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罗氏2026三季度销售更新:9个月CER增长6%、全年指引仅确认未上调(Investing.com AI复述版,无新增事实)
已处理事件库命中同一具体催化:罗氏2026年Q3/前三季度销售更新(Art.53 LR一手通稿,2026-10-22 05:03 UTC已研判为不做,覆盖RO.SW/RHHBY.US/4519.JP)。本篇Investing.com文章为9小时后对同一份公司演示材料的AI生成综述(文末明确标注AI生成),所有核心数字(9M CER +6%、Q3 CER +7%、CHF 46.5十亿、全年指引确认、20 NME by 2030、日本ERP时点效应Q4反转)均已在早间公告中披露,无任何上调指引、新订单、新获批或超预期事实。超大市值药企例行明牌更新,且股价YTD +53%、处52周高点,无正期望edge。
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Roche Q3 2026 slides: 6% growth, 20 NMEs targeted by 2030
Meta dips 5% despite earnings beat; capex outlook narrowed amid AI spending surge Introduction & Market Context Roche H…
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Meta dips 5% despite earnings beat; capex outlook narrowed amid AI spending surge
Introduction & Market Context
Roche Holding AG (SIX:ROG) presented its year-to-date September 2026 results on October 22, 2026, reporting continued strong financial performance with 6% sales growth at constant exchange rates and reaffirming full-year guidance. The Swiss pharmaceutical and diagnostics giant demonstrated broad-based momentum across its diversified portfolio while highlighting significant pipeline progress, including up to 20 new molecular entities (NMEs) with launch potential by 2030.
The company’s shares traded at $31.05 following the update, near the top of their 52-week range of $20.47 to $31.05, reflecting investor confidence in Roche’s transformation and growth trajectory. With a year-to-date return of 53% and 66% over the past twelve months, the stock has rewarded shareholders as management executes on its strategic priorities.
Quarterly Performance Highlights
The following table illustrates Roche’s year-to-date September 2026 sales performance across its two main divisions, showing the pharmaceutical business as the primary growth driver.
Roche delivered CHF 46.5 billion in total sales for the nine months ended September 2026, up 6% at constant exchange rates (CER) from CHF 45.9 billion in the prior-year period. The Pharmaceuticals Division generated CHF 36.2 billion, growing 7% at CER, while the Diagnostics Division contributed CHF 10.3 billion with 4% CER growth. In Swiss franc terms, Group sales increased just 1%, reflecting significant currency headwinds that have been easing throughout the year.
Chief Executive Thomas Schinecker emphasized the company’s sustained momentum: "We had a strong performance yet again, and we made significant portfolio progress. We have good line of sight for growth to the end of the decade and beyond."
The company noted that third-quarter Pharma sales in Japan were positively impacted by timing effects related to implementation of a new enterprise resource planning (ERP) system. Excluding this effect, underlying Pharma growth would have been 6% year-to-date, still representing solid performance. Management confirmed the ERP benefit will reverse in the fourth quarter.
The following chart demonstrates Roche’s consistent growth trajectory from the COVID-19 pandemic through the current post-pandemic period, with base business growth averaging 7% in the most recent phase.
Diversified Portfolio Drives Growth
Roche’s growth is supported by a broad and diversified portfolio spanning multiple therapeutic areas, as illustrated in the following breakdown of 2026 sales by segment.
The portfolio analysis reveals balanced contributions across major franchises. Oncology/Hematology remained the largest segment at CHF 18.3 billion with 6% growth, driven by Phesgo’s ongoing conversion in HER2+ breast cancer, Tecentriq’s expansion into new indications, and strong uptake of Polivy in first-line diffuse large B-cell lymphoma (DLBCL), Columvi in second-line DLBCL, and Lunsumio in follicular lymphoma.
Neurology delivered CHF 7.6 billion with 10% growth, powered by Ocrevus’s global expansion, particularly the subcutaneous formulation, and Evrysdi’s strengthening position in spinal muscular atrophy. Ophthalmology contributed CHF 5.0 billion with 9% growth as Vabysmo continued its global market share gains in retinal diseases.
The Diagnostics Division generated CHF 10.3 billion with 4% growth, with Pathology Lab showing particularly strong performance while Core Lab grew despite ongoing healthcare pricing reforms in China. Immunology added CHF 3.3 billion with 4% growth, led by Xolair’s continued expansion in food allergy, though partially offset by biosimilar impact on Actemra.
The company expects a loss of exclusivity (LOE) impact of roughly CHF 0.6 billion in 2026 from global losses of Avastin, Herceptin, MabThera/Rituxan, Lucentis, and Actemra. Despite this headwind, Roche’s newer products are more than compensating for the erosion.
Regional Performance Analysis
The following table breaks down Roche’s Pharmaceuticals sales by geographic region, highlighting strong performance in the United States, Japan, and International markets.
The United States remained the largest market at CHF 18.7 billion, growing 5% at CER despite flat reported growth in Swiss francs due to currency effects. Europe contributed CHF 6.8 billion with 2% CER growth, while Japan delivered CHF 2.4 billion with an impressive 25% CER growth, significantly boosted by the ERP timing effects mentioned earlier. The International region generated CHF 8.3 billion with solid 10% CER growth.
A more detailed view of product-level performance across regions shows the depth and breadth of Roche’s growth drivers.
This analysis reveals that growth is not dependent on a single product or region but rather distributed across the portfolio. Xolair led with 20% growth driven by food allergy uptake, while newer launches like Lunsumio (+187%), Itovebi (+153%), and Columvi (+67%) showed strong momentum. Established products like Hemlibra (+12%), Ocrevus (+7%), and Phesgo (+18%) continued to deliver solid growth.
Oncology and Hematology Franchise Performance
The oncology portfolio demonstrated steady growth driven by Phesgo and Tecentriq, with important pipeline progress in breast cancer.
