Halozyme Therapeutics Inc (HALO) 2025 Q1 法說會逐字稿

Good afternoon. My name is Bailey, and I'll be your conference operator today. At this time, I would like to welcome everyone to Halozyme's first-quarter 2025 financial and operating results conference call. (Operator Instructions) Please note, this event is being recorded. I will now turn the call over to Tram Bui, Halozyme's Vice President of Investor Relations and Corporate Communications. Please go ahead.

午安.我叫貝利，今天我將擔任您的會議主持人。現在，我歡迎大家參加 Halozyme 2025 年第一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。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 first-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. 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.

謝謝您，接線生。下午好，歡迎參加我們 2025 年第一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。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；以及我們的財務長 Nicole LaBrosse，她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. 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. I will now turn the call over to Dr. Helen Torley.

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 財務指標相協調。現在我將電話轉給海倫·托利博士。

Good afternoon, everyone, and thank you for joining us today. It really has been a tremendous start to 2025. Before I describe the many events and successes in the first quarter, let me begin by thanking the many shareholders and sell-side analysts who participated in our investor feedback interviews earlier this year. We really appreciate your feedback and it has been invaluable. Your feedback helped us understand more granularly the role that we are playing in different investor portfolios.

大家下午好，感謝大家今天的參與。2025 年確實有了一個非常好的開始。在描述第一季的眾多事件和成功之前，我首先要感謝今年稍早參加我們的投資人回饋訪談的眾多股東和賣方分析師。我們非常感謝您的回饋，它非常寶貴。您的回饋幫助我們更詳細地了解我們在不同投資者投資組合中所扮演的角色。

And we're very pleased to be considered your consistent stock grower. Not surprisingly, each of you recognized our leadership in drug delivery for biologics and how this foundation can be expanded to additional areas of drug delivery. All investors agreed on key themes about Halozyme. For example, no investor wants Halozyme to invest in drug development binary risk. We agree. All investors want to make sure that we maximize the organic growth represented by ENHANZE and our auto-injectors by fully investing where there are opportunities. Again, we agree.

我們非常高興被視為您持續的股票種植者。毫不奇怪，你們每個人都認可我們在生物製劑藥物傳遞領域的領導地位，以及如何將此基礎擴展到其他藥物傳遞領域。所有投資者都同意有關 Halozyme 的關鍵主題。例如，沒有投資者希望 Halozyme 投資藥物開發二元風險。我們同意。所有投資者都希望確保我們透過在有機會的地方進行充分投資來最大化 ENHANZE 和我們的自動注射器所代表的有機成長。我們再次表示同意。

And later this year, we will schedule an update about potential new ENHANZE uses and the opportunity. All investors encourage us to also seek to grow inorganically through M&A. While opinions differed about the exact destination for our M&A, all investors want us to remain disciplined about our net leverage, and we listened to your feedback.

今年晚些時候，我們將安排更新有關 ENHANZE 的潛在新用途和機會。所有投資者都鼓勵我們透過併購尋求無機成長。雖然對於我們併購的具體目的地有不同意見，但所有投資者都希望我們保持對淨槓桿的自律，我們也聽取了您的回饋。

With this in mind, I am pleased to reiterate our strategy. Our goal, said simply, is to grow organically and through serial acquisitions, excelling in licensing disruptive drug delivery platform technologies that improve the patient treatment experience and result in better outcomes. With the strategy, we aim to deliver strong and durable revenue and EBITDA growth well into the next decade.

考慮到這一點，我很高興重申我們的策略。簡而言之，我們的目標是透過有機成長和連續收購，在許可顛覆性藥物輸送平台技術方面表現出色，從而改善患者的治療體驗並帶來更好的治療效果。透過該策略，我們的目標是在未來十年實現強勁而持久的收入和 EBITDA 成長。

We will achieve this performance by continuing to focus, first and foremost, on organic growth. We will continue to invest in and grow ENHANZE and our auto-injector businesses, where we are absolutely the best positioned company to capitalize on the growing pharma and patient priority for at-home patient-delivered treatment.

我們將繼續首先關注有機成長，以實現這一業績。我們將繼續投資並發展 ENHANZE 和我們的自動注射器業務，在這些業務中，我們絕對是利用製藥公司和患者對在家接受治療日益增長的需求的最佳公司。

We will also seek to grow inorganically through M&A. Our focus here is on identifying new drug delivery platforms where the business model results in long, durable revenue streams such as through royalties and where we see the opportunity to license to multiple pharma partners. We heard you on leverage and we will be seeking deals that can be accomplished without the need for significant increase in net debt to EBITDA leverage. And we heard how much our share buybacks are appreciated by our investors given the high IRR they have delivered. I am pleased to announce that we are planning to continue this in 2025, announcing today the plan to repurchase $250 million in shares.

我們還將尋求透過併購實現無機成長。我們的重點是尋找新的藥物輸送平台，其商業模式可以帶來長期、持久的收入流，例如透過特許權使用費，並且我們看到了向多個製藥合作夥伴授權的機會。我們聽取了您對槓桿率的意見，我們將尋求無需大幅增加淨債務與 EBITDA 槓桿率即可完成的交易。我們也聽說，鑑於我們的股票回購實現了較高的內部收益率，投資者對我們的股票回購表示高度讚賞。我很高興地宣布，我們計劃在 2025 年繼續這樣做，今天宣布回購價值 2.5 億美元的股票的計劃。

Let me now move to the Q1 performance, beginning on slide 3. Now here's how I'd like you to think about our business, our performance, and our future. Firstly, we have three blockbusters that are driving our current growth. We'll go into more detail on those in a moment. Secondly, we have 11 new growth catalysts that have either just happened or will happen in the next month.

現在讓我轉到第一季的表現，從投影片 3 開始。現在，我希望您這樣看待我們的業務、我們的業績和我們的未來。首先，我們有三部大片推動著我們目前的成長。我們稍後會更詳細地討論這些內容。其次，我們有 11 個新的成長催化劑，它們要么剛剛發生，要么將在下個月發生。

These catalysts will drive our growth for multiple years to come. And thirdly, we have several products in our development pipeline plus our auto-injector technology that will drive additional future growth. As an example, today, we are pleased to announce our very first high-volume auto-injector agreement. Turning now to slide 4. Let me briefly highlight the strong first quarter results.

這些催化劑將推動我們未來多年的成長。第三，我們還有幾款產品正在開發中，加上我們的自動注射器技術，這些將推動未來的進一步成長。例如，今天，我們很高興地宣布我們第一份大容量自動注射器協議。現在翻到幻燈片 4。讓我簡要介紹一下第一季的強勁業績。

Total revenue increased 35% year-over-year to $265 million, with royalty revenue increasing by 39% to $168 million, primarily driven by the 3 blockbusters: DARZALEX subcutaneous, Phesgo, and VYVGART Hytrulo. Adjusted EBITDA increased to $162 million and non-GAAP EPS increased to $1.11, both representing approximately 40% year-over-year growth. Net income also grew an impressive 54% in the quarter to $118 million. Let me now expand on the 3 blockbusters that are our key revenue drivers and that are projected to keep growing for years to come: DARZALEX FASPRO, Phesgo, and VYVGART Hytrulo. I'll begin with DARZALEX shown on slide 5.

總收入年增 35% 至 2.65 億美元，特許權使用費收入成長 39% 至 1.68 億美元，主要得益於三大重磅藥物：DARZALEX 皮下注射劑、Phesgo 和 VYVGART Hytrulo。調整後 EBITDA 增至 1.62 億美元，非 GAAP EPS 增至 1.11 美元，均較去年同期成長約 40%。本季淨收入也大幅成長 54%，達到 1.18 億美元。現在，讓我詳細介紹一下作為我們主要收入驅動力且預計未來幾年將繼續增長的三大重磅藥物：DARZALEX FASPRO、Phesgo 和 VYVGART Hytrulo。我將從幻燈片 5 上顯示的 DARZALEX 開始。

In the first quarter, Johnson & Johnson reported another strong quarter of growth for DARZALEX, which increased 22% year-over-year on an operational basis to $3.2 billion. The growth was primarily driven by continued share gains of approximately 3 points across all lines of therapy and approximately 5 points in the frontline setting as well as through market growth. DARZALEX subcutaneous with ENHANZE, which is marketed as DARZALEX FASPRO in the United States, accounts for approximately 95% of all DARZALEX sales in the United States and commands a similarly high proportion of share in the major ex-US markets. And DARZALEX continues to set the standard in multiple myeloma treatment with Johnson & Johnson's commitment to its clinical advancement continuing to solidify its role as the backbone of treatment across front and second-line patients.

