Halozyme Therapeutics Inc (HALO) 2025 Q2 法說會逐字稿

Good afternoon. My name is Kayla, and I will be your conference operator today. At this time, I would like to welcome everyone to the Halozyme second-quarter 2025 financial and operating results conference call. (Operator Instructions) Please note this event is being recorded.

午安.我叫凱拉 (Kayla)，今天我將擔任您的會議主持人。現在，我歡迎大家參加 Halozyme 2025 年第二季財務與經營業績電話會議。（操作員指示）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。

Thank you, operator. Good afternoon, and welcome to our second-quarter 2025 financial and operating results conference call. 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.

謝謝您，接線生。下午好，歡迎參加我們 2025 年第二季財務與經營業績電話會議。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引用的補充幻燈片簡報。

Leading the call will be Dr. Helen Torley, Halozyme's President and Chief Executive Officer, who will provide an update on our business; and Nicole LaBrosse, our Chief Financial Officer, who will review our financial results as well as our outlook.

主持此次電話會議的將是 Halozyme 總裁兼執行長 Helen Torley 博士，她將介紹我們的業務最新情況；我們的財務長 Nicole LaBrosse 將回顧我們的財務表現和前景。

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. 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.

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提交的文件，以獲取風險和不確定性的完整清單。電話會議期間，我們將討論 GAAP 和非 GAAP 財務指標。在我們的收益新聞稿和幻燈片簡報中，某些非 GAAP 或調整後的財務指標與可比較的 GAAP 財務指標相協調。

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。

Good afternoon, everyone, and thank you for joining us today. Let me begin on slide 3. I'm pleased to announce another record quarter, which highlights the significant growth and accelerating momentum we have across the business. Total revenue in the quarter was $326 million, representing a 41% increase over second quarter prior year. This robust growth was driven by continued strong royalty revenue performance driven by our three established blockbuster subcutaneous therapies, DARZALEX subcutaneous, subcutaneous Phesgo, and VYVGART Hytrulo.

大家下午好，感謝大家今天的參與。我從幻燈片 3 開始。我很高興地宣布又一個創紀錄的季度，這凸顯了我們整個業務的顯著增長和加速勢頭。本季總營收為 3.26 億美元，比去年同期第二季成長 41%。這一強勁增長得益於我們三種成熟的重磅皮下療法——DARZALEX 皮下注射、Phesgo 皮下注射和 VYVGART Hytrulo——持續強勁的特許權使用費收入表現。

This quarter's royalty revenue grew an impressive 65% year over year to $206 million. And adjusted EBITDA increased an outstanding 65% over prior year second quarter to $226 million. This was driven by the accelerating growth of our high-margin royalty revenue streams as a result of increasing demand for products incorporating our leading drug delivery technology in hand.

本季特許權使用費收入年增 65%，達到 2.06 億美元。調整後的 EBITDA 較去年同期第二季大幅成長 65%，達到 2.26 億美元。這是由於採用我們領先的藥物輸送技術的產品需求不斷增加，導致我們的高利潤特許權使用費收入流加速成長。

Based on this strong continued performance and the growth trends, I am pleased to announce that we are raising our 2025 financial guidance for the second time this year. We are now projecting total revenue of $1.275 billion to $1.355 billion, representing 26% to 33% growth over 2024. This is a further increase to revenue guidance of $75 million after raising guidance by approximately $50 million in the first quarter reporting.

基於這一強勁的持續表現和成長趨勢，我很高興地宣布，我們今年第二次上調了 2025 年財務指導。我們現在預計總收入為 12.75 億美元至 13.55 億美元，比 2024 年成長 26% 至 33%。繼第一季報告將營收預期上調約 5,000 萬美元之後，此次收入預期又進一步上調至 7,500 萬美元。

2025 full year royalty revenue guidance is increased to $825 million to $860 million, representing growth year over year of 44% to 51%. Adjusted EBITDA and non-GAAP EPS guidance have also been raised, and Nicole will go into more detail on this shortly.

2025 年全年特許權使用費收入預期上調至 8.25 億美元至 8.6 億美元，年增 44% 至 51%。調整後的 EBITDA 和非 GAAP EPS 指引也已上調，Nicole 將很快對此進行更詳細的介紹。

During the quarter, we completed the second $250 million share repurchase tranche of our authorized $750 million share repurchase plan. I'm pleased that we also initiated our third $250 million share repurchase program under the approved $750 million plan. Importantly, the strength of our revenue growth and the resulting strong cash generation enabled us to be able to add this additional $250 million of share repurchases while being able to pursue our M&A goals.

本季度，我們完成了授權的 7.5 億美元股票回購計畫中的第二筆 2.5 億美元股票回購。我很高興我們還根據批准的 7.5 億美元計劃啟動了第三個 2.5 億美元的股票回購計劃。重要的是，強勁的收入成長和由此產生的強勁現金流使我們能夠在追求併購目標的同時，增加這 2.5 億美元的股票回購。

With regard to M&A, we are continuing to focus on identifying new drug delivery platforms where their business model results in long durable revenue streams such as through royalties and where we see the opportunity to license the technology to multiple pharma partners. We heard your leverage, and we are seeking deals that can be accomplished without the need for significant increases in net debt to EBITDA leverage.

關於併購，我們將繼續專注於尋找新的藥物輸送平台，其商業模式將帶來長期持久的收入流，例如透過特許權使用費，並且我們看到了將該技術授權給多個製藥合作夥伴的機會。我們了解您的槓桿率，我們正在尋求無需大幅增加淨債務與 EBITDA 槓桿率即可完成的交易。

I'll move now to slide 4. On the first-quarter call, I highlighted multiple catalysts for our current portfolio, which had just occurred of which we are expecting throughout the year that will drive incremental strong revenue and EBITDA growth for multiple years to come. There are now 14 catalysts, of which I'm pleased to note 11 have already occurred. While I will highlight these exciting growth catalysts in more detail as we review each product, I want to highlight and emphasize how each catalyst represents a meaningful revenue growth inflection for our royalty revenue.

我現在轉到投影片 4。在第一季的電話會議上，我強調了我們目前投資組合的多個催化劑，這些催化劑剛剛出現，我們預計全年這些催化劑將在未來幾年推動強勁的收入和 EBITDA 成長。現在有 14 個催化劑，我很高興地註意到其中 11 個已經發生。雖然在審查每種產品時我會更詳細地強調這些令人興奮的成長催化劑，但我想強調並強調每種催化劑如何代表我們的特許權使用費收入的有意義的收入成長轉折點。

Let me begin with a new product approval and a new royalty revenue stream, which was for Rybrevant subcutaneous in Europe in April. Johnson & Johnson has commented on the critical role that subcutaneous Rybrevant is playing in achieving their ambitions to grow Rybrevant to become a $5 billion brand.

首先，我要介紹一下 4 月在歐洲批准的 Rybrevant 皮下注射劑的一項新產品和新的特許權使用費收入來源。強生公司曾表示，皮下注射 Rybrevant 在實現其將 Rybrevant 發展成為價值 50 億美元的品牌的宏偉目標中發揮著關鍵作用。

There are two recent first-time approvals in a major region, specifically for Opdivo subcutaneous in Europe and provide that Hytrulo in chronic inflammatory demyelinating polyneuropathy, or CIDP, also in Europe, both of which occurred in the second quarter, and which represents additional revenue inflecting opportunity as adoption grows in Europe.

最近，主要地區有兩項藥物首次獲得批准，分別是歐洲的 Opdivo 皮下注射劑和歐洲的 Hytrulo 用於治療慢性發炎性脫髓鞘性多發性神經病變 (CIDP)，這兩項批准均發生於第二季度，隨著歐洲採用率的提高，這代表著額外的收入成長機會。

There have been five new indication approvals. Let me highlight DARZALEX subcutaneous, which gained new indication approvals in smaller and multiple myeloma and in a new frontline indication in Europe, which expands their TAM in patients early in the disease and provides a meaningful new growth opportunity and revenue inflection opportunity to Halozyme.

已有五項新適應症獲得批准。讓我重點介紹 DARZALEX 皮下注射劑，該藥物獲得了針對較小和多發性骨髓瘤的新適應症批准，並在歐洲獲得了新的一線適應症批准，這擴大了早期疾病患者的 TAM，並為 Halozyme 提供了有意義的新增長機會和收入拐點機會。

Another new indication approval was the Hytrulo prefilled syringe, which we know is already contributing and creating an inflection in the growth of VYVGART Hytrulo after just one quarter. And I will close on three major reimbursement milestones, which have recently occurred, including Phesgo's reimbursement in China, and permanent codes added for OCREVUS ZUNOVO and Opdivo Qvantig, all of which add to and will expand our opportunity, adoption, and create royalty revenue inflection.

另一項新的適應症批准是 Hytrulo 預充式註射器，我們知道，僅一個季度後，注射器就已經為 VYVGART Hytrulo 的成長做出了貢獻並創造了轉折點。最後，我將結束最近發生的三個主要報銷里程碑，包括 Phesgo 在中國的報銷，以及為 OCREVUS ZUNOVO 和 Opdivo Qvantig 添加的永久代碼，所有這些都將增加並擴大我們的機會、採用，並創造特許權使用費收入的變化。

In our history as a company, we have never had such a broad and meaningful set of growth catalysts, creating new additional incremental royalty streams and revenue inflection across so many products. These catalysts extend beyond supporting our growing commercial success but also reflect the important role our ENHANZE technology is playing in significantly enhancing patient access, improving convenience for patients, and addressing unmet patient needs.

在我們公司的歷史上，我們從未擁有過如此廣泛和有意義的成長催化劑，為如此多的產品創造了新的額外增量特許權使用費流和收入轉折點。這些催化劑不僅支持我們不斷增長的商業成功，還反映了我們的 ENHANZE 技術在顯著增強患者就醫機會、提高患者便利性和滿足未滿足的患者需求方面發揮的重要作用。

I'll now focus on the three blockbuster products that are driving our remarkable current growth, starting with DARZALEX, which is shown on slide 5. Johnson & Johnson reported strong second-quarter results for DARZALEX with revenue increasing almost 22% to $3.5 billion in the quarter. Growth was driven by share gains of approximately 4 points across all lines of therapy and almost 8 points in the frontline setting in addition to market growth.