Oncology/Hematology sales reached CHF 11.2 billion with 1% YoY CER growth. Phesgo grew 18% to CHF 2.1 billion as the global conversion rate from intravenous Perjeta climbed to 59%. Tecentriq added CHF 2.6 billion with 5% growth, supported by new indication approvals including stage III dMMR colon cancer. Alecensa contributed CHF 1.2 billion with 6% growth, with management raising full-year guidance to low single-digit growth from previously flat expectations.
The recently launched Itovebi grew 153% to CHF 163 million as the first-line launch in PIK3CA-mutant HR+ breast cancer continues. Giredestrant represents a significant upcoming catalyst, with two U.S. PDUFA dates set for November 30 (adjuvant HR+ breast cancer) and December 18 (post-CDK4/6i HR+ metastatic breast cancer).
The hematology portfolio delivered even stronger performance with 17% growth, as shown in the following breakdown.
Hematology sales totaled CHF 7.1 billion, driven by Hemlibra’s CHF 3.8 billion (up 12%) as the established standard of care in hemophilia A. Polivy grew 24% to CHF 1.3 billion with continued strong uptake in first-line DLBCL. Columvi expanded 67% to CHF 327 million, driven by second-line DLBCL adoption, while Lunsumio surged 187% to CHF 206 million with strong third-line follicular lymphoma uptake.
A key third-quarter milestone was the positive Phase III CELESTIMO readout for Lunsumio in combination with lenalidomide in second-line follicular lymphoma, which will be submitted to health authorities and presented at an upcoming medical meeting.
Neurology: Ocrevus Subcutaneous Driving Growth
The neurology franchise delivered 10% growth, led by Ocrevus’s subcutaneous formulation adoption.
Neurology sales reached CHF 7.6 billion, with Ocrevus contributing CHF 5.3 billion and 7% growth. The subcutaneous version, Ocrevus Zunovo, now treats approximately 56,000 patients globally and has become the fastest-growing anti-CD20 therapy in the U.S., driven particularly by uptake in community practices. About 60% of U.S. subcutaneous volume comes from community settings.
Evrysdi expanded 18% to CHF 1.5 billion, strengthening its position in spinal muscular atrophy with more than 27,000 patients treated globally. Enspryng grew 28% to CHF 319 million, with recent U.S. filing achieved for MOGAD (myelin oligodendrocyte glycoprotein antibody-associated disease) with priority review granted and a PDUFA date of January 10, 2027.
The following charts illustrate the strong global launch momentum of Ocrevus subcutaneous, showing both patient count growth and conversion from the intravenous formulation.
The subcutaneous formulation now accounts for more than 20% of total Ocrevus volume, driven by both new-to-brand patients and conversion from intravenous administration. An on-body injector for convenient twice-yearly at-home self-administration is in development, with data expected in 2027.
Fenebrutinib: Differentiated BTK Inhibitor Profile
One of Roche’s most significant pipeline advances is fenebrutinib, the first and only BTK inhibitor with positive Phase III results in both relapsing and primary progressive multiple sclerosis. The following data from the MSToronto 2026 meeting demonstrates its comprehensive efficacy profile.
Fenebrutinib achieved a 70% risk reduction in no evidence of disease activity (NEDA-3) at 96 weeks compared to teriflunomide, with a hazard ratio of 0.30. The compound also showed a 23% relative reduction in brain volume loss and continued improvement in CSF biomarkers for progressive biology through 96 weeks, including markers for microglia and astrocyte activity.
The annualized relapse rate data positions fenebrutinib as a high-efficacy disease-modifying therapy, as illustrated in the following comparison.
With a 55% reduction in annualized relapse rate versus active comparator, fenebrutinib is the first and only oral therapy to demonstrate greater than 50% improvement versus active comparator in relapsing MS. This positions it competitively alongside anti-CD20 monoclonal antibodies in the high-efficacy category. U.S. filing was achieved with priority review granted using a priority review voucher, and EU filing was also completed.
Immunology and Ophthalmology Franchises
The immunology portfolio grew 4%, driven primarily by Xolair’s expansion in food allergy.
Immunology sales reached CHF 5.0 billion, with Xolair contributing CHF 2.5 billion and impressive 20% growth. More than 145,000 patients have been treated for food allergy since launch. The first U.S. biosimilar has launched, but management expects continued growth given the relatively sticky allergy market. Actemra declined 10% to CHF 1.6 billion due to biosimilar impact in the U.S., EU, and International markets.
Gazyva showed strong initial uptake in lupus nephritis with approximately 5,000 patients treated globally since launch, and achieved U.S. approval in childhood-onset idiopathic nephrotic syndrome. A key immunology pipeline milestone was the positive Phase III IMAGINATION interim data for sefaxersen in IgA nephropathy, demonstrating best-in-class potential for selective complement suppression.
In ophthalmology, Vabysmo continued its global market expansion with 9% portfolio growth.
Ophthalmology generated CHF 3.3 billion, with Vabysmo contributing CHF 3.2 billion and 10% growth. Strong uptake continues with approximately 1.5 million patients treated globally, and more than 60% of U.S. patient starts are treatment-naïve. Updated real-world VOYAGER data for more than 5,000 patients presented at EURETINA reinforced robust effectiveness and durability across neovascular age-related macular degeneration, diabetic macular edema, and retinal vein occlusion.
Enspryng achieved U.S. approval in thyroid eye disease, while vamikibart achieved U.S. and EU filings in uveitic macular edema with a U.S. PDUFA date of July 23, 2027. Susvimo received EU approval in neovascular AMD.
CVRM Pipeline: Expanding Obesity Franchise
Roche is building a significant presence in cardiovascular, renal, and metabolism (CVRM), particularly in obesity, as shown in the following pipeline overview.
