Halozyme Therapeutics Inc (HALO) 2024 Q4 法說會逐字稿

完整原文

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  • Operator

    Operator

  • Good afternoon. My name is Karen, and I will be your conference moderator today. At this time, I would like to welcome everyone to the Halozyme fourth-quarter and full-year 2024 financial and operating results conference call. Please note, this event is being recorded.

    午安.我的名字是 Karen,今天我將擔任你們的會議主持人。現在,我歡迎大家參加 Halozyme 第四季和 2024 年全年財務和經營業績電話會議。請注意,此事件正在被記錄。

  • I will now turn the call over to Tram Bui, Halozyme's Vice President of Investor Relations and Corporate Communications. Please go ahead.

    現在我將把電話轉給 Halozyme 投資者關係和企業傳播副總裁 Tram Bui。請繼續。

  • Tram Bui - Vice President - Investor Relations and Corporate Communications

    Tram Bui - Vice President - Investor Relations and Corporate Communications

  • Thank you, operator. Good afternoon and welcome to our fourth quarter and full-year 2024 financial and operating results conference call.

    謝謝您,接線生。下午好,歡迎參加我們的 2024 年第四季和全年財務和營運業績電話會議。

  • In addition to the press release issued today after the market closed, you could find a supplementary slide presentation that will be referenced during today's call in the Investor Relations section of our website. Leading the call will be Dr. Helen Torley, Halozyme's President and Chief Executive Officer who will provide an update in our business; and Nicole Labrosse, our Chief Financial Officer, will review our financial results as well as our outlook.

    除了今天收盤後發布的新聞稿外,您還可以在我們網站的投資者關係部分找到今天電話會議中參考的補充幻燈片簡報。本次電話會議由 Halozyme 總裁兼執行長 Helen Torley 博士主持,她將介紹我們業務的最新進展;我們的財務長 Nicole Labrosse 將審查我們的財務表現以及前景。

  • On today's call, we will be making forward-looking statements as outlined on slide 2. I would also refer you to our SEC filings for a full list of risks and uncertainties.

    在今天的電話會議上,我們將做出如投影片 2 中概述的前瞻性陳述。我還建議您參閱我們向美國證券交易委員會 (SEC) 提交的文件,以獲取完整的風險和不確定性清單。

  • During the call, both GAAP and non-GAAP financial measures will be discussed. Certain non-GAAP or adjusted financial measures are reconciled with the comparable GAAP financial measures in our earnings press release and slide presentation.

    電話會議期間將討論 GAAP 和非 GAAP 財務指標。某些非 GAAP 或調整後的財務指標與我們收益新聞稿和幻燈片簡報中的可比較 GAAP 財務指標進行了協調。

  • I will now turn the call over to Dr. Helen Torley.

    現在我將電話轉給海倫·托利博士。

  • Helen Torley - President, Chief Executive Officer, Director

    Helen Torley - President, Chief Executive Officer, Director

  • Thank you, Tram, and good afternoon, everyone. Our strong fourth quarter results concluded what proved to be an exceptional year for Halozyme. I will start by recapping our record-breaking performance in 2024. Total revenue exceeded $1 billion for the first time, growing 22% over prior year. We also raised our financial guidance twice during the year, and I'm pleased to report that full year results exceeded our raised guidance for royalty revenue, adjusted EBITDA and non-GAAP EPS.

    謝謝Tram,大家下午好。我們強勁的第四季業績為 Halozyme 帶來了非凡的一年。首先,我將回顧我們在 2024 年破紀錄的表現。總收入首次超過10億美元,較上年成長22%。我們在本年度還兩次提高了財務預期,我很高興地報告,全年業績超過了我們上調的特許權使用費收入、調整後 EBITDA 和非 GAAP EPS 預期。

  • We estimate that one million patients have now received drugs delivered subcutaneously with ENHANZE, establishing unsurpassed and we believe unsurpassable safety database to inform regulators and new partners. Importantly, multiple impressive milestones were achieved in 2024 that will accelerate our near-term and long-term growth and extend the durability of the royalty revenue streams.

    我們估計,目前已有 100 萬名患者接受了 ENHANZE 皮下注射藥物,建立了無與倫比的、我們相信無與倫比的安全資料庫,以告知監管機構和新合作夥伴。重要的是,2024 年我們實現了多個令人印象深刻的里程碑,這將加速我們的近期和長期成長,並延長特許權使用費收入流的持久性。

  • Four major products or new indications with ENHANZE received approval in a major region, adding future growth. Current partners nominated five new targets to advance into the clinic for subcutaneous development expanding opportunity. We extended the patent protection of ENHANZE in Europe out to 2029 with issuance of a new patent with the effect of maintaining our royalty rate for DARZALEX subcutaneous and amivantamab subcutaneous unchanged at the mid-single-digit rate for the next five years until March of 2029.

    ENHANZE 的四種主要產品或新適應症在主要地區獲得批准,增加了未來的成長。目前的合作夥伴提名了五個新目標進入臨床階段,以擴大皮下開發的機會。我們透過頒發新專利將 ENHANZE 在歐洲的專利保護延長至 2029 年,其效果是,在未來五年內,直至 2029 年 3 月,DARZALEX 皮下注射和 amivantamab 皮下注射的專利使用費率將維持在中等個位數不變。

  • And we also remain confident in the opportunity for the U.S. patent reissue, which will have the same effect of extending full royalty rate, in this case, from September of 2027 to March of 2029, noting that this is currently not reflected in our five-year financial outlook. This remarkable financial and operational performance plus our continued business expansion will deliver strong revenue and earnings growth for many years to come.

    我們對美國專利重新頒發的機會也充滿信心,這將產生與延長全額專利使用費率相同的效果,在這種情況下,從 2027 年 9 月到 2029 年 3 月,但需要注意的是,這目前尚未反映在我們的五年財務展望中。這項卓越的財務和營運業績加上我們持續的業務擴張將在未來許多年帶來強勁的收入和獲利成長。

  • Moving now to slide 4. I'll just call out a few financial highlights before I provide more details on the key business drivers.

    現在轉到投影片 4。在提供有關關鍵業務驅動因素的更多細節之前,我只想介紹一些財務亮點。

  • Our strong fourth quarter performance resulted in record full year 2024 results. Strong royalty revenue growth of 27% in 2024 resulted in $571 million in royalty revenue, exceeding our raised guidance, and that was a key driver of total revenues exceeding $1 billion. And this strong revenue performance, coupled with our careful management of expenses resulted in 2024 net income, increasing an impressive 58% year over year to $444 million.

    我們第四季的強勁表現帶來了 2024 年全年創紀錄的業績。2024 年特許權使用費收入強勁成長 27%,實現 5.71 億美元的特許權使用費收入,超過了我們上調的預期,這是總收入超過 10 億美元的關鍵驅動力。強勁的收入表現,加上我們對費用的精心管理,使得 2024 年的淨收入年增 58%,達到 4.44 億美元。

  • As we discussed in January on our 2025 and multiyear guidance call, the momentum and opportunity we have across our business gives us confidence that we are firmly on track to deliver another record year and to meet our targets in 2025 and beyond.

    正如我們在今年 1 月的 2025 年及多年期指導電話會議上所討論的那樣,我們整個業務的勢頭和機遇讓我們有信心,我們正堅定地走在創造另一個創紀錄的一年並實現 2025 年及以後的目標的軌道上。

  • I'm pleased to reiterate our 2025 guidance, including for total revenue, where we project $1.15 billion to $1.225 billion, representing growth of 13% to 21% year over year. his continued strong growth will be primarily driven by three products, DARZALEX subcutaneous, Phesgo, and VYVGART Hytrulo.

    我很高興重申我們 2025 年的指導,包括總收入,我們預計總收入將達到 11.5 億美元至 12.25 億美元,年增 13% 至 21%。其持續強勁成長將主要得益於三種產品:DARZALEX 皮下注射、Phesgo 和 VYVGART Hytrulo。

  • Let me begin with DARZALEX on slide 5. For the fourth quarter of 2024, Johnson & Johnson reported worldwide sales of DARZALEX grew almost 24% on an operational basis to $3.1 billion with full year revenue reaching $11.7 billion. We are delighted that DARZALEX's growth and total revenue was driven by demand for DARZALEX subcutaneous with ENHANZE, which represents 95% share of total DARZALEX sales in the United States and has a similar high share of sales outside the United States too.

    讓我從第 5 張投影片上的 DARZALEX 開始。2024 年第四季度,強生公司報告稱,DARZALEX 全球銷售額按營運基礎增長近 24%,達到 31 億美元,全年收入達到 117 億美元。我們很高興 DARZALEX 的成長和總收入受到對 DARZALEX 皮下注射劑 ENHANZE 的需求推動,這佔了 DARZALEX 在美國總銷售額的 95%,並且在美國以外的銷售額份額也同樣高。

  • DARZALEX growth was driven by share gains of over three points across all lines of therapy, and importantly, by 6 points of growth in the longer treatment duration frontline setting. DARZALEX now represents J&J's largest product with strong continued growth projected for many years. This growth is a result of investments Johnson & Johnson has made in new studies to increase access to DARZALEX subcutaneous with ENHANZE for more early stage and frontline patients, further expanding the commercial opportunity.

    DARZALEX 的成長得益於所有治療系列的份額增長超過 3 個百分點,而且重要的是,在較長治療時間的一線治療領域,其份額增長了 6 個百分點。DARZALEX 現在是強生公司最大的產品,預計未來多年將持續強勁成長。這一增長得益於強生公司對新研究的投資,旨在增加更多早期和第一線患者使用 DARZALEX 皮下注射和 ENHANZE 的機會,進一步擴大商業機會。

  • As examples, in 2024, DARZALEX subcutaneous with ENHANZE in US and European regulatory approval for newly diagnosed patients who are eligible for autologous stem cell transplant in a combination regimen. A supplemental BLA has also been submitted for FDA approval for DARZALEX subcutaneous with ENHANZE as part of a quadruplet regimen for newly diagnosed multiple myeloma patients for whom autologous stem cell transplant is deferred or they are ineligible. And we're also anticipating US and European approval for smoldering multiple myeloma. Each of these represents a compelling growth opportunity for DARZLEX subcutaneous.

