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Operator
Operator
Good afternoon. My name is Tiffany, and I will be your conference operator today. At this time, I would like to welcome everyone to Halozyme's third-quarter 2025 financial and operating results conference call. (Operator Instructions) Please note this event is being recorded.
午安.我叫蒂芬妮,今天我將擔任你們的會議接線生。在此,我謹代表Halozyme公司歡迎各位參加2025年第三季財務及營運業績電話會議。(操作說明)請注意,本次活動正在錄影。
I will now turn the call over to Tram Bui, Halozyme's Vice President of Investor Relations and Corporate Communications. Please go ahead.
現在我將把電話轉交給 Halozyme 的投資人關係和企業傳播副總裁 Tram Bui。請繼續。
Tram Bui - Vice President - Investor Relations and Corporate Communications
Tram Bui - Vice President - Investor Relations and Corporate Communications
Thank you, Operator. Good afternoon and welcome to our third-quarter 2025 financial and operating results conference call. In addition to the press release issued today after the market closed, you could find a supplementary slide presentation that will be referenced during today's call in the Investor Relations section of our website.
謝謝接線生。下午好,歡迎參加我們2025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一份補充幻燈片演示文稿,該演示文稿將在今天的電話會議上提及。
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.
本次電話會議將由 Halozyme 總裁兼執行長 Helen Torley 博士主持,她將介紹公司的最新業務狀況;財務長 Nicole LaBrosse 將回顧公司的財務業績以及展望。
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. 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.
在今天的電話會議上,我們將按照投影片 2 中概述的內容做出前瞻性聲明。我還建議您參閱我們向美國證券交易委員會提交的文件,其中列出了所有風險和不確定因素。電話會議期間,我們將討論GAAP和非GAAP財務指標。某些非GAAP或調整後的財務指標已在我們的獲利新聞稿和幻燈片簡報中與相應的GAAP財務指標進行了核對。
I will now turn the call over to Dr. Helen Torley.
現在我將把電話交給海倫·托利博士。
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
Good afternoon, everyone, and thank you for joining us today. I will begin on slide 3. I am very pleased to report another quarter of record royalty revenue of $236 million, representing a remarkable 52% increase year over year, and resulting in total revenue of $354 million, representing 22% growth year over year. These results were driven by the continued momentum of our three established blockbuster subcutaneous therapies: DARZALEX subcutaneous, Phesgo, and VYVGART Hytrulo.
各位下午好,感謝各位今天參加我們的節目。我將從第3張投影片開始。我非常高興地宣布,本季版稅收入再創新高,達到 2.36 億美元,年增 52%,總收入達到 3.54 億美元,年增 22%。這些成果得益於我們三款已上市的重磅皮下療法的持續發展勢頭:DARZALEX 皮下注射劑、Phesgo 和 VYVGART Hytrulo。
Adjusted EBITDA growth exceeded top-line growth, increasing 35% over prior year third quarter to $248 million, reflecting the strength inherent in our royalty-based business model.
經調整的 EBITDA 成長超過了營收成長,比上年同期成長 35% 至 2.48 億美元,反映了我們基於特許權使用費的商業模式的固有優勢。
Our core ENHANZE drug delivery technology continues to drive the significant momentum in our business and reflects a powerful and growing opportunity for subcutaneous delivery to reshape the future of healthcare. ENHANZE can allow treatments that once required lengthy infusions in hospitals or infusion suites to be administered in minutes more conveniently, including in the doctor's office and in the patient's home.
我們的核心 ENHANZE 藥物輸送技術持續推動著我們業務的顯著發展勢頭,並反映了皮下給藥在重塑醫療保健的未來方面擁有強大而不斷增長的機會。ENHANZE 可以讓以前需要在醫院或輸液室進行長時間輸液的治療,在幾分鐘內就能更方便地進行,包括在醫生辦公室和患者家中。
For patients, it means less time spent traveling, fewer invasive procedures, and greater independence, all while maintaining efficacy and safety. At the same time, it is reducing the burden on the healthcare systems, lowering total cost of care, and freeing up capacity in hospitals and infusion centers.
對患者而言,這意味著更少的旅行時間、更少的侵入性手術和更大的獨立性,同時也能維持療效和安全性。同時,它減輕了醫療系統的負擔,降低了醫療總成本,並釋放了醫院和輸液中心的容量。
Turning now to slide 4. Year to date, 13 of the 15 growth catalysts have been achieved, including new product approvals, expanded indications, reaching new regions, and achieving key reimbursement milestones across major markets. These new growth catalysts support our near- and long-term revenue opportunity.
現在請看第4張投影片。今年迄今為止,15項成長催化劑中有13項已經實現,包括新產品獲批、擴大適應症、進入新地區以及在主要市場實現關鍵報銷里程碑。這些新的成長催化劑為我們近期和長期的收入成長提供了支持。
This quarter, there were two notable indication approvals for our two leading growth drivers. Firstly, DARZALEX subcutaneous received European Commission approval for a new indication in smoldering multiple myeloma, providing another meaningful growth catalyst for the franchise.
本季度,我們兩大主要成長驅動因素均獲得了兩項重要的適應症批准。首先,DARZALEX 皮下注射劑獲得了歐盟委員會的批准,用於治療冒煙型多發性骨髓瘤,為該系列產品提供了另一個重要的成長催化劑。
Smouldering multiple myeloma is a precursor condition to active multiple myeloma, expanding DARZALEX subcutaneous reach into a new early disease stage patient population and potentially increasing treatment duration and the lifetime value per patient.
冒煙型多發性骨髓瘤是活動性多發性骨髓瘤的前兆,這使得 DARZALEX 皮下注射療法能夠應用於新的早期疾病階段患者群體,並有可能延長治療持續時間和提高每位患者的終身價值。
And the second indication was argenx's VYVDURA pre-filled syringe within hands, approved in Japan for self-injection for generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy. Delivered as a once-weekly, 30- to 90-second subcutaneous injection, VYVDURA can be self-administered at home, eliminating the need for lengthy infusions in clinical settings.
第二個適應症是 argenx 的 VYVDURA 預充式註射器,該注射器已在日本獲準用於治療全身性重症肌無力和慢性發炎性脫髓鞘性多發性神經病變,可自行注射。VYVDURA 每週只需皮下注射一次,每次注射時間為 30 至 90 秒,患者即可在家中自行注射,無需在臨床環境中進行長時間輸液。
The pre-filter rinse with ENHANZE is a key enabler of broader adoption because it simplifies administration, reduces treatment burden, and potentially enhances patient adherence. Rounding out the 15 growth catalysts, we project two additional meaningful US approvals this year, one for DARZALEX subcutaneous and smouldering multiple myeloma, and the second for RYBREVANT subcutaneous in EGFR-mutated non-small cell lung cancer.
使用 ENHANZE 進行預過濾沖洗是更廣泛應用的關鍵推動因素,因為它簡化了給藥過程,減輕了治療負擔,並有可能提高患者的依從性。最後,我們預計今年美國還將有兩項重要的藥物獲批,一項是用於治療冒煙型多發性骨髓瘤的皮下注射藥物 DARZALEX,另一項是用於治療 EGFR 突變型非小細胞肺癌的皮下注射藥物 RYBREVANT。
I'll move now to slide 5. Driven by the continued strong performance of our core enhanced technology, we are pleased to rate our full year 2025 guidance ranges. Driven by royalty revenue, we now project total revenue of $1.3 billion to $1.375 billion, reflecting 28% to 35% growth over 2024.
現在我來看第5張投影片。由於我們核心增強技術的持續強勁表現,我們很高興對 2025 年全年業績預期範圍進行評估。受特許權使用費收入的推動,我們現在預計總收入將達到 13 億美元至 13.75 億美元,比 2024 年增長 28% 至 35%。
Royalty revenue is now expected to go 49% to 54% to $850 million to $880 million for the full year. Primarily driven by our three established blockbuster subcutaneous therapies, DARZALEX subcutaneous, Phesgo, and VYVGART Hytrulo with ENHANZE.
預計全年特許權使用費收入將成長 49% 至 54%,達到 8.5 億美元至 8.8 億美元。主要得益於我們三款已上市的重磅皮下療法:DARZALEX 皮下注射、Phesgo 和 VYVGART Hytrulo with ENHANZE。
We now anticipate adjusted EBITDA of between $885 million and $935 million, representing year-over-year growth of 40% to 48%. And we expect non-GAAP diluted earnings for sure of $6.10 to $6.50, representing year over year growth of 44% to 54%.
我們現在預計調整後的 EBITDA 將在 8.85 億美元至 9.35 億美元之間,年增 40% 至 48%。我們預計非GAAP稀釋後收益將達到6.10美元至6.50美元,年增44%至54%。
Moving now to slide 6. Recently, we announced the acquisition of Elektrofi, furthering our vision to enable at-home administration of biologic therapies. This strategic move supports our ambition to expand our portfolio of drug delivery technologies. With Elektrofi's innovative technology, we aim to extend subcutaneous delivery to a broader range of biologics, reinforcing our focus on patient-centric drug delivery technology solutions.
現在來看第6張投影片。最近,我們宣布收購 Elektrofi,進一步實現了我們讓生物療法能夠在家中進行治療的願景。這項策略舉措符合我們擴大藥物傳輸技術組合的願景。借助 Elektrofi 的創新技術,我們旨在將皮下給藥擴展到更廣泛的生物製劑,從而加強我們對以患者為中心的藥物傳輸技術解決方案的關注。
By applying Elektrofi's Hypercon technology, concentrations of 400 to 500 milligrams per mL, or as much as four to five times higher than many current conventional formulations, can now be achieved. This breakthrough technology will enable more drugs to be delivered at home via autoinjector. A treatment option we know is of high interest and demand for pharma and biotech companies, particularly those working in inflammation and immunology, neurology, nephrology, and oncology.
透過應用 Elektrofi 的 Hypercon 技術,現在可以達到每毫升 400 至 500 毫克的濃度,比許多目前的傳統配方高出四到五倍。這項突破性技術將使更多藥物能夠透過自動注射器在家中給藥。我們知道,這種治療方案引起了製藥和生物技術公司的極大興趣和需求,尤其是那些從事發炎和免疫學、神經病學、腎臟病學和腫瘤學研究的公司。
By bringing together now three innovative drug delivery technology solutions, ENHANZE, our auto-injectors, and Hypercon, we will create a new commercial opportunity for our partners and further strengthen Halozyme's role as the partner of choice in patient-centered drug delivery, expanding our long-term growth horizon.