The CVRM pipeline now includes multiple assets in obesity with or without type 2 diabetes, including enicepatide (CT-388), petrelintide, tifeglipron (CT-996), and a recently added UCN2 analog through the Hanmi partnership. The company also has programs in MASH (pegozafermin, afimkibart), hypertension (zilebesiran), and other cardiovascular indications.
Key third-quarter achievements included positive Phase II data for enicepatide in obesity with T2D (study 104), positive Phase II data for tifeglipron (CT-996) in obesity (study 702), and positive Phase II data for petrelintide in obesity with T2D (ZUPREME-2). Phase III programs have been initiated for petrelintide (ZUPREME-3/4/5) in obesity.
The following detailed view illustrates Roche’s ambition to become a top-three player in obesity through development of enicepatide and petrelintide as monotherapies and in combination.
Enicepatide, a biased ligand GLP-1R or GIPR agonist, demonstrated robust weight loss with no plateau at week 48 in Phase II studies. The Phase III program is expanding to include glycemic control in T2D with head-to-head comparison versus tirzepatide, heart failure with reduced ejection fraction, and cardiovascular outcomes trials.
Petrelintide, a long-acting amylin analog suitable for once-weekly dosing, has the potential to redefine the weight management experience with double-digit weight loss and improved tolerability. The Phase III monotherapy program in obesity with or without T2D has been initiated, and a Phase II combination study (ZYNERGY) with enicepatide will begin in the fourth quarter of 2026.
Pipeline Transformation and R&D Productivity
Roche’s pipeline has undergone significant transformation, with improved quality metrics and expanded potential.
The company now has up to 20 NMEs with launch potential by 2030, spanning oncology/hematology, neurology, immunology, ophthalmology, and CVRM. Peak sales potential ranges from CHF 0.5-1 billion to greater than CHF 3 billion per asset, with multiple blockbuster opportunities identified. Recent additions include tambotatug pelitecan in small cell lung cancer and VEGF x IL6 DutaFab in diabetic macular edema.
The portfolio health has improved significantly, as demonstrated in the following risk-reward analysis.
Assets with pivotal go decisions post the "Bar" (Roche’s internal review process) show higher probability of technical success (PTS) in Phase III and higher value (aNPV) compared to pre-Bar decisions. The year-to-date Phase III success rate has exceeded 80%, with seven positive Phase III readouts including divarasib (KRASCENDO 1) in KRAS G12C+ NSCLC, Lunsumio (CELESTIMO) in follicular lymphoma, fenebrutinib (FENhance 1) in RMS, Enspryng (METEOROID) in MOGAD, Gazyva (MAJESTY) in membranous nephropathy, sefaxersen (IMAGINATION) in IgAN, and Vabysmo (POYANG) in myopic CNV.
Pipeline evolution continues through both internal development and business development, as shown in the following quarterly changes.
The clinical pipeline reached 60 NMEs by YTD September 2026, with ongoing prioritization balancing additions and removals. Since the first half of 2026, Roche has announced six platform discovery deals across modalities and therapeutic areas, including partnerships with DualityBio (ADC platform), Hansoh Pharma (novel ADC portfolio), Earendil Labs (AI-powered bispecific antibodies), Defand Therapeutics (molecular glue degraders), Qualitas Therapeutics (bispecific antibodies), and Atavistik (allosteric small molecule therapeutics).
AI-Driven R&D Innovation
Roche is leveraging artificial intelligence to increase research portfolio productivity through its Lab-in-the-Loop implementation.
The company’s AI strategy encompasses three pillars: EverydayAI (85,000 employees trained with 75% weekly active users), Reshape (80+ use cases across functions with 14 beyond pilot phase), and Big Ideas such as Lab-in-the-Loop. The company is deploying an AI Factory with more than 3,500 Blackwell GPUs to support these initiatives.
Lab-in-the-Loop has delivered impressive results in early R&D, with lead identification go decisions growing at a 37% CAGR from 2022 to 2026, lead optimization go decisions at 20% CAGR, and internal development go decisions at 14% CAGR. From 2022 to 2025, the company achieved 155% growth in lead identification go, 75% growth in lead optimization go, and 50% growth in internal development go.
Diagnostics Innovation and Technology Launches
The Diagnostics Division is driving future growth through key technology platform launches.
Three major platform launches are underway: AXELIOS 1 sequencing solution for molecular lab (launched June 2026), cobas i 601 Mass Spec for core lab (launched 2024), and Accu-Chek SmartGuide for near patient care (launched 2024). The AXELIOS 1 launch is showing strong momentum, with approximately one-third of the Year 1 order target of 100 instruments already achieved.
Customer testimonials highlight key benefits, with Eric Chow of UCSF describing AXELIOS 1 as "exciting," Michael Quail of Wellcome Sanger Institute noting it’s "faster than any sequencing technology" before and enables new applications, and Edwin Cuppern of Hartwig Medical Foundation mentioning that sequencing cost has shrunk to a "minority of the total cost of the test."
The following illustration demonstrates AXELIOS capabilities across multiple applications, including single-cell libraries, simplex and duplex whole genome sequencing, and target enrichment through collaboration with Twist Bioscience.
AXELIOS achieved 0.99 total correlation with existing single-cell sequencing workflows while delivering approximately three times longer single-cell RNA reads (300 bp versus 90 bp), enabling deeper isoform resolution. In rare disease applications, the platform showcased consolidation onto a single platform delivering both short- and longer-read WGS, with high concordance on all samples for SNVs, indels, and mitochondrial variants.
Roche also announced CE mark approval for cobas HDV, the first fully automated diagnostic solution to identify hepatitis D virus, the most severe form of viral hepatitis.
