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Operator
Operator
My name is Julianne, and I will be your conference facilitator today for the Amgen Q2 2026 earnings conference call. (Operator Instructions)
我叫 Julianne,今天將擔任安進(Amgen)2026 年第二季財報電話會議的會議主持人。(接線員指示)
I would now like to introduce Casey Capparelli, Vice President of Investor Relations. Mr. Capparelli, you may now begin.
現在我想介紹投資人關係副總裁 Casey Capparelli。Capparelli 先生,您現在可以開始。
Casey Capparelli - Vice President - Investor Relations
Casey Capparelli - Vice President - Investor Relations
Thank you, Julianne. Good afternoon, everyone, and welcome to our second quarter of 2026 earnings call. Bob Bradway will lead the call today, and be followed by a broader review of our performance by Murdo Gordon, Jay Bradner, and Peter Griffith.
謝謝你,Julianne。各位下午好,歡迎參加我們 2026 年第二季財報電話會議。今天由 Bob Bradway 主持,接著 Murdo Gordon、Jay Bradner 與 Peter Griffith 將更全面回顧我們的業績表現。
Through the course of our discussion today, we will use non-GAAP financial measures to describe our performance and have provided appropriate reconciliations within the materials that accompany this call. We will also make some forward-looking statements, which are qualified by our safe harbor statement. And please note that actual results can vary materially.
在今天的討論過程中,我們將使用非 GAAP 財務衡量指標來說明我們的表現,並已在本次電話會議隨附資料中提供適當的調節表。我們也將做出若干前瞻性陳述,並受我們的安全港聲明所規範。並請注意,實際結果可能會有重大差異。
Over to you, Bob.
交給你了,Bob。
Robert Bradway - Chairman of the Board, President, Chief Executive Officer
Robert Bradway - Chairman of the Board, President, Chief Executive Officer
Good afternoon, and thank you for joining us. Our strong results were driven by the breadth and depth of our portfolio, and once again demonstrate our ability to grow through patent expirations and increased competition. We're pleased with the momentum across our business and expect to reach more patients with our innovative medicines and biosimilars in the second half of the year than ever before, as volume demand for our products continues to grow strongly. This broad-based performance is exactly what our strategy is intended to deliver, and it's why we remain confident in our ability to deliver durable growth well into the next decade.
各位下午好,感謝各位加入。我們的強勁成果來自產品組合的廣度與深度,並再次展現我們在專利到期與競爭加劇的情況下仍能成長的能力。我們對整體業務動能感到滿意,並預期在今年下半年,隨著產品需求量持續強勁成長,我們將以前所未有的規模,讓更多病患使用我們的創新藥物與生物相似藥。這種全面性的表現正是我們策略所要達成的成果,也因此我們對於在未來十年乃至更久仍能實現持續成長充滿信心。
Turning to the quarter. Total revenues exceeded $10 billion, a 10% year-over-year increase. Notably, 22 products delivered double-digit sales growth, and 17 products annualized at more than $1 billion based on second quarter sales.
回到本季表現。總營收超過 100 億美元,年增 10%。值得注意的是,有 22 項產品實現兩位數銷售成長,且以第二季銷售額年化計算,有 17 項產品年化銷售額超過 10 億美元。
These results, including strong earnings and margin performance, were achieved while we increased our investment in innovation, reflecting the sound financial structure of our business. That sound financial structure also gives us the flexibility to invest with discipline in both our internal pipeline and external innovation, while supporting the long-term needs of the business.
在我們加大對創新投資的同時,仍達成了這些成果(包括強勁的獲利與利潤率表現),反映出我們業務穩健的財務結構。這樣的穩健財務結構也讓我們具備彈性,能以嚴謹的紀律投資於內部研發管線與外部創新,同時支援業務的長期需求。
As we've discussed for some time, our six key growth drivers are propelling the business forward. Together, they grew at an aggregate rate of 26% year-over-year, and represented nearly 70% of our second quarter product sales.
如同我們一段時間以來所討論的,我們的六大關鍵成長動能正推動業務向前。合計而言,這六大動能年增 26%,並占我們第二季產品銷售近 70%。
Importantly, many of our first-in-class and best-in-class medicines address large and underpenetrated disease areas, giving us confidence that significant opportunities remain to reach many more patients and contribute to durable long-term growth. For example, while more than a million people in the US are on Repatha, there are tens of millions more who would benefit from the therapy.
重要的是,我們許多同類首創(first-in-class)與同類最佳(best-in-class)藥物所對應的疾病領域規模龐大且滲透率仍低,這讓我們有信心仍存在顯著機會,可觸及更多病患並帶來可持續的長期成長。例如,雖然美國已有超過 100 萬人使用 Repatha,但仍有數千萬人可從該療法中受益。
As our products continue to grow, we're also investing in expanding their long-term potential. We're adding indications, broadening geographic reach, improving dosage administration, and expanding payer access across our medicines.
隨著產品持續成長,我們也在投資以擴大其長期潛力。我們正增加適應症、擴大地理覆蓋、改善給藥方式,並在各項藥物上擴大支付方(payer)可及性。
Our late-stage pipeline is progressing well, and also provides additional opportunities for growth. MariTide, Olpasiran, and Xaluritamig are advancing through Phase 3 development and have the potential to address areas of significant unmet medical need. We remain focused on disciplined execution and generating high-quality evidence required to bring these medicines to patients. Jay will discuss our progress there in a few moments.
我們的後期研發管線進展良好,也提供額外的成長機會。MariTide、Olpasiran 與 Xaluritamig 正推進至第三期臨床開發,並有潛力解決重大未被滿足的醫療需求領域。我們仍專注於以嚴謹紀律執行,並產出將這些藥物帶給病患所需的高品質證據。稍後 Jay 會談到我們在這方面的進展。
Underpinning these efforts are our investments in technology, data, and artificial intelligence, which are helping us advance promising medicines more efficiently, from discovery through development and manufacturing.
支撐這些努力的是我們在科技、數據與人工智慧方面的投資,這些投資正協助我們更有效率地推進具潛力的藥物,從探索、開發到製造。
In summary, the business continues to perform well, and we're excited about the future and our ability to deliver durable growth well into the next decade.
總結來說,業務持續表現良好,我們對未來以及在未來十年乃至更久實現持續成長的能力感到振奮。
Let me take a moment to thank my Amgen colleagues around the world for their dedication to our mission to serve patients and for the quality of their work every day.
我想花點時間感謝全球安進同仁,感謝大家對我們服務病患使命的投入,以及每天所展現的工作品質。
I'll now turn it over to Murdo.
接下來交給 Murdo。
Murdo Gordon - Executive Vice President - Amgen Global Markets and Policy
Murdo Gordon - Executive Vice President - Amgen Global Markets and Policy
Thanks, Bob. Our second quarter results reflect not only the breadth of our portfolio, but the strength and consistency of our execution across key brands and geographies.
謝謝,Bob。我們第二季的成果不僅反映產品組合的廣度,也反映我們在關鍵品牌與各主要地區的執行力之強與一致性。
The next phase of Amgen's growth is fueled by six key drivers: Repatha, which grew 37% in second quarter, EVENITY at 38%, TEZSPIRE 42%, rare disease at 21%, innovative oncology at 18%, and biosimilars at 29%. As Bob mentioned, this combined portfolio of products is now representing approximately 70% of sales. These growth drivers are delivering strong performance, with the majority of these medicines addressing large areas of public health.
安進下一階段的成長由六大關鍵動能驅動:Repatha(第二季成長 37%)、EVENITY(38%)、TEZSPIRE(42%)、罕見疾病(21%)、創新腫瘤(18%)以及生物相似藥(29%)。如 Bob 所提到,這個產品組合目前約占銷售額的 70%。這些成長動能帶來強勁表現,其中多數藥物所對應的是規模龐大的公共衛生領域。
In rare disease and innovative oncology, we're sustaining growth through additional indications, international expansion, and disciplined pricing. Together, they're driving durable performance and positioning Amgen for sustained growth well into the next decade.
在罕見疾病與創新腫瘤領域,我們透過新增適應症、國際擴張與有紀律的定價來維持成長。合計而言,這些因素正推動可持續的表現,並使安進在未來十年乃至更久具備持續成長的定位。
Starting with General Medicine, Repatha delivered $953 million in second quarter sales, growing at 37% year-over-year. Momentum continues to build for Repatha, with new-to-brand prescriptions growing more than 50% year-over-year in the US, supported by increased urgency to treat, both in secondary prevention and high-risk primary prevention patients.
先從一般醫學(General Medicine)談起,Repatha 第二季銷售額達 9.53 億美元,年增 37%。Repatha 的動能持續增強;在美國,新轉用本品牌(new-to-brand)處方量年增超過 50%,其背後動因是治療急迫性提升,涵蓋次級預防與高風險初級預防病患。
The clinical evidence supporting Repatha is unrivaled in its class. Repatha is the only PCSK9 inhibitor with Phase 3 outcomes data in both primary and secondary prevention. Our landmark VESALIUS-CV trial reinforces that earlier and more intensive LDL-C lowering before cardiovascular events occur can deliver meaningful risk reduction. These data further strengthened the case for Repatha to be the first therapy considered when intensifying LDL-C treatment beyond statins.
支持 Repatha 的臨床證據在同類產品中無可匹敵。Repatha 是唯一一款 PCSK9 抑制劑,在初級與次級預防兩者皆擁有第三期臨床結局(outcomes)數據。我們具里程碑意義的 VESALIUS-CV 試驗再次證實,在心血管事件發生前更早且更積極地降低 LDL-C,可帶來具意義的風險降低。這些數據進一步強化了 Repatha 的定位:當 LDL-C 治療需在他汀類藥物之外加強時,Repatha 應成為優先考量的第一線療法。
Repatha should be central to an aggressive LDL-lowering strategy for the estimated 100 million patients worldwide who are still above their LDL-C goals. Repatha has broad access and is uniquely positioned to close the treatment gap and drive sustained growth into the next decade.
對於全球估計仍有 1 億名病患 LDL-C 仍高於目標值而言,Repatha 應成為積極 LDL 降低策略的核心。Repatha 具備廣泛可及性,並以其獨特優勢有望縮小治療落差,推動未來十年乃至更久的持續成長。
EVENITY sales increased 38% in the second quarter to $714 million, building on 27% growth in the previous quarter. In the US, the opportunity remains significant, with approximately 2 million women at very high risk of a fracture, and EVENITY reaching only mid-single-digit penetration today.
EVENITY 第二季銷售額年增 38% 至 7.14 億美元,延續前一季 27% 的成長。在美國,機會仍相當可觀:約有 200 萬名女性骨折風險極高,而 EVENITY 目前的滲透率僅達中個位數百分比。
EVENITY continues to lead the US bone builder market, and is well positioned to reach even more patients. In Japan, EVENITY holds category leadership, with more than 55% volume share. 1 million patients have now been treated in Japan alone, representing a major milestone in clinical adoption.
EVENITY 持續領先美國促骨生成(bone builder)市場,並具備良好條件觸及更多病患。在日本,EVENITY 亦居同類領導地位,市占量(volume share)超過 55%。目前僅日本就已有 100 萬名病患接受治療,這是臨床採用上的重要里程碑。
Moving to inflammation. TEZSPIRE sales grew 42% year-over-year, reaching $486 million, driven by strong demand in severe uncontrolled asthma. In the second quarter, TEZSPIRE was the market leader in new-to-brand prescription share in severe uncontrolled asthma among allergists, and continues to grow with pulmonologists.
接著談發炎領域。TEZSPIRE 銷售額年增 42% 至 4.86 億美元,主要由重度未受控制氣喘的強勁需求所帶動。第二季,TEZSPIRE 在過敏專科醫師(allergists)針對重度未受控制氣喘的新轉用本品牌處方市占(new-to-brand prescription share)中居市場領先,並持續在胸腔/肺科醫師(pulmonologists)族群中成長。
TEZSPIRE is reaching more patients today through expanded Medicare access, including coverage for self-administration, with additional opportunity ahead as Part D access improves. Uptake in chronic rhinosinusitis with nasal polyps is encouraging and is already extending TEZSPIRE's impact beyond severe asthma. We expect additional indications to deliver continued catalysts for growth in the future, and Jay will share more about those in a moment.