透過將 ENHANZE(我們的自動注射器)和 Hypercon 這三項創新的藥物輸送技術解決方案整合在一起,我們將為我們的合作夥伴創造新的商業機會,並進一步鞏固 Halozyme 作為以患者為中心的藥物輸送領域首選合作夥伴的地位,從而拓展我們的長期增長前景。
Moving now to slide 7. Importantly, Hypercon is at a value inflection point. The three-partner agreements in place have resulted in two products projected to enter the clinic and begin clinical development of the Hypercon formulation by the end of 2026 or earlier. Each of these two products, as a different formulation, is already approved and has achieved blockbuster sales already. With Halozyme's established expertise in subcutaneous drug delivery, we are well-positioned to identify opportunities to accelerate the time to approval and to unlock significant new revenue potential through advancing new nominations and signing new agreements.
現在來看第7張投影片。重要的是,Hypercon 正處於價值轉折點。目前已有三方合作協議,預計將有兩款產品進入臨床試驗,並於 2026 年底或更早開始 Hypercon 配方的臨床開發。這兩種產品,配方不同,都已獲得批准,並且都取得了巨大的銷售成功。憑藉 Halozyme 在皮下給藥領域的成熟專業知識,我們能夠更好地發現加快審批速度的機會,並透過推進新的提名和簽署新的協議來釋放巨大的新收入潛力。
The addition of Elektrofi's Hypercon technology further enhances our offerings, enabling us to provide best-in-class solutions and maintain strong momentum in transforming the subcutaneous delivery landscape.
Elektrofi 的 Hypercon 技術的加入進一步增強了我們的產品,使我們能夠提供一流的解決方案,並在改變皮下給藥格局方面保持強勁勢頭。
Now, let me move to slide 8, where I will review our current growth drivers for the quarter. Let me begin with DARZALEX, which continued its exceptional performance this quarter. Sales for DARZALEX increased 20% on an operational basis to $3.7 billion, primarily driven by the continued strong share gains of approximately 5.7 points across all lines of therapy, and nearly 9 points in the frontline setting, as well as through market growth. This marks the seventh consecutive quarter of frontline growth of five or more points, underscoring the continued momentum of the brand.
現在,讓我轉到第 8 張投影片,我將回顧我們本季目前的成長驅動因素。首先我想談談DARZALEX,該公司本季繼續保持了其卓越的表現。DARZALEX 的銷售額按營運基礎計算增長了 20%,達到 37 億美元,這主要得益於其在所有治療領域持續強勁的市場份額增長(約 5.7 個百分點),以及一線治療領域近 9 個百分點的增長,同時也得益於市場增長。這標誌著該品牌連續第七個季度實現一線銷售成長五個百分點以上,凸顯了其持續的成長動能。
With 96% share of sales resulting from the subcutaneous formulation with ENHANZE in the United States and more than 90% global subcutaneous share, ENHANZE is bringing value to patients earlier in treatment as they live longer on therapy. DARZALEX is, and we project will remain, the gold standard of treatment for multiple myeloma, holding more than 50% market share across all lines of therapy.
在美國,ENHANZE 皮下注射劑的銷售額佔比高達 96%,全球皮下注射劑的市佔率超過 90%,ENHANZE 讓患者在治療早期就能獲得價值,延長了他們的治療壽命。DARZALEX 是,而且我們預計它仍將是多發性骨髓瘤治療的黃金標準,在所有治療領域都佔據超過 50% 的市場份額。
And there are two additional new catalysts that are projected to continue the strength of DARZALEX subcutaneous. These include the recent European Commission approval of DARZALEX subcutaneous for patients with high-risk smoldering multiple myeloma, which occurred in July, and it marked the first approved treatment for this early stage of the disease. We also anticipate potential US approval for smouldering multiple myeloma following the FDA's favorable vote on the risk-benefit profile earlier this year.
此外,還有兩種新的催化劑預計將繼續增強 DARZALEX 皮下注射劑的療效。其中包括歐盟委員會最近於 7 月批准 DARZALEX 皮下注射劑用於治療高風險冒煙型多發性骨髓瘤患者,這標誌著該疾病早期階段的首個獲批療法。我們也預計,在今年稍早 FDA 對該藥物的風險效益比投贊成票後,該藥物可能會獲得美國批准用於治療冒煙型多發性骨髓瘤。
And separately, Johnson & Johnson reported positive top-line results from the Phase 3 MajesTEC-3 study, which further validated the role of DARZALEX FASPRO in later lines of multiple myeloma treatment. The combination with Tecvalli and DARZALEX FASPRO in relapsed refractory multiple myeloma demonstrated at a planned interim analysis is statistically significant improvement in both progression-free survival and overall survival when compared to standard of care for patients who had received one to three prior lines of treatment, highlighting once again the clinical value of DARZALEX FASPRO with ENHANZE.
此外,強生公司也發表了 3 期 MajesTEC-3 研究的正面初步結果,進一步驗證了 DARZALEX FASPRO 在多發性骨髓瘤後期治療中的作用。在計畫的中期分析中,Tecvalli 與 DARZALEX FASPRO 聯合用於治療復發難治性多發性骨髓瘤,與接受過一至三線治療的患者的標準治療相比,在無進展生存期和總生存期方面均有統計學意義上的顯著改善,再次凸顯了 DARZALEX FASPRO 與 ENHANZE 的臨床價值。
These milestones add to the growing list of approvals and clinical successes that continues to expand the reach of DARZALEX subcutaneous and to support analyst projections for the brand to reach more than $18 billion in 2028. And Halozyme will continue to earn royalties on the subcutaneous formulation of DARZALEX through 2032.
這些里程碑事件進一步擴大了 DARZALEX 皮下注射劑的核准數量和臨床成功案例,也支持了分析師對該品牌在 2028 年銷售額將超過 180 億美元的預測。Halozyme 將繼續從 DARZALEX 皮下製劑中獲得特許權使用費,直至 2032 年。
Let me move now to PHESGO, which is shown on slide 9. PHESGO continues to be Roche's number one growth driver with nine-month revenue of CHF1.8 billion, or approximately $2.3 billion, reflecting a 54% year-over-year increase. In the third quarter, the increasing conversion from intravenous Perjeta and Herceptin reached 51% in 78 launch countries, up five points from the prior quarter.
現在讓我來看看幻燈片 9 中顯示的 PHESGO。PHESGO 繼續成為羅氏最大的成長驅動力,前九個月的營收為 18 億瑞士法郎,約合 23 億美元,較去年同期成長 54%。第三季度,在 78 個上市國家/地區,從靜脈注射 Perjeta 和 Herceptin 轉為口服藥物的比例增長至 51%,比上一季度增長了 5 個百分點。
Conversion of Perjeta to PHESGO is now projected to achieve 60%, increasing from the prior 50% peak conversion, and this is driven by the strong value proposition. We are pleased with PHESGO's growing adoption, with royalties secured at the full mid-single-digit rate through 2030.
Perjeta 向 PHESGO 的轉換率預計將達到 60%,高於先前 50% 的峰值轉換率,這主要得益於其強大的價值主張。我們對 PHESGO 的日益普及感到滿意,並且已確保到 2030 年都能獲得全額中等個位數費率的版稅。
I'll turn now to VYVGART, which is shown on slide 10. VYVGART Hytrulo continues to be a key driver of the exceptional growth of the VYVGART franchise, with total sales of VYVGART increasing 96% year over year in the third quarter to $1.13 billion. The subcutaneous formulation enabled by ENHANZE has been instrumental in expanding access to new prescribers and patients across both approved indications of generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy.
現在我將轉向 VYVGART,它顯示在投影片 10 中。VYVGART Hytrulo 繼續成為 VYVGART 特許經營業務卓越成長的關鍵驅動力,VYVGART 第三季總銷售額年增 96%,達到 11.3 億美元。ENHANZE 的皮下製劑在擴大重症肌無力和慢性發炎性脫髓鞘性多發性神經病變這兩種已批准適應症的新處方醫生和患者的使用範圍方面發揮了重要作用。
Supporting both of these indications, the pre-filled syringe with ENHANZE, which was launched in April of 2025, is now approved in most major markets. By enabling self-injection in just 20 to 30 seconds, whether at home, in the clinic, or while traveling, this innovation has expanded access to new patient populations, simplified treatment logistics, and accelerated adoption in earlier lines of treatment for both gMG and CIDP.
為支持這兩種適應症,含有 ENHANZE 的預充式註射器於 2025 年 4 月推出,目前已在大多數主要市場獲得批准。這項創新使得患者無論是在家、在診所還是在旅行途中,只需 20 到 30 秒即可完成自我注射,從而擴大了新患者群體的治療範圍,簡化了治療流程,並加速了 gMG 和 CIDP 早期治療方案的採用。
The prefilled syringe has expanded the number of prescribers by 260 physicians, opening up new pockets of patients in gMG and CIDP. With approximately 50% of patients using the prefilled syringe who are new to VYVGART, argenx stated that this is still the beginning of the growth curve for both indications.
預充式註射器使處方醫生的數量增加了 260 名,為重症肌無力和慢性發炎性脫髓鞘性多發性神經病變開闢了新的患者群體。argenx 表示,使用預充式註射器的患者中約有 50% 是 VYVGART 的新用戶,這仍然只是這兩個適應症成長曲線的開始。
argenx also stated that they project VYVGART's total addressable gMG market could ultimately approach approximately 60,000 patients globally versus roughly 17,000 at launch as the biologic opportunity expands and with the future potential addition of ocular and seronegative patient populations.
argenx 也表示,他們預計 VYVGART 的 gMG 潛在市場最終可能達到全球約 60,000 名患者,而上市之初約為 17,000 名患者,這是因為生物製劑的機會擴大了,並且未來可能還會增加眼部和血清陰性患者群體。
I'll turn now to the CIDP indication. argenx commented that they are seeing consistent growth in both patient start and prescriber engagement driven by physician trust in the safety profile of VYVGART Hytrulo and its ability to deliver meaningful functional improvements. The pre-filled syringe is driving additional demand, offering convenience of self-injection and enabling flexible administration. 85% of CIDP patients are switching from IVIG and there is also early adoption amongst treatment-naive patients.
