Coherus Oncology Inc (CHRS) 2023 Q1 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Coherus BioSciences Q1 2023 Earnings Call. (Operator Instructions) Please be advised that today's conference is being recorded.

美好的一天，謝謝你的支持。歡迎來到 Coherus BioSciences 2023 年第一季度收益電話會議。 （操作員說明）請注意，今天的會議正在錄製中。

I would now like to hand the conference over to your first speaker, Marek Ciszewski of Investor Relations for Coherus BioSciences. Please go ahead.

我現在想把會議交給您的第一位發言人，Coherus BioSciences 投資者關係部的 Marek Ciszewski。請繼續。

Thank you, Crystal, and good afternoon, everyone. And thank you for joining us. We issued a press release earlier today announcing our financial results for the first quarter of 2023. This release can be found on the Coherus BioSciences website and is also attached to our Form 8-K. .

謝謝 Crystal，大家下午好。感謝您加入我們。我們今天早些時候發布了一份新聞稿，宣布了我們 2023 年第一季度的財務業績。該新聞稿可以在 Coherus BioSciences 網站上找到，也附在我們的 8-K 表格中。 .

Today's call includes forward-looking statements regarding Coherus' current expectations about future events. These statements include, but are not limited to, our ability to gain approval for multiple new products and launch them, the ability of the FDA to complete all required inspections in China or our BLA for toripalimab necessary for approval, expectations about demand, timing of our ability to gain market share for any of our approved products, expectations about future revenues and expenses and the timing of any return to profitability. All 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 forward-looking statements.

今天的電話會議包括有關 Coherus 當前對未來事件的預期的前瞻性陳述。這些聲明包括但不限於我們獲得多個新產品批准並推出它們的能力、FDA 在中國完成所有必要檢查的能力或我們批准所需的 toripalimab 的 BLA、對需求的預期、時間安排我們獲得任何批准產品的市場份額的能力、對未來收入和支出的預期以及任何恢復盈利的時間。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、業績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 that are discussed in our press release that we issued today as well as 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 statements. First quarter 2023 results are not necessarily indicative of results for future periods.

這些聲明不是未來業績的保證，並受我們今天發布的新聞稿以及我們向美國證券交易委員會提交的文件中討論的重大風險和不確定性的影響。今天電話會議上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。 2023 年第一季度的結果不一定代表未來期間的結果。

With me on today's call are Denny Lanfear, our CEO; Dr. Theresa Lavallee, Chief Development Officer; Dr. Rosh Dias, Chief Medical Officer; Paul Reider, Chief Commercial Officer; and McDavid Stilwell, Chief Financial Officer. And I will now turn the call over to Denny.

和我一起參加今天電話會議的有我們的首席執行官 Denny Lanfear；首席開發官 Theresa Lavallee 博士； Rosh Dias 博士，首席醫療官；首席商務官 Paul Reider；和首席財務官 McDavid Stilwell。我現在將把電話轉給丹尼。

Thank you, Marek, and thank you all for joining us on our Q1 2023 call. In Q1, we set the stage for revenue growth over the rest of the year as we plan for and execute multiple product launches across our diversified pipeline throughout 2023, transitioning from a single product company, one with 6 products or presentations, including our first immuno-oncology agent, toripalimab. This quarter, we executed strongly on the launches and growth catalysts in support of emerging pipeline.

謝謝 Marek，也感謝大家加入我們的 2023 年第一季度電話會議。在第一季度，我們為今年餘下時間的收入增長奠定了基礎，因為我們計劃在整個 2023 年在我們的多元化產品線中推出多項產品，從一家擁有 6 種產品或演示文稿的單一產品公司轉型，包括我們的第一個免疫-腫瘤藥物，特瑞普利單抗。本季度，我們在支持新興管道的啟動和增長催化劑方面表現強勁。

The progress includes, first, the Q-code for CIMERLI, which was implemented at the beginning of April. Demand is now increasing as expected. UDENYCA autoinjector is now ready for launch later this month, a key driver for market share increase this year. We are ready to launch YUSIMRY, our Humira biosimilar, in July, having gained all the requisite approvals and built inventory. Manufacturing facility inspection to support toripalimab approval is now scheduled for later this month, May. We expect the approval and launch of UDENYCA on-body injector later in 2023, strengthening the franchise positioning and driving additional share gains.

進展包括，首先是 CIMERLI 的 Q 碼，該代碼已於 4 月初實施。正如預期的那樣，需求現在正在增加。 UDENYCA 自動注射器現已準備好在本月晚些時候推出，這是今年市場份額增長的主要推動力。我們已準備好在 7 月推出我們的 Humira 生物仿製藥 YUSIMRY，已獲得所有必要的批准並建立庫存。支持 toripalimab 批准的製造設施檢查現在定於本月晚些時候，即 5 月進行。我們預計 UDENYCA 全身注射器將於 2023 年晚些時候獲得批准並推出，從而加強特許經營定位並推動額外的份額收益。

Following my opening remarks, Paul Reider, our Chief Commercial Officer, will update you on the impact of the CMS signed Q-code on CIMERLI sale starting the second quarter, which we expect to drive sales starting in Q2 and accelerate revenue growth throughout 2023. I will then further update you on the Q1 2023 UDENYCA sales and our launch plans for our newly approved UDENYCA autoinjector.

在我的開場白之後，我們的首席商務官 Paul Reider 將向您介紹 CMS 簽名的 Q 碼對第二季度開始的 CIMERLI 銷售的影響，我們預計這將從第二季度開始推動銷售並在整個 2023 年加速收入增長。然後，我將進一步向您介紹 2023 年第一季度 UDENYCA 的銷售情況以及我們新批准的 UDENYCA 自動注射器的發布計劃。

Dr. Theresa Lavallee, our Chief Development Officer, will update you on the status of the toripalimab inspections, the BLA review and our progress on bringing tori manufacturing to the U.S. along with other pipeline development. Chief Medical Officer, Dr. Rosh Dias, will then update on the new toripalimab clinical data being presented at ASCO as well as progress on our TIGIT-toripalimab combination studies and our ILT4 program.

我們的首席開發官 Theresa Lavallee 博士將向您介紹 toripalimab 檢查的最新狀態、BLA 審查以及我們將 tori 製造引入美國以及其他管道開發的進展。首席醫療官 Rosh Dias 博士隨後將更新在 ASCO 上展示的新特瑞普利單抗臨床數據以及我們的 TIGIT-特瑞普利單抗聯合研究和我們的 ILT4 計劃的進展。

As you know, we've been very tightly focused on actively managing expenses without jeopardizing our product sales potential. And McDavid Stilwell, our Chief Financial Officer, will provide you some additional detail on measures taken during Q1 to reduce operating expenses, sharpen our focus on ensuring the success of our product launches, key revenue drivers that we anticipate will return the company to profitability in 2024.

如您所知，我們一直非常專注於在不損害我們產品銷售潛力的情況下積極管理費用。我們的首席財務官麥克大衛·史迪威 (McDavid Stilwell) 將向您提供有關第一季度為減少運營費用而採取的措施的更多詳細信息，加強我們對確保產品發布成功的關注，我們預計主要收入驅動因素將使公司在2024.

And with that, I'll turn the call over to Paul Reider, our Chief Commercial Officer. Paul?

有了這個，我會把電話轉給我們的首席商務官 Paul Reider。保羅？

Thank you, Denny, and good afternoon. I'll provide you with an update this afternoon on the expansion of our commercial product portfolio, the potential launches of 4 products in 2023 we expect to drive top line revenue growth this year going forward. .

謝謝你，丹尼，下午好。今天下午，我將向您提供有關我們商業產品組合擴展的最新信息，我們預計將在 2023 年推出 4 種產品，以推動今年的收入增長。 .

I'll start with CIMERLI, our fully interchangeable Lucentis biosimilar launched in the fourth quarter last year. Our strategic approach to the market is to, first, maximize the conversion existing Lucentis business, which currently represents 1 million units annually; and second, grow share through new patient starts or conversion from other anti-VEGF products.

我將從 CIMERLI 開始，這是我們去年第四季度推出的完全可互換的 Lucentis 生物仿製藥。我們對市場的戰略方針是，首先，最大限度地轉換現有的 Lucentis 業務，該業務目前每年有 100 萬台；其次，通過新患者開始或從其他抗 VEGF 產品轉化來增加份額。

While the complete label with interchangeability has been well received by retinal specialists, giving them the confidence that they can safely transition currently treated Lucentis patients to CIMERLI expect the same clinical outcomes. Use of the miscellaneous J-code has hindered adoption and conversion. Billing under a miscellaneous code is prone to errors, interrupting payment flows, and even if executed correctly, could result in payment delays of 2 months or more, which disrupts practice cash flows. We expected a slower start CIMERLI sales until the activation by CMS of our permanent product-specific Q-code, which enables electronic automated billing, thus providing faster payments with much higher certainty.

雖然具有可互換性的完整標籤受到了視網膜專家的好評，使他們相信他們可以安全地將目前接受治療的 Lucentis 患者轉移到 CIMERLI，並期望獲得相同的臨床結果。雜項 J 代碼的使用阻礙了採用和轉換。雜項代碼下的計費容易出錯，中斷付款流程，即使正確執行，也可能導致 2 個月或更長時間的付款延遲，從而擾亂實踐現金流。我們預計 CIMERLI 銷售的啟動速度會較慢，直到 CMS 激活我們的永久產品特定 Q 碼，該 Q 碼可以實現電子自動計費，從而提供更快的付款和更高的確定性。

Accordingly, we focused our efforts in Q1 when obtaining the permanent Q-code from CMS and getting it deployed across ophthalmology practices and payers. Those efforts are bearing fruit. The payer front, as of April 30, over 90% of target payers have confirmed loading the Q-code. With respect to billing and reimbursement using the Q-code, numerous providers have reported receiving full reimbursement within 14 days of electronic billing.

因此，我們在第一季度集中精力從 CMS 獲取永久 Q 碼並將其部署到眼科診所和付款人中。這些努力正在取得成果。支付方方面，截至4月30日，90%以上目標支付方已確認加載二維碼。關於使用 Q 碼的計費和報銷，許多供應商報告說在電子開票後的 14 天內收到了全額報銷。

We are now seeing the expected increase in demand. Through the month of April, we've shipped over 7,200 demand units, which represents about 72% of the entire Q1 2023 unit sales.

