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Daniel Segarra - Vice President - Investor Relations and Sustainability
Daniel Segarra - Vice President - Investor Relations and Sustainability
Hello, everyone. My name is Daniel Segarra, and I serve as the Head of Investor Relations and Sustainability and Vice President at Grifols. Welcome to our review of the company's business results for the third quarter of 2025. Today, I'm joined by Grifols' Chief Executive Officer, Nacho Abia; the President of Biopharma, Roland Wandeler; and Grifols' Chief Financial Officer, Rahul Srinivasan.
大家好。我叫丹尼爾‧塞加拉,擔任 Grifols 的投資人關係與永續發展主管兼副總裁。歡迎閱讀我們對公司2025年第三季業務業績的回顧。今天,與我一同出席的有 Grifols 執行長 Nacho Abia;生物製藥總裁 Roland Wandeler;以及 Grifols 財務長 Rahul Srinivasan。
A few logistics before we get into the details. Today's call will last about an hour, including a Q&A session. As a reminder, this call is being recorded. You can find additional materials, including today's presentation, in the Investor Relations section of the Grifols' website at grifols.com. The transcript and a replay of the webcast will also be available on the Investor Relations website within 24 hours.
在深入細節之前,先先交代一些後勤上的問題。今天的電話會議將持續約一小時,包括問答環節。再次提醒,本次通話正在錄音。您可以在 Grifols 公司網站 grifols.com 的投資者關係版塊找到更多資料,包括今天的簡報。網路直播的文字稿和回放也將在 24 小時內發佈在投資者關係網站上。
Turning to slide 2, please note that this presentation includes forward-looking statements regarding, among other things, the company's future operating and financial performance, market position and business strategy. These statements are based on current expectations and available information as of the date of the recording, and they are subject to certain risks and uncertainties that may cause actual results to differ materially from those projected.
請翻到第 2 張投影片,請注意,本簡報包含有關公司未來營運和財務表現、市場地位和業務策略等方面的前瞻性陳述。這些聲明是基於截至錄製日期的當前預期和可用信息,但存在某些風險和不確定性,可能導致實際結果與預期結果有重大差異。
Grifols financial statements are prepared in accordance with EU IFRS and other applicable reporting provisions, including alternative performance measures or APMs, prepared under the Group's financial reporting as defined by the European Securities and Markets Authority. Grifols management uses APMs to provide financial performance as the basis for operational and strategic decision-making. These APMs are prepared for all the time periods presented in this document.
Grifols 的財務報表依照歐盟國際財務報告準則 (EU IFRS) 和其他適用的報告規定編制,包括替代績效指標 (APM),這些指標是根據歐洲證券和市場管理局定義的集團財務報告編制的。Grifols 管理階層使用 APM 來提供財務業績,以此作為營運和策略決策的基礎。這些 APM 適用於本文檔中列出的所有時間段。
Now moving to today's agenda, and I will turn the call to Nacho to kick it off. Nacho?
現在進入今天的議程,我將把電話交給納喬,讓他開始發言。納喬?
Nacho Abia - Chief Executive Officer, Executive Director
Nacho Abia - Chief Executive Officer, Executive Director
Thank you, Danny, and hello, everyone, and thank you for joining us. The results we are presenting today demonstrates the continued commitment to delivering on our value creation plan. The performance achieved in the first half of the year has carried through, resulting in solid operational and financial results for the third quarter.
謝謝你,丹尼,大家好,謝謝各位的參與。我們今天展示的成果表明,我們將繼續致力於實現我們的價值創造計劃。上半年取得的良好業績延續到了第三季度,帶來了穩健的營運和財務表現。
This quarter reflects the sustained underlying demand of our products, solid market dynamics and disciplined execution, while we continue to navigate exchange rate headwinds and the anticipated impact of the Inflation Reduction Act. This progress also stems from the operational focus and financial stewardship we established in our road map at the beginning of the year, which remains the central pillar of our plan.
本季反映了我們產品持續的潛在需求、穩健的市場動態和嚴謹的執行力,同時我們繼續應對匯率逆風和預期中的《通貨膨脹削減法案》的影響。這項進展也源自於我們在年初制定的路線圖中確立的營運重點和財務管理,這仍然是我們計畫的核心支柱。
Our core business continued to perform well through the third quarter, led by the immunoglobulins franchise. This top-line performance has supported margin expansion, while tight cost management and focus on free cash flow generation have driven meaningful improvement in our free cash flow.
在免疫球蛋白業務的帶動下,我們的核心業務在第三季持續保持良好表現。營收成長支撐了利潤率的提升,而嚴格的成本管理和對自由現金流的關注則顯著改善了我們的自由現金流。
While we acknowledge the challenges of the complex global operating environment, Grifols has performed with consistency and confidence. Our structural advantage, including scale, solid vertical local integration in key markets and a globally diversified footprint have enabled us so far to adapt effectively, mitigate external pressure and sustain solid performance across key markets.
儘管我們承認複雜的全球經營環境充滿挑戰,但 Grifols 的表現始終穩定可靠。我們的結構優勢,包括規模、在關鍵市場穩固的垂直本地化以及全球多元化的業務佈局,使我們迄今為止能夠有效地適應變化,減輕外部壓力,並在關鍵市場保持穩健的業績。
Regarding exchange rate headwinds, the impact was reflected at both revenue and EBITDA levels, but it did not extend to our leverage ratio or free cash flow due to the significant levels of natural hedges within our business. In any case, we continue to implement mitigating actions and maintain vigilant oversight of evolving external conditions.
關於匯率不利因素,其影響反映在收入和 EBITDA 水準上,但由於我們業務中存在大量自然對沖,因此並未波及我們的槓桿率或自由現金流。總之,我們將繼續採取緩解措施,並密切關注不斷變化的外部環境。
As we track towards year-end, we remain attentive and measured in our approach. Year-to-date performance has been solid and in line with our expectations, reflecting disciplined execution and resilience.
隨著年底臨近,我們將繼續保持謹慎和穩健的態度。今年迄今的業績表現穩健,符合我們的預期,體現了嚴謹的執行力和韌性。
Looking ahead, we recognize that the external environment remains complex and dynamic, we continue to actively manage the factors within our control. By leveraging our structural strengths and maintaining discipline, we remain on track to meet our 2025 objectives.
展望未來,我們認識到外部環境依然複雜多變,我們將繼續積極管理我們可控範圍內的因素。透過發揮我們的結構優勢並保持紀律,我們將繼續朝著實現 2025 年目標的方向前進。
Before we move on, I want to pause and take a moment to thank the entire Grifols team for their ongoing commitment, focus and passion in executing our plan and advancing our mission.
在我們繼續之前,我想停下來,花點時間感謝 Grifols 團隊全體成員,感謝他們為執行我們的計劃和推進我們的使命所付出的持續努力、專注和熱情。
And with that, let's move to slide 5. On a year-to-date basis, we achieved revenue of EUR5.5 billion, representing a year-over-year increase of 7.7% and 10.5% like-for-like after IRA and gross-to-net adjustments, both at constant currency.
接下來,我們來看第5張投影片。截至目前,我們實現了 55 億歐元的收入,年增 7.7%,經 IRA 和毛利淨額調整後,年增 10.5%(均以固定匯率計算)。
Third quarter adjusted EBITDA of EUR482 million built on a strong first half, bringing our year-to-date adjusted EBITDA to EUR1,358 million, up 11.2% and 17.3% like-for-like, both at constant currency. Both figures are well ahead of revenue growth.
第三季調整後 EBITDA 為 4.82 億歐元,延續了上半年的強勁勢頭,使我們今年迄今的調整後 EBITDA 達到 13.58 億歐元,按固定匯率計算分別增長 11.2% 和 17.3%。這兩個數字都遠超營收成長。
Improved operational execution translating directly into a positive year-to-date free cash flow pre-M&A and pre-dividends of EUR188 million, marking a significant EUR257 million year-over-year improvement. This ramp-up in cash generation highlights our sustained financial discipline, keeping this as a top priority.
營運執行的改善直接轉化為年初至今的正自由現金流(不計併購和股息),達到 1.88 億歐元,較上年同期大幅成長 2.57 億歐元。現金流的快速成長凸顯了我們持續的財務紀律,我們將財務紀律視為首要任務。
Finally, deleveraging remains a critical financial priority, too. And at the end of Q3, our leverage ratios per credit agreement landed at 4.2 times, representing nearly 1x improvement over the prior year.
最後,去槓桿化仍然是一項至關重要的財務優先事項。第三季末,我們的每項信貸協議槓桿達到 4.2 倍,比去年同期改善了近 1 倍。
We continue to reinforce our structural foundation and these year-to-date results position us soundly to execute our capital allocation priorities and continue strengthening our balance sheet, ensuring we can create sustainable long-term value for all our stakeholders.
我們持續加強結構基礎,今年迄今的業績使我們能夠穩健地執行資本配置優先事項,並繼續加強資產負債表,確保我們能夠為所有利益相關者創造可持續的長期價值。
As we have mentioned many times, the core tenets of our value creation plan are guided by three key levers: commercial growth, margin expansion and pipeline execution. Starting with commercial growth, we continue to build on the existing market demand and our robust commercial capabilities to expand sales across our portfolio. This includes deepening our penetration in existing markets and expanding into new geographies.
正如我們多次提到的,我們的價值創造計劃的核心原則由三個關鍵槓桿指導:商業成長、利潤率擴張和專案執行。從商業成長入手,我們將繼續依賴現有的市場需求和強大的商業能力,擴大我們產品組合的銷售。這包括加深我們在現有市場的滲透,並拓展到新的地域。
Margin expansion remains a core priority, supported by operational leverage, optimized plasma sourcing and manufacturing efficiencies. And through pipeline execution, we continue to drive the innovations that define and sustain Grifols' leadership in plasma-derived therapies, while our Diagnostic division advances its three cutting-edge platforms currently in advanced development.
利潤率擴張仍然是核心優先事項,透過營運槓桿、優化血漿來源和提高生產效率來支撐。透過推動產品研發,我們不斷推動創新,鞏固並維持 Grifols 在血漿衍生療法領域的領先地位;同時,我們的診斷部門也在推進其目前處於高級開發階段的三大尖端平台。
These levers are supported by two critical enablers: our plasma supply and industrial footprint and our innovation strategy, as highlighted on the slide. Our resilient, diversified plasma manufacturing network represents a decisive competitive advantage in the current global environment. It ensures reliable plasma supply and production capacity, allowing us to effectively meet growing global demand.
這些槓桿作用得益於兩個關鍵推動因素:我們的血漿供應和工業佈局以及我們的創新策略,正如幻燈片中重點介紹的那樣。我們具有韌性且多元化的等離子體製造網絡,在當前的全球環境下代表著決定性的競爭優勢。它確保了可靠的血漿供應和生產能力,使我們能夠有效地滿足不斷增長的全球需求。
Turning to innovation, I'd like to provide an update on our pipeline. We remain on track to launch fibrinogen in Europe by the end of 2025 with a planned US launch in the first half of 2026. In the US, we are proceeding with the FDA biological license application for congenital fibrinogen deficiency, for which we expect a decision in late December as planned.
談到創新,我想向大家報告我們的研發管線進度。我們仍按計畫於 2025 年底在歐洲推出纖維蛋白原,並計畫於 2026 年上半年在美國推出。在美國,我們正在推進先天性纖維蛋白原缺乏症的FDA生物製品許可申請,預計將按計畫在12月下旬決定。
For acquired fibrinogen deficiency and based on conversations with the FDA, we have decided to build additional clinical evidence before seeking regulatory approval. This will help us well to strengthen an even more solid case to sustain the market development efforts we envision in the US market for the years to come.
對於獲得性纖維蛋白原缺乏症,根據與 FDA 的溝通,我們決定在尋求監管部門批准之前,先累積更多的臨床證據。這將有助於我們進一步加強對未來幾年我們所設想的美國市場發展工作的信心。
Roland will share more details on fibrinogen shortly, but I want to mention that this decision does not affect our current Capital Markets Day plan in any meaningful way, nor does this change our long-term strategy or the significant opportunity we see ahead.