HDV affects nearly 12 million people globally and severely impacts individuals already carrying hepatitis B virus, leading to faster progression toward liver failure, cirrhosis, and liver cancer. The cobas HDV test provides reliable testing to support diagnosis and treatment monitoring in line with EASL, AASLD, and APASL guidelines, enabling consistent, high-throughput automated testing on the cobas 5800/6800/8800 systems.
The company’s comprehensive 2026 diagnostics launch portfolio includes multiple systems, tests, and digital solutions across all major lab segments.
Currency Impact and Financial Guidance
Currency headwinds have been easing throughout 2026, as illustrated in the following waterfall analysis of Group growth.
The breakdown shows that Pharma excluding LOE contributed CHF 2.8 billion in growth, while LOE reduced sales by CHF 355 million. Diagnostics excluding China added CHF 558 million, while China healthcare pricing reforms reduced sales by CHF 170 million. Foreign exchange had a negative impact of CHF 2.2 billion, resulting in net reported growth of 1% in Swiss francs versus 6% at constant exchange rates.
The currency impact by major currency pair shows the progression throughout the year.
The U.S. dollar had the largest negative impact at -2.9 percentage points, followed by the Japanese yen at -0.7 percentage points and the euro at -0.3 percentage points. However, the quarterly trend has improved significantly, with currency impact moving from -11 percentage points in Q1 to -4 percentage points in Q2 to +1 percentage point in Q3.
Expected currency impact for 2026 assumes September 30, 2026, exchange rates remain stable through year-end.
For the full year 2026, currency is expected to reduce sales growth by 3 percentage points and core operating profit and Core EPS growth by 5 percentage points. The improving trend provides a more favorable backdrop for the fourth quarter and into 2027.
2026 Guidance and Long-Term Outlook
Roche reaffirmed its full-year 2026 guidance.
The company expects mid-single-digit sales growth at constant exchange rates, high-single-digit Core EPS growth at constant exchange rates, and a further increase in the dividend in Swiss francs. This guidance incorporates the expected LOE impact of roughly CHF 0.6 billion and assumes the reversal of the Japan ERP timing benefit in the fourth quarter.
Chief Financial Officer Alan Hippe indicated that margins will expand in 2027 despite higher R&D spending, helped by efficiency gains and internal resource reallocation. Management expressed confidence in maintaining momentum through the next several years while continuing to invest in the pipeline.
The following strategic outlook illustrates Roche’s vision for sustained growth beyond 2030.
The company’s growth strategy is built on multiple pillars: business development to further accelerate pipeline growth, major late-stage readouts in new diseases from 2027 to 2030 (including IBD, Alzheimer’s, MASH, Parkinson’s, obesity, and uncontrolled hypertension), and the on-market Pharma portfolio including Gazyva in immunology, giredestrant, and fenebrutinib to deliver strong growth overcompensating for generic erosion.
Management emphasized that there is "no patent cliff ahead" and that Pharma core operating profit margin should be at least stable. In Diagnostics, growth will be driven by the on-market portfolio and key launches, with unique blockbuster opportunities in sequencing, mass spectrometry, and continuous glucose monitoring. The division is expected to deliver mid- to high-single-digit sales growth with core operating profit growth ahead of sales growth.
Near-Term Regulatory Catalysts
The company has significant newsflow expected through the remainder of 2026 and into 2027.
Key 2026 regulatory milestones include U.S. and EU filings for giredestrant in adjuvant and post-CDK4/6i breast cancer (with U.S. approvals expected), U.S. and EU approvals for Gazyva in systemic lupus erythematosus, membranous nephropathy, and childhood-onset idiopathic nephrotic syndrome, U.S. and EU approvals for Enspryng in MOGAD, and U.S. and EU approvals for vamikibart in uveitic macular edema.
Clinical results expected include pivotal Phase III readout for Itovebi in post-CDK4/6i PIK3CA-mutant HR+/HER2- metastatic breast cancer (INAVO121). Several diagnostic launches are also planned, including VENTANA BAP1 for mesothelioma differentiation.
The Diagnostics Division regional performance shows balanced growth across geographies.
Diagnostics sales by division show Core Lab at CHF 5.8 billion (up 5% CER), Molecular Lab at CHF 1.8 billion (up 3% CER), Near Patient Care at CHF 1.3 billion (down 5% CER), and Pathology Lab at CHF 1.3 billion (up 10% CER). The impact of China healthcare pricing reforms continues to moderate, and management expects Diagnostics to return to mid- to high-single-digit growth as this pressure normalizes.
The geographic breakdown of Diagnostics sales illustrates the global footprint.
North America contributed approximately 33% of divisional sales with 9% growth, EMEA approximately 36% with 3% growth, Asia Pacific approximately 23% with -4% growth (impacted by China), and Latin America approximately 8% with 12% growth.
Comprehensive Pipeline Overview
For investors seeking detailed pipeline information, Roche provided extensive tables covering all development stages.
The Phase I and Phase II pipeline includes 33 NMEs plus 6 additional indications in Phase I, and 11 NMEs plus 5 additional indications in Phase II, spanning oncology/hematology, immunology, CVRM, neurology, ophthalmology, and other therapeutic areas.
The Phase III and registration pipeline includes 13 NMEs plus 22 additional indications in Phase III, and 3 NMEs plus 8 additional indications in registration in the U.S. and EU, representing near-term commercial opportunities.
The expected regulatory submission timeline provides visibility into future catalysts.
Major pending approvals by region show the breadth of near-term opportunities across the U.S., EU, China, and Japan.
Conclusion
Roche’s year-to-date September 2026 presentation demonstrated continued strong execution across a diversified portfolio, with 6% sales growth at constant exchange rates driven by broad-based gains in pharmaceuticals and improving diagnostics performance. The company’s pipeline has been significantly strengthened, with up to 20 NMEs targeted for launch by 2030, a Phase III success rate exceeding 80%, and major advances in high-value therapeutic areas including oncology, neurology, immunology, ophthalmology, and the emerging obesity franchise.