第一季度，強生公司報告 DARZALEX 再次實現強勁成長，營運收入年增 22%，達到 32 億美元。成長主要得益於所有治療領域的份額持續成長約 3 個百分點、第一線治療領域的份額持續成長約 5 個百分點以及市場成長。DARZALEX 皮下注射劑與 ENHANZE 在美國以 DARZALEX FASPRO 的名稱銷售，占美國 DARZALEX 總銷售額的 95% 左右，並且在美國以外主要市場也佔有同樣高的份額。DARZALEX 繼續在多發性骨髓瘤治療中樹立標準，強生公司致力於臨床進步，繼續鞏固其作為一線和二線患者治療支柱的地位。

Moving now to the first of the 11 new growth catalysts, which is the recent European approval of a DARZALEX-based quadruplet regimen for patients with newly diagnosed multiple myeloma regardless of transplant eligibility, further supports near-term growth and the analyst estimates for DARZALEX to reach $17 billion in sales in 2028 with the subcutaneous formulation driving this growth and the vast majority of the sales. We project royalties on DARZALEX subcutaneous through 2032.

現在來看看 11 個新增長催化劑中的第一個，即歐洲最近批准了基於 DARZALEX 的四聯療法，用於治療新診斷的多發性骨髓瘤患者，無論其是否有資格進行移植，這進一步支持了近期的增長，分析師估計 DARZALEX 的銷售額到 2028 年將達到 170 億美元，其中銷售額將推動這一銷售額將推動這一銷售額將推動這一增長。我們預計到 2032 年 DARZALEX 皮下注射劑的特許權使用費將會增加。

Let me move now to slide 6 and Roche's Phesgo, which is the combined therapy of Perjeta, Herceptin, and ENHANZE. Phesgo continues to demonstrate strong adoption and commercial success. In the first quarter, Phesgo was the number one growth driver in Roche's pharmaceutical portfolio, with sales increasing 52% to approximately $675 million with strong performance in international regions.

現在請允許我轉到幻燈片 6 和羅氏的 Phesgo，它是 Perjeta、Herceptin 和 ENHANZE 的聯合療法。Phesgo 持續展現出強大的應用能力和商業成功。第一季度，Phesgo 是羅氏製藥產品組合中的第一大成長動力，銷售額成長 52% 至約 6.75 億美元，在國際地區表現強勁。

Our second new growth catalyst is Phesgo gaining national reimbursement drug listing in China, with Roche commenting on their Q1 call that the growth in China is accelerating noticeably following the listing, which happened earlier this year. Conversion from Perjeta to Phesgo is ongoing, reaching 47% in the 58 launched countries in the first quarter, with expectations for conversion to reach more than 50% across global markets in 2025.

我們的第二個新的成長催化劑是 Phesgo 在中國獲得國家健保藥品名單，羅氏在其第一季電話會議上表示，在今年稍早上市之後，中國市場的成長正在明顯加速。Perjeta 向 Phesgo 的轉換正在進行中，第一季在 58 個上市國家中已達到 47%，預計 2025 年全球市場的轉換率將達到 50% 以上。

In April of 2025, the CHMP recommendation in Europe to expand the Phesgo label to allow administration outside of a clinical setting is our third growth catalyst. Availability of this option will deliver on patient preference for at-home administration. We see this also as an important step in freeing up cancer care capacity in the clinical setting.

2025 年 4 月，歐洲 CHMP 建議擴大 Phesgo 標籤以允許在臨床環境之外進行給藥，這是我們的第三個成長催化劑。此選項的可用性將滿足患者對在家治療的偏好。我們認為這也將是釋放臨床環境中癌症治療能力的重要一步。

Sales of Phesgo are projected to reach approximately $3.3 billion by 2028, entirely from the ENHANZE-enabled subcutaneous formulation, where we earn a mid-single-digit royalty on net sales through 2030. The product's strong growth and broad geographic uptake underscore the commercial success possible with ENHANZE-enabled therapies.

預計到 2028 年，Phesgo 的銷售額將達到約 33 億美元，全部來自採用 ENHANZE 技術的皮下製劑，到 2030 年，我們將從淨銷售額中獲得中等個位數的特許權使用費。該產品的強勁成長和廣泛的地理覆蓋凸顯了 ENHANZE 療法可能帶來的商業成功。

Let me now move to argenx's VYVGART and VYVGART Hytrulo, which is the subcutaneous version enabled by ENHANZE. These are shown on slide 7. Today VYVGART Hytrulo is approved for two indications in the United States, generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy; and for one indication, generalized myasthenia gravis, in Europe.

現在讓我轉到 argenx 的 VYVGART 和 VYVGART Hytrulo，這是由 ENHANZE 啟用的皮下版本。這些顯示在第 7 張投影片上。目前VYVGART Hytrulo在美國已獲準用於兩種適應症，即全身性重症肌無力和慢性發炎性脫髓鞘性多發性神經病變；在歐洲，該藥物用於治療全身性重症肌無力。

In the United States, VYVGART Hytrulo with ENHANZE has played a pivotal role in adding new prescribers and new patients in the first approved indication, generalized myasthenia gravis, reaching patients earlier in the treatment paradigm and accessing new-to-brand patients. Moving now to the second approved US indication, CIDP. VYVGART Hytrulo was approved as a subcutaneous-only treatment recently in September of 2024. Argenx has reported initial strong demand from patients and physicians, highlighting the unmet need for safe and effective treatment alternatives.

在美國，VYVGART Hytrulo 與 ENHANZE 聯合使用在首個獲準適應症——全身性重症肌無力中發揮了關鍵作用，為患者增加了新的處方醫生和患者，使患者在治療模式的早期就得到了治療，並接觸到了新品牌患者。現在轉到第二個核准的美國適應症，CIDP。VYVGART Hytrulo 於 2024 年 9 月獲準為僅皮下治療藥物。Argenx 報告稱，患者和醫生最初需求強勁，凸顯了對安全有效的治療替代方案尚未滿足的需求。

As reported in February of 2025, more than 1,000 CIDP patients were on therapy. For CIDP, argenx has stated that they have attained favorable or highly favorable coverage for 90% of US lives. They further commented that their recent sales force expansion has contributed to deeper community reach, noting that 25% of prescribers for CIDP are new to VYVGART. In Europe, VYVGART Hytrulo was approved for generalized myasthenia gravis in November of 2023. VYVGART total sales reached $2.2 billion in 2024, with continued strong growth, especially of VYVGART Hytrulo projected in 2025.

根據 2025 年 2 月通報，超過 1,000 名 CIDP 患者正在接受治療。對於 CIDP，argenx 表示他們已經為 90% 的美國人實現了良好或非常良好的覆蓋範圍。他們進一步評論說，他們最近的銷售團隊擴張有助於更深入地涵蓋社區，並指出 25% 的 CIDP 處方者都是 VYVGART 的新客戶。在歐洲，VYVGART Hytrulo 於 2023 年 11 月獲準用於治療全身性重症肌無力。VYVGART 的總銷售額在 2024 年達到 22 億美元，並將繼續保持強勁成長，尤其是 VYVGART Hytrulo 預計在 2025 年將實現成長。

Turning now to slide 8. I'll comment on the growth catalysts number 5, 6, and 7. In April of 2025, the FDA approved the new option for patients to self-inject argenx's VYVGART Hytrulo prefilled syringe, which contains the same VYVGART, which is co-formulated with ENHANZE as is in the vial and where Halozyme received the same mid-single-digit royalty on net sales. This FDA approval of the prefilled syringe is our fifth new growth catalyst.

現在翻到幻燈片 8。我將對成長催化劑 5、6 和 7 進行評論。2025 年 4 月，FDA 批准了患者自行注射 argenx 的 VYVGART Hytrulo 預充式註射器的新選擇，該注射器包含相同的 VYVGART，與小瓶中的 ENHANZE 共同配製，而 Halozyme 則獲得了相同的中等個位數淨銷售額稅。FDA 對預充式註射器的批准是我們第五個新的成長催化劑。

The VYVGART Hytrulo prefilled syringe is approved as a 20- to 30-second subcutaneous injection, which is administered by a patient, a caregiver, or a health care professional and will contribute to VYVGART Hytrulo's strong growth trajectory for 2025 and beyond. The prefilled syringe also received a positive recommendation in Europe for use in generalized myasthenia gravis patients in February of this year. This is projected to result in approval in the second quarter of 2025 and is our sixth growth catalyst.