接下來我將討論CIDP適應症。 argenx公司表示,由於醫生對VYVGART Hytrulo的安全性及其顯著改善功能的能力充滿信心,患者起始用藥量和處方醫生參與度均持續增長。預充式註射器因其方便患者自行注射且給藥方式靈活,正在推動市場需求成長。 85%的慢性發炎性脫髓鞘性多發性神經病變(CIDP)患者已從靜脈注射免疫球蛋白(IVIG)轉為使用預充式註射器,且初治患者也開始早期接受這種療法。
argenx believes they are at the beginning of the growth curve for CIDP and that they will see continued expansion of the prescriber base. VYVGART Hytrulo's strong commercial success, growing approvals, launches in gMG and CIDP, and plans to expand its autoimmune disease indication footprint represent a compelling royalty growth opportunity for Halozyme.
Argenx 認為他們正處於 CIDP 成長曲線的開端,並且他們會看到處方醫生群體持續擴大。VYVGART Hytrulo 強大的商業成功、不斷增長的批准、在 gMG 和 CIDP 中的上市,以及擴大其自身免疫性疾病適應症範圍的計劃,為 Halozyme 帶來了極具吸引力的特許權使用費增長機會。
We project VYVGART Hytrulo will be a durable contributor to our long-term financial performance, with analysts projecting total VYVGART sales of $7.7 billion in myasthenia gravis and CIDP in 2028, and with Halozyme earning royalties through the early 2040s.
我們預計 VYVGART Hytrulo 將成為我們長期財務表現的持久貢獻者,分析師預測 VYVGART 在重症肌無力和 CIDP 治療方面的總銷售額將在 2028 年達到 77 億美元,而 Halozyme 將在 2040 年代初獲得特許權使用費。
It is truly remarkable how only these three products I've just described, DARZALEX subcutaneous, PHESGO, and VYVGART Hytrulo, are driving our 52% year-over-year growth in royalty revenue this quarter and will have continued growth opportunity for years to come.
真正令人驚嘆的是,我剛剛描述的這三種產品——DARZALEX 皮下注射劑、PHESGO 和 VYVGART Hytrulo——推動了我們本季度特許權使用費收入同比增長 52%,並且在未來幾年內還將有持續增長的機會。
Moving now to slide 11, I'll review the progress of our recently launched products, which will begin to contribute meaningfully in 2026, beginning with OCREVUS. Roche reported continued strong momentum for OCREVUS, which represented CHF5.2 billion, or approximately $6.5 billion, up 7% for the first nine months of 2025.
現在轉到第 11 張投影片,我將回顧我們最近推出的產品的進展情況,這些產品將於 2026 年開始做出有意義的貢獻,首先是 OCREVUS。羅氏公司報告稱,OCREVUS 持續保持強勁勢頭,2025 年前九個月銷售額達 52 億瑞士法郎(約 65 億美元),成長 7%。
The company reaffirmed its expectation for high single-digit growth of OCREVUS this year. OCREVUS ZUNOVO, which utilizes our enhanced technology, received approval in 2024 and offers a rapid 10-minute subcutaneous injection, a significant improvement over the multi-hour intravenous administration and monitoring process.
該公司重申了對 OCREVUS 今年實現高個位數成長的預期。OCREVUS ZUNOVO 採用我們增強的技術,於 2024 年獲得批准,可快速進行 10 分鐘皮下注射,與數小時的靜脈注射和監測過程相比,這是一個顯著的改進。
The subcutaneous formulation of OCREVUS is a key growth driver for Roche's neurology franchise. It enables penetration into community neurology practices and rural areas where IV infusion capacity is limited, which unlocks access to previously underserved patient populations. More than 12,500 patients are now on the subcutaneous formulation globally, representing more than a 75% increase from the 7,000 patients receiving subcutaneous OCREVUS that we reported last quarter.
OCREVUS 的皮下製劑是羅氏神經病學業務的關鍵成長驅動力。它能夠滲透到社區神經科診所和靜脈輸液能力有限的農村地區,從而為以前服務不足的患者群體提供醫療服務。目前全球已有超過 12,500 名患者使用皮下製劑,比上季報告的 7,000 名接受皮下注射 OCREVUS 的患者增加了 75% 以上。
Uptake is also increasing in the United States, following the permanent J-code which was granted on April 1st, which is simplifying reimbursement and enabling broader adoption. In the United States, approximately 800 healthcare providers are now prescribing OCREVUS ZUNOVO with ENHANZE, and 60% of the subcutaneous volume is coming from community practices, demonstrating strong traction outside the traditional site of academic centers.
在美國,隨著4月1日永久性J代碼的授予,報銷流程簡化,推廣應用,技術的普及率也不斷提高。在美國,目前約有 800 名醫療保健提供者正在開立 OCREVUS ZUNOVO with ENHANZE 處方,其中 60% 的皮下注射量來自社區診所,這表明該藥物在傳統學術中心之外也獲得了強勁的市場認可。
50% of OCREVUS renewable patients are new to brand, indicating market expansion beyond IV conversions. In early launch countries like Germany, similar trends are being observed, reinforcing the enhanced formulation's ability to grow the overall OCREVUS patient base. Roche anticipates the subcutaneous formulation to represent an incremental $2 billion opportunity, while analysts predict the total OCREVUS brand opportunity will reach $10 billion by 2028.
50% 的 OCREVUS 再生患者是首次使用該品牌,這表明市場已擴展到靜脈輸液以外的領域。在德國等早期上市國家,也觀察到了類似的趨勢,這進一步證實了增強配方能夠擴大 OCREVUS 患者群體的整體規模。羅氏預計皮下製劑將帶來 20 億美元的增量市場機會,而分析師預測,到 2028 年,OCREVUS 品牌的總市場機會將達到 100 億美元。
We're pleased with how OCREVUS ZUNOVO powered by our ENHANZE technology is transforming the multiple sclerosis treatment landscape with its rapid 10-minute subcutaneous delivery, unlocking new patient access, accelerating adoption across community practices, and driving meaningful franchise growth. Halozyme will earn royalties on the subpoenas formulation at the full mid-single-digit royalty rate through 2030 and at a step-down rate until at least 2034.
我們很高興看到,採用我們 ENHANZE 技術的 OCREVUS ZUNOVO 正在改變多發性硬化症的治療格局,它只需 10 分鐘即可快速皮下注射,從而為新患者打開了治療渠道,加速了社區診所的採用,並推動了有意義的特許經營增長。Halozyme 將從傳票配方中獲得版稅,從 2030 年起按全額個位數中段版稅率計算,之後至少到 2034 年按遞減稅率計算。
Let me turn now to Roche's Tecentriq Hybreza with ENHANZE. Tecentriq Hybreza was approved in the United States and Europe in 2024 for all of the IV indications, offering patients and providers a more convenient seven-minute subcutaneous injection. Roche has stated its strategy is to drive conversion from IV to subcutaneous use.
現在讓我來談談羅氏的 Tecentriq Hybreza with ENHANZE。Tecentriq Hybreza 於 2024 年在美國和歐洲獲準用於所有靜脈注射適應症,為患者和醫護人員提供了一種更方便的七分鐘皮下注射方式。羅氏公司已明確表示,其策略是推動從靜脈注射到皮下注射的轉變。
Tecentriq generated CHF2.6 billion in revenue for the first nine months of 2025, or approximately $3.3 billion. And analysts project revenue of approximately $4.5 billion by 2028. Halozyme earns royalties and net sales of the subcutaneous formulation at the full mid-single-digit rate through the 2040s, underscoring the long-term value of this partnership.
Tecentriq 在 2025 年前九個月創造了 26 億瑞士法郎的收入,約 33 億美元。分析師預測,到 2028 年,公司營收將達到約 45 億美元。Halozyme 將在 2040 年代以中等個位數的成長率獲得皮下製劑的特許權使用費和淨銷售額,這凸顯了該合作關係的長期價值。
Let me move now to Bristol Myers Squibb's Opdivo. In the third quarter, global Opdivo sales reached approximately $2.5 billion, reflecting a 6% year-over-year increase driven primarily by strong demand. The US launch of Opdivo Qvantig with ENHANZE is progressing well, with growth fueled by the continued use of Opdivo Qvantig across all of the indicated tumor types, as well as the permanent J-code, which was received in the quarter.
現在讓我來談談百時美施貴寶公司的Opdivo。第三季度,Opdivo 全球銷售額達到約 25 億美元,較去年同期成長 6%,主要得益於強勁的需求。Opdivo Qvantig 與 ENHANZE 在美國的上市進展順利,成長得益於 Opdivo Qvantig 在所有適應症腫瘤類型中的持續使用,以及本季獲得的永久性 J 代碼。
Sales in the third quarter were $67 million, a doubling from $30 million in the second quarter. Opdivo Qvantig offers the convenience of a three to five-minute subcutaneous administration and the flexibility of outpatient infusion, features that are driving growing adoption among both patients and providers across all of the indicated tumor types.
第三季銷售額為 6,700 萬美元,比第二季的 3,000 萬美元翻了一番。Opdivo Qvantig 具有皮下注射只需 3 到 5 分鐘的便利性以及門診輸注的靈活性,這些特點正在推動其在所有適應症腫瘤類型中得到越來越廣泛的應用,患者和醫療服務提供者都對其青睞有加。
Based on the strong year-to-date performance of Opdivo and Opdivo Qvantig, BMS now expects stronger growth than previously guided, with sales expected in the high single-digit to the low double-digit range for the full year. Analyst forecasts total brand sales of $9.1 billion by 2028.
鑑於 Opdivo 和 Opdivo Qvantig 今年迄今的強勁表現,BMS 現在預計成長將比之前預期的更為強勁,全年銷售額預計將達到個位數高點至兩位數低點。分析師預測,到 2028 年,該品牌的總銷售額將達到 91 億美元。
And let me move now to RYBREVANT. RYBREVANT continues to demonstrate strong growth. In the third quarter, Johnson & Johnson reported total RYBREVANT IV and SC revenue of $198 million, reflecting triple-digit year-over-year growth. The European approval of RYBREVANT subcutaneous with ENHANZE in April marks RYBREVANT's 10th commercialized partner product and is a key milestone in our global expansion.