With reaffirmed full-year guidance for mid-single-digit sales growth and high-single-digit Core EPS growth, easing currency headwinds, no patent cliff ahead, and expanding margins expected in 2027, management has provided investors with confidence in the company’s trajectory through the end of the decade and beyond. The combination of established product momentum, successful new launches, robust pipeline progress, and strategic investments in AI-driven R&D and diagnostic innovation positions Roche for sustained long-term growth.
Full presentation:
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
Introduction & Market Context
Roche Holding AG (SIX:ROG) presented its year-to-date September 2026 results on October 22, 2026, reporting continued strong financial performance with 6% sales growth at constant exchange rates and reaffirming full-year guidance. The Swiss pharmaceutical and diagnostics giant demonstrated broad-based momentum across its diversified portfolio while highlighting significant pipeline progress, including up to 20 new molecular entities (NMEs) with launch potential by 2030.
The company’s shares traded at $31.05 following the update, near the top of their 52-week range of $20.47 to $31.05, reflecting investor confidence in Roche’s transformation and growth trajectory. With a year-to-date return of 53% and 66% over the past twelve months, the stock has rewarded shareholders as management executes on its strategic priorities.
Quarterly Performance Highlights
The following table illustrates Roche’s year-to-date September 2026 sales performance across its two main divisions, showing the pharmaceutical business as the primary growth driver.
Roche delivered CHF 46.5 billion in total sales for the nine months ended September 2026, up 6% at constant exchange rates (CER) from CHF 45.9 billion in the prior-year period. The Pharmaceuticals Division generated CHF 36.2 billion, growing 7% at CER, while the Diagnostics Division contributed CHF 10.3 billion with 4% CER growth. In Swiss franc terms, Group sales increased just 1%, reflecting significant currency headwinds that have been easing throughout the year.
Chief Executive Thomas Schinecker emphasized the company’s sustained momentum: "We had a strong performance yet again, and we made significant portfolio progress. We have good line of sight for growth to the end of the decade and beyond."
The company noted that third-quarter Pharma sales in Japan were positively impacted by timing effects related to implementation of a new enterprise resource planning (ERP) system. Excluding this effect, underlying Pharma growth would have been 6% year-to-date, still representing solid performance. Management confirmed the ERP benefit will reverse in the fourth quarter.
The following chart demonstrates Roche’s consistent growth trajectory from the COVID-19 pandemic through the current post-pandemic period, with base business growth averaging 7% in the most recent phase.
Diversified Portfolio Drives Growth
Roche’s growth is supported by a broad and diversified portfolio spanning multiple therapeutic areas, as illustrated in the following breakdown of 2026 sales by segment.
The portfolio analysis reveals balanced contributions across major franchises. Oncology/Hematology remained the largest segment at CHF 18.3 billion with 6% growth, driven by Phesgo’s ongoing conversion in HER2+ breast cancer, Tecentriq’s expansion into new indications, and strong uptake of Polivy in first-line diffuse large B-cell lymphoma (DLBCL), Columvi in second-line DLBCL, and Lunsumio in follicular lymphoma.
Neurology delivered CHF 7.6 billion with 10% growth, powered by Ocrevus’s global expansion, particularly the subcutaneous formulation, and Evrysdi’s strengthening position in spinal muscular atrophy. Ophthalmology contributed CHF 5.0 billion with 9% growth as Vabysmo continued its global market share gains in retinal diseases.
The Diagnostics Division generated CHF 10.3 billion with 4% growth, with Pathology Lab showing particularly strong performance while Core Lab grew despite ongoing healthcare pricing reforms in China. Immunology added CHF 3.3 billion with 4% growth, led by Xolair’s continued expansion in food allergy, though partially offset by biosimilar impact on Actemra.
The company expects a loss of exclusivity (LOE) impact of roughly CHF 0.6 billion in 2026 from global losses of Avastin, Herceptin, MabThera/Rituxan, Lucentis, and Actemra. Despite this headwind, Roche’s newer products are more than compensating for the erosion.
Regional Performance Analysis
The following table breaks down Roche’s Pharmaceuticals sales by geographic region, highlighting strong performance in the United States, Japan, and International markets.
The United States remained the largest market at CHF 18.7 billion, growing 5% at CER despite flat reported growth in Swiss francs due to currency effects. Europe contributed CHF 6.8 billion with 2% CER growth, while Japan delivered CHF 2.4 billion with an impressive 25% CER growth, significantly boosted by the ERP timing effects mentioned earlier. The International region generated CHF 8.3 billion with solid 10% CER growth.
A more detailed view of product-level performance across regions shows the depth and breadth of Roche’s growth drivers.
This analysis reveals that growth is not dependent on a single product or region but rather distributed across the portfolio. Xolair led with 20% growth driven by food allergy uptake, while newer launches like Lunsumio (+187%), Itovebi (+153%), and Columvi (+67%) showed strong momentum. Established products like Hemlibra (+12%), Ocrevus (+7%), and Phesgo (+18%) continued to deliver solid growth.
Oncology and Hematology Franchise Performance
The oncology portfolio demonstrated steady growth driven by Phesgo and Tecentriq, with important pipeline progress in breast cancer.
Oncology/Hematology sales reached CHF 11.2 billion with 1% YoY CER growth. Phesgo grew 18% to CHF 2.1 billion as the global conversion rate from intravenous Perjeta climbed to 59%. Tecentriq added CHF 2.6 billion with 5% growth, supported by new indication approvals including stage III dMMR colon cancer. Alecensa contributed CHF 1.2 billion with 6% growth, with management raising full-year guidance to low single-digit growth from previously flat expectations.