VYVGART Hytrulo 預充式註射器已被批准用於 20 至 30 秒的皮下注射，由患者、護理人員或醫療保健專業人員進行管理，並將促進 VYVGART Hytrulo 在 2025 年及以後的強勁增長軌跡。今年 2 月，該預充式註射器還在歐洲獲得了治療全身性重症肌無力患者的積極推薦。預計該提案將於 2025 年第二季獲得批准，這也是我們的第六個成長催化劑。

In April of 2025, argenx received a positive opinion for VYVGART Hytrulo from the CHMP in Europe for the indication of chronic inflammatory demyelinating polyneuropathy. With approval expected to occur mid-year 2025, following the CHMP opinion, this new indication, which we expect to be for the vial and for the prefilled syringe, will significantly expand the opportunity and add new growth, and this is our seventh new growth catalyst in 2025.

2025年4月，argenx獲得了歐洲CHMP對VYVGART Hytrulo用於治療慢性發炎性脫髓鞘性多發性神經病變的正面評估。根據 CHMP 的意見，該新適應症預計將於 2025 年中期獲得批准，我們預計該適應症將適用於小瓶和預充式註射器，這將大大擴大機會並帶來新的增長，這是我們 2025 年的第七個新的增長催化劑。

VYVGART is just starting its journey of innovation. As you will see on slide 9, argenx has multiple active subcutaneous programs in development with ENHANZE, including for ocular myasthenia gravis and for thyroid eye disease, which will further fuel the revenue growth. With Halozyme earning royalties through the early 2040s, VYVGART Hytrulo represents one of the most significant and durable contributors to our long-term financial performance. Continue to expand on the new growth catalysts, I'll now move to slide 10, and the 4 additional recently launched products that are just warming up and are at the start of what's promised to be exciting launches. Let me begin with OCREVUS ZUNOVO with ENHANZE, which was approved last year for multiple sclerosis as an approximately 10-minute subcutaneous injection.

VYVGART 的創新之旅才剛開始。正如您在幻燈片 9 上看到的，argenx 與 ENHANZE 合作開發了多個活性皮下注射項目，包括用於治療眼部重症肌無力和甲狀腺眼疾的項目，這將進一步推動收入成長。由於 Halozyme 將在 2040 年代初獲得特許權使用費，VYVGART Hytrulo 將成為我們長期財務表現最重要和最持久的貢獻者之一。繼續擴大新的成長催化劑，我現在轉到第 10 張投影片，另外 4 款最近推出的產品才剛剛熱身，並且正處於令人興奮的發布的開始階段。首先我要介紹的是 OCREVUS ZUNOVO 與 ENHANZE，該藥物去年獲得批准，用於治療多發性硬化症，只需大約 10 分鐘的皮下注射。

This compares with multiple hours that is typically required for the intravenous administration. Importantly, and the eighth new growth catalyst, Roche recently reported that OCREVUS ZUNOVO received its permanent J Code in the US on April 1, which they stated will help accelerate uptake in the second half of 2025. Outside the United States, work continues to gain that all-important reimbursement in each country. Roche reported that 50% of patients who started on OCREVUS ZUNOVO were naive to the brand, providing Roche with confidence that ZUNOVO will open up new patient populations to OCREVUS and not simply cannibalize existing share.

相比之下，靜脈注射通常需要幾個小時。重要的是，作為第八個新的成長催化劑，羅氏公司最近報告稱，OCREVUS ZUNOVO 於 4 月 1 日在美國獲得了永久 J 代碼，他們表示這將有助於加速 2025 年下半年的吸收。在美國以外的國家，工作繼續獲得至關重要的報酬。羅氏公司報告稱，50% 開始使用 OCREVUS ZUNOVO 的患者對該品牌並不熟悉，這讓羅氏公司有信心 ZUNOVO 將為 OCREVUS 開闢新的患者群體，而不是簡單地蠶食現有的市場份額。

Roche believes that OCREVUS ZUNOVO could represent an incremental approximately $2 billion opportunity for the brand through this expansion, resulting in an approximately 10 billion analyst projection for IV and subcutaneous OCREVUS in 2028. OCREVUS ZUNOVO is projected to earn Halozyme royalties at its full mid-single-digit rate until 2030 and at a step-down rate until at least 2034.

羅氏認為，透過此次擴張，OCREVUS ZUNOVO 可為該品牌帶來約 20 億美元的增量機會，因此分析師預測 2028 年靜脈注射和皮下注射 OCREVUS 的銷售額將達到約 100 億美元。預計到 2030 年，OCREVUS ZUNOVO 將以全額中位數個位數利率獲得 Halozyme 特許權使用費，並且至少到 2034 年，其特許權使用費將以逐步下降的利率獲得。

I'll move now to Roche's TECENTRIQ Hybreza with ENHANZE, which gained FDA and EMA approval in 2024. The approvals were for all of the intravenous indications, offering patients the convenience of an approximately 7-minute subcutaneous injection. With the permanent J Code in place and work continuing to gain reimbursement in all countries, the strategy is to convert IV TECENTRIQ patients to TECENTRIQ Hybreza.

我現在要談談羅氏的 TECENTRIQ Hybreza 與 ENHANZE，該產品於 2024 年獲得 FDA 和 EMA 的批准。此核准適用於所有靜脈注射適應症，為患者提供約 7 分鐘皮下注射的便利性。隨著永久 J 代碼的實施和在所有國家繼續獲得報銷的工作，該策略是將 IV TECENTRIQ 患者轉變為 TECENTRIQ Hybreza。

Halozyme will earn royalties on TECENTRIQ Hybreza at the full mid-single-digit rate until the 2040s. Moving now to Bristol Myers Squibb OPDIVO Qvantig. This subcutaneous formulation of nivolumab with ENHANZE, which was granted FDA approval at the end of 2024 in the United States. BMS is focused on continuing to increase breadth of prescribing in both the community and academic settings. And the permanent J Code, our ninth new growth catalyst, is expected on July 1.

到 2040 年代，Halozyme 將以中等個位數的利率獲得 TECENTRIQ Hybreza 的專利使用費。現在轉向百時美施貴寶 OPDIVO Qvantig。這款皮下製劑的 nivolumab 與 ENHANZE 於 2024 年底在美國獲得 FDA 批准。BMS 致力於繼續擴大社區和學術環境中的處方範圍。我們的第九個新成長催化劑—永久性 J 代碼預計將於 7​​ 月 1 日生效。

The J Code is expected to drive adoption of the subcutaneous formulation in the second half of the year. BMS recently commented that they're receiving promising early feedback from practices and patients on the subcutaneous formulation, which is a 3 to 5-minute subcutaneous injection. Use is predominantly happening in the community setting and is occurring across multiple tumor types. In April of 2025, BMS announced the positive CHMP opinion for OPDIVO subcutaneous with ENHANZE, representing our tenth new growth catalyst. We anticipate European approval in mid-2025.

J 法規預計將在今年下半年推動皮下製劑的採用。BMS 最近表示，他們收到了來自實踐和患者的關於皮下製劑的有希望的早期反饋，這是一種 3 至 5 分鐘的皮下注射。該療法主要在社區環境中使用，並涉及多種腫瘤類型。2025 年 4 月，BMS 宣布 CHMP 對 OPDIVO 皮下注射 ENHANZE 給予正面評價，這是我們第十個新的成長催化劑。我們預計歐洲將於 2025 年中期批准。

I'll move now to subcutaneous RYBREVANT, which is Johnson & Johnson's innovative EGFR c-MET inhibitor. Johnson & Johnson gained European approval of subcutaneous RYBREVANT co-formulated with ENHANZE in April of 2025 for use in combination with lazertinib in the first-line treatment of adult patients with advanced EGFR-mutated non-small cell lung cancer. Subcutaneous RYBREVANT represents a more convenient patient-friendly formulation, reducing administration time from multiple hours required for the IV to just 5 minutes for the subcutaneous. Importantly, there is a 5-fold reduction in infusion-related reactions compared to the IV formulation. Work is now underway to gain reimbursement for subcutaneous RYBREVANT in each country.