    例如,2024年,DARZALEX 皮下注射與 ENHANZE 聯合療法獲得美國和歐洲監管部門批准,用於適合接受自體幹細胞移植的新診斷患者。此外,還提交了一份補充生物製品許可申請 (BLA) 供 FDA 批准,將 DARZALEX 皮下注射與 ENHANZE 聯合作為四聯療法的一部分,用於治療新診斷的多發性骨髓瘤患者,這些患者自體幹細胞移植被推遲或不符合條件。我們也期待美國和歐洲批准該藥物用於治療冒煙型多發性骨髓瘤。這些都為 DARZLEX 皮下注射劑帶來了巨大的成長機會。

  • These advancements support analyst projections of more than $17 billion in total revenue for DARZALEX in 2028 with virtually all of this coming from DARZALEX subcutaneous with ENHANZE. And recall, we predict earning royalties in DARZALEX subcutaneous until 2032.

    這些進展支持了分析師對 DARZALEX 2028 年總收入超過 170 億美元的預測,其中幾乎全部來自 DARZALEX 皮下注射 ENHANZE。回想一下,我們預測到 2032 年 DARZALEX 皮下注射劑的特許權使用費將會增加。

  • I'll now move to our second key driver, which is Roche's Phesgo, shown on slide 6. Phesgo is a combined therapy of Perjeta, Herceptin, and ENHANZE, which is given in a single seven-minute subcutaneous injection for the treatment of breast cancer. We believe Phesgo is an underappreciated asset that has been garnering growing adoption globally. In the fourth quarter, Roche reported that Phesgo grew to CHF500 million representing an increase of 72% year over year and reached CHF1.7 billion or approximately USD2 billion for full year 2024. Phesgo had strong uptake across all regions with conversion climbing to 46% in the 55 launched countries.

    現在我將轉到我們的第二個關鍵驅動因素,即羅氏的 Phesgo,如幻燈片 6 所示。Phesgo 是 Perjeta、Herceptin 和 ENHANZE 的聯合療法,只需一次七分鐘的皮下注射即可治療乳癌。我們認為 Phesgo 是一項被低估的資產,在全球範圍內越來越受到人們的歡迎。羅氏第四季報告顯示,Phesgo 銷售額成長至 5 億瑞士法郎,年增 72%,預計 2024 年全年銷售額將達到 17 億瑞士法郎,約合 20 億美元。Phesgo 在所有地區都得到了大力推廣,在 55 個已推出該服務的國家中,轉換率攀升至 46%。

  • Roche commented that they project conversion will continue to increase and will exceed 50% in 2025. With these strong results and expectations for continued growth, analysts project Phesgo will reach $3.4 billion in revenue in 2028, all of which is subcutaneous with ENHANZE. And recall, we project earning mid-single-digit royalties on Phesgo until 2030.

    羅氏公司表示,他們預計轉換率將繼續增加,到 2025 年將超過 50%。憑藉這些強勁的業績和持續成長的預期,分析師預測 Phesgo 的營收將在 2028 年達到 34 億美元,全部來自使用 ENHANZE 的皮下注射。回想一下,我們預計到 2030 年 Phesgo 的特許權使用費收入將達到中位數個位數。

  • Let me now transition to argenx's VYVGART and VYVGART Hytrulo with ENHANZE on slide 7. Argenx preannounced preliminary results in January, with total VYVGART, including VYVGART Hytrulo with ENHANZE, fourth quarter sales reaching $737 million for full year revenue of $2.2 billion. This remarkable on success is driven predominantly by continued growth and adoption in generalized myasthenia gravis, where VYVGART Hytrulo with ENHANZE was approved in 2023. VYVGART Hytrulo with ENHANZE is playing a key role in VYVGART growth by expanding the number of physicians using VYVGART, adding those who do not wish to or who cannot administer IV infusions.

    現在讓我在第 7 張投影片上轉換到 argenx 的 VYVGART 和 VYVGART Hytrulo 以及 ENHANZE。Argenx 在一月份公佈了初步業績,包括 VYVGART Hytrulo 和 ENHANZE 在內的 VYVGART 總銷售額第四季度達到 7.37 億美元,全年收入為 22 億美元。這項顯著成功主要得益於全身性重症肌無力治療領域的持續成長和應用,VYVGART Hytrulo 與 ENHANZE 於 2023 年獲得批准。VYVGART Hytrulo 與 ENHANZE 一起在 VYVGART 的發展中發揮關鍵作用,它擴大了使用 VYVGART 的醫生數量,增加了那些不願意或不能進行靜脈輸液的醫生。

  • The ease of use subcutaneous delivery is also enabling VYVGART to move earlier in the treatment paradigm, expanding the addressable population. And note that we project earning royalties in VYVGART Hytrulo through the early 2040. Further innovation that will expand the VYVGART Hytrulo with ENHANZE opportunity is projected in the United States in April of 2025 with the potential FDA approval of a prefilled syringe treatment option for VYVGART Hytrulo with ENHANZE for all of the currently approved indications.

    易於使用的皮下注射也使 VYVGART 能夠在治療模式中更早發展,擴大了可針對的人群。請注意,我們預計到 2040 年初將在 VYVGART Hytrulo 中獲得版稅。進一步的創新將擴大 VYVGART Hytrulo 與 ENHANZE 的機會,預計 2025 年 4 月美國將出現這種創新,FDA 可能會批准 VYVGART Hytrulo 與 ENHANZE 的預充式註射器治療方案,用於所有目前批准的適應症。

  • Halozyme co-created the prefilled syringe with argenx, which may allow patients self-administration in just 20 seconds. argenx is also expecting the prefilled syringe to be approved in Europe, Japan and Canada in 2025. Halozyme will receive the same royalty rate on the prefilled syringe delivery as we receive on the file, also through the early 2040s.

    Halozyme 與 argenx 共同研發了預充式註射器,可讓患者在短短 20 秒內完成自行給藥。 argenx 也預計該預充式註射器將於 2025 年在歐洲、日本和加拿大獲得批准。Halozyme 將獲得與我們在文件中獲得的相同的預充式註射器交付特許權使用費率,直到 2040 年代初。

  • Let me move now to the second indication with a chronic inflammatory demyelinating polyneuropathy, or CIDP, which is a subcutaneous VYVGART Hytrulo with ENHANZE-only indication. This is an exciting new growth driver that is really just beginning, following the mid-2024 approval in the United States and the end of 2024 approval in Japan.

    現在讓我談談第二種適應症,即慢性發炎性脫髓鞘多發性神經病變(CIDP),這是一種皮下 VYVGART Hytrulo,僅適用於 ENHANZE。繼美國於 2024 年中期批准和日本於 2024 年底批准之後,這是一個令人興奮的新成長動力,而這才剛開始。

  • argenx has seen strong interest and adoption with more than 1,000 CIDP patients already receiving VYVGART Hytrulo. The patient testimonial shared by argenx tell a powerful story of how VYVGART Hytrulo is helping CIDP patients regain their lives. Strong progress has been made in gaining that all important coverage and access, with now 90% of covered lives having access to VYVGART Hytrulo for CIDP under favorable or highly favorable policies. The brand is also benefiting from a halo effect of argenx being able to promote CIDP next to generalized myasthenia gravis to open up new prescribers. Already, 25% of prescribers for CIDP were physicians who had not previously been seen by argenx.

    argenx 引起了人們的濃厚興趣和採用,已有超過 1,000 名 CIDP 患者接受 VYVGART Hytrulo 治療。argenx 分享的病人感言講述了 VYVGART Hytrulo 如何幫助 CIDP 患者重獲新生的動人故事。在獲得所有重要的覆蓋和訪問方面我們已經取得了長足的進展,現在 90% 的受保人都可以根據優惠或非常優惠的政策獲得 VYVGART Hytrulo 的 CIDP 服務。該品牌還受益於 argenx 的光環效應,能夠在全身性重症肌無力之後推廣 CIDP,以開拓新的處方者。目前,25% 的 CIDP 處方者是之前未曾接受過 argenx 診治的醫生。

  • In 2025, argenx projects to continue on this powerful trajectory and also to expand the number of global approvals in CIDP. And not only are we just at the beginning in terms of these two indication launches. As you can see on slide 8, Halozyme's journey with argenx on their next wave of innovation for VYVGART highlights the many exciting opportunities for many years to come, with multiple active subcutaneous programs with ENHANZE in development, including in thyroid eye disease and ocular myasthenia gravis.

    2025 年,argenx 計畫繼續保持這一強勁勢頭,並擴大 CIDP 的全球批准數量。就這兩項適應症的推出而言,我們才剛開始。正如您在幻燈片 8 上看到的,Halozyme 與 argenx 合作為 VYVGART 進行下一波創新的歷程凸顯了未來許多年的許多激動人心的機遇,其中包括與 ENHANZE 合作開發的多個主動皮下項目,包括甲狀腺眼病和眼重症肌無力。

  • And as we look out even further, our journey with argenx was enhanced in 2024 with four new nominations with ENHANZE which creates new opportunity and reinforces our leadership position as argenx's rapid, large volume subcutaneous delivery technology of choice.

    當我們放眼長遠時,我們與 argenx 的合作之旅在 2024 年得到了增強,我們與 ENHANZE 獲得了四項新提名,這創造了新的機遇並鞏固了我們作為 argenx 首選快速、大容量皮下輸送技術的領導地位。

  • I'll move now to slide 9. We had three additional significant approvals in 2024 for OCREVUS Zunovo, TECENTRIQ Hybreza, and OPDIVO Qvantig. Based on benchmarks, we assume it will take six to nine months in the United States and more than 12 months in Europe to achieve robust access coverage and reimbursement.

    我現在要翻到第 9 張投影片。2024 年,我們又獲得了 OCREVUS Zunovo、TECENTRIQ Hybreza 和 OPDIVO Qvantig 三項重要批准。根據基準,我們估計,美國需要 6 到 9 個月、歐洲需要 12 個月以上才能獲得強大的覆蓋範圍和報銷。

  • Given the recent approvals, we have projected minimal contribution from these products in our 2025 revenues, with contributions becoming more meaningful in 2026 and beyond. Let me begin with Roche's OCREVUS Zunovo, which received EMA and FDA approval for the treatment of multiple sclerosis in 2024.

