Brian McMichael, our Interim Chief Financial Officer; Paul Reider, our Chief Commercial Officer; Rosh Dias, Chief Medical Officer; and Theresa LaVallee, our Chief Development Officer.

謝謝你，接線生。下午好，歡迎參加 Coherus BioSciences 2024 年第一季財報電話會議。今天與我一起討論我們結果的是 Coherus 執行長 Denny Lanfear； Brian McMichael，我們的臨時財務長； Paul Reider，我們的首席商務長；羅什‧迪亞斯，首席醫療官；還有我們的首席開發長 Theresa LaVallee。

Before we get started, I'd like to remind you that today's call includes forward-looking statements regarding Coherus' current expectations about future events. These statements include, but are not limited to the following, our ability to advance our pipeline, projections of future growth, revenue expenses, head count and debt levels. All of these forward-looking statements involve substantial risks and uncertainties that are beyond our control and could cause actual results, performance or achievements to differ from those implied by the forward-looking statements.

在我們開始之前，我想提醒您，今天的電話會議包含有關 Coherus 當前對未來事件的預期的前瞻性陳述。這些陳述包括但不限於以下內容：我們推進管道的能力、對未來成長的預測、收入支出、員工人數和債務水準。所有這些前瞻性陳述都涉及我們無法控制的重大風險和不確定性，並可能導致實際結果、績效或成就與前瞻性陳述所暗示的不同。

These statements are not guarantees of future performance and are subject to substantial risks and uncertainties, including risks and uncertainties inherent in the clinical drug development process that are discussed in our press release that we issued today as well as in the documents that we file with the SEC. Forward-looking statements provided on the call today are made as of this date, and we undertake no duty to update or revise any forward-looking statement.

這些陳述不是對未來業績的保證，並且受到重大風險和不確定性的影響，包括臨床藥物開發過程中固有的風險和不確定性，這些風險和不確定性在我們今天發布的新聞稿以及我們向FDA 提交的文件中進行了討論。今天的電話會議中提供的前瞻性陳述是截至該日期作出的，我們不承擔更新或修改任何前瞻性陳述的義務。

And now I'll turn the call over to Denny.

現在我將把電話轉給丹尼。

Thank you, Jami. Good afternoon, everyone, and thank you for joining us on our call today. As we open the call, let me emphasize two things. First, the strength of our first quarter results, and secondly, the strategic initiatives we are successfully executing to position our company for long-term success.

謝謝你，賈米。大家下午好，感謝您今天加入我們的電話會議。當我們開始通話時，讓我強調兩件事。首先，我們第一季業績的實力，其次，我們正在成功執行的策略舉措，以使我們的公司取得長期成功。

As you are aware, in the fourth quarter of 2023, we received two US FDA approvals for products vital for our commercial portfolio. First, LOQTORZI for Nasopharyngeal Carcinoma, a rare devastating cancer for which is the only FDA approved therapy. And the UDENYCA on-body injector, an innovative drug delivery mechanism with novel features that opens up large portions of the pegfilgrastim market that we previously could not access.

如您所知，2023 年第四季度，我們獲得了兩項美國 FDA 批准的產品，這些產品對我們的商業產品組合至關重要。首先，LOQTORZI 用於治療鼻咽癌，這是一種罕見的毀滅性癌症，是 FDA 批准的唯一療法。UDENYCA 體內注射器是一種創新的藥物輸送機制，具有新穎的功能，打開了我們以前無法進入的大部分聚乙二醇非格司亭市場。

In the last three months, we launched both products, leveraging synergies derived from our company's focus on oncology. Our Chief Commercial Officer. Paul Reider will describe these launches in more detail just a moment to share with you the enthusiasm with which both products have been received in the market and the revenue growth each has experienced this quarter. The recently launched innovative products are fully aligned to our company's mission of extending the survival of cancer patients.

在過去的三個月裡，我們利用公司專注於腫瘤學所產生的協同效應推出了這兩種產品。我們的首席商務官。Paul Reider 將更詳細地描述這些產品，以便與您分享這兩款產品在市場上受到的熱烈歡迎以及各自在本季度所經歷的收入增長。最近推出的創新產品完全符合我們公司延長癌症患者存活期的使命。

On the development side, just a moment, Dr. Therese Lavalle, and Dr. Rosh Dias will describe how our R&D pipeline is advancing to plan, with impressive data consistently presented at major medical conferences and more to come. Across every key dimension, company is executing well and to plan. Regarding strategic initiatives, we have focused on exercising our strategic optionality to strengthen the company's balance sheet and enhance long-term value for our shareholders consistent with our mission.

在開發方面，請稍後，Therese Lavalle 博士和 Rosh Dias 博士將描述我們的研發管道如何按計劃推進，並在主要醫學會議和未來的更多會議上不斷呈現令人印象深刻的數據。在每個關鍵方面，公司都執行良好並且有計劃。在策略性舉措方面，我們專注於運用我們的策略選擇權來加強公司的資產負債表，並根據我們的使命為股東提高長期價值。

This is particularly relevant to the commitment we have demonstrated strengthening Coherus' capital structure for strong progress has been made. I'll highlight just two of the recent steps in developments. Early in the first quarter, we announced the divestiture of CIMERLI, a non-core, non-oncology asset for $170 million upfront cash payments, plus an additional $17.8 million in cash for inventory. This divestiture has allowed us to pay down a large portion of our $250 million term loan debt while reducing interest costs, reducing head count and overhead costs, and significantly improving our gross margins.

這與我們所表現出的加強 Coherus 資本結構以取得強勁進展的承諾尤其相關。我將僅重點介紹最近的兩個發展步驟。第一季初，我們宣布以 1.7 億美元的預付款現金以及額外 1,780 萬美元的庫存現金剝離 CIMERLI，這是一項非核心非腫瘤資產。此次剝離使我們能夠償還 2.5 億美元定期貸款債務中的大部分，同時降低利息成本、減少員工數量和管理費用，並顯著提高我們的毛利率。

Today, we announced a new non-dilutive debt and royalty financing, which fully repays the remaining $75 million to which was otherwise due in October 2025. With this transaction completed, we have now reduced our structured term loan debt by 85% over the recent three-month period, while the remaining $37.5 million and moving to due date out five years to 2029 with no springing maturity. Timeline for debt maturity under this agreement extends beyond that the development horizon of our products.

今天，我們宣布了一項新的非稀釋性債務和特許權使用費融資，該融資將全額償還 2025 年 10 月到期的剩餘 7,500 萬美元。這項交易完成後，我們在最近三個月內將結構性定期貸款債務減少了85%，而剩餘的3,750 萬美元到期日將在5 年內到期，即2029 年，且不會提前到期。本協議下的債務到期時間表超出了我們產品的開發期限。

And with that, let me turn the call over to Paul Reider. Paul?

接下來，讓我把電話轉給保羅·雷德。保羅？

Thank you, Denny, and good afternoon, everyone. With the ophthalmology divestiture, we are now an oncology centered commercial organization, which supports our overarching business objectives. The ongoing oncology launches, LOQTORZI, UDENYCA on-body, UDENYCA auto-injector enables singular focus on driving top line revenue. We are executing to plan. We're pleased with our progress.

謝謝丹尼，大家下午好。透過眼科剝離，我們現在是一個以腫瘤學為中心的商業組織，這支持我們的整體業務目標。正在進行的腫瘤學產品 LOQTORZI、UDENYCA 體內註射器、UDENYCA 自動注射器使我們能夠專注於推動營收。我們正在按計劃執行。我們對我們的進展感到滿意。

Regarding the quarter's performance, total net product revenue was $76.7 million, a 137% increase over Q1 2023. For our core oncology brands, Q1 UDENYCA net revenue was $42.7 million, an 18% increase quarter-over-quarter and a 63% increase over Q1 2023. LOQTORZI net revenue was $2 million in the quarter. Still early in launch and in line with our expectations and with new patient accrual momentum building.

