Fact-checked by Grok 2 weeks ago

CSL Vifor

CSL Vifor is a global specialty pharmaceuticals business unit of the biotechnology company CSL Limited, specializing in innovative therapies for iron deficiency, iron deficiency anaemia, and nephrology, including chronic kidney disease across all stages. Headquartered in St. Gallen, Switzerland, with approximately 2,000 employees, it operates in over 100 countries and traces its origins to 1872 through the legacy of Vifor Pharma, which CSL acquired in August 2022 for US$11.7 billion to expand its portfolio in renal and iron therapies.^[1]^[2]^[3] The company focuses on addressing unmet needs in therapeutic areas such as heart failure, gastroenterology, inflammatory bowel disease, patient blood management, women's health, dialysis, and renal disease prevention, with a strong emphasis on preserving renal function and managing complications.^[1] Its portfolio includes leading iron therapies like FERINJECT® (ferric carboxymaltose), an intravenous treatment for iron deficiency and anaemia, and Maltofer®, an oral iron formulation, alongside nephrology products targeting dialysis and non-dialysis segments, with recent additions such as FILSPARI® and TAVNEOS® for rare kidney diseases.^[2]^[4] In fiscal year 2025, CSL Vifor generated revenue of US$2,199 million, with iron products contributing US$1,034 million, dialysis US$871 million, and non-dialysis nephrology US$267 million, reflecting a 49.1% operating margin.^[4] CSL Vifor maintains a robust research and development pipeline aligned with CSL's broader investments of US$1,359 million in 2024/25, targeting new indications, geographic expansion, and real-world evidence generation to tap into the under-developed intravenous iron market.^[4] The unit also includes a joint venture, Vifor Fresenius Medical Care Renal Pharma (55% owned by CSL), with Fresenius Medical Care, enhancing its presence in renal care.^[1] Post-acquisition integration has focused on cost synergies achieved ahead of expectations, quality assurance—such as managing a 2024 recall of Maltofer® drops—and settling legacy disputes, positioning CSL Vifor as a key driver in CSL's mission to deliver precision healthcare solutions.^[2]^[4]

History

Founding and early years

Vifor Pharma, the foundational entity of CSL Vifor, traces its origins to 1872, when Swiss pharmacist Caspar Friedrich Hausmann established a pharmacy in St. Gallen, Switzerland. Initially focused on preparing pharmaceutical products, the pharmacy emphasized galenical formulations and specialized in mineral salts as key components of early medicinal remedies. This establishment laid the groundwork for a Swiss pharmaceutical heritage centered on therapeutic innovations derived from natural and mineral-based substances.^[1]^[5] In the early 20th century, the business evolved from a local pharmacy into a broader pharmaceuticals company, with a growing emphasis on iron-based therapies to address deficiencies common in medical practice at the time. Key developments included the creation of initial iron supplements, reflecting Hausmann's pioneering approach to mineral-derived treatments for anemia and related conditions. By the 1920s, the operation expanded through collaborative efforts, as 16 pharmacists formed the Collaboration Pharmaceutique SA in 1927—a joint purchasing and production center that acquired the Hausmann pharmacy and advanced the specialization in chemical-pharmaceutical specialties, including iron preparations.^[6]^[7] This period marked the transition toward structured pharmaceutical manufacturing, with the establishment of Laboratorien Dr. G. Hausmann AG as a dedicated entity for producing iron and mineral-based products. A significant milestone came in 1944 with the establishment of Vifor Ltd., which concentrated on non-prescription medicines and further solidified the focus on accessible iron therapies. By the mid-20th century, these foundations had positioned the company as a leader in Swiss pharmaceutical innovation, particularly in mineral salts and iron supplementation, setting the stage for later global expansion while preserving its heritage in St. Gallen.^[6]

Growth and key milestones

Following its origins in a St. Gallen pharmacy established in 1872, Vifor Pharma experienced significant post-World War II expansion, leveraging its expertise in pharmaceutical preparations to address unmet needs in therapeutic areas.^[1] In the 1960s, the company had established key research facilities that supported the development of innovative iron therapies, such as the launch of Maltofer®, an oral iron supplement that became a cornerstone of its portfolio over five decades later.^[8] This period marked a shift toward specialized R&D, enabling Vifor to build a foundation for sustained growth in patient-centric treatments. In the 1970s, Vifor entered the nephrology field, recognizing the growing demand for therapies in kidney disease management, which became a pivotal area for its expansion.^[8] This strategic focus culminated in the 1998 launch of Venofer® (iron sucrose), a landmark intravenous iron product for treating anemia in patients with chronic kidney disease, which quickly established Vifor as a leader in iron deficiency therapies and generated over 30 million patient years of experience by 2021.^[9]^[8] Building on this momentum, Vifor formed a joint venture in 2000 with Fresenius Medical Care, creating Vifor Fresenius Medical Care Renal Pharma (VFMCRP), where Vifor held a 55% stake; this partnership enhanced access to dialysis patients worldwide and bolstered renal therapy distribution.^[8] The 2000s saw accelerated international expansion, with Vifor's therapies reaching over 100 countries by 2010 through targeted market entries and partnerships that diversified its global footprint.^[8] Key financial milestones included its initial public offering on the SIX Swiss Exchange in 2017, which provided capital for further innovation and growth initiatives.^[8] By 2021, these efforts drove net sales to CHF 1.75 billion, reflecting robust performance in iron deficiency and nephrology segments amid a recovering market.^[8]

