Calliditas Therapeutics (CALTX) investor relations material

Executive summary

• Achieved record Q2 2024 net product revenues, with TARPEYO sales reaching $46.3 million (SEK 493.4 million), a 90% year-over-year increase, and Nefecon franchise sales around $53 million.

• Operational profitability was reached, excluding one-time costs related to the Asahi Kasei offer and incentive provisions.

• Positive clinical milestones: phase III NefIgArd study concluded, phase II proof-of-concept in head and neck cancer and primary biliary cholangitis showed significant results, and phase IIb PBC trial met primary endpoints.

• Asahi Kasei announced a public cash offer to acquire all shares at SEK 208 per share, an 83% premium, with board recommendation and major shareholder support; acceptance period runs through August 30, 2024.

• Full approval of Kinpeygo in Europe and commercial launch of Nefecon in China marked key milestones.

Financial highlights

• Q2 2024 net revenues were SEK 559.8 million, up from SEK 269.4 million year-over-year; TARPEYO net product sales were SEK 493.4 million ($46.3 million), a 90% increase from Q2 2023.

• Adjusted operating profit was SEK 70.2 million, but reported operating loss was SEK 31.5 million due to SEK 101.7 million in one-time costs.

• Cash position at June 30, 2024 was SEK 797.3 million, with cash burn of SEK 7 million in Q2.

• Gross profit for Q2 2024 was SEK 506.3 million, and operating expenses were SEK 537.8 million.

• Cash flow used in operating activities for Q2 2024 was SEK 7.0 million, a significant improvement from SEK 163 million in Q2 2023.

Outlook and guidance

• Full-year 2024 revenue guidance for the Nefecon franchise raised to $165 million–$185 million, up from previous guidance.

• Expectation of continued operating profitability for the remainder of the year, excluding deal-related costs.

• Anticipate further revenue growth from TARPEYO and Nefecon, supported by expanded market access, full approvals, and upcoming KDIGO guideline updates.

• EUR 10 million milestone payment expected in Q3 from Kinpeygo's full approval in Europe.