The recently launched Itovebi grew 153% to CHF 163 million as the first-line launch in PIK3CA-mutant HR+ breast cancer continues. Giredestrant represents a significant upcoming catalyst, with two U.S. PDUFA dates set for November 30 (adjuvant HR+ breast cancer) and December 18 (post-CDK4/6i HR+ metastatic breast cancer).
The hematology portfolio delivered even stronger performance with 17% growth, as shown in the following breakdown.
Hematology sales totaled CHF 7.1 billion, driven by Hemlibra’s CHF 3.8 billion (up 12%) as the established standard of care in hemophilia A. Polivy grew 24% to CHF 1.3 billion with continued strong uptake in first-line DLBCL. Columvi expanded 67% to CHF 327 million, driven by second-line DLBCL adoption, while Lunsumio surged 187% to CHF 206 million with strong third-line follicular lymphoma uptake.
A key third-quarter milestone was the positive Phase III CELESTIMO readout for Lunsumio in combination with lenalidomide in second-line follicular lymphoma, which will be submitted to health authorities and presented at an upcoming medical meeting.
Neurology: Ocrevus Subcutaneous Driving Growth
The neurology franchise delivered 10% growth, led by Ocrevus’s subcutaneous formulation adoption.
Neurology sales reached CHF 7.6 billion, with Ocrevus contributing CHF 5.3 billion and 7% growth. The subcutaneous version, Ocrevus Zunovo, now treats approximately 56,000 patients globally and has become the fastest-growing anti-CD20 therapy in the U.S., driven particularly by uptake in community practices. About 60% of U.S. subcutaneous volume comes from community settings.
Evrysdi expanded 18% to CHF 1.5 billion, strengthening its position in spinal muscular atrophy with more than 27,000 patients treated globally. Enspryng grew 28% to CHF 319 million, with recent U.S. filing achieved for MOGAD (myelin oligodendrocyte glycoprotein antibody-associated disease) with priority review granted and a PDUFA date of January 10, 2027.
The following charts illustrate the strong global launch momentum of Ocrevus subcutaneous, showing both patient count growth and conversion from the intravenous formulation.
The subcutaneous formulation now accounts for more than 20% of total Ocrevus volume, driven by both new-to-brand patients and conversion from intravenous administration. An on-body injector for convenient twice-yearly at-home self-administration is in development, with data expected in 2027.
Fenebrutinib: Differentiated BTK Inhibitor Profile
One of Roche’s most significant pipeline advances is fenebrutinib, the first and only BTK inhibitor with positive Phase III results in both relapsing and primary progressive multiple sclerosis. The following data from the MSToronto 2026 meeting demonstrates its comprehensive efficacy profile.
Fenebrutinib achieved a 70% risk reduction in no evidence of disease activity (NEDA-3) at 96 weeks compared to teriflunomide, with a hazard ratio of 0.30. The compound also showed a 23% relative reduction in brain volume loss and continued improvement in CSF biomarkers for progressive biology through 96 weeks, including markers for microglia and astrocyte activity.
The annualized relapse rate data positions fenebrutinib as a high-efficacy disease-modifying therapy, as illustrated in the following comparison.
With a 55% reduction in annualized relapse rate versus active comparator, fenebrutinib is the first and only oral therapy to demonstrate greater than 50% improvement versus active comparator in relapsing MS. This positions it competitively alongside anti-CD20 monoclonal antibodies in the high-efficacy category. U.S. filing was achieved with priority review granted using a priority review voucher, and EU filing was also completed.
Immunology and Ophthalmology Franchises
The immunology portfolio grew 4%, driven primarily by Xolair’s expansion in food allergy.
Immunology sales reached CHF 5.0 billion, with Xolair contributing CHF 2.5 billion and impressive 20% growth. More than 145,000 patients have been treated for food allergy since launch. The first U.S. biosimilar has launched, but management expects continued growth given the relatively sticky allergy market. Actemra declined 10% to CHF 1.6 billion due to biosimilar impact in the U.S., EU, and International markets.
Gazyva showed strong initial uptake in lupus nephritis with approximately 5,000 patients treated globally since launch, and achieved U.S. approval in childhood-onset idiopathic nephrotic syndrome. A key immunology pipeline milestone was the positive Phase III IMAGINATION interim data for sefaxersen in IgA nephropathy, demonstrating best-in-class potential for selective complement suppression.
In ophthalmology, Vabysmo continued its global market expansion with 9% portfolio growth.
Ophthalmology generated CHF 3.3 billion, with Vabysmo contributing CHF 3.2 billion and 10% growth. Strong uptake continues with approximately 1.5 million patients treated globally, and more than 60% of U.S. patient starts are treatment-naïve. Updated real-world VOYAGER data for more than 5,000 patients presented at EURETINA reinforced robust effectiveness and durability across neovascular age-related macular degeneration, diabetic macular edema, and retinal vein occlusion.
Enspryng achieved U.S. approval in thyroid eye disease, while vamikibart achieved U.S. and EU filings in uveitic macular edema with a U.S. PDUFA date of July 23, 2027. Susvimo received EU approval in neovascular AMD.
CVRM Pipeline: Expanding Obesity Franchise
Roche is building a significant presence in cardiovascular, renal, and metabolism (CVRM), particularly in obesity, as shown in the following pipeline overview.
The CVRM pipeline now includes multiple assets in obesity with or without type 2 diabetes, including enicepatide (CT-388), petrelintide, tifeglipron (CT-996), and a recently added UCN2 analog through the Hanmi partnership. The company also has programs in MASH (pegozafermin, afimkibart), hypertension (zilebesiran), and other cardiovascular indications.
Key third-quarter achievements included positive Phase II data for enicepatide in obesity with T2D (study 104), positive Phase II data for tifeglipron (CT-996) in obesity (study 702), and positive Phase II data for petrelintide in obesity with T2D (ZUPREME-2). Phase III programs have been initiated for petrelintide (ZUPREME-3/4/5) in obesity.