Roland 稍後會分享更多關於纖維蛋白原的細節,但我想指出的是,這一決定不會對我們目前的資本市場日計劃產生任何實質性的影響,也不會改變我們的長期戰略或我們看到的未來重大機會。
Other than Fibrinogen, we are maintaining disciplined investment in R&D while advancing clinical programs across both life cycle management and new product candidates. Key initiatives, including SPARTA and alpha-1 with subcutaneous formulation are progressing as planned, underscoring our commitment to sustaining innovation, patient impact and long-term value creation.
除了纖維蛋白原之外,我們在研發方面也保持嚴格的投資,同時推動生命週期管理和新產品候選藥物的臨床計畫。包括 SPARTA 和皮下製劑 alpha-1 在內的關鍵舉措正在按計劃推進,這凸顯了我們對持續創新、患者影響和長期價值創造的承諾。
And with that, I will hand this over to Roland to expand on these and other market and business updates.
接下來,我將把發言權交給羅蘭,讓他詳細介紹這些以及其他市場和業務的最新動態。
Roland Wandeler - President - Biopharma
Roland Wandeler - President - Biopharma
Thank you, Nacho. I am pleased to share an update on our biopharma business and highlight the key factors driving our performance this year. As we continue to deliver on our value creation plan, I am proud of the dedication, the passion and commitment our team shows every day to deliver for patients and drive forward towards the goals we set out in terms of commercial growth, margin expansion and innovation.
謝謝你,納喬。我很高興與大家分享我們生物製藥業務的最新進展,並重點介紹今年推動我們業績的關鍵因素。在我們繼續推進價值創造計劃的過程中,我為我們的團隊每天展現出的奉獻精神、熱情和投入感到自豪,他們為患者提供服務,並朝著我們在商業增長、利潤率提升和創新方面設定的目標不斷前進。
With that, let's turn to slide 8 for our commercial performance. In the third quarter, our biopharma portfolio grew by 10.9%, lifting our year-to-date growth to 9.1%, both at constant currency. Our immunoglobulins franchise led the way, outpacing the market with 18% growth in the quarter and 14% year-to-date, both at constant currency. This performance was driven by GAMUNEX and XEMBIFY with IVIg and subcu Ig delivering 12-month growth of 13% and 62%, respectively. We remain confident in XEMBIFY's strong trajectory, supported by continued strength in the US and expansion into new markets in Europe. I'll dive deeper into our Ig franchise on the next slide.
接下來,讓我們翻到第 8 張投影片,看看我們的商業表現。第三季度,我們的生物製藥業務組合成長了 10.9%,使年初至今的成長達到 9.1%(以固定匯率計算)。我們的免疫球蛋白產品線表現突出,本季成長 18%,年初至今成長 14%(均以固定匯率計算),均超過了市場平均。這項表現主要得益於 GAMUNEX 和 XEMBIFY,其中 IVIg 和皮下注射免疫球蛋白分別達到了 12 個月 13% 和 62% 的成長。我們對 XEMBIFY 的強勁發展勢頭依然充滿信心,這得益於其在美國市場的持續強勁表現以及在歐洲新市場的擴張。下一張投影片我將更深入探討我們的 Instagram 品牌。
Turning to albumin, third quarter volumes remained solid, but were offset by ongoing pricing pressure in China as market demand slowed down in face of government-imposed cost controls. This resulted in a contraction of 4.5% for the quarter and 3.9% year-to-date, both at constant currency.
再來看白蛋白,第三季銷售依然穩健,但由於政府實施成本控制,中國市場需求放緩,價格持續承壓,抵銷了部分銷售成長。這導致該季度經濟萎縮 4.5%,年初至今萎縮 3.9%(均以固定匯率計算)。
While these dynamics were anticipated, we continue to work with our local partner, Shanghai RAAS, on how to best manage market dynamics and sustain a strong position in China as the principal market for albumin. At the same time, we are working on strengthening our presence and unlocking additional growth opportunities in the US and other markets in order to help us balance albumin with our IgG growth over time.
儘管這些動態在我們預料之中,但我們仍將繼續與我們的本地合作夥伴上海瑞安生物技術有限公司合作,探討如何最好地應對市場動態,並在中國這個白蛋白主要市場保持強勢地位。同時,我們正在努力加強我們在美國和其他市場的地位,並挖掘更多的成長機會,以幫助我們隨著時間的推移平衡白蛋白和 IgG 的成長。
Looking at our Alpha-1 and specialty proteins franchises, we continue to make solid progress. In the third quarter, revenues grew by 3.3%, bringing growth to 4.3% year-to-date, both at constant currency. These results reflect our continued market leadership in alpha-1 and HyperRAB. I'll share more detail on this franchise in a later slide.
從我們的 Alpha-1 和特種蛋白產品線來看,我們持續取得穩定進展。第三季營收成長 3.3%,以固定匯率計算,年初至今累計成長 4.3%。這些結果反映了我們在 alpha-1 和 HyperRAB 領域持續的市場領先地位。我會在後面的幻燈片中分享更多關於這個系列的細節。
Now let's turn to immunoglobulins or Ig as the main growth driver of our business on slide 9. Over the last two years, we saw an opportunity to use our strong Ig inventory position to accelerate Ig growth, build momentum in key markets and win back market share in the US. We have since delivered on this plan. We have strengthened our US organization and commercial capabilities, expanded subcu Ig penetration through XEMBIFY and leveraged the strong profile of GAMUNEX as a leading IVIg to win share in strategic accounts.
現在讓我們來看看第 9 張幻燈片,免疫球蛋白或 Ig 是我們業務的主要成長驅動力。過去兩年,我們看到了一個利用我們強大的免疫球蛋白庫存地位來加速免疫球蛋白成長、在關鍵市場建立勢頭並在美國贏回市場份額的機會。我們此後已落實了這項計劃。我們加強了美國組織和商業能力,透過 XEMBIFY 擴大了子包衣 Ig 的滲透率,並利用 GAMUNEX 作為領先的 IVIg 的強大形象贏得了戰略客戶的份額。
These actions have delivered clear results. Our Ig business has posted double-digit growth over these last quarters, ahead of the market and driven by demand as we regained share in the US and Europe and thus reset our position in the Ig market.
這些措施已取得顯著成效。在過去的幾個季度裡,我們的免疫球蛋白業務實現了兩位數的成長,超過了市場平均水平,這得益於我們在美國和歐洲重新奪回市場份額,從而重新確立了我們在免疫球蛋白市場的地位。
Looking ahead, from this higher base, we now expect to grow more in line with or slightly ahead of the market, consistent with the 6% to 8% CAGR range we shared as part of our value creation plan. The fundamentals for continued growth of Ig remain strong, as key indications continue to be underdiagnosed and increasing global awareness of Ig as the treatment of choice in many conditions means that more patients get to benefit from our medicines with a long track record of proven efficacy and safety.
展望未來,基於這一更高的基數,我們現在預計成長速度將與市場保持同步或略高於市場,這與我們先前在價值創造計畫中提出的 6% 至 8% 的複合年增長率範圍相一致。Ig 持續成長的基本面仍然強勁,因為關鍵適應症仍未得到充分診斷,而且全球對 Ig 作為多種疾病首選治療方案的認識不斷提高,這意味著更多患者能夠受益於我們這些擁有長期療效和安全性證明的藥物。
Looking at our three main indications, growth remains solid in primary immunodeficiency, where increased awareness and better diagnosis are expanding access to therapy. In secondary immunodeficiency, the largest growth opportunity within Ig, demand continues to rise, driven by an aging population and an increase in immunocompromised patients.
從我們的三大主要適應症來看,原發性免疫缺陷領域的成長依然穩健,這得益於人們對該領域認識的提高和診斷水平的改善,從而擴大了治療的覆蓋範圍。在繼發性免疫缺陷領域,Ig 的最大成長機會在於,由於人口老化和免疫功能低下患者的增加,需求持續上升。
And in CIDP, we are seeing continued growth, albeit at a lower level after the significant step-up in diagnosis last year with the entrance of FcRns, which has helped expand this market. CIDP is a complex neurological condition with multifactorial origins, meaning the disease can present very differently across patients. This is precisely where Ig therapy stands out.
在 CIDP 領域,我們看到持續成長,儘管由於去年 FcRns 的出現,診斷水準大幅提高,市場規模擴大,因此成長速度有所放緩。CIDP是一種病因複雜的神經系統疾病,其病因複雜,這意味著該疾病在不同患者身上的表現可能截然不同。這正是免疫球蛋白療法的優點。
With its broad and well-established range of immunomodulatory and immune-supportive modes of action, Ig can address multiple disease mechanisms and improve functional outcomes across a wide range of patients. As we build on this strong foundation, innovation continues to be a cornerstone of our Ig strategy. We're advancing next-generation products, new formulations and expanded indications that strengthen our competitive position and enhance patient experience.
免疫球蛋白具有廣泛且成熟的免疫調節和免疫支持作用機制,可以解決多種疾病機制,並改善眾多患者的功能性結果。在這個堅實的基礎上,創新仍然是我們 Ig 策略的基石。我們正在推動下一代產品、新配方和擴大適應症,以增強我們的競爭地位並提高患者體驗。
In terms of next-generation Igs, YIMMUGO, our novel IVIg from Biotest has launched in the US in the fourth quarter of 2025, adding another differentiated therapy to our portfolio. XEMBIFY continues to gain strong traction, growing more than 60% over the last 12 months, and we're expanding into new markets through 2026.
就下一代免疫球蛋白而言,我們來自 Biotest 的新型靜脈注射免疫球蛋白 YIMMUGO 已於 2025 年第四季在美國上市,為我們的產品組合增添了另一種差異化療法。XEMBIFY 持續獲得強勁成長,在過去 12 個月中成長超過 60%,我們將在 2026 年前拓展到新市場。
In terms of life cycle management, we are advancing new delivery formats, including XEMBIFY and prefilled syringes to improve convenience and adherence. In parallel, we are progressing with our studies to expand indications in the US with GAMUNEX-C and XEMBIFY advancing in SID and XEMBIFY in CIDP. Together with our ongoing improvements in end-to-end Ig yield and operational efficiency, which will help us expand margins, this focus on innovation will ensure that our Ig franchise remains a cornerstone of sustainable and profitable growth for Grifols.
在生命週期管理方面,我們正在推動新的給藥形式,包括 XEMBIFY 和預充式註射器,以提高便利性和依從性。同時,我們正在推進研究,以擴大在美國的適應症,其中 GAMUNEX-C 和 XEMBIFY 在 SID 中取得進展,XEMBIFY 在 CIDP 中取得進展。結合我們不斷改進的端到端免疫球蛋白產量和營運效率,這將有助於我們擴大利潤率,這種對創新的關注將確保我們的免疫球蛋白業務仍然是 Grifols 可持續盈利增長的基石。
Now turning to slide 10. Let's take a closer look at our alpha-1 franchise and our strategy and progress in this area. Grifols has established itself as a leader in alpha-1 with today approximately 70% market share across both the US and ex US. Our position is testament to Grifols' leadership in building this market, our best-in-class patient support programs and our unique testing capabilities.
現在請看第10張投影片。讓我們仔細看看我們的 alpha-1 特許經營權以及我們在該領域的策略和進展。Grifols 已成為 alpha-1 的領導者,目前在美國和美國以外地區擁有約 70% 的市場份額。我們的地位證明了 Grifols 在建立這個市場方面的領導地位、我們一流的患者支援計劃以及我們獨特的檢測能力。
Despite important progress throughout these last decades, we are today still only treating about 10% to 15% of the alpha-1 patient population across the world, leaving a large unmet need and untapped market opportunity. Testing is the key to unlocking this potential. We have, over the last years, complemented traditional screening with the rollout of our point-of-care and at-home direct-to-patient screening kits. Still, we only see a part of physicians systematically testing their COPD patients for AATD.