    鑑於最近獲得的批准,我們預計這些產品對我們 2025 年收入的貢獻很小,而 2026 年及以後的貢獻將變得更大。首先要說的是羅氏的 OCREVUS Zunovo,該藥物於 2024 年獲得 EMA 和 FDA 批准用於治療多發性硬化症。

  • OCREVUS Zunovo with ENHANZE allows for an approximately 10 minutes subcutaneous injection, which compares with multiple infusion that is typically required for the IV administration time. Roche has been very consistent with their comments that we believe the subcutaneous formulation with ENHANZE will expand the addressable market and grow the brand, adding prescribers and patients who did not have access to an infusion suite.

    OCREVUS Zunovo 與 ENHANZE 可進行約 10 分鐘的皮下注射,而靜脈給藥通常需要多次輸注。羅氏公司一直堅持他們的評論,我們相信 ENHANZE 的皮下製劑將擴大潛在市場並發展品牌,增加無法使用輸液套件的處方者和患者。

  • In its most recent earnings call, Roche commented that the launch is progressing very much as planned with more than 2,500 patients on OCREVUS Zunovo globally. In the United States, they are seeing positive signals with 50% share of new OCREVUS subcutaneous patients being naive to OCREVUS. This is great news for two reasons.

    羅氏在最近的財報電話會議上表示,該產品的上市進展非常順利,全球已有超過 2,500 名患者使用 OCREVUS Zunovo。在美國,他們看到了正面的訊號,50%的新OCREVUS皮下治療患者是首次使用OCREVUS的患者。這是一個好消息,原因有二。

  • Firstly, it demonstrates market expansion and growth for OCREVUS, which is being driven by subcutaneous Zunovo. Secondly, the remaining 50% is coming from early conversion to subcutaneous OCREVUS from the very large patient pool who are on intravenous OCREVUS. Focusing on market expansion and growth, Roche commented that they are seeing accounts that have not used OCREVUS IV in the past for now prescribing subcutaneous Ocrevus.

    首先,它展示了OCREVUS的市場擴張和成長,而這得歸功於皮下注射Zunovo。其次,剩下的 50% 來自於大量使用靜脈注射 OCREVUS 的患者,早期轉換為皮下注射 OCREVUS。羅氏公司專注於市場擴張和成長,並表示他們看到過去沒有使用 OCREVUS IV 的客戶現在開始開皮下注射 Ocrevus 的處方。

  • With the permanent J code expected in April and projected to accelerate uptake, Roche further commented that they are confident that OCREVUS Zunovo represents an incremental CHF2 billion or more than $2 billion opportunity for the brand. With full year 2024 sales reaching CHF6.7 billion or approximately USD7.7 billion, this represents a very attractive growth opportunity for Halozyme. We predict receiving mid-single-digit royalties on OCREVUS Zunovo until 2030 and at a step-down rate until at least 2034.

    由於永久性的 J 代碼預計將於 4 月發布,並預計將加速普及,羅氏進一步表示,他們相信 OCREVUS Zunovo 能為品牌帶來 20 億瑞士法郎或超過 20 億美元的增量機會。2024 年全年銷售額將達到 67 億瑞士法郎或約 77 億美元,這對 Halozyme 來說是一個非常有吸引力的成長機會。我們預計,到 2030 年,OCREVUS Zunovo 的專利使用費將達到中等個位數,並且至少到 2034 年專利使用費將逐漸減少。

  • We're also excited that Roche's TECENTRIQ Hybreza with ENHANZE in FDA approval in September of 2024. The approval was for all of the IV indications and offers patients and providers with a more convenient treatment option with an approximately seven-minute subcutaneous injection. Total TECENTRIQ revenue represented CHF3.6 billion or approximately USD4 billion in 2024. Roche plans to drive IV to subcu conversion and believe that subcutaneous formulation will be protective of the brand. And recall that we project receiving royalties on TECENTRIQ Hybriza until 2040.

    我們也很高興羅氏的 TECENTRIQ Hybreza 與 ENHANZE 將於 2024 年 9 月獲得 FDA 批准。此次批准適用於所有靜脈注射適應症,透過大約七分鐘的皮下注射為患者和提供者提供了更方便的治療選擇。2024 年 TECENTRIQ 的總收入為 36 億瑞士法郎,約 40 億美元。羅氏計劃推動靜脈注射向皮下注射的轉變,並相信皮下注射配方將保護該品牌。回想一下,我們預計到 2040 年才能收到 TECENTRIQ Hybriza 的專利費。

  • Moving now to Bristol-Myers Squibb's OPDIVO Qvantig which was approved by the FDA in December of 2024 and represents our ninth approved product with ENHANZE. I will also note that the European submission is currently under review. Bristol-Myers Squibb commented recently that they are excited for the launch and what it could mean for patients, physicians, and the durability of their immuno-oncology business, with the new subcutaneous formulation helping to extend the reach and impact of our immuno-oncology franchise into the next decade. With our sales team out in the field, relaying the benefits of OPDIVO Qvantig, Bristol shares that the early feedback has been positive for the shorter injection time compared to IV nivolumab.

    現在轉向百時美施貴寶的 OPDIVO Qvantig,該藥物於 2024 年 12 月獲得 FDA 批准,是我們與 ENHANZE 合作獲批的第九款產品。我還要指出的是,歐洲的提交文件目前正在審查中。百時美施貴寶公司最近表示,他們對該產品的推出感到非常興奮,這對患者、醫生以及他們的免疫腫瘤業務的持久性都具有重要意義,新的皮下製劑有助於將我們的免疫腫瘤業務的影響力擴展到下一個十年。我們的銷售團隊在現場宣傳 OPDIVO Qvantig 的優勢,布里斯托表示,與靜脈注射 nivolumab 相比,其註射時間較短,早期回饋是正面的。

  • Initial positive feedback they highlighted is in use in the adjuvant patients. And in patients who are treated in combination with [urofit], such as in first-line metastatic melanoma and renal cell carcinoma. Bristol expects that 30% to 40% of OPDIVO IV could be converted to subcutaneous. Similar to any launch, reimbursement dynamics are going to take time, and BMS projects conversion will accelerate in the second half of 2025 after they transition to our permanent J code in July. OPDIVO Qvantig represents another very attractive conversion opportunity for Halozyme.

    他們強調的初步正向回饋是在輔助治療患者中被使用。以及與 [urofit] 合併治療的患者,例如第一線轉移性黑色素瘤和腎細胞癌。布里斯托預計 30% 至 40% 的 OPDIVO IV 可以轉為皮下注射。與任何發布類似,報銷動態需要時間,而 BMS 專案轉換將在 2025 年下半年 7 月過渡到我們的永久 J 代碼後加速。OPDIVO Qvantig 為 Halozyme 帶來了另一個非常有吸引力的轉換機會。

  • OPDIVO, which is a brand name for IV nivolumab, grew 7%, excluding FX in the fourth quarter to $2.5 billion and reached $9.3 billion in annual sales in 2024. Now let me also take this opportunity to comment on amivantamab subcutaneous which would represent our tenth approved partner product. Recall, amivantumab is included in our longer-term projections as we consider it derisk following its strong Phase 3 data. Recently, Johnson & Johnson announced that they have received a positive opinion from the Committee for medicinal products of human use of the European Medicines Agency, recommending an extension of marketing authorization for the subcutaneous formulation of amivantamab with ENHANZE in combination with elasefrinib in the first-line treatment of adult patients with advanced non-small cell lung cancer.

    OPDIVO 是 IV nivolumab 的品牌名,不包括外匯,第四季銷售額成長 7% 至 25 億美元,2024 年年銷售額將達到 93 億美元。現在,我也藉此機會對皮下注射 amivantamab 進行評論,它是我們第十個獲批的合作夥伴產品。回想一下,amivantumab 被納入我們的長期預測中,因為我們認為在其強勁的 3 期數據之後它的風險已經降低。近日,強生公司宣布,已收到歐洲藥品管理局人用藥品委員會的積極意見,建議延長阿米凡他單抗皮下製劑ENHANZE的上市許可,與伊拉昔利尼聯合用於晚期非小細胞肺癌成年患者的一線治療。

  • The European Commission approval is typically granted 67 days after the recommendation, which would support approval in the April 2025 time frame. We're excited for the amivantimab/subcu potential approval and what this could mean for patients. The subcutaneous formulation of amivantimab offers an improved treatment experience for patients reducing administration time to approximately five minutes compared to anything from two to four hours for the IV. Importantly, there is also a fivefold reduction in infusion-related reactions.

    歐盟委員會通常會在建議提出後 67 天給予批准,這將支持在 2025 年 4 月的時間範圍內獲得批准。我們對 amivantimab/subcu 的潛在批准以及這對患者意味著什麼感到非常興奮。皮下注射阿米凡單抗可為患者帶來更好的治療體驗,將給藥時間縮短至約五分鐘,而靜脈注射則需要兩到四個小時。重要的是,輸液相關反應也減少了五倍。

  • Moving now to the US timeline. In December, Johnson & Johnson and that they had received a complete response letter for amivantamab subcutaneous, which was related to observations as part of a standard preapproval inspection at a manufacturing facility. J&J highlighted that the CRL is unrelated to the product formulation or the efficacy and safety data submitted in the regulatory application and that the FDA is not requesting any additional clinical studies. They are working closely with the FDA to bring subcutaneous amavantimab to patients as quickly as possible and are confident in a path to resolution. J&J has possibly commented that they believe amivantamab has a $5 billion revenue potential.

