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Operator
Operator
Good afternoon. My name is Joel, and I will be your conference operator today. At this time, I would like to welcome everyone to Halozyme's second quarter 2026 financial and operating results conference call. (Operator Instructions) Please note, this event is being recorded.
各位下午好。我叫 Joel,今天將擔任本次電話會議的接線員。此刻,我謹代表公司歡迎各位參加 Halozyme 2026 年第二季財務與營運成果電話會議。(接線員指示) 請注意,本活動正在錄音。
I will now turn the call over to Tram Bui, Halozyme's Vice President of Investor Relations.
接下來我將把電話交給 Halozyme 投資人關係副總裁 Tram Bui。
Please go ahead.
請開始。
Tram Bui - Head of Investor Relations and Corporate Communications
Tram Bui - Head of Investor Relations and Corporate Communications
Thank you, operator. Good afternoon, and welcome to our Second Quarter 2026 Financial and Operating Results Conference Call.
謝謝,接線員。各位下午好,歡迎參加我們 2026 年第二季財務與營運成果電話會議。
In addition to the press release issued today after the market close, you could find a supplementary slide presentation that will be referenced during today's call in the Investor Relations section of our website.
除了今天收盤後發布的新聞稿之外,您也可以在我們網站的投資人關係專區找到一份補充投影片簡報,今天的電話會議將引用該簡報內容。
Leading the call will be Dr. Helen Torley, Halozyme's President and Chief Executive Officer, who will provide an update on our business; and Darren Snellgrove, our Chief Financial Officer, will review our financial results as well as our outlook.
本次電話會議將由 Halozyme 總裁兼執行長 Helen Torley 博士主持,提供公司業務最新進展;我們的財務長 Darren Snellgrove 將回顧財務結果並說明展望。
On today's call, we will be making forward-looking statements as outlined on Slide 2. I would also refer you to our SEC filings for a full list of risks and uncertainties.
在今天的電話會議中,我們將如投影片第 2 頁所述發表前瞻性陳述。我也建議各位參閱我們向 SEC 提交的文件,以取得完整的風險與不確定性清單。
During the call, both GAAP and non-GAAP financial measures will be discussed. Certain non-GAAP or adjusted financial measures are reconciled with the comparable GAAP financial measures in our earnings press release and slide presentation. I will now turn the call over to Dr. Helen Torley, and we will start on Slide 3.
在本次電話會議中,將同時討論 GAAP 與非 GAAP 財務衡量指標。部分非 GAAP 或調整後財務衡量指標,已在我們的財報新聞稿與投影片簡報中與相對應的 GAAP 財務衡量指標進行調節。接下來我將把電話交給 Helen Torley 博士,我們將從投影片第 3 頁開始。
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
Thank you, Tram, and good afternoon, everyone. I am pleased to report our results from an exceptionally strong second quarter, led by ENHANZE royalty revenue growth and new deal momentum that resulted in meaningful upfront milestones.
謝謝你,Tram,各位下午好。我很高興報告,我們在第二季取得了格外強勁的成果,主要由 ENHANZE 權利金收入成長以及新交易動能所帶動,並帶來具實質意義的預付款里程碑收入。
You've heard me say before that ENHANZE is a unique compounding platform engine. On this call, we will share multiple proof points demonstrating how ENHANZE is delivering on all of the attractive features of a compounding platform engine.
各位以前聽我說過,ENHANZE 是一個獨特的複利式平台引擎。在本次電話會議中,我們將分享多項佐證,展示 ENHANZE 如何兌現複利式平台引擎的所有吸引人特質。
I'm talking about the repeatability of success, the scalability and diversification and the durability of revenues that flow from this. The ENHANZE value proposition is attracting new partners and additional products from our current partners at a cracking pace.
我指的是成功的可重複性、可擴展性與多元化,以及由此帶來的收入持久性。ENHANZE 的價值主張正以驚人的速度吸引新合作夥伴,並促使現有合作夥伴導入更多產品。
On top of this, Hypercon is already off and running as a second future compounding platform engine for Halozyme, showing the same features and, in fact, doing so even earlier in the life cycle than ENHANZE, as we apply the knowledge and learnings of the last decade.
此外,Hypercon 已經啟動並運作,作為 Halozyme 第二個未來的複利式平台引擎,展現相同特質;事實上,隨著我們運用過去十年的知識與學習成果,它在生命週期更早期就展現出這些特質。
Let's look now at what's new in the quarter. I will start with the broadening diversification and record growth of our royalty revenue streams. We are reporting increasing contributions of our newer launch products, Opdivo SC, Ocrevus SC and Rybrevant SC to our royalty revenues, with 80% growth quarter-on-quarter.
現在來看看本季有哪些新進展。我將先從我們權利金收入來源的多元化擴大與創紀錄成長談起。我們報告顯示,較新上市產品 Opdivo SC、Ocrevus SC 與 Rybrevant SC 對權利金收入的貢獻持續增加,季對季成長 80%。
This is repeating and building on top of the success and continued growth and performance of DARZALEX SC, VYVGART Hytrulo and Phesgo.
這是在 DARZALEX SC、VYVGART Hytrulo 與 Phesgo 的成功、持續成長與表現之上,進一步重複並疊加的成果。
What I love about this is that over the last years, we have moved from all focus being on DARZALEX SC performance to then expanding to Phesgo and then to VYVGART Hytrulo as it was recognized just how much opportunity these products represented.
我喜歡這一點的是,過去幾年我們從所有焦點都放在 DARZALEX SC 的表現,接著擴展到 Phesgo,然後隨著市場認知到 VYVGART Hytrulo 代表的巨大機會,又再擴展到 VYVGART Hytrulo。
Now we're expanding to six products to focus on. This is exactly what I meant by the compounding platform engine, multiple winners, creating revenue diversification and durability.
現在我們擴展到六個產品作為重點。這正是我所說的複利式平台引擎:多個贏家,創造收入多元化與持久性。
This broadened launch portfolio resulted in record total royalty revenue growth of 50% year-over-year to $308 million, providing strong support to and conviction for the 2026 to 2028 financial guidance and for the revenues in 2029 and beyond.
這個擴大的上市產品組合帶動權利金總收入創紀錄年增 50%,達到 3.08 億美元,為 2026 至 2028 年財務指引,以及 2029 年及以後的收入提供強力支撐與信心。
Let me now move to the second highlight, the significant expansion in new partnerships for ENHANZE and Hypercon in the quarter. In the second quarter, we signed four new collaboration and licensing agreements, and we signed a fifth agreement in July.
接下來我談第二個重點:本季 ENHANZE 與 Hypercon 新合作夥伴關係的大幅擴張。在第二季,我們簽署了四項新的合作與授權協議,並在 7 月又簽署了第五項協議。
We have never had this pace of new collaboration agreements in the history of Halozyme. And for those of you who asked, can they sign great new deals for ENHANZE? The answer is a resounding, emphatic and demonstrated yes, with three of these five agreements being for ENHANZE.
在 Halozyme 的歷史上,我們從未有過如此快的新增合作協議速度。對於那些問我們是否還能為 ENHANZE 簽下很棒新交易的各位,答案是響亮、明確且已被證明的「可以」,因為這五項協議中有三項是針對 ENHANZE。
This year, we have added new ENHANZE agreements with GSK, Incyte and a third confidential partner. And we added two new Hypercon agreements with Vertex and with Oruka.
今年,我們新增了與 GSK、Incyte 以及第三家未公開合作夥伴的 ENHANZE 協議。我們也新增了兩項 Hypercon 協議,分別與 Vertex 以及 Oruka。
And I will add, not only did we broadly expand the number of partners, we also expand in use areas to beyond monoclonal antibodies into two new expanding and leading-edge modality areas, ADCs and nucleic acids. This means brand-new growth opportunity for ENHANZE.
我還要補充的是,我們不僅大幅擴增合作夥伴數量,也將應用領域從單株抗體擴展到兩個新的、正在擴張且處於前沿的治療模態領域:ADC 與核酸。這代表 ENHANZE 全新的成長機會。
The new CLAs contributed $35.5 million in upfront collaboration revenue in the quarter, approximately evenly split across ENHANZE and Hypercon.