儘管在過去的幾十年裡取得了重要進展,但如今我們仍然只治療了全球約 10% 到 15% 的 α-1 患者群體,這造成了巨大的未滿足需求和未開發的市場機會。測試是釋放這種潛力的關鍵。過去幾年,我們透過推出即時檢測和居家直接面向患者的篩檢試劑盒,對傳統篩檢方式進行了補充。然而,我們只看到一部分醫生系統性地對他們的 COPD 患者進行 AATD 檢測。
We believe that we have a possibility to change this and dramatically increase the number of diagnosed patients with the readout of our outcome study SPARTA, continued advances in AI-enabled screening of electronic medical records to highlight patients at risk as well as increasing awareness in the market for new entrants. Raising awareness and improving diagnosis remain critical levers to enhance patient outcomes and enable market growth.
我們相信,透過我們的結果研究 SPARTA 的成果、人工智慧賦能的電子病歷篩檢技術的不斷進步,以及提高市場對新進者的認知,我們有可能改變這種現狀,並大幅增加確診患者的數量。提高公眾意識和改進診斷仍然是改善患者治療效果和促進市場成長的關鍵手段。
As a company that firsthand gets to see the continued unmet need and the difference our medicines can make for the grievous illnesses we get to treat, we always welcome innovation that raises awareness and might provide additional options for patients, especially in a condition where the vast majority remain undiagnosed and untreated. As a leader in this space, we want to meaningfully contribute to this innovation, both through our outcome study that will address important questions for the field as well as both the subcutaneous and a long-acting treatment option in our pipeline.
作為一家親眼目睹持續存在的未滿足需求以及我們的藥物能夠為我們所治療的嚴重疾病帶來改變的公司,我們始終歡迎能夠提高人們意識並可能為患者提供更多選擇的創新,尤其是在絕大多數患者仍未確診和治療的情況下。作為該領域的領導者,我們希望透過我們的結果研究(該研究將解決該領域的重要問題)以及我們正在研發的皮下注射和長效治療方案,為這項創新做出有意義的貢獻。
SPARTA is the largest efficacy study ever conducted in alpha-1 antitrypsin deficiency and is designed to show clinical outcomes in real-life lung tissue preservation different from other studies primarily focused on pharmacokinetic endpoints. The results of this study have the potential to significantly strengthen the clinical and payer value proposition for augmentation therapy, increase testing awareness and improve patient access in the US as well as support broader reimbursement in Europe.
SPARTA 是迄今為止針對 α-1 抗胰蛋白酶缺乏症進行的最大規模的療效研究,旨在展示真實肺組織保存的臨床結果,這與其他主要關注藥物動力學終點的研究有所不同。這項研究的結果有可能顯著增強增強療法的臨床和支付方價值主張,提高人們對檢測的認識,改善美國患者的就醫途徑,並支持在歐洲擴大報銷範圍。
The trial also includes a double-dose regimen, which could represent an important advancement in treatment. We expect the readout of SPARTA in the second half of 2026. In parallel, we are advancing a 15% subcutaneous formulation and a next-generation alpha-1 therapeutic to enhance patient convenience, expand access and continue strengthening our position in this growing market.
該試驗還包括雙倍劑量方案,這可能代表治療的重要進展。我們預計 SPARTA 試驗結果將於 2026 年下半年公佈。同時,我們正在推動 15% 皮下製劑和下一代 α-1 療法的研發,以提高患者的便利性,擴大用藥範圍,並繼續鞏固我們在這一不斷增長的市場中的地位。
In summary, we remain confident in the continued success of PROLASTIN, supported by its value proposition and proven 30-plus year track record of safety and efficacy.
總之,我們對 PROLASTIN 的持續成功充滿信心,這得益於其價值主張以及 30 多年來經過驗證的安全性和有效性。
Turning to slide 11, innovation is at the heart of our business. Our pipeline reflects a focused and disciplined approach to advancing high-value programs that drive life cycle management, expand indications for our existing medicines and bring new products to market both within plasma as well as beyond plasma. We have already covered the innovation underway for our Ig and alpha-1 franchises.
翻到第 11 張投影片,創新是我們業務的核心。我們的研發管線體現了我們專注而嚴謹的態度,致力於推進高價值項目,推動生命週期管理,擴大現有藥物的適應症,並將新產品推向市場,無論是在血漿領域還是在血漿領域之外。我們已經介紹了 Ig 和 alpha-1 系列產品正在進行的創新。
Turning now to fibrinogen, as Nacho mentioned, we have refined our go-to-market approach to maximize our long-term opportunity. In the near term, the largest opportunity for fibrinogen lies in Europe, where markets such as Germany and Austria have adopted fibrinogen concentrate as standard of care. For these markets, we are on track for our launch of this product later this year. We have received the end of procedure notice from Germany and are awaiting approval in this key market shortly to be followed by additional countries in Europe. We are confident that our differentiated product positions us well to effectively compete and gain share over time in these markets.
現在來說說纖維蛋白原,正如 Nacho 所提到的,我們已經改進了市場推廣策略,以最大限度地掌握長期機會。短期來看,纖維蛋白原最大的市場在歐洲,德國和奧地利等市場已將纖維蛋白原濃縮物作為標準療法。對於這些市場,我們正按計劃於今年稍後推出該產品。我們已收到德國的程序結束通知,並正在等待該關鍵市場盡快批准,隨後將獲得歐洲其他國家的批准。我們相信,我們差異化的產品使我們能夠有效地參與競爭,並隨著時間的推移在這些市場中獲得份額。
Longer term, the largest opportunity remains in the US, where the use of fibrinogen today, though, is still low and the market has a long way to go to fully embrace this more targeted approach to bleeding management as standard of care. Here, we are on track with our BLA for congenital fibrinogen deficiency or CFD, with a PDUFA date end of December. We expect to launch this indication in the first half of 2026.
從長遠來看,最大的機會仍然在美國,儘管目前纖維蛋白原在美國的使用率仍然很低,而且市場還有很長的路要走,才能將這種更有針對性的出血管理方法完全接受為標準治療。目前,我們針對先天性纖維蛋白原缺乏症(CFD)的生物製品許可申請(BLA)進展順利,PDUFA 申請日期為 12 月底。我們預計將於 2026 年上半年推出此適應症。
As Nacho mentioned, following conversations with the FDA and observing the slow growth of fibrinogen in the US over the last year, we have decided to focus our BLA on CFD for now and use the time to further strengthen our body of evidence with US patients for an sBLA for acquired fibrinogen deficiency or AFD at a later point in time. While this delays our indication for AFD in the US, this staged approach allows us to provide access to our medicines for US patients with CFD in the first half of next year, while giving more time for the market to evolve, further strengthen our position for a possibly differentiated label in AFD and set us up for a leading position in the US over time.
正如 Nacho 所提到的,在與 FDA 進行溝通並觀察到過去一年美國纖維蛋白原增長緩慢之後,我們決定暫時將我們的 BLA 重點放在 CFD 上,並利用這段時間進一步加強我們在美國患者中的證據,以便在稍後某個時候申請針對獲得性纖維蛋白原缺乏症 (AFD) 的 sBLA。雖然這會推遲我們在美國批准 AFD 適應症,但這種分階段的方法使我們能夠在明年上半年為美國 CFD 患者提供藥物,同時給市場更多的時間來發展,進一步鞏固我們在 AFD 領域可能存在的差異化標籤的地位,並使我們最終在美國佔據領先地位。
As Nacho noted, these updates do not affect our guidance and the long-term goals outlined during our Capital Markets Day, nor do they change our broader development efforts and our conviction in a meaningful opportunity ahead as the standard of care continues to evolve toward concentrate-based therapies. We remain confident in the program's progress and long-term success as we continue to invest in its global rollout for the benefit of patients.
正如納喬所指出的,這些更新不會影響我們在資本市場日上概述的指導方針和長期目標,也不會改變我們更廣泛的開發努力以及我們對未來重要機會的信念,因為護理標準將繼續向濃縮療法發展。我們對該計畫的進展和長期成功充滿信心,並將繼續投資其全球推廣,以造福患者。
Taking a step back, while we certainly look forward to the launch of fibrinogen, our pipeline reflects our focused and disciplined approach to advance innovation and create value across all our therapeutic areas.
退一步講,雖然我們非常期待纖維蛋白原的上市,但我們的產品線體現了我們專注而嚴謹的方法,以推進創新並在我們所有治療領域創造價值。
We've already covered our advancements in immunology and pulmonology. In infectious diseases, our trimodulin Phase 3 trial in severe community-acquired pneumonia is progressing steadily. With its innovative polyclonal antibody profile, trimodulin has the potential to address a significant unmet need. And in ophthalmology, our ocular surface Ig program for dry eye disease in Phase 2 has the potential to expand use of Ig into new therapeutic areas.
我們已經介紹了我們在免疫學和肺病學方面的進展。在傳染病領域,我們針對嚴重社區型肺炎的 trimodulin 3 期試驗正在穩步進行。憑藉其創新的多克隆抗體特性,trimodulin 有潛力滿足一項重大的未滿足需求。在眼科領域,我們針對乾眼症的眼表免疫球蛋白計畫目前處於第 2 期臨床試驗階段,該計畫有望將免疫球蛋白的應用擴展到新的治療領域。
In the earlier stages of development, our pipeline spans both plasma-based and non-plasma programs, including a next-generation GAMUNEX process with improved yield, recombinant therapies and novel treatments for infectious diseases.
在早期研發階段,我們的研發管線涵蓋了基於血漿和非血漿的項目,包括具有更高產量的下一代 GAMUNEX 製程、重組療法和傳染病新療法。
Overall, our pipeline reflects a balanced mix of near-term launches and long-term innovation aligned with our value creation plan and reinforcing Grifols leadership in plasma-derived medicines aimed at driving sustainable, profitable growth for years to come.
總體而言,我們的產品線體現了近期上市和長期創新之間的平衡組合,這與我們的價值創造計劃相一致,並鞏固了 Grifols 在血漿衍生藥物領域的領導地位,旨在推動未來幾年的可持續盈利增長。
With that, I now hand it over to Rahul to provide more details on our financial performance.
接下來,我將把發言權交給 Rahul,讓他詳細介紹我們的財務表現。
Rahul Srinivasan - Chief Financial Officer
Rahul Srinivasan - Chief Financial Officer
Thanks, Roland. On slide 12, the words continued resilience sum up not just the Grifols' financial performance, but also very aptly describes both the Grifols business that has been built over many decades as well as the Grifols spirit of our over 24,000 teammates and our shared commitment towards the Grifols mission.
謝謝你,羅蘭。在第 12 張幻燈片中,「持續的韌性」一詞不僅概括了 Grifols 的財務業績,而且非常貼切地描述了 Grifols 幾十年來建立的業務,以及我們 24,000 多名團隊成員的 Grifols 精神和我們對 Grifols 使命的共同承諾。
Slide 13. From a financial performance standpoint, Q3 was a robust quarter across the board that presents an equally robust across-the-board year-to-date picture. There have been some favorable phasing and mix benefits that have contributed to this robust year-to-date financial performance that I will elaborate on in the upcoming slides. As a reminder, our reported figures included the impact of IRA and the fee-for-service GPO reclassification, which could distort the underlying performance and hence, to improve comparability to prior periods, we will continue to disclose the like-for-like column for the remainder of the year, which we believe will be helpful to all our stakeholders.
第13張幻燈片。從財務業績角度來看,第三季各方面表現強勁,也展現出年初至今同樣強勁的業績。今年迄今強勁的財務表現得益於一些有利的階段安排和組合優勢,我將在接下來的幻燈片中詳細說明。提醒各位,我們報告的數據包含了 IRA 和按服務收費的 GPO 重新分類的影響,這可能會扭曲實際業績,因此,為了提高與前期數據的可比性,我們將繼續在今年剩餘時間內披露同店銷售額,我們相信這將對所有利益相關者有所幫助。
Starting with Q3 financial highlights. Net revenues of just under EUR1.87 billion, up 9.1% versus Q3 '24 on a constant currency basis, led by Biopharma, and adjusted EBITDA of EUR482 million, resulting in an adjusted EBITDA margin of 25.8% for the quarter. And a slightly higher impact on group profit than was the case in Q2 this year. And free cash flow pre-M&A pre-dividends for the quarter of $203 million, up meaningfully versus Q3 '24.