    現在轉到美國時間軸。12 月,強生公司表示,他們收到了關於皮下注射阿米凡他單抗的完整回覆信,該回覆信與製造工廠標準預批准檢查的一部分觀察結果有關。強生公司強調,CRL 與產品配方或監管申請中提交的功效和安全性數據無關,且 FDA 並未要求進行任何額外的臨床研究。他們正與 FDA 密切合作,盡快為患者提供皮下注射 amavantimab,並對找到解決問題的方法充滿信心。強生公司可能曾表示,他們相信 amivantamab 有 50 億美元的營收潛力。

  • Moving now to slide 10. We are confident in reaching our $1 billion royalty revenue projected in 2027. And indeed, we project we will exceed that. This confidence is driven by the expectation for the continued strong growth of our two lead assets, DARZALEX and Phesgo, which represent a $20 billion total opportunity; and the layering of the four recent launches of VYVGART Hytrulo, TECENTRIQ Hybreza, OCREVUS Zunovo, and OPDIVO Qvantig; plus the upcoming detention of abuzantumab subcutaneous. Analysts predict these five products represent an even greater opportunity in 2028 of $35 billion.

    現在轉到第 10 張投影片。我們有信心在 2027 年實現預計 10 億美元的特許權使用費收入。事實上,我們預計我們將超越這個數字。這種信心源自於我們對兩項主要資產 DARZALEX 和 Phesgo 持續強勁成長的預期,這代表著 200 億美元的總機會;以及最近推出的四款 VYVGART Hytrulo、TECENTRIQ Hybreza、OCREVUS Zunovo 和 OPDIVO Qvantig 的分層;加上即將被拘留的阿布贊單抗皮下注射劑。分析師預測,這五種產品在 2028 年將帶來更大的 350 億美元的商機。

  • I know that you agree that the near-term revenue growth in 2020 is very strong. And I often get the question, what's next? The good news is that the launched and launching products that we've just reviewed continue to provide very strong revenue post 2028. And we project several current pipeline products will contribute additional meaningful revenue post 2028 too.

    我知道您同意 2020 年的近期營收成長非常強勁。我常常會問,下一步該怎麼辦?好消息是,我們剛剛審查過的已推出和即將推出的產品將在 2028 年後繼續提供非常強勁的收入。我們預計,目前幾款正在研發的產品也將在 2028 年後帶來額外的可觀收入。

  • Let me walk you through some of the specifics, which are shown on slide 11. Phesgo is projected to continue to grow post 2028 and earn Halozyme royalties at its full unchanged mid-single-digit rate until 2030. DARZALEX, FASPRO and subcutaneous is projected to remain our largest revenue driver until 2032.

    讓我向您介紹一些具體內容,它們顯示在幻燈片 11 上。Phesgo 預計將在 2028 年後繼續成長,並在 2030 年前以完全不變的中個位數利率獲得 Halozyme 的特許權使用費。預計到 2032 年,DARZALEX、FASPRO 和皮下注射仍將是我們最大的收入來源。

  • In Europe earning Halozyme royalties at its full unchanged mid-single rate until March of 2029. And to continue to earn as royalties at half that rate until 2032. In the United States, we are confident that the pending new manufacturing IP will be issued which would also result in Halozyme earning royalties at the unchanged mid-single-digit rate until March of 2029 and continue to earn as royalties at half that rate until 2032.

    在歐洲,Halozyme 的專利使用費將以完整不變的中單費率收取,直至 2029 年 3 月。並且繼續以一半的費率賺取版稅直至2032年。在美國,我們相信即將頒發的新製造智慧財產權,這也將導致 Halozyme 直到 2029 年 3 月都以不變的中等個位數利率獲得特許權使用費,並且直到 2032 年仍以該利率的一半繼續獲得特許權使用費。

  • This is not currently reflected in our long-term guidance. VYVGART Hytrulo is projected to earn Halozyme royalties for all of its indications sold either in the vial or through the prefilled syringe at its full unchanged current mid-single-digit royalty rate until March of 2029, and then to continue to earn royalties until 2033 at a mid-single-digit rate even after a step down in the royalty rate. Royalties will continue until the 2040s after further step down in rate.

    這目前尚未反映在我們的長期指導中。VYVGART Hytrulo 預計將以目前未變的中位數特許權使用費率 (以小瓶或預充注射器形式銷售) 為所有適應症獲得 Halozyme 特許權使用費,直至 2029 年 3 月,並且即使在特許權使用費率下降後,仍將繼續以中等個位數的獲得特許權使用費率。在稅率進一步降低後,特許權使用費將持續到 2040 年代。

  • Moving to OCREVUS Zunovo. This is projected to earn Halozyme royalties at the full mid-single-digit rate until 2030 and as a step-down rate until at least 2034.

    移至 OCREVUS Zunovo。預計到 2030 年,Halozyme 的專利使用費將以中等個位數的速率成長,而到至少 2034 年,專利使用費的成長率將呈現逐步下降趨勢。

  • And with TECENTRIQ Hybreza projected to earn Halozyme royalties at its full mid-single-digit rate until the 2040s and OPDIVO Qvantig projected to earn Halozyme royalties until at least 2034. You can see why we project continued strong revenue from the current launch products beyond 2028.

    預計 TECENTRIQ Hybreza 到 2040 年代將以中位數的速率獲得 Halozyme 特許權使用費,而預計 OPDIVO Qvantig 至少到 2034 年將獲得 Halozyme 特許權使用費。您可以看到為什麼我們預測目前推出的產品在 2028 年後將繼續保持強勁的收入。

  • In addition, we are confident that the more advanced derisked products from our pipeline will contribute revenue post 2028. For example, OPDIVO fixed-dose combination with relatlimab, and TAK-881 are two additional derisk revenue growth drivers post 2028. And we also anticipate additional products from our current Phase 1 pipeline, new nominations from existing partners and from new deals will add additional royalty revenue streams.

    此外,我們相信,我們產品線中更先進的去風險產品將在 2028 年後貢獻收入。例如,OPDIVO 固定劑量組合與 relatlimab 以及 TAK-881 是 2028 年後另外兩個降低風險的收入成長動力。我們也預計,我們目前第一階段的研發線中的其他產品、現有合作夥伴的新提名以及新交易將增加額外的特許權使用費收入來源。

  • Now let me turn to the very important topic of new deals and new nominations. Our discussions continue with multiple companies regarding enhanced new nominations, enhance new deals, our high-volume ultra injector, and our small volume auto-injector. I'm going to start with some very exciting news on our small volume auto-injector. I'm pleased to announce that yesterday, we signed a development agreement for our small volume auto injector with one of our current partners for a commercial product.

    現在,讓我來談談非常重要的主題:新協議和新提名。我們繼續與多家公司討論加強新提名、加強新交易、我們的大容量超級注射器以及我們的小容量自動注射器。我首先要宣布一些關於我們的小容量自動注射器的非常令人興奮的消息。我很高興地宣布,昨天我們與我們現有的一位合作夥伴簽署了一份針對小容量自動注射器的商業產品開發協議。

  • Moving to ENHANZE, recall, we have two paths for growth. The first is gaining new nominations by current partners and the second is through signing new deals. Beginning with the new nominations, in 2024, we made excellent progress with current partners, selecting five new targets for ENHANZE. In 2025, we will continue to work closely with partners to identify opportunities to select new nominations from the currently available open slot. Recall these additional new nominations, together with our current expanded pipeline, drive durability of revenue post 2029.

    轉向 ENHANZE,回想一下,我們有兩條成長路徑。第一是透過現有合作夥伴獲得新的提名,第二是透過簽署新協議。從新的提名開始,2024 年,我們與現有合作夥伴取得了卓越的進展,為 ENHANZE 選擇了五個新目標。2025 年,我們將繼續與合作夥伴密切合作,尋找從目前可用的空缺席位中選出新提名的機會。回想一下,這些額外的新提名,加上我們目前擴大的管道,將推動 2029 年後收入的持久性。

  • And moving to the new enhanced deals, we are in active discussions with multiple companies. In 2025, our goal is to advance the collaboration and licensing agreements with at least one. And moving to our high-volume auto-injector, our goal is to advance to a development agreement this year.

    關於新的增強型交易,我們正在與多家公司進行積極討論。2025 年,我們的目標是與至少一家公司達成合作與授權協議。至於我們的大容量自動注射器,我們的目標是今年要達成開發協議。

  • I'm often asked why we have not yet signed a deal with a high-volume auto-injector. What's the holdup? Our high-volume auto injector is a real innovation, which means some components are not available off the self. Some parts needed to be invented and designed. In 2024, we made progress with this, securing an exclusive supply for a high-volume primary container. This accomplishment has significantly derisked the high volume of injector for partners, and we're actively engaged in discussions with several parties.

    我經常被問到為什麼我們還沒有與大容量自動注射器簽訂協議。有什麼阻礙嗎?我們的大容量自動注射器是一項真正的創新,這意味著某些組件無法單獨使用。有些部分需要發明和設計。2024年,我們在這方面取得了進展,確保了大容量主容器的獨家供應。這項成果大大降低了合作夥伴大量注入的風險,我們正積極與多方進行討論。

  • With that, let me now turn the call over to Nicole, who will discuss our financial results in more detail.

    說完這些,現在我將把電話轉給妮可,她將更詳細地討論我們的財務表現。

  • Nicole Labrosse - Chief Financial Officer, Senior Vice President

    Nicole Labrosse - Chief Financial Officer, Senior Vice President

  • Thank you, Helen. Our strong fourth quarter results marked the end to another record year for the company, with the achievement of more than $1 billion in total revenue for the year. We grew total revenue by 22% and beat our guidance which we increased twice during the year and helped us grow non-GAAP EPS by 53%.

    謝謝你,海倫。我們強勁的第四季業績標誌著該公司又一個創紀錄的年份,全年總收入超過 10 億美元。我們的總收入增長了 22%,超出了我們的預期,我們年內兩次上調了預期,並幫助我們的非 GAAP 每股收益增長了 53%。

  • With our bottom line growth outpacing the top line due to our high-margin royalty revenue, we converted 74% of our adjusted EBITDA into free cash flow, representing $468 million. Free cash flow is expected to increase over the next few years to 80% of adjusted EBITDA in 2026.

    由於我們的高利潤特許權使用費收入,我們的底線成長超過了頂線成長,我們將 74% 的調整後 EBITDA 轉化為自由現金流,即 4.68 億美元。預計未來幾年自由現金流將增加,到 2026 年將達到調整後 EBITDA 的 80%。

  • As we look ahead, we remain firmly on track to hit another milestone in 2027 and with projections of more than $1 billion in royalty revenue with our achievements to date.