現在，我將重點介紹推動我們目前顯著成長的三款重磅產品，首先是投影片 5 上顯示的 DARZALEX。強生公司公佈了 DARZALEX 第二季度的強勁業績，本季營收成長近 22%，達到 35 億美元。除了市場成長之外，推動成長的因素還包括所有治療系列的份額增長約 4 個百分點，一線治療的份額增長近 8 個百分點。

I want to highlight two critical points here. Firstly, the subcutaneous delivery of DARZALEX with ENHANZE has reached 96% conversion in the United States with a similarly high conversion rate outside the United States, meaning that it is a subcutaneous treatment version on which Halozyme receives a mid-single-digit royalty that is driving and benefiting from the strong growth I just mentioned.

我想在這裡強調兩個關鍵點。首先，DARZALEX 與 ENHANZE 的皮下給藥在美國已達到 96% 的轉化率，在美國以外的轉化率也同樣高，這意味著它是一種皮下治療版本，Halozyme 可以從中獲得中等個位數的版稅，這推動並受益於我剛才提到的強勁增長。

And secondly, quarter after quarter, Johnson & Johnson has commented on the robust share gains for DARZALEX subcutaneous in the frontline setting. This is important as frontline patients as a whole have a longer survival and often a longer duration of treatment compared to the later life patients. The increased penetration in frontline is what is driving today's strong growth, and we project that it will continue for many years to come.

其次，強生公司每季都對 DARZALEX 皮下注射劑在前線治療領域的強勁份額成長發表了評論。這很重要，因為與晚期患者相比，第一線患者整體存活期更長，治療時間也更長。一線滲透率的提高是推動當今強勁成長的動力，我們預計這種趨勢將持續多年。

Moving now to the recent catalysts that provide new opportunity and growth. DARZALEX subcutaneous recently received two new approvals in Europe. The first is for subcutaneous DARZALEX as part of a quadruplet regimen for newly diagnosed patients regardless of transplant eligibility. And the second is for high-risk smoldering multiple myeloma.

現在轉向提供新機會和成長的近期催化劑。DARZALEX 皮下注射劑最近在歐洲獲得了兩項新批准。第一種是將皮下 DARZALEX 作為四聯療法的一部分，用於新診斷的患者，無論其是否符合移植資格。第二種是針對高風險冒煙型多發性骨髓瘤。

The approval in high-risk smoldering multiple myeloma was based on the Phase III AQUILA study, which saw a significantly reduced risk of progression to active multiple myeloma or death by 51% compared to the current standard of care, which is active monitoring. The new indication addresses a long-standing unmet clinical need and marks a critical advancement in the early intervention of the disease for those who are at high risk.

高風險冒煙型多發性骨髓瘤的核准是基於 III 期 AQUILA 研究，該研究發現與目前的標準治療（即主動監測）相比，進展為活動性多發性骨髓瘤或死亡的風險顯著降低了 51%。這項新適應症解決了長期未滿足的臨床需求，標誌著對高風險族群進行疾病早期幹預方面取得了重大進展。

To help you dimensionalize this opportunity, in Europe in 2022, approximately 35,000 patients were diagnosed with multiple myeloma, often 15% had smoldering multiple myeloma. For those with high-risk smoldering multi myeloma, half will progress to multiple myeloma within two years. For these patients, this approval for DARZALEX subcutaneous marks the first ever approved therapeutic intervention and the hope that progression to full-blown multiple myeloma can be slowed.

為了幫助您具體了解這個機會，2022 年，歐洲約有 35,000 名患者被診斷出罹患多發性骨髓瘤，其中 15% 患有冒煙型多發性骨髓瘤。對於有高風險冒煙型多發性骨髓瘤的患者，有一半會在兩年內發展為多發性骨髓瘤。對於這些患者來說，DARZALEX 皮下注射劑的批准標誌著首個獲批的治療幹預措施，並有望減緩多發性骨髓瘤的進展。

Turning to the US regulatory approval status, in May, Johnson & Johnson announced the US Food and Drug Administration, Oncologic Drug Advisory Committee voted in favor of the benefit/risk profile of DARZALEX (inaudible) for the treatment of adult patients with high-risk smoldering multiple myeloma. The projection from analysts for DARZALEX is approximately $18 billion in sales in 2028, and Halozyme will earn royalties in DARZALEX with ENHANZE through 2032.

談到美國監管部門的批准情況，5 月份，強生公司宣布，美國食品藥物管理局腫瘤藥物諮詢委員會投票支持 DARZALEX（聽不清楚）用於治療高風險冒煙型多發性骨髓瘤成年患者的獲益/風險概況。分析師預測 DARZALEX 2028 年的銷售額約為 180 億美元，而 Halozyme 將在 2032 年之前透過 ENHANZE 獲得 DARZALEX 的特許權使用費。

Turning to our second blockbuster, Roche's Phesgo, which is shown on slide 6. Phesgo, which is the combination of Perjeta, Herceptin, and ENHANZE, represented the leading growth driver in Roche's pharma portfolio with first half 2025 revenue of CHF1.2 billion or approximately USD1.5 billion, reflecting a 55% year-over-year growth. There was strong uptake across all regions with the global conversion from Perjeta to Phesgo at 46% across 78 launch countries, which increased from 58 launch countries in the first quarter.

談到我們的第二款重磅產品，羅氏的 Phesgo，如幻燈片 6 所示。Phesgo 是 Perjeta、Herceptin 和 ENHANZE 的組合，是羅氏製藥產品組合中的主要成長動力，2025 年上半年的收入為 12 億瑞士法郎或約 15 億美元，年成長 55%。所有地區的採用率均表現強勁，全球 78 個上市國家從 Perjeta 轉換為 Phesgo 的比例為 46%，高於第一季的 58 個上市國家。

The convenience of Phesgo was also reinforced in April, with a CHMP recommendation for European label expansion, allowing administration outside of clinical settings, such as at home by a healthcare professional once safety has been established. This label expansion represents another growth catalyst for Phesgo.

今年 4 月，CHMP 建議擴大 Phesgo 的歐洲標籤範圍，從而進一步增強了 Phesgo 的便利性，一旦確定了安全性，即可在臨床環境之外進行給藥，例如由醫療保健專業人員在家中進行給藥。此次品牌擴張是 Phesgo 的另一個成長催化劑。

Roche project conversion from Perjeta will continue bringing an improved treatment experience for patients and the potential to significantly reduce treatment administration costs. We are pleased with Phesgo's increasing reach and the impact of our ENHANZE technology platform, with royalties at the full mid-single-digit rate through 2030.

羅氏公司從 Perjeta 進行的該計畫轉換將繼續為患者帶來更好的治療體驗，並有可能大幅降低治療管理成本。我們對 Phesgo 不斷擴大的影響力和 ENHANZE 技術平台的影響力感到滿意，到 2030 年，其特許權使用費將保持中等個位數的成長率。

Let me move now to slide 7. Our partnership with argenx reflects assured mission to provide innovative new treatment options for patients globally. The success of VYVGART and VYVGART Hytrulo, which is a subcutaneous formulation with ENHANZE, are a great demonstration of how innovation can support patient outcomes. VYVGART Hytrulo continues to be a key driver of the exceptional growth of VYVGART total sales, which increased 97% year over year in the second quarter to $949 million.

現在請容許我翻到第 7 張投影片。我們與 argenx 的合作體現了我們為全球患者提供創新治療方案的堅定使命。VYVGART 和 VYVGART Hytrulo（一種含有 ENHANZE 的皮下製劑）的成功充分證明了創新如何支持患者的治療效果。VYVGART Hytrulo 繼續成為 VYVGART 總銷售額卓越成長的主要推動力，第二季總銷售額年增 97%，達到 9.49 億美元。

VYVGART Hytrulo is now approved in the United States and Europe in two indications: generalized myasthenia gravis and CIDP. The subcutaneous formulation with ENHANZE has been essential to broaden five parts reach to gain new prescribers and new patients in both indications. And the prefilled syringe for subcutaneous delivery, which is also enabled by ENHANZE, is playing a key role in reading even more patients earlier in the treatment paradigm.

VYVGART Hytrulo 目前已在美國和歐洲獲準用於治療兩種疾病：全身性重症肌無力和 CIDP。ENHANZE 的皮下製劑對於擴大五個部分的覆蓋範圍以獲得兩種適應症的新處方者和新患者至關重要。同樣由 COHANZE 支援的用於皮下輸送的預充式註射器在治療模式的早期讀取更多患者資訊方面發揮關鍵作用。

I'll begin with generalized myasthenia gravis and provide some more details. Organic reported a strong quarter in generalized myasthenia gravis, marking the 14th quarter of consistent growth. The launch of the prefilled syringe is helping argenx reach new GMG patient segments particularly those who have previously been out of reach for the HCP administered option.

我將從全身性重症肌無力開始並提供更多細節。Organic 報告稱，本季全身性重症肌無力治療表現強勁，連續第 14 個季度持續成長。預充式註射器的推出正在幫助 argenx 接觸到新的 GMG 患者群體，特別是那些以前無法獲得 HCP 給藥選擇的患者。

argenx further commented that they see that myasthenia gravis total addressable market to be 60,000 patients in the United States, which is significantly higher than the initial estimates at launch, which were of 17,000 patients. This increase is driven by the potential addition of seronegative myasthenia gravis and ocular myasthenia gravis indications plus the availability of biologics adding 25,000 patients to the addressable population.

argenx 進一步評論說，他們認為重症肌無力在美國的總目標市場為 60,000 名患者，這大大高於最初推出時的估計值 17,000 名患者。這一增長是由於血清陰性重症肌無力和眼部重症肌無力適應症的潛在增加，以及生物製劑的可用性，使可尋址人群增加了 25,000 名患者。

The prefilled syringe is emerging as a key differentiator that will help increase penetration into this additional 25,000 patient opportunity.