Acquisition by CSL

On December 14, 2021, CSL Limited announced an all-cash tender offer to acquire Vifor Pharma Ltd. for an equity value of US$11.7 billion (CHF 10.9 billion), representing CSL's largest acquisition to date and a 40% premium over Vifor's closing share price on December 13, 2021.^[10]^[11] The offer price was set at US$179.25 (CHF 167) per share, with the total transaction consideration reaching US$12.3 billion including Vifor's existing debt of CHF 540 million.^[10] The strategic rationale centered on diversifying CSL's portfolio beyond plasma-derived therapies into specialty pharmaceuticals, particularly in iron deficiency, anemia, and nephrology, to address unmet needs in renal disease and complement CSL's existing focus areas in hematology, cardiovascular-metabolic diseases, and transplantation.^[10] This move aimed to enhance CSL's global scale, R&D capabilities, and product delivery while leveraging Vifor's established therapies like Ferinject for iron deficiency.^[12] The acquisition process involved obtaining regulatory clearances from multiple jurisdictions, including antitrust approvals from the European Commission on June 2, 2022, and authorities in the United States, Australia, Switzerland, and others, which delayed the timeline beyond initial expectations of June 2022.^[13]^[14] All necessary approvals were secured by August 2, 2022, with settlement completed on August 9, 2022, resulting in CSL holding over 97% of Vifor shares and initiating a compulsory squeeze-out for remaining shareholders.^[15]^[16] Following completion, Vifor Pharma was rebranded as CSL Vifor and integrated into CSL's structure as a dedicated business unit focused on specialty pharmaceuticals, with planning for operational synergies well advanced at the time of closure.^[15]^[1] The transaction increased CSL's leverage, funded partly through a US$6 billion bridge debt facility later refinanced with longer-term debt, resulting in a pro forma net debt-to-EBITDA ratio of approximately 2.65x for FY2021.^[12] CSL anticipated annual pre-tax cost synergies of US$75 million by full run-rate in 2025, primarily from supply chain, manufacturing, and administrative efficiencies.^[12] Post-acquisition, CSL Vifor continued to advance its portfolio, including European Commission approval of FILSPARI® (sparsentan) for IgA nephropathy in April 2024. In June 2024, a recall was issued for Maltofer® Drops (50 mg/ml) due to the presence of plastic particles, affecting certain batches distributed in Singapore and other regions. In May 2025, the UK Competition and Markets Authority (CMA) concluded an investigation into suspected anti-competitive conduct regarding intravenous iron treatments, accepting commitments from CSL Vifor to improve market competition, including data sharing and supply assurances. These events marked ongoing integration challenges and regulatory scrutiny as CSL Vifor expanded under CSL's ownership.^[17]^[18]^[19]

Corporate structure

Ownership and governance

CSL Vifor operates as a wholly-owned subsidiary of CSL Limited, an Australian biotechnology company founded in 1916 and listed on the Australian Securities Exchange (ASX: CSL).^[20] This ownership structure was established following CSL's acquisition of Vifor Pharma in 2022, integrating it fully into the CSL Group without subsequent changes as of 2025.^[20] Despite CSL's broader restructuring efforts, including the planned demerger of its Seqirus vaccine business, CSL Vifor's ownership remains unchanged and stable within the parent company.^[21] In terms of governance, CSL Vifor reports directly to CSL Limited's global leadership team and falls under the oversight of CSL's Board of Directors, which maintains high standards of corporate governance to maximize shareholder value.^[22] The board operates through standing committees, including the Corporate Governance and Nomination Committee, Audit and Risk Management Committee, and others, ensuring integrated decision-making across CSL's subsidiaries like Vifor.^[23] CSL Vifor adheres to CSL's ethical standards, as outlined in its comprehensive compliance program, which includes a Code of Conduct and policies covering anti-bribery, data privacy, and regulatory adherence.^[24] As a Swiss-headquartered entity, CSL Vifor complies with Swiss regulations, including the Swiss Code of Obligations, while also meeting international standards such as those from the OECD and EU for pharmaceutical operations.^[25] This dual framework supports transparent governance and risk management tailored to its specialty pharmaceutical focus. A notable aspect of its structure is the continued operation of Vifor Fresenius Medical Care Renal Pharma Ltd., a 50/50 joint venture with Fresenius Medical Care, dedicated to renal pharmaceuticals and treated as an equity method investee by CSL.^[26] This partnership, established prior to the acquisition, remains active in 2025 for specific nephrology products, providing CSL Vifor with targeted market access in dialysis therapies.^[27]

Leadership and headquarters

CSL Vifor is headquartered in St. Gallen, Switzerland, which serves as the global hub for its research and development, marketing, and administrative functions.^[28] This location supports the company's focus on specialty pharmaceuticals, particularly in iron deficiency and nephrology, by centralizing strategic operations in a region with strong biopharmaceutical infrastructure.^[1] The leadership of CSL Vifor is integrated within the broader CSL Limited structure, with Paul McKenzie serving as Chief Executive Officer and Managing Director of CSL since March 2023, overseeing the overall direction including Vifor's operations as of 2025.^[29] At the Vifor level, Hervé Gisserot has been Senior Vice President and General Manager since August 2022, appointed to lead following the 2022 acquisition and confirmed in this role through 2025; he reports directly to McKenzie and emphasizes expertise in nephrology and iron therapies.^[30] Gisserot succeeded Abbas Hussain, who was CEO of Vifor Pharma until the 2023 transition post-acquisition. The executive team includes key roles such as Elodie Berger as Head of Medical Affairs, focusing on patient education and evidence-based strategies in specialty areas.^[31] Commercial operations are led under Gisserot's oversight, with a team experienced in global market access for therapies addressing unmet needs in anemia and dialysis.^[30] In 2025, CSL's restructuring initiative, announced in August, included a net headcount reduction of up to 15% across the group to streamline operations and achieve $500–$550 million in annual cost savings over three years, impacting CSL Vifor with specific cuts such as 55 positions in Pennsylvania focused on commercial and medical roles.^[32] This led to potential leadership adjustments in support functions but preserved core executive stability to maintain focus on high-impact areas like nephrology.^[33] Under this leadership, CSL Vifor aligns with CSL's governance by committing to patient-centric innovation, as evidenced by its silver rating in the 2022 Patient Partnership Index and ongoing efforts to develop therapies that improve quality of life for patients with chronic kidney disease and iron deficiency.^[25] Gisserot has highlighted this dedication in advancing next-generation treatments for underserved populations.^[34]