新的合作與授權協議(CLA)在本季貢獻了 3,550 萬美元的預付款合作收入,約略在 ENHANZE 與 Hypercon 之間平均分配。
This was also an important contributor to record total revenue in the quarter. This is how we said we would and how we are bending the curve in the 2029 plus period.
這也是本季總收入創新高的重要貢獻來源。這正是我們所說將會、也正在做的:在 2029 年以後期間拉升成長曲線。
The third area I want to highlight is development portfolio expansion and progress. In the second quarter, we advanced our pipeline of future potential royalty streams with two new Phase I study starts.
我想強調的第三個領域是研發產品組合的擴張與進展。在第二季,我們以兩項新的第一期研究啟動,推進了未來潛在權利金收入來源的產品線。
It is our goal to have 13 ENHANZE development programs in 2026, which is also bending the curve in the 2029 plus period. Moving now to Slide 4. I'll highlight the second quarter financial results.
我們的目標是在 2026 年擁有 13 項 ENHANZE 開發計畫,這同樣是在 2029 年以後期間拉升成長曲線。接著到投影片第 4 頁。我將重點說明第二季財務結果。
For the second quarter, total revenue increased 48% year-over-year to $481 million. This was largely driven by robust royalty revenues of $308 million, a strong 50% year-over-year growth.
第二季總收入年增 48%,達到 4.81 億美元。這主要由強勁的權利金收入 3.08 億美元所帶動,年增幅達 50%。
The robust revenue performance resulted in adjusted EBITDA of $329 million, adjusted EBITDA margin of more than 65% and non-GAAP earnings per share of $2.28, highlighting the strength of our diversified royalty portfolio and the operating leverage that's inherent in our differentiated business model.
強勁的收入表現帶來調整後 EBITDA 3.29 億美元,調整後 EBITDA 利潤率超過 65%,以及非 GAAP 每股盈餘 2.28 美元,凸顯我們多元化權利金組合的實力,以及我們差異化商業模式所固有的營運槓桿。
Moving now to Slide 5. Based on the strong second quarter and, in particular, the robust royalty revenue growth, we are pleased to raise full year 2026 guidance. What I will highlight is the increase in total revenue guidance of [$110 million] (sic - "$112.5 million") at the midpoint.
接著到投影片第 5 頁。基於強勁的第二季表現,尤其是權利金收入的強勁成長,我們很高興上調 2026 全年指引。我要強調的是,總收入指引在中位數上調了 [$110 million] (sic - "$112.5 million")。
This is driven by the increased projected royalty revenues from established products and the new launch products that I discussed earlier and also by the upfront milestones resulting from what has already been a record year for new collaboration and licensing agreements.
這主要由我先前提到的既有產品與新上市產品之預估權利金收入上調所驅動,同時也包括因今年已成為新增合作與授權協議創紀錄的一年,而帶來的預付款里程碑收入。
Let me move now to Slide 6, and I'll provide additional detail on the key business drivers in the quarter, beginning with the current ENHANZE portfolio. In the second quarter, the contribution from the more recently launched subcutaneous products with ENHANZE including OCREVUS ZUNOVO, OPDIVO Qvantig and RYBREVANT subcutaneous increased by approximately 80% quarter-on-quarter.
接著到投影片第 6 頁,我將就本季關鍵業務驅動因素提供更多細節,先從目前的 ENHANZE 產品組合開始。第二季,較近期上市、採用 ENHANZE 的皮下給藥產品(包括 OCREVUS ZUNOVO、OPDIVO Qvantig 與 RYBREVANT 皮下劑型)的貢獻季對季增加約 80%。
OCREVUS ZUNOVO is demonstrating how ENHANZE-enabled subcutaneous delivery can compound the value for our partners' products by expanding the accessible patient population.
OCREVUS ZUNOVO 正在展示 ENHANZE 賦能的皮下給藥如何透過擴大可及的病患族群,為我們合作夥伴的產品疊加價值。
On their second quarter call, Roche reported that the number of patients receiving the subcutaneous formulation increased to 44,000.
在第二季電話會議中,羅氏(Roche)表示,接受皮下劑型治療的病患人數已增加至 44,000 人。
Contrast that with the 17,500 patients at the end of the fourth quarter of 2025, and you can see just how many new patients have been added for this every 6-month subcutaneous treatment. ZUNOVO is now the fastest-growing anti-CD20 multiple sclerosis brand in the United States.
相較於 2025 年第四季末的 17,500 人,你可以看到這項每 6 個月一次的皮下治療新增了多少新病患。ZUNOVO 現已成為美國成長最快的抗 CD20 多發性硬化症品牌。
Roche noted that approximately 60% of the US OCREVUS ZUNOVO starts are coming from community practices, demonstrating how ENHANZE-enabled delivery can reach new sites of care, enabling access to Ocrevus for new patients.
羅氏指出,美國 OCREVUS ZUNOVO 的新開始治療中約有 60% 來自社區診所,顯示 ENHANZE 賦能的給藥方式可觸及新的照護場域,讓新病患得以使用 Ocrevus。
Bristol's OPDIVO Qvantig continued its strong launch trajectory with subcutaneous conversion reported to have increased to 15%, well on track for BMS' targeted 30% to 40% conversion rate.
百時美施貴寶(Bristol)的 OPDIVO Qvantig 延續強勁的上市動能,據報皮下轉換率已提升至 15%,正穩步朝 BMS 目標的 30% 至 40% 轉換率前進。
Moving now to Bristol Myers Squibb. Bristol's OPDIVO Qvantige continued its strong launch trajectory with subcutaneous conversion reported to have increased to 15%, well on track for BMS' targeted 30% to 40% conversion rate.
接下來談百時美施貴寶(Bristol Myers Squibb)。百時美施貴寶的 OPDIVO Qvantige 延續強勁的上市動能,據報皮下轉換率已提升至 15%,正穩步朝 BMS 目標的 30% 至 40% 轉換率前進。
This resulted in global sales growth of more than 200% year-over-year to $261 million in the second quarter. Based on this, OPDIVO Qvantig is projected to exceed $1 billion in annualized revenue. Johnson & Johnson's RYBREVANT FASPRO is another strong example of how ENHANZE creates value for our partners and for Halozyme.
因此,第二季全球銷售額年增超過 200%,達到 2.61 億美元。基於此,預期 OPDIVO Qvantig 的年化營收將超過 10 億美元。嬌生(Johnson & Johnson)的 RYBREVANT FASPRO 是另一個強而有力的例子,展現 ENHANZE 如何為我們的合作夥伴以及 Halozyme 創造價值。
For the second quarter of 2026, J&J highlighted rapid uptake of RYBREVANT FASPRO, contributing to the strong 62% year-over-year growth. Supporting growth acceleration in the upcoming quarters, the permanent J-code was awarded on July 1.
在 2026 年第二季,嬌生強調 RYBREVANT FASPRO 的快速採用,推動其年增 62% 的強勁成長。為支持未來幾季的成長加速,永久 J-code 已於 7 月 1 日核發。
This has been a contributor to broadening adoption and growth in multiple prior subcutaneous launches. J&J also commented that they have submitted a filing to the FDA for head and neck cancer. We are pleased to note that the FDA recently granted priority review to the filing, meaning an FDA review time line of approximately 6 months.
這在先前多項皮下上市產品中,已成為擴大採用與成長的助力。嬌生也提到,他們已就頭頸癌向 FDA 提交申請。我們很高興指出,FDA 近期已授予該申請優先審查,意味著 FDA 的審查時程約為 6 個月。
Upon approval, this new indication would expand the opportunity for RYBREVANT FASPRO beyond its existing lung cancer indications into this new area of high unmet need. It is certainly very exciting to see the growth and contribution of these three newer launch brands, where for these three brands alone, the total IV and subcutaneous opportunity based on total sales is projected to be $25 billion in 2028.
一旦獲批,這項新適應症將使 RYBREVANT FASPRO 的機會從既有的肺癌適應症,擴展至這個未滿足醫療需求高度集中的新領域。看到這三個較新的上市品牌的成長與貢獻,確實令人振奮;僅就這三個品牌而言,依總銷售額推估,其靜脈注射(IV)與皮下的總機會在 2028 年將達 250 億美元。
This is resulting in a diversified set of six products contributing royalty revenues where the total opportunity now exceeds $55 billion. I'll move now to DARZALEX subcutaneous, VYVGART Hytrulo and Phesgo, beginning with DARZALEX.