現在讓我來談談 RYBREVANT。RYBREVANT 持續保持強勁成長動能。第三季度,強生公司報告稱,RYBREVANT IV 和 SC 的總收入為 1.98 億美元,年增三位數。RYBREVANT 與 ENHANZE 聯合皮下注射劑於 4 月獲得歐洲批准,這標誌著 RYBREVANT 的第十個商業化合作夥伴產品,也是我們全球擴張的一個重要里程碑。
The subcutaneous delivery of ENHANZE provides the strong efficacy profile of IV RYBREVANT, while reducing administration time from multiple hours to just minutes and results in a five-fold reduction in the potentially serious adverse event of infusion-related reactions when compared to the IV formulation. J&J's strategy to simplify treatment and enhance patient convenience is resonating with physicians for use in combination with lazertinib in the first-line treatment of adult patients with advanced EGFR-mutated non-small-cell lung cancer and for the same population following failure of a platinum-based regimen.
皮下注射 ENHANZE 可達到 IV RYBREVANT 的強效療效,同時將給藥時間從數小時縮短至數分鐘,與 IV 製劑相比,輸注相關反應等潛在嚴重不良事件的發生率降低了五倍。強生公司簡化治療、提高患者便利性的策略引起了醫生的共鳴,他們考慮將該藥物與拉澤替尼聯合用於一線治療晚期 EGFR 突變非小細胞肺癌成年患者,以及用於鉑類方案治療失敗後的同類患者。
RYBREVANT is an important brand for Johnson & Johnson, who are continuing to invest in clinical studies to demonstrate the full potential. Recently published results in the New England Journal of Medicine from the Phase 3 MARIPOSA study reported that RYBREVANT significantly reduced the risk of death when compared to osimertinib, which is the current standard of care in EGFR-mutated non-small cell lung cancer.
RYBREVANT 是強生公司旗下的重要品牌,該公司將繼續投資臨床研究,以證明其全部潛力。最近發表在《新英格蘭醫學雜誌》上的 MARIPOSA 3 期研究結果顯示,與目前 EGFR 突變型非小細胞肺癌的標準療法奧希替尼相比,RYBREVANT 顯著降低了死亡風險。
Recall, osimertinib is marketed as TAGRISSO by AstraZeneca and generated $6.6 billion in global revenue in 2024, which underscores the potential commercial opportunity for RYBREVANT. And at ESMO 2025, Johnson & Johnson also presented new data in a different high-end-need patient population from the OrigAMI-4 studies, showing that subcutaneous amivantamab enabled by ENHANZE achieved a 45% overall response rate in patients with recurrent or metastatic head and neck cancer. These results could mark a turning point in the treatment paradigm and certainly could provide further support for Johnson & Johnson's statements that Ribrovent will be a $5 billion product.
回想一下,奧希替尼由阿斯特捷利康公司以泰瑞沙(TAGRISSO)的商品名銷售,2024 年在全球創造了 66 億美元的收入,這凸顯了 RYBREVANT 的潛在商業機會。在 2025 年 ESMO 大會上,強生公司也公佈了 OrigAMI-4 研究中針對不同高端需求患者群體的新數據,結果顯示,ENHANZE 支持的皮下注射阿米萬他單抗在復發性或轉移性頭頸癌患者中實現了 45% 的總體緩解率。這些結果可能標誌著治療模式的轉折點,並且肯定會進一步支持強生公司關於Ribrovent將成為一款價值50億美元的產品的說法。
Dimentalizing all of the opportunity for Halozyme are three blockbusters that are driving today's strong growth. DARZALEX, PHESGO, and VYVGART represent an approximately $30 billion in TAM opportunity in 2028. What is very exciting is that these newer launches I've just described also represent an additional approximately $30 billion in opportunity in 2028.
充分挖掘 Halozyme 的所有機遇,主要歸功於三款重磅產品,它們正在推動公司目前的強勁成長。DARZALEX、PHESGO 和 VYVGART 代表 2028 年約 300 億美元的市場規模。令人興奮的是,我剛剛描述的這些新推出的產品,到 2028 年還將帶來約 300 億美元的額外機會。
With the recent approvals, our total opportunity doubled, setting the stage for our strong continued royalty revenue performance. Our portfolio of 10 launch products is well-positioned to deliver $1 billion in annual revenue in 2027. And this milestone reflects the strength of our long-term strategy and our partnerships. Importantly, we anticipate sustained royalty contributions from all products through at least 2030, with several extending into the 2040s, ensuring a robust and durable revenue stream.
隨著近期各項審批的通過,我們的總機會翻了一番,為我們持續強勁的特許權使用費收入表現奠定了基礎。我們擁有 10 款上市產品,預計在 2027 年實現 10 億美元的年收入。這一里程碑體現了我們長期策略和合作夥伴關係的優勢。重要的是,我們預計所有產品至少到 2030 年都將持續獲得特許權使用費收入,其中一些產品的收入還將持續到 2040 年代,從而確保穩健持久的收入來源。
Let me turn now to slide 12, and I'll review the development opportunities that are not reflected in our royalty revenue projections today. We have eight programs that are currently in various stages of clinical development, with two additional programs anticipated. Among the most advanced opportunities are Bristol Myers Squibb's subcutaneous Nivolumab with Relatlimab and Takeda's TAK-881, both of which are in Phase 3 development. These programs represent potential new royalty growth opportunities beyond what is currently reflected in our forecast through 2028.
現在讓我翻到第 12 張投影片,我將回顧目前我們的特許權使用費收入預測中尚未反映出的發展機會。我們目前有八個項目處於不同的臨床開發階段,另有兩個項目正在籌備中。其中最先進的機會包括百時美施貴寶的皮下注射藥物Nivolumab合併Relatlimab以及武田的TAK-881,這兩項藥物均處於3期臨床開發階段。這些項目代表著潛在的新的特許權使用費成長機會,超出了我們目前到 2028 年的預測。
And let me now turn to our progress in new deals. I have said before that we will sign a new ENHANZE agreement this year and remain confident that we will. This confidence is supported by the state of the discussions we are having and the proximity to finalization. Interest in ENHANZE is strong as more companies seek meaningful competitive differentiation. And on our two development auto-injector agreements, I am pleased to say we are making progress and project completion of planned human factor studies by mid-2026.
現在讓我談談我們在新交易方面的進展。我之前說過,我們今年將簽署新的ENHANZE協議,並且仍然對此充滿信心。這種信心源自於我們目前的討論進度以及即將達成最終協議。隨著越來越多的公司尋求有意義的競爭差異化,人們對ENHANZE的興趣日益濃厚。關於我們的兩項自動注射器開發協議,我很高興地告訴大家,我們正在取得進展,計劃在 2026 年年中完成人體因素研究專案。
With that, let me now turn the call over to Nicole
那麼,現在就讓我把電話交給妮可吧。
Nicole Labrosse - Chief Financial Officer, Senior Vice President
Nicole Labrosse - Chief Financial Officer, Senior Vice President
Thank you, Helen. Our strong third quarter performance continues to reflect the momentum of our core enhanced technology. Total quarterly revenues grew by approximately 22% to $354 million, with royalty revenue increasing 52% to $236 million. Suggested EBITDA grew 35%, outpacing top-line growth and showcasing the exceptional leverage of our high-margin royalty-driven model.
謝謝你,海倫。我們強勁的第三季業績繼續反映了我們核心增強型技術的良好發展勢頭。季度總收入成長約 22% 至 3.54 億美元,其中特許權使用費收入成長 52% 至 2.36 億美元。建議 EBITDA 成長 35%,超過了營收成長,展現了我們高利潤率特許權使用費驅動模式的卓越槓桿作用。
Let me start on slide 13. We continue to generate robust cash flow, which supports our balanced capital allocation priorities. Year-to-date, we repurchased $342 million of shares, with $158 million remaining under the current authorized plan. Since 2019, we have returned approximately $1.9 billion to shareholders through repurchases. representing greater than 100% of cumulative free cash flow over that period.
讓我們從第13張投影片開始。我們持續產生強勁的現金流,這為我們均衡的資本配置策略提供了支持。今年迄今為止,我們已回購了價值 3.42 億美元的股票,根據目前的授權計劃,還剩下 1.58 億美元。自 2019 年以來,我們已透過股票回購向股東返還了約 19 億美元,相當於該期間累計自由現金流的 100% 以上。
We have a strong balance sheet with cash, cash equivalents, and marketable securities of $702 million on September 30, 2025, compared to $596.1 million on December 31, 2024. The increase is driven by an increase in cash generated from operations, primarily offset by share repurchases.
截至 2025 年 9 月 30 日,我們的資產負債表穩健,現金、現金等價物及有價證券為 7.02 億美元,截至 2024 年 12 月 31 日為 5.961 億美元。這一成長主要得益於經營活動產生的現金增加,但主要被股票回購所抵銷。
Our net debt to EBITDA ratio was 0.9 times at the end of the third quarter. As Helen mentioned, we announced our acquisition of Elektrofi in the third quarter, a transaction that strengthens our leadership in drug delivery and complements our strong organic growth opportunities. We are pleased that the acquisition is expected to have a minimal increase in our net leverage, estimated to be at approximately 2 times net debt to EBITDA at closing. Our goal is to de-lever in the subsequent quarters supported by our robust free cash flows.
第三季末,我們的淨負債與 EBITDA 比率為 0.9 倍。正如海倫所提到的,我們在第三季宣布收購了 Elektrofi,這項交易鞏固了我們在藥物輸送領域的領先地位,並補充了我們強大的內生成長機會。我們很高興此次收購預計只會使我們的淨槓桿率略有增加,預計在交易完成時淨債務與 EBITDA 的比率約為 2 倍。我們的目標是在接下來的幾個季度裡,借助強勁的自由現金流,降低槓桿率。
Let me now turn to our detailed third quarter results on slide 14. Total revenue grew 22% to $354.3 million compared to $290.1 million in the prior year period. Royalty revenue of $236 million increased by 52% from $155.1 million in the prior year period. The commercial success of subsidiaries DARZALEX, PHESGO, and VYVGART Hytrulo continue to drive robust royalty revenue growth.