預充式註射器正在成為關鍵的差異化因素，有助於提高對這另外 25,000 名患者機會的滲透率。

I'll turn now to CIDP. As of the end of June, argenx reported over 2,500 CIDP patients had been treated globally with VYVGART Hytrulo. A majority of these patients are in the United States. argenx also noted that the launches in Japan and Germany are off to a fast start. This momentum was driven by the unmet need, meaningful outcomes driven by the safety and efficacy profile, and the availability of the prefilled syringe.

現在我來談談 CIDP。截至 6 月底，argenx 報告全球已有超過 2,500 名 CIDP 患者接受 VYVGART Hytrulo 治療。這些患者大多數在美國。 argenx 也指出，日本和德國的上市工作進展迅速。這一勢頭是由未滿足的需求、安全性和有效性所驅動的有意義的結果以及預充式註射器的可用性所推動的。

With an estimated 12,000-patient population, there is significant growth opportunity ahead in CIDP. Recall, only VYVGART Hytrulo with ENHANZE is approved to treat CIDP. So 100% of sales are subcutaneous on which Halozyme receives a mid-single-digit royalty.

CIDP 擁有約 12,000 名患者，未來具有巨大的成長機會。請記住，只有 VYVGART Hytrulo 與 ENHANZE 被批准用於治療 CIDP。因此，100% 的銷售額來自皮下注射，Halozyme 從中獲得中等個位數的版稅。

Moving now to the prefilled syringe, which was approved in the United States and Europe in the second quarter. argenx on their second quarter call, commented that the introduction of the prefilled syringe led to a notable increase in demand. In the United States, argenx reported that prefilled syringe drove record patient adoption with 50% of prefilled syringe users being entirely new to the brand and the rest switching from vial or IV.

現在談談預充式註射器，該注射器於第二季在美國和歐洲獲得批准。 argenx 在其第二季度電話會議上評論說，預充式註射器的推出導致需求顯著增加。在美國，argenx 報告預充式註射器推動了創紀錄的患者採用率，其中 50% 的預充式註射器用戶是該品牌的新用戶，其餘用戶則是從小瓶或靜脈注射轉換而來。

The prefilled syringe also broadened the prescriber base with over 1,000 physicians writing prescriptions in the first quarter of launch, 15% of whom were first-time prescribers of any VYVGART product presentation. This really is a testament to the innovative technology, convenience of treatment, and suggests that the prefilled syringe is a long-term growth enabler for all current and future indications for VYVGART Hytrulo.

預充式註射器也擴大了處方者基礎，在推出的第一季度，已有超過 1,000 名醫生開立處方，其中 15％ 是首次開立 VYVGART 產品的處方者。這確實證明了創新技術和治療的便利性，並表明預充式註射器是 VYVGART Hytrulo 所有當前和未來適應症的長期成長推動因素。

VYVGART Hytrulo is a prime example of a durable contributor to our long-term financial expectations, with analyst projections of $7 billion just in myasthenia gravis and CIDP and Halozyme earning royalties through the early 2040s.

VYVGART Hytrulo 是我們長期財務預期的持久貢獻者的典型例子，分析師預測僅在重症肌無力領域就將創造 70 億美元的收入，而 CIDP 和 Halozyme 將在 2040 年代初獲得特許權使用費。

Now in addition to these three blockbusters that are driving our growth to date, we have four recently launched products with ENHANZE: OCREVUS ZUNOVO, Tecentriq Hybreza, OPDIVO Qvantig, and Rybrevant subcutaneous, which are still early in their launches and will become more meaningful contributors in 2026 and beyond.

現在，除了這三款迄今為止推動我們成長的重磅產品之外，我們還有四款最近與 ENHANZE 合作推出的產品：OCREVUS ZUNOVO、Tecentriq Hybreza、OPDIVO Qvantig 和 Rybrevant 皮下注射，這些產品仍處於推出初期，並將在 2026 年及以後成為更有意義的貢獻者。

I'll now move to slide 8 and begin with OCREVUS. Roche reported continued good momentum for OCREVUS, with total revenue increasing 8% to CHF3.5 billion or approximately USD4.4 billion in the first half of 2025. Roche recently affirmed that they are confident in their outlook for OCREVUS to grow high single digits in 2025.

我現在轉到投影片 8，從 OCREVUS 開始。羅氏報告稱，OCREVUS 持續保持良好發展勢頭，2025 年上半年總收入成長 8%，達到 35 億瑞士法郎或約 44 億美元。羅氏公司最近表示，他們對 OCREVUS 在 2025 年實現高個位數成長的前景充滿信心。

OCREVUS ZUNOVO with ENHANZE was approved in 2024, and allows for an approximately 10 minutes subcutaneous injection, which compares with multiple hours that is typically required for the intravenous administration and monitoring time.

OCREVUS ZUNOVO 與 ENHANZE 於 2024 年獲得批准，可進行約 10 分鐘的皮下注射，而靜脈給藥和監測時間通常需要數小時。

In the second quarter, Roche reported that almost 7,000 patients have already been treated with the subcutaneous formulation globally. With 50% of new OCREVUS ZUNOVO patients in the United States and Germany being reported as being naive to the brand, OCREVUS ZUNOVO is expected to continue to increase access and reach more patients. Existing large academic centers are adopting OCREVUS ZUNOVO as a more convenient option for patients, while community neurologists with more limited IV capacity are seeing it open up the patient population they are able to treat.

羅氏公司在第二季度報告稱，全球已有近 7,000 名患者接受了皮下注射劑型治療。據報道，美國和德國 50% 的新 OCREVUS ZUNOVO 患者對該品牌並不熟悉，預計 OCREVUS ZUNOVO 將繼續擴大其可及性並惠及更多患者。現有的大型學術中心正在採用 OCREVUS ZUNOVO 作為對患者更方便的選擇，而靜脈注射能力較有限的社區神經科醫生則發現它擴大了他們能夠治療的患者群體。

The ongoing launch of the subcutaneous formulation with ENHANZE is expected to continue to accelerate in the United States following the permanent J-code, which was granted on April 1. We look forward to increasing adoption of subcutaneous coming from both switches from the IV formulation and from new-to-brand patients. The total brand opportunity for OCREVUS is projected by analysts to be $10 billion in 2028 and Halozyme will earn royalties on the subcutaneous formulation at its full mid-single-digit base until 2030, and that's a step-down rate until at least 2034.

繼 4 月 1 日獲得永久 J 代碼批准後，ENHANZE 皮下製劑的持續上市預計將在美國繼續加速。我們期待越來越多的患者從靜脈注射劑型轉換到皮下注射，並接受新品牌藥物治療。分析師預測，到 2028 年，OCREVUS 的品牌總商機將達到 100 億美元，而 Halozyme 將在 2030 年前以中等個位數的基數獲得皮下製劑的特許權使用費，而且這一費率至少在 2034 年之前會逐步下降。

I'll move now to Roche's Tecentriq Hybreza with ENHANZE. Tecentriq Hybreza was approved in the United States and Europe in 2024 for all of the IV indications and the ENHANZE-enabled formulation offers patients and providers with a more convenient seven-minute subcutaneous injection. Roche has previously commented that it is their strategy to convert the IV to subcutaneous use. Tecentriq represented CHF1.7 billion of revenue in the first half of 2025. Looking forward, analysts project revenue of approximately $4.5 billion in 2028. Halozyme will earn royalties on net sales of the subcutaneous formulation at its full mid-single-digit rate until the 2040s.

我現在將轉向使用 ENHANZE 的 Roche 的 Tecentriq Hybreza。Tecentriq Hybreza 於 2024 年在美國和歐洲獲得批准，用於所有靜脈注射適應症，而採用 ENHANZE 技術的配方為患者和提供者提供了更方便的七分鐘皮下注射。羅氏公司先前曾表示，他們的策略是將靜脈注射轉換為皮下注射。Tecentriq 在 2025 年上半年的收入為 17 億瑞士法郎。展望未來，分析師預測 2028 年的營收約為 45 億美元。到 2040 年代，Halozyme 將以中等個位數的稅率獲得皮下製劑淨銷售額的特許權使用費。

Now moving to Bristol Myers Squibb Opdivo subcutaneous with ENHANZE, which was granted FDA approval at the end of 2024 and approval in Europe in May. BMS recently reported that the early feedback in the US is encouraging with the three-minute subcutaneous treatment saving patients, caregivers, and providers time while also improving clinic efficiency, increasing patient comfort, and reducing treatment complexity. Additionally, (inaudible) procedures streamline care, allowing physicians to treat more patients.

現在轉向百時美施貴寶 Opdivo 皮下注射與 ENHANZE，該藥物於 2024 年底獲得 FDA 批准，並於 5 月在歐洲獲得批准。BMS 最近報告稱，美國的早期回饋令人鼓舞，三分鐘的皮下治療節省了患者、照護者和提供者的時間，同時提高了診所效率、增加了患者的舒適度並降低了治療的複雜性。此外，（聽不清楚）程序簡化了護理，使醫生能夠治療更多的患者。

In the second quarter, OPDIVO Global sales were approximately $2.6 billion, up 7%, driven primarily by demand. BMS reported that the US launch of Quantis is progressing well with sales of approximately $30 million, with the use across all indicated tumor types. The permanent J-Code that was received on July 1 will support additional conversion. The strong year-to-date performance of OPDIVO plus Opdivo Qvantig are now projected to result in mid- to high single-digit growth of global OPDIVO sales for the full year.

第二季度，OPDIVO全球銷售額約26億美元，成長7%，主要受需求推動。BMS 報告稱，Quantis 在美國的上市進展順利，銷售額約 3,000 萬美元，適用於所有適應症腫瘤類型。7 月 1 日收到的永久 J-Code 將支援額外的轉換。OPDIVO 和 Opdivo Qvantig 今年迄今的強勁表現預計將推動 OPDIVO 全年全球銷售額實現中高個位數成長。

Analysts project total brand sales of $9.5 billion in 2028.