透過擴大的 Medicare 可及性(包括自我給藥的給付範圍),TEZSPIRE 目前正觸及更多病患;隨著 Part D 可及性改善,未來仍有更多機會。在伴鼻息肉的慢性鼻竇炎(chronic rhinosinusitis with nasal polyps)方面的採用情況令人鼓舞,且已開始將 TEZSPIRE 的影響力延伸至重度氣喘之外。我們預期未來新增適應症將持續帶來成長催化劑,稍後 Jay 會分享更多相關內容。
Prolia and XGEVA combined delivered $1.1 billion in second quarter sales, a decrease of 33% year-over-year. This is in line with our expectations, given several biosimilar competitors have now launched.
Prolia 與 XGEVA 合計在第二季帶來 11 億美元銷售額,較去年同期下降 33%。鑑於目前已有多個生物相似藥競爭對手上市,這與我們的預期一致。
Turning to our rare disease portfolio, which grew 21% year-over-year to $1.6 billion, you can clearly see our strategy coming to life. Growth is driven by additional indications, international expansion, and disciplined pricing. And we're highly encouraged by the value these products continue to deliver for patients and for Amgen's long-term growth.
接著看我們的罕見疾病產品組合,年增 21% 至 16 億美元,您可以清楚看到我們的策略正在落地。成長動能來自新增適應症、國際擴張,以及嚴謹的定價紀律。我們也深受鼓舞,這些產品持續為病患以及安進(Amgen)的長期成長帶來價值。
UPLIZNA sales increased 90% year-over-year to $335 million in the second quarter, reflecting sustained momentum across all three approved indications. The compelling biology of UPLIZNA's CD19 targeted mechanism, which is designed to deplete the B-cells driving autoimmune pathology, is resonating with both physicians and patients. UPLIZNA's durable efficacy and convenient twice-yearly dosing further reinforce this impact. These attributes, along with broad payer coverage and Amgen's comprehensive patient access services, are enabling rapid initiation and continuity of care across indications.
UPLIZNA 第二季銷售額年增 90% 至 3.35 億美元,反映其在三項已核准適應症上皆維持強勁動能。UPLIZNA 以 CD19 為標的的作用機轉具備強而有力的生物學基礎,旨在耗竭驅動自體免疫病理的 B 細胞,正獲得醫師與病患的認同。UPLIZNA 的持久療效與每年兩次的便利給藥,進一步強化了這項影響。這些特性,加上廣泛的支付方給付涵蓋與安進完善的病患可近性服務,使各適應症得以快速啟動治療並維持照護連續性。
Uptake in GMG continues to build, supported by an almost even mix of bionaive and switch patients, with a doubling of US prescribers since the previous quarter. We believe UPLIZNA is well positioned to establish market leadership in this category.
在 GMG 的使用採納持續提升,受惠於生物製劑初治(bionaive)與轉換用藥病患幾乎各半的組合,以及美國開立處方醫師數自上一季以來倍增。我們相信 UPLIZNA 具備在此類別建立市場領導地位的良好條件。
Growth also continues in IgG4-related disease, where significant underdiagnosis remains, and increased disease awareness is helping more physicians identify appropriate patients. Recent long-term follow-up data illustrate the durable efficacy profile for patients with IgG4-related disease. And as you'll hear from Jay, we see meaningful opportunity to extend the UPLIZNA's growth trajectory through additional indications. These clinical programs further leverage the advantages of CD19-directed B-cell depletion across a broader range of autoimmune diseases.
在 IgG4 相關疾病方面,成長亦持續進行;該領域仍存在顯著的未診斷情形,而疾病認知提升正協助更多醫師辨識合適病患。近期的長期追蹤數據顯示,IgG4 相關疾病病患具有持久的療效表現。此外,正如您稍後將聽 Jay 提到的,我們看到透過新增適應症延伸 UPLIZNA 成長軌跡的重大機會。這些臨床計畫進一步運用 CD19 導向的 B 細胞耗竭優勢,擴展至更廣泛的自體免疫疾病範疇。
TEPEZZA sales grew 14% year-over-year to $576 million in the second quarter. We're seeing strong uptake globally, with solid execution in Japan following last year's launch. TEPEZZA has now launched in 13 countries around the world, with an additional six planned in the coming months. Since approval in the US, more than 25,000 patients have been treated with TEPEZZA. We're continuing to build momentum by expanding awareness and broadening the prescriber base, including endocrinologists and ophthalmologists, to reach more eligible patients.
TEPEZZA 第二季銷售額年增 14% 至 5.76 億美元。我們看到全球採納強勁,日本在去年上市後的執行表現也相當穩健。TEPEZZA 目前已在全球 13 個國家上市,未來數月另規劃再新增 6 個國家。自美國核准以來,已有超過 25,000 名病患接受 TEPEZZA 治療。我們持續透過提升認知並擴大開立處方的醫師基礎(包括內分泌科與眼科醫師)來累積動能,以觸及更多符合條件的病患。
Looking ahead, the advancement of our subcutaneous on-body injector for TEPEZZA represents a meaningful step forward. The Phase 3 data demonstrated comparable efficacy to IV TEPEZZA, supporting a clear path to subcutaneous administration without compromising clinical benefit. This option enhances convenience, enables more sites of care for patients, and has the potential to drive long-term growth.
展望未來,我們推進 TEPEZZA 的皮下「貼身式」注射器(on-body injector),代表一項重要的進展。第三期數據顯示其療效可與靜脈注射(IV)TEPEZZA 相當,支持在不犧牲臨床效益的前提下,具備清晰的皮下給藥路徑。此選項可提升便利性,讓病患有更多照護場域選擇,並有潛力帶動長期成長。
Turning to innovative oncology. The portfolio grew 18% year-over-year, generating approximately $2 billion of sales in the second quarter. IMDELLTRA sales increased 115% year-over-year to $288 million. After years with little meaningful innovation for patients with small cell lung cancer, IMDELLTRA has emerged as the best-in-class treatment option to improve overall survival in the second-line setting. We're seeing strong clinical conviction, rapid adoption across sites of care, and clear differentiation from other available therapies. And IMDELLTRA is supported by NCCN recommendation.
接著談創新腫瘤領域。該產品組合年增 18%,第二季創造約 20 億美元銷售額。IMDELLTRA 銷售額年增 115% 至 2.88 億美元。在小細胞肺癌病患多年缺乏具實質意義的創新之後,IMDELLTRA 已成為二線治療情境中、可改善整體存活期的同類最佳(best-in-class)治療選項。我們看到強烈的臨床信心、在各照護場域快速採用,以及相較其他可用療法的明確差異化。此外,IMDELLTRA 亦獲 NCCN 推薦。
While we have made important inroads, there's still significant opportunity to further penetrate the second-line patient population. Too many patients are still being treated with chemotherapies that do not offer the survival benefit demonstrated by IMDELLTRA. As we continue to expand in the second-line setting, we look forward to data in the first-line extensive-stage small cell lung cancer, which has the potential to further expand IMDELLTRA's impact and unlock additional growth.
雖然我們已取得重要進展,但在二線病患族群的滲透率方面仍有顯著機會可再提升。仍有太多病患持續接受化學治療,而這些療法並未提供 IMDELLTRA 所展現的存活效益。在我們持續擴大二線治療布局的同時,也期待取得一線廣泛期小細胞肺癌的數據;這有潛力進一步擴大 IMDELLTRA 的影響力並釋放額外成長。
BLINCYTO sales increased 23% year-over-year to $472 million in the second quarter, driven by broad prescribing across both academic and community settings in the US, and 64% growth outside the US. International performance was led by broader first-line adoption, robust treatment duration, and strong demand across Europe and Japan.
BLINCYTO 第二季銷售額年增 23% 至 4.72 億美元,動能來自其在美國學術與社區醫療場域的廣泛處方,以及美國以外市場 64% 的成長。國際市場表現主要由更廣泛的一線採用、穩健的治療持續時間,以及歐洲與日本的強勁需求所帶動。
Our biosimilar portfolio delivered 29% year-over-year growth, generating $855 million in sales in the second quarter. PAVBLU, our biosimilar to EYLEA, increased sales 121% year-over-year to $287 million in the quarter. Adoption continues to expand among retina specialists who value PAVBLU's ready-to-use prefilled syringe format and Amgen's track record of quality biologics manufacturing and delivering reliable supply.
我們的生物相似藥產品組合第二季年增 29%,創造 8.55 億美元銷售額。PAVBLU(我們的 EYLEA 生物相似藥)本季銷售額年增 121% 至 2.87 億美元。在重視 PAVBLU 即用型預充填注射器劑型,以及安進在高品質生物製劑製造與穩定供應方面良好紀錄的視網膜專科醫師之間,採用持續擴大。
Since our first biosimilar approvals in 2018, the portfolio has generated more than $15 billion in sales. Amgen's deep biologics expertise, global manufacturing scale, and commercial capabilities differentiate us and support reliable supply for patients around the world. Our next wave of biosimilars, candidates for EYLEA HD, OPDIVO, KEYTRUDA, and OCREVUS are in late-stage clinical development and represent large market opportunities, with the potential to further expand patient access.
自 2018 年我們首次取得生物相似藥核准以來,該產品組合已創造超過 150 億美元銷售額。安進深厚的生物製劑專業、全球製造規模與商業化能力,使我們具備差異化優勢,並支持為全球病患提供可靠供應。我們下一波生物相似藥,包括 EYLEA HD、OPDIVO、KEYTRUDA 與 OCREVUS 的候選產品,正處於後期臨床開發階段,代表龐大的市場機會,並有潛力進一步擴大病患可近性。
Our second quarter results reflect focused high-quality execution, portfolio strength, and continued progress in expanding the impact of our medicines for patients worldwide. Reflecting on these results and the broader set of portfolio opportunities, it's clear that we are delivering a level of consistent, compelling performance that's rarely seen in our industry. This performance is grounded in a portfolio anchored by first-in-class or best-in-class medicines, a team that executes with urgency, and a disciplined approach to access that reduces friction for patients. These efforts position us to unlock future growth and drive durable impact in areas of significant unmet need well into the next decade.
我們第二季的成果反映出聚焦且高品質的執行、產品組合的強勁實力,以及持續擴大我們藥物對全球病患影響力的進展。回顧這些成果與更廣泛的產品組合機會,很明顯我們正交出一種在本產業中罕見的、穩定且具說服力的表現水準。這樣的表現奠基於以同類首創(first-in-class)或同類最佳(best-in-class)藥物為核心的產品組合、一支以急迫感執行的團隊,以及一套降低病患取得阻力的嚴謹可近性策略。這些努力使我們得以釋放未來成長,並在未被滿足醫療需求顯著的領域中,於未來十年持續帶來長期且深遠的影響。
And I'd like to now hand it over to Jay.
接下來我想把時間交給 Jay。
James Bradner - Executive Vice President - Research and Development, Artificial Intelligence and Data
James Bradner - Executive Vice President - Research and Development, Artificial Intelligence and Data
Thank you, Murdo, and good afternoon, everyone. In the second quarter, we enjoyed continued progress advancing our late-stage pipeline and expanding the impact of our in-line medicines.
謝謝你,Murdo,各位下午好。第二季,我們在推進後期研發管線以及擴大既有上市藥物影響力方面,持續取得進展。
Starting with cardiovascular disease, where Amgen is a global leader in developing medicines that target remaining, often genetically defined cardiometabolic risk factors for heart disease. Repatha anchors our cardiovascular efforts as the only PCSK9-targeting therapy with outcomes data in both primary and secondary prevention, supported by 51 clinical trials involving more than 57,000 patients and over 100,000 patient years of exposure.