我們現在看到預期的需求增長。整個 4 月份，我們已經發貨了 7,200 多個需求單位，約佔 2023 年第一季度全部單位銷售額的 72%。

Also during Q1, we doubled the number of accounts that have ordered CIMERLI to 185. And of those, 54% have reordered. Among these ordering accounts, CIMERLI market share was 20%, which reinforces the potential of CIMERLI once accounts begin adopting.

同樣在第一季度，我們將訂購 CIMERLI 的賬戶數量翻了一番，達到 185 個。其中，54% 已經重新訂購。在這些訂購賬戶中，CIMERLI 的市場份額為 20%，一旦賬戶開始採用，這將增強 CIMERLI 的潛力。

As momentum built in Q1 prior to deploying the Q-code, doctors are reporting that they are seeing the same clinical outcomes for CIMERLI that they would expect to see with Lucentis. So CIMERLI has successfully established an excellent safety and efficacy track record with retinal specialists. This helped fuel the doubling of demand in Q1, resulting in an average ranibizumab market share for the quarter of 4.1% compared to 2.4% in the prior quarter.

由於在部署 Q 代碼之前在第一季度建立了勢頭，醫生報告說他們看到 CIMERLI 的臨床結果與他們期望在 Lucentis 上看到的相同。因此，CIMERLI 已成功地與視網膜專家建立了良好的安全性和有效性跟踪記錄。這有助於推動第一季度需求翻番，導致本季度雷珠單抗的平均市場份額為 4.1%，而上一季度為 2.4%。

At the same time, inventory levels on hand were higher at year-end, given Q4 was the launch quarter and have begun to normalize. And for the first quarter, sales of CIMERLI was $6.2 million compared to $6.95 million for Q4. Reordering reflects new patient starts and conversion from other products. And with the chronic nature of the disease and frequency of injections, this results in a compounding growth trajectory. Therefore, we continue to expect that in 2023, CIMERLI revenues will exceed $100 million.

與此同時，鑑於第四季度是發布季度並且已開始正常化，年底手頭庫存水平較高。第一季度，CIMERLI 的銷售額為 620 萬美元，而第四季度為 695 萬美元。重新訂購反映了新患者開始和其他產品的轉換。由於疾病的慢性性質和注射頻率，這導致了複合增長軌跡。因此，我們繼續預計，到2023年，CIMERLI的收入將超過1億美元。

I'll now turn to our oncology franchise, starting with UDENYCA and the launch plans for the 2 new presentations this year. As you know, the pegfilgrastim prefilled syringe segment is increasingly competitive as reflected by continued price erosion. Accordingly, our strategy is not to compete solely on price but to launch additional presentations that provide a differentiated value proposition to patients and providers, filling the unmet needs in the market with the objective to regain share.

我現在將談談我們的腫瘤專營權，從 UDENYCA 和今年兩個新演示的啟動計劃開始。如您所知，pegfilgrastim 預填充注射器部分的競爭越來越激烈，這從持續的價格下跌中可以看出。因此，我們的戰略不是僅僅在價格上競爭，而是推出額外的展示，為患者和提供者提供差異化的價值主張，填補市場上未滿足的需求，以重新獲得市場份額。

The past year, we told you that we would sacrifice share to preserve pricing power for these future presentation launches as all product presentations are linked to the same average selling price, and we maintain a strong ASP on which to launch our 2 new innovative presentations this year. We plan to launch UDENYCA autoinjector later this month. This presentation represents the first innovation in the pegfilgrastim class 8 years, and customer receptivity has been overwhelmingly positive. This confirms that there is a large market segment unserved by Neulasta Onpro, the on-body device, which still retains 43% of the margin.

過去一年，我們告訴過您，我們將犧牲份額以保留這些未來演示發布的定價權，因為所有產品演示都與相同的平均銷售價格掛鉤，並且我們保持強勁的 ASP，在此基礎上推出我們的 2 個新的創新演示年。我們計劃在本月晚些時候推出 UDENYCA 自動注射器。本次展示代表了 pegfilgrastim 類 8 年來的首次創新，客戶的接受度非常積極。這證實了體上設備 Neulasta Onpro 未服務於很大的細分市場，它仍保留著 43% 的利潤率。

The UDENYCA autoinjector provides convenience, administration flexibility, independence and certain delivery in under 10 seconds. The autoinjector thus provides providers and patients a highly desired alternative to Onpro and has the potential to drive market share increase over the coming quarters.

UDENYCA 自動注射器提供方便、管理靈活性、獨立性和在 10 秒內的一定交付。因此，自動注射器為供應商和患者提供了一個非常理想的 Onpro 替代品，並有可能在未來幾個季度推動市場份額的增長。

Q1 2023 was our last quarter competing with 1 undifferentiated presentation. UDENYCA net sales were $26 million, declined from the prior quarter, resulting from 4 key factors: First, a market share decline of 1% from the prior quarter to 11.5%; a 9% decline in net selling price required to maintain a competitive position in prefilled syringe segment; higher wholesale inventory levels at the end of Q4, which have now normalized; and finally, a nonrecurring $1.7 million charge resulting from a contingent liability arising from a dispute.

2023 年第一季度是我們與 1 個無差別展示競爭的最後一個季度。 UDENYCA 淨銷售額為 2600 萬美元，環比下降，主要有 4 個因素：一是市場份額環比下降 1% 至 11.5%；保持在預充式註射器領域的競爭地位所需的淨售價下降 9%；第四季度末批發庫存水平較高，現已正常化；最後，因爭議產生的或有負債產生的 170 萬美元非經常性費用。

Going forward, we believe the UDENYCA franchise is well positioned to regain market share beginning the second half of 2023. UDENYCA is now the only pegfilgrastim brand in both prefilled syringe and autoinjector presentations. Later this year, if the on-body injector is approved, we will be the only pegfilgrastim brand with all 3 product presentation. This will provide a path for maximum market penetration and market share growth this year and beyond.

展望未來，我們相信 UDENYCA 特許經營權已做好準備，從 2023 年下半年開始重新獲得市場份額。 UDENYCA 現在是預充式註射器和自動注射器展示中唯一的 pegfilgrastim 品牌。今年晚些時候，如果身上註射器獲得批准，我們將成為唯一一個擁有所有 3 種產品展示的培非格司亭品牌。這將為今年及以後的最大市場滲透和市場份額增長提供途徑。

We expect our next oncology launch to be toripalimab, if approved, and we cover some of our launch plans next. Launching the company's first immuno-oncology product is a critical step forward in the advancement of our bio franchise. Our mission is to extend cancer patient survival and to offer new hope to patients, and nasopharyngeal carcinoma is an excellent example.

如果獲得批准，我們預計我們的下一個腫瘤藥物上市將是 toripalimab，接下來我們將介紹我們的一些上市計劃。推出公司的第一個免疫腫瘤學產品是我們生物特許經營權向前邁出的關鍵一步。我們的使命是延長癌症患者的生存期，為患者帶來新的希望，鼻咽癌就是一個很好的例子。

Today, NPC patients have no FDA-approved treatments, including IO therapies, and therefore, constitutes a high unmet need. Toripalimab is a next-generation PD-1 inhibitor and if approved, will be the first and only PD-1 inhibitor in the U.S. indicated for relapsed metastatic nasopharyngeal carcinoma, establishing a new standard of care in all lines of therapy, including first line.

如今，NPC 患者沒有獲得 FDA 批准的治療方法，包括 IO 療法，因此構成了高度未滿足的需求。 Toripalimab 是下一代 PD-1 抑製劑，如果獲得批准，將成為美國第一個也是唯一一個適用於復發轉移性鼻咽癌的 PD-1 抑製劑，為包括一線在內的所有治療線建立新的護理標準。

As such, we feel confident that toripalimab plus chemo will gain a dominant market share and estimate the NPC market opportunity could reach $200 million at peak. Preparation for toripalimab's commercial launch, we are executing on a number of prelaunch activities. We created and launched npcfacts.com, which is designed to be a primary source of disease state information for patients and their caregivers to learn about NPC. The sister site for health care professionals was also launched. Npcfacts.com allows patients and their caregivers to join our community, enabling us to share disease state education that is tailored to each patient at each stage of NPC disease progression.

因此，我們有信心特瑞普利單抗加化療將獲得主導市場份額，並估計 NPC 市場機會在高峰期可能達到 2 億美元。為 toripalimab 的商業發布做準備，我們正在執行一些預發布活動。我們創建並推出了 npcfacts.com，旨在成為患者及其護理人員了解 NPC 的疾病狀態信息的主要來源。還推出了面向醫療保健專業人員的姊妹網站。 Npcfacts.com 允許患者及其護理人員加入我們的社區，使我們能夠分享針對每個患者在 NPC 疾病進展的每個階段量身定制的疾病狀態教育。

Our aspiration is to identify and appropriately engage with all NPC patients in the U.S. by the end of the year. We continue to train our oncology sales force so they will be ready at launch to educate doctors of toripalimab's differentiated mechanism of action and the impressive patient survival benefit demonstrated at NPC, irrespective of PD-L1 expression status.

我們的願望是在年底前確定美國所有 NPC 患者並與之適當接觸。我們繼續培訓我們的腫瘤學銷售人員，以便他們在上市時做好準備，向醫生介紹特瑞普利單抗的差異化作用機制以及在 NPC 上展示的令人印象深刻的患者生存益處，無論 PD-L1 表達狀態如何。

Finally, we will launch a peer-to-peer educational program featuring the nation's leading opinion leaders in the field of head and neck cancers and NPC, and we look forward to engaging with these KOLs at the upcoming ASCO.

最後，我們將推出一項點對點教育計劃，邀請全國頭頸癌和 NPC 領域的領先意見領袖參與，我們期待在即將舉行的 ASCO 上與這些 KOL 互動。

A sub-modest marketing investment will be required to identify patients and educate physicians and providers on the benefits of toripalimab. Our oncology commercial capabilities were built to scale with significant overlap between UDENYCA customers and toripalimab targeted prescribers. Therefore, the launch of toripalimab is being efficiently integrated into our existing oncology commercial infrastructure. We are ready to launch toripalimab upon approval and expect to successfully address the entire NPC patient population across all lines of therapy and irrespective of PD-L1 expression status.