Operations

Manufacturing and research

CSL Vifor's primary manufacturing facilities are located in Switzerland, including the high-tech site in St. Gallen for producing iron therapies and renal products.^[1]^[20]^[35] In the United States, manufacturing operations are integrated into CSL's broader network to ensure supply chain efficiency for North American markets.^[1]^[20]^[35] The company's research and development efforts emphasize next-generation iron formulations and innovative nephrology drugs, with pre-acquisition annual R&D spending reaching approximately CHF 253 million to advance clinical pipelines.^[36] Following the 2022 integration into CSL Limited, these activities have been incorporated into CSL's global R&D framework, which consolidates operations at six anchor sites including Switzerland to optimize innovation in iron deficiency and kidney disease therapies.^[20] Key research areas include ongoing clinical trials evaluating intravenous iron therapies, such as ferric carboxymaltose, for iron deficiency in heart failure patients, with a major multicenter randomized trial (FAIR-HF2) enrolling 1,126 participants demonstrating improved quality of life in 2025.^[20]^[37] Efforts also extend to rare anemias and kidney disorders through partnerships, notably with Travere Therapeutics for treatments targeting focal segmental glomerulosclerosis (FSGS) and immunoglobulin A nephropathy (IgAN), including the April 2025 EU full approval of FILSPARI (sparsentan) for IgAN, focusing on rare disease applications without direct gene therapy involvement for Vifor-specific projects.^[38]^[39] CSL Vifor maintains strict adherence to Good Manufacturing Practice (GMP) standards, undergoing regular regulatory inspections to ensure product quality and safety across its facilities. Post-2022 expansions have focused on enhancing production capacity for global supply, including new launches in iron and nephrology portfolios such as FILSPARI and Vafseo to meet growing demand.^[40]^[20]^[41] In 2025, CSL's broader cost-cutting initiatives, aimed at achieving annual savings of $500-550 million, have led to R&D consolidation and workforce reductions impacting Vifor operations, including 55 job cuts in Pennsylvania in October 2025, potentially slowing certain projects amid a dampened sales outlook for the nephrology segment.^[40]^[20]^[41]^[33]

Global presence and distribution

CSL Vifor maintains a robust international footprint, conducting operations in over 100 countries across North and South America, Europe, the Middle East, and the Asia-Pacific region.^[1]^[4] Its major markets are concentrated in Europe and North America, reflecting a strategic emphasis on established and emerging healthcare systems.^[1]^[4] This global reach is supported by regional hubs, including its European headquarters in St. Gallen, Switzerland, dedicated U.S. operations under CSL Vifor US Inc., and ongoing expansion into Latin America and the Middle East to tap into growing demand for specialized therapies.^[1]^[26] The company's distribution model combines direct sales in core markets with strategic partnerships and local distributors to ensure efficient market access and regulatory compliance.^[1] A key component is the joint venture with Fresenius Medical Care, known as Vifor Fresenius Medical Care Renal Pharma Ltd., in which CSL Vifor holds a 55% stake; this collaboration facilitates targeted supply to dialysis centers across Europe, China, and other regions, enhancing penetration in nephrology settings.^[4] As of fiscal year 2025, CSL Vifor generated revenue of US$2.2 billion, with iron deficiency products contributing approximately 46% of sales through this multifaceted approach.^[4]^[20] In 2025, CSL Vifor encountered challenges including regulatory hurdles in the U.S. for expanding indications, which contributed to revised lower growth expectations amid competitive pressures and post-acquisition integration efforts.^[42]^[4] Despite these, the company continues to leverage its global network for sustained market expansion.^[20]

Therapeutic areas

Iron deficiency and anemia

Iron deficiency, one of the most common nutritional disorders worldwide, affects approximately 2 billion people globally, leading to significant health burdens including fatigue, reduced quality of life, and increased morbidity.^[43] This condition is particularly prevalent in populations with chronic diseases, where it often coexists with anemia and exacerbates underlying pathologies such as chronic kidney disease (CKD) and heart failure, contributing to unmet needs in timely diagnosis and effective treatment.^[44] In CKD patients, iron deficiency arises from reduced erythropoietin production, blood loss during dialysis, and inflammation-induced functional iron restriction, while in heart failure, it impairs cardiac function and worsens prognosis, highlighting the need for targeted interventions beyond traditional oral supplementation.^[45] The therapeutic approach to iron deficiency and associated anemias emphasizes intravenous (IV) iron as a first-line option for rapid repletion, especially in cases where oral iron proves inadequate due to limitations like gastrointestinal intolerance, poor absorption, and slower hemoglobin response.^[46] Unlike oral formulations, which require daily dosing and can take weeks to months for efficacy, IV iron delivers higher doses in fewer administrations, improving patient compliance and outcomes in high-burden settings such as CKD and heart failure.^[47] Guidelines from organizations like KDIGO recommend IV iron for CKD patients with absolute or functional iron deficiency to optimize anemia management and reduce reliance on erythropoiesis-stimulating agents.^[48] Clinical evidence underscores the benefits of IV iron in mitigating complications of iron deficiency anemia. For instance, the PIVOTAL trial demonstrated that proactive high-dose IV iron in hemodialysis patients with CKD reduced the risk of hospitalization for heart failure by 33% compared to reactive low-dose regimens, alongside fewer cardiovascular events overall.^[49] Meta-analyses further support these findings, showing IV iron therapy associated with 20-30% lower risks of heart failure hospitalization and cardiovascular mortality in CKD populations, emphasizing its role in improving long-term prognosis without excessive safety concerns when monitored appropriately.^[50] These studies highlight IV iron's capacity to address unmet needs by enhancing iron availability for erythropoiesis and reducing inflammatory burdens in comorbid conditions. In fiscal year 2025, CSL Vifor generated revenue of US$2,199 million, with iron products contributing US$1,034 million, reflecting growth and a leading position in the IV iron market.^[4] CSL Vifor holds a global leadership position in the IV iron market, driven by its focus on innovative therapies for iron deficiency, as evidenced by sustained revenue growth.^[4] The company holds a leading position in the high-dose IV iron segment, positioning it as a key player in addressing the underpenetrated market where many eligible patients remain untreated.^[51] Looking ahead, CSL Vifor's efforts build on established applications in nephrology, where iron therapies overlap with dialysis management to support comprehensive care for CKD-related anemias.^[48]