    展望未來,我們仍有望在 2027 年再創里程碑,並預計憑藉迄今為止的成就,特許權使用費收入將超過 10 億美元。

  • Let me now turn to our detailed fourth quarter results on slide 12. Revenue grew 30% to $298 million compared to $230 million in the prior year period. Growth was primarily driven by royalty revenue, up 40% to $170 million; and higher revenues under collaborative agreements, up 70% to $48 million, mainly due to more milestones achieved for enhanced sales-based milestones.

    現在讓我來看看第 12 張投影片上的第四季詳細業績。營收較去年同期的 2.3 億美元成長 30%,達到 2.98 億美元。成長主要受特許權使用費收入的推動,成長 40%,達到 1.7 億美元;合作協議下的收入增加,成長 70%,達到 4,800 萬美元,這主要歸因於增強銷售里程碑的實現。

  • The continued commercial success of subcutaneous STARZLEX and Phesgo and early growth of VYVGART Hytrulo for GMG, which launched in 2023 were the main drivers for our royalty revenue growth for the quarter.

    皮下注射 STARZLEX 和 Phesgo 的持續商業成功以及 2023 年推出的 GMG 的 VYVGART Hytrulo 的早期成長是我們本季特許權使用費收入成長的主要驅動力。

  • Adjusted EBITDA increased 61% to $196 million in the fourth quarter from $122 million in the prior year period, driven by high gross margins of 86%, and coupled with modest operating expense growth of 5%.

    第四季調整後 EBITDA 較去年同期的 1.22 億美元成長 61% 至 1.96 億美元,這得益於 86% 的高毛利率,以及 5% 的小幅營運費用成長。

  • We also maintained a strong balance sheet with cash, cash equivalents and marketable securities at $596 million on December 31, 2024, and compared to $336 million on December 31, 2023. Our net debt position was $929 million, with a net leverage ratio of 1.3x. The increase in cash was primarily a result of cash generated from operations, offset by $250 million deployed for share repurchases.

    我們也維持了強勁的資產負債表,截至 2024 年 12 月 31 日,現金、現金等價物和有價證券為 5.96 億美元,而 2023 年 12 月 31 日為 3.36 億美元。我們的淨債務狀況為 9.29 億美元,淨槓桿率為 1.3 倍。現金增加主要由於經營活動產生的現金,但用於股票回購的 2.5 億美元抵消了增加。

  • Turning now to slide 13, for our detailed financial results for the full year 2024. I will briefly touch on some highlights here with more details available in our press release and 10-K filed with the SEC today.

    現在翻到第 13 頁,查看我們 2024 年全年的詳細財務表現。我將在這裡簡要介紹一些亮點,更多詳細資訊請參閱我們的新聞稿和今天向美國證券交易委員會提交的 10-K 文件。

  • Total revenues grew 22% year over year to $1.015 billion in 2024, off an already substantial revenue base in 2023 of $829 million. Robust growth was primarily driven by 27% growth in royalty revenue, totaling $571 million, as well as higher revenues on collaborative agreements and higher sales of proprietary products.

    2024 年總營收年增 22% 至 10.15 億美元,而 2023 年的營收基礎已經相當可觀,為 8.29 億美元。強勁的成長主要得益於特許權使用費收入成長27%,總額達到5.71億美元,以及合作協議收入的增加和專有產品銷售額的增加。

  • Research and development expenses were $79 million compared to $76 million in 2023, primarily due to planned investments in ENHANZE related to the development of our new high-yield rHuPH20 manufacturing process.

    研發費用為 7,900 萬美元,而 2023 年為 7,600 萬美元,這主要是由於計劃對 ENHANZE 進行投資,用於開發我們新的高產 rHuPH20 製造流程。

  • Selling, general, and administrative expenses were $154 million compared to $149 million in 2023 primarily due to increased compensation expense and professional service fees, partially offset by planned reductions in commercial marketing expenses.

    銷售、一般及行政費用為 1.54 億美元,而 2023 年為 1.49 億美元,主要是由於薪酬費用和專業服務費增加,但部分被商業行銷費用的計劃減少所抵消。

  • Adjusted EBITDA increased 48% to $632 million, from $426 million in 2023. GAAP diluted earnings per share was $3.43 and non-GAAP diluted earnings per share was $4.23. This is compared to the GAAP diluted earnings per share of $2.10 and non-GAAP diluted earnings per share of $2.77 in 2023. In January, we raised our previous 2025 financial guidance for total revenue, our high-margin royalty revenue, adjusted EBITDA and non-GAAP EPS.

    調整後的 EBITDA 從 2023 年的 4.26 億美元成長 48% 至 6.32 億美元。GAAP 稀釋每股收益為 3.43 美元,非 GAAP 稀釋每股收益為 4.23 美元。相比之下,2023 年的 GAAP 稀釋每股收益為 2.10 美元,非 GAAP 稀釋每股收益為 2.77 美元。今年 1 月,我們上調了先前確定的 2025 年總收入、高利潤特許權使用費收入、調整後 EBITDA 和非 GAAP EPS 的財務預期。

  • As you can see on slide 14, continue to expect total revenue of $1.15 billion to $1.225 billion, representing year-over-year growth of 13% to 21%. We royalty revenues of $725 million to $750 million, representing year-over-year growth of 27% to 31%.

    正如您在第 14 頁上看到的,預計總收入將繼續達到 11.5 億美元至 12.25 億美元,年增 13% 至 21%。我們的特許權使用費收入為 7.25 億美元至 7.5 億美元,年增 27% 至 31%。

  • As Helen touched on, we project DARZALEX subcu and Phesgo will continue to grow substantially in 2025. And for the first time, VYVGART Hytrulo with ENHANZE is expected to be the largest royalty dollar growth driver. When you couple our high-margin royalty growth with flat operating expenses from our continued focus on operational efficiencies, we expect adjusted EBITDA of between $755 million and $805 million, representing year-over-year growth of 19% to 27% and non-GAAP diluted EPS of $4.95 to $5.35, representing year-over-year growth of 17% to 26%.

    正如海倫所提到的,我們預計 DARZALEX subcu 和 Phesgo 將在 2025 年繼續大幅成長。並且,VYVGART Hytrulo 與 ENHANZE 預計將首次成為最大的特許權使用費美元成長動力。如果將我們高利潤的特許權使用費成長與我們持續關注營運效率而導致的營運費用持平結合起來,我們預計調整後的 EBITDA 在 7.55 億美元至 8.05 億美元之間,同比增長 19% 至 27%,非 GAAP 稀釋每股收益在 4.95 美元至 5.35 美元之間,同比增長 26% 至 26%。

  • Let me also take the opportunity to highlight how to think about the quarterly cadence for modeling. We expect first quarter royalty revenue to be less than the fourth quarter of 2024 by approximately 10% and due to annual contractual rate resets with quarterly sequential growth thereafter. We project total revenues to decrease sequentially from the fourth quarter of 2024 the first quarter of 2025 and as no milestones are planned in the first quarter and milestones are expected to be weighted in the second half of the year. And our product sales are also expected to be weighed in the second half of 2025.

    我還想藉此機會強調如何思考建模的季度節奏。我們預計第一季的特許權使用費收入將比 2024 年第四季下降約 10%,這是由於年度合約費率重置以及此後季度連續增長。我們預計總收入將從 2024 年第四季到 2025 年第一季逐季下降,因為第一季沒有規劃里程碑,預計里程碑將在下半年加權。而我們的產品銷售也預計會在2025年下半年有所體現。

  • Let me now turn to slide 15 and highlight the remarkable growth we project over the next four years. From 2024 to 2028, we expect royalty revenue, adjusted EBITDA and non-GAAP earnings per share will more than double, while total revenue comes close to doubling increasing from our record greater than $1 billion we just achieved to $1.7 billion to $1.9 billion in 2028.

    現在讓我翻到第 15 張投影片,重點介紹我們預計未來四年將實現的顯著成長。從 2024 年到 2028 年,我們預計特許權使用費收入、調整後的 EBITDA 和非 GAAP 每股收益將增長一倍以上,而總收入將接近翻倍,從剛剛實現的創紀錄的 10 億美元增至 2028 年的 17 億至 19 億美元。

  • Let me conclude on slide 16 and provide an update on our share repurchases. In December of 2024, we entered into a $250 million ASR under the $750 million approved program from February of 2024. This will complete by the end of the first quarter of 2025. Since the inception of the first program in 2019, we have returned $1.55 billion in share repurchases, an average of approximately $250 million a year, the average repurchase price from 2019 to 2023 was $31.46 per share. The impact of share repurchases has allowed us to reduce our diluted share count by 10%.

    讓我在第 16 張投影片上結束演講並提供有關我們股票回購的最新情況。2024 年 12 月,我們根據 2024 年 2 月批准的 7.5 億美元計劃簽訂了 2.5 億美元的 ASR。該項目將於 2025 年第一季末完成。自2019年第一個計畫啟動以來,我們已透過股票回購返還了15.5億美元,平均每年約2.5億美元,2019年至2023年的平均回購價格為每股31.46美元。股票回購的影響使我們的稀釋股份數量減少了 10%。

  • As disciplined stewards of free cash flow, we will continue to evaluate share repurchase opportunities that offer a compelling return versus other capital deployment initiatives. Our strong EBITDA growth significantly derisks our capital position as we have capacity to cover our debt obligations without overextending our resources as evidenced by our low net leverage profile of 1.3x at year-end, coupled with our impressive interest rate coverage of 30x. We are in an excellent capital position to execute on both share repurchases and growth opportunities via M&A.

    作為自由現金流的嚴格管理者,我們將繼續評估與其他資本配置措施相比能帶來誘人回報的股票回購機會。我們強勁的 EBITDA 成長顯著降低了我們的資本狀況風險,因為我們有能力償還債務而不會過度擴張我們的資源,這一點從我們年底 1.3 倍的低淨槓桿率以及令人印象深刻的 30 倍利率覆蓋率就可以看出。我們擁有良好的資本狀況,可以實現股票回購和透過併購實現的成長機會。

  • With that, I'll now turn the call back over to Helen.