就本季業績而言，產品淨收入總額為 7,670 萬美元，比 2023 年第一季成長 137%。對於我們的核心腫瘤品牌，UDENYCA 第一季淨收入為 4,270 萬美元，較上季成長 18%，比 2023 年第一季成長 63%。LOQTORZI 本季淨收入為 200 萬美元。仍處於啟動初期，符合我們的預期以及新的患者累積勢頭的建立。

Now for our non-core products, Q1 net revenue for YUSIMRY was $3.9 million, 77% growth quarter-over-quarter. And finally, CIMERLI, given the deal closed on March 1, net revenue for the quarter was $28.2 million, and only reflects sales for January and February.

現在，就我們的非核心產品而言，YUSIMRY 第一季淨收入為 390 萬美元，季增 77%。最後，CIMERLI 考慮到交易於 3 月 1 日完成，該季度的淨收入為 2820 萬美元，並且僅反映 1 月和 2 月的銷售額。

I'll now speak in more detail about our core oncology assets, starting with LOQTORZI. The commercial launch of LOQTORZI now establishes Coherus in the immuno-oncology therapeutic area, serves as the foundation upon which we will commercialize our exciting pipeline of IO products. LOQTORZI has a broad label and is approved in combination with cisplatin, gemcitabine for first-line treatment of adults with metastatic or with recurrent locally advanced NPC and as a single agent for adults with recurrent unresectable or metastatic NPC disease progression on or after a platinum-containing chemotherapy.

我現在將更詳細地介紹我們的核心腫瘤學資產，從 LOQTORZI 開始。LOQTORZI 的商業推出現在奠定了 Coherus 在免疫腫瘤治療領域的地位，並為我們將令人興奮的 IO 產品系列商業化奠定了基礎。LOQTORZI 具有廣泛的標籤，並被批准與順鉑、吉西他濱聯合用於一線治療成人轉移性或複發性局部晚期鼻咽癌，並作為單一藥物治療鉑類藥物治療期間或之後復發性不可切除或轉移性鼻咽癌疾病進展的成人。

But today, the standard of care is chemotherapy. So our ambition is to establish LOQTORZI plus chemo as the new standard of care and offer NPC patients the hope for greater survival. Based on the final overall survival results from the JUPITER-02 trial, in which LOQTORZI plus chemo, resulted in a 37% reduction in the risk of death versus chemotherapy alone. And educating NPC treating oncologists on these clinical data remain a top priority, and it's being amplified by the advocacy of the nation's leading MPC opinion leaders, who've affirmed the strength of the LOQTORZI clinical data and its position as the new standard of care.

但今天，標準治療是化療。因此，我們的目標是將 LOQTORZI 聯合化療建立為新的護理標準，並為鼻咽癌患者提供更大生存的希望。根據 JUPITER-02 試驗的最終總體生存結果，其中 LOQTORZI 聯合化療與單獨化療相比，死亡風險降低了 37%。對NPC 治療腫瘤學家進行這些臨床數據的教育仍然是重中之重，並且透過國家領先的MPC 意見領袖的倡導，這一點得到了放大，他們肯定了LOQTORZI 臨床數據的優勢及其作為新護理標準的地位。

Since launch, we've achieved a series of milestones necessary to enable broad prescribing over the course of 2024 and beyond. And I'll highlight four examples. First, LOQTORZI was included in NCCN, ASCO and Clin path guidelines. In HCCN, LOQTORZI is the only PD-1 with Category 1 designation for first line use and the only preferred regimen in second line plus. Second, payer coverage has been confirmed now on greater than 85% medical benefit lives in health plans, including Medicare fee-for-service, Medicare Advantage, national and regional commercial plans. Third, among the top academic research hospitals, LOQTORZI was added to the formulary on 55% of the 33 NCCN institutions, with the remaining institutional reviews scheduled. Formulary position is highly expected to be achieved with all NCCN institutions by the end of Q2 2024.

自推出以來，我們已經實現了一系列必要的里程碑，以實現 2024 年及以後的廣泛處方。我將重點介紹四個例子。首先，LOQTORZI 被納入 NCCN、ASCO 和 Clin 路徑指南。在 HCCN 中，LOQTORZI 是唯一具有 1 類一線使用指定的 PD-1，也是二線及以上的唯一首選方案。其次，目前已確認付款人承保健康計劃中超過 85% 的醫療福利生活，包括 Medicare 按服務收費、Medicare Advantage、國家和地區商業計劃。第三，在頂尖學術研究醫院中，LOQTORZI 已被納入 33 家 NCCN 機構中 55% 的處方集，其餘機構審核已安排在進行中。預計到 2024 年第二季末，所有 NCCN 機構都將獲得處方地位。

Finally, product-specific, permanent J-Code has been granted by CMS, will take effect July 1, 2024. This will enable more efficient billing processes, speed the time to reimbursement for providers. Based on LOQTORZI's labeled indication, we estimate approximately 2000 patients will fall within the addressable market opportunity for LOQTORZI. With the hospital formulary conversion process underway, the enthusiasm with which the community is bracing the product, we're building momentum as the launch continues. In Q1, approximately 80 patients received LOQTORZI treatment across all lines of therapy, combination with chemo or as monotherapy, which was in line with our expectations. We are pleased that the launch is progressing to plan.

最後，CMS 已授予產品特定的永久 J 代碼，將於 2024 年 7 月 1 日生效。這將實現更有效率的計費流程，並加快提供者的報銷時間。根據 LOQTORZI 的標籤適應症，我們估計大約 2000 名患者將屬於 LOQTORZI 的潛在市場機會。隨著醫院處方轉換過程的正在進行，以及社區支持該產品的熱情，我們正在為產品的推出不斷積蓄動力。第一季度，約 80 名患者接受了 LOQTORZI 治療，包括聯合化療或單一療法，符合我們的預期。我們很高興發射正在按計劃進行。

Returning to UDENYCA. UDENYCA delivered another quarter of revenue growth, driven by continued strong execution. Strength of our execution is fueled by three drivers. First, the commercial launch of UDENYCA on-body, a novel and proprietary state-of-the-art delivery system for pegfilgrast, enabling UDENYCA to now compete across the entire pegfilgrastim market.

返回烏登尼卡。在持續強勁的執行力推動下，UDENYCA 的營收又實現了一個季度的成長。我們的執行力由三個驅動因素推動。首先，UDENYCA on-body 的商業推出，這是一種新穎且專有的最先進的聚乙二醇非格司特遞送系統，使UDENYCA 現在能夠在整個聚乙二醇非格司亭市場上競爭。

Second, UDENYCA is the only pegfilgrastim brand with three device options to meet the unique needs of providers and patients. To strengthen our competitive position, it allows us to compete on factors other than price. Third, we come into 2024 with payer coverage nearly two times that of 2023, opening up access significantly more patient lives.

其次，UDENYCA 是唯一具有三種設備選擇的聚乙二醇非格司亭品牌，可滿足醫療服務提供者和患者的獨特需求。為了加強我們的競爭地位，它使我們能夠在價格以外的因素上競爭。第三，進入 2024 年，付款人覆蓋範圍幾乎是 2023 年的兩倍，從而顯著延長了患者的生命。

As for key performance indicators for the quarter, UDENYCA franchise demand grew 36% quarter-over-quarter, driven primarily by the prefilled syringe and the auto-injector presentations. In addition, franchise market share was 25%, an increase of 10 market share points quarter over quarter.

至於本季的關鍵績效指標，UDENYCA 特許經營需求環比增長 36%，這主要是由預充式註射器和自動注射器演示推動的。此外，特許經營市場佔有率為25%，季增10個市佔率點。

Regarding the launch of UDENYCA on-body, customer receptivity has been very positive. Specifically, providers are pointing to UDENYCA on-body's five-minute injection time, which is approximately 90% faster medication delivery than Neulasta Onpro. This is noted as a key differentiator, and this differentiation is translating into strong customer adoption. In summary, UDENYCA franchise now offers providers and patients, the total solution and we expect continued unit and revenue growth with a focus on improving margins over the course of 2024.