將需要適度的營銷投資來識別患者並就 toripalimab 的益處對醫生和提供者進行教育。我們的腫瘤學商業能力是根據 UDENYCA 客戶和 toripalimab 靶向處方者之間的顯著重疊而建立的。因此，特瑞普利單抗的推出正在有效地整合到我們現有的腫瘤商業基礎設施中。我們準備好在獲得批准後推出 toripalimab，並期望通過所有治療線成功解決整個 NPC 患者群體，無論 PD-L1 表達狀態如何。

I'll end with YUSIMRY, our Humira biosimilar, which is on track to launch in July. Market feedback confirms that price, robust supply and product presentation are the key criteria used to making formulary decisions, and YUSIMRY is well positioned to compete on each of these criteria. YUSIMRY will have a state-of-the-art autoinjector presentation. It includes our proprietary nonstinging citrate-free formulation and a 29-gauge needle for maximum patient comfort.

我將以 YUSIMRY 結束，我們的 Humira 生物仿製藥有望在 7 月上市。市場反饋證實，價格、穩健的供應和產品介紹是用於製定處方決策的關鍵標準，而 YUSIMRY 在這些標準中的每一個方面都處於有利地位。 YUSIMRY 將展示最先進的自動注射器。它包括我們專有的無刺痛無檸檬酸鹽配方和 29 號針頭，可最大限度地提高患者的舒適度。

We will have substantial supply volumes at launch with hundreds of thousands of YUSIMRY units ready for distribution in July. We are confident in our ability and our commercial approach, and we look forward to updating you in more detail on our strategy on our August call after we launch.

我們將在發佈時提供大量供應量，數十萬個 YUSIMRY 單位準備在 7 月分發。我們對我們的能力和我們的商業方法充滿信心，我們期待在我們推出後的 8 月電話會議上向您更詳細地介紹我們的戰略。

In summary, we are now at the inflection point of our growth story with 5 ongoing and new product launches to drive top line revenue over the next 3 years.

總而言之，我們現在正處於增長故事的轉折點，我們將繼續推出 5 款新產品，以推動未來 3 年的收入增長。

I'll now turn the call over to Theresa Lavallee. Theresa?

我現在將電話轉給 Theresa Lavallee。有一個？

Thank you, Paul, and good afternoon, everyone. Let me begin with an update on our toripalimab inspections and projected approval. As you know, due to COVID travel restrictions in China, the PDUFA date was missed for toripalimab NPC application in December 2022. In January, the travel restrictions related to the COVID-19 pandemic were eliminated, and the inspection is now scheduled for the second half of this month, May. We wish to thank our partner, Junshi BioSciences, for their thorough and diligent preparation efforts to make the inspection of success. .

謝謝保羅，大家下午好。讓我首先介紹我們的特瑞普利單抗檢查和預計批准的最新情況。如您所知，由於中國的 COVID 旅行限制，2022 年 12 月特瑞普利單抗 NPC 申請錯過了 PDUFA 日期。1 月，取消了與 COVID-19 大流行相關的旅行限制，現在安排了第二次檢查這個月的一半，五月。我們要感謝我們的合作夥伴君實生物，為這次考察的成功所做的周密和勤奮的準備工作。 .

With respect to the sufficiency of the clinical data to support the NPC BLA, we note again that the FDA granted toripalimab breakthrough therapy designation as there are no approved treatments for NPC. The agency has consistently recognized this unmet need and stated NPC warrants regulatory flexibility. The review of the BLA is now substantially complete. The FDA conducted an extensive remote regulatory clinical assessment and did not identify any deficiencies. We continue to work with FDA to complete the clinical site inspections.

關於支持 NPC BLA 的臨床數據的充分性，我們再次注意到 FDA 授予 toripalimab 突破性治療指定，因為沒有批准的 NPC 治療方法。該機構一直認識到這一未滿足的需求，並表示 NPC 保證監管靈活性。 BLA 的審查現已基本完成。 FDA 進行了廣泛的遠程監管臨床評估，未發現任何缺陷。我們繼續與 FDA 合作完成臨床現場檢查。

Toripalimab is a next-generation PD-1 with a differentiated mechanism of action and has demonstrated an impressive survival benefit in multiple tumor types in combination with chemotherapy, irrespective of PD-L1 status. Based on these observations, we conducted mechanistic studies to better understand the basis of this differentiation. We have just completed preclinical studies for journal submission, demonstrating that toripalimab has higher potency on T cell activation compared to pembrolizumab. These data further support the evolving understanding and appeal that PD-1 antibodies are not all the same or necessarily equivalent. And we plan to present our findings at a scientific meeting later this year.

特瑞普利單抗是具有差異化作用機制的下一代 PD-1，無論 PD-L1 狀態如何，與化療相結合在多種腫瘤類型中均顯示出令人印象深刻的生存獲益。基於這些觀察，我們進行了機理研究，以更好地理解這種分化的基礎。我們剛剛完成了期刊投稿的臨床前研究，表明與派姆單抗相比，特瑞普利單抗對 T 細胞活化具有更高的效力。這些數據進一步支持不斷發展的理解和吸引力，即 PD-1 抗體並不完全相同或不一定等同。我們計劃在今年晚些時候的一次科學會議上展示我們的發現。

We believe that this makes toripalimab an ideal foundation for our IO pipeline as well as a combination agent for non-Coherus novel compound. Thus, we are actively seeking additional development opportunities to expand toripalimab use beyond NPC, with combinations, as Dr. Dias will describe.

我們相信，這使得 toripalimab 成為我們 IO 管線的理想基礎以及非 Coherus 新型化合物的組合劑。因此，我們正在積極尋求更多的發展機會，以將特瑞普利單抗的使用擴展到 NPC 之外，並結合使用，正如 Dias 博士將描述的那樣。

I'm also pleased to report that Coherus' regulatory and manufacturing teams continue to execute at a very high level. In the first quarter, we gained approval for the YUSIMRY autoinjector as well as the facility change for large-scale manufacturing. Additional approvals included the UDENYCA autoinjector presentation, the fourth approval of the quarter. UDENYCA BLA supplement for the on-body injector presentation is progressing well, and we look forward to approval this year.

我也很高興地報告 Coherus 的監管和製造團隊繼續以非常高的水平執行。第一季度，我們獲得了 YUSIMRY 自動注射器的批准以及大規模製造的設施變更。其他批准包括 UDENYCA 自動注射器演示，這是本季度的第四次批准。用於全身注射器演示的 UDENYCA BLA 補充劑進展順利，我們期待今年獲得批准。

Lastly, regarding tech transfer of the toripalimab manufacturing to the United States, I can report that we've recently successfully completed the large-scale engineering rent needed to onshore manufacturing supply. We plan to execute the process qualification lots this fall and have prioritized these efforts.

最後，關於將 toripalimab 製造技術轉移到美國，我可以報告說，我們最近已經成功完成了陸上製造供應所需的大規模工程租賃。我們計劃在今年秋天執行工藝鑑定批次，並將這些工作列為優先事項。

I'll now turn it over to Dr. Rosh Dias, our Chief Medical Officer, for a clinical update on the Coherus IO pipeline. Rosh?

我現在將其轉交給我們的首席醫療官 Rosh Dias 博士，以獲取 Coherus IO 管道的臨床更新。羅什？

Thanks very much, Theresa, and good afternoon, everyone. Toripalimab continues to form the backbone of our immuno-oncology franchise. We believe that the publication of pivotal data across nasopharyngeal carcinoma, non-small cell lung cancer,and esophageal squamous cell carcinoma in top-tier journals, continuing positive data sets being released across multiple tumor types, together with its differentiated mechanism of action, will position toripalimab effectively as a partner of choice of combinations.

非常感謝，Theresa，大家下午好。特瑞普利單抗繼續構成我們免疫腫瘤專營權的支柱。我們相信，在頂級期刊上發表鼻咽癌、非小細胞肺癌和食管鱗狀細胞癌的關鍵數據，持續發布跨多種腫瘤類型的陽性數據集，以及其差異化的作用機制，將將 toripalimab 有效地定位為組合選擇的合作夥伴。

Several toripalimab data sets across multiple tumor types and tumor settings have been accepted for presentation at the upcoming ASCO 2023 Annual Meeting. These include data in non-small cell lung cancer with final overall survival and biomarker analogies for CHOICE-01, the first-line non-small cell study, as well as event-free survival data for NEOTORCH in the perioperative treatment of Stage II/III non-small cell lung cancer being presented. Metastatic or recurrent triple-negative breast cancer PFS data will be presented from the TORCHLIGHT study.

在即將舉行的 ASCO 2023 年會上，已經接受了多個跨多種腫瘤類型和腫瘤環境的特瑞普利單抗數據集。這些包括非小細胞肺癌的最終總生存期數據和一線非小細胞研究 CHOICE-01 的生物標誌物類比，以及 NEOTORCH 在 II 期 / III 非小細胞肺癌被提出。轉移性或複發性三陰性乳腺癌 PFS 數據將來自 TORCHLIGHT 研究。

We will also be presenting the final overall survival analysis of JUPITER-02, a registration study in the first-line treatment for recurrent or metastatic NPC on Monday, June 5, which shows clinically and statistically significant results. This will build upon the positive progression-free survival data presented in Nature Medicine in 2021 and at the 2021 ASCO plenary session and which forms the basis of our BLA submission in NPC.

我們還將在 6 月 5 日星期一展示 JUPITER-02 的最終總體生存分析，這是一項針對複發性或轉移性 NPC 的一線治療的註冊研究，它顯示了臨床和統計學上的顯著結果。這將建立在 2021 年《自然醫學》和 2021 年 ASCO 全體會議上提出的積極無進展生存數據的基礎上，這些數據構成了我們在 NPC 提交 BLA 的基礎。

With respect to our internal pipeline, we remain excited about our Phase I/IIa toripalimab-TIGIT study, which is currently active in the U.S. with anticipated results next year. In addition, our ILT4 asset remains on track as we proceed towards IND submission towards the end of this year.

關於我們的內部管道，我們仍然對我們的 I / IIa 期 toripalimab-TIGIT 研究感到興奮，該研究目前在美國活躍，預計明年會取得結果。此外，隨著我們在今年年底提交 IND，我們的 ILT4 資產仍在軌道上。

I'll now turn it over to David Stilwell, our Chief Financial Officer. David?

