Halozyme Therapeutics Inc (HALO) 2024 Q3 法說會逐字稿

Good afternoon. My name is Jal, and I'll be your conference operator today. At this time, I would like to welcome everyone to the Halozyme third-quarter 2024 financial and operating results conference call.

午安.我叫 Jal，今天我將擔任你們的會議操作員。此時，我歡迎大家參加 Halozyme 2024 年第三季財務與營運業績電話會議。

(Operator Instructions) Please note, this event is being recorded. I'll now turn the call over to Tram Bui, Halozyme's Vice President of Investor Relations and Corporate Communications. Please go ahead.

（操作員說明）請注意，正在記錄此事件。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 third quarter 2024 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.

謝謝你，接線生。下午好，歡迎參加我們的 2024 年第三季財務與營運業績電話會議。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將在今天的電話會議期間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, will review our financial results as well as our outlook.

Halozyme 總裁兼執行長 Helen Torley 博士將主持此次電話會議，她將介紹我們業務的最新情況；我們的財務長 Nicole LaBrosse 將審查我們的財務表現以及我們的前景。

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，我們將做出投影片 2 中概述的前瞻性聲明。我還建議您參閱我們向 SEC 提交的文件，以了解風險和不確定性的完整清單。在電話會議期間，將討論公認會計原則和非公認會計原則財務指標。某些非公認會計原則或調整後的財務指標與我們的收益新聞稿和幻燈片簡報中的可比較公認會計原則財務指標一致。我現在將把電話轉給海倫·托利博士。

Thank you, Tram, and good afternoon, everyone. Let me start on slide 3. I am very pleased to report we delivered strong third-quarter financial results with a 34% increase in total revenues to reach an all-time high of $290 million in the quarter. This was largely driven by royalty revenue, which increased 36% to another record amount of $155 million.

謝謝你，Tram，大家午安。讓我從幻燈片 3 開始。我很高興地向大家報告，我們第三季的財務表現強勁，總收入成長了 34%，本季達到 2.9 億美元的歷史新高。這主要是由特許權使用費收入推動的，特許權使用費收入增加了 36%，達到創紀錄的 1.55 億美元。

This performance reflects the continued expansion and broadening of adoption of our ENHANZE drug delivery technology, with continued strong growth of DARZALEX Subcutaneous, Phesgo, and VYVGART Hytrulo.

這一業績反映了我們的 ENHANZE 藥物傳輸技術的持續擴展和廣泛採用，以及 DARZALEX 皮下注射劑、Phesgo 和 VYVGART Hytrulo 的持續強勁增長。

Based on our strong year-to-date performance, we are raising our total revenue, our royalty revenue, adjusted EBITDA, and non-GAAP earnings per share guidance ranges for the full year. Notably, this year we now expect to deliver high double-digit revenue growth of 17% to 23%, and an impressive adjusted EBITDA growth of 40% to 47%. Nicole will go into more detail on this in a moment.

基於我們今年迄今的強勁表現，我們正在提高全年的總收入、特許權使用費收入、調整後的 EBITDA 和非公認會計準則每股收益指導範圍。值得注意的是，我們現在預計今年將實現 17% 至 23% 的兩位數高收入成長，以及 40% 至 47% 的令人印象深刻的調整後 EBITDA 成長。妮可稍後將詳細介紹這一點。

Operationally, it was also another strong quarter. Two current partners nominated new targets for ENHANZE under expanded licensing agreements, adding new revenue in terms of milestones and reinforcing the value of our leading drug delivery technology. We've also continued our focus on securing new ENHANZE deals and also new agreements for our small and our high-volume auto-injector with discussions continuing and advancing.

從營運角度來看，這也是另一個強勁的季度。兩個現有合作夥伴根據擴大的許可協議為 ENHANZE 提名了新的目標，在里程碑方面增加了新的收入，並增強了我們領先的藥物輸送技術的價值。我們也繼續專注於獲得新的 ENHANZE 交易以及我們的小型和大容量自動注射器的新協議，討論仍在繼續並取得進展。

Roche, one of our most tenured partners, gained two significant regulatory approvals with the FDA approval for TECENTRIQ subcutaneous within ENHANZE and for OCREVUS subcutaneous within ENHANZE. And adding to this, multiple partners continue to expand their geographic approvals and advance their clinical development programs.

羅氏是我們最長期的合作夥伴之一，獲得了兩項重要的監管批准：FDA 批准了 ENHANZE 中的 TECENTRIQ 皮下注射和 ENHANZE 的 OCREVUS 皮下注射。除此之外，多個合作夥伴繼續擴大其地域批准並推進其臨床開發計畫。

These achievements are key drivers of our current and future growth trajectory. They reinforce our leading position and rapid large volume subsidy in these drug delivery and illustrate the well proven success and predictability of our platform technology.

這些成就是我們當前和未來成長軌跡的關鍵驅動力。它們鞏固了我們在這些藥物傳輸領域的領先地位和快速大批量補貼，並說明了我們平台技術已得到充分證明的成功和可預測性。

I'll now move to slide 4, and we'll provide some more details on these recent accomplishments. In September, we were delighted to announce two highly anticipated partner approvals, which reinforce ENHANZE's track record of 100% Phase 3 to regulatory approval success.

現在我將轉到投影片 4，我們將提供有關這些近期成就的更多詳細資訊。9 月份，我們很高興地宣布兩項備受期待的合作夥伴批准，這鞏固了 ENHANZE 在第 3 階段 100% 獲得監管批准的成功記錄。

The US approval of Roche's TECENTRIQ HYBREZA with ENHANZE represents the availability of the first and only subcutaneous anti- PD-L1 cancer immunotherapy. Approval was granted for all of the adult IV TECENTRIQ indications, with treatment delivered as an approximately 7-minute subcutaneous injection.

羅氏的 TECENTRIQ HYBREZA 與 ENHANZE 的美國批准代表了第一個也是唯一一個皮下抗 PD-L1 癌症免疫療法的可用性。所有成人 IV TECENTRIQ 適應症均獲得批准，治療透過約 7 分鐘的皮下注射進行。

Roche also received US approval of OCREVUS ZUNOVO with ENHANZE, which is our eight partnered products approval and further extended ENHANZE's reach into neurology. With OCREVUS ZUNOVO, multiple sclerosis patients can now receive their treatment as a 10-minute subcutaneous injection given twice a year, compared to a multi-hour treatment for the intravenous also given twice a year.

羅氏也獲得了 OCREVUS ZUNOVO 和 ENHANZE 的美國批准，這是我們的八個合作產品的批准，並進一步擴展了 ENHANZE 在神經病學領域的影響力。透過 OCREVUS ZUNOVO，多發性硬化症患者現在可以每年接受兩次 10 分鐘的皮下注射治療，而靜脈注射則需要每年兩次的數小時治療。

This dramatic simplification of treatment also creates the opportunity for patients to receive their treatment outside an IV infusion facility potentially closer to their home. These two recent approvals add to the significant growth opportunity we have right in front of us building on and adding to the recent European launches of TECENTRIQ and OCREVUS subcutaneous with ENHANZE.

這種治療的顯著簡化也為患者創造了在可能離家較近的靜脈輸液設施之外接受治療的機會。最近的兩項批准增加了我們面前的重大成長機會，建立在最近歐洲推出的 TECENTRIQ 和 OCREVUS 皮下注射與 ENHANZE 的基礎上。

Let me move now to the partner agreement expansions. ENHANZE is the gold standard for rapid, subcutaneous, large-volume drug delivery. This has been established over the last 10 years as a result of the strong safety track record and the unmatched history of global regulatory approvals and commercial success. This success is supporting productive conversations with existing partners who have experienced firsthand the success they can achieve with ENHANZE.

現在讓我談談合作夥伴協議擴展。ENHANZE 是快速、皮下、大容量藥物輸送的黃金標準。這項成就是在過去 10 年裡憑藉強大的安全記錄以及無與倫比的全球監管批准和商業成功歷史而建立的。這項成功支持了與現有合作夥伴進行富有成效的對話，這些合作夥伴親身體驗了 ENHANZE 所取得的成功。

We are pleased that this has resulted in five new target nominations in the quarter. In early October, we announced that argenx expanded their agreement for the exclusive license to ENHANZE by nominating four additional targets. Based on this expansion, argenx has now exclusively licensed ENHANZE for a total of six targets, including VYVGART Hytrulo.

我們很高興這在本季度產生了五個新的目標提名。10 月初，我們宣布 argenx 透過提名四個額外目標擴大了對 ENHANZE 獨家許可的協議。基於此次擴展，argenx 目前已獨家授權 ENHANZE 用於總共 6 個目標，其中包括 VYVGART Hytrulo。

As part of the agreement, argenx will make a $30 million payment to Halozyme for the four new targets. There are potential future milestone payments related to development progress, regulatory approvals and sales attainment of up to $85 million per new target. We are very excited to expand our relationship with argenx who is an innovative leader in immunology.

作為協議的一部分，argenx 將針對四個新目標向 Halozyme 支付 3000 萬美元。每個新目標未來可能會收到與開發進度、監管批准和銷售實現相關的里程碑付款，最高可達 8,500 萬美元。我們非常高興能夠擴大與免疫學領域創新領導者 argenx 的關係。

As their partner of choice for rapid large-volume subcutaneous drug delivery, we appreciate their patient-centric mission that is so closely aligned with our own commitment to improving the lives of patients through our innovative drug delivery technologies.