現在讓我翻到第 14 頁,詳細介紹一下我們第三季的業績。總營收成長 22%,達到 3.543 億美元,而去年同期為 2.901 億美元。特許權使用費收入為 2.36 億美元,比去年同期的 1.551 億美元成長了 52%。子公司 DARZALEX、PHESGO 和 VYVGART Hytrulo 的商業成功持續推動特許權使用費收入的強勁成長。
Product sales of $94.2 million increased by 9% from $86.7 million in the prior year period, mainly driven by the contribution from proprietary product sales. Collaboration revenues of $24 million compared to $48.4 million in the prior year period. The difference was primarily due to the timing of milestones achieved.
產品銷售額為 9,420 萬美元,比去年同期的 8,670 萬美元成長了 9%,主要得益於自有產品銷售額的成長。合作收入為 2,400 萬美元,而去年同期為 4,840 萬美元。主要差異在於達成里程碑的時間節點不同。
Research and development expenses were $17.3 million compared to $18.5 million in the prior year period. The decrease was primarily due to lower compensation expense driven by resource optimization and labor allocation initiatives. by the timing of planned investments in ENHANZE related to the development of our new high-yield rHuPH20 manufacturing process.
研發費用為 1,730 萬美元,而去年同期為 1,850 萬美元。下降的主要原因是資源優化和勞動力分配措施帶來的薪酬支出減少,以及與開發我們新的高產率 rHuPH20 生產流程相關的 ENHANZE 計畫投資的時間表。
Selling general and administrative expenses were $46.1 million, up from $41.2 million in the prior year period, primarily due to increased consulting and professional service fees, partially offset by compensation expense.
銷售一般及行政費用為 4,610 萬美元,高於去年同期的 4,120 萬美元,主要原因是諮詢和專業服務費增加,部分被薪酬支出抵銷。
Adjusted EBITDA increased by 35% to $248.2 million from $183.6 million in the prior year.
調整後 EBITDA 成長 35%,從上年的 1.836 億美元增至 2.482 億美元。
GAAP diluted earnings per share was $1.43 and non-GAAP diluted earnings per share was $1.72. This is compared with GAAP diluted earnings per share of $1.05 and non-GAAP diluted earnings per share of $1.27 in the third quarter of 2024.
以美國通用會計準則計算,稀釋後每股收益為 1.43 美元,以非美國通用會計準則計算,稀釋後每股收益為 1.72 美元。相較之下,2024 年第三季以美國通用會計準則計算,稀釋後每股收益為 1.05 美元,以非美國通用會計準則計算,稀釋後每股收益為 1.27 美元。
Turning now to slide 15. Based on our strong performance year to date, we are raising our guidance ranges for the full year. As a reminder, our expectations exclude the impact of the accounting treatment of the electrified transaction. The final determination of whether this transaction will be accounted for as a business combination or an asset acquisition will be determined at the close.
現在翻到第15張投影片。鑑於我們今年迄今的強勁業績,我們將上調全年業績預期範圍。需要提醒的是,我們的預期不包括電氣化交易的會計處理的影響。最終確定該交易是作為企業合併還是資產收購進行會計處理,將在交易完成時確定。
We now expect total revenues of $1.3 billion to $1.375 billion, representing year-over-year growth of 28% to 35%, driven by an increase in projections for royalty revenues. Royalty revenues of $850 million to $880 million, representing year-over-year growth of 49% to 54%.
我們現在預計總收入為 13 億美元至 13.75 億美元,年增 28% 至 35%,主要得益於特許權使用費收入預期的增加。特許權使用費收入為 8.5 億美元至 8.8 億美元,年增 49% 至 54%。
We continue to expect DARZALEX SC, PHESGO, and VYVGART Hytrulo to drive the strong expectations, with VYVGART Hytrulo being the largest royalty dollar growth driver.
我們繼續預期 DARZALEX SC、PHESGO 和 VYVGART Hytrulo 將推動強勁的預期,其中 VYVGART Hytrulo 將是最大的特許權使用費美元成長驅動力。
Product sales of $340 million to $365 million, representing year-over-year growth of 12 to 20%. Collaboration revenues of $110 million to $130 million. Adjusted EBITDA of between $885 million and $935 million, representing year-over-year growth of 40% to 48%. and non-GAAP diluted EPS of $6.10 to $6.50, representing year-over-year growth of 44% to 54%.
產品銷售額為 3.4 億美元至 3.65 億美元,年增 12% 至 20%。合作收入為 1.1 億美元至 1.3 億美元。調整後 EBITDA 為 8.85 億美元至 9.35 億美元,年增 40% 至 48%;非 GAAP 稀釋後每股收益為 6.10 美元至 6.50 美元,年增 44% 至 54%。
Regarding the future financial expectations of our acquisition of Elektrofi, we continue to expect the transaction to be less than 5% dilutive to non-GAAP diluted EPS over the medium term, excluding potential milestone payments related to the programs in development, which could offset dilution, prior to the projected royalty revenues in 2030 and beyond. We also expect full-year 2026 incremental operating expense of approximately $55 million.
關於我們對收購 Elektrofi 的未來財務預期,我們仍然預計,在中期內,該交易對非 GAAP 稀釋後每股收益的稀釋作用將低於 5%,這不包括與正在開發的項目相關的潛在里程碑付款(這些付款可能會抵消稀釋作用),以及在 2030 年及以後預計的特許權使用費收入。我們也預計 2026 年全年新增營運費用約為 5,500 萬美元。
With that, I'll now turn the call back over to Helen.
好了,現在我把電話轉回給海倫。
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
Thank you, Nicole. In closing, our third-quarter results reflect the continued strength of our core enhanced business and the accelerating momentum across our partner portfolio. with 10 launch products, a robust pipeline of future royalty streams, and the addition of the Hypercon technology. We're well-positioned to deliver strong revenue and shareholder value for years to come.
謝謝你,妮可。綜上所述,我們第三季的業績反映了我們核心增強業務的持續強勁表現,以及合作夥伴業務組合的加速成長勢頭。我們推出了10款新產品,擁有充足的未來特許權使用費收入,並新增了Hypercon技術。我們已做好充分準備,在未來幾年內實現強勁的收入成長和股東價值提升。
And let me just close with a few words on Nicole. While Nicole will be with us on our fourth quarter call in February, I did want to take this moment to thank Nicole for her many contributions to Halozyme. These have really helped us accomplish our growth strategy to date. Throughout this time, Nicole has helped design and lead multiple financing transactions that provided the capital that enabled the strong growth that you see today. Nicole will be transitioning to a new opportunity in 2026 when a new CFO is hired or by March 30, 2026.
最後,我想簡單談談妮可。雖然妮可將於二月份與我們一起參加第四季度電話會議,但我確實想藉此機會感謝妮可對 Halozyme 做出的諸多貢獻。這些措施確實幫助我們實現了迄今為止的成長策略。在此期間,妮可參與設計並領導了多項融資交易,為公司提供了資金,從而實現瞭如今我們所看到的強勁增長。妮可將於 2026 年迎來新的機遇,屆時公司將聘請新的財務官,或最遲於 2026 年 3 月 30 日。
Operator, with that, we are now ready to open the call for questions.
操作員,現在我們可以開始接受提問了。
Operator
Operator
(Operator Instructions) Sean Laaman, Morgan Stanley.
(操作說明)肖恩·拉曼,摩根士丹利。
Sean Laaman - Analyst
Sean Laaman - Analyst
Good afternoon, Helen. I hope you're well. Yeah, on capital allocation. You're 2 times levered now. How do you think about paying down debt, getting an even more conservative balance sheet, and weighing that up against potential buybacks for next year? And what Elektrofi-like opportunities there might be out there? That's the first question.
下午好,海倫。希望你一切都好。是的,關於資本配置。你現在的槓桿是2倍。您如何看待償還債務、使資產負債表更加保守,以及權衡這些因素與明年潛在的股票回購之間的關係?那麼,未來還有哪些類似 Elektrofi 的機會呢?這是第一個問題。
And then the second part would be, how are investors going to be able to monitor the performance of Elektrofi going forward?
其次,投資人將如何監控 Elektrofi 未來的業績表現?
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
Yeah, so I'll start by just saying with regard to opportunities like Elektrofi, we are continuing to look for those opportunities, Sean, because we do believe that we're in a great position to be the partner of choice for our pharma and biotech partners as they're looking to optimize the patient treatment experience. So, keeping looking and obviously we will transact when we do find appropriate things.
是的,首先我想說的是,關於像 Elektrofi 這樣的機會,肖恩,我們仍在繼續尋找這些機會,因為我們相信,我們處於非常有利的地位,可以成為製藥和生物技術合作夥伴的首選合作夥伴,幫助他們優化患者的治療體驗。所以,我們會繼續尋找,找到合適的東西後自然會進行交易。
Let me ask though Nicole to comment on the capital allocation and the plan to delever.
我想請妮可就資本配置和去槓桿化計畫發表一下看法。
Nicole Labrosse - Chief Financial Officer, Senior Vice President
Nicole Labrosse - Chief Financial Officer, Senior Vice President
Yeah, thanks, Sean. So we do have robust cash flows and cash growth in the coming quarters. And so while we will have a modest draw on our credit facility to fund the Elektrofi acquisition, we do expect to pay that down in the coming quarters and to delever very quickly. And so what you've seen us be able to do this year is have capital to fund share repurchases. We've done $342 million within the year and be able to fund the Elektrofi acquisition. And you'll see us continue to have that balanced approach going forward.
是啊,謝謝你,肖恩。因此,我們未來幾季的現金流和現金成長都將保持強勁。因此,雖然我們將小幅動用信貸額度來為收購 Elektrofi 提供資金,但我們預計將在未來幾季償還這筆款項,並很快降低槓桿率。因此,你們也看到了,我們今年能夠擁有資金來回購股票。我們一年內完成了 3.42 億美元的收入,足以支付收購 Elektrofi 的費用。未來我們將繼續採取這種平衡的策略。
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
All right. And, Sean, the last part of it, how to monitor the success of Elektrofi. I'm going to give you three metrics there.
好的。肖恩,最後一部分是如何監控 Elektrofi 的成功情況。我將給出三個指標。
One is we are anticipating the potential for two partner first-in-human starts, both with already blockbuster products in their current formulation. That will happen by the end of 2026 or before. So that will be the first metric.