Nephrology and dialysis

Chronic kidney disease (CKD) affects approximately 10% of the global population, impacting over 800 million individuals worldwide and representing a significant public health challenge.^[52] In patients with end-stage renal disease (ESRD) undergoing dialysis, anemia prevalence exceeds 90%, driven by reduced erythropoietin production and iron deficiency, which exacerbates fatigue, cardiovascular risks, and overall morbidity.^[53] CSL Vifor targets these renal complications through specialized therapies that support kidney disease management across stages, including dialysis settings, emphasizing the role of iron deficiency in CKD progression.^[54] Key interventions from CSL Vifor include phosphate binders and iron therapies designed to control hyperphosphatemia and anemia in ESRD patients on dialysis. Phosphate binders, such as the iron-based sucroferric oxyhydroxide (Velphoro), bind dietary phosphate in the gastrointestinal tract to lower serum phosphorus levels, reducing risks of vascular calcification and secondary hyperparathyroidism.^[55] Iron therapies address anemia by replenishing stores depleted by dialysis and inflammation, improving hemoglobin levels and minimizing transfusion needs in this vulnerable population.^[1] Innovations in this area include the development of next-generation phosphate binders like Velphoro, a non-calcium, chewable formulation that reduces daily pill burden by approximately 50% compared to traditional binders such as sevelamer, enhancing patient adherence and convenience.^[56] Additionally, CSL Vifor's integration with Fresenius Medical Care through the Vifor Fresenius Medical Care Renal Pharma joint venture facilitates seamless delivery of therapies directly in dialysis clinics, providing access to a significant number of patients through Fresenius Medical Care's global network.^[57] Clinical trials of CSL Vifor-supported interventions, such as difelikefalin for CKD-associated pruritus in dialysis patients, have demonstrated significant quality-of-life improvements, with up to 49% of treated patients achieving meaningful reductions in itch severity scores compared to 28% on placebo, correlating with enhanced sleep and reduced distress.^[58] These outcomes, measured via tools like the Skindex-10, reflect 20-30% greater overall health-related quality-of-life gains in pruritus management, underscoring the broader benefits for dialysis patients beyond symptom relief.^[59] In 2025, the European Commission approved the conversion from conditional to standard marketing authorisation for sparsentan (FILSPARI) in IgA nephropathy.^[39]

Rare diseases and other specialties

CSL Vifor has developed a portfolio targeting rare kidney disorders, including collaborations on therapies for conditions such as C3 glomerulopathy and IgA nephropathy. In C3 glomerulopathy, an ultra-rare complement-mediated disease, CSL Vifor supported the phase 2 ACCOLADE trial of avacopan, which demonstrated statistically significant improvements in estimated glomerular filtration rate (eGFR) compared to standard care, addressing the progressive decline in renal function typical of this condition.^[60] Similarly, through its partnership with Travere Therapeutics, CSL Vifor co-promotes sparsentan (FILSPARI), which received conditional marketing authorisation in the European Union in 2024 and standard marketing authorisation in 2025 for adults with primary IgA nephropathy at risk of rapid disease progression, offering a non-immunosuppressive option to slow kidney function decline and reduce proteinuria. These efforts stem from Vifor Pharma's pre-acquisition focus on unmet needs in rare renal pathologies, now integrated into CSL Vifor's broader nephrology strategy.^[1] Beyond rare kidney diseases, CSL Vifor extends its iron deficiency expertise to other specialties, including cardiology, gastroenterology, and women's health. In cardiology, intravenous iron therapies address anemia in heart failure patients with cardio-renal syndrome, where iron deficiency affects up to 50% of cases and contributes to worsened outcomes; clinical evidence supports improved exercise capacity and quality of life with such interventions.^[1] For gastroenterology, particularly inflammatory bowel disease, CSL Vifor targets anemia management, as iron deficiency anemia impacts around one-third of patients due to chronic blood loss and malabsorption, with iron supplementation helping to mitigate fatigue and disease burden.^[61] In women's health, oral and intravenous iron products like ferric carboxymaltose are indicated for anemia during pregnancy, supporting maternal hemoglobin levels and fetal development, especially in regions with high prevalence rates exceeding 40%.^[62] These applications overlap briefly with nephrology in rare renal disorders involving anemia complications. Post-acquisition by CSL in 2022, synergies with CSL Behring's immunology portfolio have enhanced CSL Vifor's capabilities in rare anemias, combining iron therapies with immunotherapies for conditions like immune-mediated hemolytic anemias, thereby broadening treatment options for patients with overlapping hematologic and renal issues.^[26] Rare diseases form a strategic priority, with orphan drug designations for assets like sparsentan facilitating faster regulatory approvals and market access for these low-prevalence conditions.^[63] In 2025, amid CSL's broader cost-control measures including R&D consolidation, CSL Vifor advanced external partnerships, such as ongoing collaborations with Travere for rare nephropathies and alignment with CSL's emphasis on gene therapy ecosystems, though specific Vifor-led gene therapy initiatives remain in exploratory stages.^[64]

