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About Calliditas Therapeutics AB
Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) is a clinical-stage biopharmaceutical company headquartered in Stockholm, Sweden. The company specializes in identifying, developing, and commercializing innovative therapies for orphan diseases, with a primary focus on renal and hepatic conditions that present significant unmet medical needs. By combining scientific expertise with a patient-centric approach, Calliditas aims to address complex and underserved medical conditions, improving the quality of life for affected individuals worldwide.
Core Business Areas
Calliditas Therapeutics operates at the intersection of biotechnology and pharmaceuticals, leveraging cutting-edge research to develop targeted treatments. Its flagship products include:
- TARPEYO® (budesonide delayed-release capsules): Approved in the United States for the treatment of primary immunoglobulin A nephropathy (IgAN), TARPEYO is the first and only FDA-approved therapy designed to reduce kidney function decline by targeting the production of galactose-deficient IgA1 antibodies.
- Kinpeygo®: The first fully approved treatment for IgAN in the European Union, Kinpeygo addresses a broader patient population following its expanded label approval by the European Commission in 2024.
- Setanaxib: A first-in-class NOX enzyme inhibitor, currently being evaluated in multiple clinical trials for indications such as cancer, idiopathic pulmonary fibrosis (IPF), primary biliary cholangitis (PBC), and Alport syndrome.
Strategic Partnerships and Global Reach
Calliditas employs a strategic partnership model to enhance its global footprint. Collaborations with organizations such as Everest Medicines in China and STADA Arzneimittel AG in Europe enable the company to commercialize its therapies in key international markets. These partnerships not only expand accessibility but also optimize resource allocation for clinical development and regulatory compliance.
Commitment to Innovation
The company is deeply committed to advancing scientific understanding and therapeutic options for rare diseases. Its robust pipeline includes late-stage clinical trials for setanaxib in oncology and fibrotic diseases, as well as exploratory studies in other orphan conditions. Calliditas' focus on intellectual property protection, evidenced by its recently granted patents for setanaxib in oncology, underscores its dedication to long-term innovation.
Market Position and Competitive Landscape
Operating in the highly specialized biopharmaceutical sector, Calliditas Therapeutics distinguishes itself through its focus on orphan indications. Its ability to secure regulatory approvals, such as FDA and EMA authorizations, positions it as a leader in the rare disease treatment market. The company's emphasis on targeted therapies and disease-modifying treatments provides a competitive edge against broader-spectrum pharmaceutical approaches.
Regulatory and Ethical Standards
Calliditas adheres to stringent regulatory guidelines across its global operations. Its clinical trials are designed to meet the highest ethical standards, ensuring patient safety and data integrity. The company's transparent communication with stakeholders further reinforces its reputation as a trustworthy and reliable entity in the biopharmaceutical industry.
Future Outlook
With a strong pipeline, strategic partnerships, and a focus on addressing unmet medical needs, Calliditas Therapeutics is well-positioned for sustained growth. Its continued investment in research and development, coupled with its commitment to patient-centric solutions, underscores its potential to remain a key player in the rare disease treatment landscape.
Calliditas Therapeutics AB has updated its share structure as of July 29, 2022. The company has issued 51,399 ordinary shares related to its long-term incentive program for board members and converted 5,908,018 class C-shares into ordinary shares, establishing its at-the-market program. Following these changes, the total number of shares and votes stands at 59,157,587. Calliditas focuses on developing treatments for orphan diseases, with its lead product Nefecon receiving FDA accelerated approval.
Everest Medicines announced that Calliditas Therapeutics has received conditional marketing authorization from the European Commission for Kinpeygo® (NEFECON) to treat primary IgA nephropathy (IgAN) in adults. This approval marks Kinpeygo as the first and only EMA-approved treatment for IgAN in Europe, essential for patients with a high risk of disease progression. The authorization is applicable across all 27 EU Member States and three additional countries. The approval is based on positive outcomes from the Phase 3 NefIgArd study, with a planned application for China in the second half of 2022.