先從心血管疾病談起;安進是全球領導者,致力於開發可針對心臟病殘餘、且往往由基因所界定之心代謝風險因子的藥物。Repatha 是我們心血管布局的核心,作為唯一一項具備初級與次級預防結局數據的 PCSK9 標的治療,並由 51 項臨床試驗支持,涵蓋超過 57,000 名病患與逾 100,000 病患年(patient years)的暴露量。
We continue to generate additional insights from VESALIUS-CV, the landmark study of Repatha in pre-event cardiovascular disease. We recently reported that for patients with high-risk diabetes, with and without atherosclerosis, Repatha reduced 3-point major adverse cardiovascular events by 29%, and produced a nominal 21% reduction in the risk of all-cause death. Also based on the positive VESALIUS-CV study, we recently received a positive CHMP opinion supporting a broader label for Repatha in the EU.
我們持續從 VESALIUS-CV(Repatha 於事件前心血管疾病的里程碑研究)中產出更多洞見。我們近期報告指出,對於高風險糖尿病病患(不論是否合併動脈粥樣硬化),Repatha 可將三點主要不良心血管事件(3-point MACE)降低 29%,並在全因死亡風險上呈現名目上(nominal)21% 的降低。此外,基於 VESALIUS-CV 研究的正面結果,我們近期也收到 CHMP 的正面意見,支持在歐盟為 Repatha 擴大適應症標示。
Our cardiovascular leadership further extends to Olpasiran, targeting lipoprotein(a) or Lp(a). Elevated Lp(a) is an independent genetically defined risk factor for cardiovascular disease, affecting approximately 1 in 5 people. Having demonstrated greater than 95% reduction in Lp(a) levels in Phase 2, Olpasiran advanced into 2 ongoing Phase 3 outcome studies in both primary and secondary prevention. Deep Lp(a) suppression and quarterly dosing position Olpasiran for a potentially best-in-class profile.
我們在心血管領域的領導地位亦延伸至 Olpasiran,其靶向脂蛋白(a)(lipoprotein(a),或 Lp(a))。Lp(a) 升高是一項獨立且由遺傳所界定的心血管疾病風險因子,約影響每 5 人中的 1 人。在第 2 期試驗中已證實 Lp(a) 水準降低超過 95% 後,Olpasiran 已推進至兩項正在進行的第 3 期結局研究,涵蓋初級與次級預防。深度抑制 Lp(a) 與每季一次給藥,使 Olpasiran 具備潛在同類最佳(best-in-class)的產品特徵。
A third widely prevalent and modifiable risk for cardiovascular disease is, of course, obesity. Our lead obesity asset in MariTide is fundamentally different from other GLP-1 therapies, as MariTide is uniquely designed for monthly therapy, with the potential for as few as four or six doses per year.
第三個廣泛盛行且可調整的心血管疾病風險因素,當然就是肥胖。我們在 MariTide 的主力肥胖資產,從根本上不同於其他 GLP-1 療法;MariTide 為每月治療而獨特設計,且有望每年僅需 4 次或 6 次給藥。
Clinical development of MariTide continues to progress rapidly, with nine ongoing and three additional planned Phase 3 studies across obesity and related serious chronic diseases. Beyond establishing efficacy, these studies will guide how to start and stay on MariTide, and how to switch from other GLP-1-based therapies and stay on MariTide.
MariTide 的臨床開發持續快速推進,目前在肥胖及相關嚴重慢性疾病領域共有 9 項正在進行、以及另外 3 項規劃中的第 3 期研究。除建立療效外,這些研究也將指引如何開始並持續使用 MariTide,以及如何從其他以 GLP-1 為基礎的療法轉換至 MariTide 並維持治療。
One, start and stay on MariTide. MariTide Phase 3 dosing features a simple three-step dose escalation, allowing patients to start MariTide to reach their target dose in only two months, followed by monthly dosing thereafter. MariTide's unique monoclonal antibody backbone with appended GLP-1 peptide is designed for extended dosing. Our Phase 3 maintenance extension studies will evaluate how patients stay on MariTide to maintain weight loss while transitioning from monthly dosing to as few as four or six doses per year.
第一,開始並持續使用 MariTide。MariTide 第 3 期的給藥設計採用簡單的三步驟劑量遞增,使患者僅需兩個月即可開始 MariTide 並達到目標劑量,之後改為每月給藥。MariTide 獨特的單株抗體骨架並接合 GLP-1 胜肽,係為延長給藥間隔而設計。我們的第 3 期維持延伸研究將評估患者如何持續使用 MariTide 以維持減重效果,同時從每月給藥過渡至每年僅需 4 次或 6 次給藥。
Two, switch and stay on MariTide. The next chapter in obesity treatment is not simply greater weight loss, but achieving long-term persistent benefit. We are, therefore, evaluating switching for weekly GLP-1 therapies to MariTide in a dedicated Phase 3 study, with the goal of enabling patients to move from weekly injections to a maintenance schedule with, again, as few as four or six doses per year. Through the comprehensive program, we aim to establish MariTide as the first monthly or less frequent obesity therapy and make long-term treatment easier for patients to sustain weight loss and enjoy durable health benefits.
第二,轉換並持續使用 MariTide。肥胖治療的下一章不僅是更大的減重幅度,而是達成長期且持續的效益。因此,我們在一項專門的第 3 期研究中評估由每週 GLP-1 療法轉換至 MariTide,目標是讓患者從每週注射轉為維持性療程,同樣有望每年僅需 4 次或 6 次給藥。透過此一完整計畫,我們旨在將 MariTide 建立為首個每月或更低頻率的肥胖療法,讓長期治療更容易,協助患者維持減重並享有持久的健康效益。
Closing out our cardiometabolic pipeline, we have decided to stop development of AMG 513, a Phase 1 asset. As I said before, the bar is high at Amgen for obesity medicines. Our next generation of differentiated preclinical programs continues to progress, featuring both incretin and non-incretin mechanisms of action.
在我們的心代謝研發管線收尾之際,我們已決定停止開發第 1 期資產 AMG 513。如我先前所說,安進(Amgen)對肥胖藥物的門檻很高。我們下一代具差異化的臨床前計畫仍持續推進,涵蓋腸促胰素(incretin)與非腸促胰素(non-incretin)的作用機轉。
Let me now turn to rare disease, where we are focused on challenging and rare autoimmune diseases with UPLIZNA, Dazodalibep and blinatumomab. UPLIZNA has established the benefit of CD19-directed B-cell depletion in severe autoimmune diseases, including NMOSD, myasthenia gravis, and IgG4-related disease, with strong efficacy, durable benefit and twice yearly maintenance dosing.
接下來談罕見疾病;我們聚焦於具挑戰性且罕見的自體免疫疾病,相關產品包括 UPLIZNA、Dazodalibep 與 blinatumomab。UPLIZNA 已確立以 CD19 為導向的 B 細胞耗竭在嚴重自體免疫疾病中的效益,包括 NMOSD、重症肌無力,以及 IgG4 相關疾病,展現強勁療效、持久效益,並採每年兩次的維持給藥。
In IgG4-related disease, we recently completed a one-year open-label extension of the Phase 3 MITIGATE study. Building on the remarkable 87% reduction in flare risk versus placebo in year 1 of UPLIZNA therapy, 100% of patients who continued UPLIZNA treatment remained flare-free at year 2, and 71.4% achieved complete remission without glucocorticoids.
在 IgG4 相關疾病方面,我們近期完成第 3 期 MITIGATE 研究為期一年的開放標籤延伸試驗。在 UPLIZNA 治療第 1 年相較安慰劑使復發風險降低 87% 的顯著成果基礎上,於第 2 年持續接受 UPLIZNA 治療的患者中,100% 仍維持無復發,且 71.4% 在未使用糖皮質激素的情況下達到完全緩解。
Based on the emerging profound clinical impact of UPLIZNA in autoantibody-mediated disease, we have initiated the registrational MERCURY study in autoimmune hepatitis, a disease affecting as many as 150,000 patients in the US.
基於 UPLIZNA 在自體抗體介導疾病中日益顯現的深遠臨床影響,我們已在自體免疫性肝炎啟動註冊性 MERCURY 研究;該疾病在美國影響患者多達 150,000 人。
We are also planning a Phase 3 study in chronic inflammatory demyelinating polyneuropathy, a rare and debilitating autoimmune condition that attacks the myelin sheath on peripheral nerves, affecting about 35,000 patients in the US.
我們也規劃在慢性發炎性脫髓鞘性多發性神經病變(CIDP)進行第 3 期研究;這是一種罕見且致殘的自體免疫疾病,會攻擊周邊神經的髓鞘,在美國約影響 35,000 名患者。
For patients suffering from Sjögren's disease, we are developing Dazodalibep. Dazodalibep targets CD40 ligand-mediated signaling between activated T cells and B cells, and has been artfully designed to avoid the platelet-related adverse events observed with first-generation CD40 ligand-targeting agents. We are conducting two dedicated Phase 3 studies in symptomatic and in systemic disease. Results are expected later this year.
針對受修格蘭氏症(Sjögren's disease)所苦的患者,我們正在開發 Dazodalibep。Dazodalibep 靶向由 CD40 配體介導、活化 T 細胞與 B 細胞之間的訊號傳遞,並經精心設計,以避免第一代 CD40 配體靶向藥物所觀察到的血小板相關不良事件。我們正在症狀性疾病與系統性疾病中各進行兩項專門的第 3 期研究。預期結果將於今年稍晚公布。
Turning to inflammation. TEZSPIRE has validated targeting TSLP and the alarmin pathway in severe asthma and chronic rhinosinusitis with nasal polyps. We are now extending its potential to other diseases where epithelial driven inflammation plays a key role. Our Phase 3 study in eosinophilic esophagitis, or EoE, is expected to complete in the second half of the year. EoE is a chronic progressive inflammatory disorder, characterized by epithelial-driven inflammation, remodeling, and dysfunction of the esophagus, affecting over 400,000 patients in the US.
接著談發炎領域。TEZSPIRE 已在重度氣喘與伴鼻息肉的慢性鼻竇炎中,驗證靶向 TSLP 與警報素(alarmin)途徑的策略。我們正將其潛力延伸至其他由上皮驅動發炎扮演關鍵角色的疾病。我們在嗜酸性食道炎(eosinophilic esophagitis,或 EoE)的第 3 期研究,預計將於今年下半年完成。EoE 是一種慢性進行性發炎性疾病,其特徵為上皮驅動的發炎、重塑與食道功能障礙,在美國影響超過 400,000 名患者。
Building on the impact of TEZSPIRE, we are developing sunakiment, previously AMG-104, as an inhaled anti-TSLP fragment antigen-binding protein, or Fab. In the Phase 2 LEVANTE dose-ranging study of sunakiment, we observed numerical reductions in composite asthma exacerbation events, or CompEx, as the primary endpoint at 12 weeks. Although the primary endpoint was not statistically significant, we are encouraged by the overall profile and are planning a Phase 3 program with AstraZeneca.
在 TEZSPIRE 影響力的基礎上,我們正在開發 sunakiment(先前為 AMG-104),其為吸入式抗 TSLP 的抗原結合片段蛋白(fragment antigen-binding protein,或 Fab)。在 sunakiment 的第 2 期 LEVANTE 劑量範圍研究中,我們在 12 週時觀察到以複合型氣喘惡化事件(composite asthma exacerbation events,或 CompEx)為主要終點呈現數值上的降低。儘管主要終點未達統計顯著性,我們仍對整體特徵感到鼓舞,並正與阿斯特捷利康(AstraZeneca)規劃第 3 期計畫。
In oncology, we continue to expand our bispecific T cell engager or BiTE platform across tumor types and to earlier lines of treatment. IMDELLTRA or tarlatamab, is becoming a standard of care after first-line treatment for small cell lung cancer, supported by a strong survival benefit. We're actively advancing IMDELLTRA into earlier treatment lines, where we hope to further impact survival, with three Phase 3 studies well underway. Success in these early-stage settings would allow IMDELLTRA to reach as many as 28,000 addressable patients in the US.