一是我們預計會有兩位合作夥伴首次進行人體試驗,這兩位合作夥伴目前的產品配方都已經是重磅產品。這將在2026年底或之前發生。所以這將是第一個衡量指標。
I do think as we work through working with Elektrofi closely, we'll be finding opportunities to develop and be able to communicate a streamlined development plan approach, which we see as another benefit of bringing our two expertise together.
我認為,隨著我們與 Elektrofi 的密切合作,我們將有機會制定並傳達一個精簡的開發計劃方法,我們認為這是我們雙方專業知識相結合的另一個好處。
And then the third one, we will continue to look for Elektrofi and support the advancement of Hypercon with the current partners potentially agreeing to move more products into the clinic from their open nomination slots, or indeed signing new deals.
第三,我們將繼續尋找 Elektrofi,並支持 Hypercon 的發展,現有合作夥伴可能會同意將更多產品從其開放的提名名額中推向臨床,或簽署新的協議。
And so we're very excited about the Elektrofi acquisition. Still in the planning phase, obviously, at this point in time, but we see great opportunity for the business synergies that are going to come from being able to bring our two companies together.
因此,我們對收購 Elektrofi 感到非常興奮。顯然,目前仍處於計劃階段,但我們看到,將我們兩家公司合併在一起,將會帶來巨大的業務協同效應,這是一個巨大的機會。
Sean Laaman - Analyst
Sean Laaman - Analyst
Wonderful. Thank you, Helen. Thank you, Nicole. Appreciate it.
精彩的。謝謝你,海倫。謝謝你,妮可。謝謝。
Operator
Operator
Jason Butler, Citizens JMP.
Jason Butler,Citizens JMP。
Jason Butler - Analyst
Jason Butler - Analyst
Hi. Thanks for taking the questions, and congrats on the quarter. Let me pass my congratulations on to Nicole as well. So let me start on Elektrofi, understanding that the deal hasn't closed yet. Can you talk about what you think the awareness level of the company and the technology is with your current ENHANZE partners and just any feedback you've gotten from partners on the company?
你好。感謝您回答問題,並祝賀您本季取得佳績。也請容許我向妮可轉達我的祝賀。那麼,讓我先從 Elektrofi 開始說起,需要說明的是,這筆交易尚未完成。您能否談談您認為目前 ENHANZE 的合作夥伴對公司及其技術的認知程度,以及您從合作夥伴那裡收到的關於公司的任何反饋?
And then second, on OCREVUS, can you talk a little bit about where market growth is coming from? Are they taking share from other therapies? Are they getting used earlier in treatment? Just how should we think about how that market opportunity is growing? Thanks.
其次,關於 OCREVUS,您能否談談市場成長的來源?它們是否從其他療法中搶佔市場份額?它們是否在治療早期階段就被使用?我們該如何看待這個市場機會的成長方式?謝謝。
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
Yes, Sam (sic - "Jason"), thanks. With regard to the knowledge level of our current partners for Elektrofi, I can say we're only aware of that really by the diligence we've done because we're still at a stage of we're not talking about Elektrofi and they're not talking about us, obviously, given that the HSR review hasn't closed. But I would say just based on our diligence and market research we did prior to the acquisition, there is a good awareness of the Hypercon technology. But obviously, one of the benefits of bringing our companies together is to elevate that awareness and broaden that awareness within each of the companies based on who we're each talking with.
是的,Sam(原文如此,應為“Jason”),謝謝。關於我們目前合作夥伴對 Elektrofi 的了解程度,我可以說,我們只是通過盡職調查才真正了解這一點,因為我們目前仍處於不談論 Elektrofi,他們也不談論我們的階段,顯然,考慮到 HSR 審查尚未結束。但我認為,僅根據我們在收購前所做的盡職調查和市場調查,市場對 Hypercon 技術已經有了相當高的認知。但很顯然,將我們各公司聚集在一起的好處之一是,根據我們各自與哪些人交談,提高和擴大各公司內部的這種意識。
We've received small amounts of spontaneous feedback. Again, I think people are being thoughtful and cautious that the deal hasn't closed, but a number of our partners, particularly the ones who are working with both companies, have provided feedback that I would say signals strong support for the additional opportunities that might exist of being able to work across both of our platforms. So definitely resounding support from everything that we are hearing with regard to that.
我們收到了一些自發性回饋。再次強調,我認為大家對交易尚未完成持謹慎態度,但我們的一些合作夥伴,特別是那些與兩家公司都有合作的合作夥伴,已經提供了反饋,我認為這表明他們強烈支持在兩個平台上開展合作可能帶來的額外機會。所以,我們聽到的所有回饋都給予了強而有力的支持。
On OCREVUS, based on the comments that Roche made on the last call, obviously, delighted to see that they grew 5,000 patients from the 7,500 patients on therapy. That was the number in the second quarter. They are saying that in US and Germany, in particular, 50% of the patients are new to brand.
根據羅氏在上次電話會議上的評論,關於 OCREVUS,顯然很高興看到接受治療的患者人數從 7,500 人增加到 5,000 人。那是第二季的數字。他們表示,尤其是在美國和德國,50% 的患者都是第一次使用該品牌。
Jason, I didn't hear them say exactly where those patients were coming from, so I don't know if it is brand new to treatment patients or it is switched from other therapies. We haven't been provided that level of granularity.
傑森,我沒聽到他們具體說這些病人來自哪裡,所以我不知道這種療法對病人來說是全新的,還是從其他療法轉過來的。我們還沒有獲得如此細緻的資訊。
But what I do obviously think is terrific to know is that this is expanding the market footprint for OCREVUS exactly as Roche anticipated, no allowing patients to be treated in physician offices, community hospitals, and opening up access that was a bit restricted before because of the capacity constraints and infusion suites. So sorry I can't answer that specifically. If we do find out about that, we will make sure to update on the next call.
但我認為最令人振奮的是,這正如羅氏所預期的那樣,擴大了 OCREVUS 的市場範圍,使患者能夠在醫生診所、社區醫院接受治療,並開放了以前由於容量限制和輸液室不足而受到一定限制的治療途徑。非常抱歉,我無法給出具體答案。如果我們查明情況,我們會在下次通話中及時告知。
Sean Laaman - Analyst
Sean Laaman - Analyst
Okay, thank you.
好的,謝謝。
Operator
Operator
Michael DiFiore, Evercore ISI.
Michael DiFiore,Evercore ISI。
Michael DiFiore - Analyst
Michael DiFiore - Analyst
Hi, guys. Thanks so much for taking my questions, and congrats on the continued progress. Two for me. The first, I want to expand upon the M&A question that was asked before. Obviously, your press release said in no uncertain terms that the next chapter of growth will include M&A.
嗨,大家好。非常感謝您解答我的問題,也恭喜您持續的進步。我兩個。首先,我想就之前提出的併購問題進行更詳細的闡述。顯然,你們的新聞稿明確指出,下一階段的成長將包括併購。
And I guess my question is, how high are you willing to lever up for this transaction? And I know you said that we can expect for you to delever in the next few quarters. And so I guess the ultimate question is, could we possibly expect another transaction towards the end of the year? And I have a follow-up.
我想問的是,您願意為這筆交易投入多少槓桿?我知道您說過,我們可以預期您將在未來幾季降低槓桿率。所以,最終的問題是,我們是否有可能在年底前看到另一筆交易?我還有一個後續問題。
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
Yeah, thanks for that, Mike. Obviously, our focus at the moment is completing the Elektrofi acquisition, and so I think I can say that it's unlikely there'll be another acquisition this year. But we are actively looking, because we do want to be able to continue to add to our growth and our momentum that is so strong at this point in time.
謝謝你,麥克。顯然,我們目前的重點是完成對 Elektrofi 的收購,所以我認為今年不太可能再有其他收購了。但我們正在積極尋找機會,因為我們希望能夠繼續保持目前強勁的成長勢頭。
Nicole, will you comment on the approach we're taking to leverage?
妮可,你能否談談我們目前採取的利用槓桿的方法?
Nicole Labrosse - Chief Financial Officer, Senior Vice President
Nicole Labrosse - Chief Financial Officer, Senior Vice President
Yeah. And as Helen noted, while we will evaluate targets, I can say from a firepower perspective, we do have the capacity. We're willing to go up to three times net leverage. You know, we mentioned with this transaction at close, we expect to be at about two times, but that will quickly come down. And so there will be capacity, and again, we'll just be patient and find the right next opportunity.
是的。正如海倫所指出的那樣,雖然我們會評估目標,但我可以從火力角度來看,我們確實有能力做到這一點。我們願意接受高達三倍的淨槓桿。你知道,我們之前提到過,當這筆交易完成時,我們預計市盈率會達到兩倍左右,但很快就會下降。所以產能是有的,我們只需要耐心等待,找到下一個適合的機會。
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
Yeah, and I think just to kind of emphasize what Nicole said, you've seen us demonstrate a lot of patience in terms of finding the right asset, doing the appropriate and so forth. And because of our strong cash flow, we're in a position to contemplate that in 2026, but only if we find it meets our criteria and is the right next move for Halozyme.
是的,我想強調妮可剛才說的話,你們已經看到我們在尋找合適的資產、採取適當的措施等方面表現出了很大的耐心。由於我們強勁的現金流,我們有能力在 2026 年考慮此事,但前提是它符合我們的標準,並且是 Halozyme 的正確下一步。
Michael DiFiore - Analyst
Michael DiFiore - Analyst
Excellent. Thank you for that, Helen. And my follow-up question is, again, I know it's super early regarding Elektrofi, but on the prior call, I think I asked about the potential to combine in-hands with Hypercon.And I think you had said that feasibility studies regarding the combinability still need to be done. When might we see such studies be conducted? And, yeah, I'll just leave it there. Thank you.
出色的。謝謝你,海倫。我的後續問題是,我知道現在討論 Elektrofi 還為時過早,但在之前的電話會議中,我似乎問過它與 Hypercon 結合使用的可能性。我記得您當時說過,關於結合可行性的研究還需要進行。我們何時才能看到此類研究開展?嗯,我就說到這裡吧。謝謝。
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
Yeah, thanks, Mike. Yes, it is something obviously that we are interested in and it is one of the work streams that will be one of the early conversations that we're going to have between the technical experts from both companies to determine what the path would be for that.