這使得目前有六項產品以多元化的組合貢獻權利金收入,而總機會現已超過 550 億美元。接下來我將談 DARZALEX 皮下劑型、VYVGART Hytrulo 與 Phesgo,先從 DARZALEX 開始。
DARZALEX continued to demonstrate robust revenue growth, increasing approximately 18% year-over-year to over $4 billion in the quarter, with virtually all global sales being for DARZALEX subcutaneous with ENHANZE.
DARZALEX 持續展現強勁的營收成長,該季年增約 18% 至超過 40 億美元,且幾乎所有全球銷售皆為搭載 ENHANZE 的 DARZALEX 皮下劑型。
J&J attributed the strong performance to continued market growth and share gains across all lines of therapy, including nearly 11 percentage points of share gain in the frontline setting.
嬌生將強勁表現歸因於市場持續成長,以及在所有治療線別的市占提升,其中在一線治療情境的市占提升近 11 個百分點。
It's also worth noting that following the FDA approval in March, the all subcutaneous regimen of TECVAYLI plus DARZALEX FASPRO is bringing new hope to patients with relapsed and refractory multiple myeloma.
同時也值得注意的是,在 3 月獲 FDA 核准後,TECVAYLI 加上 DARZALEX FASPRO 的全皮下療程,正為復發與難治型多發性骨髓瘤病患帶來新的希望。
I'll move now to argenx. Total VYVGART sales grew 60% year-over-year to $1.5 billion in the second quarter, driven by continued strong adoption of the ENHANZE-enabled VYVGART Hytrulo pre-filled syringe, which I will refer to as the PFS.
接下來談 argenx。第二季 VYVGART 總銷售額年增 60% 至 15 億美元,主要受 ENHANZE 賦能的 VYVGART Hytrulo 預充式注射器持續強勁採用所帶動;我將其稱為 PFS。
The PFS is expanding the prescriber base and bringing more patients into therapy with approximately 80% of US PFS patients in the quarter reported to be new to VYVGART.
PFS 正在擴大開立處方的醫師基礎並讓更多病患進入治療;據報該季美國 PFS 病患中約有 80% 為 VYVGART 新病患。
This demonstrates how ENHANZE, by supporting continued innovation and administration, can meaningfully broaden patient reach and support long-term product growth.
這顯示 ENHANZE 透過支持持續創新與給藥方式,能實質擴大病患觸及並支持產品長期成長。
Driving continued growth, recent regulatory and clinical milestones continue to expand the long-term opportunity for VYVGART Hytrulo. VYVGART is now the first and only therapy approved across all gMG serotypes, including seronegative patients.
為推動持續成長,近期的法規與臨床里程碑持續擴大 VYVGART Hytrulo 的長期機會。VYVGART 現已成為首個且唯一獲准涵蓋所有 gMG 血清型的治療,包括血清陰性病患。
The US approval in seronegative gMG in May expands the addressable opportunity by approximately 11,000 patients.
5 月在美國獲准用於血清陰性 gMG,使可服務的機會約增加 11,000 名病患。
Positive Phase 3 data in ocular myasthenia gravis further highlights the opportunity to expand the franchise and drive future growth upon approval. Moving now to Phesgo. Phesgo continues to demonstrate the value of ENHANZE-enabled subcutaneous delivery within Roche's HER2 franchise.
眼肌型重症肌無力的第三期正向數據,進一步凸顯在獲批後擴大產品系列並推動未來成長的機會。接下來談 Phesgo。Phesgo 持續展現 ENHANZE 賦能皮下給藥在羅氏 HER2 產品系列中的價值。
During the first half of 2026, Phesgo delivered strong growth of 18%, with global conversion reaching 54% in the 85 launch countries. Roche reiterated its expectation for at least 60% conversion at peak and highlighted Phesgo is a key component of the franchise's long-term durability.
在 2026 年上半年,Phesgo 實現 18% 的強勁成長,且在 85 個上市國家的全球轉換率達到 54%。羅氏重申其對高峰期至少 60% 轉換率的預期,並強調 Phesgo 是該產品系列長期韌性的關鍵組成。
I'll move now to Slide 7. Looking beyond the current decade, our future launch portfolio represents a significant source of long-term value with the potential to expand and further diversify our royalty revenue streams and deliver durable revenue for many years to come. Beginning in the 2029-plus time frame, we have three revenue engines.
接下來請看第 7 張投影片。放眼本十年之後,我們未來的上市產品組合代表重要的長期價值來源,具備擴大並進一步多元化權利金收入來源的潛力,並在未來多年帶來具韌性的營收。自 2029 年及之後的時間範圍開始,我們有三個營收引擎。
The first is our 10 currently approved ENHANZE products. The second are the multiple launches that are arising from our growing and robust ENHANZE development portfolio. And the third is Hypercon partner products.
第一個是我們目前已核准的 10 項 ENHANZE 產品。第二個是源自我們持續成長且強健的 ENHANZE 開發產品組合的多項上市產品。第三個是 Hypercon 合作夥伴產品。
We project that by year-end of 2026, we will have up to 13 ENHANZE partner products in development with potential approvals beginning in the 2029-plus time frame. These programs represent the next generation of royalty-producing assets and extend our future opportunity beyond the currently approved portfolio.
我們預估至 2026 年底,將有多達 13 項 ENHANZE 合作夥伴產品處於開發中,且潛在核准可自 2029 年及之後的時間範圍開始。這些計畫代表下一代可產生權利金的資產,並將我們的未來機會延伸至目前已核准的產品組合之外。
During the second quarter, two new ENHANZE targets initiated Phase 1 testing. This is resulting in nine development products and keeps us well on track for the 13 development products by year-end.
在第二季,有兩個新的 ENHANZE 標的啟動第一期試驗。因此目前共有九項開發中產品,並使我們在年底達成 13 項開發中產品的目標進展順利。
This broad and growing portfolio of future potential launches clearly demonstrates why we're so confident that ENHANZE will be a significant long-term revenue driver for Halozyme. I will now move to Hypercon, which we intend to make into a second compounding platform engine and recreate the amazing success of ENHANZE.
這個廣泛且持續成長的未來潛在上市產品組合,清楚展現我們為何對 ENHANZE 將成為 Halozyme 重要的長期營收驅動因素充滿信心。接下來我將談 Hypercon;我們計畫將其打造為第二個複利式平台引擎,並重現 ENHANZE 的卓越成功。
Hypercon is designed to address growing demand for lower volume subcutaneous administration, enabling highly concentrated formulations that can potentially support at-home and physician office administration.
Hypercon 的設計旨在因應對更低注射體積皮下給藥日益增加的需求,實現高濃度配方,並有潛力支持居家與醫師診所給藥。
We made strong progress in the quarter, advancing preparations to provide clinical supply to support the first Hypercon clinical starts in the first half of 2027.
本季我們取得重大進展,推進相關準備工作以提供臨床供應,支援 2027 年上半年首批 Hypercon 臨床試驗啟動。
Our projected first launch timing for these two new products is in the 2030, 2031 time frame, and we continue to expect Hypercon to launch multiple products and achieve approximately $1 billion in royalty revenue in the mid-2030s.
我們預計這兩項新產品的首次上市時間落在2030年至2031年期間,且我們仍預期Hypercon將推出多項產品,並在2030年代中期達成約10億美元的權利金收入。
Let me now turn to the new collaboration and licensing agreements, which are summarized on Slide 8. I mentioned at the start that this has been our most successful year ever with record performance for ENHANZE and for Hypercon. The pace of recent collaboration activity reflects the growing importance of subcutaneous delivery across the biopharmaceutical industry.
接下來我將談到新的合作與授權協議,相關內容彙總於投影片8。我在一開始提到,這是我們有史以來最成功的一年,ENHANZE與Hypercon皆創下創紀錄的表現。近期合作活動的加速,反映皮下給藥在整個生物製藥產業中的重要性日益提升。
Pharma and biotech companies are increasingly focused on improving the patient treatment experience, reducing treatment burden, expanding access across sites of care and differentiating their products.
製藥與生技公司正日益聚焦於改善病患治療體驗、降低治療負擔、擴大不同照護場域的可近性,並使其產品更具差異化。
In the second quarter, we announced the new ENHANZE agreement with GSK, which included the opportunity to use ENHANZE in a new use area with antibody drug conjugates.
