Calliditas Therapeutics(CALT) - 2024 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company reported net revenues of SEK295.5 million for the quarter, an increase from SEK191.3 million in the same quarter last year, representing a growth of approximately 54% [10] - TARPEYO net product sales for the quarter amounted to SEK278.3 million or $26.8 million, which is a reported increase of 50% from the same quarter previous year [10] - The operating loss for the quarter was SEK203.8 million compared to a loss of SEK180.1 million for the same quarter last year [11] - Cash flow used in operating activities was SEK198.2 million, compared to SEK31.9 million for the same quarter previous year, leaving a net decrease in cash of SEK207.5 million [11] - The company maintains a healthy cash position of SEK810.3 million at the end of the quarter [11] Business Line Data and Key Metrics Changes - The company experienced a record quarter with 705 new enrollments and 354 new unique prescribers for TARPEYO, reflecting strong demand [31] - The increase in sales and marketing expenses was primarily related to the promotion of TARPEYO in the US, with costs rising to SEK240.1 million from SEK167.2 million in the same quarter last year [113] Market Data and Key Metrics Changes - The company anticipates that the KDIGO guidelines, expected to be published in the second half of 2024, will broaden the definition of the at-risk population and support the use of TARPEYO [9] - The company has seen updates from major payers, including United Healthcare, which updated their policy in May to reflect the new label for TARPEYO [9][135] Company Strategy and Development Direction - The company is focused on expanding its market presence for TARPEYO, leveraging the full approval received at the end of the previous year [11] - The company is also preparing for potential full approval of Kinpeygo in Europe and is excited about the commercial launch in China [61] - The company plans to continue engaging with US payers to ensure their policies align with the new label for TARPEYO [9] Management's Comments on Operating Environment and Future Outlook - Management acknowledged a negative impact of approximately $4.7 million due to a cyber-attack affecting claims processing, but indicated that this revenue is expected to roll forward into the next several months [60][85] - Management expressed optimism about the strong demand for TARPEYO and the anticipated updates from payers, which should facilitate access for patients [9][24] Other Important Information - The company received a new patent for TARPEYO, which extends protection until 2043, and was granted orphan exclusivity for the new indication until December 2030 [10][31] - The company is awaiting updates on the Phase II study in IPF and expects to share results in Q4 [3] Q&A Session Summary Question: What is the impact of the cyber-attack on revenues? - Management indicated that the cyber-attack led to a negative impact of approximately $4.7 million, but this revenue is not lost and will be realized in the coming months [60][85] Question: How is the company addressing the new prescriber base? - Management noted that there is healthy growth in both new and existing prescribers, with no significant change in the types of prescribers [15] Question: What are the expectations for the KDIGO guidelines? - Management expects the KDIGO guidelines to broaden the definition of the at-risk population and include TARPEYO as a potential treatment [91][94] Question: What are the anticipated changes in operating expenses? - Management expects a 15% to 20% increase in operating expenses for the year, particularly in sales and marketing [103]