CALT Overview

FDA Approval of Filspari: Travere Therapeutics received full FDA approval for its drug Filspari (sparsentan) to treat IgA nephropathy, making it the only non-immunosuppressive medication for this kidney disease. The approval expands the patient population eligible for treatment and is based on positive results from the PROTECT study.

Market Impact and Competitors: Following the announcement, Travere's stock rose nearly 11%, reflecting investor confidence in the expanded indication. The IgAN market also includes competitors like Calliditas Therapeutics with Tarpeyo and Novartis with Fabhalta, both of which have received FDA approvals for similar indications.

Asahi Kasei's Acquisition of Calliditas: Asahi Kasei Corporation has acquired over 90% of Calliditas Therapeutics AB and plans to initiate compulsory redemption of the remaining shares, leading to corporate actions including delisting from Nasdaq Stockholm and the Nasdaq Global Select Market.

Extraordinary General Meeting Announcement: Calliditas' Board of Directors has scheduled an Extraordinary General Meeting for September 30, 2024, at Asahi Kasei's request, to elect a new Board of Directors amidst these changes.

Q2 2024 Financial Performance: Calliditas Therapeutics reported a record quarter with net revenues of $46.3 million from TARPEYO, achieving operational profitability and updating revenue guidance for 2024 to between $165 million and $185 million.

Key Developments: The company concluded its Phase 3 NefIgArd study, received full approval for Kinpeygo in Europe, and reported positive results from its Phase 2b trial in Primary Biliary Cholangitis (PBC) with setanaxib, alongside a public cash offer from Asahi Kasei for the company's shares.

Financial Performance: Calliditas Therapeutics reported significant growth in net sales for Q2 2024, reaching SEK 559.8 million compared to SEK 269.4 million in Q2 2023, with TARPEYO® contributing SEK 493.4 million. The operating loss decreased from SEK 75.2 million in 2023 to SEK 31.5 million in 2024, and adjusted operating profit stood at SEK 70.2 million after accounting for specific expenses.

Key Developments: In Q2 2024, Calliditas achieved positive trial results for Nefecon and setanaxib, launched Nefecon in China through a partner, and received a favorable opinion for Kinpeygo® in the EU. Additionally, Asahi Kasei Corporation made a public cash offer to acquire Calliditas, which is currently under consideration until August 30, 2024.

Financial Performance: Calliditas Therapeutics reported a significant increase in net sales for Q2 2024, amounting to SEK 559.8 million, with TARPEYO® contributing SEK 493.4 million. The operating loss decreased to SEK 31.5 million from SEK 75.2 million in the same quarter of 2023.

Key Developments: The company achieved positive results from clinical trials for Nefecon and setanaxib, launched Nefecon in China, and received a favorable opinion for Kinpeygo® in the EU. Additionally, Asahi Kasei Corporation made a public cash offer to acquire Calliditas at a premium price.

Calliditas CEO Participation: Renée Aguiar-Lucander, CEO of Calliditas Therapeutics, will speak at the Women in Nephrology Leadership Conference on August 9-10, focusing on female leadership and representation in the industry.

Importance of Diversity: Aguiar-Lucander emphasizes the need for mentorship and support for women in leadership roles to drive innovation and growth, acknowledging the ongoing challenges in a male-dominated field.