對於 UDENYCA 身體用藥的推出，顧客的反應非常正面。具體來說，供應商指出 UDENYCA 體內注射時間為 5 分鐘，比 Neulasta Onpro 的藥物傳輸速度快約 90%。這被認為是關鍵的差異化因素，而這種差異化正在轉化為強大的客戶採用率。總而言之，UDENYCA 特許經營現在為提供者和患者提供整體解決方案，我們預計單位和收入將持續成長，重點是在 2024 年提高利潤率。

I will now turn the call to Dr. Rosh Dias, our Chief Medical Officer. Rosh?

我現在將電話轉給我們的首席醫療官羅什迪亞斯博士。羅什？

Thanks very much, Paul, and good afternoon, everyone. LOQTORZI or toripalimab with a profound survival advantage demonstrated nasopharyngeal carcinoma, together with additional positive efficacy data sets published across a variety of tumor types continues to form the foundational element of our immuno-oncology portfolio.

非常感謝，保羅，大家午安。LOQTORZI 或特瑞普利單抗在鼻咽癌中具有顯著的生存優勢，加上針對多種腫瘤類型發布的其他積極療效數據集，繼續構成我們免疫腫瘤學產品組合的基礎要素。

As an I-O company with an approved and highly efficacious PD-1, it affords us the opportunity to prosecute three distinct strategies for further development of the wider variety of tumor types. Mostly, combinations with our own internal pipeline, which consists of three competitively well-positioned assets, tightly focused development plans, all of which are progressing according to plan. As does our Casdozokitug, our IL-27 targeting antibody, CHS-114, our CCR8 targeting antibody, and our anti ILT4.

作為一家擁有獲批且高效的 PD-1 的 I-O 公司，它使我們有機會實施三種不同的策略，以進一步開發更廣泛的腫瘤類型。大多數情況下，與我們自己的內部管道相結合，其中包括三個具有競爭力的定位資產、重點突出的開發計劃，所有這些都按計劃進行。我們的 Casdozokitug（IL-27 標靶抗體）、CHS-114（CCR8 標靶抗體）和抗 ILT4 也是如此。

Secondly, development opportunities where toripalimab is studied in combination with novel compounds, with nearer-term registration opportunities fully funded by partner companies in Phase 3 registration, enabling studies such as the INOVIO vaccine combination study in head and neck squamous cell carcinoma response by INOVIO, where we're providing toripalimab supply and the ongoing Junshi BTLA-toripalimab combination study, limited stage small cell lung cancer.

其次，特瑞普利單抗與新型化合物聯合研究的發展機會，近期註冊機會由合作夥伴公司在第3 階段註冊中全額資助，從而使INOVIO 進行頭頸鱗狀細胞癌反應的INOVIO 疫苗組合研究等研究成為可能，我們提供特瑞普利單抗供應以及正在進行的君實 BTLA-特瑞普利單抗聯合研究，針對有限期小細胞肺癌。

And thirdly, development opportunities for toripalimab with partner companies that have earlier-phase novel compounds for which they are looking for a PD-1 partner. With respect to our internal pipeline, let me first start with cutover. We remain excited about the potential of Casdozo in both non-small cell lung cancer, where we have demonstrated monotherapy activity in PD-L1 refractory subjects in the advanced setting. And also in hepatocellular carcinoma, where we have demonstrated encouraging overall response rate in the first-line advanced setting.

第三，特瑞普利單抗與合作夥伴公司的開發機會，這些公司擁有早期階段的新型化合物，正在尋找 PD-1 合作夥伴。關於我們內部的管道，首先讓我從割接開始。我們對 Casdozo 在兩種非小細胞肺癌中的潛力仍然感到興奮，我們已經在晚期環境中證明了對 PD-L1 難治性受試者的單藥治療活性。在肝細胞癌方面，我們在一線晚期治療中表現出了令人鼓舞的整體緩解率。

We're taking forward the non-small cell lung cancer data with our Phase 2 study that is currently ongoing and is active in the US and where we remain on track to report out data towards the end of this year or early next year. Our second development program of Casdozo in advanced HCC also remains on track to start in the second half of this year, building upon the promising data presented earlier this year at ASCO GI.

我們正在透過目前正在進行的第二階段研究來推進非小細胞肺癌數據，該研究目前正在美國開展，我們仍有望在今年底或明年初報告數據。我們的 Casdozo 治療晚期 HCC 的第二個開發項目也預計在今年下半年啟動，該計畫以今年稍早在 ASCO GI 上公佈的有希望的數據為基礎。

Turning to CHS-114, our CCR8 bispecific antibody, we've continued to make good progress through dose escalation and are now moving on to the next stage of the study with expansion into head and neck squamous cell carcinoma where the disease leakage is particularly strong. We're excited that an abstract has been accepted for presentation at ASCO in a few weeks' time, with for further detail data from the dose escalation portion of the trial. Theresa will speak more about the status of our ILT4 program and will highlight data presented at the recent AACR meeting.

轉向我們的 CCR8 雙特異性抗體 CHS-114，我們透過劑量遞增繼續取得良好進展，現在正在進入下一階段的研究，將範圍擴展到疾病滲漏特別嚴重的頭頸鱗狀細胞癌。我們很高興幾週後 ASCO 接受了一份摘要，其中包含來自試驗劑量遞增部分的進一步詳細數據。Theresa 將更多地談論我們的 ILT4 計劃的狀況，並將重點介紹最近 AACR 會議上提供的數據。

Next, with respect to our pivotal partnered programs with nearer-term registration opportunities, our partnership with INOVIO continues with Phase 3 registration enabling study in HPV positive locally advanced head and neck squamous cell carcinoma, currently actively in development. In addition, the toripalimab BTLA Phase 3 combination study in limited stage small cell lung cancer led by our partner. Junshi, continues to progress in the US and also other multi-regional sites. And this serves as a further example, the potential of toripalimab to act as a foundational element for novel combinations.

接下來，關於我們具有近期註冊機會的關鍵合作項目，我們與 INOVIO 的合作夥伴關係將繼續進行 3 期註冊，從而能夠對 HPV 陽性局部晚期頭頸鱗狀細胞癌進行研究，目前正在積極開發中。此外，由我們的合作夥伴領導的針對有限期小細胞肺癌的特瑞普利單抗 BTLA 3 期聯合研究。君實繼續在美國和其他多區域網站取得進展。這進一步證明了特瑞普利單抗作為新型組合的基礎元素的潛力。

Finally, with respect to earlier-stage novel combinations, we were delighted to announce yesterday that toripalimab was selected by Cancer Research Institute as the PD-1 backbone for exploration with EMV Therapeutics endothelin B inhibitor within a platform ovarian cancer study exploring novel combinations in this patient population that historically has been underserved by immunotherapy. Selection of toripalimab by CRI provides further validation of our strategic trials approach of utilizing toripalimab as an investigational PD-1 backbone in these areas outside NTT.

最後，關於早期的新型組合，我們昨天很高興地宣布，癌症研究所選擇特瑞普利單抗作為PD-1 骨幹，在一項卵巢癌研究平台中與EMV Therapeutics 內皮素B 抑製劑一起探索該平台的新型組合。CRI 選擇特瑞普利單抗進一步驗證了我們在 NTT 以外的這些領域利用特瑞普利單抗作為研究性 PD-1 骨幹的策略性試驗方法。

I'll now turn the call over to Dr. LaValle, our Chief Development Officer. Theresa?