首先是第三季財務亮點。淨收入略低於 18.7 億歐元,以固定匯率計算比 2024 年第三季成長 9.1%,主要得益於生技製藥業務的成長;調整後 EBITDA 為 4.82 億歐元,本季調整後 EBITDA 利潤率為 25.8%。對集團利潤的影響比今年第二季略高。併購前自由現金流(不含股息)為 2.03 億美元,較 2024 年第三季大幅成長。
Moving on to year-to-date financial performance. Net revenues of over $5.5 billion, up 7.7% on a constant currency basis, led by Biopharma that, as Roland mentioned earlier, is up 9.1% on a constant currency basis.
接下來來看年初至今的財務表現。淨收入超過 55 億美元,以固定匯率計算增長 7.7%,其中生物製藥業務表現突出,正如羅蘭之前提到的,該業務按固定匯率計算增長了 9.1%。
Year-to-date adjusted EBITDA of over $1.35 billion is up 11.2% versus 2024 on a constant currency basis despite the impact of IRA, albeit benefiting from some phasing and favorable mix that I referenced earlier. Both gross margin and adjusted EBITDA margin are up versus 2024, notwithstanding the impact of IRA.
儘管受到 IRA 的影響,但截至目前,經調整的 EBITDA 超過 13.5 億美元,以固定匯率計算比 2024 年增長 11.2%,儘管受益於我之前提到的一些分階段實施和有利的組合。儘管受到 IRA 的影響,但毛利率和調整後的 EBITDA 利潤率均較 2024 年有所提高。
Year-to-date group profit of $304 million is up over 245% versus year-to-date 2024. Free cash flow pre-M&A pre-dividends is up $257 million versus year-to-date 2024, and I will elaborate on the drivers of this free cash flow improvement a couple of slides later.
今年迄今為止,集團利潤為 3.04 億美元,比 2024 年同期成長超過 245%。扣除併購和股息前的自由現金流比 2024 年同期增加了 2.57 億美元,我將在後面的幾張幻燈片中詳細說明自由現金流改善的驅動因素。
Furthermore, the leverage and liquidity picture has significantly improved versus Q3 2024. And with secured leverage at only 2.6 times, we have almost 2 EBITDA turns of secured leverage capacity, giving us material flexibility, thus rounding out the robust and improving balance sheet that is referenced in the title of the slide.
此外,槓桿率和流動性狀況與 2024 年第三季相比已顯著改善。由於槓桿率僅為 2.6 倍,我們擁有近 2 倍 EBITDA 的槓桿能力,這賦予了我們極大的靈活性,從而完善了幻燈片標題中提到的穩健且不斷改善的資產負債表。
And finally, I have deliberately not dwelled on the like-for-like performance that you see on this slide as we consider the impact of IRA as part of our regular cost structure now. But the numbers in this column are eye-popping, and are helpful context to the underlying momentum of the business.
最後,我特意沒有過多關注您在這張投影片上看到的同類業績,因為我們現在要考慮 IRA 作為我們常規成本結構的一部分的影響。但本專欄的數字令人瞠目結舌,有助於理解企業的潛在發展動能。
Slide 14. Notwithstanding the impact of IRA, year-to-date revenue growth was up 7.7% on a constant currency basis, whilst clearly Biopharma led, we also had a positive contribution from our Diagnostics business that continues to execute in keeping with our plan.
第14張幻燈片。儘管受到 IRA 的影響,但以固定匯率計算,今年迄今的收入成長了 7.7%。雖然生物製藥業務明顯領先,但我們的診斷業務也做出了積極貢獻,該業務繼續按照我們的計劃執行。
As Roland alluded to earlier, the Biopharma revenue growth continues to benefit from robust underlying Biopharma demand on the back of continued Ig momentum as well as progress from our alpha-1 and specialty protein franchise. Albumin, however, is an area that we continue to keep a close eye on. And finally, year-to-date performance has benefited from some phasing-related gains that have also contributed to a 9.1% constant currency growth versus 2024.
正如羅蘭之前提到的那樣,生物製藥收入的增長繼續受益於強勁的生物製藥潛在需求,這得益於免疫球蛋白的持續增長勢頭以及我們的α1和特種蛋白產品線的進展。然而,白蛋白是我們持續密切關注的領域。最後,年初至今的業績受益於一些與分階段實施相關的收益,這些收益也促成了與 2024 年相比 9.1% 的固定匯率成長。
Slide 15. Year-to-date adjusted EBITDA in 2025 is at $1.358 billion, up from $1.253 billion in 2024 after absorbing the year-to-date IRA impact of $75 million with adjusted EBITDA up 11.2% on a constant currency basis and adjusted EBITDA margins improving versus 2024 by 60 basis points to 24.5%.
第15頁。截至目前,2025 年調整後 EBITDA 為 13.58 億美元,高於 2024 年的 12.53 億美元。這已吸收了截至目前 IRA 7500 萬美元的影響,調整後 EBITDA 按固定匯率計算增長了 11.2%,調整後 EBITDA 利潤率較 2024 年提高了 60 個基點,達到 24.5%。
The EBITDA growth was mainly led by Biopharma, supported by each of the following: strong volume growth aided by some phasing benefit, a favorable geographic mix adding to the phasing benefit with a proportion of EBITDA from the US better than expectations and up meaningfully year-to-date, continuing improvements in CPL and finally, continued focus on OpEx discipline and driving the benefits of operational leverage.
EBITDA 成長主要由生物製藥業務帶動,並得到以下各項的支持:銷售強勁增長,部分得益於階段性效益;有利的地域組合進一步增強了階段性效益,其中來自美國的 EBITDA 佔比高於預期,且年初至今增幅顯著;CPL 持續改善;最後,持續關注運營支出紀律,並推動運營槓桿效益。
As for the IRA impact, it is broadly in line with the guidance we provided in Q2, and we expect full year impact to be between $100 million to $125 million. Whilst the impact on EBITDA of a weakening US dollar is considerably more sheltered than revenues as a result of the various natural hedges in our cost structure, it has still been a stiff headwind.
至於 IRA 的影響,與我們在第二季度提供的指導基本一致,我們預計全年影響將在 1 億美元至 1.25 億美元之間。儘管由於成本結構中各種天然對沖措施,美元走弱對 EBITDA 的影響遠小於對收入的影響,但這仍然是一個巨大的不利因素。
Whilst the weakening US dollar has been the main issue from an FX standpoint, other currencies have also contributed to the total FX impact versus the FX rates embedded in our guidance for the year as set out in our Capital Markets Day presentation.
從外匯角度來看,美元走弱是主要問題,但其他貨幣也對整體外匯影響有所貢獻,這與我們在資本市場日簡報中闡述的年度外匯指引中所包含的匯率有所不同。
Slide 16. Over the last number of quarters, we have talked about our expectation for continued convergence between adjusted and reported EBITDA on a cash basis or said another way, focusing on reducing the amount of cash adjustments between adjusted and reported EBITDA.
第16張幻燈片。在過去的幾個季度裡,我們一直在談論我們對調整後 EBITDA 和報告 EBITDA 在現金基礎上持續趨同的預期,或者換句話說,我們專注於減少調整後 EBITDA 和報告 EBITDA 之間的現金調整。
And we are pleased to see that convergence trend on a cash basis continue over the last couple of years, and there are three specific outcomes that I would like to call out.
我們很高興地看到,在過去幾年裡,現金收支的趨同趨勢仍在持續,我想特別指出以下三個結果。
Number one, continued reduction in cash adjustments between adjusted and reported EBITDA. And as you will see on this page and the detail on page 30 in the appendix, there has been a 56% reduction in cash adjustments on an LTM basis, primarily due to lower cash adjustments pertaining to restructuring costs and transaction costs. Number two, reported EBITDA is growing at 15.7% on a constant currency basis, faster than adjusted EBITDA despite its robust 11.2% growth on a constant currency basis. And finally, three, the gap between reported and adjusted EBITDA margins is reducing. And as at Q3 '25, this gap has narrowed to 120 basis points, having been 210 basis points at the end of 2024 and 340 basis points as at the end of 2023, mainly on the back of lower cash adjustments and the convergence tends to happen rapidly, often within around six to seven months, validating the credibility of these cash adjustments.
第一,調整後 EBITDA 與報告 EBITDA 之間的現金調整持續減少。正如您將在本頁和附錄第 30 頁的詳細資訊中看到的那樣,過去 12 個月的現金調整減少了 56%,這主要是由於與重組成本和交易成本相關的現金調整減少所致。第二,報告的 EBITDA 以固定匯率計算成長了 15.7%,高於調整後的 EBITDA,儘管後者以固定匯率計算也實現了 11.2% 的強勁成長。最後,第三,報告的 EBITDA 利潤率與調整後的 EBITDA 利潤率之間的差距正在縮小。截至 2025 年第三季度,這一差距已縮小至 120 個基點,而 2024 年底為 210 個基點,2023 年底為 340 個基點,這主要是由於現金調整減少,而且這種趨同往往發生得很快,通常在六到七個月內,這驗證了這些現金調整的可信度。
We also want to proactively flag the potential of noncash adjustments in Q4 that importantly do not at all have any impact on the go-forward EBITDA growth story or free cash flow growth story. These potential noncash adjustments are simply the other side of the capital allocation discipline coin, where prioritizing our valuable capital mainly on the projects that we talked about at our Capital Markets Day in February this year, means that some other projects remain dormant or on hold and potentially there could be an impact on their carrying value. But to be clear and to repeat, we are confident that these potential noncash adjustments will not impact our go-forward adjusted EBITDA growth or free cash flow growth story.
我們還想主動指出第四季度可能出現的非現金調整,但重要的是,這些調整對未來的 EBITDA 成長或自由現金流成長沒有任何影響。這些潛在的非現金調整隻是資本配置紀律的另一面,即優先將我們寶貴的資本主要用於我們在今年 2 月資本市場日上討論的項目,這意味著其他一些項目仍然處於停滯或擱置狀態,這可能會對其賬面價值產生影響。但需要澄清並重申,我們相信這些潛在的非現金調整不會影響我們未來的調整後 EBITDA 成長或自由現金流成長。
Slide 17. A quick update on our progress towards our free cash flow pre-M&A, pre-dividends goal for the year. As you will recall, we improved our free cash flow pre-M&A, pre-dividend guidance at H1 from $350 million to $400 million up to $375 million to $425 million, considerably up from the $266 million free cash flow outperformance in 2024, and we expressed our confidence that the business could do meaningfully better over time.
第17頁。簡單報告我們今年在併購前、分紅前自由現金流目標的進展。您應該還記得,我們上半年將併購前、分紅前的自由現金流預期從 3.5 億至 4 億美元提高到 3.75 億至 4.25 億美元,比 2024 年 2.66 億美元的自由現金流超預期大幅提高,並且我們表示有信心,隨著時間的推移,業務可以做得更好。
And finally, recall that unlike EBITDA, free cash flow pre-M&A, pre-dividends is more insulated from euro-dollar volatility. The punchline on our year-to-date free cash flow performance is that we are tracking well versus our improved free cash flow guidance provided in our H1 call, as at the end of Q3, we are EUR257 million better than we were in 2024 at the same point.