我現在將其轉交給我們的首席財務官大衛史迪威。大衛？

Thank you, Rosh. Today, we reiterate our prior financial guidance for 2023. We project revenue growth from accelerating CIMERLI sales and with the launches this year of toripalimab and YUSIMRY and the UDENYCA autoinjector and on-body injector. For the full year, we expect to book at least $275 million in net sales, with at least $100 million of CIMERLI net product revenue.

謝謝你，羅什。今天，我們重申我們之前對 2023 年的財務指導。我們預計收入增長將來自加速 CIMERLI 銷售以及今年推出 toripalimab 和 YUSIMRY 以及 UDENYCA 自動注射器和全身注射器。全年，我們預計淨銷售額至少為 2.75 億美元，CIMERLI 產品淨收入至少為 1 億美元。

In the first quarter, we took measures to reduce operating expenses with a reduction in force and the rescoping of the toripalimab joint development.plan. Along with other measures we implemented last year, we have significantly reduced expected 2023 R&D and SG&A expenses to a range of $315 million to $335 million. This range excludes nonrecurring milestones in upfront payments, and it includes approximately $50 million in noncash stock compensation expense.

第一季度，我們採取措施減少運營費用，包括裁員和重新確定 toripalimab 聯合開發計劃的範圍。連同我們去年實施的其他措施，我們已將 2023 年的預期研發和 SG&A 費用大幅減少至 3.15 億美元至 3.35 億美元。此範圍不包括預付款中的非經常性里程碑，並且包括大約 5000 萬美元的非現金股票補償費用。

During the start of the year, we requested and obtained a waiver for the revenue covenant of our term loan through the first 2 quarters of 2023, recognizing that the CIMERLI Q-code would not be available until April 1 and that the UDENYCA autoinjector would not launch until May.

在今年年初，我們申請並獲得了對 2023 年前兩個季度的定期貸款收入契約的豁免，因為我們認識到 CIMERLI Q 碼要到 4 月 1 日才能使用，並且 UDENYCA 自動注射器不會發射到五月。

For my review today of first quarter financial results, I'll touch on just a few highlights as the details are in the press release, 8-K and 10-Q we filed this afternoon. Net loss for the first quarter of 2023 was $75.7 million or $0.96 per share on a diluted basis compared to a net loss of $96.1 million or $1.24 per share on a diluted basis for the same period in 2022. We incurred approximately $4.9 million to nonrecurring charges in connection with the restructuring in March 2023.

對於我今天對第一季度財務業績的回顧，我將只談幾個重點，因為細節在我們今天下午提交的新聞稿 8-K 和 10-Q 中。 2023 年第一季度淨虧損為 7570 萬美元或攤薄後每股 0.96 美元，而 2022 年同期淨虧損為 9610 萬美元或攤薄後每股 1.24 美元。我們產生了大約 490 萬美元的非經常性費用與 2023 年 3 月的重組有關。

Net revenue for the first quarter of 2023 was $32.4 million and included $26.2 million of net sales of UDENYCA and $6.2 million in net sales of CIMERLI.

2023年第一季度的淨收入為3240萬美元，其中包括2620萬美元的UDENYCA淨銷售額和620萬美元的CIMERLI淨銷售額。

Net sales of UDENYCA were reduced by a $1.7 million charge for a contingent liability related to resolving a dispute. Net revenue declined compared to the same quarter 1 year ago ergo, primarily due to a decrease in the number of units of UDENYCA sold as well as a lower net realized price. Cost of goods sold was $16.9 million during the first quarter of 2023.

UDENYCA 的淨銷售額因與解決爭議相關的或有負債而減少了 170 萬美元。因此，與一年前的同一季度相比，淨收入有所下降，這主要是由於 UDENYCA 的銷售單位數量減少以及淨實現價格較低。 2023 年第一季度的銷售成本為 1690 萬美元。

Recall that UDENYCA COGS includes a mid-single-digit royalty on net sales payable through the first half of 2024 and CIMERLI COGS includes a low to mid-50% royalty on gross profits. COGS in the first quarter of 2023 included two nonrecurring items, a $3 million contract modification fee with one of our manufacturers and a $2.7 million write-off of inventory that was damaged during processing at one of our manufacturers.

回想一下，UDENYCA COGS 包括到 2024 年上半年應付淨銷售額的中等個位數特許權使用費，而 CIMERLI COGS 包括毛利潤中低至 50% 的特許權使用費。 2023 年第一季度的銷貨成本包括兩項非經常性項目，與我們的一家製造商簽訂的 300 萬美元合同修改費，以及我們一家製造商在加工過程中損壞的 270 萬美元庫存註銷。

Research and development expense for the first quarter of 2023 was $34.2 million, significantly lower than the year ago quarter when we reported $47.9 million in R&D expenses after excluding a $35 million license fee paid to Junshi BioSciences for the TIGIT-antibody, CHS-006.

2023 年第一季度的研發費用為 3420 萬美元，大大低於去年同期，當時我們報告的研發費用為 4790 萬美元，其中不包括支付給 Junshi BioSciences 的 TIGIT 抗體 CHS-006 的 3500 萬美元許可費。

R&D expense for the first quarter of 2023 included $3.6 million in costs associated with the recent reduction in force. Selling, general and administrative expense for the first quarter of 2023 was $49.2 million, roughly equivalent to the $48.8 million in SG&A expenses for the same period in 2022. SG&A expenses are primarily driven by commercialization activities to support current UDENYCA and CIMERLI sales and costs incurred in preparation for multiple anticipated new product launches in 2023. SG&A expense for the first quarter of 2023 included $1.3 million in costs associated with the recent reduction in force.

2023 年第一季度的研發費用包括與最近裁員相關的 360 萬美元成本。 2023 年第一季度的銷售、一般和行政費用為 4920 萬美元，大致相當於 2022 年同期的 4880 萬美元 SG&A 費用。SG&A 費用主要由商業化活動推動，以支持當前 UDENYCA 和 CIMERLI 的銷售和產生的成本為 2023 年多個預期的新產品發布做準備。2023 年第一季度的 SG&A 費用包括與最近裁員相關的 130 萬美元成本。

Cash, cash equivalents and investments in marketable securities were $128.1 million as of March 31, 2023 compared to $191.7 million at year-end. Cash burn was elevated in the first quarter of 2023 by headcount related costs specific to the quarter and was further impacted by introductory payment terms for the CIMERLI launch, which delayed cash receipts for product sales. We expect the timing of cash receipts to normalize in the second half of the year.

截至 2023 年 3 月 31 日，現金、現金等價物和有價證券投資為 1.281 億美元，而年底為 1.917 億美元。 2023 年第一季度，由於該季度特定的員工相關成本，現金消耗有所增加，並進一步受到 CIMERLI 推出的介紹性付款條款的影響，這延遲了產品銷售的現金收入。我們預計現金收入的時間將在下半年正常化。

In 2023, we are focused on ensuring the success of our new product launches and generation of the anticipated revenue growth. we will continue to maintain tight control over our operating expenses as we aim toward a potential return to profitability in 2024.

2023 年，我們將專注於確保成功推出新產品並實現預期的收入增長。我們將繼續嚴格控制我們的運營費用，因為我們的目標是在 2024 年恢復盈利。

I'll now turn the call back to Denny.

我現在將電話轉回給丹尼。

Thank you, McDavid, and thank you all for joining us on our Q1 2023 earnings call.

謝謝 McDavid，也感謝大家加入我們的 2023 年第一季度財報電話會議。

Now that the CIMERLI Q-code is active and we're to beginning to see the impact in the second quarter, we look forward to accelerating CIMERLI sales throughout the year.

現在 CIMERLI Q 代碼已激活，我們將開始在第二季度看到影響，我們期待 CIMERLI 全年銷售加速。

On the UDENYCA front, our launch later this month of a new innovative product presentation, UDENYCA autoinjector, will provide patients and physicians with a unique option to differentiate UDENYCA in the pegfilgrastim market, driving share gains.

在 UDENYCA 方面，我們本月晚些時候推出了一款新的創新產品 UDENYCA 自動注射器，這將為患者和醫生提供一個獨特的選擇，使 UDENYCA 在 pegfilgrastim 市場上脫穎而出，從而推動份額增長。

Development of our immuno-oncology franchise is progressing well. Toripalimab, our foundational asset and anchor, continues in study after study to demonstrate strong efficacy and safety across multiple tumor types. For the next-generation of PD-1, it positions Coherus ideally as the partner of choice for those developing combination treatments with their own proprietary agents and a number of cancers. With the manufacturing inspection scheduled this month, we're optimistic that approval in the first indication nasopharyngeal cancer will occur in Q3.

我們的免疫腫瘤專營權的發展進展順利。 Toripalimab 是我們的基礎資產和錨點，在一項又一項研究中繼續進行研究，以證明其對多種腫瘤類型的強大療效和安全性。對於下一代 PD-1，它將 Coherus 理想地定位為那些開發與自己的專有藥物和多種癌症聯合治療的人的首選合作夥伴。由於本月安排了製造檢查，我們樂觀地認為第一個適應症鼻咽癌的批准將在第三季度發生。

Lastly, through the thoughtful and disciplined cost and expense control, we've significantly reduced our 2023 expenses by about $100 million to about $325 million and will continue to look for more efficiencies and savings as we progress our efforts to drive revenue increases while controlling expenditures to achieve profitability in 2024.

最後，通過深思熟慮和嚴格的成本和費用控制，我們已將 2023 年的費用大幅減少約 1 億美元至約 3.25 億美元，並將繼續尋求更高的效率和節省，因為我們在控制支出的同時努力推動收入增長到 2024 年實現盈利。

Operator, we are ready for the questions.

接線員，我們準備好提問了。

(Operator Instructions) Our first question comes from the line of Robyn Karnauskas of Truist Securities.

（操作員說明）我們的第一個問題來自 Truist Securities 的 Robyn Karnauskas。

Congrats on getting the manufacturing inspection. That's great news. So I have two sets of questions. I'll be really brief. So on tori, it seems like there was a press release by your partner, Junshi, around small cell lung cancer, which has typically been very difficult to treat with checkpoint inhibitors, given it's a cold tumor. So I had a few questions on that.