我現在將把電話轉給我們的首席開發官 LaValle 博士。有一個？

Thank you, Rosh, and good afternoon, everyone. I'm pleased to update you on additional progress and our efforts to pursue development of our tumor microenvironment or TME focused pipeline. We have two approaches; combinations broadly with immune activators with partners, and the internal development plans focused on combination with LOQTORZI. The Casdozokitug clinical data in non-small cell lung cancer in HCC that were presented in December 2023, in January 2024 has demonstrated clinical efficacy in early clinical studies.

謝謝羅什，大家下午好。我很高興向您通報我們在腫瘤微環境或 TME 重點研發管線方面的最新進展和努力。我們有兩種方法；與合作夥伴廣泛聯合免疫活化劑，內部開發計劃專注於與 LOQTORZI 聯合。Casdozokitug於2023年12月、2024年1月提交的針對HCC非小細胞肺癌的臨床數據已在早期臨床研究中證明了臨床療效。

Importantly, the study show a favorable safety profile, lending Casdozo combination treatments and of equal importance, immune activation in cancer patients. In the Casdozo of Phase 1 study, the biomarker data show a casdozo doses of 10 mgs/kg or higher, but not at 3 mgs/kg or lower that IL-27 signaling is inhibited, and further, NK and T cells are activated. While rebalancing the immune system with anti-cytokine antibodies is well established in inflammatory diseases, such as rheumatoid arthritis, inflammatory bowel disease, and psoriasis, this approach has not yet been successfully demonstrated for the treatment of cancer. Casdozokitug is an antagonist and first-in-class. If blocks IL-27, which is in the IL-23, IL-12, IL-6 family of cytokines, a family that has multiple approved antibody drugs in inflammatory diseases.

重要的是，該研究顯示出良好的安全性，為癌症患者提供了 Casdozo 聯合治療以及同樣重要的免疫活化。在Casdozo 的1 期研究中，生物標記數據顯示casdozo 劑量為10 mgs/kg 或更高，但在3 mgs/kg 或更低時，IL-27 信號傳導不會受到抑制，並且進一步激活NK 和T 細胞。雖然用抗細胞激素抗體重新平衡免疫系統在類風濕性關節炎、發炎性腸道疾病和牛皮癬等發炎性疾病中已被廣泛應用，但這種方法尚未成功證明可用於治療癌症。Casdozokitug 是一種拮抗劑，也是一流的。如果阻斷IL-27，IL-27屬於IL-23、IL-12、IL-6細胞激素家族，該家族在發炎性疾病中有多種核准的抗體藥物。

Our scientific adviser, Dr. Christopher Hunter from University of Pennsylvania was honored for his research on IL-27 with the distinguished lecture at the American Association of Immunologists Congress in Chicago on May 4. In Dr. Hunter's lecture, he described the basic research in mouse models to understand the immune regulatory role of IL-27 and how the absence of IL-27 results in immune pathology due to an overactive immune system, specifically dysregulated and activated T cells and NK cells.

我們的科學顧問、賓州大學的 Christopher Hunter 博士於 5 月 4 日在芝加哥舉行的美國免疫學家協會大會上發表傑出演講，因其對 IL-27 的研究而受到表彰。在Hunter 博士的演講中，他描述了小鼠模型的基礎研究，以了解IL-27 的免疫調節作用，以及IL-27 的缺失如何導致免疫系統過度活躍，特別是失調和活化的T 細胞和免疫病理學。

Interestingly, these effects are both notable liver, lung, and brain tissue. In translation of this work to cancer and treatment of patients with Casdozokitug showing anti-tumor activity in lung and liver cancer is very exciting. The strong line of sight for tumor indications where IL-27 biology is critical for regulating immune response allows Coherus to have a focused development finance.

有趣的是，這些影響在肝臟、肺臟和腦組織中都很顯著。將這項工作轉化為癌症並用 Casdozokitug 治療患者，在肺癌和肝癌中顯示出抗腫瘤活性，這是非常令人興奮的。Coherus 對腫瘤適應症（其中 IL-27 生物學對於調節免疫反應至關重要）的強烈關注使 Coherus 能夠擁有集中的開發資金。

I'm also proud to say that at the recent AACR meeting, our team presented IND-enabling studies for ILT4 antibody CHS-1000. CHS-1000 is our first internally discovered and developed I-O drug candidate. We remain on track for FDA feedback on the IND in second quarter 2024.

我還很自豪地說，在最近的 AACR 會議上，我們的團隊展示了 ILT4 抗體 CHS-1000 的 IND 研究。CHS-1000是我們第一個內部發現和開發的I-O候選藥物。我們仍將在 2024 年第二季取得 FDA 對 IND 的回饋。

I'll now turn the call to Brian McMichael

我現在將電話轉給布萊恩麥克邁克爾

Thank you, Theresa, and good afternoon, everyone. Since Denny covered the updates to our capital structure and Paul covered revenues I will focus on the rest of the P&L and cash. Cost of goods sold during Q1 2024 was $34.6 million. Excluding the impact of the inventory write-down in Q4, COGS would have decreased $3 million or 8% from Q4 2023. R&D decreased $5.7 million and 17% from Q1 a year ago, primarily reflecting savings from reduced headcount and reduced development costs on biosimilars, partially offset by investments in our I-O pipeline.

謝謝特蕾莎，大家下午好。由於丹尼介紹了我們資本結構的更新，保羅介紹了收入，我將專注於其餘的損益表和現金。2024 年第一季的銷售成本為 3,460 萬美元。排除第四季庫存減記的影響，銷貨成本將比 2023 年第四季減少 300 萬美元，即 8%。研發費用較去年第一季減少 570 萬美元，下降 17%，主要反映了人員數量減少和生物相似藥開發成本降低的節省，部分被我們 I-O 管道的投資所抵消。

SG&A increased to $7.4 million or 15%, driven by a net $6.8 million charge in Q1 2024 associated with the non-cash write off of NZV930, which is now license obtained in the Surface Oncology acquisition that was terminated by Novartis. For the first quarter of 2024, we reported net income of $102.9 million or $0.83 per diluted share compared to a net loss of $75.7 million or $0.96 per diluted share for the same period in 2023. Non-GAAP net loss per share, which excludes the gain on divestiture and the net charge associated with the termination from Novartis mentioned earlier, was $35.8 million or $0.32 per diluted share in Q1 2024 compared to $59.5 million or $0.75 per diluted share for the same period in 2023.

SG&A 增加至 740 萬美元，即 15%，原因是 2024 年第一季與 NZV930 的非現金註銷相關的 680 萬美元淨費用，NZV930 目前是諾華終止的 Surface Oncology 收購中獲得的許可。2024 年第一季度，我們報告的淨利潤為 1.029 億美元，即稀釋後每股 0.83 美元，而 2023 年同期淨虧損為 7,570 萬美元，即稀釋後每股 0.96 美元。2024 年第一季度，非GAAP 每股淨虧損（不包括剝離收益和與諾華終止相關的淨費用）為3,580 萬美元，即稀釋後每股0.32 美元，而同一季度的每股淨虧損為5,950 萬美元，即稀釋後每股0.75 美元。

Cash and cash equivalents and investments and marketable securities were $259.8 million as of March 31, 2023, compared to $117.7 million at year end. As noted earlier, we used the cash on hand to pay $175 million in principles after the quarter ended. Today, we are reiterating our expected range of combined 2024 R&D and SG&A expenses of $250 million to $265 million. This guidance includes approximately $40 million of stock-based compensation and excludes business development activities and other unforeseen activities.

截至 2023 年 3 月 31 日，現金和現金等價物以及投資和有價證券為 2.598 億美元，而去年底為 1.177 億美元。如前所述，我們在季度結束後使用手頭現金支付了 1.75 億美元的本金。今天，我們重申 2024 年研發和銷售及管理費用合計預計範圍為 2.5 億美元至 2.65 億美元。該指導包括約 4000 萬美元的股票薪酬，不包括業務開發活動和其他不可預見的活動。

With that, I will turn the call back over to Denny for closing remarks.