在第二季,我們宣布與GSK達成新的ENHANZE協議,其中包含在抗體藥物複合體(ADC)這一新的應用領域使用ENHANZE的機會。
In July, we announced a second agreement with Incyte, working with Incyte on a subcutaneous formulation of its first-in-class mutant calreticulin monoclonal antibody.
7月,我們宣布與Incyte簽署第二項協議,與Incyte合作開發其同類首創(first-in-class)的突變型鈣網蛋白(mutant calreticulin)單株抗體之皮下劑型。
Today, we are pleased to announce a third new agreement signed in the second quarter with an undisclosed partner to explore the use of ENHANZE with a nucleic acid therapeutic.
今天,我們很高興宣布第二季與一位未揭露的合作夥伴簽署第三項新協議,以探索將ENHANZE用於核酸治療(nucleic acid therapeutic)。
This is the first of what we hope will be several collaborations in this emerging area where ENHANZE brings the potential to enable subcutaneous delivery of large volume nucleic acid conjugate formulations and LNPs while mitigating the inflammatory and immune response that can be otherwise generated from subcutaneous administration.
這是我們希望在此新興領域展開多項合作的第一項;在該領域中,ENHANZE有潛力促成大體積核酸偶聯劑型與脂質奈米粒(LNP)的皮下給藥,同時減輕皮下施用可能引發的發炎與免疫反應。
We are excited to expand into these two new areas of ADCs and nucleic acids that represent brand-new growth market segments for ENHANZE and where we estimate that there are at least 100 commercial and development products that may benefit.
我們很興奮能拓展至ADC與核酸這兩個新領域;它們代表ENHANZE全新的成長市場區隔,我們估計至少有100項商業化與開發中產品可能受益。
Also in the second quarter, we signed two new Hypercon collaboration agreements, one with Vertex and one with Oruka. These agreements establish strategic platform relationships that have the potential to expand over time through additional targets and future development programs.
同樣在第二季,我們簽署了兩項新的Hypercon合作協議,一項與Vertex,另一項與Oruka。這些協議建立了策略性平台合作關係,未來可望透過新增標的與後續開發計畫,隨時間擴大合作範圍。
When we combine the up to 13 ENHANZE development programs by year-end and this expanding opportunity that's created by the current and new ENHANZE, Hypercon agreements, we have created a substantial portfolio of new potential royalty opportunities extending well into the next decade.
當我們把年底前最多可達13項ENHANZE開發計畫,與現有及新增的ENHANZE、Hypercon協議所帶來的擴大機會結合起來,我們已建立一個可延伸至下一個十年的龐大潛在權利金機會組合。
What you've heard me describe is the power of having an established compounding platform engine with ENHANZE, and we're creating just the same for Hypercon.
各位聽到我所描述的,是ENHANZE作為既有複利式平台引擎的力量,而我們也正在為Hypercon打造同樣的模式。
We have demonstrated time and again the repeatability and diversification with now six separate and growing royalty streams delivering record revenue.
我們一次又一次證明其可重複性與多元化,如今已有六條獨立且持續成長的權利金收入來源,帶來創紀錄的營收。
We've demonstrated scalability with multiple waves of new launches now extending well into the 2030s. The durability is clear with 50% royalty revenue growth more than 12 years after our first launch.
我們已展現可擴展性,多波新產品上市的浪潮如今可延伸至2030年代。其持久性也很明確:在我們首次上市超過12年後,權利金收入仍成長50%。
And we're very proud that our partner products are clinical breakthroughs that we have helped create into multiple blockbuster subcutaneous products. Our priority in 2026 remains executing on these significant organic growth opportunities.
我們也非常自豪,合作夥伴的產品是臨床突破,而我們協助將其打造為多項重磅的皮下產品。我們在2026年的優先事項,仍是執行這些重要的內生成長機會。
We are also continuing to evaluate selective M&A opportunities that can expand our drug delivery technology offering and royalty duration. But any external opportunity must meet our criteria of a strong strategic fit, durable value creation and attractive returns.
我們也持續評估具選擇性的併購(M&A)機會,以擴大我們的藥物遞送技術組合與權利金存續期間。但任何外部機會都必須符合我們的標準:高度策略契合、可持續的價值創造,以及具吸引力的報酬。
With that, I'm pleased to turn the call over to Darren.
接下來,我很高興把電話會議交給Darren。
Darren Snellgrove - Chief Financial Officer
Darren Snellgrove - Chief Financial Officer
Thank you, Helen. I am thrilled to be joining Halozyme at such an exciting point in the company's evolution. Over the past few months, I've had the opportunity to dive deeper into the business, and what has stood out to me is the strength of Halozyme's business model. It's rare to find a company that offers such outstanding current performance and future potential.
謝謝你,Helen。我很興奮能在公司演進如此令人振奮的時刻加入Halozyme。過去幾個月,我有機會更深入了解這項業務,而最令我印象深刻的是Halozyme商業模式的強勁。能找到一家同時具備如此卓越的當前表現與未來潛力的公司並不常見。
Halozyme's combination of strong growth, exceptional profitability and robust free cash flow, coupled with disciplined capital allocation, positions the company well as we continue to accelerate innovation and provide significant returns to shareholders.
Halozyme兼具強勁成長、卓越獲利能力與穩健自由現金流,再加上嚴謹的資本配置,使公司在我們持續加速創新並為股東帶來可觀回報的過程中,具備良好定位。
Having spent nearly three decades in the industry, I was familiar with the value Halozyme creates for partners, patients and the health care system.
我在產業深耕近三十年,早已熟悉Halozyme為合作夥伴、病患與醫療體系所創造的價值。
After joining the company, I have an even greater appreciation for the opportunities ahead.
加入公司後,我對未來的機會有了更深一層的體會。
One of the unique characteristics of the business is what I would call the halo effect. Every successful ENHANZE-enabled product does more than generate high-margin, scalable royalty revenue. We enable our partners and improve products for patients.
這項業務的一個獨特特徵,我稱之為「光環效應」。每一項成功的ENHANZE賦能產品,不僅能帶來高毛利、可擴展的權利金收入。我們也賦能合作夥伴,並為病患改善產品。
Our platforms reinforce the clinical and commercial value of subcutaneous delivery and create additional opportunities for target nominations, platform expansions and new collaborations. This cycle continues to broaden our opportunities and increase the durability of our long-term diversified model.
我們的平台強化皮下給藥在臨床與商業上的價值,並創造更多標的提名、平台擴展與新合作的機會。這個循環持續擴大我們的機會,並提升我們長期多元化模式的持久性。
The strong second quarter results reinforce that view as the company delivered another record quarter, exceeding expectations for royalty revenue, driving strong EBITDA growth and, at the same time, investing in our future growth platforms.
第二季的強勁成果也印證了這一點:公司再度交出創紀錄的一季,權利金收入超出預期,帶動EBITDA強勁成長,同時也投資於我們未來的成長平台。
Let me start on Slide 9. Total revenue increased 48% to $481 million compared to $325.7 million in the prior year period. This performance was driven by robust royalty revenue growth and higher collaboration revenue, reflecting new deals signed during the quarter.
我先從投影片9開始。總營收較去年同期的3.257億美元成長48%至4.81億美元。此表現主要由權利金收入的強勁成長與較高的合作收入所帶動,反映本季簽署的新交易。
Royalty revenue of $307.7 million increased 50% from $205.6 million in the prior year period and exceeded our expectations.
權利金收入為3.077億美元,較去年同期的2.056億美元成長50%,並超出我們的預期。
These results reflect increasing contributions from more recently launched ENHANZE products as well as the continued commercial success of DARZALEX subcu and VYVGART Hytrulo. DARZALEX generated $4 billion in global sales for J&J in the second quarter, representing close to 18% operational growth, further demonstrating the strength, durability and continued momentum of the franchise. These strong sales translated into $152.2 million of royalty revenue to Halozyme, representing an increase of 27% year-over-year.