恭喜獲得製造檢驗。這真是個好消息。所以我有兩組問題。我會很簡短。所以在 tori 上，你的搭檔 Junshi 似乎發布了一篇關於小細胞肺癌的新聞稿，鑑於它是一種冷腫瘤，通常很難用檢查點抑製劑治療。所以我有幾個問題。

What are your thoughts on like why tori worked given -- is it the differentiated epitope and MOA, do you think, is driving the response? And then how does this change your overall strategy with tori? You talked about partnering going forward. It seems like this would be a pretty big deal if it works in SCLC. So talk a little bit about how much collaboration interest there is and how aware people are of this new data set. And then I have one on UDENYCA.

你對為什麼 tori 起作用有什麼看法——你認為是分化的表位和 MOA 正在推動反應嗎？那麼這將如何改變您的 tori 總體策略？你談到了未來的合作夥伴關係。如果它在 SCLC 中有效，這似乎是一件大事。因此，請談談有多少合作興趣以及人們對這個新數據集的了解程度。然後我在 UDENYCA 上有一個。

Thank you, Robyn, for that question. Yes, we were very pleased to see the small cell data announcement this morning. I'll let Dr. Lavallee address the issues of mechanism of action of toripalimab. Subsequently, I'll have Dr. Dias address your secondary question, which is of the potential combination in these other indications, including small cell agents. Theresa?

羅賓，謝謝你提出這個問題。是的，我們很高興今天早上看到小型基站數據公告。我會讓 Lavallee 博士解決 toripalimab 的作用機制問題。隨後，我將讓迪亞斯博士回答你的第二個問題，即這些其他適應症的潛在組合，包括小細胞藥物。有一個？

Yes. Thanks, Robyn. We are excited to see another positive Phase III clinical study with toripalimab and particularly in a difficult tumor that has not shown benefit with some other PD-1 antibodies. This positive survival results are consistent with our preclinical studies showing that toripalimab has more potent activation of T cells compared to pembrolizumab. And I think that really sets it up well to really think about combinations. I'll let Rosh expand further.

是的。謝謝，羅賓。我們很高興看到 toripalimab 的另一項積極的 III 期臨床研究，特別是在一些其他 PD-1 抗體未顯示出益處的疑難腫瘤中。這一積極的生存結果與我們的臨床前研究一致，表明與 pembrolizumab 相比，特瑞普利單抗對 T 細胞的激活更有效。我認為這確實為真正考慮組合做好了準備。我會讓 Rosh 進一步擴展。

Yes. Thanks, Theresa, and thanks, Robyn, for the question. So I think you're quite right. First of all, looking at small cell lung cancer, I think there's a real unmet need here. It represents about 15% to 20% of all lung cancers, extensive stage, continues to have a poor prognosis, and the current therapies that are out there continue to have marginal benefit.

是的。謝謝 Theresa，也謝謝 Robyn 提出的問題。所以我認為你是對的。首先，看看小細胞肺癌，我認為這裡確實存在未滿足的需求。它約佔所有肺癌的 15% 至 20%，屬於廣泛期，預後仍然很差，目前的治療方法仍然具有邊際效益。

So with that in mind, I think we are very excited about the benefits in both PFS and [OS stage] as, I think, you know, were co-primary endpoints. And I think if we look at the overall space, we -- I think this stage set continues to add to the breadth of the data available across multiple different tumor types. As we mentioned for lung alone, we have CHOICE-01 now in non-small cell lung cancer, we have NEOTORCH in perioperative and now small cell lung cancer all showing positive results. I do think that this sets us up really well for combinations across small cells, but also other forms of lung cancer and then also additional genotype without additional data set.

因此，考慮到這一點，我認為我們對 PFS 和 [OS 階段] 的好處感到非常興奮，因為我認為，你知道，它們是共同主要終點。而且我認為，如果我們看一下整體空間，我們 - 我認為這個階段集會繼續增加跨多種不同腫瘤類型的可用數據的廣度。正如我們提到的肺部疾病，我們現在在非小細胞肺癌中有 CHOICE-01，我們在圍手術期有 NEOTORCH，現在小細胞肺癌都顯示出積極的結果。我確實認為這讓我們非常適合跨小細胞的組合，但也適用於其他形式的肺癌，然後還有額外的基因型，無需額外的數據集。

Robyn, just an additional remark with respect to this. When we selected toripalimab from a broad array of available PD-1 agents some 3 years ago, we consistently saw it outperforming other agents, such as pembro and various in vitro and cell-based studies, although we didn't quite understand all the implications of it now. I think it's very rewarding, first of all, to see the mechanism of action story readout, as Dr. Lavallee indicated. But it's also now very rewarding to see this readout in several cancers where toripalimab continues, as we said, to demonstrate really a very potent track record here as far as efficacy.

Robyn，關於這個的補充說明。大約 3 年前，當我們從大量可用的 PD-1 藥物中選擇特瑞普利單抗時，我們一直認為它優於其他藥物，例如 pembro 和各種體外和基於細胞的研究，儘管我們不太了解所有含義現在。正如 Lavallee 博士所指出的，我認為首先，看到行動故事的機制讀出是非常有益的。但是，正如我們所說，在幾種癌症中看到這種讀數現在也是非常有益的，正如我們所說，在這些癌症中，特瑞普利單抗在療效方面確實證明了非常有效的記錄。

With that, I think you had a follow-up question on UDENYCA, perhaps, you said.

有了這個，我想你有一個關於 UDENYCA 的後續問題，也許，你說。

Yes. And one small one. I mean, given that it's an Asian-based study, I mean, I'm sure that doctors will be super excited to see the detailed data. Do you have any sense, whether it be in a publication or presentation, on that?

是的。還有一個小的。我的意思是，鑑於這是一項基於亞洲的研究，我的意思是，我敢肯定醫生們看到詳細數據後會非常興奮。您對此有任何看法，無論是在出版物還是演示文稿中？

And the UDENYCA question is really about the autoinjector and the fact that you're going to have the autoinjector or the on-body device and the prefilled syringe. I'm just trying to get a better sense of how do payers view the autoinjector, what are you getting as an early read on the interest for this autoinjector and that's being differentiated now. And then it's really -- so given you have 3, and just help us tease out like how do we think about these 3 products taking share in different markets.

UDENYCA 的問題實際上是關於自動注射器以及您將擁有自動注射器或身體上設備和預裝注射器的事實。我只是想更好地了解付款人如何看待自動注射器，作為對這種自動注射器的興趣的早期閱讀，你得到了什麼，現在正在區分。然後它真的 - 所以如果你有 3 個，請幫助我們梳理一下我們如何看待這 3 個產品在不同市場中的份額。

Thanks. That's a great question. So I'll let Paul frame that out for you. First of all, what the differentiated value proposition is for the autoinjector compared to the various dosage forms, which are on the market today. And then secondarily, some of the progress that we're making with the payers on that front. Paul?

謝謝。這是一個很好的問題。因此，我會讓保羅為您制定框架。首先，與當今市場上的各種劑型相比，自動注射器的差異化價值主張是什麼。其次，我們在這方面與付款人取得的一些進展。保羅？

Robyn, thanks for your question. Yes, we're excited to launch the autoinjector later this month, and we expect it will cause some market share stabilization this quarter and then really increase growth in the second half of the year. I think what the autoinjector enables us to do in the market is to now compete in both the in-clinic segment against the competitive prefilled syringe competitors. But it also enables us to now compete more effectively in the at-home segment, where Onpro still has 43% share. And it will do that because of the patient benefits. There's really 3 important ones.

羅賓，謝謝你的問題。是的，我們很高興在本月晚些時候推出自動注射器，我們預計它會在本季度穩定一些市場份額，然後在下半年真正增加增長。我認為自動注射器使我們能夠在市場上做的是現在在臨床領域與競爭激烈的預充式註射器競爭對手競爭。但它也使我們現在能夠在家庭領域更有效地競爭，Onpro 在該領域仍佔有 43% 的份額。由於患者的利益，它會這樣做。真的有3個重要的。

First is the autoinjector will give patients more dependence over their injection experience. So essentially, they'll be able to inject when and where they desire. And the second is ease of use. So this can be delivered in less than 10 seconds as opposed to where the on-body for an entire day and navigating through a 45-minute injection time. And then the third is flexibility. So the patients who live far away or can't come back to the office can simply do this at home. So we believe it's going to be able to penetrate all segments of the market. And our payer coverage is actually coming online very nicely. Where we have coverage today, we've got confirmed coverage for autoinjector in over 90% of those plans. So the team is now working with customers, getting it on formularies and will be ready to launch at the end of the month.

首先是自動注射器會讓患者更加依賴於他們的注射體驗。所以基本上，他們將能夠在他們想要的時間和地點進行注射。第二個是易用性。因此，這可以在不到 10 秒的時間內交付，而不是一整天都在身上並通過 45 分鐘的注射時間進行導航。第三是靈活性。因此，住在很遠或無法返回辦公室的患者可以在家中簡單地進行此操作。所以我們相信它將能夠滲透到市場的所有部分。我們的付款人覆蓋範圍實際上非常好地上線了。在我們今天覆蓋的地方，我們已經確認在 90% 以上的計劃中自動注射器的覆蓋範圍。因此，該團隊現在正在與客戶合作，將其納入處方集，並準備在月底推出。

Our next question comes from the line of Salim Syed with Mizuho.

我們的下一個問題來自 Salim Syed 與 Mizuho 的對話。

I guess, a couple for me, if I can, one on perhaps toripalimab and then another on UDENYCA. On tori, Paul, you mentioned that you believe on NPC, you can reach a peak sales number around $200 million. I know you haven't disclosed your pricing framework here, but by my math, that would suggest something about like an $85,000 net price per patient. Just curious if you could point us in the right direction, if that's -- ballpark is correct based on your $200 million peak, if you were to actually be able to get into all patients, all lines.

我想，如果可以的話，對我來說有一對，一個可能在 toripalimab 上，然後另一個在 UDENYCA 上。在托里，保羅，你提到你相信 NPC，你可以達到 2 億美元左右的最高銷售額。我知道你沒有在這裡透露你的定價框架，但根據我的計算，這表明每位患者的淨價約為 85,000 美元。只是好奇你是否能為我們指明正確的方向，如果那是——根據你 2 億美元的峰值，如果你真的能夠進入所有患者，所有線路，那麼球場是正確的。

Let me first take that one, Salim. We -- as a matter of policy, we don't comment on pricing for products which are not approved. So after we have the product approved, we'll be happy to revert there on projected pricing. But as Paul said in his remarks, we will have both first line and other lines of care. And we do have about, I think, 2,500-plus patients per year. But we're happy to chat a little bit about pricing approval.