    說完這些,我現在將電話轉回給海倫。

  • Helen Torley - President, Chief Executive Officer, Director

    Helen Torley - President, Chief Executive Officer, Director

  • Thank you, Nicole. We're truly at a remarkable time in Halozyme history with nine products now approved and one launched in multiple regions. Our high 2025 revenue and royalty growth is driven by just three of these products, DARZALEX subcutaneous, Phesgo and VYVGART Hytrulo, each of which bring durable revenues until at least 2030, and in the case of VYVGART Hytrulo into the 2040. Our confidence and conviction in our multiyear guidance was further reinforced with the 2024 approvals of TECENTRIQ Hybreza, OCREVUS Zunovo, and OPDIVO Qvantig.

    謝謝你,妮可。我們正處於 Halozyme 歷史上的一個輝煌時刻,目前有九種產品已獲批准,有一種產品已在多個地區上市。我們 2025 年的高收入和特許權使用費成長僅由其中三種產品推動,即 DARZALEX 皮下注射、Phesgo 和 VYVGART Hytrulo,每種產品都能帶來持久收入至少到 2030 年,而 VYVGART Hytrulo 則可以帶來到 2040 年。TECENTRIQ Hybreza、OCREVUS Zunovo 和 OPDIVO Qvantig 於 2024 年獲得批准,進一步增強了我們對多年期指導的信心和信念。

  • Next up will be amivantamab subcu following the successful completion of the regulatory reviews. This adds four additional durable royalty streams, which will begin to contribute meaningfully in 2026 and continue to at least the mid-2030s and in several cases to the 2040s. Our progress and performance would not have occurred without the dedication and hard work of the exceptional Halozyme team and our partners. And I'd like to take just a moment to thank everybody who contributed.

    在成功完成監管審查後,下一步將是進行 amivantamab subcu 治療。這增加了四個額外的持久特許權使用費流,它們將在 2026 年開始做出有意義的貢獻,並至少持續到 2030 年代中期,在某些情況下甚至會持續到 2040 年代。如果沒有 Halozyme 團隊和合作夥伴的傑出奉獻和努力,我們的進步和業績就不可能實現。我想花一點時間感謝所有做出貢獻的人。

  • Operator, we are now ready to open the call for questions.

    接線員,我們現在可以開始回答問題了。

  • Operator

    Operator

  • (Operator Instructions) Sean Laaman, Morgan Stanley.

    (操作員指示) 摩根士丹利的 Sean Laaman。

  • Sean Laaman - Analyst

    Sean Laaman - Analyst

  • Hi, Helen, Nicole, and Tram. Hope you're all well and Nice set of results, congratulations. I guess over the last week and it's not lost on me that you've provided 2018 guidance, which not many companies look out that far. But I guess a lot of the inbound that I get is what's beyond that? And what sort of terminal value should you think about with Halozyme.

    嗨,海倫、妮可和特拉姆。希望你們一切都好,取得不錯的成績,恭喜。我想,在過去一周裡,我並沒有忘記您已經提供了 2018 年的指導,而許多公司並沒有考慮到那麼長遠的情況。但我想我收到的很多資訊都是超出這個範圍的?您應該考慮 Halozyme 具有什麼樣的最終價值。

  • So looking at your slide 11 and some of the issues that are going on there what's your confidence around some of the new users, for example, earth you've detailed today, and maybe even some of the further Argenx-related programs that might come on board to mitigate any reduction in sort of earnings beyond that sort of '28 period -- 2030 period?

    那麼,看看您投影片 11 中提到的一些問題,您對一些新用戶有什麼信心,例如您今天詳細介紹的地球,甚至可能還有一些與 Argenx 相關的計劃,這些計劃可能會減輕 28 年到 2030 年期間以後的收入減少?

  • Helen Torley - President, Chief Executive Officer, Director

    Helen Torley - President, Chief Executive Officer, Director

  • Great. Thanks, Sean and welcome to the coverage of Halozyme. It's a great in the prepared remarks, I cover that the way we think about post 2020 is really to look at the current 10 products are approved or soon to be approved with amivantamab subcu and consider that they are going to continue to be contributing considerably at that time. And the slide that we show with the duration and royalty rate really does help bring that picture into perspective, showing every product will get royalties until 2030.

    偉大的。謝謝,肖恩,歡迎收看 Halozyme 的報道。在準備好的評論中,我談到了我們對 2020 年後的看法,實際上是看看目前已獲批准或即將與 amivantamab subcu 一起獲批的 10 種產品,並認為它們將在那時繼續做出巨大貢獻。我們展示的帶有期限和版稅率的幻燈片確實有助於使該圖景更加清晰,表明到 2030 年每種產品都將獲得版稅。

  • Many of them will go to the mid-2030s and multiple ones will also go to the 2040s. Now four or five (inaudible) in particular, that is just considering GMG and CIDP. We are aware we will get six products that are public that are already subcu development plans are soon to start within Argenx. But I do think we're going to have to wait for the results. on a mechanistic basis, I have high confidence are IgG-driven diseases, and there's a lot of mechanistic rationale for why they work. But we don't forecast them in our near-term revenues just until we see that data.

    其中許多將到 2030 年代中期,多個也將到 2040 年代。現在特別是四、五個(聽不清楚),這只是考慮 GMG 和 CIDP。我們知道我們將獲得六款公開的產品,這些產品的開發計劃已經很快在 Argenx 內部啟動。但我確實認為我們必須等待結果。從機制上講,我高度確信這些疾病是由 IgG 驅動的,而且它們起作用的原因有很多機制原理。但直到我們看到這些數據之前,我們不會預測我們的近期收入。

  • Now on top of that, though, don't forget that we have a pipeline, which is in the deck as well. And if we look at some of the pipeline products like relatlimab Opdivo and TAK-881, those are highly derisked as they already are approved as an IV and other format. And so those will layer on top. Other products in that pipeline that are currently in Phase 1, new nominations that we expect from current and new deals all start to potentially contribute in that '28, '29 timeframe as well.

    不過,最重要的是,不要忘記我們還有一條管道,它也在甲板上。如果我們看一些正在研發的產品,例如 relatlimab Opdivo 和 TAK-881,它們的風險是極低的,因為它們已經被批准用於 IV 和其他形式。所以它們會分層放在最上面。目前處於第一階段的其他產品線產品、我們預期從現有交易和新交易中獲得的新提名也都可能在 28、29 年的時間範圍內做出貢獻。

  • And so on top of that strong base, we've got multiple opportunities to layer and add on it, and that's what makes us so excited about the durability and the strength of our royalty revenues for many years to come.

    因此,在這個強大的基礎上,我們還有多個機會進行分層和擴展,這也是讓我們對未來許多年特許權使用費收入的持久性和強勁性感到興奮的原因。

  • Sean Laaman - Analyst

    Sean Laaman - Analyst

  • Thank you. I might say the rest of my questions from when we're due to talk later this evening, but thank you.

    謝謝。我可能會在今晚晚些時候談話時回答其餘的問題,但還是謝謝你。

  • Operator

    Operator

  • Brendan Smith, TD Cowen.

    布倫丹·史密斯(TD Cowen)。

  • Brendan Smith - Analyst

    Brendan Smith - Analyst

  • Great. Thanks for taking the questions. Congrats on another strong quarter. Maybe really quickly on BD. Can you just tell us a bit more about what is the inclusion or integration of that small volume auto-injector realistically do for the existing -- or new partnerships for that matter when you're having those BD conversations really just in terms of economics? And does that answer any different for the high-volume auto-injector. And then just on the ENHANZE conversations, maybe what is left in some of those late-stage discussions to really get partners over the finish line that gives you confidence in signing at least one new deal this year.?

    偉大的。感謝您回答這些問題。恭喜您又一個強勁的季度。在 BD 上可能真的很快。當您在進行 BD 對話時,您能否從經濟角度告訴我們,加入或整合小容量自動注射器對現有或新的合作關係有何實際影響?這對於大容量自動注射器有什麼不同的答案嗎?然後就在 ENHANZE 對話中,也許在一些後期討論中還剩下什麼才能真正讓合作夥伴跨過終點線,讓您有信心今年簽署至少一項新協議?

  • Helen Torley - President, Chief Executive Officer, Director

    Helen Torley - President, Chief Executive Officer, Director

  • Yeah. Thanks, Brendon. And obviously, we're excited to announce the small volume autoinjector deal with a current partner who signed up for a commercial product. Now, that particular deal and any more information is confidential at this time, but what we can see is that when we add on a small volume injector deal, it starts with a development agreement.

    是的。謝謝,布蘭登。顯然,我們很高興地宣布與現有合作夥伴達成小容量自動注射器商業產品交易。現在,該特定交易及任何其他資訊目前均處於保密狀態,但我們可以看到,當我們添加小容量注射器交易時,它是從開發協議開始的。

  • Those are structured in such a way that there's a certain fee for if you think about like that as we make progress in creating and developing the auto-injector, And then as our progress is made, we move into discussions on the commercial agreement. And for small volume injectors the traditional structure would be that there would be a certain price per device depending on volume that includes a margin or a markup the manufacturer in the case of Halozyme. So it will be another revenue stream for Halozyme that would be reflected in product sales.

    它們的結構是這樣的,如果你這樣想的話,當我們在創建和開發自動注射器方面取得進展時,就會產生一定的費用,然後隨著我們的進展,我們就會開始討論商業協議。對於小容量注射器,傳統的結構是每個裝置根據容量確定一定的價格,其中包括利潤或加價(就 Halozyme 而言)。因此,這將成為 Halozyme 的另一個收入來源,並反映在產品銷售中。

  • Now that's specific for the small volume auto injector but that does not need in it necessarily. When we think about the opportunity for the high-volume auto-injector, ENHANZE is the secret sauce for the high-volume auto-injector to work. And so high-volume auto-injector deals will be either associated with our current partners who have ENHANZE or could be with new partners who are licensing in hand and the high-volume auto-injector.