分析師預測 2028 年品牌總銷售額將達到 95 億美元。

I'll move now to Johnson & Johnson's Rybrevant subcutaneous, which represents our 10th approved partner product. Rybrevant subcutaneous, coformulated with ENHANZE, was approved in Europe in April of 2025 for using combination with lazatrinib for the first-line treatment of adult patients with advanced EGFR-mutated non-small cell lung cancer. The subcutaneous delivery with ENHANZE reduces administration time from multiple hours to minutes and results in a fivefold reduction in the potentially serious adverse event of infusion-related reactions when compared to the IV formulation.

現在我將談談強生公司的 Rybrevant 皮下注射劑，這是我們第 10 種獲準的合作夥伴產品。Rybrevant 皮下注射劑與 ENHANZE 聯合用藥，於 2025 年 4 月在歐洲獲得批准，與拉扎曲尼聯合用於晚期 EGFR 突變非小細胞肺癌成年患者的一線治療。與靜脈注射相比，ENHANZE 皮下給藥可將給藥時間從數小時縮短至數分鐘，並使輸液相關反應的潛在嚴重不良事件減少五倍。

Furthermore, in an exploratory analysis, the subcutaneous formulation improved overall survival compared to the IV formulation. In the second quarter, Johnson & Johnson reported Rybrevant revenue of $179 million, representing an increase of over 100% year over year and growth of approximately 27% sequentially, which was driven by continued strong launch uptake.

此外，在一項探索性分析中，與靜脈注射製劑相比，皮下注射製劑提高了整體存活率。強生公司公佈，第二季 Rybrevant 營收為 1.79 億美元，年成長超過 100%，季增約 27%，這得益於持續強勁的上市熱潮。

There were share gains in both first and second lines of treatment and consistent growth and intent to prescribe. Rybrevant subcutaneous with ENHANZE is currently under FDA review in the United States. Our 10 launched products are on track to deliver over $1 billion in royalty revenue, now possibly even before 2027.

第一線和第二線治療藥物的份額均有所增長，且處方意圖持續成長。Rybrevant 皮下注射 ENHANZE 目前正在接受美國 FDA 的審查。我們推出的 10 款產品預計將帶來超過 10 億美元的特許權使用費收入，甚至可能在 2027 年之前實現。

Recall that 10 years ago, I made the projection that we would achieve $1 billion in royalty revenue in 2027, and we're delivering according to this guidance. Notably, we also predict all products will continue to generate royalties to at least 2030, and that mainly are expected to continue into the 2040s.

回想一下，10 年前，我曾預測到 2027 年我們的特許權使用費收入將達到 10 億美元，而我們目前正按照這一預期來實現這一目標。值得注意的是，我們還預測所有產品至少到 2030 年將繼續產生特許權使用費，並且預計這種情況將主要持續到 2040 年代。

On slide 9 is an overview of our pipeline, which includes a total of nine product candidates and highlights multiple future potential new growth drivers and royalty streams that I will remind you, are not included in our multiyear royalty guidance. Bristol's subcutaneous nivolumab plus relatlimab and Takeda's TAC-881 are the first potential new royalty revenue growth drivers with potential to launch in the next two years. Both are progressing in Phase III.

第 9 張投影片概述了我們的產品線，其中包括總共 9 種候選產品，並重點介紹了未來多個潛在的新增長動力和特許權使用費流，我要提醒您的是，這些都不包括在我們的多年特許權使用費指導中。布里斯託的皮下注射 nivolumab 加 relatlimab 以及武田的 TAC-881 是首批潛在的新特許權使用費收入增長動力，有可能在未來兩年內推出。兩項研究均已進入第三階段。

In addition, we have one product in Phase II testing and six products that are in planning are in or if completed Phase I studies. This includes argenx 213, argenx's next-generation FCRM blocker, which recently started a Phase I study.

此外，我們有一款產品處於第二階段測試階段，還有六款產品正在規劃中，正在進行或已完成第一階段研究。其中包括 argenx 的下一代 FCRM 阻斷劑 argenx 213，該藥物最近已啟動 I 期研究。

We expect two additional new target Phase I trial starts, one this year and one that has now moved into 2026. Now also adding to our new growth will be new nominations and new deals. Our new partner discussions with ENHANZE are progressing well, and we are on track for at least one new ENHANZE deal enhancement this year.

我們預計將啟動另外兩個新的目標 I 期試驗，一個在今年，另一個已進入 2026 年。現在，新的提名和新的交易也將促進我們的新成長。我們與 ENHANZE 的新合作夥伴談判進展順利，今年我們預計將達成至少一項新的 ENHANZE 交易增強協議。

Our conversations range from approved IV treatment where the partner wishes to move to subcutaneous, developmental IV assets for the partner wishes to move to subcu for an improved treatment patient experience and products that are already subcutaneous where the goal is subcutaneous extended dosing also for improved patient experience, but also improved adherence and compliance.

我們的討論範圍包括已獲批准的靜脈注射治療（合作夥伴希望將其轉為皮下治療）、正在開發的靜脈注射資產（合作夥伴希望將其轉為皮下治療以改善患者的治療體驗）以及已經是皮下的產品（目標是皮下延長給藥，也是為了改善患者體驗，同時也提高依從性和順應性）。

Let me now turn to our auto injector business, which consists of two partnered products, Teva EpiPen and their version of teriparatide plus the (inaudible), which is in development with our small volume auto-injector over the prevention of myocardial infarction.

現在讓我來談談我們的自動注射器業務，它由兩種合作產品組成，即 Teva EpiPen 及其特立帕肽版本以及（聽不清楚），這是我們的小容量自動注射器在預防心肌梗塞方面的開發成果。

As announced on our Q4 2024 call, we were pleased to have signed a development agreement for our small volume multi-injector with a current partner. We expect to enter clinical testing with this partner in 2026.

正如我們在 2024 年第四季電話會議上宣布的那樣，我們很高興與現有合作夥伴簽署了小容量多噴油嘴的開發協議。我們預計將於 2026 年與該合作夥伴一起進入臨床測試階段。

We also announced the high-volume autoinjector development agreement also with the current partner on our first-quarter 2025 call, and we are projecting to conduct a human factor study on usability by the end of this year. In parallel, we have been investing in advancing our high-volume devices for clinical readiness. We expect our 5 ml high-volume auto-injectors to be ready for use in clinical human studies in the fourth quarter.

我們也在 2025 年第一季電話會議上與現任合作夥伴宣布了大容量自動注射器開發協議，並且我們計劃在今年年底之前進行可用性人為因素研究。同時，我們一直在投資改進我們的大容量設備，以備臨床使用。我們預計我們的 5 毫升大容量自動注射器將在第四季度準備好用於臨床人體研究。

In addition, the updated design of our 10 mL high-volume auto-injector will be ready for partner testing in a nonclinical setting also in the fourth quarter. And we're continuing to seek new partner agreements for both the small volume and the high-volume auto injectors, where I'm pleased to say we're hearing consistently from pharma that there is a clear goal to enable more and more at-home delivery of biologics by the patient.

此外，我們 10 毫升大容量自動注射器的更新設計也將在第四季度準備好在非臨床環境中進行合作夥伴測試。我們正在繼續為小容量和大容量自動注射器尋求新的合作夥伴協議，我很高興地說，我們不斷聽到製藥公司的消息，他們的明確目標是讓越來越多的患者能夠在家中註射生物製劑。

I'm now pleased to turn the call over to Nicole.

我現在很高興將電話轉給妮可。

Thank you, Helen. Our outperformance in the second quarter reflects the growing momentum in the business, supporting another raise to our 2025 financial guidance. Total quarterly revenue increased by 41%, with $206 million in royalty revenue increasing 65%. The adjusted EBITDA growth of 65% once again outpaced top line growth with high-margin royalty revenue contributing to the $98 million in free cash flow in the quarter.

謝謝你，海倫。我們第二季的出色表現反映了業務的成長勢頭，支持我們再次提高 2025 年的財務預期。季度總收入成長 41%，其中特許權使用費收入 2.06 億美元，成長 65%。調整後的 EBITDA 成長率達到 65%，再次超過了營收成長率，高利潤的特許權使用費收入為本季 9,800 萬美元的自由現金流做出了貢獻。

Moving to slide 10. In the second quarter, we completed the $250 million share repurchases announced in May of 2025. Given our expectation for continued strong cash generation, we have allocated an additional $250 million to share repurchases. Of this third and final tranche of our current $750 million approved plan, $53.5 million was deployed in the second quarter, bringing our total share repurchases in the second quarter to $303.5 million. This brings total share repurchases since 2019 to more than $1.85 billion, reflecting 117% of our cumulative free cash flow during that period.

移至投影片 10。第二季度，我們完成了 2025 年 5 月宣布的 2.5 億美元股票回購。鑑於我們對持續強勁現金流的預期，我們已額外撥款 2.5 億美元用於股票回購。在我們目前批准的 7.5 億美元計畫的第三筆也是最後一筆中，有 5,350 萬美元已在第二季部署，使我們第二季的股票回購總額達到 3.035 億美元。這使得 2019 年以來的股票回購總額超過 18.5 億美元，佔該期間累計自由現金流的 117%。

We continue to balance our use of capital with a focus on evaluating M&A opportunities to complement our strong organic growth profile, while remaining disciplined about our net leverage.

我們繼續平衡資本的使用，並專注於評估併購機會，以補充我們強勁的有機成長狀況，同時對我們的淨槓桿保持紀律。

Let me now turn to our detailed second-quarter results on slide 11. Revenue grew 41% to $325.7 million, compared to $231.4 million in the prior year period. Royalty revenue of $205.6 million increased by 65% from $124.9 million in the prior year period. The continued commercial success of subcutaneous DARZALEX and Phesgo and the robust growth of VYVGART Hytrulo contributed to the higher-than-expected royalty growth.