在腫瘤領域,我們持續將雙特異性 T 細胞接合器(bispecific T cell engager,或 BiTE)平台擴展至更多腫瘤類型,並推進至更早期的治療線。IMDELLTRA(tarlatamab)在小細胞肺癌一線治療後,憑藉強勁的存活獲益,正逐步成為標準治療。我們正積極推進 IMDELLTRA 至更早的治療線,期望進一步改善存活,目前已有三項第 3 期研究進展順利。若在這些早期治療情境中取得成功,IMDELLTRA 在美國可望觸及多達 28,000 名可治療患者。
We are also pursuing more convenient administration. DeLLphi-309 is informing our strategy for extended interval dosing, while the new Phase 3 DeLLphi-315 study is evaluating subcutaneous tarlatamab. Building on the success of our BiTE platform in solid tumors, Xaluritamig is advancing in two Phase 3 studies of metastatic castration-resistant prostate cancer while we also evaluate opportunities in earlier stages of this disease.
我們也在追求更便利的給藥方式。DeLLphi-309 正在為我們的延長給藥間隔策略提供資訊,而新的第 3 期 DeLLphi-315 研究則在評估皮下給藥的 tarlatamab。在我們 BiTE 平台於實體腫瘤的成功基礎上,Xaluritamig 正在兩項轉移性去勢抗性前列腺癌的第 3 期研究中推進,同時我們也評估在該疾病更早期階段的機會。
Shifting gears before closing, I'll briefly comment on artificial intelligence. Amgen has a differentiated foundation in proprietary human data, high-performance computing, and deep scientific expertise. We are applying AI strategically across discovery, development, and manufacturing, and access to medicines to improve insight, speed, and decision quality. The impact and insight from these investments are already proving valuable. For example, in Amgen Research, we recently established a Frontier AI laboratory that combines advanced models with proprietary data and scientific capabilities unique to Amgen. Bringing agentic workflows to discovery research powerfully augments the insights and ideas of our brilliant research scientists. We look forward to sharing more over time.
在結束前轉換一下話題,我將簡要談談人工智慧。安進在專有的人體資料、高效能運算,以及深厚的科學專業方面,具備差異化的基礎。我們正策略性地將 AI 應用於藥物發現、開發與製造,以及藥物可近性,以提升洞察力、速度與決策品質。這些投資所帶來的影響與洞察已開始證明其價值。例如,在安進研究部門,我們近期成立了 Frontier AI 實驗室,結合先進模型與安進獨有的專有資料與科學能力。將代理式(agentic)工作流程導入探索研究,可強力增強我們傑出研究科學家的洞察與想法。我們期待未來逐步分享更多內容。
In closing, I'd like to thank my colleagues across Amgen for their continued focus on patients and their commitment to advancing innovative medicines for serious diseases.
最後,我想感謝安進(Amgen)各地的同仁持續以病患為中心,並致力於推動針對嚴重疾病的創新藥物。
I'll now turn it over to Peter for the financial update.
接下來我把時間交給 Peter 進行財務更新。
Peter Griffith - Chief Financial Officer, Executive Vice President
Peter Griffith - Chief Financial Officer, Executive Vice President
Thank you, Jay. Our strong second quarter performance reinforces confidence in our six key growth drivers and our ability to grow through losses of exclusivity. Together, they demonstrate the breadth and the depth of our business and continue to provide a strong foundation for sustained long-term growth.
謝謝你,Jay。我們第二季的強勁表現,強化了我們對六大關鍵成長驅動因素以及在專利到期(失去獨占性)後仍能持續成長能力的信心。這些因素共同展現了我們業務的廣度與深度,並持續為長期、可持續的成長提供堅實基礎。
Our non-GAAP operating margin was 48%. We continue to invest in our portfolio and pipeline while achieving strong operating results, with non-GAAP R&D spending increasing 10% year-over-year in the second quarter. This reflects continued investment in the innovation that will drive future growth, including MariTide, Xaluritamig, and Olpasiran, as well as our marketed medicines, including UPLIZNA, TEZSPIRE, and IMDELLTRA.
我們的非 GAAP 營業利益率為 48%。我們在取得強勁營運成果的同時,持續投資於產品組合與研發管線;第二季非 GAAP 研發支出年增 10%。這反映我們持續投資於將帶動未來成長的創新,包括 MariTide、Xaluritamig 與 Olpasiran,以及我們已上市的藥品,包括 UPLIZNA、TEZSPIRE 與 IMDELLTRA。
Our non-GAAP cost of sales as a percentage of product sales was 19.6%. The year-over-year increase primarily reflected higher profit sharing and royalty expenses, as well as changes in sales mix. These factors reflect the continuing evolution of our product portfolio, and momentum from several of our growth drivers. We remain focused on operational efficiency, execution excellence, and continue to benefit from our leadership in high-quality, world-class biologics manufacturing at scale.
我們的非 GAAP 銷貨成本占產品銷售額的比例為 19.6%。年增主要反映較高的利潤分成與權利金費用,以及銷售組合的變化。這些因素反映我們產品組合持續演進,以及多項成長驅動因素所帶來的動能。我們仍專注於營運效率與卓越執行,並持續受惠於我們在高品質、世界級且具規模的生物製劑製造方面的領導地位。
We generated $3.5 billion in free cash flow in the second quarter, reflecting continued momentum across the business, and enabling us to continue investing for future growth. We spent $500 million in the second quarter on capital expenditures, driven by investments across our United States manufacturing sites, including North Carolina, Ohio, and Puerto Rico. We continue to expect capital expenditures of approximately $2.6 billion in 2026, reflecting significant investment in our business to scale manufacturing capacity for volume growth, including for MariTide's launch. Our commitment to investing in our business and enabling additional capacity supports our long-term growth well into the next decade.
第二季我們創造了 35 億美元的自由現金流,反映業務各面向持續的動能,並使我們得以持續投資於未來成長。第二季我們在資本支出上投入 5 億美元,主要來自對美國各製造據點的投資,包括北卡羅來納州、俄亥俄州與波多黎各。我們仍預期 2026 年資本支出約為 26 億美元,反映我們為擴大製造產能以因應銷量成長(包括 MariTide 上市)而對業務進行的重大投資。我們對業務投資並提升額外產能的承諾,將支持我們在未來十年乃至更長期的成長。
In addition, we returned capital to shareholders through competitive dividend payments of $2.52 per share, representing a 6% increase compared to the second quarter of 2025.
此外,我們透過具競爭力的股利發放(每股 2.52 美元)回饋股東,較 2025 年第二季增加 6%。
Let's turn to the outlook for the business for the remainder of 2026. We are pleased with our strong execution in the first half of the year, and we are raising our 2026 guidance ranges for both revenue and non-GAAP earnings per share. We now expect 2026 total revenues in the range of $38.2 billion to $39.4 billion, and non-GAAP earnings per share between $22.30 and $23.50.
接下來談談 2026 年剩餘期間的業務展望。我們對上半年強勁的執行成果感到滿意,並上調 2026 年營收與非 GAAP 每股盈餘(EPS)的指引區間。我們目前預期 2026 年總營收介於 382 億至 394 億美元,非 GAAP 每股盈餘介於 22.30 至 23.50 美元。
Let me highlight a few updates to our outlook for the remainder of the year. For the full year, we now expect other revenue to be approximately $1.9 billion. We expect full year non-GAAP R&D expense to grow high single digits year-over-year, which includes nine ongoing global Phase 3 clinical trials for MariTide. This outlook also includes a business development transaction, resulting in a $100 million upfront payment that will increase our non-GAAP R&D expense in the third quarter. We now anticipate non-GAAP other income expense to be in the range of $2.1 billion to $2.2 billion of expense in 2026.
我再強調幾項今年剩餘期間展望的更新。就全年而言,我們目前預期其他收入約為 19 億美元。我們預期全年非 GAAP 研發費用將呈現高個位數的年增率,其中包含 MariTide 目前進行中的 9 項全球第三期臨床試驗。此展望亦包含一項業務發展交易,將帶來 1 億美元的預付款,並使我們第三季的非 GAAP 研發費用增加。我們目前預期 2026 年非 GAAP 其他收入/費用淨額將為費用 21 億至 22 億美元。
And let me remind you of several additional guidance items. We continue to expect the full year non-GAAP operating margin as a percentage of product sales to be roughly 45% to 46%. Our commercial performance allows us to continue investing behind the next generation of growth drivers while maintaining strong operating margins.
另外提醒各位幾項其他指引項目。我們仍預期全年非 GAAP 營業利益率占產品銷售額的比例約為 45% 至 46%。我們的商業表現使我們得以在維持強勁營業利益率的同時,持續投資於下一代成長驅動因素。
In addition to the third quarter business development transaction noted earlier, our strong revenue performance has enabled us to make incremental third quarter investments in the pipeline and our commercial brands to drive continued momentum into 2027. As a result, and consistent with 2025, we expect a meaningful sequential increase in operating expenses in the third quarter.
除了先前提到的第三季業務發展交易外,我們強勁的營收表現也使我們能在第三季對研發管線與商業品牌進行額外投資,以推動動能延續至 2027 年。因此,且與 2025 年一致,我們預期第三季營業費用將出現顯著的季增。
We expect a non-GAAP tax rate in the range of 15.0% to 16.5%. We expect share repurchases not to exceed $3 billion.
我們預期非 GAAP 稅率介於 15.0% 至 16.5%。我們預期庫藏股回購金額不超過 30 億美元。
We remain focused on executing our strategy, staying focused on our growth drivers, investing in the best innovation, and maintaining our rigorous financial discipline that enables us to deliver sustained long-term growth and create value for patients, staff, and shareholders. I'm grateful to work with all of our colleagues worldwide and our mission to serve patients.
我們仍專注於執行策略、聚焦成長驅動因素、投資於最佳創新,並維持嚴謹的財務紀律,使我們能實現可持續的長期成長,並為病患、員工與股東創造價值。我很感謝能與全球所有同仁一起工作,並共同肩負服務病患的使命。
And with that, this concludes our financial update. I'll now hand it over to Bob for Q&A.
以上為我們的財務更新。接下來我把時間交給 Bob 進行問答。
Robert Bradway - Chairman of the Board, President, Chief Executive Officer
Robert Bradway - Chairman of the Board, President, Chief Executive Officer
Okay. Thank you for that strong report, Pete. And before we open up to questions, let me just remind you that this is Pete's swan song earnings call with us, so I'll take a few minutes at the end of our Q&A to thank him and recognize his contributions to our firm.
好的。謝謝你帶來這份強勁的報告,Pete。在我們開始提問之前,我想提醒各位,這是 Pete 與我們一起參與的最後一場財報電話會議(告別之作),因此我會在問答結束時花幾分鐘感謝他並表彰他對公司的貢獻。
But now, Julianne, let's open the line up for questions.
不過現在,Julianne,讓我們開放電話線進行提問。
Operator
Operator
(Operator Instructions) Michael Yee, UBS.
(接線員指示)Michael Yee,瑞銀(UBS)。
Dina Elmonshed - Analyst
Dina Elmonshed - Analyst
This is Dina on for Mike. Just a quick question for Lp(a), two-part question. Just thinking about how you designed the protocol, is that involving an interim?
我是 Dina,代替 Mike 提問。關於 Lp(a) 有個簡短的兩部分問題。想請教你們在設計試驗方案時,是否包含期中分析(interim)?
And then maybe just -- I know that you guys are doing a MACE-3 endpoint, opposed to Novartis is doing MACE-4. Just given that, do you see the exclusion of stroke to be affecting the time of your study versus having a MACE-4 endpoint?
另外也想請教——我知道你們採用的是 MACE-3 終點,而諾華(Novartis)採用的是 MACE-4。在這樣的差異下,你們排除中風(stroke)是否會影響研究所需時間,相較於採用 MACE-4 終點?
James Bradner - Executive Vice President - Research and Development, Artificial Intelligence and Data
James Bradner - Executive Vice President - Research and Development, Artificial Intelligence and Data
Yes. Thanks for your question. As you know, our development of Olpasiran, which is a potentially best-in-class siRNA for modifying the risk of cardiovascular disease attributable to Lp(a) elevations affect one in five patients. It's a serious and profound unmet need, and it's terrific to see so much attention for what is one of the last known and well-defined genetically modifiable risk factors.