作為他們選擇的快速大容量皮下藥物輸送合作夥伴，我們讚賞他們以患者為中心的使命，這與我們透過創新藥物輸送技術改善患者生活的承諾密切相關。

In the quarter, ViiV also expanded their existing global collaboration and licensing agreement, which gives them exclusive access to our ENHANZE drug delivery technology for one additional undisclosed target. Now with that overview, I'll move now to discuss the progress of our milestone and royalty-generating subcutaneous commercial products, starting with Johnson & Johnson's DARZALEX on slide 5.

在本季度，ViiV 還擴大了其現有的全球合作和授權協議，這使他們能夠獨家使用我們的 ENHANZE 藥物輸送技術來治療另一個未公開的目標。現在，有了概述，我現在將討論我們的里程碑和產生專利費的皮下商業產品的進展，從幻燈片 5 上的強生公司的 DARZALEX 開始。

In the quarter, worldwide sales for DARZALEX increased almost 23% on an operational basis to represent the first asset in the J&J portfolio to reach $3 billion in a single quarter. DARZALEX' growth was primarily driven by share gains of 4 points across all lines of therapy with 7.7 points of growth in frontline setting as well as continued market growth.

本季度，DARZALEX 的全球銷售額在營運基礎上成長了近 23%，成為強生投資組合中首個單季達到 30 億美元的資產。DARZALEX 的成長主要得益於所有治療領域的份額增長 4 個百分點，其中一線治療領域的份額增長 7.7 個百分點，以及市場的持續增長。

With conversion to DARZALEX FASPRO with ENHANZE exceeding 90% share of sales in the United States and with very high conversion rates outside the United States, subcutaneous DARZALEX is the driver of this remarkable continued strong DARZALEX growth.

隨著 ENHANZE 的 DARZALEX FASPRO 在美國的銷售份額超過 90%，並且在美國以外地區的轉換率非常高，皮下注射 DARZALEX 成為 DARZALEX 持續強勁成長的推動力。

Further expanding DARZALEX subcutaneous indications and opportunity, during the quarter, J&J announced additional new approvals and regulatory submissions. US and European approval were recently received for an additional indication for DARZALEX with ENHANZE in newly diagnosed multiple myeloma patients who are eligible for autologous stem cell transplant in combination with bortezomib, lenalidomide and dexamethasone.

為了進一步擴大 DARZALEX 皮下適應症和機會，強生在本季宣布了更多新的批准和監管提交。美國和歐洲最近批准了 DARZALEX 聯合 ENHANZE 的一項額外適應症，用於治療新診斷的多發性骨髓瘤患者，這些患者有資格聯合硼替佐米、來那度胺和地塞米松進行自體幹細胞移植。

The company also announced the submission of a supplemental BLA to the Food and Drug Administration for approval of a new indication of DARZALEX FASPRO as part of a quadruplet regimen for the treatment of adult patients with newly diagnosed multiple myeloma for whom autologous stem cell transplant is deferred or who are ineligible.

該公司還宣布向美國食品和藥物管理局提交補充 BLA，以批准 DARZALEX FASPRO 的新適應症作為四聯療法的一部分，用於治療新診斷的多發性骨髓瘤成年患者，這些患者推遲自體幹細胞移植或不符合資格的人。

With that, I'll now turn to Roche's Phesgo, which is shown on slide 6. Phesgo, which is a fixed combination of Perjeta and Herceptin with ENHANZE continues to demonstrate excellent growth momentum. Sales increased 58% to CHF 1.2 billion for the first 9 months of 2024.

現在，我將轉向羅氏的 Phesgo，如幻燈片 6 所示。Phesgo 是 Perjeta 和 Herceptin 與 ENHANZE 的固定組合，繼續表現出出色的成長動能。2024 年前 9 個月銷售額成長 58%，達到 12 億瑞士法郎。

Uptake remains strong as additional countries launch with 55 countries now launched. Conversion of Perjeta has also increased to 43% in those countries. Phesgo is on a strong trajectory and is well positioned to reach and exceed 50% conversion by 2026.

隨著更多國家推出，採用率仍然強勁，目前已推出 55 個國家。在這些國家，Perjeta 的轉換率也增加至 43%。Phesgo 發展勢頭強勁，預計在 2026 年實現並超過 50% 的轉換率。

Also shown in the slide is updated analyst revenue consensus for Phesgo. With the strong growth and momentum I've just discussed, Phesgo is now projected to become a $3.5 billion brand in 2028. As all of this $3.5 billion in sales represents subcutaneous sales on which Halozyme has paid a mid-single-digit royalty, Phesgo represents another strong growth opportunity for Halozyme.

幻燈片中也顯示了 Phesgo 的最新分析師收入共識。憑藉我剛才討論的強勁成長和勢頭，Phesgo 目前預計將在 2028 年成為價值 35 億美元的品牌。由於這 35 億美元的銷售額全部為皮下銷售額，Halozyme 已為此支付了中個位數的特許權使用費，因此 Phesgo 代表了 Halozyme 的另一個強勁增長機會。

Moving now to additional highlights on Roche's two most recent launch products, which are shown on slide 7. I'll start with TECENTRIQ HYBREZA. Following European approval in January of this year, we were very pleased that similarly to Europe, the US approval was granted for all of the adult IV indications. TECENTRIQ HYBREZA, co-formulated with ENHANZE allows for an approximately 7-minute subcutaneous injection compared to 30 to 60 minutes for the IV infusion.

現在轉向羅氏最近推出的兩款產品的更多亮點，如幻燈片 7 所示。我將從 TECENTRIQ HYBREZA 開始。繼今年 1 月獲得歐洲批准後，我們非常高興地看到，與歐洲類似，所有成人靜脈注射適應症都獲得了美國批准。TECENTRIQ HYBREZA 與 ENHANZE 共同配製，皮下注射僅需約 7 分鐘，而靜脈輸注則需要 30 至 60 分鐘。

Dimensionalizing the opportunity, Roche reported TECENTRIQ revenue of CHF 2.7 billion for the first 9 months of 2024. Analysts predict that TECENTRIQ will achieve $5 billion in 2028. Roche has stated that they expect the majority of the sales of subcutaneous TECENTRIQ will come from conversion of the intravenous portion.

羅氏將這一機遇具體化，報告指出 TECENTRIQ 2024 年前 9 個月的收入為 27 億瑞士法郎。分析師預測 TECENTRIQ 將在 2028 年實現 50 億美元的營收。羅氏表示，他們預計皮下注射 TECENTRIQ 的大部分銷售額將來自靜脈注射部分的轉換。

Let me move now to Roche's OCREVUS ZUNOVO. I'm particularly excited for the US launch following the Food and Drug Administration approval in September. This approval follows closely on the European approval, which occurred in June of this year.

現在讓我談談羅氏的 OCREVUS ZUNOVO。我對 9 月獲得食品和藥物管理局批准後在美國的推出感到特別興奮。此次批准緊隨今年 6 月歐洲批准之後。

OCREVUS ZUNOVO with ENHANZE expands our reach in neurology and offers multiple sclerosis patients a treatment administration time of just 10 minutes via subcutaneous injection with ENHANZE, which compares to multiple hours required for the IV infusion. The subcutaneous formulation offers patients all of the benefits that they expect from OCREVUS in terms of the strong clinical profile and every 6-month dosing, while easing the administration burden of receiving treatment.

OCREVUS ZUNOVO 與 ENHANZE 擴大了我們在神經病學領域的影響力，透過皮下注射 ENHANZE 為多發性硬化症患者提供僅需 10 分鐘的治療給藥時間，而靜脈輸注則需要數小時。皮下製劑為患者提供了他們期望從 OCREVUS 獲得的所有益處，包括強大的臨床特徵和每 6 個月給藥一次，同時減輕了接受治療的管理負擔。

OCREVUS revenue increased 9% to CHF5 billion for the first 9 months of the year, driven by all regions. Roche has commented on the recent quarterly call that they are confident that subcutaneous formulation with ENHANZE will expand OCREVUS' footprint in the multiple sclerosis market and represent an incremental $2 billion sales opportunity.

在所有地區的推動下，OCREVUS 營收今年前 9 個月成長了 9%，達到 50 億瑞士法郎。羅氏在最近的季度電話會議上表示，他們相信 ENHANZE 的皮下製劑將擴大 OCREVUS 在多發性硬化症市場的足跡，並帶來 20 億美元的增量銷售機會。

The availability of subcutaneous also makes this possible by opening up the treatment opportunity at smaller community hospitals as an example, making it easier for patients to travel to receive treatment. Roche also sees an opportunity for patients to convert from IV OCREVUS to the subcutaneous version.

皮下注射也使這成為可能，例如，在較小的社區醫院提供了治療機會，使患者更容易前往接受治療。羅氏也看到了患者從 IV OCREVUS 轉換為皮下注射的機會。

Roche has commented that they are seeing promising first signals regarding the uptake in the US., which is supporting market expansion. About 80% of the new starts on OCREVUS ZUNOVO are coming from patients who are new to brand and who are not switchers from OCREVUS IV.

羅氏表示，他們看到了美國市場的正面訊號，這支持了市場擴張。大約 80% 的新開始使用 OCREVUS ZUNOVO 的患者來自剛接觸該品牌且未從 OCREVUS IV 換用的患者。

Let me move now to argenx and VYVGART Hytrulo, which is shown on slide 8. argenx' VYVGART continues to experience strong momentum in its first indication of generalized myasthenia gravis. argenx recently commented that they expect subcutaneous VYVGART will grow in importance with patients, physicians and payers.