Calliditas Therapeutics AB (Nasdaq: CALT) announced the European Commission has granted conditional marketing authorization for Kinpeygo, the first approved treatment for primary immunoglobulin A nephropathy (IgAN). This decision applies to all 27 EU member states, Iceland, Norway, and Liechtenstein. Kinpeygo is intended for adults with a urine protein-to-creatinine ratio ≥1.5 g/gram at risk of rapid disease progression. The approval is based on positive results from a Phase 3 study showing a significant reduction in proteinuria and improved renal function. STADA Arzneimittel AG will exclusively market Kinpeygo in the EEA.
Calliditas Therapeutics AB (NASDAQ: CALT) announced on July 11, 2022, the addition of two key members to its management team: Sandra Frithiof, Head of Human Resources, and Jonathan Schur, Group General Counsel. Jonathan Schur brings over 40 years of legal experience, particularly in the pharmaceutical sector, while Sandra Frithiof has over 23 years of HR experience across various industries. The company continues its focus on developing treatments for renal and hepatic diseases, with its lead product, TARPEYO, already FDA approved and awaiting European Commission approval.
Calliditas Therapeutics US is actively raising awareness for IgA nephropathy (IgAN), a rare kidney disease, through various events in July 2022. The company, which has the first FDA-approved treatment for IgAN, emphasizes the importance of patient advocacy in supporting affected individuals and their caregivers. Initiatives include the Rare Kidney Disease Week from July 18-22, a webinar on July 21, and the SPARK 2022 symposium on July 24-25. Additionally, Calliditas launched the IgAN Connect educational campaign to provide resources and support for those living with the disease.
Calliditas Therapeutics has issued 5,908,018 class C-shares as part of its at-the-market program, increasing total shares to 59,106,188 and votes to 53,788,971.8 as of June 30, 2022. The company focuses on developing treatments for orphan indications, particularly renal and hepatic diseases. Its lead product, TARPEYO, has received FDA approval and awaits European Commission approval. Calliditas is also conducting clinical trials for its NOX inhibitor setanaxib in various conditions. The common shares are listed on Nasdaq Stockholm under ticker CALTX and American Depositary Shares under CALT.
Calliditas Therapeutics AB has filed a registration statement with the SEC for a U.S. At-the-Market (ATM) program to raise up to $75 million through the sale of American Depositary Shares (ADSs). The sales may occur at market prices on the Nasdaq Global Select Market, depending on various factors. Proceeds are intended to fund development of candidates from the NOX inhibitor platform, including setanaxib for various indications, and to support commercial activities for TARPEYO. The registration statement is pending effectiveness.
On May 19, 2022, Calliditas Therapeutics held its annual general meeting, adopting the financial statements for 2021 and discharging the Board from liability. Notably, no dividends were declared for 2021, with SEK 1,203,117 thousand carried forward. The board was restructured, with six members elected, including re-elections for four and new members Henrik Stenqvist and Elisabeth Björk. An authorization was granted to issue new shares, with a limit of 15% dilution. Additionally, the company introduced a long-term incentive program for the Board and management, ensuring strategic flexibility.
On May 19, 2022, Calliditas Therapeutics announced that the CHMP of the EMA adopted a positive opinion for KinpeygoTM, recommending conditional marketing authorization for treating primary IgA nephropathy (IgAN) in adults at risk of rapid disease progression. If approved by the EC, Kinpeygo will be the first treatment for IgAN, addressing a significant unmet need as over 50% of patients may progress to end-stage renal disease. The final decision from the EC is expected in Q3 2022.
Calliditas has officially launched its first commercial product, TARPEYO, in the US, supported by a skilled sales team. The product generated $1.9M in net revenues within the initial months. For Q1 2022, net sales reached SEK 49.7M, with TARPEYO contributing SEK 18.0M. However, the company reported an operating loss of SEK 208.4M compared to SEK 150.8M in the same period last year. Despite these challenges, Calliditas aims to expand its TARPEYO franchise while continuing clinical trials for other product candidates.
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