這些結果反映近期上市的ENHANZE產品貢獻增加,以及DARZALEX皮下劑型與VYVGART Hytrulo持續的商業成功。J&J第二季DARZALEX全球銷售額達40億美元,約18%的營運成長,進一步展現該產品線的強勁、持久性與持續動能。這些強勁銷售為Halozyme帶來1.522億美元的權利金收入,年增27%。
Halozyme's royalties from VYVGART Hytrulo increased 143% to $72.6 million in the second quarter. Total VYVGART brand sales for the second quarter reached $1.5 billion, up 60% versus prior year, reflecting strong demand for the ENHANZE-enabled pre-filled syringe, which continues to broaden the prescriber base and support adoption across gMG and CIDP.
Halozyme來自VYVGART Hytrulo的權利金在第二季成長143%至7,260萬美元。VYVGART品牌第二季總銷售額達15億美元,較去年同期成長60%,反映市場對ENHANZE賦能的預充式注射器需求強勁;該產品持續擴大開立處方醫師基礎,並支持其在gMG與CIDP的採用。
Other royalty revenues grew 85% to $54.4 million, driven by increasing partner product sales of recently launched products, OCREVUS subcu, Opdivo Qvantig, RYBREVANT subcu and Tecentriq subcu.
其他權利金收入成長85%至5,440萬美元,主要由近期上市產品的合作夥伴銷售增加所帶動,包括OCREVUS皮下劑型、Opdivo Qvantig、RYBREVANT皮下劑型與Tecentriq皮下劑型。
We are pleased with the early momentum and see a significant opportunity ahead given that estimates for the total brand growth of these four products is approximately $30 billion in 2028.
我們對早期動能感到滿意,並認為未來機會可觀,因為市場估計這四項產品在2028年的品牌總成長規模約為300億美元。
Moving to Slide 10 for more detail on the quarterly results. Research and development expenses were $27.7 million compared to $17.5 million in the prior year period, reflecting the addition of Hypercon and SurfBio and our continued investment in advancing these technologies.
接著看投影片10,以更詳細說明本季結果。研發費用為2,770萬美元,去年同期為1,750萬美元,主要反映新增Hypercon與SurfBio,以及我們持續投資推進這些技術。
Selling, general and administrative expenses were $57 million in the quarter compared to $41.6 million in the prior year period. Net income increased 39% to $229.9 million from $165.2 million in the prior year period.
本季銷售、一般及行政費用為5,700萬美元,去年同期為4,160萬美元。淨利較去年同期的1.652億美元成長39%至2.299億美元。
Adjusted EBITDA increased 46% to $328.8 million from $225.5 million in the prior year period, driven by continued strong royalty growth. GAAP diluted earnings per share was $1.90 compared to $1.33 in the prior year period, and non-GAAP diluted earnings per share was $2.28 compared to $1.54 in the second quarter of 2025.
調整後 EBITDA 較去年同期的 2.255 億美元成長 46% 至 3.288 億美元,主要受持續強勁的權利金成長帶動。依 GAAP 計算的稀釋每股盈餘為 1.90 美元,去年同期為 1.33 美元;非 GAAP 稀釋每股盈餘為 2.28 美元,2025 年第二季為 1.54 美元。
Moving to Slide 11. We generate substantial free cash flow from our asset-light model, and our strong financial position gives us the flexibility to execute a disciplined capital allocation strategy.
接著看第 11 張投影片。我們的輕資產模式帶來可觀的自由現金流,而強勁的財務狀況讓我們能夠靈活執行嚴謹的資本配置策略。
Our priorities are straightforward: fund the highest return organic opportunities, maintain a strong balance sheet and return excess capital to shareholders through a disciplined buyback program.
我們的優先事項很明確:投入報酬率最高的內生成長機會、維持強健的資產負債表,並透過嚴謹的庫藏股回購計畫將多餘資本回饋股東。
We view share repurchases as an attractive use of capital when we believe the stock does not fully reflect the durability and growth of our royalty streams.
當我們認為股價尚未充分反映我們權利金收入流的耐久性與成長性時,我們將股票回購視為具吸引力的資本運用方式。
That is why we purchased $332.8 million worth of shares in the second quarter against our target of $400 million for the full year, while also investing in long-term growth and expanding the ENHANZE platform as more products launch and gain share.
因此,我們在第二季回購了 3.328 億美元的股票,朝全年 4 億美元的目標邁進;同時也持續投資長期成長,並隨著更多產品上市並提升市占而擴大 ENHANZE 平台。
Turning now to Slide 12 and our updated 2026 outlook. As Helen mentioned earlier, we are pleased to raise the guidance for the remainder of the year.
接著看第 12 張投影片以及我們更新後的 2026 年展望。如 Helen 先前提到的,我們很高興上調今年剩餘期間的財測指引。
We now expect total revenue of $1.835 billion to $1.91 billion, representing year-over-year growth of 31% to 37%, driven by an increase in royalty revenue projections and product sales from API.
我們目前預期總營收為 18.35 億至 19.10 億美元,年增 31% 至 37%,主要由權利金營收預估上調以及 API 的產品銷售所帶動。
Royalty revenues of $1.22 billion to $1.245 billion, representing year-over-year growth of 41% to 43%. We expect growing contributions from the recently launched ENHANZE products, while DARZALEX subcu, VYVGART Hytrulo and Phesgo remain the largest revenue contributors.
權利金營收為 12.20 億至 12.45 億美元,年增 41% 至 43%。我們預期近期上市的 ENHANZE 產品貢獻將持續增加,同時 DARZALEX 皮下劑型、VYVGART Hytrulo 與 Phesgo 仍將是最大的營收貢獻來源。
We expect adjusted EBITDA of between $1.225 billion and $1.28 billion, which includes approximately $60 million of planned investment in Hypercon and SurfBio, and non-GAAP diluted EPS of $8.65 to $9. I will now turn the call back over to Helen.
我們預期調整後 EBITDA 介於 12.25 億至 12.80 億美元之間,其中包含約 6,000 萬美元對 Hypercon 與 SurfBio 的計畫性投資;非 GAAP 稀釋每股盈餘為 8.65 至 9.00 美元。接下來我把電話交回給 Helen。
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
Thank you, Darren. In closing, let me highlight that our record second quarter results reinforce our confidence in both the strength of our business today and in the opportunities ahead.
謝謝你,Darren。最後我想強調,我們創紀錄的第二季成果,進一步強化了我們對當前業務實力以及未來機會的信心。
The growing contributions of our recently launched ENHANZE products and the continued strong performance of DARZALEX subcutaneous and VYVGART give us confidence in the 2026 to '28 financial guidance and beyond.
近期上市的 ENHANZE 產品貢獻持續提升,加上 DARZALEX 皮下劑型與 VYVGART 的持續強勁表現,讓我們對 2026 至 2028 年的財務指引以及更長期的展望充滿信心。
In the quarter, we demonstrated meaningful progress to add to this and will bend the curve, including through multiple new ENHANZE and Hypercon collaboration and licensing agreements and multiple new clinical study starts. Thank you for your attention today. And operator, you can now open the line for questions.
本季我們也展現了顯著進展,持續加碼並推動成長曲線上行,包括多項新的 ENHANZE 與 Hypercon 合作與授權協議,以及多項新的臨床研究啟動。感謝各位今天的聆聽。接線員,現在可以開放提問。
Operator
Operator
(Operator Instructions) Sean Laaman, Morgan Stanley.
(接線員指示) Morgan Stanley 的 Sean Laaman。
Natasha Sanders - Analyst
Natasha Sanders - Analyst
This is Natasha on for Sean. So you raised royalty guide of $1.22 billion to $1.245 billion against the $548 million in the first half royalties, implies around $336 million to $348 million per quarter in the back half, which is a step-up from 2Q's $308 million. I just wanted to ask what's driving that implied acceleration from here? Is it primarily the newer launch cohort or the established products?
我是代替 Sean 的 Natasha。你們將權利金指引上調至 12.20 億到 12.45 億美元,而上半年權利金為 5.48 億美元,這意味著下半年每季約 3.36 億到 3.48 億美元,較第二季的 3.08 億美元有所提升。我想請問,從現在起這個隱含的加速成長主要是由什麼驅動?主要是較新的上市產品組合,還是既有成熟產品?
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
Thanks, Natasha. I'll turn that over to Darren.
謝謝你,Natasha。我把這題交給 Darren。
Darren Snellgrove - Chief Financial Officer
Darren Snellgrove - Chief Financial Officer
Yes. Thanks for the question. And as you noted, royalties were an important component of the beat in the first half.