現在讓我談談 argenx 和 VYVGART Hytrulo，如幻燈片 8 所示。 argenx 最近評論說，他們預計皮下 VYVGART 對於患者、醫生和付款人來說將變得越來越重要。

We're pleased that subcutaneous VYVGART with ENHANZE is already expanding the market by bringing in new patients and providers to VYVGART, with patients switching from oral medications to subcutaneous, including patients who don't have easy access to an IV infusion center.

我們很高興看到皮下注射 VYVGART 與 ENHANZE 已經透過為 VYVGART 引入新的患者和提供者來擴大市場，患者從口服藥物轉向皮下注射藥物，包括那些不易進入靜脈輸液中心的患者。

Moving now to chronic inflammatory demyelinating polyneuropathy, the second indication. While the launch is recent, argenx has commented that with the unmet medical need, they are happy to see high awareness for the subcutaneous option amongst patients and physicians. argenx expects to create fast and broad access for CIDP patients, similar to what they accomplished in their launch in myasthenia gravis.

現在轉向慢性發炎性脫髓鞘性多發性神經病變，這是第二個適應症。雖然該產品是最近才推出的，但 argenx 評論說，由於醫療需求未得到滿足，他們很高興看到患者和醫生對皮下注射選擇的高度認識。 argenx 期望為 CIDP 患者提供快速、廣泛的治療機會，類似於他們在重症肌無力方面的推出所取得的成就。

We're also looking forward to the approval of a prefilled syringe for VYVGART Hytrulo with ENHANZE, which will introduce a more convenient administration option for patients with gMG and also CIDP. The prefilled syringe filing has a PDUFA action date of April 10, 2025.

我們也期待批准用於 VYVGART Hytrulo 和 ENHANZE 的預充填注射器，這將為 gMG 和 CIDP 患者帶來更方便的給藥選擇。預充式註射器備案的 PDUFA 行動日期為 2025 年 4 月 10 日。

And argenx is also continuing to expand its presence in additional regions. Most recently, its BLA for efgartigimod subcutaneous with ENHANZE for gMG was approved in China, increasing number of approvals to more than 25 countries globally.

argenx 也持續擴大在其他地區的業務。最近，其用於 efgartigimod 皮下注射的 BLA 與用於 gMG 的 ENHANZE 在中國獲得批准，使全球超過 25 個國家的批准數量不斷增加。

Given the strong launch of VYVGART, multiple analysts currently project total sales to reach almost $5 billion in 2028 for just the first 2 approved indications. We believe there is considerable opportunity to increase the total addressable market for VYVGART as argenx continues to advance its pipeline and the product strategy by expanding to additional indications over time.

鑑於 VYVGART 的強勁推出，多位分析師目前預計，僅前 2 個核准適應症的總銷售額將在 2028 年達到近 50 億美元。我們相信，隨著 argenx 隨著時間的推移不斷擴展到其他適應症，繼續推進其管道和產品策略，有很大的機會增加 VYVGART 的總潛在市場。

We're pleased to be supporting two registrational studies evaluating VYVGART Hytrulo with ENHANZE administered by prefilled syringe in thyroid eye disease, an indication where there is still a high unmet need.

我們很高興支持兩項註冊研究，評估 VYVGART Hytrulo 與 ENHANZE 透過預充式註射器給藥治療甲狀腺眼疾，這表明仍有很高的未滿足需求。

In addition, in October, argenx initiated a Phase 3 study evaluating VYVGART Hytrulo with ENHANZE for ocular myasthenia gravis. And also recently, argenx initiated a Phase 2 trial in kidney transplant recipients with antibody-mediated rejection.

此外，10 月，argenx 啟動了一項 3 期研究，評估 VYVGART Hytrulo 與 ENHANZE 治療眼部重症肌無力的效果。最近，argenx 在腎臟移植受者中啟動了一項抗體介導排斥反應的 2 期試驗。

Now beyond VYVGART Hytrulo, argenx has a robust pipeline of multi-indication assets, including empasiprubart, or ARGX-117. As an innovator committed to improving patients' lives, argenx was at the forefront of recognizing the benefit of subcutaneous delivery. The early success of VYVGART Hytrulo is a strong proof point in the value proposition of ENHANZE-enabled subcutaneous delivery. And we are very pleased to have expanded our agreement with argenx from two to six nominations and to be their partner of choice for rapid large-volume subcutaneous drug delivery.

現在，除了 VYVGART Hytrulo 之外，argenx 還擁有強大的多重適應症資產管道，包括 empasiprubart 或 ARGX-117。作為致力於改善病患生活的創新者，argenx 處於認識皮下給藥益處的最前線。VYVGART Hytrulo 的早期成功有力地證明了 ENHANZE 皮下給藥的價值主張。我們非常高興將與 argenx 的協議從兩項提名擴大到六項，並成為他們快速大容量皮下給藥的首選合作夥伴。

Let me now move to slide 9 for an update pipeline product that are awaiting regulatory approval and launch. I'll begin with Bristol-Myers Squibb nivolumab subcutaneous. Bristol received regulatory filing acceptance in the US last quarter for nivolumab subcutaneous with ENHANZE, with a PDUFA action date of December 29 of this year.

現在讓我轉到投影片 9，以了解正在等待監管部門批准和發布的更新管道產品。我將從百時美施貴寶納武單抗皮下注射開始。Bristol 上季度在美國獲得了 ENHANZE 皮下注射納武單抗的監管備案受理，PDUFA 行動日期為今年 12 月 29 日。

The European submission is also under review. Once approved, this would represent our ninth approved product with ENHANZE. Nivolumab subcutaneous with ENHANZE has the potential to benefit both patients and physicians with a less than 5-minute treatment administration time.

歐洲提交的資料也在審查中。一旦獲得批准，這將是我們與 ENHANZE 合作的第九個獲得批准的產品。納武單抗皮下注射與 ENHANZE 有可能在不到 5 分鐘的治療時間內使患者和醫生受益。

Opdivo, which is the brand name for IV nivolumab, is currently $9 billion in annual sales. Bristol has stated that it projects the granted subcutaneous indications will represent 75% of these total sales. They also stated they expect to convert between 30% to 40% of the IV nivolumab to subcutaneous nivolumab.

Opdivo 是 IV nivolumab 的品牌名稱，目前年銷售額為 90 億美元。布里斯托表示，預計已批准的皮下注射適應症將佔總銷售額的 75%。他們還表示，預計將 30% 至 40% 的靜脈注射納武單抗轉化為皮下注射納武單抗。

Johnson & Johnson's amivantamab subcutaneous with ENHANZE is also pending regulatory approval and is currently under priority review with the FDA. Approval would represent our 10th launched partner product.

強生公司的 amivantamab 皮下注射與 ENHANZE 也正在等待監管部門的批准，目前正在接受 FDA 的優先審查。此次批准將是我們第十個推出的合作夥伴產品。

Earlier this year, exciting data from the PALOMA-3 trial for amivantamab subcutaneous was presented at ASCO. The presenters highlighted a five-fold reduction in infusion-related reactions as compared to the intravenous, a five-fold reduction in treatment time, and also, they presented the results of an exploratory analysis, which revealed an improved overall survival rate for the subcutaneous treatment arm.

今年早些時候，ASCO 上公佈了阿米萬他皮下注射 PALOMA-3 試驗的令人興奮的數據。講者強調，與靜脈注射相比，輸注相關反應減少了五倍，治療時間減少了五倍，此外，他們還介紹了探索性分析的結果，該結果表明皮下注射的總體存活率有所提高治療臂。

During their last earnings call, J&J highlighted that they believe RYBREVANT, which is a brand name for amivantamab IV is one of the three largest underappreciated assets in their portfolio in terms of revenue projections versus what analysts are currently estimating for the back half of this decade.

在上次財報電話會議上，強生強調，他們認為RYBREVANT（阿米萬他單抗IV 的品牌名稱）是其投資組合中三大被低估的資產之一，與分析師目前對本十年後半段的收入預測相比。

What is clearly exciting is that the five recently launched and soon-to-be-launched products represent almost $35 billion in total brand opportunity according to analysts and company estimates. This represents an even larger opportunity than the DARZALEX subcutaneous and Phesgo opportunity, where analyst projections are $20 billion in 2028.

顯然令人興奮的是，根據分析師和公司的估計，最近推出和即將推出的五種產品代表了近 350 億美元的總品牌機會。這比 DARZALEX 皮下注射和 Phesgo 的機會更大，分析師預測 2028 年這兩種藥物的銷售額將達到 200 億美元。

As Halozyme receives on average a mid-single-digit royalty on subcutaneous sales, you can clearly see how these products will add significant revenue over the next years and result in our projecting to achieve greater than $1 billion in royalty revenue in 2027.

由於Halozyme 皮下銷售平均獲得中個位數的特許權使用費，因此您可以清楚地看到這些產品將如何在未來幾年顯著增加收入，並導致我們預計在2027 年實現超過10 億美元的特許權收入。

Let me now move to slide 10, where I'll mention a few highlights in some of our future potential launch products. Bristol-Myers has continued to advance their Phase 3 study for nivolumab plus relatlimab with ENHANZE in first-line non-small cell lung cancer.

現在讓我轉到幻燈片 10，我將在其中提到我們未來可能推出的一些產品的一些亮點。百時美施貴寶繼續推進 nivolumab 合併 relatlimab 與 ENHANZE 治療一線非小細胞肺癌的 3 期研究。

The IV combination is already approved and has the brand name Opdualag. Takeda also continues to advance our Phase 3 study with TAK-881, their 20% IgG product candidate, which is progressing in a Phase 3 trial for the treatment of primary immunodeficiency.