至此，我將把電話轉回給丹尼進行總結發言。

Thank you, Brian. As we have emphasized throughout our remarks today, we are executing well in our four-part plan to deliver shareholder value. First, driving the top line of our revenues, and secondarily, controlling our operating expenses. We're making great progress advancing our pipeline of tumor microenvironment focused assets. And lastly, as I disclosed, improving our capital structure. I'm fully confident in both the progress we are making and, of course, we have charted as an innovative oncology company.

謝謝你，布萊恩。正如我們今天在演講中所強調的那樣，我們正在很好地執行我們的四部分計劃，以實現股東價值。首先，推動我們的收入成長，其次，控制我們的營運支出。我們在推動以腫瘤微環境為中心的資產管道方面取得了巨大進展。最後，正如我所揭露的，改善我們的資本結構。我對我們正在取得的進展充滿信心，當然，我們已經成為一家創新的腫瘤公司。

Operator, we're now happy to open the line for questions.

接線員，我們現在很高興開通提問線路。

(Operator Instructions)

（操作員說明）

Yigal Nochomovitz, Citi.

伊格爾·諾霍莫維茨，花旗銀行。

Hi, this is Ashwin Navar coming in for Yigal. Thanks for taking my questions and congrats on the quarter. I joined a little bit late, so I apologize if I missed this, but how are you thinking about the contribution of each presentation of UDENYCA to the revenue mix for the quarter? And more importantly, how is that how is that going to look like moving forward? I kind of assume that weighting will increase towards the new presentations but I'm wondering how you're thinking about it

大家好，我是阿什溫·納瓦爾 (Ashwin Navar)，替補伊格爾 (Yigal)。感謝您回答我的問題並祝賀本季。我加入得有點晚，所以如果我錯過了這一點，我深表歉意，但是您如何看待 UDENYCA 的每次演示對本季度收入組合的貢獻？更重要的是，未來的發展會如何？我有點認為新演示的權重會增加，但我想知道你是如何看待它的

Hi. Thank you very much for your question, Paul Reider will be happy to further describe the contribution to revenues for the three presentations that we now have on the market. Paul?

你好。非常感謝您提出問題，Paul Reider 將很樂意進一步描述我們現在市場上的三種簡報對收入的貢獻。保羅？

So in the first quarter, the prefilled syringe still represented a larger share of our SKU mix. It was around 90%, the auto-injector was around 8% and the on-body came in around 2%, recalling that we launched mid-quarter. So we only had about half of the quarter, the on-body. So that's the breakdown of the SKU mix. It varies a little bit by segment, so our clinics and hospitals tend to customize the SKU that works best for them, which is exactly how we are now competitively positioning the franchise.

因此，在第一季度，預充式註射器仍然在我們的 SKU 組合中佔據較大份額。回想起來，我們是在季度中期推出的，約 90%，自動注射器約 8%，體貼約 2%。所以我們只有大約一半的時間，也就是身體上的。這就是 SKU 組合的細分。每個細分市場略有不同，因此我們的診所和醫院傾向於定制最適合他們的 SKU，這正是我們現在對特許經營權進行競爭定位的方式。

And we're the only franchise that could offer providers and patients three different options to meet the unique needs of each individual patient or how they deliver pegfilgrastim. So you could see how that differentiation has translated into market share growth. 10% points quarter-over-quarter to 25%. And so and we're going to continue to drive that differentiation as the remainder of the year unfolds.

我們是唯一一家可以為提供者和患者提供三種不同選擇的特許經營商，以滿足每個患者的獨特需求或他們如何提供聚乙二醇非格司亭。因此，您可以看到這種差異化如何轉化為市場份額的成長。環比下降 10% 至 25%。因此，隨著今年剩餘時間的展開，我們將繼續推動這種差異化。

And how do we see the market share of each of the presentations evolving through the rest of the year? Can we get a line of sight on that?

我們如何看待今年剩餘時間每個演示的市場份額的變化？我們能看到這一點嗎？

Yeah, I think it's still early in the on-body launch, so we are gaining feedback from customers as where it's fitting in. I can tell you right now that it's moving primarily in the clinic segment and also different segments of the hospitals. But I think we're still going to see throughout this year at least the prefilled syringe still holding a good percentage of the SKU mix with the remainder being auto-injector and the on-body. But the on-body growth has largely been in the clinic segment. We would expect that to continue throughout the year.

是的，我認為現在還處於車身發布的早期階段，因此我們正在從客戶那裡獲得回饋，以了解它的適合情況。我現在可以告訴你，它主要在診所領域以及醫院的不同領域發展。但我認為今年全年我們仍然會看到至少預充式註射器仍佔 SKU 組合的很大比例，其餘部分是自動注射器和貼身注射器。但身體上的成長主要集中在臨床領域。我們預計這種情況將持續全年。

Thank you for your question.

謝謝你的問題。

Got it. That's super helpful --

知道了。這非常有幫助--

[Kribas Dbarkanda] Truist Securities.

[Kribas Dbarkanda] Truist 證券。

Hey guys, thank you so much for taking my question. For LOQTORZI, you mentioned that the launch is going well. Can you maybe provide some color on whether the drug has been used more in frontline or second line setting? And also, I think it's a new launch and its relatively rare disease. So we mentioned it can take time to get on the formularies. You talked about 55% -- being on 55% of the 33 NCCN hospitals. Is this in line with your expectations? Thank you.

嘿夥計們，非常感謝你們回答我的問題。對於 LOQTORZI，您提到發布進展順利。您能否提供一些關於該藥物是否更多地用於一線或二線設定的資訊？而且，我認為這是一個新推出的產品，其疾病相對罕見。所以我們提到，進入處方集可能需要時間。你談到了 55%——在 33 家 NCCN 醫院的 55%。這符合您的預期嗎？謝謝。

Kribas, thank you for your question. Paul would be happy to cover a little about frontline versus second line utilization and the 55% NCCN conversion. Paul?

克里巴斯，謝謝你的提問。Paul 很樂意介紹一些有關前線與二線利用率以及 55% NCCN 轉換率的內容。保羅？

Yeah, thanks for your question. So going back to the labeled indication for LOQTORZI, it's indicated in the earlier stage of the recurrent locally advanced patients. And if we are seeing LOQTORZI used in those in those patients, it's typically in that case and combined with chemotherapy. What we also saw, as expected, was contribution of LOQTORZI in both the metastatic setting in both the front-line and second line plus.

是的，謝謝你的提問。回到 LOQTORZI 的標籤適應症，它適用於復發性局部晚期患者的早期階段。如果我們看到 LOQTORZI 用於這些患者，通常是在這種情況下與化療結合。正如預期的那樣，我們也看到了 LOQTORZI 在一線和二線+轉移環境中的貢獻。

And in those cases, if it's frontline, it was being combined with chemotherapy consistent with the JUPITER-02 trial and our labeled indication and more as monotherapy when it's second line plus. So as expected, it's being positioned all throughout the indicated uses. The only thing, and I think you mentioned this was like when in the second line and later lines of therapy, these patients' duration is likely going to be less.

在這些情況下，如果是一線治療，則與 JUPITER-02 試驗和我們標記的適應症一致的化療相結合，而當是二線治療時，則更多地作為單一療法。因此，正如預期的那樣，它被放置在所有指定的用途中。唯一的事情是，我想你提到過，在二線和以後的治療中，這些患者的持續時間可能會更短。

And if when we have eligible patients, those that are already on and off label PD-1, those will be difficult for LOQTORZI to capture. So value of the franchise will occur over the next three years as we build up the large majority of the new standard of care in the frontline setting.