The following detailed view illustrates Roche’s ambition to become a top-three player in obesity through development of enicepatide and petrelintide as monotherapies and in combination.
Enicepatide, a biased ligand GLP-1R or GIPR agonist, demonstrated robust weight loss with no plateau at week 48 in Phase II studies. The Phase III program is expanding to include glycemic control in T2D with head-to-head comparison versus tirzepatide, heart failure with reduced ejection fraction, and cardiovascular outcomes trials.
Petrelintide, a long-acting amylin analog suitable for once-weekly dosing, has the potential to redefine the weight management experience with double-digit weight loss and improved tolerability. The Phase III monotherapy program in obesity with or without T2D has been initiated, and a Phase II combination study (ZYNERGY) with enicepatide will begin in the fourth quarter of 2026.
Pipeline Transformation and R&D Productivity
Roche’s pipeline has undergone significant transformation, with improved quality metrics and expanded potential.
The company now has up to 20 NMEs with launch potential by 2030, spanning oncology/hematology, neurology, immunology, ophthalmology, and CVRM. Peak sales potential ranges from CHF 0.5-1 billion to greater than CHF 3 billion per asset, with multiple blockbuster opportunities identified. Recent additions include tambotatug pelitecan in small cell lung cancer and VEGF x IL6 DutaFab in diabetic macular edema.
The portfolio health has improved significantly, as demonstrated in the following risk-reward analysis.
Assets with pivotal go decisions post the "Bar" (Roche’s internal review process) show higher probability of technical success (PTS) in Phase III and higher value (aNPV) compared to pre-Bar decisions. The year-to-date Phase III success rate has exceeded 80%, with seven positive Phase III readouts including divarasib (KRASCENDO 1) in KRAS G12C+ NSCLC, Lunsumio (CELESTIMO) in follicular lymphoma, fenebrutinib (FENhance 1) in RMS, Enspryng (METEOROID) in MOGAD, Gazyva (MAJESTY) in membranous nephropathy, sefaxersen (IMAGINATION) in IgAN, and Vabysmo (POYANG) in myopic CNV.
Pipeline evolution continues through both internal development and business development, as shown in the following quarterly changes.
The clinical pipeline reached 60 NMEs by YTD September 2026, with ongoing prioritization balancing additions and removals. Since the first half of 2026, Roche has announced six platform discovery deals across modalities and therapeutic areas, including partnerships with DualityBio (ADC platform), Hansoh Pharma (novel ADC portfolio), Earendil Labs (AI-powered bispecific antibodies), Defand Therapeutics (molecular glue degraders), Qualitas Therapeutics (bispecific antibodies), and Atavistik (allosteric small molecule therapeutics).
AI-Driven R&D Innovation
Roche is leveraging artificial intelligence to increase research portfolio productivity through its Lab-in-the-Loop implementation.
The company’s AI strategy encompasses three pillars: EverydayAI (85,000 employees trained with 75% weekly active users), Reshape (80+ use cases across functions with 14 beyond pilot phase), and Big Ideas such as Lab-in-the-Loop. The company is deploying an AI Factory with more than 3,500 Blackwell GPUs to support these initiatives.
Lab-in-the-Loop has delivered impressive results in early R&D, with lead identification go decisions growing at a 37% CAGR from 2022 to 2026, lead optimization go decisions at 20% CAGR, and internal development go decisions at 14% CAGR. From 2022 to 2025, the company achieved 155% growth in lead identification go, 75% growth in lead optimization go, and 50% growth in internal development go.
Diagnostics Innovation and Technology Launches
The Diagnostics Division is driving future growth through key technology platform launches.
Three major platform launches are underway: AXELIOS 1 sequencing solution for molecular lab (launched June 2026), cobas i 601 Mass Spec for core lab (launched 2024), and Accu-Chek SmartGuide for near patient care (launched 2024). The AXELIOS 1 launch is showing strong momentum, with approximately one-third of the Year 1 order target of 100 instruments already achieved.
Customer testimonials highlight key benefits, with Eric Chow of UCSF describing AXELIOS 1 as "exciting," Michael Quail of Wellcome Sanger Institute noting it’s "faster than any sequencing technology" before and enables new applications, and Edwin Cuppern of Hartwig Medical Foundation mentioning that sequencing cost has shrunk to a "minority of the total cost of the test."
The following illustration demonstrates AXELIOS capabilities across multiple applications, including single-cell libraries, simplex and duplex whole genome sequencing, and target enrichment through collaboration with Twist Bioscience.
AXELIOS achieved 0.99 total correlation with existing single-cell sequencing workflows while delivering approximately three times longer single-cell RNA reads (300 bp versus 90 bp), enabling deeper isoform resolution. In rare disease applications, the platform showcased consolidation onto a single platform delivering both short- and longer-read WGS, with high concordance on all samples for SNVs, indels, and mitochondrial variants.
Roche also announced CE mark approval for cobas HDV, the first fully automated diagnostic solution to identify hepatitis D virus, the most severe form of viral hepatitis.
HDV affects nearly 12 million people globally and severely impacts individuals already carrying hepatitis B virus, leading to faster progression toward liver failure, cirrhosis, and liver cancer. The cobas HDV test provides reliable testing to support diagnosis and treatment monitoring in line with EASL, AASLD, and APASL guidelines, enabling consistent, high-throughput automated testing on the cobas 5800/6800/8800 systems.
The company’s comprehensive 2026 diagnostics launch portfolio includes multiple systems, tests, and digital solutions across all major lab segments.
Currency Impact and Financial Guidance
Currency headwinds have been easing throughout 2026, as illustrated in the following waterfall analysis of Group growth.