最後,需要記住的是,與 EBITDA 不同,併購前、分紅前的自由現金流受歐元兌美元匯率波動的影響較小。今年迄今為止的自由現金流表現的關鍵在於,我們目前的進展與我們在上半年電話會議中給出的改進後的自由現金流預期相符,截至第三季度末,我們的自由現金流比 2024 年同期高出 2.57 億歐元。
The principal driver of the improving performance is greater vigilance on cash flow across the entire organization. In addition to that, improved EBITDA contribution, lower cash adjustments, tight working capital management, disciplined CapEx and capitalized IT and R&D spend and an improvement in cash interest expense as a result of debt paydown in 2024 and significantly lower utilization of RCF has supported our year-to-date progress on the free cash flow front. And more on free cash flow guidance for 2025 on the next slide.
業績提升的主要驅動因素是整個組織對現金流的更加關注。除此之外,EBITDA貢獻的提高、現金調整的減少、嚴格的營運資本管理、有紀律的資本支出和資本化的IT及研發支出,以及由於2024年償還債務和循環信貸額度使用率大幅降低而導致的現金利息支出的改善,都支持了我們今年迄今為止在自由現金流方面取得的進展。下一頁將提供更多關於 2025 年自由現金流預測的資訊。
Finally, on slide 18, updates on both capital structure and our outlook for the year. First, on capital structure. The clear tightening of our longest-dated bonds in our capital structure by over 200 basis points in just the last three to four quarters is evidence of the clear progress in the re-rating of the Grifols story. And by that, we mean not just from a credit perspective, but also our clear focus on progressing on the immense equity re-rating opportunity we believe there is.
最後,在第 18 頁,我們將更新資本結構和我們對今年的展望。首先,關於資本結構。在過去三到四個季度裡,我們資本結構中期限最長的債券殖利率明顯收緊了 200 多個基點,這證明了 Grifols 的重新評估取得了明顯的進展。我們所說的“指的不僅是信用評級”,還包括我們對推進我們認為存在的巨大股權重新評級機會的明確關注。
And it is also pleasing to see a number of our banking partners further corroborate the re-rating progress implied by our tightening bond yields by proactively offering meaningful upside support for a potential upsized RCF as part of the refinancing that we are targeting in H1 2026. All very helpful steps forward on the capital structure front and preparations are ongoing.
令人欣慰的是,我們的許多銀行合作夥伴也積極為可能擴大的循環信貸額度提供實質性的上行支持,進一步證實了我們債券收益率收緊所暗示的重新評級進展,這是我們在 2026 年上半年計劃進行的再融資的一部分。在資本結構方面,所有步驟都非常有益,相關準備工作正在進行中。
We have also just a short while ago launched a harmonizing exercise to align the documentation of the two bonds we currently have maturing in 2030. As I alluded to before, both bonds continue to trade very positively, hence, the launch of this nice-to-have action.
不久前,我們還啟動了一項協調工作,以統一我們目前將於 2030 年到期的兩隻債券的文件。正如我之前提到的,這兩種債券的交易情況都繼續非常積極,因此,才推出了這項錦上添花的舉措。
Before speaking about outlook, it might be helpful for us to contextualize our year-to-date performance. Notwithstanding very stiff FX headwinds and the IRA impact, our performance has been robust for the reasons we have already discussed. We have also benefited from some positive phasing and mix gains and thereby accelerating aspects of our EBITDA performance for the year, which we expect will partly reverse in Q4.
在討論前景之前,或許有必要先對我們今年迄今為止的業績進行一些背景分析。儘管面臨非常嚴峻的外匯逆風和 IRA 的影響,但由於我們已經討論過的原因,我們的業績仍然穩健。我們也受益於一些積極的階段安排和組合收益,從而加速了我們今年的 EBITDA 業績,但我們預計這種情況將在第四季度部分逆轉。
When considering year-over-year comparison to Q4, please remember that we are lapping our best quarter in history from an EBITDA perspective, a quarter that itself back then benefited considerably from phasing. And taking that together with IRA and the FX headwinds, we expect a robust Q4 '25. However, it will compare less favorably to Q4 '24 in absolute terms. The team remains very focused on ensuring that we execute with the same discipline and intensity as we have all year.
在考慮與第四季度進行同比比較時,請記住,從 EBITDA 的角度來看,我們正在超越歷史上最好的季度,而當時的第四季度本身也受益於分階段實施。考慮到 IRA 和外匯逆風等因素,我們預計 2025 年第四季業績將表現強勁。然而,從絕對值來看,它與 2024 年第四季相比就沒那麼好。團隊將繼續專注於確保我們能夠像全年一樣,以相同的紀律和強度執行戰術。
It is also worth reminding the market of our updates in prior quarters of the impact of a weakening US dollar and how that headwind reduces as we move down our P&L as a result of the natural hedges embedded in our business, from a weaker US dollar having a significant impact at the revenue level to being broadly neutral at the net income or group profit level and indeed broadly neutral on free cash flow, too. And absent any abrupt movements in FX, euro-dollar in particular, as we move to the end of the year, we expect it to be broadly neutral on leverage, too, which then leads me to the final section on guidance.
此外,值得提醒市場的是,我們在前幾個季度更新了美元走弱的影響,以及隨著我們損益表的下移,這種不利因素如何因我們業務中嵌入的自然對沖而減少:美元走弱對收入層面的影響很大,但對淨收入或集團利潤層面的影響基本中性,實際上對自由現金流的影響也基本中性。而且,如果沒有外匯市場(尤其是歐元兌美元)出現任何突然波動,隨著年底臨近,我們預期槓桿率也將保持大致中性,這就引出了關於指引的最後一部分。
On the right-hand side, we compare our updated guidance to the original guidance we provided at our Capital Markets Day on 27 February 2025 at guidance FX rates. And on the left-hand side, we estimate the full year FX impact to be roughly around EUR70 million on adjusted EBITDA if FX rates stay as they are currently for the rest of the year versus the guidance FX rates in order to assist all our stakeholders with their analysis.
在右側,我們將更新後的指導意見與我們在 2025 年 2 月 27 日資本市場日上提供的原始指導意見(以指導外匯匯率為準)進行了比較。在左側,我們估計,如果匯率在今年剩餘時間內保持不變,則全年匯率對調整後 EBITDA 的影響約為 7000 萬歐元,而指導匯率則有所不同,以便幫助我們所有的利害關係人進行分析。
As you will see on the right-hand side, our updated guidance at guidance FX rates compares favorably to the original guidance we provided at our Capital Markets Day, improving updated guidance at guidance FX rates for both revenues and free cash flow pre-M&A, pre-dividends.
如您在右側所見,我們按指導匯率計算的最新指引與我們在資本市場日提供的原始指引相比,表現更佳,在併購前、分紅前的收入和自由現金流方面,按指導匯率計算的最新指引均有所改善。
And on the latter, we are once again improving our guidance further to EUR400 million to EUR425 million. And adjusted EBITDA guidance FX rates is reaffirmed to be consistent with the original guidance provided and that we are currently tracking very comfortably within the guidance range provided, which, as I mentioned at the start of the financial performance section, speaks to the resilience of the Grifols business, notwithstanding the highly dynamic markets that we have navigated well thus far this year.
至於後者,我們再次將預期值上調至 4 億歐元至 4.25 億歐元。經過調整的 EBITDA 指導匯率與最初提供的指導一致,我們重申了這項指導,並且我們目前非常輕鬆地達到了提供的指導範圍。正如我在財務表現部分開頭提到的那樣,這表明 Grifols 業務具有韌性,儘管我們今年迄今為止已經很好地應對了高度動態的市場。
With that, let me hand it back to Nacho for his concluding remarks.
那麼,現在讓我把麥克風交還給納喬,請他做總結發言。
Nacho Abia - Chief Executive Officer, Executive Director
Nacho Abia - Chief Executive Officer, Executive Director
Thank you, Rahul. I would like to conclude today's presentation with just a few final remarks. Our third quarter results confirm that the strategic road map we set in motion this year is delivering results. The value creation plan is driving measurable progress from continued market share gains and sustained top line growth to a significant improvement in free cash flow generation. This performance underscores our focus on strengthening financial fundamentals and executing with the discipline required to turn a strategic vision into financial performance.
謝謝你,拉胡爾。今天我的演講到此結束,最後我想補充幾點。我們第三季的業績證實,我們今年制定的策略路線圖正在取得成效。價值創造計畫正在推動可衡量的進展,從持續的市場份額成長和持續的營收成長,到自由現金流的顯著改善。這項業績凸顯了我們對加強財務基本面的重視,以及將策略願景轉化為財務績效所需的嚴謹執行力。
We have also further strengthened our balance sheet through deleveraging, enhanced free cash flow generation and a disciplined financial and capital allocation. This combination provides the flexibility to invest in growth while maintaining a prudent approach to leverage and liquidity.
我們也透過去槓桿化、增強自由現金流產生以及嚴格的財務和資本配置,進一步加強了資產負債表。這種組合既能靈活地投資於成長,又能保持審慎的槓桿和流動性策略。
As we approach year-end, we remain vigilant as market conditions continue to be dynamic with foreign exchange pressure and other external factors still present. These potential headwinds are being closely monitored. And as in previous periods, we are confident in our ability to respond with resilience and execution. Therefore, we reaffirm full year 2025 revenue and adjusted EBITDA guidance and the exchange rate presented at our Capital Markets Day and updated free cash flow guidance to more than EUR400 million.
隨著年底臨近,由於外匯壓力和其他外部因素仍然存在,市場狀況仍然瞬息萬變,我們將保持警惕。我們正在密切關注這些潛在的不利因素。與以往一樣,我們對自身的韌性和執行力充滿信心,相信能夠應對挑戰。因此,我們重申 2025 年全年收入和調整後 EBITDA 指引,以及我們在資本市場日提出的匯率,並將自由現金流指引更新為超過 4 億歐元。
Finally, I want to recognize once again the dedication of the entire Grifols team whose commitment to our value creation plan continues to drive this company forward. We are executing with focus, accountability and discipline and remain fully committed to creating long-lasting value for all our patients, donors and stakeholders. Thank you, as always, for your continued support.
最後,我要再次感謝 Grifols 全體團隊的奉獻精神,他們對我們價值創造計畫的承諾不斷推動公司向前發展。我們秉持著專注、負責和嚴謹的態度執行各項工作,並始終致力於為所有患者、捐助者和利害關係人創造持久價值。一如既往,感謝您的持續支持。
And with that, Danny, back to you.
丹尼,現在把鏡頭交還給你。
Daniel Segarra - Vice President - Investor Relations and Sustainability
Daniel Segarra - Vice President - Investor Relations and Sustainability
Thank you, Nacho. Now let's turn to the Q&A session. (EventInstructions) Let's start with Charles from Barclays.
謝謝你,納喬。現在進入問答環節。(活動說明)我們先從巴克萊銀行的查爾斯開始。
Charles Pitman-King - Analyst
Charles Pitman-King - Analyst
Just first one on fibrinogen. Just I want to clarify what the driver there is behind the fibrinogen and AFD being delayed to the US. Is this kind of FDA pushback on -- is that reflective of their internal resourcing? Or is it reflective of the quality, quantity of your supporting data for the indication? Just because thinking about this asset previously, a key differentiating factor for Grifols was to be the first US approved asset with both forms of the disease as part of the label. So just to your point about not impacting the midterm guidance, kind of how do you expect to be able to continue to differentiate against the competition? Or is this just set to be a very short delay?
先從纖維蛋白原入手。我只是想澄清一下,導致纖維蛋白原和AFD延遲運往美國的原因是什麼。FDA的這種抵制是否反映了他們的內部資源狀況?或者,這是否反映了您支持該適應症的數據的品質和數量?因為之前考慮過這項資產,Grifols 的一個關鍵區別因素是,它是美國第一個批准的、標籤上同時包含這兩種疾病形式的資產。所以,針對您提到的不影響中期業績預期這一點,您預計如何才能繼續在競爭中保持差異化優勢?或者這只是一個很短的延遲?
And then my other question is just for Rahul on the refinancing. Just coming back to terminology there, you're highlighting the harmonization process of the 2030 bonds. Can you confirm whether this means that you're also considering refinancing of these 2030 maturities as part of the 1H '26 targeted refinancing for the '27 maturing bonds? And just wondering, as part of that refinancing as well, is there any potential to renegotiate the terms of the GIC deal?