是的。謝謝你的問題。如你所知,我們正在開發的 Olpasiran,是一款可能同級最佳(best-in-class)的 siRNA,用於降低因 Lp(a) 升高所致的心血管疾病風險;Lp(a) 升高影響每五位病患中的一位。這是一項嚴重且重大的未被滿足醫療需求;很高興看到大家對此投入大量關注,因為這是目前已知且界定清楚、可透過基因途徑調整的最後幾個風險因子之一。
We have a terrific study design with OCEAN(a). This is a double-blind randomized controlled trial, as you asked, 7,297 patients have been enrolled in record time, and there are distinguishing features of our design. One is the requirement for elevations of Lp(a) above 200, that's nanomoles per liter. With this every-12-week dosing in an event-driven study, we'll read out a primary event, as you shared, of 3-point MACE.
我們在 OCEAN(a) 的研究設計非常出色。如你所問,這是一項雙盲、隨機分派的對照試驗;共有 7,297 名病患在創紀錄的時間內完成入組,而且我們的設計有幾個具區別性的特點。其中之一是要求 Lp(a) 升高至 200 以上(單位為奈莫耳/公升)。在這項以事件驅動的研究中採每 12 週給藥一次,我們將以你提到的 3 點 MACE 作為主要事件終點讀出。
We focus on 3-point MACE after extensive human genetics and population science analysis indicated to us that the association of ischemic stroke and Lp(a) elevation was not as compelling as other cardiac-specific cardiovascular endpoints. And this is, therefore, a potentially important distinction between this study and others. And you asked, does the stroke -- the lack of inclusion of stroke and the endpoint influenced the event rate, not by our modeling.
在廣泛的人類遺傳學與族群科學分析後,我們將重點放在 3 點 MACE,因為分析顯示缺血性中風與 Lp(a) 升高之間的關聯性,不如其他更偏心臟特異性的心血管終點那麼有說服力。因此,這可能是本研究與其他研究之間的一項重要差異。你也問到:未納入中風作為終點是否會影響事件率;依我們的模型推估,不會。
Casey Capparelli - Vice President - Investor Relations
Casey Capparelli - Vice President - Investor Relations
Julianne, next question, please.
Julianne,請下一題。
Operator
Operator
Salveen Richter, Goldman Sachs.
Salveen Richter,高盛。
Salveen Richter - Analyst
Salveen Richter - Analyst
On business development, you have reiterated a focus on securing the best innovation, and appear agnostic on site structure, as long as the deal meets your criteria. Walk us through how your latest thinking here is playing out currently, and the capital allocation strategy, more broadly. And how much of the near-term BD strategy depends on outcomes from clinical readouts from MariTide and Lp(a)?
在業務開發方面,你們一再強調聚焦於取得最佳創新,且似乎對據點/場址結構持開放態度,只要交易符合你們的標準即可。請帶我們了解你們目前最新的思考如何落地執行,以及更廣泛的資本配置策略。另外,短期的 BD 策略在多大程度上取決於 MariTide 與 Lp(a) 的臨床讀出結果?
Robert Bradway - Chairman of the Board, President, Chief Executive Officer
Robert Bradway - Chairman of the Board, President, Chief Executive Officer
Look, Salveen, I think our business development strategy is pretty consistent. We've articulated it, I think, in that way now over a number of years. So we're focused on the therapeutic areas where we think we can add value in research and in development. We're focused on the four areas that you've heard us discuss on this call, and we're continuing to look at interesting opportunities there. And we frequently repeat that our objective is to find and advance the best innovation, whether it's generated internally or externally, and that's what we're doing.
Salveen,你看,我認為我們的業務開發策略相當一致。我想我們已經用這樣的方式闡述了好幾年。因此,我們聚焦在我們認為能在研究與開發上創造價值的治療領域。我們聚焦在你們在這通電話中聽到我們討論的四個領域,並持續在那裡尋找有趣的機會。我們也經常重申,我們的目標是找到並推進最佳創新,不論是內部或外部產生的,而這正是我們正在做的。
I would just observe that we're seeing some exciting early-stage progress in our industry right now. So I suspect we're not the only ones that are interested in some of the emerging shoots that look intriguing. So we are looking, but primarily in smaller earlier-stage assets.
我只想補充觀察到,我們目前在產業中看到一些令人振奮的早期進展。所以我猜我們並不是唯一對一些看起來很有吸引力的新興苗頭感興趣的人。因此我們正在尋找,但主要聚焦在較小、較早期階段的資產。
And not -- the answer to your question about the late Phase 3 trials is not directly. Obviously, our operational plate is pretty full in the late-stage clinical development right now, for example, in cardiometabolic disease. But we try to be mindful of that as we look for external opportunities, but it's not linked as directly as your question implies.
至於你問到晚期第三期試驗的問題——答案並不是直接相關。顯然,我們目前在晚期臨床開發上的營運負荷相當滿,例如在心腎代謝疾病領域。但我們在尋找外部機會時會留意這點,不過它並不像你的問題所暗示的那樣直接連動。
Thanks. Let's move on to the next question, Julianne.
謝謝。我們進入下一題,Julianne。
Operator
Operator
Chris Schott, JPMorgan.
Chris Schott,摩根大通。
Taylor Hanley - Analyst
Taylor Hanley - Analyst
This is Taylor Hanley on for Chris at JPMorgan. Thank you so much for taking our question. We had a follow-up on Lp(a). So there's competitor LP(a) data that's expected shortly. What will you be looking for when this dataset reads out? And specifically, if we do see a 13%- to 15%-type benefit from that study, how would you think about the potential read-throughs for Olpasiran?
我是摩根大通的 Taylor Hanley,代 Chris 提問。非常感謝讓我們提問。我們有一個關於 Lp(a) 的追問。競品的 Lp(a) 數據預計很快就會公布。當這組資料讀出時,你們會重點關注什麼?具體而言,如果我們確實看到該研究呈現 13% 到 15% 類型的獲益,你們會如何看待對 Olpasiran 的潛在讀穿(read-through)意涵?
James Bradner - Executive Vice President - Research and Development, Artificial Intelligence and Data
James Bradner - Executive Vice President - Research and Development, Artificial Intelligence and Data
Thanks for the interest, Taylor. Again, with a huge unmet need affecting so many humans globally, and the American Heart Association recommending testing, it's understandable that there will be so much attention on Lp(a), and we quite like our chances with Olpasiran and its profile.
Taylor,謝謝你的關注。再次強調,這是一個影響全球眾多患者、存在巨大未被滿足需求的領域,而且美國心臟協會也建議進行檢測,因此大家對 Lp(a) 有如此高度的關注是可以理解的;我們也相當看好 Olpasiran 及其特性所帶來的勝算。
What can we expect from the pelacarsen data? We're following it with interest. We can expect perhaps directional insight, but not decisional perspective, owing to the superior properties of our molecule that delivered 95% Lp(a) reduction compared to, say, 70% with that molecule, and also some differences in the study design, which we just described.
我們可以從 pelacarsen 的數據期待什麼?我們也在密切關注。我們或許可以期待一些方向性的洞見,但不至於形成決策性的觀點,原因在於我們分子的特性更優,能帶來 95% 的 Lp(a) 降幅,相較之下該分子大約是 70%;此外,研究設計也存在一些差異,我們剛才也已說明。
Casey Capparelli - Vice President - Investor Relations
Casey Capparelli - Vice President - Investor Relations
Great. Next question, Julianne?
很好。下一題,Julianne?
Operator
Operator
Umer Raffat, Evercore ISI.
Umer Raffat,Evercore ISI。
Umer Raffat - Equity Analyst
Umer Raffat - Equity Analyst
Thanks for taking my questions. Jay, I have two, if I may, for you. One, based on everything you know right now on all the titration that's been put into place, how confident are you that the vomiting rates in Phase 3 trials of MariTide will be mid-20s or better?
謝謝讓我提問。Jay,如果可以的話我有兩個問題。第一,基於你們目前所掌握的一切資訊,以及已經導入的所有劑量遞增(titration)措施,你們對 MariTide 第三期試驗中的嘔吐發生率會落在 20% 中段或更好,有多大信心?
And secondly, are you tracking malignancies on a blinded basis in the ongoing dazo -- I always get it wrong, on the CD40 trial? I'd be very curious.
第二,在正在進行的 dazo——我總是念錯——那個 CD40 試驗中,你們是否在盲態下追蹤惡性腫瘤事件?我很想了解。
James Bradner - Executive Vice President - Research and Development, Artificial Intelligence and Data
James Bradner - Executive Vice President - Research and Development, Artificial Intelligence and Data
Dazodalibep, Umer. Dazodalibep, it rolls right off tongue. Yes. First, regarding the MariTide clinical development program, we are noses down delivering a very compelling Phase 3 data package right now. 2026 is a year of very disciplined data generation. Trial enrollment is strong, I think a clear sign of the remaining unmet need, and also an interest in the MariTide profile. We're executing a broad therapeutic program very well, and we are very confident in the profile of this medicine.
Dazodalibep,Umer。Dazodalibep,順口得很。是的。首先,關於 MariTide 的臨床開發計畫,我們正全力以赴,致力於交付一套非常具說服力的第三期數據組合。2026 年將是非常嚴謹產出數據的一年。試驗收案進展強勁,我認為這清楚顯示仍存在未被滿足的需求,也反映出對 MariTide 特性的興趣。我們正在非常出色地執行一個廣泛的治療計畫,並且對這項藥物的特性非常有信心。
Second, around Dazodalibep, as appropriate for any medicine in Phase 3 clinical investigation, especially immunomodulatory medicines, we have a data safety monitoring committee associated with these studies that is just doing their job perfectly. As we would expect, they're capturing all high and potentially associated, as well as really any incident effects of the medicine. And we'll learn more about Dazodalibep in H2 of this year.
第二,關於 Dazodalibep,對任何處於第三期臨床研究的藥物而言——尤其是免疫調節藥物——我們都設有資料安全監測委員會(DSMC)來配合這些研究,而他們正非常到位地履行職責。如同我們所預期,他們正在收集所有嚴重且可能相關的事件,以及實際上任何藥物的不良影響。我們將在今年下半年(H2)對 Dazodalibep 有更多了解。
Casey Capparelli - Vice President - Investor Relations
Casey Capparelli - Vice President - Investor Relations
Next question please, Julianne.
下一題,Julianne。
Operator
Operator
Yaron Werber, TD Cowen.
Yaron Werber,TD Cowen。
Yaron Werber - Analyst
Yaron Werber - Analyst
Quick question on Dazo as well. The -- you're the only company running both systemic and symptomatic studies, and a lot of the feedback from KOLs is that that's obviously a huge area of interest for them. A lot of the patients that are systemic naturally obviously have glandular manifestations, and so the symptomatic are really extraglandular manifestations. Can you talk about the difference? And at the end, how much of a differentiated label can you get relative to companies who are only working in systemic disease?
也快速問一題關於 Dazo。你們是唯一一家同時進行系統性(systemic)與症狀性(symptomatic)研究的公司,而許多 KOL 的回饋是,這顯然是他們非常感興趣的領域。很多系統性患者自然也會有腺體表現,因此所謂症狀性其實是腺體外表現。你能談談兩者的差異嗎?最後,相較於只做系統性疾病的公司,你們能取得多大程度的差異化適應症標示(label)?
James Bradner - Executive Vice President - Research and Development, Artificial Intelligence and Data
James Bradner - Executive Vice President - Research and Development, Artificial Intelligence and Data
Yes, thank you. This is a terrific question. As you know, Dazodalibep is a potentially first-in-class CD40 ligand Fc chimeric protein that's just beautifully designed in order to maximize inhibition of CD40 ligand signaling from activated T cells to B cells and epithelial cells. They're enriched for CD40 in the milieu of lymphocytic infiltrated glandular tissue, like the salivary glands that you mentioned in your question.
好的,謝謝。這是個很棒的問題。如你所知,Dazodalibep 是一種可能的同類首創(first-in-class)CD40 配體 Fc 嵌合蛋白,設計得非常精巧,目的是最大化抑制由活化 T 細胞傳遞至 B 細胞與上皮細胞的 CD40 配體訊號。在淋巴細胞浸潤的腺體組織環境中(例如你問題中提到的唾液腺),CD40 表現更為富集。
We are pursuing the Phase 3 clinical investigation of Dazodalibep in both the systemic population as well as the symptomatic population because there's tremendous unmet need. There's 350,000 or more patients with Sjögren's disease. There's few effective therapies. Those therapies that are FDA approved are by and large local and symptomatic management therapies.