現在讓我來看看投影片 11 上我們第二季的詳細業績。營收成長 41% 至 3.257 億美元，去年同期為 2.314 億美元。特許權使用費收入為 2.056 億美元，較去年同期的 1.249 億美元成長 65%。皮下注射 DARZALEX 和 Phesgo 的持續商業成功以及 VYVGART Hytrulo 的強勁增長促成了高於預期的特許權使用費增長。

Product sales of $81.5 million increased by 3% from $78.9 million in the prior year period, mainly driven by higher proprietary product sales. Collaboration revenue of $38.6 million, an increase of 40% from $27.5 million in the prior year period reflect the milestone recognition of the approval in EU launch of Rybrevant SC in April and a milestone recognized for the EU approval of Opdivo SC.

產品銷售額為 8,150 萬美元，較去年同期的 7,890 萬美元成長 3%，主要得益於專有產品銷售額的增加。合作收入為 3860 萬美元，比去年同期的 2750 萬美元增長 40%，反映了 4 月份 Rybrevant SC 在歐盟獲得批准的里程碑以及 Opdivo SC 在歐盟獲得批准的里程碑。

Research and development expenses were $17.5 million compared to $21 million in the prior year period. The decrease was primarily due to lower compensation expense driven by resource optimization and labor allocation initiatives, offset by timing of planned investments in ENHANZE related to the development of our new high-yield rHUPH20 manufacturing process.

研發費用為 1,750 萬美元，去年同期為 2,100 萬美元。下降的主要原因是資源優化和勞動力配置措施導致的薪酬支出降低，但與我們新的高產量 rHUPH20 製造流程的開發相關的 ENHANZE 計劃投資時間所抵消。

Selling, general and administrative expenses were $41.6 million in the quarter, up from $35.7 million in the prior year period, primarily due to increased compensation expense and consulting and professional service fees. Adjusted EBITDA increased by 65% to $225.5 million from $137 million last year. GAAP diluted earnings per share was $1.33, and non-GAAP diluted earnings per share was $1.54. This is compared with GAAP diluted earnings per share of $0.72 and non-GAAP diluted earnings per share of $0.91 in the second quarter of 2024.

本季銷售、一般和行政費用為 4,160 萬美元，高於去年同期的 3,570 萬美元，主要原因是薪酬費用以及諮詢和專業服務費用增加。調整後的 EBITDA 從去年的 1.37 億美元成長 65% 至 2.255 億美元。GAAP稀釋每股盈餘為1.33美元，非GAAP稀釋每股盈餘為1.54美元。相較之下，2024年第二季GAAP稀釋每股收益為0.72美元，非GAAP稀釋每股收益為0.91美元。

We continue to maintain a strong balance sheet, with cash, cash equivalents and marketable securities of $548.2 million on June 30, 2025, compared to $596.1 million on December 31, 2024. The decrease was primarily a result of share repurchases, offset by an increase in cash generated from operations. Our net debt position was $977 million, with a net leverage ratio of 1.2 times.

我們繼續保持強勁的資產負債表，2025 年 6 月 30 日的現金、現金等價物和有價證券為 5.482 億美元，而 2024 年 12 月 31 日為 5.961 億美元。下降主要是由於股票回購，但被經營活動產生的現金增加所抵消。我們的淨債務狀況為 9.77 億美元，淨槓桿率為 1.2 倍。

Turning now to slide 12 and our updated 2025 guidance. We are excited to be able to raise our guidance for the second time this year. We now expect total revenues of $1.275 billion to $1.355 billion, representing year-over-year growth of 26% to 33% driven by an increase in projections for royalty revenues. Royalty revenue of $825 million to $860 million, representing year-over-year growth of 44% to 51%. As Helen touched on, we expect DARZALEX SC, Phesgo, and VYVGART Hytrulo to drive the strong expectations with VYVGART Hytrulo being the largest royalty dollar growth driver.

現在翻到第 12 張投影片，看看我們更新後的 2025 年指南。我們很高興今年能夠第二次提高我們的指導。我們現在預計總收入為 12.75 億美元至 13.55 億美元，年增 26% 至 33%，這得益於特許權使用費收入預測的增加。特許權使用費收入為 8.25 億美元至 8.6 億美元，年增 44% 至 51%。正如海倫所提到的，我們預計 DARZALEX SC、Phesgo 和 VYVGART Hytrulo 將推動強勁的預期，其中 VYVGART Hytrulo 將成為最大的特許權使用費美元成長動力。

Product sales have not changed at $340 million to $365 million, representing year-over-year growth of 12% to 20%. Collaboration revenue is also maintained at $110 million to $130 million.

產品銷售額沒有變化，為 3.4 億美元至 3.65 億美元，年增 12% 至 20%。合作收入也維持在1.1億美元至1.3億美元之間。

We expect adjusted EBITDA of between $865 million and $915 million, representing year-over-year growth of 37% to 45%, reflecting high-margin royalty growth, coupled with flat operating expense from our continued focus on operational efficiency. And non-GAAP diluted EPS of $6 to $6.40, representing year-over-year growth of 42% to 51%.

我們預計調整後的 EBITDA 將在 8.65 億美元至 9.15 億美元之間，年增 37% 至 45%，這反映了高利潤的特許權使用費成長，加上我們持續關注營運效率而導致的營運費用持平。非公認會計準則稀釋每股收益為 6 美元至 6.40 美元，年增 42% 至 51%。

As you refine your models, I'd also like to reiterate the following: we expect collaboration revenue for the rest of the year to be more weighted in the fourth quarter. We expect product sales for the rest of the year to also be more weighted in the fourth quarter with quarterly sequential growth in each quarter. For royalties, we expect quarterly sequential growth for the remaining quarters in the year.

當您完善模型時，我還想重申以下幾點：我們預計今年剩餘時間的合作收入將在第四季度佔據更大的比重。我們預計今年剩餘時間的產品銷售在第四季也將佔據更大的比重，每季都將持續成長。對於特許權使用費，我們預計今年剩餘季度將持續成長。

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。

Thank you, Nicole. It is certainly an exciting time in Halozyme's history as we continue to achieve new record revenue and earnings growth. With 14 catalysts for growth now realized are on the near-term horizon, we have even greater conviction and line of sight in the durability of our revenue streams and the expanding opportunities ahead. Our success would not have been possible without the incredible dedication of our employees and the trust and collaboration of our valued partners.

謝謝你，妮可。這無疑是 Halozyme 歷史上激動人心的時刻，因為我們繼續實現新的營收和獲利成長記錄。隨著 14 個成長催化劑在近期內實現，我們對收入流的持久性和未來不斷擴大的機會更加有信心，也更加有遠見。如果沒有我們員工的非凡奉獻以及我們尊貴的合作夥伴的信任和合作，我們的成功就不可能實現。

And with that, operator, we are now ready to open the call for questions.

接線員，現在我們可以開始提問了。

(Operator Instructions) [Carina Chin], Wells Fargo.

（操作員指示）[Carina Chin]，富國銀行。

This is (inaudible) on for Mohit Bansal. Congrats on the quarter. Can you help us understand the status of the IP litigation with Merck? We saw that with the patent grant review being instituted, I was just wondering like what are the next steps and potential outcomes of the next decision?

這是（聽不清楚）關於 Mohit Bansal 的。恭喜本季。您能幫助我們了解與默克的智慧財產權訴訟的現況嗎？我們看到專利授權審查已經開始，我只是想知道下一步該怎麼做，以及下一個決定可能產生什麼結果？

Yes. So with regard to our litigation against Merck, this is the district court case that we have filed and pursuing Merck for infringing 15 of our MDA patents. We do not yet have a settling order from the court that would set up the schedule for the proceedings, but we do expect to receive that in the next couple of months.

是的。關於我們對默克公司的訴訟，這是我們向地區法院提起的訴訟，指控默克公司侵犯了我們的 15 項 MDA 專利。我們尚未收到法院的和解令來確定訴訟程序的時間表，但我們預計在未來幾個月內收到該命令。

Okay. And then just wondering, I think the PGR might be a separate process that you have at agree what the time line is there?

好的。然後我只是想知道，我認為 PGR 可能是一個單獨的過程，您是否同意那裡的時間表是怎樣的？

Yes. With regard to the PGRs, there have been four PGRs filed by Merck that have been instituted by the patent office. And all of these have been given a hearing date that is set for March 2 in 2026. We anticipate that the first decisions on the issues that are common to all of those four PGR petitions will occur on June 2, 2026. So in terms of the time line, that final adjudication on these first four invalidity challenges that were brought by Merck will be adjudicated.

是的。關於PGR，默克公司已提交四項PGR，並已由專利局立案。所有這些案件的聽證日期都定於 2026 年 3 月 2 日。我們預計，針對這四項 PGR 請願書共同存在的問題，將於 2026 年 6 月 2 日做出首批決定。因此，就時間軸而言，將對默克公司提出的前四項無效挑戰作出最終裁決。

There remains several other PGR petitions that are still under review by the PTAB at this time, but you'll start to get insights next year. And I'll just say we continue to be very confident in the fact that we will prevail on these validity issues in all of the PGRs and that Merck will be found to be infringing, but we just have to go through this entire process.

目前，還有其他幾項 PGR 請願書仍在接受 PTAB 的審查，但您將在明年開始獲得見解。我只想說，我們仍然非常有信心，我們將在所有 PGR 的有效性問題上取得勝利，而默克將被判定侵權，但我們必須經歷整個過程。

Sean Laaman, Morgan Stanley.

摩根士丹利的肖恩拉曼。

Congratulations on some very strong results. Your crystal ball seems to be working pretty well. On the regulatory front, you just -- there's been quite a few moving pieces over the last few months, a lot of scuttlebutt on your stock a few months back with respect to certain issues, (inaudible) draft guidance, et cetera. But as you sit today, what's your confidence that we're going to see no change that will be impactful on the regulatory front?

恭喜您取得了非常出色的成績。你的水晶球似乎運作得很好。在監管方面，過去幾個月發生了不少變化，幾個月前關於貴公司股票的傳聞很多，涉及某些問題、（聽不清楚）指導草案等等。但是，今天您坐在這裡，您是否有信心我們不會看到對監管方面產生影響的變化？

Yes. So I'll start with the IRA, which as you rightly see, is something that is -- this call is a little bit of commentary a few weeks ago. I can say that on the IRA this is related to fixed combinations of 2 active ingredients where for the Part B guidance, there was some slightly different wording that was proposed.

