Calliditas Therapeutics

What Calliditas Therapeutics does

Calliditas Therapeutics AB is a Stockholm-headquartered specialty biopharmaceutical company focused on developing and commercializing treatments for rare diseases, primarily in renal and hepatic indications. The company's lead commercial product is TARPEYO (budesonide) delayed release capsules, which became the first FDA-approved treatment specifically designed for IgA nephropathy (IgAN) in December 2021, receiving full approval in December 2023. TARPEYO is marketed directly by Calliditas in the US and licensed to STADA Arzneimittel AG (Kinpeygo brand) in Europe and to Everest Medicines and Viatris in Asia-Pacific markets. The underlying technology is the proprietary TARGIT formulation platform, licensed from Archimedes Development Ltd in 2011, which enables targeted delivery of budesonide to the ileum where gut-associated lymphoid tissue is implicated in IgAN pathogenesis.

The company's pipeline is anchored by setanaxib, a first-in-class NOX1 and NOX4 enzyme inhibitor acquired through the 2021 takeover of Genkyotex SA. Setanaxib targets reactive oxygen species production implicated in fibrotic diseases and is in clinical development across multiple orphan indications including Primary Biliary Cholangitis (Phase 2b), Alport Syndrome (Phase 2 proof-of-concept), Idiopathic Pulmonary Fibrosis (investigator-led Phase 2), and CAF-rich solid tumors (Phase 2). Calliditas earns revenue through three streams: direct product sales of TARPEYO in the US, tiered royalties and milestone payments from regional licensing partners (up to USD 121M from Everest, EUR 97.5M from STADA, USD 100M from Viatris), and Named Patient Program distribution via Tanner Pharma Group. In May 2024, Asahi Kasei Corporation launched a public cash tender offer that closed with 98.38% ownership by September 2024, initiating a compulsory buy-out and converting Calliditas into a wholly owned subsidiary of the Japanese conglomerate.

Name

Calliditas Therapeutics

Legal name

Calliditas Therapeutics AB

Website

https://calliditas.se

Company type

Public

Founded year

2004

Operating status

Operating

Headcount range

101–250 employees

Ownership category

akta.pro rank

Product category

Specialty Rare Disease Pharmaceuticals

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Rare Pediatric & Congenital Disorder Therapies (HLAIAIAN)

akta.pro secondary industries

Pulmonary Hypertension & Rare Pulmonary Disease Therapies (HLAIAIAG), Onconephrology (Kidney Care in Cancer Patients) (HLAKAHAM)

Keywords

• Rare disease therapeutics
• Specialty pharmaceuticals
• IgA nephropathy treatment
• Orphan drug development
• Anti-fibrotic therapies

Headquarters

HQ city

Stockholm

HQ country

Sweden

HQ region

Europe

Offices5 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Marketing or Sales, Supply Chain, Operations

Revenue model

1. Product Sales (TARPEYO/Kinpeygo): Direct product sales of TARPEYO (budesonide) delayed release capsules in the US market following full FDA approval in December 2023. Kinpeygo marketed by STADA in EEA under licensing agreement.
2. Licensing & Milestone Payments: Upfront payments, development milestones, and sales milestones from licensing partners: Everest Medicines (up to USD 121M + royalties for Greater China), STADA (EUR 97.5M + royalties for EEA), Viatris (up to USD 100M for Japan).
3. Debt Financing: USD 75 million term loan facility from Kreos Capital, denominated in euros, divided into three tranches secured by US intellectual property, contingent on milestones and regulatory approval.

Pricing tiers

Go-to-market motion3 records

Distribution channels5 records

Marketing channels6 records

Core offering

Calliditas Therapeutics is a specialty biopharmaceutical company developing and commercializing treatments for rare diseases with unmet medical need. Its commercial portfolio centers on TARPEYO/Kinpeygo/Nefecon (budesonide delayed release capsules), the first and only treatment specifically approved for IgA nephropathy. The company also has a clinical pipeline anchored by setanaxib, a first-in-class NOX1/4 inhibitor being developed for fibrotic diseases including Primary Biliary Cholangitis, Alport Syndrome, Idiopathic Pulmonary Fibrosis, and CAF-rich solid tumors.

Product overview

Calliditas Therapeutics is a biopharmaceutical company that has developed a portfolio of products for IgA nephropathy and a pipeline of novel medications for rare fibrotic diseases and solid tumors. The commercial portfolio consists of TARPEYO (budesonide) delayed release capsules, approved and marketed in the United States, and Kinpeygo, approved in Europe via partnership with STADA Arzneimittel AG. The company's pipeline is anchored by setanaxib, a NOX1/4 inhibitor being developed across multiple indications including Primary Biliary Cholangitis, Idiopathic Pulmonary Fibrosis, Alport Syndrome, and solid tumors. Nefecon serves as the product development name with regional partnerships for China (Everest Medicines) and Japan (Viatris).