IV 組合已獲得批准，品牌名稱為 Opdualag。武田也繼續推進我們的 TAK-881 3 期研究，TAK-881 是其 20% IgG 候選產品，該產品正在治療原發性免疫缺陷的 3 期試驗中取得進展。

With all of this continued strong growth of our approved products, the exciting launches that are just beginning and the regulatory and clinical advancements, we are well positioned to continue to deliver double-digit top and bottom-line growth in the coming years.

隨著我們已批准產品的持續強勁增長、剛開始的令人興奮的上市以及監管和臨床方面的進步，我們已做好準備，在未來幾年繼續實現兩位數的營收和利潤增長。

Let me now transition to slide 11, and I'll make some comments on intellectual property. Our extensive patent estate supports the durability of our revenue streams, and we continue to take actions to extend and protect our IP portfolio. In June, we were granted a new patent for ENHANZE by the European Patent Office, which extended patent coverage of our technology in that region to March 6, 2029. This resulted in an update to our guidance.

現在讓我轉到投影片 11，我將就智慧財產權發表一些評論。我們廣泛的專利資產支持我們收入來源的持久性，並且我們將繼續採取行動來擴展和保護我們的智慧財產權組合。6 月，歐洲專利局授予我們 ENHANZE 的新專利，將我們技術在該地區的專利覆蓋範圍延長至 2029 年 3 月 6 日。這導致我們的指南更新。

We currently have a similar pending reissue patent in the United States that we're confident will be granted. We look forward to providing an updated financial outlook if that reissue patent is granted with similar claims.

我們目前在美國有一項類似的待批重新頒發專利，我們有信心會獲得批准。如果該再頒發專利以類似的主張獲得批准，我們期待提供最新的財務前景。

And as a pioneer in developing human hyaluronidases for subcutaneous administration of medicines, we were very excited to introduce our MDASE patent portfolio that broadly covers modified human hyaluronidases.

作為開發用於皮下給藥的人類透明質酸酶的先驅，我們非常高興地介紹我們的 MDASE 專利組合，該組合廣泛涵蓋修飾的人類透明質酸酶。

Halozyme created the first soluble human hyaluronidase that was activate with neutral pH, which we call ENHANZE. Notably, we did not stop there. We continue to innovate and experiment. And over many years and thousands and thousands of experiments, we created a large and comprehensive library of modifications, and we characterize those modifications.

Halozyme 創造了第一個在中性 pH 值下活化的可溶性人類透明質酸酶，我們稱為 ENHANZE。值得注意的是，我們並沒有就此止步。我們不斷創新和實驗。經過多年的數千次實驗，我們創建了一個龐大而全面的修飾庫，並描述了這些修飾的特徵。

This groundbreaking work and other research projects created the technology protected by the MDASE patents, which are distinct from the patents that cover the truncated human hyaluronidase that we license as our ENHANZE technology.

這項開創性的工作和其他研究項目創造了受 MDASE 專利保護的技術，該技術與我們作為 ENHANZE 技術授權的截短人類透明質酸酶的專利不同。

Now, why are we discussing the MDASE portfolio now? There really are two key reasons. Firstly, we've recently been issued multiple new MDASE patents, bringing the total granted and pending patents to nearly 100, and we wanted to distinguish the MDASE patents from ENHANZE to avoid any confusion.

現在，我們為什麼要討論 MDASE 產品組合？確實有兩個關鍵原因。首先，我們最近獲得了多項新的 MDASE 專利，使已授權和正在申請的專利總數接近 100 項，我們希望將 MDASE 專利與 ENHANZE 區分開來，以避免任何混淆。

Secondly, as an intellectual property licensor, we always are looking for new opportunities to commercialize our discoveries and to enable others to bring forward new solutions and therapies that help patients. The ENHANZE technology is the derisked gold standard for conversion of IV therapies to subcutaneous administration.

其次，作為知識產權授權人，我們始終在尋找新的機會將我們的發現商業化，並使其他人能夠提出新的解決方案和療法來幫助患者。ENHANZE 技術是將靜脈注射療法轉變為皮下注射療法的無風險黃金標準。

However, we do recognize that not every drug and biologics supplier might be able to or select to use ENHANZE. But they do wish to utilize or are utilizing Halozyme's pioneering modified hyaluronidase intellectual property. It's in those cases that the MDASE patents are now available for license and would open up new opportunities for Halozyme that do not impact our ENHANZE business. I'll now hand the call over to Nicole, who will discuss our financial results in more detail.

然而，我們確實認識到，並非每個藥物和生物製品供應商都能夠或選擇使用 ENHANZE。但他們確實希望利用或正在利用 Halozyme 的開創性修飾透明質酸酶智慧財產權。正是在這些情況下，MDASE 專利現在可供許可，並將為 Halozyme 帶來新的機會，而不會影響我們的 ENHANZE 業務。我現在將把電話轉給妮可，她將更詳細地討論我們的財務表現。

Thank you, Helen. I'll begin with an overview of our third quarter performance and then review the increased guidance ranges for 2024 that are resulting from our strong progress. Our robust financial results for the third quarter exceeded expectations due to higher revenues from royalties and collaboration revenues in the quarter.

謝謝你，海倫。我將首先概述我們第三季的業績，然後回顧由於我們的強勁進展而提高的 2024 年指導範圍。由於本季特許權使用費和合作收入的增加，我們第三季強勁的財務業績超出了預期。

The result is an impressive 34% increase in total revenue from prior year, with adjusted EBITDA and non-GAAP earnings per share growth outpacing our top line growth at 60% and 69%, respectively, a clear demonstration of the significant leverage we have with our high-margin business model.

結果是總收入比上年增長了34%，令人印象深刻，調整後EBITDA 和非GAAP 每股收益增長分別超過我們的營收增長60% 和69%，這清楚地表明了我們擁有的巨大影響力我們的高利潤商業模式。

Let me now turn to Slide 12 for our detailed financial results for the third quarter. Revenue grew 34% to $290.1 million compared to $216 million in the prior year period. Royalty revenues for the quarter were $155.1 million, an increase of 36% compared to $114.4 million in the prior year period. The continued growth of subcutaneous DARZALEX, Phesgo and VYVGART Hytrulo were the main drivers of our royalty revenue growth in the quarter. The contribution from all three products exceeded our expectations for the quarter, resulting in an increase in guidance for the full year.

現在讓我轉向投影片 12，了解我們第三季的詳細財務表現。營收成長 34%，達到 2.901 億美元，而去年同期為 2.16 億美元。本季的特許權使用費收入為 1.551 億美元，比去年同期的 1.144 億美元成長 36%。皮下 DARZALEX、Phesgo 和 VYVGART Hytrulo 的持續成長是我們本季特許權使用費收入成長的主要驅動力。所有三種產品的貢獻都超出了我們對本季的預期，導致全年指引值增加。

Collaboration revenues for the quarter were $48.4 million compared to $15 million in the prior year period. The performance exceeded our expectations for the quarter due to the meaningful expansion of our argenx collaboration. Research and development expenses were $18.5 million compared to $17.3 million in the prior year period. The increase was primarily due to increased compensation expense.

本季的協作收入為 4,840 萬美元，而去年同期為 1,500 萬美元。由於我們與 argenx 合作的有意義的擴展，本季度的業績超出了我們的預期。研發費用為 1,850 萬美元，去年同期為 1,730 萬美元。增加的主要原因是補償費用增加。

Selling, general and administrative expenses were $41.2 million in the quarter, up from $35.3 million in the prior year period, primarily due to increased compensation expense and consulting and professional service fees. Adjusted EBITDA increased 60% to $183.6 million from $114.9 million last year.

本季銷售、一般和管理費用為 4,120 萬美元，高於去年同期的 3,530 萬美元，主要是由於薪酬費用以及諮詢和專業服務費增加。調整後 EBITDA 成長 60%，從去年的 1.149 億美元增至 1.836 億美元。

GAAP diluted earnings per share was $1.05, and non-GAAP diluted earnings per share was $1.27. This is compared with GAAP diluted earnings per share of $0.61 and non-GAAP diluted earnings per share of $0.75 in the third quarter of 2023.

GAAP 稀釋後每股收益為 1.05 美元，非 GAAP 稀釋後每股收益為 1.27 美元。相比之下，2023 年第三季 GAAP 攤薄每股收益為 0.61 美元，非 GAAP 攤薄每股收益為 0.75 美元。

We maintained a strong balance sheet with cash, cash equivalents and marketable securities at $666.3 million on September 30, 2024, compared to $529 million on June 30, 2024. The increase was primarily a result of cash generated from operations. Our net leverage ratio was 1.4 times at the end of the quarter, and we still expect to reduce our net leverage ratio as EBITDA continues to grow.

截至 2024 年 9 月 30 日，我們的現金、現金等價物及有價證券資產負債表保持強勁，為 6.663 億美元，而 2024 年 6 月 30 日為 5.29 億美元。增加的主要原因是營運產生的現金。截至本季末，我們的淨槓桿率為 1.4 倍，隨著 EBITDA 的持續成長，我們仍預期會降低淨槓桿率。

As a result of our strong year-to-date performance and expectations for continued momentum in the fourth quarter, we are raising our guidance ranges for the full year as shown on slide 13. We now expect total revenue of $970 million to $1.020 billion, an increase year-over-year from $829 million, which represents an increase of 17% to 23% over 2023. This includes our expectation that collaboration revenue will contribute $130 million to $150 million, and product sales will contribute $290 million to $305 million for the full year.