是的。因此，我將從 IRA 開始，正如您所看到的，這是——這個電話是幾週前的一點評論。我可以說，在 IRA 中，這與 2 種活性成分的固定組合有關，而對於 B 部分指南，提出了一些略有不同的措辭。

We've been very and have submitted a comment letter to CMS that lays out how the draft policy as written is flawed in both a policy and a legal basis. And very importantly, we laid out all of the clinically meaningful benefit subcu delivery with ENHANZE is brought to patients, which is one of the key areas that we know CMS was asking for back on.

我們非常憤怒，並已向 CMS 提交了一封評論信，其中詳細說明了該政策草案在政策和法律依據方面存在缺陷。非常重要的是，我們列出了 ENHANZE 皮下注射給患者帶來的所有具有臨床意義的益處，這是我們知道 CMS 要求支持的關鍵領域之一。

We know that many other groups have done the same, Sean, very similar arguments that they arrived at, and we've been very active meeting with the OMB also with members of Senate Staff and Congress to articulate these arguments and why really, there should be no change in the definition of fixed combination between the Part D guidance, which has been in play for the last two rounds of IP and the -- and Part B.

肖恩，我們知道許多其他團體也做了同樣的事情，他們得出的論點非常相似，我們一直非常積極地與 OMB 以及參議院工作人員和國會成員會面，以闡明這些論點，以及為什麼實際上不應該改變 D 部分指導之間的固定組合定義，該定義在過去兩輪 IP 和 B 部分中一直在發揮作用。

Now we believe it's the fall when the final guidance will be there, and we believe we have very compelling arguments and that we will prevail and there being no changes with regard to that. I think that's only with the regulatory one we're talking about.

現在我們相信最終指導意見將在秋季出台，我們相信我們有非常令人信服的論據，我們將佔上風，在這方面不會有任何改變。我認為我們所談論的只是監管方面。

Sean, is there anything else you wanted to get our feedback on?

肖恩，還有什麼事情您還想聽聽我們的回饋嗎？

No. On a separate topic, if I may, just on the -- that's great on the regulatory front, I appreciate it. But on the setting of guidance front, congratulations on the upgrade, but how much do you use sell side as an input to setting guidance?

不。如果可以的話，我談談另一個主題，就監管方面而言，這很棒，我很感激。但在製定指導方針方面，祝賀您升級，但您在多大程度上使用賣方作為製定指導的輸入？

Nicole?

妮可？

Yes, I can take that one, Sean. So when we look at our guidance, we're really using the trends. And at this time in the second quarter, we have a new data point that indicated new trends, and that's why we're so excited to share new full year projections for the full year. So we look at trends. We have inputs from our partners.

是的，我可以接受，肖恩。因此，當我們查看指導時，我們實際上是在利用趨勢。在第二季的這個時候，我們有了一個新的數據點，顯示了新的趨勢，這就是為什麼我們如此興奮地分享新的全年預測。因此我們關注趨勢。我們得到了合作夥伴的投入。

We have our royalty reports that we get on a quarterly basis. So all of that is really the data points that we triangulate to use to now give the updated view for the full year.

我們每季都會收到版稅申報。因此，所有這些實際上都是我們三角測量使用的數據點，現在可以提供全年的更新視圖。

Awesome. And just a very quick one, Nicole, the $250 million buyback. Just remind us on the comfort levels or targets for gearing ratios.

驚人的。妮可，我簡單問一下，2.5 億美元的回購。只需提醒我們舒適度或槓桿率的目標。

I'm sorry, what ratios?

抱歉，請問比例是多少？

Sorry, for gearing or leverage or how much -- what's sort of the debt equity balance that you like to keep on the balance sheet?

抱歉，對於槓桿率或槓桿率或多少——您希望在資產負債表上保留什麼樣的債務股權餘額？

Okay. So we do have a very nice leverage ratio at the moment. We're just at about one time, we are very committed to continuing to use our capital for share repurchases as well as using it for investing in the business and for M&A. And so we do see that we have room. We can increase our leverage, especially if we found the right opportunity for M&A.

好的。因此，我們目前的槓桿率確實非常好。我們只是一度致力於繼續使用我們的資本進行股票回購以及用於業務投資和併購。所以我們確實看到我們有空間。我們可以提高我們的槓桿率，特別是如果我們找到了合適的併購機會。

We really like around 3 times leverage if we were in that type of situation. And so because of our robust cash flow, we really have all of those opportunities available to us to continue to use cash and keep a very nice net leverage ratio.

如果我們處於那種情況，我們確實希望使用大約 3 倍的槓桿。因此，由於我們擁有強勁的現金流，我們確實擁有所有可用的機會來繼續使用現金並保持非常好的淨槓桿率。

Jason Butler, Citizens JMP.

傑森‧巴特勒 (Jason Butler)，公民 JMP。

Congrats on a strong quarter. I'm wondering if I could maybe ask you to expand a little bit on the guidance and longer-term guidance, howling you pointed to reiterating on track to hit that $1 billion in royalty revenue. If you take Nicole's comments that you'll expect to see sequential increases in royalties in the second half of the year, it looks like you're going to end up annualizing in fourth quarter at a level well above your guide at the upper end of your guidance range for 2026. Just any comments there on the potential to update the longer-term guidance ranges?

恭喜本季業績強勁。我想知道我是否可以請您稍微擴展一下指導和長期指導，您指出重申有望實現 10 億美元的特許權使用費收入。如果您採納妮可的評論，預計今年下半年特許權使用費將連續增加，那麼看起來您最終將在第四季度實現年化，達到遠高於您 2026 年指導範圍上限的水平。對於更新長期指導範圍的可能性，您有什麼評論嗎？

Yes. Thanks, Jason. So we do see great trends in 2025 -- our practice is during the calendar year, as we have these new data points, we do update the current calendar year. subsequent years in those guidance updates, we do once a year and at the start of the year. So more to come next year on that.

是的。謝謝，傑森。因此，我們確實看到了 2025 年的巨大趨勢——我們的做法是在日曆年期間，當我們有了這些新的數據點時，我們會更新當前日曆年。在隨後的幾年中，我們會每年更新一次指導，並在年初進行。明年我們會有更多相關內容。

Got it. And then maybe just, Helen, on the OCREVUS launch. Anything you can say about where patients are coming on to drug? Is it new to brand patients versus switches? Or is there a weighting between the two?

知道了。然後也許只是，海倫，在 OCREVUS 的發布會上。您能說說患者開始服用藥物的情況嗎？對於品牌患者和轉換者來說，這是否是新鮮事？或者兩者之間是否存在權重？

Yes. What Roche has commented on is an indicator there about patients globally who have started OCREVUS subcu, which I think is excellent, obviously, adoption as we expected, given the 10-minute subcu injection versus the many hours for the IV. They have commented that about 50% of patients in the US are coming on new to brand. So doing exactly what they hoped the availability of subcu would expand the number of doctors and patients who have access to the drug, and about 50% of patients are coming from IV switch.

是的。羅氏公司所評論的是關於全球範圍內已開始使用 OCREVUS 皮下注射的患者的指標，我認為這非常好，顯然，考慮到皮下注射只需 10 分鐘，而靜脈注射則需要數小時，因此採用率正如我們預期的那樣。他們評論說，美國約有 50% 的患者都是新來的患者。因此，正如他們所希望的那樣，皮下注射的普及將擴大能夠獲得該藥物的醫生和患者的數量，大約 50% 的患者來自靜脈注射。

So exactly on track with what they had hoped to see with the launch of this very nice expansion in the total market and sales for OCREVUS over time.

因此，隨著 OCREVUS 的整體市場和銷售額隨著時間的推移而得到非常好的擴張，這完全符合他們的期望。

Great. And then just last one for me. You mentioned that the high-volume auto-injector will be ready for partners to start working with later this year. What's the interest level right now? Or do you have people lined up waiting for that device?

偉大的。對我來說這是最後一個了。您提到，大容量自動注射器將於今年稍後準備好供合作夥伴開始使用。目前的興趣程度如何？或是有人在排隊等待設備嗎？

Yes, Jason, I can comment that we're in multiple discussions on this, and they're all at different stages, as you would imagine with any of these licensing conversations we talk about. We have the current partners who has signed a development agreement with us, is continuing to advance with us towards that development and additional testing of the high-volume auto injector. And we have other ones who are waiting to see and test themselves this new prototype that will have for the high-volume auto-injector.

是的，傑森，我可以說我們正在就此進行多次討論，而且它們都處於不同的階段，正如你所想像的我們談論的任何許可對話一樣。我們目前的合作夥伴已經與我們簽署了開發協議，並將繼續與我們一起推進大容量自動注射器的開發和額外測試。還有其他人正在等待查看和測試這個用於大容量自動注射器的新原型。

So definitely strong interest. And I did say in my remarks, and I just want to underscore it that in areas like inflammation and immunology, neurology, nephrology, there has been a concerted effort by companies to get products that can be delivered at home by the patient. It's recognized particularly for those indications. That's just the way of the future. The government, as an example, in terms of the outpatient payment schedule, commented that too many drugs are being delivered in hospitals and there's a real push for this.

所以我的興趣一定很濃厚。我在演講中確實說過，我只是想強調，在發炎和免疫學、神經病學、腎臟病學等領域，各公司一直在齊心協力地開發患者可在家中服用的產品。它因這些症狀而受到特別認可。這就是未來的方式。以門診付費計畫為例，政府表示，醫院配送的藥品太多，因此政府正在大力推動這項計畫。

So we are definitely seeing a very nice response to our auto-injectors as the companies are looking to get more and more drugs into the patient's home delivered by the patient themselves.

因此，我們確實看到了市場對自動注射器的良好反應，因為各公司都希望讓越來越多的藥物由患者自己送到家中。

Brendan Smith, TD Cowen.