我現在要談談皮下注射 RYBREVANT，這是強生公司的創新 EGFR c-MET 抑制劑。強生公司於 2025 年 4 月獲得歐洲批准，將皮下注射 RYBREVANT 與 ENHANZE 聯合使用，與拉澤替尼聯合用於晚期 EGFR 突變非小細胞肺癌成年患者的一線治療。皮下 RYBREVANT 代表了一種更方便的患者友善配方，將給藥時間從靜脈注射所需的數小時縮短至皮下注射的僅 5 分鐘。重要的是，與靜脈注射製劑相比，輸液相關反應減少了 5 倍。目前，各國正努力爭取皮下注射 RYBREVANT 的報銷。

And our 11th new growth catalyst is the potential US approval of RYBREVANT subcutaneous. J&J is continuing to work on gaining this approval in 2025. I wanted to also highlight recent data on RYBREVANT. Very excitingly, the results of the Phase III MARIPOSA trial were presented at the European Lung Cancer Congress in March of 2025.

我們的第 11 個新增長催化劑是美國可能批准 RYBREVANT 皮下注射劑。強生公司正在繼續努力，爭取在 2025 年獲得此項批准。我還想強調一下 RYBREVANT 的最新數據。令人興奮的是，第三階段 MARIPOSA 試驗的結果於 2025 年 3 月在歐洲肺癌大會上發表。

The combination of RYBREVANT and lazertinib significantly reduced the risk of death by 25% versus Tagrisso, which is considered by many to be the current standard of care in patients with newly diagnosed EGFR mutated non-small cell lung cancer. With a projected improvement projected of more than 12-month survival benefit over this current standard of care, this is certainly a potentially important advance for patients with this type of cancer, where only 20% of patients survive beyond 5 years today.

RYBREVANT 與拉澤替尼的組合較 Tagrisso 顯著降低了 25% 的死亡風險，後者被許多人認為是目前新診斷的 EGFR 突變非小細胞肺癌患者的治療標準。與目前的治療標準相比，預計生存期將延長 12 個月以上，這對於患有此類癌症的患者來說無疑是一個潛在的重要進步，因為目前只有 20% 的患者能夠存活超過 5 年。

With our now 10 launched products, which are shown on slide 11, we remain on track to deliver over $1 billion in royalty revenue in 2027 with all products continue to generate royalties to at least 2030 and many expected to continue to the 2040s. I'll move now to slide 12 and to some highlights on our pipeline that represent potential new growth drivers, the royalty revenues of which are not included in our multiyear guidance. During the first quarter, Acumen reported top line results for sabirnetug subcutaneous with ENHANZE for Alzheimer's disease, which support further clinical development for the subcutaneous formulation with ENHANZE.

我們目前已推出 10 款產品（如投影片 11 所示），我們仍有望在 2027 年實現超過 10 億美元的特許權使用費收入，所有產品至少在 2030 年之前將繼續產生特許權使用費，預計許多產品將持續到 2040 年代。我現在將轉到第 12 張投影片，介紹我們產品線中的一些亮點，這些亮點代表了潛在的新成長動力，其特許權使用費收入並未包含在我們的多年指導中。在第一季度，Acumen 報告了用於治療阿茲海默症的 sabirnetug 皮下注射 ENHANZE 的頂線結果，這支持對 ENHANZE 皮下製劑進行進一步的臨床開發。

ViiV also reported positive Phase II data for N6LS subcutaneous with ENHANZE in combination with Cabotegravir. The study demonstrated the promise of an every four-month treatment in combination with Cabotegravir. This is another terrific example of how ENHANZE can support a more extended dosing interval, reducing the treatment burden for patients. And we were also very hard at work during the quarter, continuing discussions with several companies and entering into discussions with multiple new companies with regard to new deals. I'm pleased to announce that we have signed our first development agreement with the current ENHANZE partner for development of our high-volume auto-injector.

ViiV 也報告了 N6LS 皮下注射 ENHANZE 與 Cabotegravir 聯合使用的積極 II 期數據。該研究證明了每四個月與卡博特韋合併治療的前景。這是 ENHANZE 如何支持更長的給藥間隔、減輕患者治療負擔的另一個絕佳例子。本季我們也非常努力地工作，繼續與多家公司進行討論，並與多家新公司討論新交易。我很高興地宣布，我們已經與目前的 ENHANZE 合作夥伴簽署了第一份開發協議，用於開發我們的大容量自動注射器。

The majority of the ongoing discussions continue to focus on ENHANZE alone and ENHANZE with the high-volume auto-injector if the volume is between 2 to 10 mls. I can update that we are progressing through the multistep review and decision-making committees in several of these discussions. And turning to our small volume auto-injector business, I'm pleased to say that one of our current partners is progressing now to test the small volume auto-injector in a Phase I study.

目前正在進行的討論主要集中在單獨使用 ENHANZE 以及使用大容量自動注射器（如果劑量在 2 至 10 毫升之間）使用 ENHANZE 的問題上。我可以更新一下，我們在其中幾次討論中正在通過多步驟審查和決策委員會取得進展。談到我們的小容量自動注射器業務，我很高興地說，我們目前的一個合作夥伴現在正在進行第一階段研究中的小容量自動注射器測試。

There has not been a time in Halozyme history when we have been in such a strong position in terms of having 10 derisked proven approved subcutaneous products with 11 recent or soon-to-happen events that are catalysts to expand opportunity, adoption, and growth. The underlying continued strength of DARZALEX subcutaneous, Phesgo, and VYVGART Hytrulo plus these new growth catalysts have resulted in the increased 2025 guidance, which Nicole will review in a moment after she discusses our first quarter results in more detail. Nicole?

在 Halozyme 的歷史上，我們從未像現在這樣處於如此強大的地位，擁有 10 種經過驗證的低風險皮下注射產品，以及 11 種近期或即將發生的事件，這些事件是擴大機會、採用和增長的催化劑。DARZALEX 皮下注射劑、Phesgo 和 VYVGART Hytrulo 的潛在持續強勁表現，加上這些新的成長催化劑，導致了 2025 年指引的提高，Nicole 將在更詳細地討論我們的第一季度業績後對此進行回顧。妮可？

Thank you, Helen. The first quarter of 2025 represented a strong start to the year. And we are excited to raise our full year expectations based on these strong results. We grew revenue by 35% with EBITDA growth of 40% as we continue to drive leverage on our high-margin royalty revenue, contributing $153 million in free cash flow in the quarter. Let me start on slide 13.

謝謝你，海倫。2025 年第一季是強勁的開局。基於這些強勁的業績，我們很高興提高全年預期。由於我們繼續利用高利潤的特許權使用費收入，本季我們的收入成長了 35%，EBITDA 成長了 40%，貢獻了 1.53 億美元的自由現金流。我從第 13 張投影片開始。

In the first quarter, we completed the $250 million ASR announced in December of 2024. Since 2019, we have repurchased $1.55 billion of shares, which is on average, $250 million each year at an average price of $33.72. Due to the strong performance to date, we are announcing an additional $250 million of share repurchases to be executed during the remainder of the year. As Helen mentioned, we continue to evaluate M&A opportunities to complement our organic growth expectations. Let me now turn to our detailed first quarter results on slide 14.

第一季度，我們完成了 2024 年 12 月宣布的 2.5 億美元 ASR。自 2019 年以來，我們已回購了價值 15.5 億美元的股票，平均每年回購 2.5 億美元，平均價格為 33.72 美元。由於迄今為止的強勁表現，我們宣布將在今年剩餘時間內額外回購 2.5 億美元的股票。正如海倫所提到的，我們將繼續評估併購機會以補充我們的有機成長預期。現在讓我轉到第 14 張投影片來介紹我們第一季的詳細業績。

Revenue grew 35% to $264.9 million compared to $195.9 million in the prior year period. This includes higher-than-expected revenue in all categories. Royalty revenue of $168.2 million, increased by 39% from $120.6 million in the prior year and was higher than our original expectations. The continued commercial success of subcutaneous DARZALEX and Phesgo and the robust growth of VYVGART Hytrulo exceeded our expectations for the quarter, driving an increase in our full year guidance. Product sales of $78 million increased by 33% from $58.6 million in the prior year period, mainly driven by higher API sales than originally estimated due to an increase in partner orders.