如果我們有符合條件的患者，即那些已經在標籤上和標籤外的 PD-1 患者，那麼 LOQTORZI 將很難捕獲這些患者。因此，隨著我們在前線環境中建立大部分新護理標準，特許經營權的價值將在未來三年內顯現。

As for the formularies, yeah, that's very much in line with our expectations. Academic medical centers have processes. It takes time to go through those formularies. And as I mentioned, we would expect all the remaining NCCN institutions to be completed by the end of the year.

至於處方集，是的，這非常符合我們的預期。學術醫療中心有流程。瀏覽這些處方集需要時間。正如我所提到的，我們預計所有剩餘的 NCCN 機構將在今年年底前完成。

Mike Nedelcovych, TD Cowen.

麥克·內德爾科維奇，TD·考恩。

Thank you for the questions. I have two. The first is also on LOQTORZI. Your progress in gaining formulary access is impressive. Is that basically the lever that's needed to be pulled in order to displace any residual off-label prescription of other checkpoint inhibitors? Or is there additional work that needs to be done from a marketing or physician education perspective? So that's one question.

謝謝你的提問。我有兩個。第一個也在 LOQTORZI 上。您在取得處方藥方面取得的進展令人印象深刻。這基本上是為了取代其他檢查點抑制劑的任何殘留的標籤外處方而需要拉動的槓桿嗎？或者從行銷或醫生教育的角度來看是否還需要做額外的工作？這是一個問題。

And then my second question is on YUSIMRY. I think in the past, you've suggested that 2025 could be an inflection year for a biosimilar like YUSIMRY based on some of the IRA provisions. Are you still thinking about it that way? Does YUSIMRY have a bright future ahead or what is your latest thinking on YUSIMRY outlook? Thanks.

我的第二個問題是關於 YUSIMRY 的。我認為過去，您曾根據 IRA 的一些規定建議 2025 年可能是 YUSIMRY 等生物相似藥的轉折點年。現在還在這樣想嗎？YUSIMRY 有光明的未來嗎？謝謝。

Great. Thank you for the question. I'll let Dr. Rosh Dias firstly address the issue of the therapy selection decision that physicians now have with the launch of LOQTORZI and then Paul can secondarily talk about YUSIMRY. Rosh?

偉大的。感謝你的提問。我將首先讓 Rosh Dias 博士解決醫生現在隨著 LOQTORZI 的推出而做出的治療選擇決定的問題，然後 Paul 可以其次談談 YUSIMRY。羅什？

Yeah, thanks very much for the questions. I would say, doctors tend to be pretty evidence driven and we have three things that no other PD-1 has. First of all, we have an indication. Secondly, we have a profound survival advantage in the first-line setting, 37% risk reduction of death. And again, that's in the context of negative trials with other PD-1s in nasopharyngeal carcinoma.

是的，非常感謝您的提問。我想說，醫生往往非常注重證據驅動，我們擁有其他 PD-1 所沒有的三件事。首先，我們有一個跡象。其次，我們在一線治療中擁有顯著的生存優勢，死亡風險降低了 37%。再說一次，這是在其他 PD-1 治療鼻咽癌的陰性試驗的背景下進行的。

And then the third thing we have is also a pre-eminent positioning on the NCCN. So first line, we are the only Category 1 designated I-O therapy. And in second line and beyond, we have the -- we are the only preferred regimen actually. But I think as we start seeing patients, I think these three things are key and both team is continuing to message on those three things.

我們擁有的第三件事也是在 NCCN 上的卓越定位。因此，我們是第一線唯一指定的 1 類 I-O 療法。在第二線及以後，我們實際上是唯一首選的治療方案。但我認為，當我們開始接診患者時，我認為這三件事是關鍵，兩個團隊都在繼續就這三件事傳達訊息。

Thank you. Paul, do you want to comment a little about our expectations for YUSIMRY going into 2025 with IRA?

謝謝。Paul，您想談談我們對 YUSIMRY 與 IRA 一起進入 2025 年的期望嗎？

Sure, Denny. Thanks for your question, Mike. Yeah, the 2025 formulary negotiations are ongoing. And YUSIMRY and Coherus are actively engaged in that process. So we continue to believe that that will be the I think, the point where you see even greater inflection of biosimilars in the adalimumab space. So I think we're well positioned there based on our price point and the value that this product brings to the health care systems in patients.

當然，丹尼。謝謝你的提問，麥克。是的，2025 年處方談判正在進行中。YUSIMRY 和 Coherus 正在積極參與這一過程。因此，我們仍然相信，我認為這將是阿達木單抗領域生物相似藥發生更大變化的時刻。因此，我認為根據我們的價格點以及該產品為患者的醫療保健系統帶來的價值，我們在這方面處於有利地位。

Thank you.

謝謝。

Thank you for your question.

謝謝你的問題。

(Operator Instructions)

（操作員說明）

Balaji Prasad, Barclays.

巴拉吉·普拉薩德，巴克萊銀行。

Good afternoon. This is [Shao] on for Balaji. Thanks for taking our question. Just a quick follow-up question on the UDENYCA franchise. You recently announced that the license needs pegfilgrastim on-body injector and prefilled auto-injector, and they expect to submit the BLA in first quarter of 2025. And there are a few other players that trying to get into this landscape. So what is your expectation for the pegfilgrastim on-body injector landscape and the entire markets for the next two to three years? And do you have any plans or mechanism to build and defend your market shares against those potential new entrants. Thank you.

午安.這是巴拉吉的[Shao]。感謝您提出我們的問題。只是一個關於 UDENYCA 特許經營權的快速後續問題。你們最近宣布該許可證需要聚乙二醇非格司亭體內注射器和預充式自動注射器，他們預計在 2025 年第一季提交 BLA。還有一些其他參與者試圖進入這個領域。那麼您對聚乙二醇非格司亭體內注射器的前景以及未來兩到三年的整個市場有何期望？您是否有任何計劃或機制來建立和捍衛您的市場份額以對抗那些潛在的新進入者？謝謝。

I'm sorry, I don't understand. We're having a difficult time hearing you. We're not understanding your question. Is your question with respect to future entrants in the on-body space with the pegfilgrastim market or with auto-injectors?

對不起，我不明白。我們很難聽到你的聲音。我們不明白你的問題。您的問題是關於未來進入體內領域的聚乙二醇非格司亭市場或自動注射器嗎？

Pegfilgrastim market, like especially the on-body injector and the pre-filled auto-injector, as Amneal recently announced that they have something in plan and the plan to sell a BLA first quarter of 2025.

Pegfilgrastim 市場，尤其是體用注射器和預填充自動注射器，Amneal 最近宣布他們有一些計劃，併計劃在 2025 年第一季銷售 BLA。

Paul, would you like to address how we view the competition in the pegfilgrastim market for future auto-injectors?

Paul，您想談談我們如何看待未來自動注射器聚乙二醇非格司亭市場的競爭嗎？

Yeah. Well, you know, first of all, we've been operating in this pegfilgrastim market now. We're in our sixth year and maintain one of the leadership positions here. What we're going to continue to do is focus on our business and the positioning of UDENYCA, which is to be the total solution for providers and patients. And we're doing this, as I mentioned, because to date, we've got all three presentations. It's tried and true and well established in the market.

是的。嗯，你知道，首先，我們現在一直在這個聚乙二醇化非格司亭市場上運作。我們已經進入第六個年頭，並保持著領導地位之一。我們將繼續專注於我們的業務和 UDENYCA 的定位，即為提供者和患者提供整體解決方案。正如我所提到的，我們正在這樣做，因為到目前為止，我們已經完成了所有三個演示。它經過考驗，是真實的，並且在市場上已經確立了良好的地位。

Secondly, we've got strong payer coverage. And so that's being recognized by payers that UDENYCA brand is a go-to brand because of all of these benefits that we bring to not only the consistency in the marketplace, the predictability, but also the high quality and reliability of this brand. So we'll be prepared for any competition if anybody else comes. But we believe we will continue to be well positioned to compete and win whatever that landscape unfolds.