由於我們年初至今的強勁業績以及對第四季度持續成長勢頭的預期，我們正在提高全年指導範圍，如幻燈片 13 所示。我們目前預計總營收為 9.7 億美元至 10.2 億美元，較去年同期的 8.29 億美元有所成長，較 2023 年成長 17% 至 23%。這包括我們預計全年協作收入將貢獻 1.3 億至 1.5 億美元，產品銷售將貢獻 2.9 億至 3.05 億美元。

We expect royalty revenues of $550 million to $565 million, an increase year over year from $448 million, which represents 23% to 26% growth over 2023. The increase in our expectation for the year is due to the strong performance of subcutaneous DARZALEX, Phesgo, and VYVGART Hytrulo.

我們預計特許權使用費收入為 5.5 億美元至 5.65 億美元，較去年同期的 4.48 億美元有所增長，較 2023 年增長 23% 至 26%。我們對今年預期的提升是由於皮下注射 DARZALEX、Phesgo 和 VYVGART Hytrulo 的強勁表​​現。

We expect adjusted EBITDA of $595 million to $625 million, an increase from $426 million in 2023, a 40% to 47% year-over-year increase. And we expect non-GAAP diluted EPS of $4 to $4.20, an increase year over year from $2.77, which is a 44% to 52% increase over 2023. With that, I'll now turn the call back over to Helen.

我們預計調整後 EBITDA 為 5.95 億美元至 6.25 億美元，較 2023 年的 4.26 億美元有所增加，年增 40% 至 47%。我們預計非 GAAP 攤薄後每股收益為 4 美元至 4.20 美元，較上年同期的 2.77 美元有所增長，較 2023 年增長 44% 至 52%。這樣，我現在將把電話轉回給海倫。

Thank you, Nicole. Our strong year-to-date performance is a reflection of the execution of our strategy and the power of our durable high-growth business model. This resulted in a meaningful raise in our expectations and our financial guidance for the year, resulting in impressive year-over-year growth and setting us up for a strong start to 2025.

謝謝你，妮可。我們今年迄今的強勁業績反映了我們策略的執行以及我們持久高成長業務模式的力量。這導致我們今年的預期和財務指導大幅提高，實現了令人印象深刻的同比增長，並為我們 2025 年的強勁開局奠定了基礎。

We have multiple drivers that will support our continued growth, including an exciting series of launches that are just beginning or soon to commence. I'd like to close by recognizing and thanking the Halozyme team and all of our collaborators, whose continued dedication and performance has made this such a remarkable quarter and year. Operator, we are now ready to open the call for questions

我們有多種驅動力來支持我們的持續成長，包括剛開始或即將開始的一系列令人興奮的發布。最後，我要對 Halozyme 團隊和我們所有的合作者表示認可和感謝，他們持續的奉獻和表現使這個季度和一年變得如此出色。接線員，我們現在準備開始提問

(Operator Instructions) Vikram Purohit, Morgan Stanley.

（操作員指令）Vikram Purohit，摩根士丹利。

Hi, everyone. Thanks for taking our question. This is Morgan on for Vikram. So one for us on the OCREVUS and TECENTRIQ recent launches. Although it's early, what's your current view on subcu conversion for these products and how that could ramp in the coming quarters and what that may look like long term on a steady-state basis? Thank you.

大家好。感謝您提出我們的問題。這是摩根替維克拉姆上場。讓我們來介紹一下最近推出的 OCREVUS 和 TECENTRIQ。雖然現在還為時過早，但您目前對這些產品的 subcu 轉換有何看法？謝謝。

Yes. Thanks, Morgan. We'll start with OCREVUS. And I think it's important to note there, and Roche reiterated this on their quarterly call just a week or so ago. Their goal with the subcu is not to immediately convert the IV to subcu. So it's not a conversion strategy.

是的。謝謝，摩根。我們將從奧克雷弗斯開始。我認為值得注意的是，羅氏在大約一周前的季度電話會議上重申了這一點。他們對 subcu 的目標不是立即將 IV 轉換為 subcu。所以這不是一個轉換策略。

It's very much a market growth strategy, where they see the availability of subcutaneous as allowing more treatment centers and more throughput of patients at infusion suites, community hospitals because of the much shorter treatment time with subcutaneous and the easier approach to subcu, which doesn't require as much infrastructure.

這在很大程度上是一種市場成長策略，他們認為皮下注射的可用性允許更多的治療中心和輸液室、社區醫院的患者更多的吞吐量，因為皮下注射的治療時間要短得多，而且皮下注射的方法更容易，這並不意味著。

Indeed, they commented that they see the availability of subcu will expand the OCREVUS market by about $2 billion. So initially for, OCREVUS, field force will be very much focused on getting new prescribers and helping those new prescribers set up and start using OCREVUS.

事實上，他們評論說，他們認為 subcu 的上市將使 OCREVUS 市場擴大約 20 億美元。因此，對於 OCREVUS，最初，現場人員將非常專注於獲得新的處方者並幫助這些新的處方者設定並開始使用 OCREVUS。

If I move to TECENTRIQ, obviously, TECENTRIQ continuing to perform well in its key tumor indications as an IV given over 30 to 60 minutes. Within that, there are patients who are receiving TECENTRIQ as an example, as monotherapy or for whom they're on a complex regimen where they want to have a shortened regimen.

如果我轉向 TECENTRIQ，顯然，TECENTRIQ 在其關鍵腫瘤適應症中繼續表現良好，作為靜脈注射超過 30 至 60 分鐘。其中，有些患者正在接受 TECENTRIQ 作為單一療法，或者他們正在接受複雜的治療方案，他們希望縮短治療方案。

And in that instances, there's going to very much be a field force focus to convert those patients from the IV to the subcu because of a much simpler regimen. And so we are going to see good conversion focus with TECENTRIQ.

在這種情況下，由於治療方案簡單得多，現場工作人員將重點放在將這些患者從靜脈注射轉為 Subcu。因此，我們將透過 TECENTRIQ 看到良好的轉換焦點。

Market growth for OCREVUS. Roche has not given out any numbers as to where they see the conversion. Our approach has generally been to look at the success they had with Herceptin subcu in Europe, which got to 60% share of volume and then to have a range around that depending on is the company driving for that subcu conversion. So particularly for TECENTRIQ, I'd think about it in those terms.

OCREVUS 的市場成長。羅氏尚未給出任何關於他們在哪裡看到轉換的數字。我們的方法通常是考察他們在歐洲使用赫賽汀 subcu 的成功，該產品佔據了 60% 的銷售份額，然後根據推動 subcu 轉換的公司來確定圍繞該範圍的範圍。因此，特別是對於 TECENTRIQ，我會從這些角度來考慮。

Brendan Smith, TD Cowen.

布倫丹·史密斯，TD·考恩。

All right, great. Thanks so much for taking the question. Congrats on the solid quarter. I wanted to first ask really kind of piggyback on that last question about OCREVUS subcu. You call up out the language from Roche about that $2 billion.

好吧，太好了。非常感謝您提出問題。恭喜季度業績穩定。我想先問一下關於 OCREVUS subcu 的最後一個問題。你調出羅氏關於那 20 億美元的語言。

Just to kind of better understand that or maybe contextualize it a bit, I mean, if consensus for peak sales is around $9 billion, $10 billion there, that might suggest only about 20% share of the subcu. Is that maybe the right way to think about that? Or is this $2 billion really kind of new-to-brand patients that would be in addition to IV to subcu switchers?

只是為了更好地理解這一點，或者稍微結合一下背景，我的意思是，如果峰值銷售額的共識約為 90 億美元，其中 100 億美元，這可能表明 subcu 只佔大約 20% 的份額。這也許是正確的思考方式嗎？或者這 20 億美元真的是一種新品牌患者，除了 IV 到 subcu 轉換者之外嗎？

And then maybe just really quickly on the Wave four pipeline. Are you able to give us any sense of at what point we might learn about the additional Roche and Chugai drugs, just whether target indication is like after Phase 2 data or something like that? Just trying to understand when we might start focusing more on that wave. Thanks very much.

然後也許在第四波管道上很快就會出現。您能否告訴我們，我們在什麼時候可以了解羅氏和中外製藥的其他藥物，無論目標適應症是像第二階段數據之後還是類似的情況？只是想了解我們什麼時候可以開始更多地關注這一浪潮。非常感謝。

Yeah. Thanks, Brendan, and thanks for asking that question because I do think the way Roche has been talking about it has led people to be a little bit confused. So there's going to be a market expansion, which is on top of the IV opportunity. And so if it's at $9 billion, my view is this is going to take the total growth in the next several years to be $11 billion.

是的。謝謝布倫丹，也謝謝你提出這個問題，因為我確實認為羅氏談論這個問題的方式讓人們有點困惑。因此，除了 IV 機會之外，還會出現市場擴張。因此，如果達到 90 億美元，我認為未來幾年的總成長將達到 110 億美元。

So you do add on the additional $2 billion. But the original IV sales of the $9 billion will, we strongly believe, be converted. When you think about what the difference is going to be for a patient, instead of up to 3.5 hours to 5.5 hours in an infusion suite, it's going to be 30 minutes in an infusion suite. And so there is also going to be that conversion of the IV to subcu.