    現在,這是針對小容量自動注射器的特定功能,但這並不是必要的。當我們考慮大容量自動注射器的機會時,ENHANZE 就是大容量自動注射器發揮作用的秘密武器。因此,大容量自動注射器交易要么與擁有 ENHANZE 的現有合作夥伴相關,要么與手頭有許可證和大容量自動注射器的新合作夥伴相關。

  • With shipper weight dose, it is driving new royalty streams for us. as it could be bringing new products into the clinic for current partners or brand new products into the clinic. And in addition to that, we would receive a fee product sales once again on the sale of each and every device that we sell. So a nice layering on of both royalty addition and product sales in the case of the high-volume auto-injector. And the current agreement with the small volume auto injector is, I think, a nice illustration of patients.

    隨著托運人重量劑量的增加,它正在為我們帶來新的特許權使用費流。因為它可以為現有合作夥伴帶來新產品或為診所帶來全新的產品。除此之外,我們也會從所銷售的每台設備中再次收取產品銷售費。因此,在大容量自動注射器的情況下,特許權使用費增加和產品銷售都得到了很好的疊加。我認為,目前與小容量自動注射器達成的協議很好地體現了患者的需求。

  • We have been in that conversation for a period of time. We've continued to work through just internal reviews and approvals, and it's exactly the same as what's happening on our discussions with high-volume well, high-volume auto-injectors and also ENHANZE. And so we're in conversations with large pharma with biotech. We're at different stages, still in technical view with some, but moved on to terms discussions with others. And we just patiently walk through each company's process to get to that decision.

    我們已經就此話題討論有一段時間了。我們一直在透過內部審查和批准開展工作,這與我們與大容量井、大容量自動注射器以及 ENHANZE 的討論完全相同。因此,我們正在與大型製藥公司和生技公司進行洽談。我們處於不同的階段,有些階段仍處於技術角度,但已與其他階段進行條款討論。我們只是耐心地了解每個公司的流程以做出決定。

  • Based on the progress that we've continued to make. And I know from the outside, it seems slow, but we are very pleased with the progress we're making. I am very confident we're going to sign additional enhanced deals and high-volume auto-injector deals. We just have to go through the processes.

    基於我們不斷的進展。我知道從外部來看,這似乎很慢,但我們對所取得的進展感到非常滿意。我非常有信心我們將簽署更多增強協議和大容量自動注射器協議。我們只是要完成這些流程。

  • Brendan Smith - Analyst

    Brendan Smith - Analyst

  • Okay, great. Thanks very much.

    好的,太好了。非常感謝。

  • Operator

    Operator

  • Mohit Bansal, Wells Fargo.

    富國銀行的莫希特·班薩爾 (Mohit Bansal)。

  • Mohit Bansal - Analyst

    Mohit Bansal - Analyst

  • Great, thank you very much for taking my questions and congrats on the progress. So a couple of questions from my side. One is Nicole, you mentioned that you're modeling negative 10% royalties for first quarter over fourth quarter. Can you help me understand what is the -- what are the dynamics there? Because it has not happened in the past.

    太好了,非常感謝您回答我的問題,並祝賀您的進展。我有幾個問題。一位是妮可,你提到你對第一季版稅的模型預測是第四季版稅為負 10%。你能幫助我理解那裡的動態嗎?因為過去沒有發生過這樣的事情。

  • And specifically, we've got -- the CIDP launch is going really well. That's the first question. And the second question is, how are you incorporating a prefill sitings transition and its uptick in the guidance because it seems to be going really well.

    具體來說,我們的 CIDP 啟動進展非常順利。這是第一個問題。第二個問題是,您如何將預填選址過渡及其上升納入指導中,因為它似乎進展得非常順利。

  • Nicole Labrosse - Chief Financial Officer, Senior Vice President

    Nicole Labrosse - Chief Financial Officer, Senior Vice President

  • Thank you. Yeah, Thanks for the question, Mohit. So when we look at royalties quarter-over-quarter, what we're seeing is we do have contracts that have an annual rate reset that will start over in January at a lower rate and as we achieve volumes during the year, it gets back to the regular rate. The most material impact to us is from DARZALEX, and we have seen that last year, but as Darzalex continues to grow and contribute more, that impact is just a little bit more impactful to us. So that is the biggest driver, I would say, in the quarter-over-quarter impact that we see.

    謝謝。是的,謝謝你的提問,Mohit。因此,當我們逐季度查看特許權使用費時,我們看到的是,我們確實有一些合同,其年度費率將重置,該費率將於 1 月份以較低的費率重新開始,並且隨著我們在年內實現交易量,費率將恢復到正常費率。對我們影響最大的是 DARZALEX,我們在去年就已經看到了這一點,但隨著 Darzalex 的不斷發展和貢獻的增加,這種影響對我們來說只會更大一些。所以我想說,這是我們看到的季度環比影響中最大的驅動因素。

  • With that product, I can share that the time to get to the full rate is very quick, it happens within the first few months of the year. So it is just a small portion of the quarter where we see that impact. And then also just highlight, too, we also see an impact related to our EpiPen royalties, that's just related to seasonality. That's also something we expect in the first quarter. But so those are really the drivers for just that sequential quarter-over-quarter growth but also highlighting the very strong sequential growth expected in 2025 for the full year, achieving full year growth from prior year of 27% to 31%.

    有了該產品,我可以分享達到全額費率的時間非常快,它在一年幾個月內就發生了。因此,我們只在本季度的一小部分看到了這種影響。然後還要強調的是,我們也看到了與我們的 EpiPen 版稅相關的影響,這與季節性有關。這也是我們預期第一季會出現的情況。但這些實際上只是推動季度環比增長的因素,同時也凸顯了預計 2025 年全年將實現非常強勁的環比增長,全年增長率將從上年的 27% 增至 31%。

  • So very strong expectations for the full year.

    因此,我們對全年的期望非常高。

  • Helen Torley - President, Chief Executive Officer, Director

    Helen Torley - President, Chief Executive Officer, Director

  • And then second question, Nicole? Mohit, would you -- you cut out a little bit for me on the second question. Would you mind just repeating it?

    那麼第二個問題,妮可?Mohit,你能幫我把第二個問題縮短一點嗎?您介意再重複一遍嗎?

  • Mohit Bansal - Analyst

    Mohit Bansal - Analyst

  • Sure, thank you for the first answer. Sure. So how are you incorporating prefilled syringe transition for VYVGART and uptake in the guidance because it seems to be going really, really well here.

    當然,謝謝你的第一個回答。當然。那麼您如何在指南中結合 VYVGART 的預充注射器轉換和吸收,因為它在這裡似乎進展得非常順利。

  • Helen Torley - President, Chief Executive Officer, Director

    Helen Torley - President, Chief Executive Officer, Director

  • Yeah, Yes. Based on public comments that Argenx has made, they're expecting the prefilled syringe approval in April of this year. I think we've talked in the past that we meet with our partners towards the end of the year, and they give us their projections arranged for performance in 2025. And so we that Argenx will have contemplated that in the information and the range they gave us. So while we can't get into specifics, it does -- our guidance already reflects potential increase that prefilled syringe could bring.

    是的,是的。根據 Argenx 的公開評論,他們預計預充式註射器將於今年 4 月獲得批准。我想我們過去曾談到過,我們會在年底與合作夥伴會面,他們會為我們提供 2025 年業績預測。因此我們認為 Argenx 會在他們提供給我們的資訊和範圍中考慮到這一點。因此,雖然我們無法詳細說明,但我們的指導已經反映了預充式註射器可能帶來的潛在成長。

  • And I think what people are, I think, very excited about, it can bring the potential for a 20-second at-home injection vacation and could be adding more patients in both gMG and CIDP in 2025. But we believe it's already reflected in the ranges we received.

    我認為讓人們非常興奮的是,它可以帶來 20 秒在家注射的潛力,並可能在 2025 年為 gMG 和 CIDP 增加更多的患者。但我們相信這已經反映在我們收到的範圍中。

  • Mohit Bansal - Analyst

    Mohit Bansal - Analyst

  • Thank you, Helen and Nicole.

    謝謝你,海倫和妮可。

  • Operator

    Operator

  • Jessica Fye, JP Morgan.

    傑西卡‧菲伊 (Jessica Fye),摩根大通 (JP Morgan)。

  • Jessica Fye - Analyst

    Jessica Fye - Analyst

  • Hey guys, good evening. Thanks for taking my questions. With the small volume auto-injector deal you signed with an existing partner for existing commercial product, when would you anticipate that we might discover which partner that was and on which product? And just for the avoidance of doubt, this was for a product that's not a current ENHANZE product. Is that correct? And then second, just a quick one. Can you just remind us how you define mid-single digits when you talk about the royalties you received? Thank you.

    大家好,晚上好。感謝您回答我的問題。透過您與現有合作夥伴簽署的現有商業產品的小容量自動注射器協議,您預計我們何時可以發現該合作夥伴是哪一個,以及針對哪種產品?為避免疑問,該產品並非目前的 ENHANZE 產品。那正確嗎?其次,我再簡單說一下。您能否提醒我們一下,當您談到所收到的版稅時,您如何定義中位數個位數?謝謝。

  • Helen Torley - President, Chief Executive Officer, Director

    Helen Torley - President, Chief Executive Officer, Director

  • All right, Jess. I'll take the first one. So obviously, we're excited that we just signed a small volume auto-injector based on the partner's desire to keep this confidential. We actually have not established with them yet when they would want to talk about it. And I really can't see any more about it at this period of time.

    好的,傑西。我要第一個。因此顯然,我們很高興我們剛剛簽署了小容量自動注射器協議,因為合作夥伴希望對此保持保密。實際上,我們尚未與他們確定何時願意談論此事。而目前我實在無法再看到任何關於它的資訊。

  • But we obviously are interested in communicating as soon as possible, and we'll provide updates as soon as we learn more with regard to that. Nicole, would you talk about the range for mid-single digits.

    但我們顯然有興趣盡快進行溝通,一旦我們了解更多相關情況,我們將立即提供更新。妮可,你能談談中等個位數的範圍嗎?

  • Jessica Fye - Analyst

    Jessica Fye - Analyst

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Michael DiFiore, Evercore ISI.