營收從去年同期的 1.959 億美元成長 35% 至 2.649 億美元。這包括所有類別的收入均高於預期。特許權使用費收入為 1.682 億美元，較上年的 1.206 億美元成長 39%，高於我們最初的預期。皮下注射 DARZALEX 和 Phesgo 的持續商業成功以及 VYVGART Hytrulo 的強勁增長超出了我們對本季度的預期，推動了我們全年指導的增長。產品銷售額為 7,800 萬美元，較去年同期的 5,860 萬美元增長 33%，主要由於合作夥伴訂單增加導致 API 銷售額高於最初估計。

We have an increase in partner orders in later quarters of 2025, which is also a driver of the increase in our full year guidance. Collaboration revenue of $18.6 million, an increase of 12% from $16.7 million in the prior year period was also higher than expected due to the achievement of a VYVGART Hytrulo sales milestone one quarter earlier than originally projected. Research and development expenses were $14.8 million compared to $19.1 million in the prior year period.

2025 年下半年，我們的合作夥伴訂單增加，這也是我們全年業績指引成長的一個推動因素。合作收入為 1,860 萬美元，比去年同期的 1,670 萬美元增長 12%，也高於預期，因為 VYVGART Hytrulo 銷售里程碑比最初預計的提前一個季度實現。研發費用為 1,480 萬美元，去年同期為 1,910 萬美元。

The decrease was primarily due to lower compensation expense, driven by resource optimization and improved labor allocations to COGS and the timing of planned investments in ENHANZE related to the development of our new high yield rHuPH20 manufacturing process. Selling, general, and administrative expenses were $42.4 million in the quarter, up from $35.1 million in the prior year period, primarily due to increased compensation expense and consulting and professional service fees.

下降的主要原因是薪酬費用降低，這得益於資源優化和勞動力分配改善，以及與開發新的高產量 rHuPH20 製造流程有關的 ENHANZE 計劃投資的時間。本季銷售、一般及行政費用為 4,240 萬美元，高於去年同期的 3,510 萬美元，主要原因是薪資費用以及諮詢和專業服務費用增加。

Adjusted EBITDA increased 40% to $162 million from $115.7 million last year. GAAP diluted earnings per share was $0.93 and non-GAAP diluted earnings per share was $1.11. This is compared with GAAP diluted earnings per share of $0.60 and non-GAAP diluted earnings per share of $0.79 in the first quarter of 2024. We continue to maintain a strong balance sheet with cash, cash equivalents, and marketable securities of $747.9 million on March 31, 2025, compared to $596.1 million on December 31, 2024. The increase was primarily a result of cash generated from operations.

調整後的 EBITDA 從去年的 1.157 億美元成長 40% 至 1.62 億美元。GAAP 稀釋每股收益為 0.93 美元，非 GAAP 稀釋每股收益為 1.11 美元。相比之下，2024 年第一季的 GAAP 稀釋每股收益為 0.60 美元，非 GAAP 稀釋每股收益為 0.79 美元。我們繼續保持強勁的資產負債表，2025 年 3 月 31 日的現金、現金等價物和有價證券為 7.479 億美元，而 2024 年 12 月 31 日為 5.961 億美元。成長主要是由於經營活動產生的現金。

Our net debt position was $777 million with a net leverage ratio of 1x. As a result of our strong first quarter performance, we are raising our guidance, as you can see on slide 15. We now expect total revenue of $1.2 billion to $1.28 billion, representing year-over-year growth of 18% to 26%, driven by increased projections in all 3 revenue categories: Royalties, product sales, and collaboration revenue. Royalty revenues of $750 million to $785 million, representing year-over-year growth of 31% to 37%. We continue to expect VYVGART Hytrulo with ENHANZE to be the largest royalty dollar growth driver.

我們的淨債務狀況為 7.77 億美元，淨槓桿率為 1 倍。由於我們第一季的強勁表現，我們提高了業績預期，正如您在第 15 張投影片上看到的那樣。我們現在預計總收入為 12 億美元至 12.8 億美元，年增 18% 至 26%，這得益於所有 3 個收入類別的預測增加：版稅、產品銷售和合作收入。特許權使用費收入為 7.5 億美元至 7.85 億美元，年增 31% 至 37%。我們繼續預計 VYVGART Hytrulo 與 ENHANZE 將成為最大的特許權使用費成長動力。

Product sales of $340 million to $365 million, driven by higher partner demand for rHuPH20 in the year. Collaboration revenue of $110 million to $130 million, driven by the EU approval of RYBREVANT SC in April, for which a milestone will be recognized in the second quarter. Adjusted EBITDA of between $790 million to $840 million, representing year-over-year growth of 25% to 33%, reflecting high-margin royalty growth, coupled with flat operating expenses from our continued focus on operational efficiency. And non-GAAP diluted EPS of $5.30 to $5.70, representing year-over-year growth of 25% to 35%, which does not include the impact of future share repurchases, including the $250 million announced today. As you refine your models, I'd like to reiterate the following.

產品銷售額達 3.4 億美元至 3.65 億美元，這得益於今年合作夥伴對 rHuPH20 的需求增加。合作收入達到 1.1 億至 1.3 億美元，這得益於歐盟 4 月批准 RYBREVANT SC，並將在第二季度實現里程碑式的成果。調整後的 EBITDA 在 7.9 億美元至 8.4 億美元之間，年增 25% 至 33%，反映了高利潤率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 5.30 美元至 5.70 美元，年增 25% 至 35%，其中不包括未來股票回購的影響，包括今天宣布的 2.5 億美元。當你完善你的模型時，我想重申以下幾點。

While we achieved a VYVGART Hytrulo milestone one quarter earlier than expected, in the first quarter, we continue to expect collaboration revenue for the year to be more weighted in the second half of 2025. We continue to expect product sales to be weighted in the second half of the year, with the second quarter flat with the first quarter. For royalties, we continue to expect quarterly sequential growth for the remaining quarters in the year. With that, I'll now turn the call back over to Helen.

雖然我們在第一季比預期提前一個季度實現了 VYVGART Hytrulo 里程碑，但我們仍然預計全年的合作收入將在 2025 年下半年佔據更大的比重。我們繼續預計下半年產品銷售將有所回落，第二季將與第一季持平。對於特許權使用費，我們繼續預計今年剩餘季度將持續成長。說完這些，我現在將電話轉回給海倫。

Thank you, Nicole. Our strong first quarter performance, particularly of DARZALEX subcutaneous, Phesgo, and VYVGART Hytrulo, plus our 11 new growth catalysts gave us the confidence to raise the full year 2025 financial guidance ranges.

謝謝你，妮可。我們第一季的業績表現強勁，尤其是 DARZALEX 皮下注射劑、Phesgo 和 VYVGART Hytrulo，再加上我們的 11 個新的成長催化劑，使我們有信心提高 2025 年全年財務指導範圍。

With 10 products now approved and launched in at least one major region, we have durable revenue streams that will continue to support our conviction in the future success of Halozyme. Our robust pipeline, along with our ability to defend our intellectual property, further strengthens our confidence in delivering sustainable growth and profitability well into the future. This is an incredibly exciting time of growth for Halozyme.

目前，我們已有 10 種產品在至少一個主要地區獲得批准並上市，我們擁有持久的收入來源，這將繼續支持我們對 Halozyme 未來成功的信心。我們強大的產品線以及保護智慧財產權的能力進一步增強了我們在未來實現永續成長和獲利的信心。對於 Halozyme 來說，這是一個令人難以置信的激動人心的增長時期。

And this would not have been possible without our terrific partners and our dedicated and expert Halozyme team. And I'd like to say a sincere thank you to everybody who has contributed. Operator, with that, we are now ready to open the call for questions. Thank you.

如果沒有我們出色的合作夥伴和我們敬業且專業的 Halozyme 團隊，這一切都不可能實現。我謹向所有貢獻的人表示誠摯的感謝。接線員，好了，我們現在可以開始提問了。謝謝。

(Operator Instructions) Mohit Bansal, Wells Fargo.

（操作員指示）Mohit Bansal，富國銀行。

This is Sadia Rahman on for Mohit. So on the IP case with Merck; I had a question about that. Can you comment on the expected timelines for the PGR decisions and what action you could take if the PGR goes in Merck's favor?