所以你確實要額外增加 20 億美元。但我們堅信，最初的 90 億美元 IV 銷售額將會被轉換。當您考慮對患者會有什麼差異時，輸液套件中的時間不再是 3.5 到 5.5 小時，而是 30 分鐘。因此，IV 也會轉換為 subcu。

I think what you're going to see is it's going to be phased. The initial launch focus is on expanding the market. And over time, we're going to see the conversion begin and grow as well. But what we're hearing from Roche, they very much want to highlight this is not just a cannibalization opportunity. So don't think about the pie staying the same size it is today. The pie is going to get bigger, and then also going to be the opportunity to convert that bigger pie to be more subcu sales.

我想你會看到它會分階段進行。最初推出的重點是擴大市場。隨著時間的推移，我們將看到轉變的開始和成長。但我們從羅氏那裡聽到的消息是，他們非常想強調這不僅僅是一個蠶食機會。因此，不要認為餡餅會保持今天的大小。蛋糕會變得更大，然後也將有機會將更大的蛋糕轉化為更多的子產品銷售。

Just on that, they also made a comment on their call that they are seeing already the strategy at work in the US, obviously, very recent launch in the US, but they're seeing that 80% of new starts on OCREVUS ZUNOVO are new to brand.

就這一點，他們也在電話中發表評論說，他們看到該策略已經在美國發揮作用，顯然是最近在美國推出的，但他們看到 OCREVUS ZUNOVO 上 80% 的新啟動都是新的品牌。

So very much supporting that approach they have where they don't want to cannibalize their IV sales. They want to further expand their opportunity while they also will be able to, over time, get that subcu conversion, too.

因此，我們非常支持他們的這種做法，因為他們不想蠶食靜脈注射的銷售。他們希望進一步擴大機會，同時隨著時間的推移，他們也能夠實現 subcu 轉換。

With regard to the specific Roche and Chugai products that are listed on our Wave four portfolio, unfortunately, until the partners want to discuss exactly what those indications are and announce their plans for them, we are unable to discuss it any further. So I can't give any updates at this time.

不幸的是，對於我們第四波產品組合中列出的羅氏和中外製藥的具體產品，在合作夥伴想要確切討論這些適應症並宣布他們的計劃之前，我們無法進一步討論。所以我現在無法提供任何更新。

Mike DiFiore, Evercore ISI.

麥克·迪菲奧裡，Evercore ISI。

Hi guys. Thanks so much for taking the question. Congrats on the solid quarter. Two for me. First question is any status update regarding your expectations for new collaboration deals to be made before the end of the year? And I have a follow-up.

嗨，大家好。非常感謝您提出問題。恭喜季度業績穩定。給我兩個。第一個問題是，您對年底前達成新合作交易的期望有何最新進展？我有一個後續行動。

All right. Thanks, Mike, for that. You saw probably that we have provided our guidance for the year on the collaboration, expecting $130 million to $150 million. And we're very pleased with the progress we've made here, obviously, strong contributions from the expanding the agreement with argenx, in particular, in the quarter.

好的。謝謝，麥克。您可能已經看到，我們已經提供了今年的合作指導，預計金額為 1.3 億至 1.5 億美元。我們對我們在這裡取得的進展感到非常滿意，顯然，擴大與 argenx 的協議做出了巨大貢獻，特別是在本季度。

I will say we are not letting our feet off the gas pedal, and we're remaining very focused on gaining new deals and additional new nominations as we close out 2024. But if you do take a look at our guidance, you can see where the range we're predicting based on what we have line of sight on today is in that $130 million to $150 million range.

我想說的是，我們不會放鬆油門，在 2024 年結束時，我們仍然非常專注於獲得新交易和更多新提名。但如果您確實查看了我們的指導，您會發現我們根據今天的視線預測的範圍在 1.3 億美元至 1.5 億美元之間。

Got it. And my follow-up question is regarding MDASE. Considering that the MDASE licensees are not exclusive and won't involve Halozyme support services or API supply, as you previously noted, how will licensees manage development and regulatory challenges that are typically supported in traditional ENHANZE partnerships? And how might this affect MDASE's adoption and commercial success compared to ENHANZE?

知道了。我的後續問題是關於 MDASE 的。考慮到 MDASE 被授權人不是排他性的，並且不會涉及 Halozyme 支援服務或 API 供應，正如您之前提到的，被授權人將如何應對傳統 ENHANZE 合作夥伴關係中通常支援的開發和監管挑戰？與 ENHANZE 相比，這會如何影響 MDASE 的採用和商業成功？

Yeah. I will be clear and say we do expect that the vast majority of companies are going to want to and be able to work with ENHANZE. And so as we think about where we're going to be focusing and our growth is going to come from, it's going to be new partners and expanded partnerships related to ENHANZE.

是的。我要明確地說，我們確實希望絕大多數公司願意並且能夠與 ENHANZE 合作。因此，當我們思考我們的重點是什麼以及我們的成長來自何處時，我們將專注於與 ENHANZE 相關的新合作夥伴和擴大的合作夥伴關係。

But as we pointed out, there may be instances where somebody is unable to or for some reason, doesn't want to work with ENHANZE, but they are utilizing our modified hyaluronidase IP, we are, in that instance, only going to grant them a license, as you point out.

但正如我們所指出的，在某些情況下，可能有人無法或出於某種原因不想與ENHANZE 合作，但他們正在利用我們修改過的透明質酸酶IP，在這種情況下，我們只會授予他們正如您所指出的，許可證。

Now we obviously don't have a modified hyaluronidase VP product substance. So that company will have to do what we did for the last 10 years, which is identify how to develop a product, engage with the regulatory authorities, start developing that safety database we have to demonstrate the product is safe and effective.

現在我們顯然還沒有改良的透明質酸酶VP產品物質。因此，該公司必須做我們過去 10 年所做的事情，即確定如何開發產品，與監管機構合作，開始開發安全資料庫，我們必須證明產品是安全有效的。

But we would not propose to help them because we are going to be continuing to support our current ENHANZE partners. But we will license the IP because they're going to be using their MDASE, the modified hyaluronidase for the same purpose as ENHANZE. And obviously, that's where the value of our IP is being realized.

但我們不會提議幫助他們，因為我們將繼續支持我們目前的 ENHANZE 合作夥伴。但我們將許可 IP，因為他們將使用他們的 MDASE（改良的透明質酸酶），其目的與 ENHANZE 相同。顯然，這就是我們智慧財產權的價值得以實現的地方。

Jason Butler, Citizens JMP.

Jason Butler，公民 JMP。

Just one on VYVGART Hytrulo and the prefilled syringe. Can you maybe just speak to the progress there with FDA and how you work with other collaborators or other products has inputted into this regulatory process?

只需使用 VYVGART Hytrulo 和預充式註射器即可。您能否談談與 FDA 的進展，以及您如何與其他合作者合作或其他產品已納入此監管流程？

Yeah. Thanks, Jason. If you listened to the call today, as we did, argenx provided the update and just summarized that they are expecting a PDUFA action date that is going to be in April. We don't have any other information that we can share with regard to that. But we are excited that they are obviously progressing with that in studies that are ongoing, both in thyroid eye disease and other indications now.

是的。謝謝，傑森。如果您像我們一樣聽取了今天的電話會議，argenx 提供了更新，並總結說他們預計 PDUFA 行動日期將在 4 月。與此相關，我們沒有任何其他資訊可以分享。但我們感到興奮的是，他們在甲狀腺眼疾和其他適應症方面正在進行的研究明顯取得了進展。

Again, this really has been work that we have done, obviously, in providing the ENHANZE for that prefilled syringe work. But I will say argenx has been lead with regard to the actual mechanical work in that. We obviously continue to advise on the formulation of ENHANZE. And so we don't have any information other than that I can share, Jason.

再說一遍，這確實是我們所做的工作，顯然，為預充式註射器工作提供 ENHANZE。但我要說的是，argenx 在這方面的實際機械工作方面處於領先地位。我們顯然會繼續就 ENHANZE 的配方提供建議。因此，除了我可以分享的信息之外，我們沒有任何信息，傑森。

Corinne Johnson, Goldman Sachs.

科琳·約翰遜，高盛。

Hi, good afternoon, everybody. Maybe could you expand a little bit on the primary drivers? Is that increase in royalty revenues? You mentioned the products that are driving it, but I'm curious if it was additional indications within DARZALEX, et cetera, better-than-expected conversion on the key products or anything else that you could kind of point to?

嗨，大家下午好。也許您可以稍微擴展一下主要驅動因素嗎？這是特許權使用費收入的增加嗎？您提到了推動這一趨勢的產品，但我很好奇是否是 DARZALEX 等方面的其他跡象、關鍵產品的轉換率好於預期或您可以指出的其他內容？

And then could you also talk a little bit about where you stand on potential auto-injector partnership deals? We haven't really seen anything yet. I'm just curious if there's any additional work you're doing to kind of prove out that technology.

然後您能否談談您在潛在的自動注射器合作夥伴交易方面的立場？我們還沒有真正看到任何東西。我只是好奇你們是否正在做任何額外的工作來證明這項技術。

Yeah. Small bits of color we can bring based on what our partners have stated publicly. I think we can say for DARZALEX, they reported a very strong quarter, obviously, with a great sequential and year-over-year growth.