我們在系統性族群與症狀性族群中都推進 Dazodalibep 的第三期臨床研究,因為未被滿足的需求非常巨大。乾燥症(Sjögren's disease)患者有 35 萬人或更多。有效療法很少。而那些獲 FDA 核准的療法,大多是局部與症狀控制的管理治療。
And the signal that we saw in our Phase 2 clinical study, as you'll recall, there were two populations: population 1 at 74 patients with systemic disease. And at day 169, we saw significant movement of the ESSDAI score of 6.3 versus 4.1 on placebo. Population 2: we had 109 patients with symptomatic disease. At day 169, the ESSPRI score in that case, appropriate for that constellation of symptoms, was also superior to placebo, negative 1.8 versus negative 0.5. So a big unmet need, and activity in these two populations that are rightly studied distinctly, because there are different clinically useful scores that physicians use to follow them. It's just a very nice data package to build upon for Phase 3.
而在我們第二期臨床研究中看到的訊號,如你所記得的,有兩個族群:族群 1 為 74 位系統性疾病患者。在第 169 天,我們看到 ESSDAI 分數有顯著改善:6.3,相較安慰劑為 4.1。族群 2:我們有 109 位症狀性疾病患者。在第 169 天,該情況下使用的 ESSPRI 分數(適用於那組症狀組合)也優於安慰劑,為負 1.8 相較負 0.5。因此,未被滿足的需求很大,而這兩個族群也確實應該分別研究,因為醫師用來追蹤它們的、具臨床實用性的評分量表不同。這是一套非常好的數據組合,可作為第三期研究的扎實基礎。
And now we're deep in Phase 3. We have 621 patients on the systemic study, 434 in the symptomatic. They need to be studied differently for the reasons I've mentioned, and we'll learn more about the impact of this medicine in that disease in H2 of this year. So we're very hopeful, but humble. It's a very challenging disease.
而現在我們已經深入第 3 期。我們在全身性研究中有 621 名患者,在症狀性研究中有 434 名。基於我提到的原因,他們需要以不同方式進行研究,而我們將在今年下半年進一步了解這款藥物在該疾病中的影響。所以我們非常有希望,但也保持謙遜。這是一種非常具挑戰性的疾病。
Casey Capparelli - Vice President - Investor Relations
Casey Capparelli - Vice President - Investor Relations
Next question please, Julianne.
Julianne,請下一題。
Operator
Operator
Courtney Breen, Bernstein.
Courtney Breen,Bernstein。
Woody Polglase - Analyst
Woody Polglase - Analyst
This is Woody Polglase on for Courtney. I would just ask what you guys are seeing on TYK impact in the dermatology market with regards to Otezla. Are you seeing a slowdown in volumes and prescribing Otezla? And how should we think about the future of this drug, especially in light of IRA selection next year?
我是代替 Courtney 的 Woody Polglase。我想問一下,你們在皮膚科市場上看到 TYK 對 Otezla 的影響是什麼?你們是否看到 Otezla 的用量與處方出現放緩?另外,特別是考量到明年 IRA 納入遴選,你們認為這款藥物的未來應該如何看待?
Robert Bradway - Chairman of the Board, President, Chief Executive Officer
Robert Bradway - Chairman of the Board, President, Chief Executive Officer
Sure. Murdo, why don't you --
好的。Murdo,要不你--
Murdo Gordon - Executive Vice President - Amgen Global Markets and Policy
Murdo Gordon - Executive Vice President - Amgen Global Markets and Policy
Yes. One of the things to remember about Otezla is given the extensive clinical experience with this medicine, the broad label that we have that includes the milder forms of psoriasis, and the really clear coverage from payers, we generally are used as a first-stop systemic agent. And what we're seeing is the new entrants are competing with each other after Otezla is tried and -- So we're not really necessarily seeing direct competition from the new entrants. We are seeing definitely some pressure on price with Otezla, given some 340B exposure on that product. But overall, the volume in Otezla is actually holding up quite good.
是的。關於 Otezla,有一點要記住:由於這款藥物累積了大量臨床使用經驗,我們也擁有涵蓋較輕度乾癬的廣泛適應症標籤,且付費方的給付覆蓋非常明確,因此我們通常被用作第一線的全身性治療藥物。而我們看到的是,新進入者在 Otezla 先被嘗試之後,彼此之間相互競爭——因此我們不一定看到新進入者與我們形成直接競爭。我們確實看到 Otezla 的價格面臨一些壓力,因為該產品有一定的 340B 曝險。但整體而言,Otezla 的用量其實維持得相當不錯。
Casey Capparelli - Vice President - Investor Relations
Casey Capparelli - Vice President - Investor Relations
Julianne, next question, please.
Julianne,請下一題。
Operator
Operator
Terence Flynn, Morgan Stanley.
Terence Flynn,Morgan Stanley。
Chris Yu - Analyst
Chris Yu - Analyst
This is Chris on for Terence. Just a two-part question on PCSK9. Merck's oral PCSK9 recently got approved. Can you compare and contrast the key label language differences from that of Repatha? And also, can you comment on the contract dynamics now that there's an oral option?
我是代替 Terence 的 Chris。關於 PCSK9 有兩個問題。Merck 的口服 PCSK9 最近獲得核准。你能否比較並對照它與 Repatha 的標籤文字在關鍵差異上有哪些不同?另外,現在有口服選項後,你能否評論一下合約(議價)動態?
Robert Bradway - Chairman of the Board, President, Chief Executive Officer
Robert Bradway - Chairman of the Board, President, Chief Executive Officer
Sure. Murdo, why don't you?
好的。Murdo,要不你來回答?
Murdo Gordon - Executive Vice President - Amgen Global Markets and Policy
Murdo Gordon - Executive Vice President - Amgen Global Markets and Policy
Yes, let me take that one. Obviously, the two labels really just don't compare. You have Repatha, as Jay mentioned, over 50,000 patients on clinical trial experience, reflected in a broad label that includes primary and secondary prevention. Repatha can be used as monotherapy or in combination with statins. 10 years of real-world experience reflected in data that we've presented at recent scientific meetings. So as we say, the data behind Repatha are unrivaled. It is the category leader, and indeed, the data are unrivaled.
好的,我來回答這題。很明顯,這兩個標籤其實沒有可比性。Repatha 如 Jay 提到的,臨床試驗累積超過 50,000 名患者的經驗,反映在一個涵蓋一級與二級預防的廣泛標籤上。Repatha 可單獨使用或與他汀類合併使用。10 年的真實世界使用經驗也反映在我們近期於科學會議上發表的數據中。所以我們常說,Repatha 背後的數據無可匹敵。它是該類別的領導者,而且確實,這些數據無可匹敵。
I think, though, what's important to remember is that this is a huge market with a lot of patients that are still not at their LDL-cholesterol goal. And additional therapies, much like when inclisiran entered the market, are treating other patients. They are not necessarily competing for share with Repatha. And so -- we think there's a lot of education that still needs to be done. And we think that the guidelines are important in this market. And we think that we are able to drive utilization in this market more effectively, given the compelling data that we generated on VESALIUS.
不過,我認為重要的是要記住:這是一個非常龐大的市場,仍有許多患者的 LDL-膽固醇尚未達標。而新增的療法——就像 inclisiran 進入市場時一樣——是在治療其他患者。它們不一定是在與 Repatha 爭奪市占。因此——我們認為仍有大量教育工作需要進行。我們也認為臨床指引在這個市場很重要。並且我們認為,憑藉我們在 VESALIUS 產生的具說服力數據,我們能更有效地推動這個市場的使用量。
The other thing that we've experienced with Repatha as we look at persistency data in the market and the real-world analysis. This is -- an every-two-week injection is a really easy regimen for patients to adhere to. And we've seen limitations with orals, including with statins, where daily oral therapy does have some compliance and some adherence challenges to it.
另外一點是,當我們觀察 Repatha 在市場上的持續用藥(persistency)數據與真實世界分析時,我們的經驗是:每兩週一次的注射,對患者而言是一個非常容易遵從的療程。而我們也看到口服藥(包括他汀類)存在一些限制:每日口服治療在服藥依從性與遵從性方面確實會有一些挑戰。
We're also seeing in the label with the new PCSK9 approval that there are indeed food restrictions, that you have to be careful with what you eat in the first 30 minutes after you take that medicine. So I think this oral versus injectable is too simplistic a compare, and you really have to look at why do you take an LDL cholesterol medicine in the first place, and it's to prevent a first or a second heart attack, and we've demonstrated that with very clear evidence for Repatha.
我們也在這次新核准的 PCSK9 標籤中看到,確實存在飲食限制:在服藥後的前 30 分鐘,你必須注意你吃的東西。所以我認為,把口服與注射做過於簡化的比較並不恰當;你必須回到最根本的問題:你為什麼要服用降 LDL 膽固醇的藥?是為了預防第一次或第二次心肌梗塞,而我們已用非常明確的證據在 Repatha 上證明了這一點。
Casey Capparelli - Vice President - Investor Relations
Casey Capparelli - Vice President - Investor Relations
Julianne, next question, please.
Julianne,請下一題。
Operator
Operator
Akash Tewari, Jefferies.
Akash Tewari,Jefferies。
Manoj Eradath - Analyst
Manoj Eradath - Analyst
This is Manoj on for Akash. Just one from our end. One of the concerns around HORIZON Lp(a) trial is around the extent of Lp effect independent of LDL-C. In HORIZON trial, we see the baseline LDL-C is around like 65 milligrams per deciliter. What's the baseline LDL-C in the OCEAN trial you are planning? Or like is it in the same level? And also, is there a possibility that Lp(a) effects manifest only in presence of a relatively higher baseline LDL-C effect? Just trying to understand that one.
我是代替 Akash 的 Manoj。我們這邊只有一個問題。關於 HORIZON Lp(a) 試驗的一個疑慮,是 Lp 的效果在多大程度上能獨立於 LDL-C。在 HORIZON 試驗中,我們看到基線 LDL-C 大約在每分升 65 毫克左右。你們規劃中的 OCEAN 試驗的基線 LDL-C 是多少?或者大概是在相同水準嗎?另外,是否有可能 Lp(a) 的效果只會在相對較高的基線 LDL-C 存在時才會顯現?我只是想釐清這一點。
James Bradner - Executive Vice President - Research and Development, Artificial Intelligence and Data
James Bradner - Executive Vice President - Research and Development, Artificial Intelligence and Data
Well, thank you for the question. As I shared moments ago, we're enrolling the OCEAN(a) study to target an Lp(a) that's a little bit higher than the HORIZON study. By targeting 200 or higher in OCEAN(a), we biased towards a slightly higher risk group of patients. We believe, and have seen data from population studies, that Lp(a) elevation to this extent is firmly independent as a risk factor of LDL-C.
謝謝你的問題。如我剛才分享的,我們正在招募 OCEAN(a) 研究,目標是納入比 HORIZON 研究略高的 Lp(a)。在 OCEAN(a) 中以 200 或以上為目標,讓我們偏向納入風險略高的一群患者。我們相信,且也從族群研究數據中看到,Lp(a) 升高到這個程度,作為風險因子是明確獨立於 LDL-C 的。
And if I understand all aspects of your question, correct me, forgive me if I did not, the reduction of LDL-C, even with improving standard of cardiovascular care, to which Repatha contributes meaningfully, would not be sufficient to drop Lp(a) meaningfully from this elevation to protect patients adequately. So LP(a) directed therapy, we believe, is urgently needed, and we're conducting the studies to assess that.
如果我理解你問題的各個面向——若有不周之處也請指正——即使透過改善心血管照護標準(Repatha 在其中有重要貢獻)來降低 LDL-C,也不足以把 Lp(a) 從這樣的升高程度有意義地降下來,以充分保護患者。因此,我們認為針對 Lp(a) 的治療迫切需要,而我們正在進行研究來評估這一點。
Casey Capparelli - Vice President - Investor Relations
Casey Capparelli - Vice President - Investor Relations
Julianne, next question, please.
Julianne,請下一題。
Operator
Operator
Mohit Bansal, Wells Fargo.