這是 Sadia Rahman 代替 Mohit 上場。因此，關於默克的智慧財產權案；我對此有一個疑問。您能否評論一下 PGR 決定的預期時間表，以及如果 PGR 對默克有利，您會採取什麼行動？

Yes. Thanks for that. With regard to the PGR, the first decision by the patent office on institution will be in early June. And if there is institution; that will mean that the case will be reviewed about 12 months from them. They also can decide not to pick up the case, in which case it would not proceed.

是的。謝謝。關於PGR，專利局將於6月初做出第一個關於制度的決定。如果有製度；這意味著該案件將在大約 12 個月後進行審查。他們也可以決定不接手該案件，在這種情況下案件就不會繼續進行。

And just related to that, is there a possibility that that PGR case and your patent infringement lawsuit could be tied together? Or is that not possible due to logistical reasons?

與此相關的是，PGR 案件和您的專利侵權訴訟有可能連結在一起嗎？或因後勤原因而無法實現？

Yes, not like difficult, but two very different approaches that are going on there. Obviously, the PGR, we consider to be, frankly, a little bit of a side show. PGRs tend to be filed when companies are concerned that they are infringing and they seek to invalidate the patents. We feel very confident in our ability to prevail in those PGRs.

是的，不算困難，但有兩種截然不同的方法。顯然，坦白說，我們認為 PGR 有點像是一場雜耍。當公司擔心自己侵權並試圖使專利無效時，他們往往會提交 PGR。我們對自己在這些 PGR 中獲勝的能力非常有信心。

And even if they were to win one or two of the PGRs because there are several in place, we do not believe that will have any impact at all on our infringement case where we have multiple additional claims that are not subject to the PGR that are the basis of that infringement case, so two very separate things. The most important one is actually the actual lawsuit that we filed. I'd keep your attention on that one.

即使他們贏得一兩項 PGR（因為已經有幾項 PGR 存在），我們也不認為這會對我們的侵權案產生任何影響，因為我們有多項不受 PGR 約束的額外索賠，而這些索賠是該侵權案的基礎，所以這是兩件截然不同的事情。最重要的其實是我們提起的實際訴訟。我會讓你關注這一點。

Sean Laaman, Morgan Stanley.

摩根士丹利的肖恩拉曼。

Congratulations on a nice set of numbers. What's the beat our number today and you've upgraded guidance? But was there one particular area of strength that surprised you during the quarter and is driving the upgrade? Or is it more broad-based?

恭喜您取得了一組不錯的成績。今天我們的數字超出預期多少？您是否升級了指導？但是本季是否有一個特別的優勢領域令您感到驚訝並推動了升級？還是其基礎更為廣泛？

Yes. I will say it's our three blockbuster products that have been performing for us for the last several years and, frankly, are expected to continue to have this excellent performance. So it's across the board with DARZALEX subcutaneous, Phesgo, and also with VYVGART Hytrulo. And so one of the other things we mentioned, not just the royalties, but we achieved a milestone on VYVGART Hytrulo one quarter earlier than we had anticipated as well and that was a commercial sales attainment milestone. So they are just continuing to perform very, very well, Sean.

是的。我想說的是，我們的三款重磅產品在過去幾年中一直表現優異，坦白說，預計它們將繼續保持這種出色的表現。因此，它與 DARZALEX 皮下注射劑、Phesgo 以及 VYVGART Hytrulo 均有合作。我們提到的另一件事不僅僅是版稅，而且我們在 VYVGART Hytrulo 上也比預期提前一個季度實現了一個里程碑，這是一個商業銷售成就里程碑。所以他們繼續表現得非常非常好，肖恩。

Behind them, we're obviously excited about the other four launched products that are really just at the very beginning. But just based on the performance comments from the partners and our estimates, we're going to continue to see strong growth from all of those products for many years to come.

在它們之後，我們顯然對其他四款剛起步的已推出產品感到興奮。但僅根據合作夥伴的業績評論和我們的估計，我們預計未來許多年所有這些產品都將保持強勁成長。

And on the small volume auto-injector, when might you be in a position to tell us who the partner is? And how do the economics of that deal compared to the high-volume auto-injector partnerships? And when do you ultimately see commercialization might be a reality?

關於小容量自動注射器，您什麼時候可以告訴我們合作夥伴是誰？與大容量自動注射器合作關係相比，該交易的經濟效益如何？您認為什麼時候商業化最終會成為現實？

Yes. With regard to when that might become public, that really will be a partner who will be in control of that. I would take an estimate and guess that when it enters clinical studies. It might be public that it's our small volume auto-injector. But for competitive reasons, we're seeing again that our partners don't want to be signaling to their competition exactly what they're doing to continue to evolve their product offering and differentiate it down for patients.

是的。至於何時公開，真正能夠控制此事的將是合作夥伴。我會進行估計並猜測它何時進入臨床研究。它可能被公開，它是我們的小容量自動注射器。但出於競爭原因，我們再次看到我們的合作夥伴不想向競爭對手透露他們正在做什麼，以繼續改進他們的產品並為患者提供差異化服務。

The small-volume and the high-volume auto-injector agreements are both development agreements, Sean. They really lay out exactly how we will work together to create an auto-injector for use in clinical development. We have yet to move forward to the commercial licensing -- supply agreement, sorry, where the actual financial terms will be there.

小容量和大容量自動注射器協議都是開發協議，肖恩。他們確實詳細闡述了我們將如何合作創造用於臨床開發的自動注射器。我們尚未推進商業許可供應協議，抱歉，其中沒有實際的財務條款。

But I would expect, in both instances, what you're going to see is going to be where we have a price per device that is based on the cost of manufacturing and the time it takes us to manufacture and some cost-plus benefit for Halozyme, but more to come on that later. We're just incredibly excited that we're now moving forward with two of our partners to be using and testing our auto-injectors in the future in their clinical studies.

但我預計，在這兩種情況下，您將看到的是，我們的每台設備的價格都基於製造成本和製造所需的時間，以及 Halozyme 的一些成本加成效益，但稍後我們會詳細介紹。我們非常高興，我們現在正與兩個合作夥伴一起在未來的臨床研究中使用和測試我們的自動注射器。

Michael DiFiore, Evercore ISI.

Michael DiFiore，Evercore ISI。

Congrats on all the continued progress. Two questions from me, centering on the Merck Halozyme litigation. Number one, do you guys see AstraZeneca's Alteogen deal as evidence that large pharma companies are willing to accept patent litigation risk rather than sign ENHANZE deals? And if so, how do you counter that narrative? Second question is, have any ENHANZE partners paused new target add-ons or renegotiations while they watch this litigation play out? And if so, how material could that be to long-term growth?

祝賀您不斷取得進步。我有兩個問題，主要圍繞在默克 Halozyme 訴訟案。首先，你們是否認為阿斯特捷利康與 Alteogen 的交易證明大型製藥公司願意接受專利訴訟風險，而不是簽署 ENHANZE 交易？如果是這樣，您如何反駁這種說法？第二個問題是，在觀看這場訴訟的過程中，是否有任何 ENHANZE 合作夥伴暫停了新的目標附加組件或重新談判？如果是這樣，這對長期成長有多重要？

Yes. I'll tackle the second one first, Mike. And no, we have not heard from any partner who is a current partner or even conversations we're having with potential future partners where anything is being paused to evaluate the outcome of the Merck litigation. And I don't expect that really to happen at all. It's very clear ENHANZE is seen as the market leader here.

是的。我先解決第二個問題，麥克。不，我們沒有聽到任何現任合作夥伴的消息，甚至沒有聽到與潛在未來合作夥伴的對話，我們暫停了一切以評估默克訴訟的結果。我根本不指望這種事真的會發生。很明顯，ENHANZE 被視為這裡的市場領導者。

We're the most derisked, the most validated with 1 million patients treated. And I can say that for all of the people who are looking at hyaluronidase, including all of the ones who have signed deals with Alteogen, all of them have come to Halozyme first and perhaps found that the target they were intending or wanting to use it for was not available. And I think we're going to continue to see that pattern.

我們是風險最低、驗證最充分的機構，已治療 100 萬名患者。我可以說，所有關注透明質酸酶的人，包括所有與 Alteogen 簽約的人，他們都首先來到 Halozyme，也許發現他們想要或想要使用它的目標並不存在。我認為我們將繼續看到這種模式。

With regard to your specific question on AstraZeneca, again, I don't want to speculate on what AstraZeneca is thinking with regard to the litigation, but I'll come back to the comment I made a moment ago. All of the people that have moved forward with the deal with Alteogen have actually discussed specific targets with Halozyme that were taken by other of our current partners. And I think, again, that is the trend that we have seen to date.