讓我先拿那個，薩利姆。我們——作為一項政策，我們不會對未經批准的產品的定價發表評論。因此，在產品獲得批准後，我們將很樂意恢復預期定價。但正如保羅在他的發言中所說，我們將同時擁有一線和其他一線護理。我認為，我們每年確實有 2500 多名患者。但我們很高興談談定價批准的問題。

Okay. Great. Maybe if I -- maybe if you could comment a little bit then on -- I guess, I'll just ask my second question on toripalimab again. Maybe you can comment a little bit on the warehousing. It sounded like you guys are trying to build a registry of patients for NPC with your website. Can you just maybe give us an idea how many patients are currently in the registry and how many you plan to warehouse prior to approval?

好的。偉大的。也許如果我——也許如果你能發表一點評論——我想，我會再次問我關於 toripalimab 的第二個問題。也許您可以對倉儲進行一些評論。聽起來你們正在嘗試通過您的網站為 NPC 建立患者登記處。您能否告訴我們目前有多少患者在登記處以及您計劃在批准之前入庫的患者數量？

Yes. Thanks, Salim. Being in rare cancer, the only company and brand that's going to be entering the space, launching npcfacts.com was really the work of our market intelligence and our customer knowledge where we found that doctors and patients really don't have a qualified centralized place to go to get information about NPC.

是的。謝謝，薩利姆。作為唯一一家將進入該領域的罕見癌症公司和品牌，推出 npcfacts.com 確實是我們市場情報和客戶知識的成果，我們發現醫生和患者確實沒有一個合格的集中場所去獲取有關NPC的信息。

And so that was the real driving force there. Now adding a community where we can invite patients and their caregivers and that they're local, localized or if they're metastatic, and we can then communicate with them appropriately. So we're going to be turning up the media around that to really start cranking up the noise level there. We'll be having our field team through appropriate disease state efforts share the website with the accounts directly. So they can actually hand this out in their patients as they come in. So we will be reporting out on actual numbers on that. But so far, we like what we're seeing there.

所以這是真正的驅動力。現在添加一個社區，我們可以邀請患者和他們的護理人員，他們是本地的、本地化的或者如果他們是轉移性的，然後我們可以與他們進行適當的溝通。因此，我們將圍繞這一點調高媒體的音量，以真正開始提高那裡的噪音水平。我們將讓我們的現場團隊通過適當的疾病狀態努力直接與客戶共享網站。所以他們實際上可以在他們進來的時候把這個分發給他們的病人。所以我們將報告實際數字。但到目前為止，我們喜歡我們在那裡看到的東西。

I would add the additional comment, Salim, that if approved, we will be the only agent approved by the FDA for this terrible disease. We feel that we have a responsibility to reach out to these patients and find these patients and educate them. These patients are otherwise progressing without toripalimab. And as Rosh indicated, the benefits of toripalimab treatment are really substantial. And so we feel a tremendous responsibility to reach out to these patients and let them know there's hope.

薩利姆，我要補充一點，如果獲得批准，我們將成為 FDA 批准用於治療這種可怕疾病的唯一藥物。我們覺得我們有責任接觸這些患者，找到這些患者並對他們進行教育。這些患者在沒有特瑞普利單抗的情況下正在取得進展。正如 Rosh 指出的那樣，特瑞普利單抗治療的好處確實很大。因此，我們感到有巨大的責任去接觸這些患者，讓他們知道有希望。

Our next question comes from the line of Mike Nedelcovych from TD Cowen.

我們的下一個問題來自 TD Cowen 的 Mike Nedelcovych。

I have two on toripalimab. The first, and you hinted at this already a little bit, but I'm curious if you have a sense of whether there's any off-label use of other checkpoint inhibitors in NPC that you may have to displace once toripalimab is approved. I realize there's no approved checkpoint inhibitor.

我有兩個在特瑞普利單抗上。首先，你已經暗示了一點點，但我很好奇你是否知道 NPC 中是否有任何標籤外使用的其他檢查點抑製劑，一旦 toripalimab 獲得批准，你可能不得不取代這些檢查點抑製劑。我意識到沒有批准的檢查點抑製劑。

And then secondly, when we think beyond NPC, it would seem given a potentially differentiated mechanism of action and a potentially differentiated clinical profile that the world is your oyster. How will you go about selecting the next set of indications to advance in the pivotal trial?

其次，當我們超越 NPC 思考時，似乎給出了一個潛在差異化的作用機制和一個潛在差異化的臨床特徵，即世界是你的牡蠣。您將如何選擇下一組適應症以推進關鍵試驗？

Mike, thank you very much for the question. I'll let Dr. Dias address your first question. And then Dr. Lavallee can address the mechanism of action question subsequently. Rosh?

邁克，非常感謝你提出這個問題。我會讓 Dias 博士回答您的第一個問題。然後 Lavallee 博士可以隨後解決作用機制問題。羅什？

So just -- thanks for the question. So I'll just reiterate a couple of points that we mentioned earlier. So first of all, there are no approved therapy for nasopharyngeal carcinoma in the U.S. So what that means is for the current standard of treatment is typically chemotherapy, gemcitabine cisplatin typically. That even though there is not an indication for other immunotherapies, there is -- the NCCN does include a couple of other therapies as potential treatment, but that importantly, actually, is on the basis of -- for our data set because there are no positive data sets in the NPC for other immunotherapies nor an indication.

所以只是 - 謝謝你的問題。因此，我將重申我們之前提到的幾點。所以首先，在美國沒有批准的鼻咽癌治療方法。這意味著目前的治療標准通常是化學療法，通常是吉西他濱順鉑。即使沒有其他免疫療法的適應症，NCCN 確實包括一些其他療法作為潛在治療，但重要的是，實際上是基於我們的數據集，因為沒有NPC 中其他免疫療法的陽性數據集也不是適應症。

Theresa, can you comment on how the mechanism of action brings forward other potential combination of therapies with toripalimab or -- and so on?

Theresa，你能評論一下作用機制如何帶來與 toripalimab 或 - 等其他潛在療法的組合嗎？

Yes. I'm seeing the increase in potency on T cells, which is related to the true mechanism to be able to activate antitumor immunity and seen across 3 large Phase III studies, the NPC, JUPITER-02, the CHOICE-01 non-small cell lung cancer study and the JUPITER-06, the ESCC study that was published in cancer cells that toripalimab in frontline studies in combination with chemotherapy works irrespective of PD-L1 status and really lends itself to combinations to really target mechanisms of resistance in those tumor types.

是的。我看到 T 細胞效力的增加，這與能夠激活抗腫瘤免疫的真正機制有關，並且在 3 項大型 III 期研究中看到，NPC、JUPITER-02、CHOICE-01 非小細胞肺癌研究和 JUPITER-06，一項在癌細胞中發表的 ESCC 研究，在一線研究中，特瑞普利單抗與化療相結合，無論 PD-L1 狀態如何，都有效，並且真正有助於組合以真正針對這些腫瘤類型的耐藥機制.

So our pipeline includes ILT4, which is looking at macrophages, which is a known resistant factor in diseases such as small cell lung cancer. So we'll be looking at the disease positioning based on the mechanism. And as we've stated a few times, we're really engaged with a number of other companies that have compounds with Phase II data to help us position tori in disease based on a strong clinical hypothesis. So I think later this year, you'll be seeing the nice development plan there.

因此，我們的管道包括 ILT4，它正在研究巨噬細胞，巨噬細胞是小細胞肺癌等疾病的已知耐藥因子。因此，我們將根據該機制研究疾病定位。正如我們多次聲明的那樣，我們確實與許多其他公司合作，這些公司擁有具有 II 期數據的化合物，以幫助我們根據強有力的臨床假設將 tori 定位在疾病中。所以我想今年晚些時候，你會在那裡看到很好的發展計劃。

Our next question comes from the line of Douglas Tsao of H.C. Wainwright.

我們的下一個問題來自 H.C. 的 Douglas Tsao。溫賴特。

Just question on CIMERLI for me. I'm just curious in terms of the accounts that have adopted it, are they switching all their ranibizumab volume to CIMERLI? Or are they typically still splitting it between CIMERLI and Lucentis?

只需在 CIMERLI 上為我提問。我只是對採用它的賬戶感到好奇，他們是否將所有雷珠單抗量都轉換為 CIMERLI？還是他們通常仍在 CIMERLI 和 Lucentis 之間進行拆分？

Thanks for your question, Doug. Paul, do you want to take that one?

謝謝你的問題，道格。保羅，你要拿那個嗎？

Sure. Thanks, Doug. Yes, as of today, our source of business from a patient standpoint is coming from a combination of new patient starts as well as conversions from other anti-VEGF therapies, including Lucentis. So we expected this, and that's what we're seeing in the market.

當然。謝謝，道格。是的，截至今天，從患者的角度來看，我們的業務來源來自新患者開始以及其他抗 VEGF 療法（包括 Lucentis）的轉化。所以我們預料到了這一點，這就是我們在市場上看到的。

Did you have a follow-on question, Doug?

道格，你有後續問題嗎？

Yes. Also, just in terms of YUSIMRY's launch, I'm just curious, do you have a sense or have you been able to start to make some progress or finalize agreements with payers because from -- that seems to be a real focus of your strategy just given the fact that you're not going to really be promoting into those indications.

是的。此外，就 YUSIMRY 的推出而言，我只是好奇，你是否有感覺，或者你是否能夠開始取得一些進展或與付款人達成協議，因為 - 這似乎是你戰略的真正重點只是考慮到您不會真正推廣到這些適應症。

Well, I think it's fair to say that the focus of any Humira biosimilar market participant competitor will be payers insofar as payers and PBMs are the primary determiners of formulary selection for this product. That being said, we have also previously indicated that we won't be making any comments regarding pricing, consider payer's conversations until after the launch in July. So that's a fair question for our August call, which we'll talk about Q2, but no further comment on that particular point at this point.