是的。我們可以根據我們的合作夥伴公開聲明的內容提供少量的顏色。我認為我們可以對 DARZALEX 說，他們報告了一個非常強勁的季度，顯然，連續和同比增長都很大。

And what they are talking about is just continued expansion of 4 points of share gains across all indications and 7.7 points of share gain in the front line. And recall the front line is actually the largest population of multiple myeloma patients, and those are the patients who stay on therapy the longest.

他們所說的只是繼續擴大所有指標的份額漲幅4個百分點和一線份額漲幅7.7個百分點。回想一下，前線其實是最多的多發性骨髓瘤患者族群，也是接受治療時間最長的患者。

And so I really think the growth that we've seen over the last several years has been fully enabled by the availability of subcu to expand as they were getting new indications into that frontline setting. So that's really, I think, where it's very exciting.

因此，我確實認為，我們在過去幾年中所看到的成長完全是由於 subcu 的可用性得以擴展，因為它們在一線環境中獲得了新的指示。我認為這確實是非常令人興奮的地方。

If we turn to VYVGART Hytrulo, based on the call this morning, what we heard was that the majority of the revenue is obviously still coming from the gMG indication where they're continuing to see broadening adoption of VYVGART and also VYVGART Hytrulo with VYVGART Hytrulo really helping move into that early line of therapy. So that is on a strong trajectory.

如果我們轉向 VYVGART Hytrulo，根據今天早上的電話會議，我們聽到的是，大部分收入顯然仍然來自 gMG 指示，他們繼續看到 VYVGART 以及 VYVGART Hytrulo 與 VYVGART Hytrulo 的廣泛採用確實有助於進入早期治療。所以這是一個強勁的軌跡。

What has begun to impact with VYVGART Hytrulo is the CIDP indication. Specific comments were made about the fact that 300 patients on therapy, many of whom who came on in September, really occurring after the payer policies were in place. And so that actually bodes very well for continued strong growth as those patients that will be reflected as a full quarter in the next quarter. And so those are some of the key drivers.

CIDP 適應症開始對 VYVGART Hytrulo 產生影響。針對 300 名接受治療的患者（其中許多人是在 9 月開始接受治療）這一事實提出了具體評論，這些患者實際上是在付款人政策到位後才接受治療的。因此，這實際上預示著這些患者將持續強勁成長，這些患者將在下個季度反映為整個季度。這些是一些關鍵驅動因素。

I'd say for Phesgo, it's just continuing on that very nice trajectory that we've seen as there's just growing recognition of what this means for patients to be able to have just the more simpler regimen and allow them to get back to their lives. So in summary, a mix of new indications, strong execution by the partners and the availability of subcu to really penetrate into earlier lines of therapy where patients tend to stay on therapy longer.

我想說，對於Phesgo，它只是繼續沿著我們所看到的非常好的軌跡發展，因為人們越來越認識到這對患者來說意味著什麼，能夠擁有更簡單的治療方案，讓他們回到自己的生活。總而言之，新的適應症、伴侶的強大執行力以及 subcu 的可用性能夠真正滲透到早期的治療方案中，患者往往會堅持更長的治療。

And then on the auto-injector side?

那麼在自動注射器方面呢？

On the auto injector side, I mentioned on the call, Corinne, we are continuing discussions both with the high-volume auto-injector and also small-volume auto-injector. Similarly, two comments I made on the ENHANZE discussions there, there just always is a process we go through as the companies go through their technical evaluation process and then their decision process.

在自動注射器方面，我在電話中提到，Corinne，我們正在繼續討論大容量自動注射器和小容量自動注射器。同樣，我在 ENHANZE 討論中發表的兩則評論是，當公司經歷技術評估過程和決策過程時​​，我們總是必須經歷一個過程。

So we're moving our way through those processes with those companies. And so no updates on that today but continuing to make progress, and that still remain. Very confident we're going to be signing and announcing deals.

因此，我們正在與這些公司一起推進這些流程。所以今天沒有更新，但繼續取得進展，而且仍然存在。我們對簽署和宣布交易非常有信心。

Mitchell Kapoor, HC Wainwright.

米切爾·卡普爾，HC 溫賴特。

Hey, everyone. Thanks for taking the question. Just wanted to know a little bit more about the MDASE platform opportunity. Can you just give a little context to how big or narrow of an opportunity this might be based on how many types of opportunities might be out there for this when you do have the ENHANZE platform and the eligible partners that were likely focused on that side of the business or the BD partnerships?

嘿，大家。感謝您提出問題。只是想更多地了解 MDASE 平台的機會。您能否根據當您確實擁有 ENHANZE 平台以及可能專注於此方面的合格合作夥伴時可能存在的機會類型來介紹一下機會的大小或範圍？

Yeah. Thanks, Mitch. And what we've talked about is the fact that we do anticipate ENHANZE will continue to be what people will come and want to license. It's a gold standard. It's the most regulatory and commercially derisked. So that is where our primary focus is.

是的。謝謝，米奇。我們所討論的是這樣一個事實，即我們確實預計 ENHANZE 將繼續成為人們想要獲得許可的產品。這是一個黃金標準。這是監理最嚴、商業風險最小的。這就是我們的主要關注點。

But we are aware that there are companies who may be considering developing a modified hyaluronidase. And in that instance, they may not want to work with ENHANZE or they may not be able to work with ENHANZE, but that's why they've chosen this modified hyaluronidase.

但我們知道有些公司可能正在考慮開發改良的透明質酸酶。在這種情況下，他們可能不想使用 ENHANZE 或他們可能無法使用 ENHANZE，但這就是他們選擇這種改良透明質酸酶的原因。

But if they're using a modified hyaluronidase, we believe they will be using some of our modified hyaluronidase IP. And that's why we have made these licenses available to them.

但如果他們使用改良的透明質酸酶，我們相信他們將使用我們的一些改良的透明質酸酶 IP。這就是我們向他們提供這些許可證的原因。

So we don't think this is in terms of the number of deals going to be like we do with ENHANZE, and we're talking about new partners with the frequency of which we've done over the years, Mitch. But for anyone who is developing or thinking about developing a drug with a modified hyaluronidase, that's going to be the opportunity for us.

因此，我們認為這不會像我們與 ENHANZE 那樣的交易數量而言，我們正在談論新合作夥伴以及我們多年來所做的頻率，米奇。但對於任何正在開發或考慮開發帶有修飾透明質酸酶的藥物的人來說，這將是我們的機會。

It's an emerging field. And so we haven't -- we can't really comment on how many people we think will want to do that. But the great news is it's another growth driver for us if companies are developing modified hyaluronidase days subcu drugs, copying what we have been doing with ENHANZE.

這是一個新興領域。所以我們還沒有——我們無法真正評論我們認為有多少人願意這樣做。但好消息是，如果公司正在開發改良的透明質酸酶日 subcu 藥物，複製我們一直在 ENHANZE 所做的事情，這對我們來說是另一個成長動力。

Great. Thank you for taking the question and congrats on the quarter.

偉大的。感謝您提出問題並祝賀本季。

Thank you.

謝謝。

Mohit Bansal, Wells Fargo.

莫希特·班薩爾，富國銀行。

Great. Thank you very much for taking my question. I have two questions. So one is, how should we think about your guidance update philosophy going forward? Because I understand that you'll be providing guidance for '25 as next year rolls over. But should we be expecting updates for subsequent years as well as the expectations change? That's number one.

偉大的。非常感謝您回答我的問題。我有兩個問題。那麼一是，我們該如何思考您未來的指導更新理念？因為我知道您將在明年結束時為 '25 提供指導。但我們是否應該期待接下來幾年的更新以及預期的變化？這是第一名。

And number two, for the MDASE platform, how differentiated it is from your ENHANZE platform? I'm asking from the point of view of your existing partners who have exclusive licensing with certain products. If it kind of infringes upon that, what gives you comfort that your existing partners would be fine with that?

第二，對於 MDASE 平台，它與你們的 ENHANZE 平台有何不同？我是從擁有某些產品獨家許可的現有合作夥伴的角度來詢問的。如果這違反了這一點，那麼現有的合作夥伴對此不會有什麼問題，這讓您感到安心嗎？

Yeah. I'll ask Nicole to comment on your question on the guidance, and I'll talk about MDASE.

是的。我將請 Nicole 對您關於指南的問題發表評論，然後我將討論 MDASE。

Yes. Thanks for the question, Mohit. So from a guidance perspective, today, we are focused on the third quarter results and the full year updated guidance, which we're really excited to raise for top line and bottom line for the full year.

是的。謝謝你的提問，莫希特。因此，從指導的角度來看，今天，我們關注的是第三季業績和全年更新的指導，我們非常高興能夠提高全年的營收和利潤。

And you saw we do republish our five-year projections. Those are unchanged at the moment, but we continue to evaluate those. In the new year, we'll give more line of sight and color into our updated expectations for 2025.

你看到我們確實重新發布了我們的五年預測。這些目前沒有變化，但我們將繼續評估它們。新的一年，我們將為2025年更新的預期賦予更多的視線和色彩。

All right. And maybe I'll take a step back and just say, we talked about all of the experiments that we did and the experiments that we did on the human hyaluronidase area. And we came up with ENHANZE that we patented, and that's a truncated human hyaluronidase. But we also did lots of experiments, thousands and thousands of experiments on different structures of hyaluronidases and we call those our modified hyaluronidase.