Products and partnerships

Core product portfolio

CSL Vifor's core product portfolio comprises over 10 key commercialized therapies focused on iron deficiency, nephrology, and rare diseases, generating total sales of US$2,029 million in fiscal year 2024, which fell short of initial projections amid generic competition and regulatory pressures on flagship offerings.^[2]^[42] Iron therapies represent the largest segment, accounting for about 50% of revenue through intravenous iron replacement products that address unmet needs in anemia management across diverse patient populations.^[2] The cornerstone of CSL Vifor's iron portfolio is Ferinject (known as Injectafer in the United States), a ferric carboxymaltose formulation indicated for the treatment of iron deficiency anemia in adults and children where oral iron is ineffective or not tolerated.^[61] This intravenous therapy has secured marketing authorization in 87 countries as of March 2024, including label expansions in Canada (for pediatric patients and iron deficiency in adults with heart failure, March 2024) and Australia (for children aged 1-13 years, February 2024), as well as approval in China for adults (November 2022).^[65]^[66]^[67] Complementing Ferinject, Venofer (iron sucrose) serves as an established intravenous option for iron deficiency anemia, particularly in chronic kidney disease patients, though it faces increasing generic erosion.^[68]^[2] Together, these iron products drove category sales of US$1,018 million in fiscal year 2024, underscoring their market dominance despite competitive challenges.^[2] In nephrology, CSL Vifor's offerings target complications of chronic kidney disease, with Velphoro (sucroferric oxyhydroxide) functioning as an iron-based phosphate binder to control serum phosphorus levels in adult and pediatric patients aged 9 years and older on hemodialysis or peritoneal dialysis.^[69] This product supports dialysis management by reducing hyperphosphatemia risks, contributing to the nephrology-dialysis segment's US$786 million in 2024 sales.^[2] Venofer also plays a dual role here, providing iron supplementation for anemia associated with non-dialysis-dependent chronic kidney disease.^[68] For rare diseases, CSL Vifor distributes Lumasiran (branded as Oxlumo), an RNA interference therapeutic in-licensed for global commercialization, indicated for primary hyperoxaluria type 1 to lower urinary and plasma oxalate levels in children and adults.^[70] This subcutaneous therapy addresses a severe metabolic disorder by targeting glycolate oxidase production in the liver, filling a critical gap in rare disease care. Lifecycle management bolsters the portfolio's longevity, with patent protections for flagship iron and renal products extending into the 2030s, including safeguards for Velphoro until at least 2030 and ongoing litigation upholding Injectafer's validity against generics.^[71]^[72] These strategies ensure sustained market exclusivity amid evolving competition.^[2]

In-licensing and collaborations

CSL Vifor has pursued strategic in-licensing agreements to expand its portfolio in nephrology and rare diseases, focusing on innovative therapies for conditions such as IgA nephropathy (IgAN) and acute kidney injury (AKI). A prominent example is the 2021 licensing agreement with Travere Therapeutics for sparsentan (FILSPARI), a dual endothelin and angiotensin receptor antagonist. Under this deal, CSL Vifor obtained exclusive commercialization rights in Europe, Australia, and New Zealand for the treatment of rare kidney disorders including IgAN and focal segmental glomerulosclerosis (FSGS).^[73]^[74] Travere received a $55 million upfront payment, up to $135 million in regulatory and commercial milestones, and tiered royalties on net sales.^[73] This partnership has supported regulatory approvals, including conditional marketing authorization from the European Medicines Agency in 2023 for IgAN, later converted to standard approval on April 29, 2025.^[75]^[76] In 2020, CSL Vifor entered a global licensing agreement with Angion Biomedica for ANG-3777, a hepatocyte growth factor mimetic aimed at preventing AKI in nephrology settings. The agreement granted CSL Vifor exclusive worldwide rights, excluding Greater China, for indications such as delayed graft function following kidney transplantation and cardiac surgery-associated AKI.^[77] Angion retained responsibility for clinical development, while CSL Vifor handled commercialization and regulatory submissions. Financial terms included a $30 million upfront payment, a $30 million equity investment in Angion, up to $20 million in clinical milestones, and potential payments of up to $260 million in regulatory and sales milestones, plus tiered royalties reaching 40% on net sales.^[77] However, phase 3 trials failed to meet endpoints in 2021, and a phase 2 trial in cardiac surgery-associated AKI showed no efficacy in 2024, leading to discontinuation of development following Angion's bankruptcy in 2022.^[78]^[79] More recently, in September 2025, CSL entered a strategic collaboration with VarmX Technologies for VMX-C001, an investigational reversal agent for factor Xa inhibitors (FXa DOACs) to manage bleeding in patients requiring urgent surgery or experiencing severe hemorrhage, often relevant to nephrology and dialysis populations. CSL committed to fully funding the Phase 3 EquilibriX-S trial, late-stage development, manufacturing, and pre-launch activities, with an upfront payment of $117 million to VarmX shareholders and potential milestones totaling up to $2.1 billion, including $388 million upon option exercise and $1.7 billion in sales-based payments.^[80] The agreement includes CSL's exclusive option to acquire all VarmX shares post-Phase 3 data, subject to regulatory approvals, enhancing CSL Vifor's capabilities in anticoagulation management for specialty care.^[80]^[81] These in-licensing efforts are complemented by broader collaborations that leverage CSL Vifor's expertise in cardio-renal and rare disease areas, often involving joint development or regional partnerships to accelerate market access. For instance, while some deals like the terminated 2022 agreement with Akebia Therapeutics for tenapanor (Vafseo) in hyperphosphatemia did not proceed long-term, they highlight CSL Vifor's active pursuit of nephrology innovations through flexible partnership models.^[82] Overall, such arrangements position CSL Vifor as a preferred partner for biotech firms seeking commercialization support in key therapeutic domains.

