Calliditas Therapeutics AB American Depositary Shares - CALT STOCK NEWS

The annual general meeting of Calliditas Therapeutics AB, held on June 17, 2024, in Stockholm, resulted in several key resolutions. The income statement and balance sheet for the financial year 2023 were adopted, and no dividends will be paid out, with SEK 904.3 million carried forward. The board of directors, comprising six members, was re-elected, including chairman Elmar Schnee. Ernst & Young was re-appointed as the auditor. An authorization was granted to the board for issuing new shares, warrants, and convertibles, up to 20% of the current share capital, to increase financial flexibility. Additionally, a long-term incentive program for the board and management was approved, including equity-based awards. The meeting also amended terms for previous incentive programs and updated remuneration guidelines for the management and board.

Calliditas Therapeutics announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Kinpeygo, recommending full marketing authorisation in treating adults with primary immunoglobulin A nephropathy (IgAN). Kinpeygo, which received conditional marketing authorisation in July 2022, now has a broader treatment label, moving from a urine protein excretion limitation of >1.5g/g to ≥0.8g/g. The positive opinion will be forwarded to the European Commission (EC) for final approval, expected in August 2024. STADA Arzneimittel AG will market Kinpeygo in the EU and UK.

Calliditas Therapeutics presented new data at the 61st European Renal Association Congress, including an additional efficacy analysis of Nefecon (TARPEYO®) and a real-world analysis of systemic glucocorticoids (SGC) in IgA nephropathy (IgAN).

Results showed that treatment with Nefecon for 9 months significantly improved estimated glomerular filtration rate (eGFR) compared to continuous sparsentan treatment. Another study highlighted the severe side effects and costs associated with SGC treatment in IgAN patients.

The presented data emphasized the potential of TARPEYO as a cornerstone therapy for IgAN, showcasing better eGFR outcomes over time compared to sparsentan, and underlined the risks of using systemic glucocorticoids, which involve significant healthcare resource utilization and side effects.

On May 28, 2024, the Board of Directors of Calliditas Therapeutics recommended shareholders accept Asahi Kasei 's public cash offer to acquire all shares and American Depositary Shares (ADS) of Calliditas. The offer values each share at SEK 208 and each ADS at SEK 416, representing a premium of 83% over the closing price and the 30-day volume-weighted average price of Calliditas shares. The offer, valued at SEK 11,164 million, is contingent upon Asahi Kasei acquiring more than 90% of Calliditas shares and securing necessary approvals. The acceptance period for the offer is expected to commence around July 18, 2024, and conclude around August 30, 2024. Major shareholders, holding about 44.65% of shares, have agreed to the offer. The board believes the transaction will benefit Calliditas by leveraging Asahi Kasei's resources and expertise, particularly in rare disease drug development.

Calliditas Therapeutics reported significant growth in Q1 2024 compared to Q1 2023. Net sales increased to SEK 295.5 million, with TARPEYO® contributing SEK 278.3 million. The company faced an operating loss of SEK 203.8 million and a loss per share of SEK 4.59. Cash reserves decreased to SEK 810.3 million from SEK 1,013.6 million. Key achievements include a 27% increase in enrollments, a new TARPEYO patent valid until 2043, and FDA's orphan drug exclusivity until 2030. Despite a USD 4.7 million revenue impact due to a cyberattack, future revenue is expected to remain stable. Upcoming events include European Commission decisions and Phase 2 trial results.

Calliditas Therapeutics announced an in-person and virtual R&D day on May 30, 2024. The event will feature presentations on the anti-fibrotic effects of Setanaxib and the mode of action of TARPEYO (Nefecon) in treating IgA nephropathy, supported by preclinical and clinical data. Keynote speakers include Gareth J. Thomas, PhD, and Jonathan Barratt, PhD, FRCP. The program will cover supportive preclinical data and a Phase 2 POC trial for Setanaxib in squamous cell carcinoma of the head and neck (SCCHN), as well as a review of upcoming clinical data from the NOX platform. The event will also include a live Q&A session.

Calliditas Therapeutics announced the release of its interim report for Q1 2024 on May 23, 2024, at 07:00 CET. The company will hold a combined audio cast and telephone conference at 14:30 CET the same day, featuring CEO Renée Aguiar-Lucander, CFO Fredrik Johansson, CMO Richard Philipson, and President North America Maria Törnsén. Stakeholders can participate via a webcast or register for the conference call to ask questions. The presentation will be in English, and further details can be obtained from Calliditas's Head of IR & Sustainability, Åsa Hillsten.

Calliditas Therapeutics announced its participation in the 61st European Renal Association (ERA) Congress in Stockholm, Sweden, from May 23 to 26, 2024. The company will present data on Nefecon (TARPEYO® (budesonide) delayed-release capsules) for primary immunoglobulin A nephropathy (IgAN) and real-world challenges with systemic glucocorticoids (SGC) in IgAN. Key presentations include an efficacy analysis of Nefecon and a real-world analysis of SGC challenges. The company will also host a symposium discussing clinical markers in IgAN.

Calliditas Therapeutics AB has scheduled its annual general meeting for June 17, 2024, in Stockholm. Shareholders must be registered by June 7, 2024, and can participate in person, by proxy, or via advance voting. Key agenda items include the election of board members and auditors, approval of financial statements, and resolutions on new share issues and long-term incentive programs. No dividend will be paid for 2023, and SEK 904,299,000 will be carried forward. The nomination committee has proposed re-electing current board members and Ernst & Young AB as auditors.