關於您關於阿斯特捷利康的具體問題，我再次強調，我不想猜測阿斯特捷利康對訴訟的看法，但我將回到我剛才的評論。所有與 Alteogen 達成交易的人實際上都與 Halozyme 討論了我們其他現有合作夥伴所採取的具體目標。我認為，這是我們迄今為止所看到的趨勢。

Jessica Fye, JPMorgan.

潔西卡費伊（Jessica Fye），摩根大通。

This is Adam on for Jess. I just wanted to ask, how are you thinking about the implications of the ENHERTU frontline breast cancer data for Phesgo sales and royalties?

這是亞當為傑西表演的。我只是想問一下，您如何看待 ENHERTU 一線乳癌數據對 Phesgo 銷售和特許權使用費的影響？

Yes. Obviously, we're keeping a close watch on that. What we are seeing with Phesgo is with the great long-term data and there's more long-term data, as you know, that's going to be coming out on Phesgo this year as well, together with the very convenient patient administration. In just 5 to 7 minutes for it, we believe that the Phesgo is going to continue to demonstrate this very strong market adoption and uptake where there is incredibly high patient satisfaction for it. So not just the clinical benefits, the administration benefits, but also the patient satisfaction.

是的。顯然，我們正在密切關注此事。我們看到 Phesgo 擁有出色的長期數據，而且如您所知，今年還會有更多關於 Phesgo 的長期數據公佈，同時還會有非常便捷的患者管理。我們相信，只需 5 到 7 分鐘，Phesgo 就將繼續展現出非常強大的市場採用率和普及度，且患者對其的滿意度極高。因此，不僅有臨床益處、管理益處，還有病患滿意度。

So we're not concerned with regard to the ENHERTU data that will be emerging. Delighted to see the strong uptake continues for Phesgo. We mentioned on the call, 47% share now and the 58 launch markets expected to get to more than 50% this year. And we've seen with our products that when a patient has moved to the subcu version of the products, they tend to be very sticky. So we are projecting continued strong growth of Phesgo for multiple years to come.

因此，我們並不擔心即將出現的 ENHERTU 數據。很高興看到 Phesgo 繼續保持強勁成長勢頭。我們在電話會議上提到，目前的市佔率為 47%，預計今年 58 個發射市場的市佔率將達到 50% 以上。我們從我們的產品中發現，當患者轉用皮下版本的產品時，它們往往會變得非常黏稠。因此，我們預計 Phesgo 在未來幾年將繼續保持強勁成長。

Mitchell Kapoor, H.C. Wainwright.

米切爾·卡普爾，H.C.溫賴特。

I wanted to ask a little bit about your views in the future of the changing proportion of the mix of royalty revenues as your pipeline evolves. Just kind of trying to understand when we could get to more even proportions versus the three blockbusters serving as the heavy weights for the royalty revenues?

我想問一下，隨著你們的管道不斷發展，您對未來特許權使用費收入結構比例的變化有何看法。只是想了解什麼時候我們才能達到更均衡的比例，而不是讓三部大片成為版稅所得的重擔？

All right. When you have such great products, Mitch, it's an embarrassment of which to choose. And we do expect several of our products that are currently just starting, their launch trajectories to also be meaningful contributors. There was a time where people were very focused on DARZALEX and it's having a very large proportion of our sales. It will continue to be a very important contributor to us for many years to come.

好的。米奇，當你有如此優秀的產品時，選擇哪一款真是令人尷尬。我們確實希望目前剛起步的幾款產品，它們的發布軌跡也能做出有意義的貢獻。曾經有一段時間，人們非常關注 DARZALEX，它佔據了我們銷售額的很大一部分。在未來的許多年裡，它將繼續為我們做出非常重要的貢獻。

But products like VYVGART Hytrulo, Phesgo, OCREVUS, others are going to be very important contributors as well. I think Nicole mentioned that this year, the larger taller growth is actually VYVGART Hytrulo, which shows you how our portfolio is broadening. So we're going to have multiple very high-impact blockbusters like DARZALEX and then frankly, by the end of this year, next year. Let me see if Nicole would add anything to that.

但 VYVGART Hytrulo、Phesgo、OCREVUS 等產品也將成為非常重要的貢獻者。我認為妮可提到過，今年更大、更高的成長實際上是 VYVGART Hytrulo，這向您展示了我們的投資組合是如何擴大的。因此，我們將推出多部像 DARZALEX 這樣具有極高影響力的大片，坦白說，到今年年底或明年。讓我看看妮可是否願意補充一些內容。

Yes. And we don't break out our royalties by products. But we have shared the buckets as we think about our royalty projections. We shared DARZALEX and Phesgo in total. The contribution that they're expected to have in the long-term.

是的。我們不會按產品分列我們的版稅。但當我們考慮特許權使用費預測時，我們已經分享了這些桶子。我們總共分享了DARZALEX和Phesgo。他們有望長期做出的貢獻。

And then the next wave of our products, so comparing it to DARZALEX and Phesgo having a $20 billion market opportunity in 2028. And then looking at the next wave of our products in totality, having a $35 billion market opportunity in 2028, I think that gives you that good sense for how over the next few years, those products will start contributing very meaningfully and taking up a good proportion of our royalty revenue.

然後是我們的下一波產品，因此與 DARZALEX 和 Phesgo 相比，它在 2028 年擁有 200 億美元的市場機會。然後從整體上看，我們的下一波產品在 2028 年將擁有 350 億美元的市場機會，我認為這會讓你很好地了解在未來幾年內這些產品將如何開始做出非常有意義的貢獻並佔據我們特許權使用費收入的很大一部分。

And one more for me. Just talking about the M&A activity and the expectations for future activity in that space. Could you talk a little bit about what you're looking for in your next BD deal there and how that contrasts with your strategy with Evotec? And then if you could just talk about the timing on when you would like to execute on one of those transactions? Is there kind of a timeline for that and kind of the size, larger or smaller, multiple smaller ones, any clarity around those particular aspects of the M&A strategy?

對我來說還有一個。只是談論併購活動以及對該領域未來活動的預期。您能否談談您在下一筆 BD 交易中尋求什麼，以及這與您對 Evotec 的策略有何不同？然後，您能否談談您希望何時執行其中一項交易？有沒有一個時間表，以及規模，是更大還是更小，多個較小的，對於併購策略的具體方面有任何明確規定嗎？

Yes. Thanks, Mitch. Well, with regard to M&A, we are very focused on seeking to find opportunities in the drug delivery space where there are platform technologies that can result in long durable revenues, including and particularly for royalties. Obviously, we like that model. But I will say we are not in a hurry to do it.

是的。謝謝，米奇。嗯，關於併購，我們非常注重在藥物傳輸領域尋找機會，該領域擁有可以帶來長期持久收入的平台技術，特別是特許權使用費。顯然，我們喜歡這個模型。但我要說的是，我們並不急於這麼做。

And we're going to be carefully evaluating and being thoughtful as we've always been to identify something that we believe would be needed and required by multiple pharma companies and will result in a very positive contribution to Halozyme long-term growth. So think drug delivery, think licensing business; that is where we are evaluating today. No specific timeline. And as we're still evaluating, Mitch, it would be premature to comment on the size. But it -- so I can't comment on that at this period of time.

我們將像往常一樣進行仔細評估和深思熟慮，以確定我們認為多家製藥公司需要和要求的東西，並將對 Halozyme 的長期成長做出非常積極的貢獻。因此，考慮藥品配送，考慮許可業務；這就是我們今天要評估的地方。沒有具體的時間表。米奇，由於我們仍在評估，因此對規模發表評論還為時過早。但是——目前我無法對此發表評論。

So that's where we're going to be focused. And we're excited to try to create new platforms and create just great businesses like ENHANZE. And that we've done so successfully with that.

所以這就是我們要關注的重點。我們很高興嘗試創建新的平台並創建像 ENHANZE 這樣的偉大企業。而我們已經成功地做到了這一點。

(Operator Instructions) Brendan Smith, TD Cowen.