References

[1]
CSL Vifor
CSL Vifor is a global leader in iron deficiency and iron deficiency anaemia therapies, with a history dating back to 1872.
[2]
[PDF] csl-annual-report-2024.pdf
Aug 12, 2024 · CSL provides lifesaving products to patients in more than. 100 countries and employs 32,000+ people. We are helping to shape a healthier world ...
[3]
CSL Limited announces tender offer to acquire Vifor Pharma Ltd
Agreement announced on the Australian Securities Exchange and SIX Swiss Exchange on 14 December 2021; Cash offer at US$179.25 per share.
[4]
Vifor Pharma at the St. Gallen site - sg-health.ch - EN
Vifor Pharma's presence in St. Gallen goes back to the St. Gallen Hecht Pharmacy, which was founded in 1872 by Caspar Friedrich Hausmann. Vifor Pharma has ...Missing: history | Show results with:history
[5]
EX-99.4 - SEC.gov
Jul 21, 2016 · We have a long history of innovation. Caspar Friedrich Hausmann founded a FDA (US Food and Drug Administration) 1872 pharmacy in St.Gallen ...
[6]
Jörg Storre - General Manager, CSL Vifor Pharma Switzerland
Nov 25, 2024 · CSL Vifor's legacy is deeply rooted in Swiss innovation, dating back to 1872 when Caspar Friedrich Hausmann first introduced iron-based ...
[7]
[PDF] ANNUAL REPORT 2021 - AnnualReports.com
2021 was a pivotal year in the history of Vifor. Pharma, driven by continued progress in transforming our company into a world-leading iron, dialysis and ...
[8]
Venofer (iron sucrose) 20 mg iron / ml, solution for injection or ...
Date of first authorisation/renewal of the authorisation. UK: 08.06.1998 / 20.05.2008. 10. Date of revision of the text. 13/12/2021. Vifor Pharma UK Limited.
[9]
CSL Limited Announces Tender Offer To Acquire Vifor Pharma Ltd
Dec 14, 2021 · Strategic and Financial Rationale. Expands Leadership Positions and Diversifies CSL's Business Model. The transaction expands CSL's portfolio ...
[10]
CSL Limited Announces Tender Offer To Acquire Vifor Pharma Ltd
Dec 14, 2021 · - US$12.3 billion / A$17.2 billion all-cash acquisition consideration(4) to be funded through a combination of A$6.3 billion (US$4.5 billion) ...
[11]
[PDF] Investor-Presentation-CSL-Swiss-Tender-Acquisition-of-Vifor.pdf
Dec 14, 2021 · The forward-looking statements contained in this Presentation include statements regarding CSL's intent, belief or current expectations with ...
[12]
CSL wins approval to buy Vifor Pharma in EU - MLex
Jun 2, 2022 · The European Commission has approved, under the EU Merger Regulation, the acquisition of Vifor Pharma Ltd. of Switzerland by CSL Limited ('CSL') ...
[13]
Update on the timeline for Vifor Pharma tender offer - Business Wire
May 12, 2022 · CSL has previously advised that it expected to be in a position to close the acquisition of Vifor Pharma AG by June 2022. While some antitrust ...
[14]
Finalization of Vifor Pharma acquisition - News Releases | CSL
Aug 2, 2022 · All regulatory clearances received for the acquisition of Vifor Pharma AG · Settlement of the offer is scheduled for 9 August 2022 · Seasoned ...Missing: 20th | Show results with:20th
[15]
CSL Behring AG completed the acquisition of a 93.99% stake in ...
Aug 8, 2022 · On August 2, 2022, CSL Limited announced it has now received all necessary regulatory clearances for the acquisition of Vifor Pharma AG. CSL has ...
[16]
CSL 2025 Annual Report
Driven by Our Promise Annual Report 2024/25 Our ambition is to deliver enduring patient impact in areas of high unmet medical need. CSL provides lifesaving.
[17]
CSL FY25 Results and Major Strategic Initiatives - Listcorp
Aug 19, 2025 · Both entities will have a sustainable capital structure and access to funding to pursue separate but distinct growth strategies. The demerger ...
[18]
Governance - CSL
CSL Limited's Board and management maintain high standards of corporate governance as part of their commitment to maximize shareholder value.
[19]
[PDF] corporate-governance-statement-2025.pdf - CSL
Aug 18, 2025 · In 2024/25 CSL had four standing Board committees: • Corporate Governance and Nomination Committee; • Audit and Risk Management Committee; • ...
[20]
[PDF] COMPREHENSIVE COMPLIANCE PROGRAM - CSL Vifor
A Code of Conduct and a comprehensive set of policies are foundational for our compliance with laws and regulations in all areas of activities. These documents ...Missing: Swiss | Show results with:Swiss
[21]
[PDF] CSL Annual Report 2023 - AnnualReports.com
Aug 14, 2023 · Key CSL Vifor products on the market include TAVNEOS®, KORSUVA®/. KAPRUVIA®, MIRCERA®, RETACRIT®, VELTASSA®, RAYALDEE®, VELPHORO® and our ...
[22]
About CSL Vifor | CSL Vifor US
CSL Vifor is a global biotech company leading the way to deliver innovative therapies for rare and serious diseases.
[23]
Vifor Fresenius Medical Care Renal Pharma 2025 Company Profile
It also specializes in manufacturing nephrology medicines. Contact Information. Ownership Status. Privately Held (backing). Financing Status. Corporate Backed ...
[24]
CSL Vifor - LinkedIn
Website: https://www.csl.com/. External link for CSL Vifor ; Industry: Pharmaceutical Manufacturing ; Company size: 10,001+ employees ; Headquarters: St. Gallen, ...<|control11|><|separator|>
[25]
Paul McKenzie | CSL Global Leadership Team
Paul McKenzie was appointed Chief Executive Officer and Managing Director of CSL on 6 March 2023. Mr. McKenzie has more than 30 years of leadership experience.