然後,我的另一個問題是關於再融資的,僅供 Rahul 參考。回到術語方面,您強調的是 2030 年債券的協調過程。你能確認一下,這是否意味著你們也在考慮將這些 2030 年到期的債券進行再融資,作為 2026 年上半年針對 2027 年到期債券的定向再融資計劃的一部分嗎?另外,作為再融資的一部分,是否有可能重新協商 GIC 交易的條款?
Nacho Abia - Chief Executive Officer, Executive Director
Nacho Abia - Chief Executive Officer, Executive Director
Thank you, Charles. On fibrinogen, I think that we always have stated and have been aware of the fact that in the United States, we would need to change the standard of care, which currently is based on cryoprecipitate in order to boost the sales of fibrinogen to the level that we expected. This is a mission that we are very committed to do. We believe, based on what we see in other markets that, that certainly will bring benefit for patients. But as I mentioned, based on the conversations with FDA, we feel that it's important to bring even more solid clinical information and clinical data with US patients in order to help with that standard of care.
謝謝你,查爾斯。關於纖維蛋白原,我認為我們一直都說過,也一直意識到,在美國,我們需要改變目前的治療標準(即冷沉澱),才能將纖維蛋白原的銷售量提升到我們預期的水平。這是我們矢志不渝要完成的任務。根據我們在其他市場觀察到的情況,我們認為這肯定會為患者帶來好處。但正如我之前提到的,根據與 FDA 的溝通,我們認為有必要向美國患者提供更多可靠的臨床資訊和臨床數據,以幫助達到該護理標準。
At the same time, I think, obviously, our focus in the short term is going to be to develop markets outside of the US. And in the US, obviously, with the congenital fibrinogen deficiency, certainly, we will start working with physicians for them to know and be more aware about the benefits of fibrinogen versus other alternatives.
同時,我認為,很顯然,我們短期內的重點將是開發美國以外的市場。顯然,在美國,對於先天性纖維蛋白原缺乏症,我們肯定會開始與醫生合作,讓他們了解並更加意識到纖維蛋白原相對於其他替代方案的益處。
I don't know, Roland, if you want to add anything else?
羅蘭,我不知道你是否還有什麼要補充的?
Roland Wandeler - President - Biopharma
Roland Wandeler - President - Biopharma
Perhaps just commenting on how this compares to the plan that we laid out at the Capital Markets Day. As mentioned, today, the largest opportunity is in Europe, north of EUR200 million. And there, we remain on track for our launch in Germany this year, and we believe that we can differentiate and gain share in this market and actually have some opportunities in ex US -- ex Europe market as well to gain share.
或許只是想評論一下這與我們在資本市場日上提出的計劃有何不同。如前所述,目前最大的機會在歐洲,金額超過 2 億歐元。而且,我們今年在德國的上市計劃仍然按計劃進行,我們相信我們能夠在這個市場中脫穎而出並獲得份額,並且實際上在美國以外的歐洲市場也有一些獲得份額的機會。
In our considerations, the US was always a slower build. And therefore, a delay of AFD at this point does not materially change our outlook in the near term. And at the same time, we believe that with a possibly differentiated label at the time of launch of AFD in the US, we have an opportunity to still lead that market and capture the long-term potential of north of EUR800 million that we laid out at the Capital Markets Day. So that's where the comments come about that we don't see a change in our outlook.
在我們看來,美國的發展速度一直比較慢。因此,此時 AFD 的延遲不會對我們近期的展望產生實質影響。同時,我們相信,如果 AFD 在美國推出時能有一個差異化的品牌,我們就有機會繼續引領該市場,並實現我們在資本市場日上提出的超過 8 億歐元的長期潛力。所以,這就是為什麼有人會說我們的觀點沒有改變。
Rahul Srinivasan - Chief Financial Officer
Rahul Srinivasan - Chief Financial Officer
And Charles, on the 2030 bond harmonization, that's just a harmonization exercise between the conditions or the documentation, if you like, between the two bonds. Your comment around 2030 refinancing, of course, we have the optionality if we so choose to refinance those. Those bonds are callable on May 1, 2026, if I recall correctly, which just gives us -- we have that optionality. And clearly, as you can see with where those bonds are trading today, there is value as we think about refinancing those in due course. But it is a part of refinancing options that are available to us. It doesn't have to be in 2026. We can decide on the right time for that.
查爾斯,關於 2030 年債券協調,那隻是兩種債券的條件或文件之間的協調練習。您提到的2030年再融資問題,當然,如果我們願意,我們可以選擇再融資。如果我沒記錯的話,這些債券可以在 2026 年 5 月 1 日贖回,這給了我們——我們擁有這種選擇權。顯然,從這些債券目前的交易情況可以看出,考慮到我們將來可能會對這些債券進行再融資,它們具有一定的價值。但這是我們可選擇的再融資方案之一。不一定要2026年。我們可以擇個合適的時機。
And then finally, on GIC, you're absolutely right, there is -- those are 8% dollar bonds and the way we look at that is at sort of unsecured risk. There is value there. Again, we -- in terms of the right time to optimize a possible redemption of that, we'll decide that in close partnership with GIC. GIC has been a partner of us for some time. We'll work through that at the right time. But clearly, there is also possible value there. In due course, we can seek to capture that from a redemption and refinancing standpoint.
最後,關於 GIC,您說得完全正確,確實存在——那些是 8% 的美元債券,我們認為它們屬於無擔保風險。這裡面蘊含著價值。再說一遍,關於何時才是優化贖回的最佳時機,我們將與 GIC 密切合作決定。GIC一直是我們的合作夥伴。我們會擇機解決這個問題。但顯然,其中也可能蘊含價值。時機成熟後,我們可以從贖回和再融資的角度來尋求實現這一目標。
Daniel Segarra - Vice President - Investor Relations and Sustainability
Daniel Segarra - Vice President - Investor Relations and Sustainability
Now let's move to the next one, Jaime from Santander.
現在我們來看下一位,來自桑坦德的傑米。
Jaime Escribano - Analyst
Jaime Escribano - Analyst
So a couple of questions from my side. The first one, could you elaborate a little bit more on the dynamics of the albumin in China? Basically, if this pricing pressure comes from the offer side, so more competition? Or is it the demand or the reimbursement or the social security there that is putting lower prices?
我這邊有幾個問題。第一個問題,您能否再詳細談談中國白蛋白的動態變化?如果這種價格壓力來自供應商一方,那麼競爭就會更加激烈嗎?或者說,是需求、報銷還是社會保障因素導致了價格下降?
And the second one regarding also fibrinogen, just for my understanding, so it seems that there are two segments, so AFD and CFD. So out of the $800 million addressable market, how much is AFD and how much is CFD? Basically, my question tries to understand the short-term opportunity when you launch for CFD versus the [additional] indication, AFD?
第二個問題也與纖維蛋白原有關,只是為了讓我理解,所以看起來有兩個部分,即 AFD 和 CFD。那麼,在 8 億美元的潛在市場中,AFD 佔多少,CFD 佔多少?我的問題主要是想了解,當您推出 CFD 時,短期內的機會與 [額外的] 指標 AFD 相比如何?
Nacho Abia - Chief Executive Officer, Executive Director
Nacho Abia - Chief Executive Officer, Executive Director
Thanks, Jaime. And let me start with the second one, and then Roland will address the one about China. So on the fibrinogen, I mean, it's not possible to see or to assess really what is the market opportunity right now because the market development effort needs to be done. I think that we know that at this point, the use of fibrinogen in the US is limited. It's very limited. It's small.
謝謝你,傑米。讓我先從第二個問題開始,然後羅蘭會談到關於中國的問題。所以就纖維蛋白原而言,我的意思是,目前還不可能真正看到或評估市場機會是什麼,因為市場開發工作還需要進行。我認為我們知道,目前纖維蛋白原在美國的使用是有限的。非常有限。它很小。
And we know as well that what is the potential that fibrinogen can have. If we managed to get the standard of care at the levels that we see in other markets like Germany or Austria. So at this point, both AFD and CFD are small. And our work is going to be to really prove and bring clinical evidence that those markets will develop to the level that we expect they will be of this $800 million Europe that over time, we are confident it will happen.
我們也知道纖維蛋白原具有怎樣的潛力。如果我們能夠達到像德國或奧地利等其他市場那樣的醫療服務水準。所以目前 AFD 和 CFD 都很小。我們的工作就是真正證明並提供臨床證據,證明這些市場將發展到我們預期的水平,即歐洲 8 億美元的規模,我們相信隨著時間的推移,這一目標終將實現。
And on China, Roland will comment now.
關於中國問題,羅蘭現在將發表評論。
Roland Wandeler - President - Biopharma
Roland Wandeler - President - Biopharma
Yes. On China, the key underlying driver are the government-imposed cost controls that we talked about across the whole health care sector. That had an impact on prices and also had an impact in terms of the demand in the market slowing down. But it is important to note that while we see this impact at this moment, China remains to be the key market and the prices actually still compare favorably with other parts of the world.
是的。就中國而言,關鍵的根本驅動因素是政府在整個醫療保健領域實施的成本控制,我們之前也討論過這一點。這既影響了價格,也導致市場需求放緩。但值得注意的是,儘管我們目前看到了這種影響,但中國仍然是主要市場,而且價格實際上仍然比世界其他地區更具優勢。
Also, as we think about China for the future, it's a key market for us. It's important. We believe that our partnership, our strategic partnership with Haier and Shanghai RAAS puts us in a strong position to navigate this market, and we are working to seize opportunities to realize growth in other parts of the world, particularly US and ex US to see how we can aid to continue to balance our albumin with the Ig growth that we foresee. So in terms of the driver, it's really coming down on this market. It's a dynamic situation, but we believe that we are in a good position to navigate this with our strategic partnership.
此外,展望中國未來,中國是我們的關鍵市場。這很重要。我們相信,我們與海爾和上海瑞安集團的戰略合作夥伴關係使我們在這個市場中處於有利地位,我們正在努力抓住機會,在世界其他地區,特別是美國和美國以外的地區實現增長,看看我們如何才能幫助我們繼續平衡白蛋白與我們預見的免疫球蛋白增長之間的關係。所以就駕駛者而言,這個市場真的在走下坡。情況瞬息萬變,但我們相信,憑藉我們的策略夥伴關係,我們有能力應對這種情況。
Daniel Segarra - Vice President - Investor Relations and Sustainability
Daniel Segarra - Vice President - Investor Relations and Sustainability
Now we will go to Alvaro Lenze from Alantra, please.
現在我們連線來自 Alantra 的 Alvaro Lenze,請。
Alvaro Lenze - Analyst
Alvaro Lenze - Analyst
The first one is on the EBITDA guidance for the year. If I take the range you provided and I subtract the EUR70 million expected FX impact implied Q4 in the lower range would be about EUR450 million adjusted EBITDA and on the upper range would be around 500 -- sorry, EUR500 million. That is on the low end, a 15% decline, and that would put Q4 less than either Q3 and Q2. So I don't know if there is any phasing there. I know Rahul explained the comparison base for Q4 last year is quite tough, but still in absolute terms, the low range of the guidance would look a bit underwhelming. So I was just wondering what your thinking process for that guidance was.
第一個問題是關於本年度的 EBITDA 預期。如果我採用你提供的範圍,並減去預期的 7000 萬歐元外匯影響,則第四季度調整後 EBITDA 在較低範圍內約為 4.5 億歐元,在較高範圍內約為 5 億歐元。這還是保守估計,下降 15%,這意味著第四季的降幅將低於第三季和第二季。所以我不知道這裡面是否有任何階段性變化。我知道 Rahul 解釋說去年第四季的比較基數相當高,但即便如此,就絕對值而言,業績指引的下限仍然顯得有些令人失望。所以我想知道您制定該指導方針的思路是什麼。
And then a second question would be, you mentioned some impairments for Q4. I just wanted to know what sort of assets are you thinking of for the impairment and when did those assets join the balance sheet, just to understand whether you are looking at past or very old investments that you no longer think are as valuable as represented in the balance sheet or if it's more recent investments that you're cutting?