好的。也許我會退一步說，我們討論了我們所做的所有實驗以及我們在人類透明質酸酶領域所做的實驗。我們想出了我們獲得專利的 ENHANZE，這是一種截短的人類透明質酸酶。但我們也做了很多實驗，對不同結構的透明質酸酶進行了成千上萬的實驗，我們稱之為改良的透明質酸酶。

So ENHANZE has got one structure. The modified hyaluronidases have different structure from ENHANZE. And when we have licensed ENHANZE, we are only licensing the IP to the structure and the activities that are related to that specific ENHANZE structure, Mohit. So that's why our partners will not -- are not upset or surprised or anything because they're totally different products and patent portfolios firstly.

所以 ENHANZE 有一種結構。修飾的透明質酸酶具有與 ENHANZE 不同的結構。當我們獲得 ENHANZE 許可時，我們僅將 IP 授權給與特定 ENHANZE 結構 Mohit 相關的結構和活動。這就是為什麼我們的合作夥伴不會——不會感到不安或驚訝或其他任何事情，因為它們首先是完全不同的產品和專利組合。

Now our ENHANZE partners do not need, unlikely to want the MDASE portfolio because they have ENHANZE, which does what it needs to do, which is this delivery of drugs, high-volume rapid subcu delivery. But there are some people and partners and makers of drugs and biologics who perhaps can't work in ENHANZE or don't want to work in ENHANZE and have chosen or will choose to work in a modified hyaluronidase.

現在我們的 ENHANZE 合作夥伴不需要、不太可能想要 MDASE 產品組合，因為他們有 ENHANZE，它可以完成它需要做的事情，即藥物輸送、大容量快速 subcu 輸送。但有些人、合作夥伴以及藥物和生物製劑製造商可能無法在 ENHANZE 中工作或不想在 ENHANZE 中工作，並且已經選擇或將選擇在修飾的透明質酸酶中工作。

And what we wanted everyone to recognize is because of our pioneering work in this area, we have actually got an extensive patent portfolio that covers many modified hyaluronidases. And so for those companies, if they want to develop a modified hyaluronidase for doing the same thing as ENHANZE, which is the rapid large-volume sub delivery, we wanted to make them aware that we are open and willing to license our patents that relate to the modified hyaluronidase.

我們希望每個人都認識到，由於我們在這一領域的開創性工作，我們實際上擁有涵蓋許多修飾透明質酸酶的廣泛專利組合。因此，對於這些公司來說，如果他們想要開發一種修飾的透明質酸酶來完成與ENHANZE 相同的事情，即快速大容量分交付，我們想讓他們意識到我們是開放的，並且願意許可我們的相關專利至修飾的透明質酸酶。

So it's a different product. It's a different structure, but Halozyme was really the pioneer of making these new offerings that have enabled such an important advancement for patients. So let me just check in and see, did that clarify for you the difference between these two?

所以這是一個不同的產品。這是一種不同的結構，但 Halozyme 確實是生產這些新產品的先驅，這些新產品為患者帶來瞭如此重要的進步。那麼讓我來看看，這是否為您澄清了這兩者之間的差異？

Jessica Fye, JPMorgan.

潔西卡法耶，摩根大通。

This is Na Sun on for Jessica Fye. Congratulations on a strong quarter. My question goes back to MDASE. I think can you just give us examples of how -- what case would a partner be unable to work with ENHANZE?

這是傑西卡·菲伊 (Jessica Fye) 的孫娜 (Na Sun)。恭喜季度表現強勁。我的問題又回到了 MDASE。我想您能否給我們舉例說明合作夥伴在什麼情況下無法與 ENHANZE 合作？

And I think I've always thought about ENHANZE giving exclusive targets as a sort of defensive for how it's attractive for and defensive for its partners. So for MDASE, wouldn't it give sort of like an escape hatch, if you will, for competitors?

我想我一直認為 ENHANZE 給予獨家目標是一種防禦，因為它對合作夥伴具有吸引力和防禦性。那麼對於 MDASE 來說，如果你願意的話，它不會為競爭對手提供某種逃生艙口嗎？

And then secondly, I noticed that for the collaboration revenue guidance, the top range came down a little bit. Can you just talk about a little bit like what is driving that?

其次，我注意到對於協作收入指導，最高範圍有所下降。您能簡單談談是什麼推動了這個趨勢嗎？

Yes. So with regard to the situation where people couldn't work with ENHANZE, and I think it's a great question. You're quite right. Because we do the exclusive targets, if somebody wasn't able to work with us because we had already licensed an exclusive target, they might choose to work with a modified hyaluronidase.

是的。因此，關於人們無法使用 ENHANZE 的情況，我認為這是一個很好的問題。你說得很對。因為我們做獨家目標，如果有人因為我們已經獲得獨家目標許可而無法與我們合作，他們可能會選擇使用改良的透明質酸酶。

What we are doing here, however, is not enabling any partner to work and develop a modified hyaluronidase subcu-enabled drug against that target. We are simply -- because we're not supporting them from a clinical development perspective, and we're also not supplying the API, we are simply making them aware that if they want to go down that path, we have got strong IP in that area that is available for license.

然而，我們在這裡所做的並不是讓任何合作夥伴能夠針對該目標開發一種改良的透明質酸酶 subcu 藥物。我們只是——因為我們不從臨床開發的角度支持他們，我們也不提供API，我們只是讓他們意識到，如果他們想走這條路，我們在這方面擁有強大的知識產權可獲得許可的區域。

And this is why as we have conversed and shared this approach with our current partners, we have really received no pushback or concerns that have been voiced on it because we're not enabling and supporting the development of drugs that are doing anything against the exclusive license of ENHANZE.

這就是為什麼當我們與現有合作夥伴討論和分享這種方法時，我們確實沒有收到對此表示的任何反對或擔憂，因為我們沒有支持和支持任何反對獨家藥物的藥物開發。

We are simply recognizing and seeking to create the value for Halozyme from our inventions that were done all those years ago related to the modified hyaluronidases. So I hope that clarified that.

我們只是認識到並尋求從我們多年前完成的與修飾透明質酸酶相關的發明中為 Halozyme 創造價值。所以我希望能夠澄清這一點。

And in terms of the guidance ranges, yes, we are -- where we sit today, we've got a line of sight to $130 million to $150 million. We are continuing, as I mentioned earlier, to work hard to gain new deals and additional new nominations. But that was our best estimate based on where we are today for how the year is going to end.

就指導範圍而言，是的，我們今天的目標是 1.3 億至 1.5 億美元。正如我之前提到的，我們正在繼續努力爭取新交易和更多新提名。但這是我們根據今天的情況對今年結束情況的最佳估計。

We certainly are going to be nicely above $130 million in terms of collaborations. And so we're definitely fully in line with our original guidance. We just tightened the range a little.

我們的合作金額肯定會遠遠超過 1.3 億美元。因此，我們絕對完全符合我們最初的指導。我們只是稍微收緊了範圍。

David Risinger, Leerink Partners.

大衛‧瑞辛格 (David Risinger)，Leerink 合夥人。

Thanks very much. So my key questions have been asked, so I just wanted to ask about product sales. So if you could just educate a little bit more, Helen, with respect to why product sales are flattish in 2024 and then why they are expected to grow by 50% over the next four years. So I see your 2028 target for revenue is up about 50% from $300 million this year to roughly $450 million in '28. Thanks so much.

非常感謝。那麼我的關鍵問題已經被問到了，所以我只想問一下產品銷售的狀況。因此，海倫，如果你能多解釋為什麼 2024 年產品銷量持平，以及為什麼它們預計在未來四年內增長 50%。因此，我認為你們 2028 年的營收目標從今年的 3 億美元成長了約 50%，到 2028 年約為 4.5 億美元。非常感謝。

Yeah, that is a great question, and I'm going to pass over to Nicole.

是的，這是一個很好的問題，我會把這個問題轉給妮可。

Yes. Thanks, David. So in product sales, what you see in product sales are, one, the products that we sell to our collaboration partners, so our API in our devices, that is where we've talked about historically, those can be lumpy quarter over quarter.

是的。謝謝，大衛。因此，在產品銷售中，您在產品銷售中看到的是，第一，我們向合作夥伴銷售的產品，因此我們設備中的API，這就是我們歷史上討論過的地方，這些可能會逐季波動。

We are making investments to have lower-cost API for our partners. So over the longer term, that revenue stream will actually decline for us because as we make lower-cost materials, that gets passed on to our partners in savings. So that is one of the drivers in product sales.

我們正在投資為我們的合作夥伴提供更低成本的 API。因此，從長遠來看，我們的收入流實際上會下降，因為當我們生產成本較低的材料時，這些收入會轉嫁給我們的合作夥伴以節省成本。所以這是產品銷售的驅動因素之一。

And then also we have our proprietary product sales. Those are the sales that you see annually year over year are increasing and also trending this year in line with our expectations for the full year. I will point out that products -- our proprietary product sales, you saw a slight decrease in sequential quarters in the third quarter, and that's due to a seasonality that we historically experienced in the third quarter, where we do see a dip in demand in the summer months. And that is a part of our plans, and you'll see that in the results for the third quarter.

然後我們也有我們的專有產品銷售。這些是您看到的每年逐年成長的銷售額，今年的趨勢也與我們對全年的預期一致。我要指出的是，我們的專有產品銷售在第三季連續幾季略有下降，這是由於我們在第三季歷史上經歷的季節性，我們確實看到需求下降夏季。這是我們計劃的一部分，您將在第三季的業績中看到這一點。

With no further questions, this concludes our Q&A session, and this also concludes today's conference call. You may now disconnect.

沒有其他問題了，我們的問答環節到此結束，今天的電話會議也到此結束。您現在可以斷開連線。