（操作員指示） Brendan Smith，TD Cowen。

Congrats on all the great updates. Maybe just another one kind of regarding the litigation for KEYTRUDA. Just kind of in plain terms, can you just confirm first that whatever the outcome for your litigation against Merck that the decision will have no impact on your actual core ENHANZE business? And then, on the flip side, kind of the same question regarding the PGR suit from Merck or is the one from them a little bit more targeted to ENHANZE itself. Just trying to kind of understand the relative potential impact down the line.

祝賀所有重大更新。也許這只是另一種有關 KEYTRUDA 訴訟的情況。簡單地說，您能否先確認，無論您對默克公司的訴訟結果如何，該判決都不會對您的實際核心 ENHANZE 業務產生影響？然後，另一方面，關於默克公司的 PGR 訴訟，也有同樣的問題，或者他們的訴訟是否更針對 ENHANZE 本身。只是想了解未來相對的潛在影響。

That's great, Brendan. And to be very clear, what is going on in the MDASE, which is a separate and distinct set of patents from ENHANZE, will have absolutely no impact whatsoever on our ENHANZE business, our guidance that we have provided, or our future growth of ENHANZE. Think of the MDASE as future upside opportunity. That has been identified as we are finding that companies are infringing our intellectual property. And we're seeking to have those companies take licenses from us.

太好了，布倫丹。需要明確的是，MDASE 中發生的事情（它是一組獨立於 ENHANZE 的專利）絕對不會對我們的 ENHANZE 業務、我們提供的指導或 ENHANZE 的未來發展產生任何影響。將 MDASE 視為未來的上升機會。我們發現有公司侵犯了我們的智慧財產權。我們正在尋求讓這些公司從我們這裡獲得許可證。

So that's its bottom line with regard to what would happen. So specifically with the outcome of the PGRs, yes, absolutely no impact on our ENHANZE business and same with the infringement case, no impact on the ENHANZE business. All potential upside if we were to win either a license with Merck or when compensatory damages as we are seeking in the litigation. So two very distinct things where MDASE is just a potential upside coming from great innovation and inventions that Halozyme has created over the years.

這就是對於將會發生什麼事情的底線。因此，具體到 PGR 的結果，是的，對我們的 ENHANZE 業務絕對沒有影響，侵權案也是如此，對 ENHANZE 業務也沒有影響。如果我們贏得默克公司的許可或獲得我們在訴訟中尋求的補償性損害賠償，那麼所有潛在的好處都將存在。因此，這是兩件截然不同的事情，其中​​ MDASE 只是 Halozyme 多年來創造的偉大創新和發明帶來的潛在優勢。

And then maybe just a quick one on tariffs just because we do get a lot of questions about this. Can you just speak really quickly to how we should be thinking about the potential impact of pharma and maybe (inaudible)? And if you've had any conversations with any of your partners about them, I guess, particularly relevant for DARZALEX and VYVGART just given their global footprint?

然後我們再快速問一下關稅問題，因為我們確實收到了很多關於這方面的問題。可以簡單談談我們應該如何看待製藥業的潛在影響嗎？（聽不清楚）？如果您曾與任何合作夥伴討論過這些問題，我想，考慮到 DARZALEX 和 VYVGART 的全球影響力，這些問題是否特別相關？

Yes. I'll start with Halozyme's manufacturing, where we've been very deliberate ourselves in establishing our manufacturing in the United States. And we also have been seeking to assure we can source all or virtually all of our components and materials needed in the United States, too. And so I can confirm that from the Halozyme point of view for the products we produce in our API, there is a very, very limited exposure to the currently imposed tariffs and any small impact is already contemplated in our guidance.

是的。我將從 Halozyme 的製造開始，我們非常謹慎地在美國建立製造基地。我們也一直在努力確保我們能夠在美國採購所需的全部或幾乎所有零件和材料。因此，我可以確認，從 Halozyme 的角度來看，對於我們在 API 中生產的產品，目前徵收的關稅的影響非常有限，並且任何微小的影響都已在我們的指導中考慮到。

With regard to the pharma tariffs, I can say that based on our agreements, if the pharma tariffs were implemented for products being imported into the US, Halozyme will not see or should not see any impact on our royalty revenues. And so it's based on our agreements and based on what we're aware of with regard to the manufacturing of our partner products and importantly, also US distribution and how that works. So we should not see any impact with regard to tariffs.

關於製藥關稅，我可以說，根據我們的協議，如果對進口到美國的產品實施製藥關稅，Halozyme 將不會或不應該看到對我們的特許權使用費收入的任何影響。因此，這是基於我們的協議，基於我們對合作夥伴產品製造的了解，更重要的是，也基於美國分銷及其運作方式。因此我們不應該看到關稅方面的任何影響。

David Risinger, Leerink Partners.

Leerink Partners 的 David Risinger。

Congrats, Helen and team, on the very strong financial progress. I have two questions. The first is with respect to external acquisitions, are you also considering broadening your royalty streams by considering acquiring royalty companies? And then with respect to potential new customer deals, could you just talk about the gating factors for new business announcements? For example, are some customers awaiting FDA guidance, or sorry, CMS guidance for IRA negotiations in coming months for 2028 under the new administration?

祝賀海倫和團隊取得了非常強勁的財務進展。我有兩個問題。首先是關於外部收購，您是否也考慮透過收購特許權使用費公司來拓寬特許權使用費來源？然後關於潛在的新客戶交易，您能否談談新業務公告的限制因素？例如，是否有一些客戶在等待 FDA 的指導，或者抱歉，等待 CMS 在新政府領導下在未來幾個月內針對 2028 年的 IRA 談判的指導？

So with regard to external acquisitions, David, I mentioned that we really are focused on creating new platform businesses that can result in durable long revenue streams such as we've created for ENHANZE. And so think drug delivery platforms as being our primary focus in terms of where we are evaluating opportunities today.

因此，關於外部收購，大衛，我提到我們真正專注於創建新的平台業務，這些業務可以帶來持久的收入流，就像我們為 ENHANZE 創建的一樣。因此，就我們目前評估的機會而言，藥物輸送平台是我們關注的重點。

On the new customer deals and specifically for ENHANZE, and I've talked about this before. What we do see in companies is there's a multi-step review process and then a multi-step decision process. And so really, what we're doing at the moment is working through that process in each company where each company has a slightly different process.

關於新客戶交易，特別是 ENHANZE 的交易，我之前已經談過這個了。我們在公司中看到的是，有一個多步驟的審查過程，然後是一個多步驟的決策過程。所以實際上，我們目前正在做的是在每家公司中推行這項流程，每家公司的流程都略有不同。

Now you do get to the end of it, as we've seen very nicely by announcing our small volume auto-injector deal last quarter, the high-volume one. And we are in several discussions, going through that process on ENHANZE. So it simply is more a question of getting through the internal decision-making processes in the pharma and biotech companies that will result in an ENHANZE deal. And I remain confident we will sign a deal on ENHANZE this year. It's been interesting on CMS.

現在你已經走到了盡頭，正如我們在上個季度宣布小容量自動注射器交易時所看到的那樣，大容量自動注射器交易也已完成。我們正在進行多次討論，探討 ENHANZE 的這項進程。因此，這只是一個透過製藥和生物技術公司內部決策過程來達成 ENHANZE 交易的問題。我仍然相信我們今年將就 ENHANZE 簽署協議。CMS 很有趣。

And people are awaiting the IRA. I would not say that's a gate at all. It just is a question of interest to see whether the CMS will continue to recognize that a product that has two active ingredients is a separate drug from the single ingredients. And so if anything, that might bring us some additional new opportunities, David. But it hasn't been holding anyone back, waiting to see that that is confirmed. Much more focused on the strong differentiation that ENHANZE is able to bring for their patients and their mission for improving the patient treatment experience.

人們正在等待愛爾蘭共和軍。我根本不會說那是一扇門。有趣的是，CMS 是否會繼續承認含有兩種活性成分的產品與單一成分的產品是不同的藥物。所以如果有的話，這可能會為我們帶來一些額外的新機會，大衛。但它並沒有阻止任何人，等待看到這一點得到證實。更重視 ENHANZE 能夠為患者帶來的強大差異化以及改善患者治療體驗的使命。

And there are no further questions at this time. This does conclude today's conference call. You may now disconnect.

目前沒有其他問題。今天的電話會議到此結束。您現在可以斷開連線。