布倫丹史密斯 (Brendan Smith)，TD Cowen。

Congrats on the quarter, great to see. I wanted to first ask maybe actually related to the CMS conversation from earlier. Can you speak just briefly to some of these next gen assets that you have advancing through the clinic, you think you highlight them on slide 9?

恭喜本季取得佳績，很高興看到。我想首先問的問題可能實際上與先前的 CMS 對話有關。您能否簡單介紹一下您在臨床中取得進展的一些下一代資產，您認為您在投影片 9 上重點介紹了它們嗎？

And really just how many of those are essentially leading more or less with subs versus maybe a slightly older strategy of bridging from a commercial IV to a subcu like DARZALEX. Just trying to get a sense of relatively how many of the next wave have been handsets would or would not potentially be impacted by whatever CMS decides.

實際上，其中有多少基本上或多或少地採用了潛艇療法，而不是採用稍微古老的從商業 IV 到 DARZALEX 等潛艇療法的橋接策略。只是想相對地了解下一波手機中有多少會或不會受到 CMS 決定的影響。

Yes. Thanks for that, Brendan. And I will say that as we do look towards that our pipeline, if you like, we -- the most advanced asset there is relatlimab with OPDIVO. Now that was approved in IV just a couple of years ago. So even in that case, companies are moving pretty fast with the subcu, but for the rest of the products in that, you make a great point that the majority of those are either subcu only or doing subcu and IV in development together that there will be not much space between an IV launch and a subcu launch or there will only be a subcu launch.

是的。謝謝你，布倫丹。我想說的是，當我們展望我們的產品線時，如果你願意的話，我們最先進的資產是 relatlimab 和 OPDIVO。幾年前，IV 就已經批准了這項技術。因此，即使在這種情況下，各公司在超臨界流體系統方面進展非常迅速，但對於其中的其餘產品，您要指出的是，大多數產品要么僅為超臨界流體系統，要么同時開發超臨界流體系統和初始階段，因此初始階段發布和超臨界流體系統發布之間不會有太大的間隔，或者只會發布超臨界流體系統。

So the majority is definitely going in that direction. And I think that's pretty in line with what I mentioned about companies recognizing at home delivery is the way to go in conditions and in that particular portfolio, we've got conditions like Alzheimer's, HIV autoimmune diseases. These are all areas where we're seeing that move towards patient self delivery or at least in the home. So the majority are going to be subcu at the start or subcu very shortly after the IV launch.

所以大多數人肯定是朝這個方向發展的。我認為這與我提到的非常一致，即公司認識到送貨上門是某些情況下的可行方式，在特定的產品組合中，我們遇到了阿茲海默症、愛滋病毒自體免疫疾病等疾病。我們看到，這些領域都朝著患者自行分娩或至少在家中分娩的方向發展。因此，大多數人將在開始時或在 IV 發射後不久進行皮下注射。

Got you. Okay. Great. And then just maybe quickly, have you heard from -- or coordinated with J&J at all just about what it would potentially mean to try and appeal to CMS for some of these biosimilar-related exemptions, maybe (inaudible) next year, if DARZALEX does wind up named in early next year after CMS draft clarification was out?

明白了。好的。偉大的。然後也許很快，您是否聽說過 - 或者與強生公司協調過，關於嘗試向 CMS 申請一些與生物仿製藥相關的豁免可能意味著什麼，也許（聽不清楚）明年，如果 DARZALEX 在明年年初 CMS 草案澄清發布後最終被列入名單？

Yes. No, we have not discussed that specific topic with J&J. One thing, Brendan, I just do want to bring up with the One Big Beautiful Bill Act, that expansion in the One Big Beautiful Bill to have drugs that have more than one orphan indication and have those drugs from the IRA, we believe, has the potential to be impacting DARZALEX IV inclusion for two indications that DARZALEX IV has, which is for multiple myeloma and for amyloidosis were both designated by the FDA's orphan drugs and the way the One Big Beautiful Bill reads, that would mean that DARZALEX would not be included as an IV in the IRA because it's only an orphan drug.

是的。不，我們沒有與強生公司討論過這個具體話題。布倫丹，有一件事我想提一下《一個大美麗法案》，《一個大美麗法案》的擴展內容是讓擁有多個孤兒藥適應症的藥物以及來自 IRA 的這些藥物，我們認為，有可能影響 DARZALEX IV 的納入，因為 DARZALEX IV 的兩種適應症，即多發性骨髓瘤和澱粉樣變性，都是由 FDA 的孤兒藥中的 IV，因為它只是一種孤兒藥。

Jessica Fye, JPMorgan.

潔西卡費伊，摩根大通。

This is Adam on for Jess. I do apologize if you mentioned this, but when could we expect more clarity on Halo driving royalties associated with the in-base patents.

這是亞當為傑西表演的。如果您提到這一點，我深感抱歉，但我們什麼時候才能更清楚地了解與基本專利相關的 Halo 駕駛版稅。

Yes. Thanks for that question. So the key place that will be fully resolved. It could happen at any time if Merck chose to settle and sign a license with us. And historically, that does happen as these types of infringement cases are going on.

是的。謝謝你的提問。所以這個關鍵的地方就要徹底解決。如果默克選擇與我們達成和解並簽署許可，這種情況隨時都有可能發生。從歷史上看，這類侵權案件發生時確實會發生這種情況。

But obviously, that's an uncertain time line. The second would be at the end of the district court case and assuming success for Halozyme, which obviously we believe we will win it because we do believe very strongly that Merck is infringing.

但顯然，這是一個不確定的時間表。第二個結果是地方法院案件結束時，假設 Halozyme 勝訴，我們顯然相信我們會贏，因為我們確實堅信默克公司侵權了。

Now we are awaiting a date for the district court case that has not been given yet. And we do expect that be a process that will take a couple of years. So there's no clear time line, Adam, but I would track 2 things: potentially Merck settling because of the strength of our case, or the second one would be upon our success and going through the district court case, which will be several years from now.

現在我們正在等待地區法院尚未公佈的開庭日期。我們確實預計這個過程將需要幾年時間。所以沒有明確的時間表，亞當，但我會追蹤兩件事：默克可能會因為我們的案子有力而達成和解，或者第二件事是我們成功並通過地方法院的案件，這將是幾年後的事。

Michael DiFiore, Evercore ISI.

Michael DiFiore，Evercore ISI。

Congrats on all the continued progress. Two for me, just on revisiting the Merck litigation. So with multiple PGRs now instituted and others potentially likely to file on similar grounds, how should we think about the likelihood or timing of a settlement? And do you believe that the expanding PTAB docket strengthens Merck's hand? And I have a follow-up.

祝賀您不斷取得進步。對我來說有兩個，只是重新審視默克訴訟。那麼，鑑於現在已經制定了多個 PGR，並且其他人可能以類似理由提出申請，我們應該如何考慮和解的可能性或時機？您是否認為擴大 PTAB 案件範圍會增強默克的實力？我還有一個後續問題。

Yes. So with regard the settlement, that obviously is in Merck's hands, Mike. We you believe very strongly that Marc is infringing our patents. And the only place that infringement will be resolved is going to be in the district court in that case and that we have patents that are part of the district court case that are not subject to the PTAB process.

是的。因此，就和解而言，這顯然掌握在默克公司的手中，麥克。我們堅信馬克侵犯了我們的專利。解決侵權問題的唯一地方是該案件中的地區法院，並且我們擁有屬於地區法院案件一部分的專利，這些專利不受 PTAB 程序的約束。

And so it really, I think, will just come down to when Merck decides they want to see if they're going to do so before we go through that whole district court case. But that is the ultimate arbiter of this infringement.

所以，我認為，這實際上將取決於默克公司何時決定在我們審理整個地區法院案件之前看看他們是否會這樣做。但這就是這侵權行為的最終裁決者。

Got it. That's helpful. Separately, just curious if deal conversations had slowed down in light of the pending final Part B guidance documents. Obviously, this could swing either way. Have you sensed that company just want to wait this out and see what happens?

知道了。這很有幫助。另外，我只是好奇，鑑於即將出台的最終 B 部分指導文件，交易談判是否已經放緩。顯然，情況可能會有好壞之分。您是否感覺到公司只是想等待並看看會發生什麼？

No. We haven't. The IRA discussions have never been a big part of our [ sales pitch ] and never been a big part of the conversations to date. And so this draft part fee guidance is not impacting it at all, Mike. And that's probably because we are, as I mentioned a moment ago, talking with a lot of companies who are considering subcu delivery even as they've initiated their initial testing with the IV or they're planning subcu right from the start.

不。我們沒有。IRA 討論從來都不是我們的[推銷]重要組成部分，而且從來都不是迄今為止談話的重要部分。因此，這份草案部分費用指導對此根本沒有影響，麥克。這可能是因為，正如我剛才提到的，我們正在與許多公司進行交談，這些公司正在考慮皮下輸液，即使他們已經開始使用靜脈注射進行初步測試，或者他們從一開始就計劃使用皮下輸液。

And so we definitely do have some conversations which are IV to subcu switch, but the wealth of opportunities and conversations or early use in consideration for subcu taking the whole IRA discussion as an irrelevance. And so that is also why it's not coming up.

因此，我們確實進行了一些從 IV 到 subcu 轉換的對話，但考慮到 subcu 的大量機會和對話或早期使用，整個 IRA 討論都變得無關緊要。這也是為什麼它沒有出現的原因。

Mitchell Kapoor, H.C. Wainright.

米切爾·卡普爾、H.C. 溫賴特。

And I'll add my congrats on the quarter. And on that note, I would like to ask that it seems like it's the third time raising guidance in 2025 when you include the increase during the multiyear guidance raise in January. It's a nice trend for us, but we're wondering how conservative or reasonable would you say the guidance is at this point?

我還要對本季表示祝賀。關於這一點，我想問一下，如果算上 1 月份多年指導上調期間的增幅，這似乎是 2025 年第三次上調指導。對我們來說這是一個很好的趨勢，但我們想知道您認為目前的指導有多保守或合理？

Yes. I'll ask Nicole to address that and then I'll add my comments.