[26]
Hervé Gisserot - CSL
Hervé Gisserot, CSL Vifor General Manager since August 2022 was appointed as Senior Vice President and member of the CSL Global Leadership Group on 15 March ...
[27]
Elodie Berger – Head Medical Affairs - LinkedIn
Elodie Berger. Head Medical Affairs. CSL Vifor University of Lausanne (Switzerland). Préverenges, Waadt, Schweiz.
[28]
CSL Vifor Information - RocketReach
CSL Vifor is a Pharmaceuticals, Pharmaceutical Manufacturing, and Pharmaceutical Products company located in Sankt Gallen, Saint Gallen with $14.7 billion ...<|control11|><|separator|>
[29]
CSL to slash headcount by 15% and spinout its CSL Seqirus ...
Aug 19, 2025 · The Australian biotech's new operating model will also see medical and commercial functions at its CSL Behring and CSL Vifor units combined.Missing: dedicated | Show results with:dedicated
[30]
Vifor to cut 55 staffers in Pa. amid CSL downsizing effort
Oct 8, 2025 · CSL, which has long focused on blood plasma products, laid out $11.7 billion to purchase Vifor and its kidney disease and iron deficiency ...
[31]
The Ironman leading the iron pharma | MedNews
Jan 30, 2023 · Gisserot was appointed General Manager in August 2022 following the company's acquisition by CSL, bringing with him not only his 35 years' experience in pharma ...
[32]
Worldwide Locations - CSL
CSL has locations globally, including head offices in Melbourne, Australia, and offices in the USA, UK, and Switzerland.
[33]
Vifor Pharma reports sustained growth in 2021 - News Releases | CSL
Vifor Pharma Group reported a solid performance in 2021 and an increase in profitability, supported by a strong recovery in Ferinject® / Injectafer® sales.
[34]
[PDF] Intravenous Ferric Carboxymaltose in Heart Failure With Iron ...
Mar 30, 2025 · failure and iron deficiency. DESIGN, SETTING, AND PARTICIPANTS This multicenter, randomized clinical trial enrolled 1105 patients with heart ...<|separator|>
[35]
What are Vifor Pharma's recent drug deals? - Patsnap Synapse
Mar 20, 2025 · It develops, manufactures, and markets pharmaceutical products that target severe and chronic diseases, such as iron deficiency anemia, ...
[36]
[PDF] csl-annual-report-2023.pdf
Aug 14, 2023 · The acquisition of Vifor Pharma in August 2022 has enhanced CSL's product portfolio, complementing ... CSL Vifor's growth is largely ...<|control11|><|separator|>
[37]
[PDF] Major strategic initiatives to transform CSL Financial Year 2025 ...
Aug 19, 2025 · CSL Behring and CSL Vifor will also combine medical and commercial functions, delivering further synergies and additional revenue growth.
[38]
[PDF] csl-annual-report-2025.pdf
Aug 18, 2025 · The 2025 Annual General Meeting (AGM) of CSL Limited (ABN 99 051 588 348) will be held on Tuesday, 28 October 2025 at 10 a.m. (Melbourne time) ...
[39]
After Vifor buyout, CSL CEO sees 'dampened' outlook for the unit as ...
Feb 14, 2024 · CSL closed its $11.7 billion acquisition of Vifor back in August of 2022. ... The company's vaccine arm, CSL Seqiris, increased sales 2% to ...Missing: debt CHF
[40]
https://www.csl.com/-/media/shared/documents/annual-report/csl-annual-report-2023.pdf
[41]
Chronic kidney disease, heart failure and anemia - PMC - NIH
Anemia is prevalent among cohorts of patients with chronic kidney disease and heart failure, indicating that its presence may serve as a central unifying ...
[42]
Anemia and Iron Deficiency in Heart Failure | Circulation
Jul 2, 2018 · Anemia and iron deficiency (ID) are 2 important comorbidities common in patients with HF and are associated with poor clinical status and worse outcomes.
[43]
Treatment of iron deficiency and iron deficiency anemia in adults
Oct 8, 2025 · Oral versus IV iron · Oral iron · - Uses for oral iron · - Choice of oral preparation · - Dosing and administration (oral iron) · - Interventions ...
[44]
Should Iron Deficiency Be Treated With Oral or IV Iron?
Feb 2, 2024 · Intravenous (IV) iron can rapidly correct iron-deficiency anemia, but some formulations can result in low phosphate levels (hypophosphatemia).
[45]
[PDF] Iron management in chronic kidney disease - KDIGO
In general, i.v. iron doses in excess of 3 g/yr are likely to be associated with an increased risk of exceeding the ongoing iron loss and inducing positive iron ...
[46]
Intravenous Iron in Patients Undergoing Maintenance Hemodialysis
Oct 26, 2018 · Safety concerns about intravenous iron therapy in patients with chronic kidney disease. Clin Kidney J 2016;9:260-267. Go to Citation.
[47]
Systematic review and meta-analysis of intravenous iron therapy for ...
Mar 30, 2025 · Uncertainty remains about the effect of intravenous (i.v.) iron on outcomes for heart failure (HF) with iron deficiency.Missing: rare | Show results with:rare
[48]
[PDF] CSL Vifor Investor Briefing
Oct 17, 2023 · • 29% market share of overall. Iron market (Global In-Market Sales. (MAT Q1 2022). • 50% market share in high dose IV iron segment. • More than ...
[49]
Intravenous Iron Drugs Market Size | Industry Report 2030
The global intravenous iron drugs market size was estimated at USD 3302.1 million in 2024 and is projected to reach USD 5578.2 million by 2030, ...<|separator|>
[50]
Global Facts: About Kidney Disease - National Kidney Foundation