好的。謝謝你的提問。如你所提到的,權利金是上半年優於預期表現的重要組成。
And I would say that we do expect royalty revenue to grow sequentially through the second half, probably won't have quite the same amount of royalty step-ups that were part of the Q1 to Q2 growth. But we do expect that to continue to ramp up in the second half.
我會說,我們確實預期權利金營收在下半年將逐季成長,雖然可能不會再出現像第一季到第二季那樣幅度的權利金跳升。但我們預期下半年仍會持續爬升。
And a lot of it is driven by some of the new product launches that you've seen. So things like RYBREVANT subcu, which has started to pick up a little bit, and some of the other new products.
其中很大一部分是由你們看到的一些新產品上市所帶動。例如 RYBREVANT 皮下劑型已開始有些起色,以及其他一些新產品。
Operator
Operator
Michael DiFiore, Evercore ISI.
Evercore ISI 的 Michael DiFiore。
Yuanyuan He - Analyst
Yuanyuan He - Analyst
This is Yuanyuan on for Mike. Congrats on the strong quarter. I'd like to ask a question on target exclusivity. So you've talked about partners who work with other providers and often approach Halozyme first, where target was already exclusively licensed.
我是代替 Mike 的 Yuanyuan。恭喜本季表現強勁。我想問一個關於標的獨家性的問題。你們曾提到,與其他供應商合作的夥伴往往會先找 Halozyme,但當時該標的已被獨家授權。
So as we look forward to 2029, how should we think about the way target exclusivity works as the base patents flow out? And then does that open up targets you couldn't take on before?
展望 2029 年,隨著基礎專利逐步到期,我們應該如何看待標的獨家性的運作方式?這是否會開放一些你們以前無法承接的標的?
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
Yes. Thanks for the question. In terms of the exclusivity, it's often very much driven by the partner company. And if they request exclusivity and they are willing to pay the enhanced economics that are associated with that, historically, in the past, we have agreed to that, and we also would still agree to that today.
是的。謝謝你的提問。就獨家性而言,很多時候其實是由合作夥伴公司所主導。如果他們要求獨家,並願意支付與之相應的更優經濟條件,過去我們通常會同意,而今天我們也仍然會同意。
I will note, however, that as you've probably seen in the latest series of agreements that we've done, there are now a lot of companies who are very comfortable with gaining a nonexclusive license.
不過我也要指出,正如你可能在我們最新一系列協議中看到的,現在有許多公司對取得非獨家授權也非常自在。
And so you're going to see a mix of the two as you go forward. And I will also say, if you think about exclusivity, exclusivity is also done in different ways. It can be exclusivity to an entire target, as an example, like we did with PD-1.
因此,未來你會看到兩者並存的組合。另外我也想說,若談到獨家,獨家的形式也有不同。例如,我們曾對整個標的給予獨家性,像是 PD-1。
But in other cases, there can be exclusivity to a specific molecule uses a target or perhaps a target that is part of a combination.
但在其他情況下,獨家性可能是針對某一個使用該標的的特定分子,或是某個作為組合療法一部分的標的。
And so we are being able to be a lot more, if you like, creative and broad in what we're able to license both on an exclusive and a nonexclusive basis as we go forward. And that really is reflected in the five recent deals across those and the additional deals we anticipate signing this year and next.
因此,展望未來,無論是以獨家或非獨家的方式,我們在授權上都能更具彈性、也更具創意與廣度。這也反映在近期跨上述類型的五筆交易,以及我們預期今年與明年將簽署的其他交易上。
Operator
Operator
Brendan Smith, TD Cowen.
TD Cowen 的 Brendan Smith。
Brendan Smith - Analyst
Brendan Smith - Analyst
Congrats on the great quarter. Maybe first, actually on Hypercon. I know we'll get confirmation of the first two assets by early next year.
恭喜本季表現非常出色。我想先問 Hypercon。我知道我們會在明年初確認前兩個資產。
Just wondering if you can give us a little bit more of a sense of timing for, kind of, subsequent assets in that pipeline and just roughly when the next wave might be, if there are others that could reach Phase 1 next year? Is that more of a '28 event?
想請問你們能否再多分享一些後續管線資產的時間點概況,以及下一波大概會在何時出現?是否有其他資產可能在明年進入第一期?還是那更像是 2028 年的事件?
And I guess, kind of related, I wanted to ask actually about that $1 billion in incremental Hypercon royalties by 2035 you've spoken to.
另外一個相關問題,我想問你們提到到 2035 年 Hypercon 權利金可增加 10 億美元。
I guess, how many different assets are you assuming would contribute to that by 2035? And I guess, are your assumptions largely just based on the current partnerships? Or are you assuming any additional ones?
我想了解,到 2035 年你們假設會有多少個不同資產對此做出貢獻?以及你們的假設主要是基於目前既有的合作夥伴關係嗎?還是也假設會有新增的合作?
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
Yes. Thanks. With regard to Hypercon and timing, there absolutely could be additional study starts in the second half of 2027, Brendan, based on the progress we're seeing with companies advancing through the preparatory stages before they're ready to advance to the clinic.
是的。謝謝。關於 Hypercon 與時程,Brendan,根據我們看到各家公司在進入臨床前所需的準備階段所取得的進展,2027 年下半年確實有可能會有額外的研究啟動。
And if you recall, while we've got five agreements, those partners have taken up to 20 targets. And so some of the companies are advancing more than one target at this point in time, and that is already creating a very nice pipeline of future clinical studies for 2027 and for 2028.
而且如果你還記得,雖然我們有五項協議,但這些合作夥伴合計已涵蓋多達 20 個標的。因此,目前有些公司正在推進不只一個標的,而這已經為 2027 年與 2028 年建立了一條非常可觀的未來臨床研究管線。
So that's the great thing about the model we have with this ability to access multiple targets in one agreement. As we projected the $1 billion in the mid-2030s, we had assumed between five and seven launches by that time period.
所以,這正是我們模式的優勢:在一份協議中就能取得多個標的的使用權。當我們預估 2030 年代中期達到 10 億美元時,我們假設到那個時間點會有 5 到 7 個產品上市。
And I think a number of those will come from the already signed agreements, but it is also possible that agreements in the next 1 to 2 years could also be contributing to that based on what we estimate the development time line to be.
我認為其中有相當一部分會來自已簽署的協議,但也有可能未來 1 到 2 年內的新協議,依據我們對研發時程的估計,也會對此有所貢獻。
So I commented on the call about -- it's very exciting to see Hypercon turning into another compounding platform engine for us, but able to do so faster and quicker in part because the market is just more receptive to subcu delivery, but we're also able to bring a lot of our learnings from how we've been able to commercialize and grow ENHANZE.
所以我在電話會議上提到——看到 Hypercon 正在成為我們另一個複方平台的成長引擎,令人非常振奮;而且它能更快、更迅速地做到這一點,部分原因是市場對皮下(subcu)給藥的接受度更高,同時我們也能把過去商業化並擴大 ENHANZE 的許多經驗帶進來。
Operator
Operator
Mitchell Kapoor, H.C. Wainwright.
Mitchell Kapoor,H.C. Wainwright。
Amit Dayal - Analyst
Amit Dayal - Analyst
This is Amit on for Mitchell. Congrats on a strong quarter. I guess, for both or all platform cadence, I guess, how are you thinking about the mix of new partner wins and follow-on nominations from existing partners?
我是 Amit,代 Mitchell 發問。恭喜本季表現強勁。我想就各平台的推進節奏請教一下:你們如何看待新合作夥伴的新增合作與既有合作夥伴後續標的提名(follow-on nominations)之間的組合?
And how would that shape the future deal cadence? And on the ADC and nucleic acid therapeutics, there's a lot of excitement about that. And I was just wondering how are you thinking about the broader opportunity? And how are you prioritizing these modalities as you pursue additional deals?
這將如何影響未來的交易節奏?另外,關於 ADC 與核酸治療,市場非常興奮。我想請問你們如何看待更廣泛的機會?在追求更多合作案時,你們如何為這些治療模態排定優先順序?
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
Yes. Thank you. With regard to the -- I'll start with the ADCs and the nucleic acids, yes, very excited now to have signed a deal, one each for both of those, opening up a brand-new growth opportunity for ENHANZE.