是的。我會讓妮可解決這個問題，然後我會添加我的評論。

Thanks, Mitchell. We do see and we're excited to see that each quarter really what we're seeing is the new latest trend point and that trend point does identify for us what are the latest projections. And so what you see at each of those stages is us taking that data and using the latest data available to really support what we see for the full year.

謝謝，米切爾。我們確實看到並且很高興地看到，每個季度我們所看到的都是新的最新趨勢點，而這個趨勢點確實為我們確定了最新的預測。因此，您在每個階段都會看到我們獲取這些數據並使用最新的可用數據來真正支持我們對全年的預測。

Just great examples of what we saw this quarter is DARZALEX outperformed for the quarter, really driven by the frontline setting. We thought Phesgo, for example, expanded it in 20 new countries and their growth remains really robust. And then, again, the strong patient and physician adoption for VYVGART Hytrulo in their launch of the PFS really supported our updated outlook. And again, that latest data point that gives us the conviction that we now have put out there for full year guidance for 2025.

我們本季看到的很好的例子是 DARZALEX 本季度表現出色，這確實受到一線環境的推動。例如，我們認為 Phesgo 已將業務擴展到 20 個新國家，並且其成長仍然非常強勁。然後，再次強調，患者和醫生在推出 PFS 時對 VYVGART Hytrulo 的強烈接受確實支持了我們最新的展望。再次，最新的數據讓我們確信，我們現在已經為 2025 年全年制定了指導。

Yes. And I'll just add. When we put our guidance in January, that is highly informed by the guidance ranges that our partners all give us. And so we do take our judgment within those ranges they give us. And so I would say first quarter -- Q4 and Q1 reporting really does reflect input we get from the partners.

是的。我再補充一下。當我們在一月份發布指導時，我們的合作夥伴給予我們的指導範圍是高度可信的。因此，我們確實在他們給予的範圍內做出判斷。所以我想說第一季——第四季和第一季的報告確實反映了我們從合作夥伴那裡得到的投入。

They definitely -- we're seeing some acceleration in momentum. Now I talked at the beginning of my prepared remarks about having achieved 11 of the 14 catalysts. Those kind of catalysts can be hard to predict exactly. But Nicole mentioned the prefilled syringe. We will see argenx itself said that that was already impacting even after just one quarter.

他們確實——我們看到了一些加速的勢頭。我在準備好的發言一開始就談到，14 個催化劑中，有 11 個已經實現。這些催化劑很難準確預測。但妮可提到了預充式註射器。我們將看到 argenx 本身表示，即使僅僅一個季度之後，這就已經產生了影響。

We are early launch in CIDP, that's another example. And for DARZALEX, just keep expanding into that population. And as I mentioned, those patients stay on therapy longer. And so it has a compounding effect the longer we go, the more it's going to compound.

我們很早就開始推出 CIDP，這是另一個例子。對於 DARZALEX 來說，只需繼續擴展到該人群即可。正如我所提到的，這些患者接受治療的時間更長。因此，它具有複合效應，我們堅持的時間越長，複合效應就越強。

And so those are just some very exciting dynamics that I think in terms of what our partners projected for the year or even more to the upside than they had indicated to us based on the information they provided. So it is all good news. It's never our intent to be conservative. We like to guide us to what we believe is going to happen. But when you're in this dynamic circumstance with lots of new catalysts, it's hard to get them all exactly right, and we're just getting a very nice benefit of partners overperforming in many of the catalysts said versus what they had anticipated.

因此，我認為這些都是非常令人興奮的動態，就我們的合作夥伴對今年的預測而言，甚至比他們根據提供的資訊向我們表明的還要好。所以這都是好消息。我們從來不想採取保守態度。我們喜歡引導我們去實現我們相信將會發生的事情。但是，當你處於這種充滿大量新催化劑的動態環境中時，很難讓它們完全正確，而我們只是從合作夥伴在許多催化劑方面的表現超出他們的預期中獲得非常好的收益。

Definitely. That's super helpful. And just one more from us. So it looks like Merck filed a couple of more since June. Can you provide your current outlook on this impact? And why do you think they're choosing these particular patents and continuing to file more instead of filing them all at once?

確實。這非常有幫助。我們再說一個。因此看起來默克公司自六月以來又提交了幾個申請。您能否提供一下目前對這影響的看法？您認為他們為什麼選擇這些特定的專利並繼續申請更多專利而不是一次性申請所有專利？

Yes. That's just our motivation for that, Mitch. I don't want to speculate. For the PGR process, that can happen within 9 months of a new patent being issued and so what they're looking at is the continued and this is work -- this happens -- has been happening for the last 10 years at Halozyme that are more patents filed and issued. And so they simply are looking at new issuances and they have elected to challenge the validity of these.

是的。這就是我們的動機，米奇。我不想猜測。對於 PGR 流程，這可能在新專利頒發後的 9 個月內發生，因此他們正在關注的是持續的工作，這是 Halozyme 過去 10 年一直在做的事情，他們提交並頒發了更多的專利。因此，他們只是在關注新發行的債券，並選擇質疑這些債券的有效性。

Now we believe very strongly that these patents are valid and that the ultimate settlement of the PTAB will show that. They're not having any impact on what is a very important thing, which is our district court case, which is not a question of the invalidity of patents, but their infringement of our patents. And no matter what happens in PTAB, we have patents that cannot be subject challenge that we believe strongly demonstrate the infringement by Merck on our IP. So that's how to think about both of those.

現在我們堅信這些專利是有效的，而 PTAB 的最終解決方案將證明這一點。他們對一件非常重要的事情沒有任何影響，那就是我們的地區法院案件，這不是專利無效的問題，而是他們侵犯我們的專利的問題。無論專利審判與上訴委員會 (PTAB) 做出何種裁決，我們都擁有不容質疑的專利，我們認為這些專利有力地證明了默克侵犯了我們的智慧財產權。這就是對這兩者的看法。

So the District Court case is obviously the key one for us to have eyes on and we'd expect Merck to continue, I believe, and news to continue on these PGRs, but we're also very focused on the district court case.

因此，地方法院的案件顯然是我們關注的重點案件，我相信我們預計默克公司將繼續推進，有關這些 PGR 的消息也將繼續，但我們也非常關注地方法院的案件。

(Operator Instructions) Corinne Johnson, Goldman Sachs.

（操作員指示）高盛的科琳·約翰遜。

Maybe one, now a couple of neurology kind of launches underway and demonstrating pretty good uptake. I guess what are your thoughts on the pace and peak potential for conversion to subcu in these markets, perhaps just relative to the oncology business?

也許有一個，現在有幾種神經病學方面的研究正在進行中，並且顯示出相當好的進展。我想您對這些市場中轉化為皮下注射的速度和峰值潛力有何看法，也許只是相對於腫瘤學業務？

And then maybe separately, on the high-volume auto-injector, the human factors that you're running with a partner by later this year. I guess, should we expect this kind of like pre-work to be done more frequently with the auto-injector deals? And maybe help us understand sort of whether a human factor studies are going to be different from drug to drug or if that's kind of auto-injectors (inaudible)

然後，也許可以單獨討論大容量自動注射器，以及今年稍後您將與合作夥伴一起運行的人為因素。我想，我們是否應該期待這種前期工作在自動注射器交易中更頻繁地完成？也許可以幫助我們了解人為因素研究是否會因藥物而異，或者這是否是一種自動注射器（聽不清楚）

Yes, thanks, Corinne. With regard to neurology launches, obviously, OCREVUS is off to a very strong start. And when you think about the value proposition here for patients, just 10 minutes versus many hours for the infusion and observation time. And for the IV, it definitely is one of the drugs where we think there will be a robust conversion, driven by the patient factors, but also infusion suite capacity constraints and the cost of care globally. So that really doesn't all the hallmarks for being a very nice uptake.

是的，謝謝，科琳。就神經病學領域的推出而言，OCREVUS 顯然取得了非常強勁的開局。當您考慮這裡對患者的價值主張時，輸液和觀察時間只需 10 分鐘，而實際時間則需要數小時。對於靜脈注射，我們認為它肯定是將出現強勁轉變的藥物之一，這不僅受到患者因素的驅動，還受到輸液室容量限制和全球護理成本的驅動。所以這其實並不代表這是一種非常好的接受。

CIDP, I would consider another neurology indication. And the great news with VYVGART Hytrulo and CIDP, of course, is that, that is all subdued. There is no IV VYVGART approval for CIDP that's 100% of the sales, mid-single-digit royalty on those. So yes, I think we're going to see very nice uptake overall in neurology and those 2 specific indications.

CIDP，我會考慮另一種神經學指徵。當然，VYVGART Hytrulo 和 CIDP 的好消息是，這一切都被抑制了。CIDP 沒有獲得 IV VYVGART 批准，即佔銷售額的 100%，其版稅為中等個位數。所以是的，我認為我們將看到神經病學和這兩個特定適應症的整體非常好的吸收。

On the high-volume auto-injector, so I think it's going to be different partner by partner. One of the things in the human factor studies are very straightforward to do. Often it is on the usability of the device. It may have a patient population where they are wanting to understand how the patient uses the device, understand is there a customization of something about the device that they want to test out before they would go into formal clinical studies. So they're pretty straightforward, short types of things, but think about it more in terms of just testing and optimizing exactly the design that they want.

對於大容量自動注射器，我認為每個合作夥伴都會有所不同。人為因素研究中的一件事非常簡單。通常它取決於設備的可用性。可能有一群患者想要了解患者如何使用該設備，了解該設備是否有一些客製化功能，他們想在進行正式臨床研究之前進行測試。所以它們都是非常簡單、簡短的東西，但更多地考慮只是測試和優化他們想要的設計。

And so I think sometimes some partners want off the shelf. Sometimes they want to do a bit of human factor testing. It will be a mix.

所以我認為有時有些合作夥伴想要現成的產品。有時他們想做一些人為因素測試。這將是混合的。

And this concludes today's conference call. You may now disconnect.

今天的電話會議到此結束。您現在可以斷開連線。