那麼第二個問題是,您提到了第四季度的一些減損情況。我只是想知道您指的是哪些類型的資產進行減值,以及這些資產是什麼時候計入資產負債表的,以便了解您指的是過去或非常久遠的投資,您認為這些投資的價值已不如資產負債表上所反映的那樣高,還是指您削減的是較新的投資?
Rahul Srinivasan - Chief Financial Officer
Rahul Srinivasan - Chief Financial Officer
Sure. Let me start with the second one on impairments. It's certainly, as you -- as I mentioned in my prepared remarks, we laid out at our Capital Markets Day, R&D and innovation plan and none of those from our standpoint are impacted at all. This really is some of the efforts in our portfolio that perhaps have not had the prioritization from a capital standpoint. And all we're doing is proactively flagging that.
當然。讓我先從第二個問題開始,那就是殘障問題。當然,正如您所說——正如我在準備好的演講中提到的,我們在資本市場日上製定了研發和創新計劃,從我們的角度來看,這些計劃都沒有受到任何影響。這確實是我們投資組合中一些可能在資金方面沒有優先考慮的項目。我們所做的只是主動標記這種情況。
But importantly, Alvaro, this does not impact our go-forward adjusted EBITDA growth story or indeed our go-forward free cash flow growth story. So just to give you an idea that just in terms of lower prioritization in terms of -- from a project standpoint. So that's on the second question.
但重要的是,阿爾瓦羅,這不會影響我們未來的調整後 EBITDA 成長預期,也不會影響我們未來的自由現金流成長預期。所以,我只是想讓您明白,從專案角度來看,優先順序較低的事項是…第二個問題的答案就在這裡。
On the first question around guidance and ranges, I said two things on our -- as I described the guidance. One, I said we are very comfortably within our guidance range for adjusted EBITDA. And then the other thing I said is we expect a robust Q4 2025. The only thing I caveated there was that the absolute comparison versus Q4 '24 that also benefited meaningfully from phasing last year is something that we just wanted to make sure that we prudently guided on. But from our standpoint, as you look at those ranges, I think the bottom end of the range that you feel very comfortable about managing and beating, and, as we've always done, focuses head down on execution with discipline and intensity. So we'll see where we get to, but we're tracking on that basis. And what we want to do is make sure we flag the phasing aspects as we've done.
關於指導和範圍的第一個問題,我談到了我們的兩件事——正如我描述指導時所說。第一,我說過,我們調整後的 EBITDA 完全符合我們的預期範圍。然後我還說,我們預計 2025 年第四季業績將強勁成長。我唯一要補充的是,與 2024 年第四季相比的絕對比較,由於去年的分階段實施也取得了顯著成效,我們只是想確保我們謹慎地進行指導。但從我們的角度來看,當你審視這些範圍時,我認為你感覺能夠輕鬆掌控和超越的範圍的下限,並且,正如我們一直以來所做的那樣,專注於以紀律和強度全力以赴地執行。所以我們會看看最終結果如何,但我們會以此為基礎進行追蹤。而我們想要做的,就是確保像我們之前做的那樣,把分階段方面的問題都標記出來。
Daniel Segarra - Vice President - Investor Relations and Sustainability
Daniel Segarra - Vice President - Investor Relations and Sustainability
Thank you so much. Now we would like to get Charlie Haywood from Bank of America.
太感謝了。現在我們想從美國銀行挖來查理海伍德。
Charlie Haywood - Analyst
Charlie Haywood - Analyst
Charlie Haywood, Bank of America. Two questions, please. First one, unless I've misunderstood, could you clarify what the FX headwind to your reported revenue guide would be for the full year? And then just on the sort of FX impact, what specifically on FX has changed since second quarter when, I guess, guide was reiterated and there wasn't an implied FX impact there?
查理·海伍德,美國銀行。請問兩個問題。首先,除非我理解有誤,您能否說明一下,外匯波動對您全年營收預期造成的不利影響是什麼?那麼就外匯影響而言,自第二季以來,外匯方面具體發生了哪些變化?當時我們重申了業績指引,並沒有暗示外匯影響。
And then the second question, just wanted to get your thoughts on, obviously, the competitor readouts we've had in alpha-1, your confidence in rebuttal of that, especially on the margin level, which I understand is slightly higher than your standard products and given also fibrinogen delay today might lead to more of a margin impact. So just high-level thoughts on how you can rebut that impact.
第二個問題,我想聽聽您對我們在 alpha-1 中看到的競爭對手數據的看法,以及您對反駁這些數據的信心,尤其是在利潤率方面,據我了解,您的利潤率略高於您的標準產品,而且考慮到今天纖維蛋白原的延遲,可能會對利潤率產生更大的影響。所以,請從宏觀層面思考如何反駁這種影響。
Rahul Srinivasan - Chief Financial Officer
Rahul Srinivasan - Chief Financial Officer
Thanks, Charlie. I'll take the first one. So if you go back to our Q1, go back to our Q2 and indeed repeating now in Q3, we've been consistent around the headwind of US dollar weakening on EBITDA. But remember, it remains broadly neutral from a leverage standpoint and indeed broadly neutral from both the group profit, bottom line net income and from a free cash flow standpoint.
謝謝你,查理。我選第一個。所以,回顧我們的第一季、第二季度,以及現在的第三季度,我們一直在應對美元走弱對 EBITDA 的不利影響。但請記住,從槓桿率的角度來看,它仍然保持大致中立;事實上,從集團利潤、淨利潤和自由現金流的角度來看,它也保持大致中性。
Number two, you will also -- if you go back to each of those presentations, you will also see that we have been reiterating, I think, Q1 and Q2, we've always taken you back to the basis on which guidance was provided, and there's no change in that respect now in Q3 either. So that's why we're always saying is that as you compare our guidance or implied guidance now relative to -- on a guidance FX rates basis, we continue to track well from a revenue and free cash flow standpoint, in fact, improved and maintain the -- or reaffirmed guidance from an EBITDA standpoint.
第二,如果您回顧一下之前的每一次演示,您還會發現我們一直在重申,我認為,在第一季度和第二季度,我們始終強調提供指導的依據,而第三季度在這方面也沒有任何變化。所以這就是為什麼我們一直強調,當你將我們目前的指引或隱含指引與——以指引匯率為基礎——進行比較時,從收入和自由現金流的角度來看,我們繼續保持良好勢頭,事實上,從 EBITDA 的角度來看,我們改進並維持了——或者說重申了指引。
Equally, we want to make sure that we are being completely upfront. We provided a sensitivity analysis in Q2. And what we're trying to do now is just give you a number if the rates as at the end of Q3 persists through to the end of the year, what that implies from an adjusted EBITDA headwind.
同樣,我們也想確保我們完全坦誠。我們在第二季度提供了敏感度分析。我們現在想做的就是,如果第三季末的利率持續到年底,那麼調整後的 EBITDA 將面臨怎樣的不利影響,並給出相應的數字。
The question around revenue impact, we've not provided that. But I mean -- but if you just assume that roughly about 2/3 or 65% of our revenues is US dollar-denominated. And if you do the rough math around that, depending on what your exchange rate assumptions are for the rest of the year, that could have an impact of anywhere between $300 million to $400 million, give or take. But on the basis of the guidance FX rates, we are guiding to an improved revenue guidance for the year. So let me leave it at that.
關於收入影響的問題,我們還沒有提供相關資訊。但我的意思是——但如果你假設我們大約 2/3 或 65% 的收入是以美元計價的。如果你粗略地計算一下,根據你對今年剩餘時間匯率的假設,這可能會產生 3 億至 4 億美元的影響,上下浮動。但根據指導性外匯匯率,我們預計今年的收入預期將有所改善。我就說到這兒吧。
And on the second question, I'll hand it over to Roland.
至於第二個問題,我將交給羅蘭回答。
Roland Wandeler - President - Biopharma
Roland Wandeler - President - Biopharma
Yes. On alpha-1, we always, as part of our plan, assumed positive top line data of the pharmacokinetic endpoints. So this was as we expected. What we hear from thought leaders are basically two questions at this point. One is waiting to see the detailed data and understanding safety of this recombinant approach.
是的。對於 alpha-1,作為我們計劃的一部分,我們始終假設藥物動力學終點的初步數據為陽性。這和我們預想的一樣。目前我們從思想領袖那裡聽到的問題基本上只有兩個。人們正在等待詳細數據,以了解這種重組方法的安全性。
And the second question is around the pathway to approval. And we're obviously also eagerly waiting to see what this means. But as we think about Alpha-1, we just want to bring it back to the immense opportunity that still remains. We only are treating 10% to 15% of patients today, which means 85% of patients are undiagnosed. And we just saw with CIDP how a new entrant can actually dramatically improve and accelerate diagnosis.
第二個問題是關於審批途徑。我們當然也迫切想知道這意味著什麼。但當我們思考 Alpha-1 時,我們只想把它帶回仍然存在的巨大機會。目前我們只治療了 10% 到 15% 的患者,這意味著 85% 的患者尚未確診。我們剛從 CIDP 的案例中看到,一種新的檢測手段實際上可以顯著改善和加快診斷過程。
Beyond that, we know that with our outcome study, SPARTA, we have it in our hands to raise awareness of this disease in the US and ensure that we can have a broader reimbursement in Europe, which gives us a growth lever. And then lastly, as we mentioned, we're excited about our subcu treatment, 15%, which we're advancing into Phase 3 and planning to submit an IND there in the coming months and our long-acting option.
除此之外,我們知道,透過我們的結果研究 SPARTA,我們可以提高美國對這種疾病的認識,並確保我們在歐洲獲得更廣泛的報銷,這為我們提供了一個成長槓桿。最後,正如我們所提到的,我們對皮下注射治療方案(15%)感到非常興奮,我們正在推進該方案進入 3 期臨床試驗,併計劃在未來幾個月內提交 IND 申請,以及我們的長效治療方案。
So as we look in -- at this market, a new entrant, but most importantly, the growth opportunity that this market has, we remain committed and confident about alpha-1. And as you think about fibrinogen concentrate, as we outlined, the path to growth is not materially affected by what we just shared. We are still in a position to compete and possibly accelerate our uptake ex US and we have an opportunity to strengthen our positioning in the US and see that we can lead in this market in the long term.
因此,當我們審視這個市場,一個新進入者,但更重要的是,這個市場所蘊含的成長機會時,我們仍然對 alpha-1 充滿信心和承諾。正如我們先前所述,在考慮纖維蛋白原濃縮物時,成長路徑並不會受到我們剛才分享的內容的實質影響。我們仍然有能力參與競爭,並有可能加快我們在美國以外的市場發展,我們有機會加強我們在美國的地位,並看到我們能夠在長期內引領這個市場。
Daniel Segarra - Vice President - Investor Relations and Sustainability
Daniel Segarra - Vice President - Investor Relations and Sustainability
Thank you so much, Roland. I appreciate the question, Charlie. Next up is Thibault from Morgan Stanley.
非常感謝你,羅蘭。查理,感謝你的提問。接下來是來自摩根士丹利的蒂博。
Thibault Boutherin - Analyst
Thibault Boutherin - Analyst
Just on the free cash flow guidance, so obviously, versus beginning of the year, EBITDA and change at constant currency, I mean, using February FX as a base, free cash flow guidance has been upgraded a couple of times since. If you can just remind us the moving parts in between for the free cash flow improvement and any risk of seeing some of these elements reversing in the future? So for example, working capital, if you could comment on your expectations for working capital position at the end of the year and what it means for potential reversal in Q1 next year?
就自由現金流預期而言,顯然,與年初相比,按固定匯率計算的 EBITDA 和變化(以 2 月份的匯率為基準),自由現金流預期已經上調了好幾次。您能否提醒我們一下,自由現金流改善涉及哪些環節,以及未來這些環節是否有逆轉的風險?例如,關於營運資金,您能否談談您對年底營運資金狀況的預期,以及這對明年第一季可能出現的逆轉意味著什麼?