謝謝你,麥克。是的,這顯然是我們感興趣的領域,也是我們兩家公司技術專家將要進行早期討論的工作流程之一,以確定實現這一目標的途徑。
But I think my more important message is each company has its own pipeline of ongoing conversations for a great fit for each of our technologies to different partner products. And so that is where the initial focus is going to be just based on the fact that for those people who are seeking a more high-volume rapid delivery in hands is the way to go.
但我認為我更重要的訊息是,每家公司都有自己的持續對話管道,以便將我們的每項技術與不同的合作夥伴產品完美匹配。因此,最初的重點將放在這裡,因為對於那些尋求大量快速交付的人來說,親自交付是最佳選擇。
If they are wanting a potential for an auto-injector in the patient's home, perhaps the Elektrofi technology and Hypercon is going to be a better one. You will see the initial focus most assuredly being on pursuing those two successful strategies to date. We're interested to see can they come together, but we don't have to wait for that data. The strategy will be to pursue each of them separately as we know there's opportunity for them individually.
如果他們希望患者在家中使用自動注射器,那麼 Elektrofi 技術和 Hypercon 或許會是更好的選擇。可以肯定的是,初期重點將放在繼續推行迄今為止行之有效的兩種策略上。我們很想看看他們能否走到一起,但我們不必等待相關數據。我們的策略是分別對它們進行考察,因為我們知道它們各自都有機會。
Michael DiFiore - Analyst
Michael DiFiore - Analyst
I see. Thanks, again.
我懂了。再次感謝。
Operator
Operator
Jessica Fai, JPMorgan.
潔西卡費伊,摩根大通。
Unidentified_1
Unidentified_1
Hello, this is Adam on for Jess. Thank you for taking our question. I really just had two. Can you share your latest thoughts on potential for new ENHANZE deals near term? I think you mentioned one in the prepared remarks, but any details around that? And second, which product or products contributed the most to the guidance upside this time around? Thank you.
大家好,我是亞當,替傑西報道。感謝您回答我們的問題。我其實只有兩個。您能否分享一下您對近期ENHANZE可能達成新交易的最新看法?我想您在準備好的演講稿中提到過一個,但能詳細說說嗎?其次,本次業績指引上調主要歸功於哪些產品?謝謝。
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
Yes, let me take the first one, and then Nicole will talk about the guidance. Adam, with regard to new deals, I did say in my prepared remarks we're very confident to have a new deal this year. That confidence comes from proximity to completion of discussions.
好的,我先講第一個,然後妮可再講解指導原則。亞當,關於新協議,我在事先準備好的演講稿中說過,我們非常有信心今年達成一項新協議。這種信心來自於談判接近尾聲。
We have several discussions that are ongoing, and so it isn't our practice to pre-announce anything, but all I can say is that we're excited with the continued interest in hands in whichever of these conversations we crossed the finish line first. We're very excited and think it represents a great opportunity for patients, but also for Halozyme.
我們目前正在進行幾項討論,因此我們通常不會提前宣布任何事情,但我只能說,無論我們首先完成哪項討論,我們都對大家持續的興趣感到興奮。我們感到非常興奮,並認為這對患者來說是一個絕佳的機會,對 Halozyme 來說也是如此。
Nicole, would you talk about the guidance?
妮可,你能談談指導意見嗎?
Nicole Labrosse - Chief Financial Officer, Senior Vice President
Nicole Labrosse - Chief Financial Officer, Senior Vice President
So our guidance is driven by the strength of our royalties, and we continue to see royalties being very strong in our main royalty drivers, which are VYVGART Hytrulo, PHESGO, and DARZALEX.
因此,我們的業績指引取決於版稅的強勁程度,我們主要版稅驅動因素(即 VYVGART Hytrulo、PHESGO 和 DARZALEX)的版稅收入持續強勁。
And I'll also point out, just recall that DARZALEX and VYVGART Hytrulo both had new indications launching this year. As you are aware, first-year launch estimates are notoriously hard to project exactly. and that's where we're seeing the upside and reflecting that now, given that latest data trend in the full-year projections.
另外,我還要指出,請記住,DARZALEX 和 VYVGART Hytrulo 今年都有新的適應症推出。如您所知,第一年的上市業績預測歷來都很難準確掌握。而這正是我們看到利好因素的地方,鑑於最新的數據趨勢,我們現在已將這一點反映在全年預測中。
Jessica Fye - Analyst
Jessica Fye - Analyst
Thank you very much.
非常感謝。
Operator
Operator
Mitchell Kapoor, HCW.
米切爾·卡普爾,HCW。
Mitchell Kapoor - Equity Analyst
Mitchell Kapoor - Equity Analyst
Hey team, thanks for taking the questions. I wanted to ask about, you know, forward guidance, of course, recognizing that you only formally update the five-year guidance once a year. We're getting close to 2026. So wondering, with the strong momentum that we have been seeing quarter to quarter and the subsequent guidance raises for this year, how you're thinking about maintaining that growth into the next few quarters in 2026?
各位同事,感謝你們回答問題。我想問關於前瞻性指引的問題,當然,我知道你們每年只正式更新一次五年指引。2026年即將到來。鑑於我們每個季度都看到了強勁的成長勢頭,並且今年也提高了業績預期,我想知道您打算如何將這種增長勢頭保持到 2026 年接下來的幾個季度?
Does the current trajectory suggest that the previous 2026 ranges might already be tracking towards the upper end of what was outlined earlier this year? Thanks.
目前的趨勢是否表明,先前預測的 2026 年價格區間可能已經接近今年稍早預測的上限?謝謝。
Nicole Labrosse - Chief Financial Officer, Senior Vice President
Nicole Labrosse - Chief Financial Officer, Senior Vice President
Yeah, thanks, Mitchell. So we will be able to provide more details on that in early in 2026 when we are able to really collect all of our trends and input from our partners comes in towards the end of the year.
是啊,謝謝你,米切爾。因此,我們將在 2026 年初提供更多細節,屆時我們將能夠真正收集所有趨勢數據,並且到年底我們將收到合作夥伴的意見。
So more details to come, but we are tracking, as you can see, to exceed 2025 original expectations, but we will be able to reflect the latest information when we give full-year guidance and update in the new year.
更多細節稍後公佈,但如您所見,我們正在朝著超過 2025 年的最初預期穩步前進,但我們將在新年發布全年指導意見和更新時反映最新資訊。
Mitchell Kapoor - Equity Analyst
Mitchell Kapoor - Equity Analyst
Okay, great. And then the second one is just on how you're doing conducting outreach for prospective partners between ENHANZE and Hypercon. Are these parallel tracks, or how do you kind of discuss those with prospective partners?
好的,太好了。第二個問題是關於 ENHANZE 和 Hypercon 之間如何進行潛在合作夥伴的拓展工作。這些是平行發展方向嗎?或者,你會如何與潛在合作夥伴討論這些問題?
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
Yes, thanks, Mike. So at the moment, until the HSR review period is completed, our two businesses are operating separately. We can have conversations about planning as to how we're going to operate together, but we do not share any information with regard to partners each of us is talking to or anything like that. So I would expect upon completion and the close, which we do expect to happen in the fourth quarter, we will be in a position to have conversations and identify who's talking to whom.
好的,謝謝你,麥克。因此,在 HSR 審查期結束之前,我們的兩家公司將獨立運作。我們可以討論合作計劃,但我們不會分享任何關於我們各自正在洽談的合作夥伴或其他類似資訊。因此,我預計在交易完成和交割之後(我們預計在第四季度完成),我們將能夠進行對話,並確定誰在與誰對話。
But at this point in time, that's not something we are aware of or want to share. We're each pursuing our own separate conversations and targeted outreach. Again, each of the products works in a slightly different space. All of them are for subcu delivery, enhances more focus towards the larger volume, which is often in the doctor's office or occasionally at home. whereas the opportunity with Elektrofi is a bit more focused at that at-home potentially auto-injector delivery because the volumes can be potentially reduced to as low as 2 mL.
但就目前而言,我們既不了解此事,也不想透露。我們各自進行各自的對話和針對性的宣傳活動。同樣,每款產品的應用領域都略有不同。它們都適用於皮下注射,更側重於大劑量注射,通常在醫生診室或偶爾在家中進行。而Elektrofi的優點更集中在家中使用自動注射器進行注射,因為其註射劑量可以低至2毫升。
So I would expect we may be talking to the same companies but probably not talking on exactly the same products which is why this is such an attractive deal expanding our TAM, because each of them is going to have a different best use case. And that's what I expect to see when we're able to talk in more detail.
因此,我預計我們可能會與同一家公司洽談,但可能不會洽談完全相同的產品,這就是為什麼這筆交易如此有吸引力,因為它擴大了我們的潛在市場,因為每家公司都有不同的最佳使用場景。這就是我希望在我們能夠進行更詳細討論時看到的情況。
Mitchell Kapoor - Equity Analyst
Mitchell Kapoor - Equity Analyst
Great. Thank you and congrats on an impressive quarter.
偉大的。謝謝,也恭喜你們取得了令人矚目的季度業績。
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
Thanks, Mitch.
謝謝你,米奇。
Operator
Operator
Brendan Smith, TD Cowen.
布倫丹史密斯,TD Cowen。
Brendan Smith - Analyst
Brendan Smith - Analyst
Great. Thanks for taking our questions and congrats on the quarter as well. Maybe just a couple quick ones from us. First, actually, on the auto-injector business, can you maybe just remind us what the development path there is looking like and how we should think about economics and timing of that over the next couple of years? You know, if you think that would be compatible with Hypercon or that would require something different with separate validation?
偉大的。感謝您回答我們的問題,也恭喜您本季取得佳績。我們可能就簡單說幾句。首先,關於自動注射器業務,您能否提醒我們該業務的發展路徑目前的情況,以及在未來幾年內我們應該如何考慮其經濟效益和時間安排?你知道,你認為這是否與 Hypercon 相容,或者是否需要採用不同的方法進行單獨的驗證?
And then just maybe quickly on the earlier pipeline, can you remind us when we can expect updates from the Vega and Acumen products? And if you disclosed anything about those economics that we should make sure that we flag as we kind of try to think about royalties for the next wave of ENHANZE drugs. Thanks.