好吧，我認為可以公平地說，任何 Humira 生物仿製藥市場參與者的焦點都將是支付者，因為支付者和 PBM 是該產品處方選擇的主要決定者。話雖這麼說，我們之前也表示我們不會就定價發表任何評論，在 7 月推出之前考慮付款人的談話。所以對於我們 8 月的電話會議來說，這是一個公平的問題，我們將討論第二季度，但目前沒有對這一特定點的進一步評論。

Our next question comes from the line of Balaji Prasad of Barclays.

我們的下一個問題來自巴克萊銀行的 Balaji Prasad。

Let's move on to the next question, operator, please, and come back.

讓我們繼續下一個問題，接線員，請回來。

Our next question comes from the line of Ash Verma of UBS.

我們的下一個問題來自瑞銀的 Ash Verma。

Congrats on the progress. I had one on tori and one on YUSIMRY. So on toripalimab, maybe I missed this, like from FDA's point of view, is the key determination in the NPC approval just the site inspection? Or does FDA still need to make up its mind, whether it will or will not adopt regulatory flexibility as it looks for a China study PD-1?

祝賀進步。我有一個在花托上，一個在 YUSIMRY 上。那麼關於特瑞普利單抗，也許我漏掉了這一點，就像從FDA的角度來看，NPC批准的關鍵決定是否只是現場檢查？或者 FDA 是否仍需要做出決定，是否會在尋找中國研究 PD-1 時採取監管靈活性？

And I'm just curious, I know that there has been a paper that was published in Lancet a couple of years ago, where they commented on NPC and SEC being these indications of high unmet need. Do you have like a confirmation from the FDA if that's not an issue anymore? Does that apply to any other indications? That's my first question.

我只是好奇，我知道幾年前在《柳葉刀》雜誌上發表過一篇論文，他們在其中評論 NPC 和 SEC 是這些未滿足的高需求的跡象。如果這不再是問題，您是否希望得到 FDA 的確認？這是否適用於任何其他適應症？這是我的第一個問題。

And then on second, so CIMERLI, so I think you mentioned the mid-single-digit royalty to be paid until 2020 -- mid-2024. Just wanted to understand if I heard that correctly. So is that like a industry standard term that you got and there's no royalty that you need to pay after 2024? It's just like based on your launch time line.

其次，CIMERLI，所以我想你提到了到 2020 年——2024 年年中要支付的中個位數版稅。只是想知道我是否沒聽錯。那麼，這是否就像您獲得的行業標準條款一樣，並且在 2024 年後無需支付版稅？這就像基於您的發佈時間線一樣。

Right. Let me take the last one first, okay? What McDavid Stilwell stated was that we had a low single-digit royalty on UDENYCA up to 2024, not CIMERLI. So CIMERLI is a different financial arrangement and in which we have a royalty profit split with our licensing, slightly different, if that's clear. .

正確的。讓我先拿最後一個，好嗎？ McDavid Stilwell 所說的是，到 2024 年，我們對 UDENYCA 的使用費較低，而不是 CIMERLI。因此，CIMERLI 是一種不同的財務安排，如果清楚的話，我們將特許權使用費利潤與我們的許可分開，略有不同。 .

With regards to your question on regulatory flexibility, I'll let Dr. Lavallee address the issue of what comprises regulatory flexibility for the FDA, what the status of that is and the consistency of their comments, particularly as it applies to NPC. Theresa?

關於你關於監管靈活性的問題，我將讓 Lavallee 博士解決 FDA 監管靈活性的問題，其狀態是什麼以及他們評論的一致性，特別是當它適用於 NPC 時。有一個？

Yes. Thanks, Ash. It's complex, but they -- as you stated, they have enumerated several times NPC warrants regulatory flexibility, both in the Lancet Oncology article and the New England Journal of Medicine article (inaudible). And the way that they look at it is several fold, one on the epidemiology of the disease, the improved available therapies. and the applicability to U.S. medical practice.

是的。謝謝，阿什。這很複雜，但他們——正如你所說，他們在柳葉刀腫瘤學文章和新英格蘭醫學雜誌文章（聽不清）中多次列舉了 NPC 保證監管靈活性。他們看待它的方式有好幾種，一種是關於疾病的流行病學，一種是改進的可用療法。以及對美國醫療實踐的適用性。

And so NPC is one that really, if you will, give you the get out of jail card free on all of those boxes, particularly given the lack of approved treatments and the profound benefit that we've observed with toripalimab both in combination with chemotherapy in the front-line study in monotherapy and second in later lines.

因此，如果您願意，NPC 真的可以在所有這些盒子上免費為您提供出獄卡，特別是考慮到缺乏批准的治療方法以及我們觀察到特瑞普利單抗與化療聯合使用的深遠益處在單藥治療的前線研究中，在後期研究中排名第二。

The only thing when you miss a PDUFA date without a letter, it usually just means the FDA can't compete what they need to do, and they've said repeatedly about not being able to travel to China last year due to the COVID-19 travel restrictions. And I think what speaks volumes is even in the pink sheet a couple of weeks ago, the FDA stated they had not reinstated doing inspections in China.

唯一當你錯過 PDUFA 日期而沒有一封信時，這通常只意味著 FDA 無法完成他們需要做的事情，而且他們一再表示去年由於 COVID- 19 旅行限制。我認為幾週前甚至在粉紅單中也能說明問題，FDA 表示他們沒有恢復在中國進行檢查。

They had told us repeatedly given the breakthrough therapy designation and the meaningful clinical benefit that we would be at the front of the list. The fact that ours is scheduled this month tells you we're at the front of the list. And I don't think they would be using their resources to go places where they had worries.

他們一再告訴我們，鑑於突破性療法的認定和有意義的臨床益處，我們將排在名單的首位。我們的會議安排在本月，這一事實告訴您我們排在名單的前面。而且我不認為他們會使用他們的資源去他們擔心的地方。

Externally and internally, the FDA has been very, very, very consistent that nasopharyngeal cancer warrants regulatory flexibility.

在外部和內部，FDA 一直非常、非常、非常一致地認為鼻咽癌需要監管靈活性。

Our next question comes from the line of Chris Schott of JPM.

我們的下一個問題來自 JPM 的 Chris Schott。

The first one was just on UDENYCA. I'm just still trying to get my hands around the, I guess, flow-through of the competitive dynamics for the traditional presentation and how insulated basically the autoinjector and on-body opportunities are from that. So obviously, companies in a much, much improved competitive position with these approvals. But I guess, does the more competitive environment for the traditional product impact the opportunity for the new presentations? Or do you view them as almost like kind of separate markets as the -- we think about kind of where pricing could shake out, et cetera, for these?

第一個就在 UDENYCA 上。我只是仍在努力了解傳統演示的競爭動態的流動，以及自動注射器和身體上的機會基本上是如何隔離的。很明顯，通過這些批准，公司的競爭地位大大提高了。但我想，傳統產品的競爭環境是否會影響新產品的展示機會？或者你是否認為它們幾乎就像是一種獨立的市場——我們考慮的是定價可能會發生變化的地方，等等，對於這些？

Thanks, Chris. I'll let Paul reply to your question with respect to PFS and autoinjector presentations, the competitive dynamics. Paul?

謝謝，克里斯。我會讓 Paul 回答你關於 PFS 和自動注射器演示、競爭動態的問題。保羅？

Yes. Chris, so when you think about the big progress to market, it's bifurcated into two segments. There's the in-office segment where the -- largely the patients come back to the office. That's predominantly been where the prefilled syringe presentations have been competing. The autoinjector can be used in that in-office setting based on nurse and patient preference that we build under the same Q-code and reimbursed through the same ASP. So the differentiated device enables us to compete there.

是的。克里斯，所以當你考慮市場的重大進展時，它分為兩個部分。在辦公室部分，主要是患者回到辦公室。這主要是預充式註射器演示一直在競爭的地方。自動注射器可根據我們在同一 Q 碼下構建並通過同一 ASP 報銷的護士和患者偏好在辦公室環境中使用。因此，差異化設備使我們能夠在那裡競爭。

And the other part of -- and that's 57% of the market. The at-home segment, where Onpro has largely had a dominant share, is where the autoinjector will be able to offer a new alternative. And in that case, it will be on the differentiation and the type of patient experience that the patient can realize using a simple, easy-to-use autoinjector versus wear in the on-body device.

而另一部分——那是 57% 的市場。 Onpro 佔據主導地位的家用市場是自動注射器能夠提供新替代品的領域。在這種情況下，將取決於患者使用簡單易用的自動注射器與穿戴在身上的設備所能實現的差異化和患者體驗類型。

So then when we add the on-body, if approved later this year, now we'll have the total solution for customers. So whether they're in the office, whether they're at home, whatever they're a hospital or a clinic, they'll have 3 presentations to meet the unique needs of the providers and patients. So we believe that will put us in a strong competitive position with the franchise and will enable us to grow share later this year and in the coming years.

因此，當我們添加體表時，如果今年晚些時候獲得批准，現在我們將為客戶提供完整的解決方案。因此，無論他們是在辦公室，還是在家裡，無論是在醫院還是在診所，他們都會有 3 個演示來滿足提供者和患者的獨特需求。因此，我們相信這將使我們在特許經營權方面處於強大的競爭地位，並使我們能夠在今年晚些時候和未來幾年擴大份額。

Great. And can I just follow up on the autoinjector versus on-body? I guess, of those two opportunities, what do you see as the bigger opportunity? Because it seems like one is kind of a unique presentation to Coherus versus the other is obviously a large segment of the market that you'll be the only kind of competitor, I guess, versus Amgen.

偉大的。我可以跟進自動注射器與身體注射器的對比嗎？我想，在這兩個機會中，您認為更大的機會是什麼？因為看起來一個對 Coherus 來說是一種獨特的展示，而另一個顯然是市場的很大一部分，我想你將是唯一的競爭對手，與 Amgen 相比。

Yes. Well, listen, we're going to launch at the end of this month, and we'll really see how customer receptivity unfolds here, but we're very, very excited about based on what we've heard now. I think at the end of the day, Chris, what's going to happen is patients are going to choose what type of experience they want and the nurses are going to be key constituents, helping to identify whatever the patient and the doctor prescribes. We want to be the total solution.