10% of the population worldwide is affected by chronic kidney disease (CKD), and millions die each year because they do not have access to affordable ...
[51]
Anemia of chronic kidney disease: Treat it, but not too aggressively
Aug 1, 2016 · Anemia is a frequent complication of chronic kidney disease, occurring in over 90% of patients receiving renal replacement therapy.
[52]
Nephrology | CSL
CSL Vifor aims to address the full spectrum of kidney disease across all stages of kidney failure, from early stages to late stages and dialysis settings.
[53]
VFMCRP announces positive results of phase-III clinical trial of ...
Apr 30, 2021 · Velphoro® is a non-calcium, iron-based, chewable phosphate binder approved for the control of phosphate levels in the blood of adults with CKD on dialysis.
[54]
Efficacy - Velphoro
Velphoro monotherapy provided rapid and sustained phosphorus reductions, with half as many tablets as sevelamer.Missing: CSL | Show results with:CSL
[55]
Vifor Fresenius Medical Care Renal Pharma – Swiss Biotech
In less than ten years, Vifor Pharma has established itself as a world leader in renal care. The successful market launch of Mircera® displaced the existing ...Missing: timeline early
[56]
Difelikefalin Injection (Korsuva) - Medical Clinical Policy Bulletins
The imputed percentage of patients with a decrease of at least 3 points in the WI-NRS score was 49.1% in the difelikefalin group, as compared with 27.9% in the ...
[57]
Chronic kidney disease–associated pruritus and quality of life ... - NIH
Sep 6, 2024 · Difelikefalin improved quality of life in CKD patients, especially with pruritus reduction. Greater pruritus reduction correlated with better ...
[58]
CSL Vifor and Travere Therapeutics announce standard EU ...
Apr 29, 2025 · The European Commission's decision follows CHMP's recommendation to convert the CMA to standard MA from February 2025. The approval is based on ...<|separator|>
[59]
The REnal Surrogacy accEpTance in Chronic Kidney Disease ... - NIH
Sep 23, 2025 · Furthermore, a variety of factors can introduce delays in drug development, regulatory review, and reimbursement processes. For example ...
[60]
News Releases | CSL
Dec 21, 2020 · “The ultra-rare disease, C3 glomerulopathy, is a progressive kidney disorder where a person's renal function inexorably declines, where we have ...
[61]
CSL Vifor Products
Pipeline. We focus on improving our current technologies while also working on longer-term transformational approaches and innovative solutions for patients.
[62]
Infographic: The Role of Iron During Pregnancy - CSL
May 8, 2024 · Balanced iron levels are essential for a healthy pregnancy and important for the baby's development and health.
[63]
CSL Vifor and Travere Therapeutics Recognize Updated KDIGO ...
Sep 26, 2025 · FILSPARI® (sparsentan) suggested for IgA Nephropathy patients who are at risk of progressive kidney function loss CSL Vifor and Travere ...
[64]
CSL trims R&D team, shifts focus toward external opportunities
Jul 7, 2025 · CSL Behring focuses on rare and serious conditions like bleeding disorders, immunodeficiencies and neurological disorders.
[65]
[PDF] Venofer Prescribing Information
Venofer is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). 2. DOSAGE AND ADMINISTRATION. 2.1. Mode of ...Missing: Velphoro | Show results with:Velphoro
[66]
Velphoro
Velphoro® (sucroferric oxyhydroxide) is a phosphate binder indicated for the control of serum phosphorus levels in adult and pediatric patients 9 years of age ...Missing: CSL Venofer
[67]
Mechanism of Action | OXLUMO® (lumasiran)
OXLUMO is an RNA interference (RNAi) therapeutic targeted to the liver. 1 OXLUMO acts upstream of the metabolic defect in AGT to reduce oxalate production.Missing: CSL Vifor distribution
[68]
CSL Vifor wins patent suit against Teva generic - Fierce Pharma
Aug 23, 2022 · The CSL Vifor patent in question expires in July 2030, although the ... CSL Vifor proposes campaign to undo messaging about safety profile of ...
[69]
https://velphoro.us/
[70]
Vifor Pharma and Travere Therapeutics ... - News Releases | CSL
Sep 16, 2021 · Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal ...Missing: history growth
[71]
Travere Therapeutics and Vifor Pharma Announce Licensing
Sep 15, 2021 · Under the terms of the agreement, Vifor Pharma will receive exclusive commercialization rights for sparsentan in Europe, Australia and New ...Missing: CSL | Show results with:CSL
[72]
CSL Vifor and Travere Therapeutics announce standard EU ...
Apr 29, 2025 · Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius ...<|control11|><|separator|>
[73]
Vifor Pharma and Angion Sign License Agreement for Ang-3777 in ...
Nov 9, 2020 · “This agreement highlights the leadership position that Vifor Pharma has developed in the nephrology space and the fact that it has become the ...
[74]
VarmX Partners With CSL in a Strategic Collaboration and Option ...
Sep 15, 2025 · "The collaboration with CSL represents a transformative step for VarmX. By securing full funding for the registrational trial, product ...
[75]
Akebia reveals list price for Vafseo and end to CSL deal
Jul 16, 2024 · A licensing deal between CSL Vifor and Akebia Therapeutics (Nasdaq: AKBA) has been terminated, as the commercial launch of Vafseo ...<|control11|><|separator|>