是的。謝謝。關於——我先從 ADC 與核酸談起:是的,我們非常興奮,因為現在已各自簽下一筆合作案,為 ENHANZE 開啟全新的成長機會。
We have previously said that there's 50 ADCs we think could benefit from ENHANZE, and we said there are about 50 nucleic acid-based therapies that we think can benefit from ENHANZE.
我們先前曾表示,我們認為有 50 個 ADC 可能受益於 ENHANZE;也說過大約有 50 個以核酸為基礎的療法,我們認為也能受益於 ENHANZE。
And so this really is an exciting opportunity. And I would say our business development team are agnostic to whether it's an monoclonal antibody, an ADC or a nucleic acid.
因此,這確實是一個令人振奮的機會。我想我們的商務拓展團隊並不偏好特定類型,不論是單株抗體、ADC 或核酸都一樣。
But what it has done is broaden the number of companies that we are speaking to and approaching with ideas as to how the ENHANZE technology can help improve their risk-benefit profile or their competitive profile.
但這確實擴大了我們正在洽談與接觸的公司數量,我們也會提出想法,說明 ENHANZE 技術如何協助改善其風險效益特徵或競爭力。
And so it just has dramatically increased the number of conversations we're having, and that's exciting in terms of what that can mean for long-term growth and expansion of the ENHANZE number of agreements.
因此,我們的對話數量大幅增加;就長期成長與擴大 ENHANZE 協議數量而言,這令人振奮。
You make a good point, and it's something I think that's often underrecognized is that signing new deals is a source of growth for us. But the number of targets that we already have under license that has not yet been nominated is a second, separate source of growth.
你提出了一個很好的觀點,而且我認為這點常常被低估:簽署新合作案是我們的成長來源之一。但我們目前已取得授權、尚未被提名的標的數量,是第二個、獨立的成長來源。
And in the first half of this year, I will say we've had one current partner nominate a product, and I actually am expecting more in the second half. And so it's going to be a mix of both really in terms of what's going to cause the continued growth and expansion of our pipeline.
而在今年上半年,我會說我們已有一位現有合作夥伴提名了一個產品,而且我其實預期下半年會有更多。因此,就推動我們管線持續成長與擴張的因素而言,將會是兩者的混合。
We expect to have 13 development products in the clinic camp this year. That's going to continue both from these current deals we're signing, adding more nominations and moving into the clinic, but even our existing partners who've still got slots left.
我們預期今年將有 13 個開發中產品進入臨床階段。這將持續來自我們目前簽署的合作案——增加更多提名並推進到臨床——同時也包括仍有名額可用的既有合作夥伴。
Now falling into the same mindset, I think, as many of the companies today of recognizing that subcu delivery means competitive differentiation, and they are advancing new nominations at a pace also that we've not necessarily seen in a long, long time.
現在他們也逐漸形成與當今許多公司相同的思維:認知到皮下(subcu)給藥代表競爭差異化,因此他們推進新提名的速度,也達到我們很久很久沒有見過的水準。
So it's an exciting time with both of those avenues for growth as well as growth coming from the ADCs and the nucleic acid new opportunity.
所以,透過這兩條成長途徑,再加上 ADC 與核酸帶來的新機會,現在確實是令人振奮的時刻。
Operator
Operator
Mohit Bansal, Wells Fargo.
Mohit Bansal,Wells Fargo。
William Zhang - Analyst
William Zhang - Analyst
This is Will Zhang on for Mohit. Congrats on the recent deals in the quarter. But I guess, I just want to understand now that some of the smaller companies are also partnering with you on ENHANZE, like is the deal structure for these smaller companies any different from your prior deals?
我是 Will Zhang,代 Mohit 發問。恭喜本季達成近期幾筆合作案。不過我想了解的是,現在一些較小型的公司也與你們在 ENHANZE 上合作,那麼這些小型公司的交易架構是否與你們過去的交易有任何不同?
And I guess, like, what conversations are you currently having with new or smaller partners?
另外,你們目前正與哪些新合作夥伴或較小型合作夥伴進行哪些對話?
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
Yes. We're excited to be continuing to be discussing ENHANZE with all size ranges of companies. If you think about just the last few months, we have GSK that certainly is a very large company.
是的。我們很高興能持續與各種規模的公司討論 ENHANZE。如果你回顧過去幾個月,我們有 GSK,這當然是一家非常大型的公司。
We've got Incyte that is a large company, and as you point out some smaller companies as well.
我們也有 Incyte,這也是一家大型公司;如你所說,也有一些較小型的公司。
I would say what is more a driver of exactly what the deal structure will be is based much more on exclusivity versus non-exclusivity. And so that is where there is some difference in the economics that's really driven by that the deal structure is shaped around exclusivity, not company size.
我會說,真正更能決定交易架構的驅動因素,是排他性(exclusivity)與非排他性(non-exclusivity)。因此,經濟條件上的差異主要是由此而來:交易架構是圍繞排他性來設計,而不是以公司規模來決定。
Operator
Operator
Dave Risinger, Leerink Partners.
Dave Risinger,Leerink Partners。
David Risinger - Analyst
David Risinger - Analyst
Thanks very much and congrats on the financial upside, and Darren, congrats on your new role. So I have a few questions, please.
非常感謝,也恭喜財務表現優於預期;Darren,也恭喜你擔任新職務。我有幾個問題想請教。
First, could you provide an update on the Merck litigation prospects? How -- that's the first question. Second, how you see Alteogen as a competitor today? And then third, your view on the acquisition landscape?
第一,能否提供 Merck 訴訟前景的最新進展?這是第一個問題。第二,你們目前如何看待 Alteogen 作為競爭對手?第三,你們對併購環境的看法?
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
All right. I'll take the first two, and I'll turn the acquisition landscape over to Darren. With regard to the Merck litigation, let me start outside the US.
好的。前兩個我來回答,併購環境的部分我交給 Darren。關於 Merck 的訴訟,我先從美國以外的地區談起。
We are currently actively pursuing injunctions in approximately eight countries outside the US with the goal of stopping the Merck infringing use of our MDASE technology.
目前我們正在美國以外約八個國家積極尋求禁制令,目標是阻止 Merck 侵害性使用我們的 MDASE 技術。
This includes the launch in countries as well as manufacturing, distribution and supply of Qlex for worldwide use. These cases are moving forward rapidly. You may have seen we did have a preliminary injunction in Germany in December.
這包括在各國的上市,以及為全球使用而進行的 Qlex 製造、配送與供應。這些案件正快速推進。你們可能已看到,我們在 12 月於德國取得了初步禁制令。
And we do expect important decisions broadly impacting Merck launches of sales in Qlex in Europe before the end of this year. So very active in Europe. With regard to the United States, we're working through the US patent office proceedings that were brought by Merck with regard to the PGRs.
我們也預期在今年年底前,歐洲將出現一些重要裁決,將廣泛影響 Merck 在歐洲 Qlex 的上市與銷售。因此在歐洲方面非常積極。至於美國,我們正在處理由 Merck 提起、與 PGR 相關的美國專利局程序。
And we expect to have more clarity once that we're through all of those steps on when the US District Court case is going to move forward once the final decisions are reached in those proceedings later this year.
我們預期在完成所有這些步驟之後,待今年稍晚這些程序作出最終決定時,將能更清楚了解美國地方法院案件何時會繼續推進。
Now I will say that it's a very active on the PGRs as well. We're going to be appealing the four initial written decisions that we received earlier this year. And we expect to hear the PTAB's decision on the remaining 10 sometime this fall.
我也要說,PGR 方面同樣非常活躍。我們將就今年稍早收到的四份初步書面決定提出上訴。我們預期將在今年秋季某個時點聽到 PTAB 對其餘 10 件的決定。
And so a lot still happening in the US case as well, David, with some clarity with regard to the PGRs at the end of this year, clarity on the timing of the district case, but certainly, our conviction and our confidence is absolutely unwavering that we will prevail in this case, and we will be appealing certainly the first four PGRs that based on our very strong conviction that the Alteogen product is infringing.