是的。好吧，聽著，我們將在本月底推出，我們將真正看到客戶接受度如何在這裡展開，但根據我們現在聽到的消息，我們非常非常興奮。克里斯，我認為歸根結底，患者將選擇他們想要的體驗類型，而護士將成為關鍵組成部分，幫助確定患者和醫生的處方。我們希望成為整體解決方案。

One additional point I would make, though, Chris, is that with an on-body system, it has to be filled by the nurse, attached to the patient, activated. The patient walks around with it for 24 hours. There's about a 3-hour period that the patient set aside for the injection. And then there's a 45-minute injection period in which the patient's basically do anything. And there's a sense, we think, with the patients of a loss of control. Your therapy is controlling you, right?

不過，克里斯，我要補充的一點是，對於貼身系統，它必須由護士填充，貼在病人身上，激活。病人帶著它走來走去 24 小時。患者留出大約 3 小時的時間進行注射。然後是 45 分鐘的注射期，患者基本上可以做任何事情。我們認為，從某種意義上說，患者會失去控制。你的治療正在控制你，對吧？

And people are living with cancer, right? So it's very attractive for a patient to be able to be administered with an autoinjector at the time of their choosing. So I think that's a very powerful patient empowerment that has -- we have seen very strong receptivity in the market.

人們患有癌症，對吧？因此，對於患者來說，能夠在他們選擇的時間使用自動注射器進行給藥是非常有吸引力的。所以我認為這是一種非常強大的患者賦權——我們已經看到市場上非常強大的接受能力。

To your question as to which segment it will take the most from it, I think it'll probably take share from non-PFS, that is, say, on-body is a new segment, but also the PFS. It's generally a new unserved segment.

關於你從哪個部分中獲取最多的問題，我認為它可能會從非 PFS 中獲取份額，也就是說，身體是一個新的部分，也是 PFS。它通常是一個新的未服務的細分市場。

Great. And then one just last one for me. I know [you kind] of comment on pricing on the biosimilar Humira side of the market until it launches. But just any observations or surprises or thoughts at all on the -- I guess, the market formation so far with the first biosimilar that's launched? Or is that generally trending as you would have anticipated for these, I guess, first 3 or 4 months in the market?

偉大的。然後是我的最後一個。我知道[你們]對市場上生物仿製藥 Humira 方面的定價發表評論，直到它推出。但是關於——我猜，到目前為止第一個生物仿製藥上市的市場形成，有什麼觀察、驚喜或想法嗎？或者這是否像您預期的一般趨勢，我猜是市場的前 3 或 4 個月？

I think the -- I think it's a fair question, but I believe that the jury is out at this point. I think we've only had 1 team launch, Amgevita. The results have been made public and so on. I think you just have to really see. I don't think market formation has really started for the Humira biosimilar market. I don't think it will until after the July date on ourselves and another -- some other market interest come in. But I think that's the point where you start to see things out.

我認為——我認為這是一個公平的問題，但我相信此時還沒有定論。我想我們只推出了 1 個團隊，Amgevita。結果已經公開等等。我認為你只需要真正看到。我認為 Humira 生物仿製藥市場的市場形成還沒有真正開始。我不認為它會在 7 月日期之後對我們自己和另一個 - 其他一些市場興趣進來。但我認為那是你開始看清事情的地方。

Our last question comes from the line of Jason Gerberry from Bank of America.

我們的最後一個問題來自美國銀行的 Jason Gerberry。

This is Bhavin on for Jason. So two questions for me. The first one is -- so we've seen the first price increase for UDENYCA in tandem with the autoinjector launch. Should we expect to see pricing sort of steady state from here? Or are there more price increases to come as the new formats come to market?

這是 Jason 的 Bhavin。所以有兩個問題要問我。第一個是——所以我們已經看到 UDENYCA 的第一次價格上漲與自動注射器的推出同步。我們是否應該期望從這裡看到定價穩定狀態？還是隨著新格式的上市，價格會上漲更多？

And then the second question is going back to your March 2022 Investor Day, where you set 2026 targets. How are you thinking about the 10% market share goal that leads to a $1.2 billion target as you transition to the commercial launch phase for multiple products?

然後第二個問題回到你 2022 年 3 月的投資者日，你在那裡設定了 2026 年的目標。當您過渡到多種產品的商業發布階段時，您如何看待導致 12 億美元目標的 10% 市場份額目標？

Thanks for your question. With respect to UDENYCA pricing, do I understand correctly that you stated there was a price increase with the additional [process]?

謝謝你的問題。關於 UDENYCA 定價，我是否正確理解您所說的額外 [流程] 價格上漲？

Yes, from the (inaudible) data.

是的，來自（聽不清）數據。

Oh, you mean the ASP increase that just occurred?

哦，你是說剛剛發生的 ASP 增長？

Yes.

是的。

Okay. Paul, could you explain the ASP increase?

好的。 Paul，你能解釋一下 ASP 的增長嗎？

Yes, sure. Just to clarify, UDENYCA list price for the autoinjector will be the same price as the prefilled syringe, which is about a 35% discount to Neulasta. As it relates to the ASP, you are correct that in the second quarter, we did have a 4% increase in our ASP, which puts it amongst the highest of the established brands in the class, including the innovator. So higher ASP leads to higher reimbursement. So that's why we've been very disciplined with management of ASP in preparation for these new presentation launches.

是的，當然。需要澄清的是，自動注射器的 UDENYCA 標價將與預裝注射器的價格相同，比 Neulasta 優惠約 35%。關於 ASP，您是正確的，在第二季度，我們的 ASP 確實增長了 4%，這使其成為同類中知名品牌中最高的，包括創新者。因此，更高的 ASP 會導致更高的報銷。因此，這就是為什麼我們在 ASP 管理方面非常嚴格，以準備這些新的演示文稿發布。

With respect to your YUSIMRY question and market share, I would point out that this market is developing consistent with our expectations. The readouts that we got 1 to 2 years ago from payers about what was important to them, that is to say, pricing scale, robustness of supply, the autoinjector, patient comfort, that's playing out pretty much as planned. We deliberately spent about $45 million to move into very large-scale manufacturing. That's an approval that Dr. Lavallee and her team got last quarter. .

關於你的 YUSIMRY 問題和市場份額，我想指出這個市場的發展符合我們的預期。我們在 1 到 2 年前從付款人那裡得到的關於對他們來說重要的東西的讀數，也就是說，定價規模、供應的穩健性、自動注射器、患者的舒適度，這幾乎按計劃進行。我們特意花費了大約 4500 萬美元進入超大規模製造領域。這是 Lavallee 博士和她的團隊在上個季度獲得的認可。 .

So I think we're well prepared in terms of scale for competing at 10-plus percent as we go forward. And just how long it takes us to get to that sort of benchmark in the market, we'll have to see given the dynamics. But we -- I can say that we are totally geared up in all aspects of that with the device, with the scale and with our cost structure for YUSIMRY.

所以我認為我們在規模方面已經做好了充分準備，可以在我們前進的過程中以 10% 以上的比例競爭。我們需要多長時間才能達到市場上的那種基準，我們必須考慮到動態。但我們——我可以說，我們在設備、規模和 YUSIMRY 的成本結構的各個方面都做好了充分準備。

And then if I can have one follow-up. Do you have any line of sight into competitor biosimilar Lucentis launches over the next 12 to 18 months? .

然後，如果我可以跟進一次。您是否對未來 12 至 18 個月內推出的競爭對手生物仿製藥 Lucentis 有任何看法？ .

Paul, do you want to take that question?

保羅，你想回答這個問題嗎？

Yes. We're only aware of one competitor ranibizumab biosimilar. And from what we understand, they're not looking for a launch until 2024 based on their public statements.

是的。我們只知道一個競爭對手雷珠單抗生物仿製藥。據我們了解，根據他們的公開聲明，他們希望在 2024 年之前推出。

I think the key issue, though, to keep in mind with CIMERLI and Lucentis biosimilar market is the impact on the Q-code that we garnered, deployed on April 1. I had the opportunity in the last couple of weeks to go out and visit a number of customers and discuss with them firsthand whatever barriers to adoption they may have had with CIMERLI and so on. And every single one of those customers, I think I saw 4 different practices and 4 different states.

不過，我認為 CIMERLI 和 Lucentis 生物仿製藥市場要牢記的關鍵問題是對我們在 4 月 1 日部署的 Q 碼的影響。過去幾週我有機會出去參觀許多客戶並與他們直接討論他們在採用 CIMERLI 等方面可能遇到的任何障礙。這些客戶中的每一位，我想我都看到了 4 種不同的做法和 4 種不同的狀態。

And I talked to at least 30 to 50 physicians contained within those practices. And they are all very enthusiastic about the impact of the Q-code and its impact on their cash flow, their ability to be certain about reimbursement. So I think that's why you're seeing the acceleration in the market share and the uptake and some of the things even that we've seen some additional data came out today and on April utilization. So I think that follows directly from the Q-code for our previous remarks. And direct feedback to me from the customers indicate that's the case also.

我與這些實踐中包含的至少 30 到 50 名醫生進行了交談。他們都非常熱衷於 Q 碼的影響及其對現金流的影響，以及他們確定報銷的能力。所以我認為這就是為什麼你看到市場份額和吸收的加速以及一些事情，甚至我們已經看到今天和 4 月份的利用率出現了一些額外的數據。所以我認為這直接來自我們之前評論的 Q 代碼。客戶給我的直接反饋表明情況也是如此。

At this time, I would like to turn it back to Denny Lanfear, the CEO of Coherus BioSciences, for closing remarks.

在這個時候，我想把它轉回給 Coherus BioSciences 的首席執行官 Denny Lanfear 作結束語。

Thank you, operator. And thank you, everyone, for joining us today. As you heard, 2023 will be an exciting year of catalyst for Coherus, and we look forward to keeping you all updated on our progress. We'll be at the Bank of America conference this week, and we'll be at UBS following that later this month. Talk to you all soon. Bye-bye.

謝謝你，運營商。感謝大家今天加入我們。正如您所聽到的，2023 年將是 Coherus 激動人心的催化劑年，我們期待讓您了解我們的最新進展。我們將在本週參加美國銀行會議，然後在本月晚些時候參加瑞銀。很快就和大家聊聊。再見。

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

感謝您參加今天的會議。這確實結束了程序。您現在可以斷開連接。