Mohit Bansal,Wells Fargo。
Susan Chor - Analyst
Susan Chor - Analyst
This is Susan on for Mohit. A quick question on Repatha, and then a longer one on Dazodalibep. On Repatha, is that portion of growth just coming from broader primary care adoption versus existing prescribers? And how do you see that changing over time?
我是代替 Mohit 的 Susan。先問一個關於 Repatha 的簡短問題,然後再問一個關於 Dazodalibep 的較長問題。關於 Repatha,那部分的成長主要是來自更廣泛的基層醫療(primary care)採用,還是來自既有開立處方者的增加?你們認為這種情況隨時間會如何變化?
And then on Dazo, historically, symptomatic Sjögren's trials have struggled with endpoint sensitivity and placebo effect. I noticed for the Phase 3 trial that there's two primary endpoints measuring symptom improvement. Can you discuss the rationale for using two endpoints here? And what's the level of importance, just based on your trial design?
接著關於 Dazo,過去症狀性乾燥症(Sjögren's)試驗常在終點敏感度與安慰劑效應上遇到困難。我注意到第 3 期試驗有兩個用來衡量症狀改善的主要終點。你能否談談在這裡使用兩個終點的理由?以及就你們的試驗設計而言,其重要性層級是什麼?
Murdo Gordon - Executive Vice President - Amgen Global Markets and Policy
Murdo Gordon - Executive Vice President - Amgen Global Markets and Policy
All right. Thanks for the question. It's Murdo. I'll take the first one on Repatha and then hand it over to Jay for the second.
好的。謝謝你的問題。我是 Murdo。我先回答 Repatha 的第一個問題,然後把第二個問題交給 Jay。
We are pleased to see that Repatha is growing very nicely, particularly in new-to-brand prescriptions, so new patient starts. We grew about 50% year-over-year in the quarter in new-to-brand prescriptions, and it's being driven by two dynamics. One, cardiologists who already use Repatha for some patients are broadening their use of Repatha. So they're increasing the number of prescriptions they generate on a per-physician basis, treating more patients mostly in secondary prevention or in very high-risk primary prevention. So that's roughly about half of our growth.
我們很高興看到 Repatha 的成長表現非常亮眼,特別是在新品牌處方(new-to-brand prescriptions)方面,也就是新病人開始用藥。本季我們的新品牌處方年增約 50%,主要由兩個動能所驅動。第一,已經在部分病人使用 Repatha 的心臟科醫師,正在擴大 Repatha 的使用範圍。因此,他們在每位醫師的處方量上有所增加,治療更多病人,主要是在次級預防,或是風險非常高的初級預防族群。這大約貢獻了我們成長的一半。
And then the other half of our growth is coming for primary care physicians and expansion in the number of primary care physicians, in particular, who are prescribing Repatha for their high-risk primary prevention patients. And there, I would highlight one specific patient type, and that's those patients who have diabetes. The primary care community see that as a patient that they should manage for their cardiovascular risk. And given the VESALIUS data and then the subsequent diabetes substudy, the data there for adding Repatha for intensifying LDL cholesterol lowering are pretty compelling, and we're seeing more and more primary care physicians adopt the Repatha for those patients in particular for primary prevention.
而我們成長的另一半,來自家庭醫學/基層照護醫師,以及開立 Repatha 的基層照護醫師人數擴增,特別是他們為高風險初級預防病人開立 Repatha。在這裡,我想特別強調一種特定病人類型,也就是糖尿病病人。基層照護社群認為這類病人應該由他們來管理其心血管風險。而基於 VESALIUS 數據以及後續的糖尿病亞研究,將 Repatha 加入以加強 LDL 膽固醇降低的數據相當具說服力,因此我們看到越來越多基層照護醫師採用 Repatha,特別是用於這些病人的初級預防。
James Bradner - Executive Vice President - Research and Development, Artificial Intelligence and Data
James Bradner - Executive Vice President - Research and Development, Artificial Intelligence and Data
And your second question around the endpoint selected for the Phase 3 clinical investigation of Dazodalibep in Sjögrenâs disease. As I shared moments ago and as you clearly understand from your question, we have undertaken to do separate Phase 3 studies in each of two populations, the systemic population. And in this case, we use the ESSDAI score, which is a physician-observed score that reports on systemic manifestations of Sjögren's disease, a single endpoint.
至於你的第二個問題,關於 Dazodalibep 在乾燥症(Sjögrenâs disease)第三期臨床研究所選擇的終點。如我剛才分享、也如你從問題中清楚理解的,我們已著手在兩個族群中分別進行獨立的第三期研究,也就是系統性族群。在這個研究中,我們使用 ESSDAI 分數,這是一個由醫師觀察的評分,用於回報乾燥症的系統性表現,作為單一終點。
And in the second study, we are studying the symptomatic population that can have a more localized disease, but symptomatic and measurable for sure. And there, our interactions with regulators and with trialists in the community, as well as our own internal guidance, was to collect both the ESSPRI score, as well as the diary for assessing Sjögren's patient reported index, the DASPRI score, at week 48. In this way, we have two measures, both validated in other late-stage clinical studies that report on the subjective or lived experience of the patients on this medicine on this study. Thank you.
而在第二個研究中,我們研究的是症狀性族群,這類病人可能是較局部的疾病,但確實有症狀且可量測。在此,我們與主管機關及社群中的試驗研究者互動後,加上我們內部的指引,是在第 48 週同時收集 ESSPRI 分數,以及用於評估乾燥症病人回報指標的日記,也就是 DASPRI 分數。透過這種方式,我們有兩個衡量指標,兩者都已在其他後期臨床研究中獲得驗證,可用來反映病人在本研究中使用此藥物的主觀或生活經驗。謝謝。
Casey Capparelli - Vice President - Investor Relations
Casey Capparelli - Vice President - Investor Relations
Next question please, Julianne.
Julianne,請下一題。
Operator
Operator
Alex Hammond, Wolfe Research.
Wolfe Research 的 Alex Hammond。
Alexandria Hammond - Equity Analyst
Alexandria Hammond - Equity Analyst
So on IMDELLTRA, given you have a number of Phase 3 trials underway to bring it into earlier lines, can you provide a little bit of detail on what Amgen is doing to kind of improve those monitoring requirements? Should we view the reduced monitoring in Europe as a good sign?
關於 IMDELLTRA,鑑於你們正在進行多項第三期試驗,想把它推進到更早期的治療線別,你能否提供一些細節,說明 Amgen 正在做什麼來改善那些監測要求?我們是否應將歐洲監測要求降低視為一個正面訊號?
And as a follow-up, could we potentially see amendments for later-line monitoring requirements for IMDELLTRA in the future?
另外追問一下,未來我們是否可能看到針對 IMDELLTRA 在較後線治療的監測要求進行修訂?
James Bradner - Executive Vice President - Research and Development, Artificial Intelligence and Data
James Bradner - Executive Vice President - Research and Development, Artificial Intelligence and Data
Yes. Alex, thanks for the question. This is Jay again. The development of T cell engagers is an area of significant expertise here at Amgen, having pioneered the field with BLINCYTO, and now bringing IMDELLTRA forward for patients with small cell lung cancer, truly the first T cell engager to address a common solid tumor.
是的。Alex,謝謝你的問題。我是 Jay,再次回答。T 細胞接合劑(T cell engagers)的開發是 Amgen 具備深厚專業的領域;我們以 BLINCYTO 開創了這個領域,現在也將 IMDELLTRA 推進,用於小細胞肺癌病人,這確實是第一個用來處理常見實體腫瘤的 T 細胞接合劑。
And so building on this experience of establishing strong efficacy and survival benefit for receiving IMDELLTRA in the second line of small cell lung cancer, we're now doing the work needed to expand the impact of this medicine. And part of that work is combination studies. And part of that work is bringing the medicine forward into frontline therapy and preparing the medicine for a combination utility. And as you ask, for sure, making the experience of receiving IMDELLTRA for the patient easier and less burdensome for healthcare providers, or institutions with regard to monitoring.
因此,基於我們在小細胞肺癌二線治療中建立 IMDELLTRA 強勁療效與存活獲益的經驗,我們現在正進行必要工作,以擴大此藥物的影響力。其中一部分工作是合併治療研究。另一部分是將藥物推進到第一線治療,並為其合併治療用途做準備。如你所問,當然也包括讓病人接受 IMDELLTRA 的體驗更容易、並降低醫療照護提供者或機構在監測方面的負擔。
The second line Phase 3 is from 16 hours of monitoring at that time, appropriate for that stage of development. We now have real-world experience and ongoing clinical study experience all the way down to one to two hours of monitoring, say, in the context of our limited stage.
二線第三期試驗當時的監測時間是 16 小時,對於那個開發階段而言是合適的。現在我們已累積真實世界經驗與持續進行的臨床研究經驗,監測時間已可一路降到 1 到 2 小時,例如在我們的有限期(limited stage)情境中。
And with this medicine, ICANS, the neurologic consequence, thankfully, is quite infrequent and predominantly was observed at the 100-milligram dose. And so this really opens the door towards sequential reductions in monitoring through prospective clinical investigation, as well as longitudinal engagement with federal regulators, global regulators with our accruing safety database.
而在這個藥物上,ICANS 這種神經學後果,所幸發生率相當低,而且主要是在 100 毫克劑量下觀察到。因此,隨著我們累積的安全性資料庫,這確實為透過前瞻性臨床研究逐步降低監測要求,以及與聯邦主管機關、全球主管機關進行長期互動,打開了大門。
Murdo, anything to add here?
Murdo,你要補充嗎?
Murdo Gordon - Executive Vice President - Amgen Global Markets and Policy
Murdo Gordon - Executive Vice President - Amgen Global Markets and Policy
Yes. Thanks, Jay. We're obviously excited, Alex, about the additional data generation that Jay and his team are leading.
是的。謝謝,Jay。Alex,我們顯然對 Jay 和他的團隊所主導的額外數據產出感到非常振奮。
In the market right now, we've actually been quite successful in getting more and more accounts operationally ready to treat patients with IMDELLTRA. We've got over 2,000 accounts in the US currently using IMDELLTRA. The opportunity for growth is to treat even more patients in the second line in the near term, and of course, we've been able to establish an overall survival benefit there against commonly used chemotherapies. And given the operational complexities, we've been able to get quite a large base with those 2,000 accounts ready to be able to treat more and more of those patients.
就目前市場而言,我們其實已相當成功地讓越來越多帳戶在營運上準備好為病人使用 IMDELLTRA。目前在美國已有超過 2,000 個帳戶正在使用 IMDELLTRA。短期的成長機會是在二線治療中讓更多病人接受治療;當然,我們也已在那裡相對於常用化療建立了整體存活期(overall survival)獲益。而考量到營運上的複雜性,我們已建立相當大的基礎,讓這 2,000 個帳戶準備就緒,能夠治療越來越多這類病人。
So with an almost doubling of revenues in the quarter, obviously, we're on a nice pace with this medicine, and helping give small cell lung cancer patients a shot at real survival benefit, which they, prior to IMDELLTRA in the second line, were unable to achieve.
因此,本季營收幾乎倍增,顯然我們在這個藥物上正以不錯的速度前進,也在幫助小細胞肺癌病人獲得真正的存活獲益機會;在 IMDELLTRA 用於二線治療之前,他們是無法達成這點的。
Casey Capparelli - Vice President - Investor Relations
Casey Capparelli - Vice President - Investor Relations
Julianne, next question, please.
Julianne,請下一題。
Operator
Operator
Dave Risinger, Leerink Partners.
Leerink Partners 的 Dave Risinger。
David Risinger - Analyst
David Risinger - Analyst
Thanks very much, and thanks for all of the details today and all the commentary on the pipeline. So my question is for Jay, please. Regarding MariTide's construct. So it's GLP-1 peptides conjugated to a GIP-tagonist antibody, of course. Could you discuss the duration of effect of each mechanism and potential implications for duration of efficacy? Obviously, since the peptide component will last a lot shorter than the antibody.