    麥可‧迪菲奧雷 (Michael DiFiore),Evercore ISI。

  • Michael DiFiore - Analyst

    Michael DiFiore - Analyst

  • Hey guys, thanks for taking my question. Congrats on the progress this year. In light of the fact that VYVGART's overall brand sales in 4Q had a noticeable inflection and your comments on how VYVGART Hytrulo will be the biggest growth contributor in 2025, just want to get your take on whether 2025 may be the year that the subcu formulation exceeds the IV sales. To the extent that you can, if you could add any color on that. I know back in November, Argenx mentioned that the IV still comprises the bulk of sales, but wondering if you see any change in the mix over the course of 2025.

    嘿夥計們,謝謝你們回答我的問題。祝賀今年的進步。鑑於 VYVGART 第四季度的整體品牌銷售額出現了明顯的變化,以及您關於 VYVGART Hytrulo 將成為 2025 年最大增長貢獻者的評論,我只想听聽您對 2025 年是否可能是皮下製劑銷售額超過靜脈注射銷售額的一年的看法。如果您可以的話,請為其添加一些顏色。我知道早在 11 月,Argenx 就提到 IV 仍然佔銷售額的大部分,但想知道在 2025 年期間這種組合是否會發生任何變化。

  • Helen Torley - President, Chief Executive Officer, Director

    Helen Torley - President, Chief Executive Officer, Director

  • Yes. Thanks for that question, Mike. I mean, obviously, the comments that Argenx has made, we're delighted with the success in that we're seeing with VYVGART, both in CIDP and gMG. In terms of [indiscernible] VYVGART subcu could take over IV, as Argenx has not provided any perspective on that, it wouldn't be appropriate for us to comment on that. But certainly, we are very much that because it's allowing more physicians to start prescribing because it's moving therapy earlier in the treatment and because the CIDP launch is going so well already with already 1,000 patients on treatment, we are very excited to when that event actually happens.

    是的。謝謝你的提問,麥克。我的意思是,顯然,正如 Argenx 所發表的評論,我們對 VYVGART 在 CIDP 和 gMG 中的成功感到高興。就 [音訊不清晰] VYVGART subcu 可能接管 IV 而言,由於 Argenx 尚未提供任何關於此的觀點,因此我們不適合對此發表評論。但可以肯定的是,我們非常重視這一點,因為它允許更多的醫生開始開處方,因為它將治療推向了治療的早期階段,而且因為 CIDP 的啟動進展順利,已有 1,000 名患者接受治療,所以我們對這一事件的真正發生感到非常興奮。

  • But I can't communicate when that's anticipated.

    但我無法傳達預計何時會發生這種情況。

  • Michael DiFiore - Analyst

    Michael DiFiore - Analyst

  • Got it, I have one quick follow-up too. Thank you for that, Helen. and maybe I'm reading too much into this, but on slide 23, the three unscored products and indications at the bottom of the table on slide 23, could this mean that three new deals are expected to be announced this year or does that reflect current partnerships? Thank you.

    明白了,我也有一個快速的後續行動。謝謝你,海倫。也許我對此有過多的解讀,但在第 23 張投影片上,表格底部有三個未評分的產品和跡象,這是否意味著預計今年將宣布三筆新交易,或者這反映了當前的合作夥伴關係?謝謝。

  • Helen Torley - President, Chief Executive Officer, Director

    Helen Torley - President, Chief Executive Officer, Director

  • Yeah, all of those three are coming from current partners. As an example, recall that we had five new nominations from current partners last year. But we also have the opportunity for our current partners also to nominate any time with their open slots. And so all of them are current partners and any new deals moving forward would be over and above that.

    是的,這三個都來自現有合作夥伴。舉個例子,回想一下,去年我們有五個來自現有合作夥伴的新提名。但我們也有機會讓我們現有的合作夥伴隨時提名他們的空缺職位。因此,他們都是現有合作夥伴,任何新的交易都將超出這一範圍。

  • Michael DiFiore - Analyst

    Michael DiFiore - Analyst

  • Got it.

    知道了。

  • Operator

    Operator

  • Jason Butler, Citizens JMP.

    傑森‧巴特勒 (Jason Butler),公民 JMP。

  • Jason Butler - Analyst

    Jason Butler - Analyst

  • Hi, thanks for taking the questions. Helen, you mentioned for the large volume auto injectors, both the need and the work you did in 2024 to and build new device components I guess to what extent is that work potentially specific to a product or a small number of products versus broadly leverageable across multiple partnering conversations. And then second question for me is, I guess, for Nicole. Just any color you can give on what's remaining on the $250 million accelerated buyback? Thanks.

    嗨,感謝您回答這些問題。海倫,您提到了大容量自動注射器的需求以及您在 2024 年為製造新設備組件所做的工作,我猜想這項工作在多大程度上可能特定於某種產品或少數產品,而不是在多個合作對話中廣泛利用。我想,我的第二個問題是針對妮可的。能透露一下 2.5 億美元加速回購還剩下多少錢嗎?謝謝。

  • Helen Torley - President, Chief Executive Officer, Director

    Helen Torley - President, Chief Executive Officer, Director

  • Yeah, with the high volume autoinjector, we have been engaged in multiple conversations with various companies, and it has given us a perspective as to what is going to be an attractive primary container. And so that's exactly what we proceeded with. We believe that what we have moved with that particular element will be suitable for multiple partners. Now it might not be suitable for every partner, someone may want something custom developed, but we decided to make the investments so that we are ready and prepared for partners who are most likely going to want that size of primary container based on the conversations that we have had.

    是的,對於大容量自動注射器,我們與多家公司進行了多次對話,這讓我們了解了什麼是有吸引力的主要容器。這正是我們所做的事情。我們相信,我們所採取的這一特定元素將適合多個合作夥伴。現在它可能不適合每個合作夥伴,有人可能想要一些定制開發的東西,但我們決定進行投資,以便根據我們的對話,為最有可能想要這種尺寸的主容器的合作夥伴做好準備。

  • Nicole, on the ASR?

    妮可,在 ASR 上嗎?

  • Nicole Labrosse - Chief Financial Officer, Senior Vice President

    Nicole Labrosse - Chief Financial Officer, Senior Vice President

  • Yes. Thanks, Jason. On the ASR, so I can't share specifically how much our bank has executed through the $250 million. They did start executing on our behalf in December that will run for a number of months. But the benefit -- recall the benefit of this is that we did get approximately an estimate of 80% of the shares delivered to us in December.

    是的。謝謝,傑森。關於 ASR,我無法具體分享我們銀行透過 2.5 億美元執行了多少。他們確實從 12 月開始代表我們執行任務,並將持續數月。但好處——回想一下,這樣做的好處是,我們確實獲得了 12 月交付給我們的約 80% 的股票。

  • So those were retired at the start of the program at the final settlement date, we will then calculate with our bank with the final average purchase price was and the final the final delivery of the shares. So we have already received a good majority of the benefit from a retiring the shares perspective and then in the coming months, we will know the final averaging data and have completed the $250 million.

    因此,這些在計劃開始時即最終結算日退出的股票,我們將與銀行一起計算最終的平均購買價格以及最終的股票交付價格。因此,從退出股票的角度來說,我們已經獲得了絕大部分的收益,在接下來的幾個月裡,我們將知道最終的平均數據,並完成 2.5 億美元的收益。

  • Jason Butler - Analyst

    Jason Butler - Analyst

  • All right, thank you.

    好的,謝謝。

  • Operator

    Operator

  • Mitchell Kapoor, H.C. Wainwright.

    米切爾·卡普爾,H.C.溫賴特。

  • Daniel Smith - Analyst

    Daniel Smith - Analyst

  • Good afternoon. This is Dan on for Mitch. Congratulations on the earnings fee. So when you think about business development, are you more focused on larger deals or groups of smaller deals? And are there any contract obligations prohibiting partnering agreements with PD-1 BGF bispecific programs? And if not, what's the interest in partnering with one?

    午安.這是丹,代替米奇。恭喜您獲得收入費用。那麼,當您考慮業務發展時,您是否更關注較大的交易還是較小的交易群體?是否存在任何合約義務禁止與 PD-1 BGF 雙特異性項目達成合作協議?如果沒有,那麼與其合作有什麼好處呢?

  • Helen Torley - President, Chief Executive Officer, Director

    Helen Torley - President, Chief Executive Officer, Director

  • Thank you. All right. Thanks for the question, Dan. With regard to BD, I can say that we are talking to multiple companies across large and small deals. As you hear, small deals, which we could define as companies who are perhaps earlier stage, can turn out to be incredibly attractive future opportunities, and I'll use the example of Argenx and VYVGART, they were purely known when we kind of started working with them. And so we look at each individual opportunity, assess that opportunity and proceed based on that.

    謝謝。好的。謝謝你的提問,丹。關於 BD,我可以說我們正在與多家公司洽談大大小小的交易。正如您所聽到的,小型交易(我們可以將其定義為可能處於早期階段的公司)可能會成為極具吸引力的未來機會,我將以 Argenx 和 VYVGART 為例,當我們開始與他們合作時,他們就已經為人所知。因此,我們會研究每一個機會,對其進行評估,並在此基礎上繼續前進。

  • But we're talking about IV to subcu conversion. We're talking about extended dose. We're talking about exclusive and nonexclusive arrangements. So it's really a very nice array of opportunities that we are progressing towards consummation of deals in 2025. With regard to the specific question on the PD-1 bispecific, based on the exclusive terms of the agreement we have with Bristol, we would not be able to partner on a PD-1 bispecific.

    但我們正在討論 IV 到 subcu 的轉換。我們正在討論延長劑量。我們正在討論獨家和非獨家安排。因此,這確實是一個非常好的機會,我們正朝著 2025 年完成交易的目標邁進。關於 PD-1 雙特異性抗體的具體問題,根據我們與布里斯托爾達成的協議中的獨家條款,我們無法在 PD-1 雙特異性抗體上進行合作。

  • Operator

    Operator

  • Okay. Thank you very much. And that's the end of our Q&A session. Ladies and gentlemen, that concludes today's call. Thank you all for joining, and you may now disconnect.

    好的。非常感謝。我們的問答環節到此結束。女士們、先生們,今天的電話會議到此結束。感謝大家加入,現在可以斷開連線了。