Rahul Srinivasan - Chief Financial Officer
Rahul Srinivasan - Chief Financial Officer
Yes. So just -- so your question is on just the various constituent parts of our free cash flow improvement. You're absolutely right in that we have improved our guidance on free cash flow a couple of times this year. The drivers of that free cash flow improvement come from the improved EBITDA on a year-to-date basis, our adjusted EBITDA is up meaningfully. And even if you eliminate some of those cash adjustments, they continue to track very well compared to 2024.
是的。所以,你的問題是關於我們自由現金流改善的各個組成部分。您說得完全正確,今年我們已經幾次提高了對自由現金流的預期。自由現金流改善的驅動因素是年初至今 EBITDA 的改善,我們調整後的 EBITDA 顯著成長。即使剔除部分現金調整,與 2024 年相比,它們的表現仍然非常出色。
On a net working capital basis, we talk about tight working capital management, notwithstanding the impact of a depreciating dollar on just sort of inventory levels and so on, our inventory levels continue to be managed on a tight basis as is the case on both from a receivables and payables standpoint. So that is tracking well and tight.
從淨營運資本的角度來看,我們談到嚴格的營運資本管理,儘管美元貶值對庫存水準等產生了影響,但我們的庫存水準仍然得到嚴格管理,應收帳款和應付帳款的情況也是如此。所以跟蹤效果很好,很精準。
As you look at CapEx and capitalized IT and R&D, clearly, we are -- as we anticipated at our Capital Markets Day, we saw 2024 as being a sort of a peak from a total CapEx. And here when we talk about CapEx, I also include what we used to refer to as extraordinary growth CapEx previously. So the total CapEx number to sales was at a peak in 2024. And all that's happening here is it's playing out as we expected, prudent and disciplined CapEx spend.
從資本支出和資本化的IT和研發來看,很明顯,正如我們在資本市場日所預期的那樣,我們認為2024年是資本支出總額的高峰。這裡我們談到資本支出時,也包括我們以前所說的超額成長資本支出。因此,資本支出總額與銷售額之比在 2024 年達到高峰。而這裡發生的一切正如我們所預期的那樣,謹慎而有紀律的資本支出。
And then finally, as you look at interest cost, we had the significant deleveraging benefit in 2024 from the partial disposition of our Shanghai RAAS stake that has helped leverage, helped debt redemption. And in addition to that, what has also helped significantly is our meaningfully lower utilization of RCF from a financing standpoint. So all of that translates to free cash flow improvement of $257 million versus last year.
最後,從利息成本來看,我們在 2024 年透過部分出售上海 RAAS 股份獲得了顯著的去槓桿化收益,這有助於降低槓桿率,並有助於償還債務。除此之外,從融資角度來看,我們大幅降低了循環信貸的使用率,也起到了很大的幫助作用。因此,所有這些因素共同作用,使得自由現金流比去年增加了 2.57 億美元。
As I look at the picture for the rest of the year, we remain confident about executing on our improved guidance of $400 million to $425 million for free cash flow pre-M&A, pre-dividends for 2025. And then -- and with respect to the impact in 2026, we will cover that off when we provide guidance in -- at the end of February next year. But certainly, we're not anticipating significantly different variations.
展望今年剩餘時間,我們仍然有信心實現我們先前提高後的業績預期,即 2025 年併購前、分紅前自由現金流達到 4 億美元至 4.25 億美元。至於 2026 年的影響,我們將在明年 2 月底發布指導方針時進行說明。但可以肯定的是,我們預計不會有顯著不同的變化。
If you recall, in Q1 this year, we had a meaningful improvement from a free cash flow standpoint versus Q1 2024. And one of the things that we will seek to do is maintain that to the extent possible. But that's something that we'll pick up in a bit more detail when we provide our guidance for 2026 at the end of February next year.
如果你還記得的話,今年第一季度,從自由現金流的角度來看,我們比 2024 年第一季有了顯著改善。我們將努力做到的一點就是盡可能地維持這種狀態。但我們將在明年二月底發布 2026 年業績指引時,對此進行更詳細的闡述。
Daniel Segarra - Vice President - Investor Relations and Sustainability
Daniel Segarra - Vice President - Investor Relations and Sustainability
Thank you so much, Rahul. Very clear. Guilherme, I think that you were waiting.
非常感謝你,拉胡爾。非常清楚。吉列爾梅,我想你一直在等。
Guilherme Sampaio - Analyst
Guilherme Sampaio - Analyst
Yes. So two, if I may. The first one, I assume that the Ig growth acceleration was positively impacted by some pricing benefits that you alluded to, but also some volume gains in the UK. You're guiding for a slowdown in terms of (inaudible) growth going forward. Just to understand a bit how going to be the phasing between Q4 and Q1, taking Q1 as a potential reference for going forward. So this 6% to 8% is something that we should consider only for Q1 and Q4 could be a bit below these references? Or is the run rate -- the 6% to 8% is the run rate that we can assume going forward?
是的。如果可以的話,我想選兩個。首先,我認為 Ig 的成長加速受到了你提到的一些價格優勢的正面影響,同時也得益於英國銷售的一些成長。你預計未來(聽不清楚)成長速度將會放緩。為了更了解第四季和第一季之間的過渡情況,我們將第一季作為未來發展的潛在參考。所以,這6%到8%的比例只適用於第一季度,第四季可能會略低於這些參考值?或者說,6%到8%的運行率是我們未來可以預期的運行率嗎?
And second question regarding 2026. So from your comment, I assume that we should expect a lower underlying growth, at least in Biopharma. But the FX typically has a positive impact in terms of margins, the weaker UK -- US dollar. So at the Capital Markets Day, you guided for a uniform margin progression across the plan. This less favorable effects on the absolute EBITDA standpoint could impact positively margins. So we might have in 2026, a faster margin expansion than what you were planning in the Capital Markets Day?
第二個問題是關於2026年的。所以根據你的評論,我認為我們應該預期基本面成長會放緩,至少在生物製藥領域是如此。但匯率通常會對利潤率產生正面影響,英鎊兌美元走弱。因此,在資本市場日,您指導了整個計劃中統一的保證金遞增。從絕對 EBITDA 的角度來看,這種不利影響可能會對利潤率產生正面影響。所以,到 2026 年,利潤率擴張速度可能會比您在資本市場日上規劃的更快?
Roland Wandeler - President - Biopharma
Roland Wandeler - President - Biopharma
Guilherme, happy to add a bit more color on the Ig side. As you may recall, in our Capital Markets Day, we said that we aim to grow Ig in line or slightly ahead of the market and gave that 6% to 8% CAGR rate, which just reflects the potential that Ig has, and we expect it to be in there.
Guilherme,很高興能在 Instagram 上增添一些色彩。您可能還記得,在我們的資本市場日上,我們說過我們的目標是讓 Ig 的成長與市場持平或略高於市場,並給出了 6% 至 8% 的複合年增長率,這恰好反映了 Ig 的潛力,我們預計它將達到這個水平。
The other part that I want to just bring up again is you may recall that in the 2023 call, leadership at the time announced a plan to win back share in the US. During the pandemic, we have lost share in the US and we have announced that we want to win it back. We have since executed on this plan using a strong inventory position that we had at the time, and that translated into this double-digit growth, well, well ahead of the market during this time. We have since regained the market share and at this higher market share, we now expect to grow in line with the market or ahead of the market. So from that perspective, I would look at these last two years as our ability to actually reposition us in the market and from here to grow with or ahead of the market moving forward.
我想再次提及的另一點是,您可能還記得,在 2023 年的電話會議上,當時的領導層宣布了一項在美國贏回市場份額的計劃。疫情期間,我們在美國失去了市場份額,我們已經宣布要贏回這些市場份額。此後,我們利用當時強大的庫存實力執行了這項計劃,並實現了兩位數的成長,遠遠領先於同期市場。我們已經重新奪回了市場份額,並且憑藉更高的市場份額,我們現在期望能夠與市場保持同步成長,甚至超越市場成長。所以從這個角度來看,我認為過去兩年是我們重新定位自身在市場中地位,並以此為基礎,在未來與市場同步成長甚至超越市場成長的機會。
Rahul Srinivasan - Chief Financial Officer
Rahul Srinivasan - Chief Financial Officer
And then finally, on the question around margins. No real change in terms of the building blocks driving our margin improvement story over the coming years. And with respect to what we had guided from a margin standpoint for 2025 was adjusted EBITDA margins to be in line with 2024, having fully absorbed the impact of IRA. And year-to-date, we're doing exactly that. You can see on a like-for-like basis and even on a year-to-date basis, our margin improvement is up. So that remains the story for 2025. And with respect to 2026 and beyond no change, we will update the market with respect to 2026 guidance specifically when we come to it at the end of February.
最後,關於利潤率的問題。未來幾年,推動我們利潤率提升的基本要素不會發生實質變化。至於我們從利潤率角度對 2025 年的預期,即調整後的 EBITDA 利潤率將與 2024 年保持一致,因為已經完全吸收了 IRA 的影響。今年迄今為止,我們正是這樣做的。從可比口徑來看,甚至從年初至今來看,我們的利潤率都有所提升。所以,2025年的情況依然如此。至於 2026 年及以後的情況,不會有任何變化,我們將在 2 月底發布 2026 年的具體指引時向市場更新相關資訊。
Daniel Segarra - Vice President - Investor Relations and Sustainability
Daniel Segarra - Vice President - Investor Relations and Sustainability
Thank you, Roland. Thank you, Rahul. We have time for the very last question. It's going to be Justin from Bernstein. Justin, please.
謝謝你,羅蘭。謝謝你,拉胡爾。我們還有時間回答最後一個問題。是來自伯恩斯坦的賈斯汀。賈斯汀,拜託了。
Justin Smith - Analyst
Justin Smith - Analyst
Yes. Justin from Bernstein. Just a quick one on fibrinogen, and apologies if I've missed some remarks here. But when you talk about the new evidence that you need to bring, are we talking about new clinical data? If so, could you just share some thoughts on execution risk there? I mean, is it a case with acquired patients? It's quite difficult to locate those patients and run the trial. So any thoughts there would be very helpful.
是的。來自伯恩斯坦的賈斯汀。關於纖維蛋白原,我簡單提一下,如果我遺漏了什麼,請見諒。但是,當您談到需要提供的新證據時,我們指的是新的臨床數據嗎?如果是這樣,您能否分享一下您對執行風險的看法?我的意思是,這是後天感染病例嗎?要找到這些患者並進行試驗相當困難。所以,任何想法都會非常有幫助。
Roland Wandeler - President - Biopharma
Roland Wandeler - President - Biopharma
Yes. The one thing to highlight is that we are obviously looking at the study in the US, and we have different proposals on the table, and we'll be looking at the best way with an eye on making sure that this obviously helps us with speed to the market at the same differentiation possibly in our label. And we do not see an execution risk there. We see the need and interest to conduct a trial like that.
是的。需要強調的是,我們顯然正在關注美國的研究,我們提出了不同的方案,我們將著眼於最佳方案,以確保這顯然有助於我們以相同的速度將產品推向市場,並可能在我們的標籤上實現差異化。我們認為這方面不存在執行風險。我們認為有必要也有興趣進行這樣的試驗。
Daniel Segarra - Vice President - Investor Relations and Sustainability
Daniel Segarra - Vice President - Investor Relations and Sustainability
Okay. Thank you so much, Roland. I say that was all for now. Thank you so much for all your questions and for joining us today. If there is any follow-up, please let us know. There is an IR team dedicated for that. Thank you so much.
好的。非常感謝你,羅蘭。我說今天就到這裡吧。非常感謝大家提出的所有問題,也感謝大家今天參與我們的節目。如有任何後續事宜,請告知我們。有一個專門負責此事的投資者關係團隊。太感謝了。