因此,美國案件方面仍有許多進展,David;今年底我們將對 PGR 有一些明確性,也會更清楚地掌握地方法院案件的時程。不過,我們的信念與信心絕對毫不動搖:我們將在此案中勝訴;而且我們當然會就前四件 PGR 提出上訴,因為我們非常堅信 Alteogen 的產品構成侵權。
The Merck product using the Alteogen technology, as you probably see better, is infringing. With regard to Alteogen, it still continues to be the case that from what is publicly available, it would appear that the people who are assigning deals at the moment with Alteogen are for targets that Halozyme has exclusively licensed, and I can say many of those companies have directly come to us, and we've had to unfortunately say we're unable to work with them. And so in light of that, obviously, while we're not finding that performance of Alteogen is directly competing with us.
採用 Alteogen 技術的 Merck 產品,如你可能更清楚地看到的,確實構成侵權。至於 Alteogen,目前仍是如此:從公開可得資訊來看,現階段與 Alteogen 洽談合作的對象似乎是 Halozyme 已取得獨家授權的標的;我可以說,其中許多公司曾直接找上我們,但我們很遺憾必須表示無法與他們合作。因此在此情況下,顯然我們並未發現 Alteogen 的表現正在直接與我們競爭。
And I will also share that when companies come to us, what they see is they want to work with Halozyme because of our track record of success because our product is being used and we've got a safety database and over 1.3 million patients with 15 years history of reliability of supply.
我也想分享的是,當公司來找我們時,他們看到的是:他們想與 Halozyme 合作,因為我們有成功的實績;我們的產品已被使用,並且擁有安全性資料庫;累計超過 130 萬名病患、15 年的供應可靠性歷史。
And our team have got the expertise to support very rapidly getting the partners into the clinic, innovative trial designs and a faster path to approval.
而我們的團隊具備專業能力,能非常快速地協助合作夥伴推進至臨床,採用創新的試驗設計,並走出更快的核准路徑。
And so the entire package that Halozyme brings is what has -- if you think about just in the last 7 or 8 months, six new ENHANZE deals, we are definitely performing incredibly well in the market, and it comes from that competitive moat that we've created from all of our years of expertise and performance.
因此,Halozyme 所帶來的整體方案——如果你回想過去 7 到 8 個月,我們新增了六筆 ENHANZE 交易——我們在市場上的表現確實非常出色,而這來自於我們多年累積的專業與績效所建立的競爭護城河。
Let me turn it to Darren for acquisition landscape.
我把問題交給 Darren,談談併購環境。
Darren Snellgrove - Chief Financial Officer
Darren Snellgrove - Chief Financial Officer
Yes. Thanks. David, with regards to M&A, we definitely continue to see M&A as an important part of our capital allocation strategy.
好的。謝謝。David,關於併購(M&A),我們確實仍將 M&A 視為資本配置策略的重要一環。
I would say, particularly when we can add differentiated technologies, new capabilities or create future growth platforms. But at the same time, I think you've heard the company say this before, we're very disciplined.
我會說,特別是在我們能夠加入具差異化的技術、新能力,或打造未來成長平台的情況下。但同時,我想你也聽公司以前說過,我們非常自律。
We indicated last quarter that for '26, we're going to really focus on organic growth and M&A is unlikely. But what I would say, the good news is given the strength of our portfolio, the growing cash flows that we have and our improving leverage profile, we really do have flexibility. But again, we remain focused on really on long-term shareholder value.
我們在上一季表示,對於 2026 年,我們將真正聚焦於有機成長,而 M&A 的可能性不高。但我想說的好消息是,鑑於我們產品組合的強勁、現金流持續成長,以及槓桿水準的改善,我們確實具備彈性。不過再次強調,我們仍專注於長期股東價值。
Operator
Operator
Mitchell Kapoor, H.C. Wainwright.
Mitchell Kapoor,H.C. Wainwright。
Amit Dayal - Analyst
Amit Dayal - Analyst
This is Amit again. But I was wondering, as you build out Hypercon manufacturing, how should we think about potential revenue beyond royalties and any incremental investment within the 2026-'28 margins?
我是 Amit,再問一個問題。我想請教,隨著你們擴建 Hypercon 製造能力,我們應該如何看待除權利金之外的潛在營收?以及在 2026 至 2028 年的利潤率中,是否會有任何額外投資?
And for -- you show that you -- or you guide to 13 ENHANZE programs in development by end of 2026 and 13 launches in 2029. I'm just wondering how are you thinking about any potential attrition? Or is that, kind of, built into your assumptions?
另外——你們提到或指引到 2026 年底將有 13 個 ENHANZE 開發中計畫,以及 2029 年有 13 個上市。我想了解你們如何看待可能的淘汰率(attrition)?或者這已經納入你們的假設之中?
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
Yes. Let me talk about the manufacturing first, and maybe I'll begin by sharing why we think it's such an exciting opportunity for us invest in the manufacturing. As you're already hearing, we've got five deals, multiple products are advancing.
是的。我先談製造,並且也許先分享一下為什麼我們認為投資製造對我們而言是如此令人振奮的機會。如你已經聽到的,我們已經有五筆交易,多個產品正在推進。
And we believe that Hypercon is going to become rapidly the same type of compounding platform engine that we have from ENHANZE.
我們相信 Hypercon 將會迅速成為類似 ENHANZE 的那種配方平台引擎。
To speed that up, and to maximize the success of that, Halozyme investing to advance manufacturing is just the right thing to do.
為了加速這一點並最大化其成功,Halozyme 投資推進製造能力是正確之舉。
We'll be able to drive that, control that at our pace and with our expertise. We have not finalized the exact planning around that.
我們將能以我們的步調並運用我們的專業來推動並掌控這件事。我們尚未完成相關的具體規劃。
So I can't share any details on the investment required or the exact business model. But what I can say is that this is going to be very exciting as we contemplate just how much more quickly Hypercon is going to grow to be that $1 billion opportunity compared to ENHANZE. So more to come on that as we finalize our plans.
因此我無法分享所需投資的任何細節或確切的商業模式。但我能說的是,當我們思考 Hypercon 相較於 ENHANZE 將能以多快的速度成長為 10 億美元的機會時,這將會非常令人振奮。待我們完成規劃後,後續會有更多資訊。
With regard to the additional launches, just to just clarify one thing. We anticipate having 13 products in the clinic by the end of this year. In terms of the 2029 number, what we said was we will begin in the launches in 2029, and those will be occurring between '29 and 2033 as an example.
至於額外的上市,我先澄清一點。我們預期在今年底前將有 13 個產品進入臨床。就 2029 年的數字而言,我們的說法是:我們將在 2029 年開始啟動上市,而這些上市將在 2029 年到 2033 年之間發生(例如)。
So there is a series of -- they're occurring over a period of time. Our development time lines generally are 4 to 5 years just to help with that. So not all 13 in 2029, but after that.
因此會是一連串——它們會在一段期間內陸續發生。我們的一般開發時程約為 4 到 5 年,提供你作為參考。所以不是 13 個都在 2029 年,而是從那之後陸續發生。
In terms of the mix of products that we have in that 13 products and very exciting products in their mechanisms of action that some of the products are already commercial, which represent a very high probability of success based on our track record.
就這 13 個產品的組合而言,這些產品在作用機轉上都非常令人振奮;其中一些產品已經商業化,基於我們的實績,成功機率非常高。
Other products are new mechanisms of action, but the majority are antibodies, and we have just got tremendous experience with antibodies, which again, from many aspects gives us confidence in the fact that ENHANZE is going to be very successful in making them into successful subcutaneous products.
其他產品則是新的作用機轉,但大多數是抗體,而我們在抗體方面擁有非常豐富的經驗;這也從多個面向讓我們對 ENHANZE 能夠成功將其轉化為成功的皮下製劑充滿信心。
So a broad range of products in there. Hard to give you specifics on them. But as a body, this ability to have up to 13 additional launches beginning in 2029 is clearly a very exciting additional growth driver that will layer on top of the already launched products.
因此其中涵蓋相當廣泛的產品範圍。很難向你提供具體細節。但整體而言,能夠自 2029 年起開始最多 13 個額外上市,顯然是一個非常令人振奮的額外成長動能,將疊加在既有已上市產品之上。
Operator
Operator
We have reached the end of the Q&A portion, which concludes today's call. Thank you so much for attending. You may now disconnect.
問答環節到此結束,也結束了今天的電話會議。非常感謝各位參與。您現在可以掛線。