Differentiator

Problem solved

Functional benefit

Brands

• IgAN Connect: Online patient platform providing resources to people living with IgA nephropathy, a chronic autoimmune disease

Products and services

• TARPEYO (budesonide) delayed release capsules FDA-approved delayed release budesonide capsules using proprietary TARGIT technology to deliver the active ingredient to the ileum, indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. Marketed exclusively by Calliditas Therapeutics AB in the United States.
• Kinpeygo (budesonide delayed release capsules) European-branded budesonide delayed release capsules for the treatment of IgA nephropathy in adults at risk of rapid disease progression. Marketed exclusively by STADA Arzneimittel AG in the European Economic Area, United Kingdom, and Switzerland under a licensing agreement with Calliditas.
• Nefecon (budesonide delayed release capsules) Budesonide delayed release formulation for IgA nephropathy distributed under the Nefecon brand in Asia, commercialized by Everest Medicines in China, Singapore, Macau and South Korea and by Viatris Pharmaceuticals Japan in Japan.
• Setanaxib (NOX1/4 inhibitor pipeline) First-in-class NOX1 and NOX4 inhibitor being developed as an anti-fibrotic therapy for multiple orphan indications including Primary Biliary Cholangitis, Idiopathic Pulmonary Fibrosis, Alport Syndrome and CAF-rich solid tumors; >320 subjects exposed across completed Phase 1 and Phase 2 trials. Not yet approved or commercially launched.

Quantifiable outcome

• FDA full approval to reduce loss of kidney function in adults with IgA nephropathy who are at risk for disease progression
• +3 more outcomes

Named customers3 records

Segments5 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Seven partnerships are on record, tiered core, supporting and minor.

• Viatris Pharmaceuticals Japan Inc.coreChannel Partner/ Reseller/ Distributor · 1 December 2022Exclusive license agreement to register and commercialize Nefecon in Japan. Agreement worth up to USD 100 million in upfront and milestone payments.
• STADA Arzneimittel AGcoreChannel Partner/ Reseller/ Distributor · 1 July 2021Licensing agreement to register and commercialize Kinpeygo for IgA nephropathy across the European Economic Area. Agreement valued at EUR 97.5 million plus tiered royalties on net sales in the low twenties to low thirties percentage range.
• GenkyotexcoreStrategic or Co-development Partner · 1 January 2021Acquired all remaining shares to make Genkyotex a wholly owned subsidiary (completed 2021). Genkyotex held the lead product setanaxib, a NOX inhibitor under clinical trials for PBC and head and neck cancer.
• Everest Medicines II LtdcoreChannel Partner/ Reseller/ Distributor · 1 June 2019Licensing agreement to develop and commercialize Nefecon for treatment of IgA nephropathy in Greater China and Singapore (June 2019), expanded to include South Korea (March 2022). Initial agreement valued at USD 121 million plus option for other indications valued at USD 20 million, plus royalties.
• Tanner Pharma GroupsupportingChannel Partner/ Reseller/ DistributorEngaged to administer Named Patient Program for TARPEYO in select countries where product is not yet available or approved. Provides controlled pre-approval access to medicines for patients who have exhausted treatment options.
• Asahi Kasei Pharma / AlchemedicineminorOthersAsahi Kasei and Alchemedicine leveraging Calliditas Therapeutics and Veloxis Pharmaceuticals to advance AK1960 (Endothelin A receptor antagonist) toward global markets. Calliditas providing strategic support for development program.
• IgA Nephropathy FoundationsupportingGTM or Marketing PartnerPatient advocacy partnership supporting Kidney Month campaign (March 2026) focused on patient education and empowerment. Calliditas served as Friend sponsor providing support for educational resources including 'Kidney Terms to Know' guide and animated nutrition tips video.

Scale indicators8 records

Recent moves5 records

Expansion highlights6 records

Direct peers

• BioMarin Pharmaceutical: Pure-play rare disease pharmaceutical company with multiple orphan drug franchises. Comparable commercial playbook for orphan pricing, payer negotiation, and specialty distribution.
• Travere Therapeutics: Direct competitor in IgA nephropathy with FILSPARI (sparsentan), the first non-immunosuppressive FDA-approved therapy for IgAN. Competes head-to-head with TARPEYO for the same nephrology prescriber audience and patient population.
• Swedish Orphan Biovitrum (Sobi): Swedish-headquartered specialty pharmaceutical company focused on rare diseases, with a comparable business model of in-licensing, developing, and commercializing orphan therapies. Direct geographic and strategic peer.
• Chinook Therapeutics (Novartis): Rare kidney disease focused biotech developing atrasentan for IgA nephropathy, acquired by Novartis in 2023. Direct overlap in IgAN mechanism and patient targeting with TARPEYO.
• Aurinia Pharmaceuticals: Develops LUPKYNIS (voclosporin) for lupus nephritis, a rare autoimmune kidney disease. Comparable specialty pharma model targeting orphan renal indications with similar field-sales commercialization approach.
• Vertex Pharmaceuticals: Large-cap rare disease specialist with a track record of launching first-in-class orphan therapies at premium pricing. Comparable business model in pursuing disease-modifying mechanisms in small patient populations.
• Argenx: Commercial-stage rare disease immunology company with similar growth profile from launching first-in-class biologics into specialty channels. Comparable trajectory from single-asset revenue to multi-indication franchise.

Broad incumbents

• Alexion Pharmaceuticals (AstraZeneca Rare Disease): Established leader in rare disease pharmaceuticals with broad orphan portfolio including nephrology-adjacent assets. Larger incumbent operating across multiple rare disease categories rather than a focused niche player.

Emerging players

• Galapagos NV: European biotech with fibrosis pipeline including work on NOX-related mechanisms through subsidiary acquisitions. Overlapping scientific platform targeting fibrotic diseases with novel small-molecule approaches.
• Vera Therapeutics: Late-stage biotech developing atacicept for IgA nephropathy. Represents next wave of IgAN competition that could pressure TARPEYO market share over time.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xtwitter.com/calliditas1
• LinkedInlinkedin.com/company/calliditas-therapeutics-ab

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Subsidiaries3 records

Funding overview

Funding rounds6 records

Investors3 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Calliditas Therapeutics