The breakdown shows that Pharma excluding LOE contributed CHF 2.8 billion in growth, while LOE reduced sales by CHF 355 million. Diagnostics excluding China added CHF 558 million, while China healthcare pricing reforms reduced sales by CHF 170 million. Foreign exchange had a negative impact of CHF 2.2 billion, resulting in net reported growth of 1% in Swiss francs versus 6% at constant exchange rates.
The currency impact by major currency pair shows the progression throughout the year.
The U.S. dollar had the largest negative impact at -2.9 percentage points, followed by the Japanese yen at -0.7 percentage points and the euro at -0.3 percentage points. However, the quarterly trend has improved significantly, with currency impact moving from -11 percentage points in Q1 to -4 percentage points in Q2 to +1 percentage point in Q3.
Expected currency impact for 2026 assumes September 30, 2026, exchange rates remain stable through year-end.
For the full year 2026, currency is expected to reduce sales growth by 3 percentage points and core operating profit and Core EPS growth by 5 percentage points. The improving trend provides a more favorable backdrop for the fourth quarter and into 2027.
2026 Guidance and Long-Term Outlook
Roche reaffirmed its full-year 2026 guidance.
The company expects mid-single-digit sales growth at constant exchange rates, high-single-digit Core EPS growth at constant exchange rates, and a further increase in the dividend in Swiss francs. This guidance incorporates the expected LOE impact of roughly CHF 0.6 billion and assumes the reversal of the Japan ERP timing benefit in the fourth quarter.
Chief Financial Officer Alan Hippe indicated that margins will expand in 2027 despite higher R&D spending, helped by efficiency gains and internal resource reallocation. Management expressed confidence in maintaining momentum through the next several years while continuing to invest in the pipeline.
The following strategic outlook illustrates Roche’s vision for sustained growth beyond 2030.
The company’s growth strategy is built on multiple pillars: business development to further accelerate pipeline growth, major late-stage readouts in new diseases from 2027 to 2030 (including IBD, Alzheimer’s, MASH, Parkinson’s, obesity, and uncontrolled hypertension), and the on-market Pharma portfolio including Gazyva in immunology, giredestrant, and fenebrutinib to deliver strong growth overcompensating for generic erosion.
Management emphasized that there is "no patent cliff ahead" and that Pharma core operating profit margin should be at least stable. In Diagnostics, growth will be driven by the on-market portfolio and key launches, with unique blockbuster opportunities in sequencing, mass spectrometry, and continuous glucose monitoring. The division is expected to deliver mid- to high-single-digit sales growth with core operating profit growth ahead of sales growth.
Near-Term Regulatory Catalysts
The company has significant newsflow expected through the remainder of 2026 and into 2027.
Key 2026 regulatory milestones include U.S. and EU filings for giredestrant in adjuvant and post-CDK4/6i breast cancer (with U.S. approvals expected), U.S. and EU approvals for Gazyva in systemic lupus erythematosus, membranous nephropathy, and childhood-onset idiopathic nephrotic syndrome, U.S. and EU approvals for Enspryng in MOGAD, and U.S. and EU approvals for vamikibart in uveitic macular edema.
Clinical results expected include pivotal Phase III readout for Itovebi in post-CDK4/6i PIK3CA-mutant HR+/HER2- metastatic breast cancer (INAVO121). Several diagnostic launches are also planned, including VENTANA BAP1 for mesothelioma differentiation.
The Diagnostics Division regional performance shows balanced growth across geographies.
Diagnostics sales by division show Core Lab at CHF 5.8 billion (up 5% CER), Molecular Lab at CHF 1.8 billion (up 3% CER), Near Patient Care at CHF 1.3 billion (down 5% CER), and Pathology Lab at CHF 1.3 billion (up 10% CER). The impact of China healthcare pricing reforms continues to moderate, and management expects Diagnostics to return to mid- to high-single-digit growth as this pressure normalizes.
The geographic breakdown of Diagnostics sales illustrates the global footprint.
North America contributed approximately 33% of divisional sales with 9% growth, EMEA approximately 36% with 3% growth, Asia Pacific approximately 23% with -4% growth (impacted by China), and Latin America approximately 8% with 12% growth.
Comprehensive Pipeline Overview
For investors seeking detailed pipeline information, Roche provided extensive tables covering all development stages.
The Phase I and Phase II pipeline includes 33 NMEs plus 6 additional indications in Phase I, and 11 NMEs plus 5 additional indications in Phase II, spanning oncology/hematology, immunology, CVRM, neurology, ophthalmology, and other therapeutic areas.
The Phase III and registration pipeline includes 13 NMEs plus 22 additional indications in Phase III, and 3 NMEs plus 8 additional indications in registration in the U.S. and EU, representing near-term commercial opportunities.
The expected regulatory submission timeline provides visibility into future catalysts.
Major pending approvals by region show the breadth of near-term opportunities across the U.S., EU, China, and Japan.
Conclusion
Roche’s year-to-date September 2026 presentation demonstrated continued strong execution across a diversified portfolio, with 6% sales growth at constant exchange rates driven by broad-based gains in pharmaceuticals and improving diagnostics performance. The company’s pipeline has been significantly strengthened, with up to 20 NMEs targeted for launch by 2030, a Phase III success rate exceeding 80%, and major advances in high-value therapeutic areas including oncology, neurology, immunology, ophthalmology, and the emerging obesity franchise.
With reaffirmed full-year guidance for mid-single-digit sales growth and high-single-digit Core EPS growth, easing currency headwinds, no patent cliff ahead, and expanding margins expected in 2027, management has provided investors with confidence in the company’s trajectory through the end of the decade and beyond. The combination of established product momentum, successful new launches, robust pipeline progress, and strategic investments in AI-driven R&D and diagnostic innovation positions Roche for sustained long-term growth.
Full presentation:
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
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008f223c8e· 2026-10-22 22:29 · doubao / doubao-seed-evolving-latest-version · 策略包658c0c1e2ba5当前