其次，我們擁有強大的付款人保障。因此，付款人認識到 UDENYCA 品牌是首選品牌，因為我們不僅帶來了市場的一致性、可預測性，而且還帶來了該品牌的高品質和可靠性。因此，如果其他人來的話，我們將為任何比賽做好準備。但我們相信，無論情況如何發展，我們都將繼續處於有利的競爭地位並贏得勝利。

Thank you, Paul. The other point that I would make is consistent with Paul's remarks. Our on-body injector represents an innovative de novo highly sophisticated device for the five-minute injection time. And the enthusiasm with which it has been received by the market, the physicians and the patients is due to that. We believe there are significant technical hurdles to such an approach, and we investigated a number of approaches before settling on this one.

謝謝你，保羅。我要說的另一點與保羅的言論是一致的。我們的身體注射器代表了一種創新的從頭高度複雜的設備，注射時間為五分鐘。也正因如此，它才受到市場、醫生和患者的熱烈歡迎。我們認為這種方法存在重大的技術障礙，在決定採用此方法之前，我們研究了多種方法。

So we think this is very important. We think we got it right. But lastly, as Paul said, we are first competitors in the pegfilgrastim market and our track record over the last six years demonstrates that we are the only team with all three presentations each filling a particular need in the market. So I believe that we are confident in our ability to compete and remain successful and grow share in this market.

所以我們認為這是非常重要的。我們認為我們做對了。但最後，正如保羅所說，我們是聚乙二醇非格司亭市場的第一批競爭對手，我們過去六年的業績記錄表明，我們是唯一一個擁有所有三個演示文稿的團隊，每個簡報都滿足了市場的特定需求。因此，我相信我們對自己在這個市場的競爭能力、維持成功和增加份額的能力充滿信心。

Thank you.

謝謝。

Douglas Tsao, HC Wainwright.

道格拉斯‧曹 (Douglas Tsao)，HC 溫賴特 (HC Wainwright)。

Hi. Good afternoon and thanks for taking the questions and congrats on the progress. Obviously, there are a number of sort of gates that you need to clear in terms of the ramp up for LOQTORZI, in particular getting on to formulary. How quickly do you think you can get through those and sort of have access at sort of the most or the majority of the market? And what other steps do you think we might need to -- you might need to clear before we really start to see an acceleration in the revenue trajectories?

你好。下午好，感謝您提出問題並祝賀取得的進展。顯然，在 LOQTORZI 的升級方面，您需要清除許多類型的關卡，特別是進入處方集。您認為您能多快完成這些任務並進入大部分市場？在我們真正開始看到收入軌跡加速之前，您認為我們可能需要採取哪些其他步驟？

Thanks for your question, Doug. Paul, would you like to comment a little bit on the aiding of the adoption of LOQTORZI and how we do that?

謝謝你的提問，道格。Paul，您想對 LOQTORZI 的採用的幫助以及我們如何做到這一點發表一些評論嗎？

Yeah. Thanks for your question, Doug. So obviously, the payer coverage is the first one and then and that's well established. And I don't really foresee any further hurdles on the payer side. The second gate is now that we've got the NCCN guidelines, what we have to ensure now is in each of the accounts that the guidelines that are translated into the order sets. So again, this enables the doctor at the time of prescribing that when they click through the order set that LOQTORZI chemo combination is there. That's ongoing, but that will typically settle in here over this next quarter.

是的。謝謝你的提問，道格。顯然，付款人保險是第一個，然後是已經確立的。我確實預計付款人方面不會遇到任何進一步的障礙。第二道門是現在我們已經有了 NCCN 指南，我們現在必須確保每個帳戶中的指南都被翻譯成訂單集。同樣，這使得醫生在開處方時，當他們點擊訂單集時，LOQTORZI 化療組合就在那裡。這種情況正在進行中，但通常會在下個季度解決。

Then, Doug, I really think the next gate is just sort of washing out all of the current patients that are on current off-label PD-1s. And in establishing the new patients with LOQTORZI as the new start and getting anybody that's on chemo today, not on a PD-1, treated with LOQTORZI. And that's just going to take a continued effort in terms of promotion, both through our sales team, from the KOLs, from the podium and through the referral networks, but also through our digital efforts.

然後，Doug，我真的認為下一個關卡就是淘汰所有目前使用標籤外 PD-1 的患者。並以 LOQTORZI 建立新患者作為新的開始，並讓今天接受化療而不是 PD-1 的任何人接受 LOQTORZI 治療。這需要在促銷方面持續努力，無論是透過我們的銷售團隊、KOL、講台和推薦網絡，還是透過我們的數位化努力。

And we're going to continue to invest and deploy those, so that at the time of decision, the oncology, the oncologist knows that LOQTORZI, and chemo is the regimen of choice for those patients. But again, it's a rare disease. It's going to ramp up, which is why we think peak is going to occur around year three of this. But we feel very confident we're going to achieve that.

我們將繼續投資和部署這些藥物，以便在做出決定時，腫瘤科、腫瘤科醫生知道 LOQTORZI 和化療是這些患者的首選治療方案。但話又說回來，這是一種罕見的疾病。它將加速，這就是為什麼我們認為高峰將在第三年左右出現。但我們非常有信心能夠實現這一目標。

So for all the reasons that Paul just elucidated, we see the growth of this market as a steady ramp up to peak market share and penetration probably out around year three. So this isn't a market and such as replacement enzyme market or something where you can get out to these patients and just find them and immediately convert them. These patients are in various stages of therapy. They may have been exposed to another PD-1.

因此，出於保羅剛剛闡明的所有原因，我們認為該市場的成長將穩步上升，市場份額和滲透率可能會在第三年左右達到高峰。因此，這不是一個市場，例如替代酶市場或您可以接觸這些患者並找到他們並立即轉變他們的市場。這些患者處於不同的治療階段。他們可能接觸過另一種 PD-1。

We're going to catch the patients that are on chemotherapy. Those are all eligible. They will all benefit. Some patients we will have to wait for them to progress to second line. But the key issue is, as Rosh Dias pointed out, we are the only first-line therapy from the FDA. We've gotten position on all the formularies. We're doing very, very well with the NCCN. But I would say, with the building blocks are in place for the market, we see a steady ramp forward over the future.

我們要去抓那些正在接受化療的病人。這些都是有資格的。他們都會受益。有些患者我們將不得不等待他們進展到二線。但關鍵問題是，正如 Rosh Dias 指出的那樣，我們是 FDA 唯一批准的一線療法。我們已經掌握了所有處方集的立場。我們與 NCCN 合作得非常非常好。但我想說，隨著市場的建構已經到位，我們看到未來將穩步向前發展。

Okay, great. And maybe a follow-up question on the UDENYCA franchise. I'm just curious, we're starting to see uptake of both your on-boxes device as well as the auto-injector. I'm just curious if you have any insight in terms of how physicians are using those two dosage forms or product types. Are there sort of themes in terms of the types of patients that are getting the on-body versus the auto-injector and vice versa? Thank you.

好的，太好了。也許還有一個關於 UDENYCA 特許經營權的後續問題。我只是很好奇，我們開始看到您的盒裝設備和自動注射器都被採用。我只是好奇您是否對醫生如何使用這兩種劑型或產品類型有任何見解。接受體內注射器與自動注射器的病患類型是否有某種主題，反之亦然？謝謝。

Paul, I guess the question is, what sort of patient settings would they go for the auto-injector with patient settings for the on-body and so on?

保羅，我想問題是，他們會為自動注射器選擇什麼樣的患者設置，為體內患者設置等等？

Yeah, Doug. So let me let me frame this in a couple of different ways. First, let's take the clinics. So the clinic segments are going to gear more towards all three of the presentations because they have patients that like to come back to the office the next day, they like the high-touch connectivity with their nurse and with their doctor. And so therefore, the prefilled syringe and the auto-injector are position for those patients. But some patients in the clinic, they want their injection experience at home. Therefore, we give them the option of the on-body device with a well-designed 5-minute injection.