另外,能否簡單提一下先前的進展,提醒我們一下 Vega 和 Acumen 產品何時會有更新?如果你透露了任何與這些經濟方面有關的信息,我們應該確保在考慮下一批 ENHANZE 藥物的專利費時將其標記出來。謝謝。
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
Yeah, thanks, Brandon. With regard to the auto-injector business, so the small-volume auto-injectors are obviously for products that are 2.25 mLs or less, and there is an immediate applicability and use with the Hypercon products if a partner is developing that. So those are basically just some customization that's possible, but for a partner who wants to integrate it into their development, that's pretty straightforward.
謝謝你,布蘭登。關於自動注射器業務,小容量自動注射器顯然適用於 2.25 毫升或更少的產品,如果合作夥伴正在開發 Hypercon 產品,則可立即套用。所以這些基本上只是一些可以進行的自訂設置,但對於想要將其整合到自身開發中的合作夥伴來說,這非常簡單直接。
With the high-volume hot injector, we have progressed to having very strong clinic-ready prototypes that are able to be integrated into development plans now. And so for a company who is wanting to use those, that is also going to be pretty straightforward for them to put into whatever clinical trial they're going to do to test it and start doing the development.
憑藉大容量熱注射器,我們已經取得了長足的進步,擁有了非常強大的臨床就緒型原型,現在可以將其整合到開發計劃中。因此,對於想要使用這些技術的公司來說,將其應用到他們將要進行的任何臨床試驗中進行測試和開發也相當簡單直接。
The actual separate development you need for a device can all happen in parallel. to the clinical development. You've got to do stability studies. There's usually human factor studies. But that is usually all happening in parallel to what's the traditional clinical pathway and integrated into single filing.
設備實際所需的獨立開發工作可以與臨床開發並行。你需要進行穩定性研究。通常會有關於人為因素的研究。但這通常都是與傳統臨床路徑並行進行的,並整合到單一的備案流程中。
So I would say we're in a great position for partners who want to use Hypercon to be using either small volume or high volume auto-injectors and integrating them immediately as soon as they want to be able to do them.
因此,我認為我們處於非常有利的地位,對於想要使用 Hypercon 的合作夥伴來說,他們可以使用小容量或大容量自動注射器,一旦需要就可以立即整合這些注射器。
On the economics, if you recall for the auto-injectors, this is much more of a business model where for the small volume auto-injector, it is generally a cost model where there's a certain charge per device. For the high-volume auto-injector, it will -- because of the size of injection, need to be used with ENHANZE, so we think of those as being associated with royalties because of the need to have enhanced use with them, but they will also come with a cost per device, adding additional revenue there.
從經濟角度來看,如果你還記得自動注射器的情況,這更多的是一種商業模式,而對於小容量自動注射器來說,通常是一種成本模式,即每個設備都有一定的費用。對於大容量自動注射器,由於注射量較大,需要與 ENHANZE 配合使用,因此我們認為這些注射器需要與 ENHANZE 配合使用才能發揮其增強作用,從而產生專利費,但每個設備也會產生費用,從而增加額外的收入。
Brendan, did that answer your question on that? And I can move to the pipeline?
布蘭登,這樣回答你的問題了嗎?我可以調到管線部門嗎?
Brendan Smith - Analyst
Brendan Smith - Analyst
It did, yeah.
是的,確實如此。
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
That'd be great, thanks. Okay. So with regard to the earlier pipeline, there haven't been any public updates from Vega or from Acumen in the last couple of quarters, and so we're not in a position of being able to share any additional information. The last update from Acumen, as you probably are aware, was that they had finished their Phase 1 testing, and so that was great to see, and they reported the results actually publicly, but we're awaiting being able to provide any updates beyond that.
那太好了,謝謝。好的。所以關於之前的管道項目,Vega 和 Acumen 在過去的幾個季度都沒有發布任何公開更新信息,因此我們目前無法分享任何額外信息。正如您可能已經知道的那樣,Acumen 的最新進展是他們已經完成了第一階段的測試,這真是個好消息,他們也公開報告了測試結果,但我們仍在等待能夠提供更多後續更新。
On the economics, when the deals were announced in the press releases, insofar as what was permitted to be made public, it does include some high-level description of the milestones and royalty structure of these agreements, Brendan, so I would recommend if you could maybe just go back and look at those, you'll get a bit of color, not granular, but a bit of color that might be helpful.
關於經濟方面,布倫丹,當這些交易在新聞稿中宣佈時,就允許公開的內容而言,其中確實包含了一些關於這些協議的里程碑和特許權使用費結構的高層次描述,所以我建議你回去看看那些新聞稿,你會得到一些細節信息,雖然不是非常具體,但這些信息可能會有所幫助。
Mitchell Kapoor - Equity Analyst
Mitchell Kapoor - Equity Analyst
Okay, great. Thank you.
好的,太好了。謝謝。
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
Thank you.
謝謝。
Operator
Operator
(Operator Instructions) Corinne Johnson, Goldman Sachs.
(操作說明)高盛集團的科琳·約翰遜。
Corrine Johnson - Analyst
Corrine Johnson - Analyst
Hi, and good afternoon. Maybe following up on some of the BD commentary earlier, I guess, how do you think about whether you currently have the partnerships you need to drive revenue growth kind of into the next decade, particularly if some of the key products, like dollars, blocks, contracts, terminate in that early 2030s period, and given there's a five-year development timeline for new partner products?
您好,下午好。或許可以接著之前 BD 的一些評論,我想問的是,您認為您目前是否擁有推動未來十年收入成長所需的合作夥伴關係?特別是考慮到一些關鍵產品(如美元、區塊、合約)將在 2030 年代初期終止,而新的合作夥伴產品需要五年時間才能開發完成。
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
Yeah, thanks, Corinne. Let me start by saying for each of the products that are in our development, we kind of group them into three groups now. We've got the current blockbusters, and I think what's the first thing to note about those is those products, and Nicole commented on it, VYVGART and DARZALEX, are having new indications every year at this point in time, which is super in terms of driving their continued growth for a period of time.
謝謝你,科琳。首先我想說的是,對於我們正在開發的每個產品,我們現在將它們大致分為三類。我們現在有幾款重磅產品,我認為首先需要注意的是,正如妮可評論的那樣,這些產品,例如 VYVGART 和 DARZALEX,目前每年都有新的適應症,這對於推動它們在一段時間內持續增長來說非常棒。
We talked about DARZALEX with smouldering multiple myeloma with first line, which is why, despite that being a product that's been in the market now for many, many years. It's still putting up 19%, 20% year-over-year growth, and we do are excited to see that continue to grow for years to come. is a very interesting one. That's very early in its life cycle, and obviously all the growth we're seeing today are driven by gMG and CIDP.
我們討論了達札瑞司(DARZALEX)作為第一線治療冒煙型多發性骨髓瘤的藥物,儘管該產品已經上市很多很多年了。它仍然保持著19%到20%的年增長率,我們很高興看到這種成長勢頭在未來幾年繼續下去。這確實是一個非常有趣的例子。這還處於其生命週期的早期階段,顯然我們今天看到的所有增長都是由 gMG 和 CIDP 驅動的。
But next year, as you're aware, there's going to be readouts in thyroid eye disease, ocular myasthenia gravis, myositis. and Phase 2 data in systemic sclerosis. So we think of VYVGART where we get royalties up to the 2040s as being an incredibly valuable growth engine for multiple years to come.
但如您所知,明年將會發表甲狀腺眼疾、眼肌型重症肌無力、肌炎的研究結果,以及系統性硬化症的第二期臨床試驗數據。因此,我們認為 VYVGART 是一個極其有價值的成長引擎,我們可以獲得直至 2040 年代的版稅,並且這種增長將持續多年。
And then if we go to the second block, which are the most recently launched ones, so OCREVUS and Opdivo and Tecentriq and amivantamab, Those are also just at the beginning of their growth trajectory where we expect growth for many years to come, given they are just at the start. And in many of those cases, we've got royalties going out certainly well into the 2030s and in some instances into the 2040s. So that's another set of sustainable royalty revenue streams.
然後,如果我們來看第二組,也就是最近推出的藥物,例如 OCREVUS、Opdivo、Tecentriq 和 amivantamab,這些藥物也正處於成長軌蹟的開始階段,鑑於它們才剛起步,我們預計它們在未來很多年裡都會保持成長。在很多情況下,版稅肯定會支付到 2030 年代,有些情況下甚至會支付到 2040 年代。所以,這是另一組可持續的版稅收入來源。
And then behind that, let's loop to our development pipeline. The products are in Phase 1, 2, and 3, so they're going to have different timings for launch, some of them potentially launching before 2020, other ones shortly after 2028. So again, another set of new royalty streams adding in in that.
然後,接下來,讓我們回到我們的開發流程。這些產品處於第 1、2 和 3 階段,因此它們的上市時間會有所不同,其中一些可能會在 2020 年之前上市,另一些可能會在 2028 年之後不久上市。所以,又有一批新的版稅收入來源加入其中。
And your point of the five years really does say that for any new deals we sign now, which we're very actively working on and have new products starting next year, those have the potential to be launching in the early 2030s, adding, once again, new wealthy revenue streams. So we continue to be very excited by these, not just waves, which are a very important part of it.
您提到的五年期限確實意味著,我們現在簽署的任何新協議(我們正在積極推進,並且明年將推出新產品),都有可能在 2030 年代初推出,再次增加新的豐厚收入來源。所以我們對這些(不僅僅是波浪)感到非常興奮,波浪是其中非常重要的一部分。
But within each several of our products, they are being developed in a way that is having them grow and grow beyond probably what we all thought initially because of the value of the new indications and the investments and the companies are making to have these become truly mega blockbuster drugs. So that's the way we think about it and that's what we work towards, just that wave upon wave of new royalty revenue.
但是,在我們眾多產品中,它們的開發方式正在使其不斷發展壯大,遠遠超出我們最初的預期,這得益於新適應症的價值,以及公司為使這些產品成為真正的超級重磅藥物而進行的投資。所以,我們就是這樣看待這個問題的,也是我們努力的方向,那就是一波又一波的新版稅收入。
Corrine Johnson - Analyst
Corrine Johnson - Analyst
Thank you.
謝謝。
Operator
Operator
Ladies and gentlemen, this concludes Halozyme's third-quarter 2025 financial and operating results conference call. Thank you all for joining. You may now disconnect.
女士們、先生們,Halozyme 2025 年第三季財務與營運業績電話會議到此結束。感謝各位的參與。您現在可以斷開連線了。