非常感謝,也謝謝今天提供的所有細節,以及對研發管線的各項評論。所以我的問題想請教 Jay。關於 MariTide 的構造。它當然是將 GLP-1 胜肽與一個 GIP-tagonist 抗體做共軛。你能否談談各個機制的作用持續時間,以及對療效持續時間可能帶來的影響?顯然,胜肽組分在體內維持的時間會比抗體短得多。
And then if you could also comment on whether you expect real-world patient-led dosing selection for every one, two, or three months maintenance dosing based upon individual experience? Is that the right way that we should be thinking about it?
另外,你也能否評論一下,你是否預期在真實世界中,病人會依據個人經驗自行選擇每 1、2 或 3 個月一次的維持劑量給藥?這是否是我們應該用來思考的正確方式?
James Bradner - Executive Vice President - Research and Development, Artificial Intelligence and Data
James Bradner - Executive Vice President - Research and Development, Artificial Intelligence and Data
Well, Dave, thank you for the question. I wish we -- only we had more time and a whiteboard to take you through the answer, I'll be succinct.
Dave,謝謝你的問題。我希望我們——如果有更多時間和一塊白板,可以帶你完整走過答案;我會簡要說明。
MariTide is truly a singularity. It's the only-of-its-kind antibody peptide conjugate, and because of the antibody design, unlike peptides, that through miracles of chemistry last maybe a week in the bloodstream, the antibody design affords a half-life of approximately 21 days. And that's the half-life of the intact molecule MariTide. MariTide-appending peptides were designed and appended in order to maximize stability to tissue proteinases and to serum esterases and other xenobiotic metabolizing enzymes in tissues and in circulation.
MariTide 確實是獨一無二的存在。它是唯一同類的抗體-胜肽共軛物;而由於抗體的設計,不同於胜肽——胜肽透過化學上的奇蹟在血液中或許只能維持約一週——抗體設計使其半衰期約為 21 天。而這就是完整分子 MariTide 的半衰期。MariTide 所接上的胜肽,是為了最大化其對組織蛋白酶、血清酯酶,以及其他在組織與循環中代謝外源性物質的酵素之穩定性而設計並接合的。
And because of this, the duration of effect of the GPR inhibitory variable chains of the antibody and the GLP-1 receptor agonizing peptides on MariTide is preserved through this long period of exposure. And what that means is that with monthly dosing, as used with starting MariTide and with the transition to less frequent dosing, maybe four to six doses per year as you start to stay on MariTide, or you switch from another medicine and then stay on MariTide, that the GLP-1 agonism and GIP receptor antagonism is quite persistent, as the molecule is quite persistent.
也正因如此,抗體的 GPR 抑制性可變鏈以及 MariTide 上的 GLP-1 受體致效胜肽,其作用持續時間得以在這段長時間暴露期間被保留。這表示,採用每月給藥(如 MariTide 起始治療所使用),並在過渡到更低頻率給藥時——當你開始維持使用 MariTide,或從其他藥物轉換後再維持使用 MariTide——可能一年四到六次給藥,GLP-1 致效作用與 GIP 受體拮抗作用都相當持久,因為該分子本身相當持久。
Why is this important? Because we're that to, say, burn off with metabolism or illumination of the drug, then rechallenge with a therapeutic dose of the drug will be very hard. And that's not what we're seeing on our clinical studies, as we've shared. With less frequent dosing, MariTide at target doses proved very, very well tolerated. And so this design is reading through to a truly differentiating clinical activity and a different experience for patients.
為什麼這很重要?因為如果藥物會被代謝或清除而「消耗殆盡」,那麼再以治療劑量重新挑戰用藥將會非常困難。而這並不是我們在臨床研究中所看到的情況,正如我們已分享的。在較低頻率給藥下,達到目標劑量的 MariTide 證明具有非常、非常良好的耐受性。因此,這項設計正轉化為真正具差異化的臨床活性,以及患者不同的用藥體驗。
Your second question is a little harder. I can't predict the way in which MariTide in the fullness of time will be utilized by prescribing physicians and by patients. But what we're seeing is activity in our Phase 2 for chronic weight management as for diabetes is observed at multiple different doses. And as we've shared, that maintenance MariTide can be administered on different schedules. And so this would -- I can say to the physician, this would seem to imply real flexibility in approaching how best to take MariTide.
你的第二個問題比較難。我無法預測隨著時間推移,處方醫師與患者將如何使用 MariTide。但我們在第二期試驗中看到,無論是慢性體重管理或糖尿病,在多個不同劑量下都觀察到療效。而且如我們所分享的,維持期的 MariTide 可以用不同的給藥時程來施用。因此——我可以對醫師說——這似乎意味著在如何最適切地使用 MariTide 方面具有真正的彈性。
Murdo, what would you add?
Murdo,你會補充什麼?
Murdo Gordon - Executive Vice President - Amgen Global Markets and Policy
Murdo Gordon - Executive Vice President - Amgen Global Markets and Policy
Well, I think your team is doing a nice job, Jay, of generating data that will inform the clinical practice and, of course, patient optionality with 12 doses, 6 doses, and perhaps even 4 doses a year. And I think that is different for MariTide than the current weekly injectables that have to be dosed 52 times a year. And there are scan data describing how you can maintain when you dose stretch on those therapies for various obvious reasons. So I think it's a good thing for patients that we're doing those trials, and I think it will be really interesting, when the data are available, to see how it changes patient behavior.
嗯,我認為你的團隊做得很好,Jay,正在產生可用來指引臨床實務的數據,當然也讓患者在一年 12 次、6 次,甚至可能 4 次給藥之間有選擇空間。我認為這對 MariTide 而言不同於目前每週注射、每年必須給藥 52 次的療法。而且也有掃描數據描述,出於各種顯而易見的原因,在那些療法上拉長給藥間隔時,你如何仍能維持療效。所以我認為我們進行這些試驗對患者是好事,而且我也覺得當數據出來時,看看它如何改變患者行為會非常有意思。
Robert Bradway - Chairman of the Board, President, Chief Executive Officer
Robert Bradway - Chairman of the Board, President, Chief Executive Officer
Okay, Julianne, why don't we take one more question.
好的,Julianne,我們再來一個問題。
Operator
Operator
Jay Olson, Oppenheimer.
Jay Olson,Oppenheimer。
Jay Olson - Analyst
Jay Olson - Analyst
Congrats to Peter for a great run at Amgen, and all the best in retirement. Our question is about your cardiovascular portfolio. As you look across Repatha, Olpasiran, and MariTide, Amgen is building a comprehensive cardiovascular risk reduction franchise. So how are you thinking about leveraging those three assets with a coordinated strategy? And what are the advantages that creates versus competitors who might be pursuing only one or two components of cardiovascular risk?
恭喜 Peter 在安進(Amgen)有一段非常出色的任期,也祝退休生活一切順利。我們的問題是關於你們的心血管產品組合。當你們綜觀 Repatha、Olpasiran 與 MariTide 時,安進正在打造一個全面的心血管風險降低產品平台。那麼你們如何思考以協同策略來運用這三項資產?相較於可能只追求心血管風險一到兩個組成要素的競爭對手,這樣做能帶來哪些優勢?
Robert Bradway - Chairman of the Board, President, Chief Executive Officer
Robert Bradway - Chairman of the Board, President, Chief Executive Officer
Murdo, why don't you share your thoughts?
Murdo,你來分享一下你的想法?
Murdo Gordon - Executive Vice President - Amgen Global Markets and Policy
Murdo Gordon - Executive Vice President - Amgen Global Markets and Policy
Well, Jay, thank you for the acknowledgment of the breadth and depth of the cardiovascular portfolio. I think it's obviously a nice opportunity, given the foundational strength we have in the LDL cholesterol-lowering market and cardiovascular risk reduction market with the leadership position we've established with Repatha.
好的,Jay,謝謝你肯定我們心血管產品組合的廣度與深度。我認為這顯然是一個很好的機會,因為我們在 LDL 膽固醇降低市場與心血管風險降低市場具備堅實的基礎實力,並且透過 Repatha 建立了領導地位。
I think what you've heard, even on today's call, and you've heard from us prior to this, is the experience that we've gained from Repatha has been applied to the clinical development and the design of the clinical programs behind Olpasiran and behind MariTide.
我想你們已經聽到——即使在今天的電話會議上,以及在此之前我們也提過——我們從 Repatha 所累積的經驗,已被應用到 Olpasiran 與 MariTide 背後的臨床開發與臨床計畫設計上。
We're not just developing Olpasiran for secondary prevention. We're looking at primary prevention. We're not just developing MariTide for weight loss. We're developing it for diabetes and for heart failure and for ASCVD. We're looking at all of the different independent metabolic risk factors that travel with losing weight. And so it's our intent to fully explore each of these unique medicines, these best-in-class, potentially first-in-class of their kind molecules, as well as potential combinations thereof.
我們不只是為了次級預防而開發 Olpasiran。我們也在看初級預防。我們不只是為了減重而開發 MariTide。我們也為糖尿病、心衰竭以及 ASCVD 開發它。我們正在檢視所有與減重伴隨而來、彼此獨立的各種代謝風險因子。因此,我們的意圖是全面探索這些獨特藥物——這些同類最佳、且可能是同類首創的分子——以及它們之間潛在的組合。
So this is an exciting time for us. We continue to develop additional molecules in the clinic, and we continue to look outside for additional external innovation that could be brought in. So it's an important part of our long-term growth strategy, and one that we expect to be durable well into the next decade.
所以這對我們而言是令人振奮的時刻。我們持續在臨床端開發更多分子,也持續向外尋找可引進的外部創新。因此,這是我們長期成長策略的重要部分,而且我們預期其韌性可延續到下一個十年。
Robert Bradway - Chairman of the Board, President, Chief Executive Officer
Robert Bradway - Chairman of the Board, President, Chief Executive Officer
Okay. Thank you, Murdo. Thank you, Jay, for the question.
好的。謝謝你,Murdo。也謝謝你,Jay,提出這個問題。
Well, as I said, let me just take a minute to thank all of you for joining our call. I hope you can see that our business is in strong shape, and that is indeed a fitting way for Pete to pass to Tom, to Thomas Dittrich, who will be in the CFO role for our next call. Recall that Thomas returns as a veteran of the Amgen finance team. We're delighted to have him back, and grateful to Pete for ensuring another smooth transition of responsibilities at Amgen.
那麼,如我所說,讓我花一點時間感謝各位參加我們的電話會議。我希望各位可以看到,我們的業務狀況非常穩健,而這也確實是 Pete 將職務交棒給 Tom——Thomas Dittrich——的一個恰當方式;他將在下一次電話會議中擔任我們的財務長(CFO)。請記得,Thomas 是以安進財務團隊資深成員的身分回歸。我們很高興他回來,也感謝 Pete 確保安進再次順利完成職責交接。
I know many of you have worked closely with Pete since he joined us at the end of 2019, and we've all had fun working with him in his role here, and are grateful to him for his many ways -- or the many ways in which he has strengthened our financial foundations. His disciplined financial leadership has enabled our largest-ever investments in research and development, acquisitions, and manufacturing capacity expansion. And he's also helped prepare Amgen for the future through our investments in technology, cybersecurity, and data capabilities that will serve us well in the years to come.
我知道你們許多人自 2019 年底 Pete 加入我們以來就與他密切合作;我們也都很享受與他在此職務上共事,並感謝他以多種方式——或說他強化我們財務基礎的諸多方式。他嚴謹自律的財務領導,使我們得以進行史上最大規模的研發投資、併購,以及製造產能擴張。此外,他也透過我們在科技、資安與數據能力上的投資,協助安進為未來做好準備,這些能力將在未來多年持續讓我們受益。
So Pete, on behalf of all of Amgen, thank you for your many contributions. You've been a great colleague and a good friend, and we wish you all the best in your next chapter of life.
所以 Pete,我代表全體安進同仁,感謝你做出的諸多貢獻。你一直是很棒的同事,也是很好的朋友;我們祝福你在人生下一個篇章一切順利。
Thank you all. Bye-bye.
謝謝大家。再見。
Operator
Operator
This concludes our Amgen Q2 2026 earnings conference call. You may now disconnect.
安進 2026 年第二季財報電話會議到此結束。您現在可以掛線。