是的，道格。因此，讓我用幾種不同的方式來闡述這一點。首先，我們來看看診所。因此，診所部分將更多地面向所有三個演示，因為他們的患者喜歡第二天回到辦公室，他們喜歡與護士和醫生的高接觸聯繫。因此，預充式註射器和自動注射器就適合這些患者。但有些診所的患者希望在家中獲得注射體驗。因此，我們為他們提供了精心設計的 5 分鐘注射的貼身設備的選擇。

But if the patient wants to self-inject and not wear the device, they can choose the auto-injector. And under 10 seconds inject themselves at the time and place that they like. So that's really how we're positioning by the patients and by the provider. The hospitals, they tend to go a little bit more with the on-body device or the prefilled syringe. So we've had some good uptake with auto-injector, in the hospital not nearly as much in the clinic because they prefer either the prefilled syringe or the on-body is the at-home preference. So that's kind of how we're seeing it. Again, being the only franchise with all three options really sets us apart from a competitive differentiation. And I think you see that in our market share growth.

但如果患者想自行注射而不配戴設備，則可以選擇自動注射器。在 10 秒內，他們可以在自己喜歡的時間和地點進行注射。這就是我們對病患和醫療服務提供者的定位。醫院傾向於更多地使用體內設備或預充式註射器。因此，我們在醫院中對自動注射器的使用率沒有在診所中那麼高，因為他們更喜歡預裝注射器，或者在家中更喜歡使用體內注射器。這就是我們的看法。同樣，作為唯一一家擁有所有三種選擇的特許經營權，確實使我們在競爭中脫穎而出。我認為您可以從我們的市場份額成長中看到這一點。

Okay, great.

好的，太好了。

Colleen Kusy, Baird.

科琳·庫西，貝爾德。

Thanks. Good afternoon and thanks for taking your questions. So for -- realizing you're not providing guidance at this point but just how do you think about what the growth drivers for UDENYCA will be in 2024? Is it growing the on-body? Is it just focusing on the prefilled syringe and the auto-injector? Just kind of thoughts around growth for UDENYCA this year. And then sorry if I missed this in the prepared remarks, but if you could just speak towards the potential reaching cash flow positivity and if that goal is still set for 2024? Thank you.

謝謝。下午好，感謝您提出問題。那麼，意識到您目前並未提供指導，但您如何看待 2024 年 UDENYCA 的成長動力是什麼？它在身體上生長嗎？僅僅關注預灌封注射器和自動注射器嗎？只是關於今年 UDENYCA 成長的一些想法。如果我在準備好的發言中錯過了這一點，我很抱歉，但您能否談談實現現金流量正值的潛力以及該目標是否仍設定在 2024 年？謝謝。

Thank you, Colleen. I'll let Paul handle the growth drivers for your UDENYCA first, and then I'll handle your secondary question with respect to 2024. Paul?

謝謝你，科琳。我將讓 Paul 首先處理您的 UDENYCA 的成長動力，然後我將處理您關於 2024 年的第二個問題。保羅？

Yeah. Thanks for your question. Yeah, I think we fully expect the on-body to be the predominant driver of our growth in 2024. As Denny mentioned that the approval of that product now opens up segments of the market that has been difficult to penetrate with our prefilled syringe and auto-injector. So we're really looking for that SKU, that presentation to drive market share growth for the remainder of the year.

是的。謝謝你的提問。是的，我認為我們完全期望 2024 年體感產品將成為我們成長的主要驅動力。正如丹尼所提到的，該產品的批准現在打開了我們的預充式註射器和自動注射器難以滲透的市場領域。因此，我們確實在尋找該 SKU、該簡報以推動今年剩餘時間的市場份額成長。

It will be buoyed and facilitated by our payer coverage, which I mentioned was doubled this year versus last year. And that payer coverage extends to all three product presentations. So really, not inhibited by payer coverage by each of those presentations. So where we've got it, we've got all three and we will leverage that as we continue to execute.

我們的付款人覆蓋範圍將推動和促進這一趨勢，我提到今年的支付覆蓋範圍是去年的兩倍。付款人的覆蓋範圍擴展到所有三個產品演示。所以實際上，這些簡報中的每一個都不會受到付款人覆蓋範圍的限制。因此，我們已經掌握了這三個方面，並且我們將在繼續執行時充分利用這一點。

Thanks, Paul. With respect to your secondary question, I would first say, 2024 is shaping up to be a more predictable year than 2023. And so far as of 2023, we had to focus a lot on getting approvals. We focused on getting the on-body approval. We did that successfully. We went and got LOQTORZI approved from the FDA. That was that took a little time. We got that done. And then we rolled into the launches, particularly the launch of the on-body, the launch of the auto-injector, now launch of LOQTORZI. So the trajectory over 2024 is continued revenue growth.

謝謝，保羅。關於你的第二個問題，我首先要說的是，2024 年將是比 2023 年更可預測的一年。截至 2023 年，我們必須專注於獲得批准。我們專注於獲得身體認可。我們成功地做到了這一點。我們獲得了 FDA 的 LOQTORZI 批准。那是花了一點時間。我們做到了。然後我們開始發布產品，特別是貼身注射器的發布、自動注射器的發布，以及現在 LOQTORZI 的發布。因此，2024 年的軌跡是營收持續成長。

We will see more LOQTORZI as we go on the year -- quarter. And we believe that we will also see continued growth with respect to UDENYCA for the reasons that Paul just laid out. The issues, like how steep will that growth curve be? How much growth? And what we are constrained by is the real-world looking experience, looking backward.

隨著本季度的進展，我們將看到更多的 LOQTORZI。我們相信，由於保羅剛剛闡述的原因，我們也將看到 UDENYCA 的持續成長。問題是，成長曲線有多陡？增長多少？我們受到的限制是現實世界的觀看體驗，向後看。

We are very early in these launches. We have just gotten out there. With respect to LOQTORZI, we're making very good progress on the formularies, but it's a rare disease. Now we have to acquire the patients and so on. But I think we're off to a very good start. So we don't want forecast with respect to our forward-looking, although clearly, as I indicated, growth will continue. So it's a question of when and how that will go up, that remains very clearly in our sights is to move forward in that direction. But the growth is something that we're happy with.

我們處於這些發布的早期階段。我們剛剛出去。關於 LOQTORZI，我們在處方集方面取得了非常好的進展，但這是一種罕見的疾病。現在我們必須獲得患者等等。但我認為我們已經有了一個很好的開始。因此，我們不希望對我們的前瞻性進行預測，儘管正如我所指出的，成長將繼續下去。因此，問題是何時以及如何上升，我們的目標仍然非常明確，那就是朝著這個方向前進。但我們對這種成長感到高興。

Great. Thanks for taking our questions.

偉大的。感謝您回答我們的問題。

Thank you, Colleen.

謝謝你，科琳。

There are no further questions at this time. Mr. Denny Lanfear, I turn the call back over to you.

目前沒有其他問題。丹尼·蘭菲爾先生，我將電話轉回給您。

Thank you, operator. Thank you all for joining us on our call today and thank you for the opportunity to enumerate for you the progress we've made across all of our key overtures, particularly with respect to driving our sales and advancing our tumor microenvironment focused pipeline, and we look forward to appraising you of our progress at our next call. Thank you.

謝謝你，接線生。感謝大家今天參加我們的電話會議，並感謝你們有機會為大家列舉我們在所有關鍵舉措方面取得的進展，特別是在推動我們的銷售和推進我們以腫瘤微環境為重點的管道方面，我們期待您在下次電話會議上評價我們的進展。謝謝。

Today's conference call. You may now disconnect.

今天的電話會議。您現在可以斷開連線。