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]

TARPEYO/Kinpeygo Commercial Performance - Q1 2024 saw record enrolments, a 27% increase over Q4, following a 51% increase over Q3[5] - Q1 2024 net sales of TARPEYO were $26.8 million[5, 24] - Preliminary net sales of TARPEYO in Q2 2024 to date are approximately $25.5 million[5, 26] - Total revenue guidance for 2024 remains unchanged at $150 - $180 million[42] - Q1 2024 total revenues were SEK 295.5 million compared to SEK 191.4 million in Q1 2023[34, 39] representing a growth of 50%[39] Setanaxib Clinical Data - Phase 2 data for Setanaxib in Head and Neck cancer showed statistically significant improvements in Progression-Free Survival (PFS) and Overall Survival (OS)[6, 17, 18] - At 6 months, OS was 92% in the Setanaxib group versus 68% in the placebo group, and at 9 months, OS was 88% versus 58% respectively (Hazard ratio=0.45)[17] - Median PFS was 5 months in the Setanaxib group versus 2.9 months in the placebo group (Hazard ratio=0.58)[20] Other Key Updates - A new patent was issued covering TARPEYO, with product protection expiring in 2043[4] - TARPEYO received seven years of orphan protection from the FDA, expiring in December 2030[4] - Commercial launch in China took place in mid-May[5, 6]

The event will feature Gareth J. Thomas, PhD (University Hospital Southampton) and Jonathan Barratt, PhD, FRCP (University of Leicester) with the following program: The event will include a discussion of positive clinical results and supportive pre-clinical and biomarker data recently announced for both programs, as well as an overview of the Company's pipeline and expected future data readouts. A live question and answer session will follow the formal presentations. STOCKHOLM, May 16, 2024 /PRNewswire/ -- ...

Core Insights - Calliditas Therapeutics will present data and host a symposium at the 61st European Renal Association Congress in Stockholm from May 23-26, 2024, focusing on Nefecon's efficacy in treating primary immunoglobulin A nephropathy (IgAN) [1][2] Company Information - Calliditas is headquartered in Stockholm and has developed the first treatment specifically designed for IgAN, addressing a significant unmet need in this rare disease [2] - The company is actively engaging with leaders in the renal space to highlight the potential of its treatment [2] Presentation Details - The oral poster presentation titled "Matching-adjusted indirect comparison of eGFR in patients with immunoglobulin A nephropathy treated with Nefecon (TRF budesonide) or sparsentan" is scheduled for May 25, 2024, from 3:15-4:30 CET [3] - A poster presentation on "Real-world challenges associated with the use of systemic glucocorticoids in a US IgAN cohort" will take place on May 26, 2024, from 8:54-9:06 CET [3] - A symposium titled "Clinical Markers in IgA Nephropathy: Is All Proteinuria the Same?" will be moderated by Prof. Jonathan Barratt on May 25, 2024, from 10:15-11:15 am [3][4] Product Information - TARPEYO is indicated for reducing kidney function loss in adults with IgAN who are at risk for disease progression [5] - TARPEYO is an oral 4mg delayed-release formulation of budesonide, designed to target mucosal B-cells in the ileum, which are involved in the pathogenesis of IgAN [14][15]

"This is a fantastic result from many years of dedication and hard work by teams from both companies and I am delighted that patients in China now can benefit from Nefecon, which has been specifically designed to address the origin of IgAN," said Renee Aguiar-Lucander, CEO. Results from the Chinese subpopulation analysis of the Phase 3 NefIgArd trial, presented at the American Society of Nephrology (ASN) Kidney Week in 2023, provided evidence that the treatment effect of Nefecon in the Chinese cohort was gr ...

STOCKHOLM, May 6, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced data from the proof-of-concept Phase 2 trial evaluating setanaxib, its lead NOX enzyme inhibitor, in combination with pembrolizumab, in patients with squamous cell carcinoma of the head and neck (SCCHN). The analysis showed statistically significant improvements in progression-free survival (PFS), as well as in overall survival (OS), with statistically significant changes ...

The success of the early access program exceeded our expectations. Without any sales representatives and despite the inconvenience of flying out to Hainan's Boao, there were approximately 700 patients signed up for the program. This strong demand underscores the urgent and significant unmet medical needs among the large IgAN patient base in China. received from nephrologists in China? How many sales people are you successful commercial launch of Nefecon? | --- | --- | --- | |-------------------------------- ...

Foreign Exchange Impact - Foreign exchange rate difference translation gains were SEK 1.3 million for the year ended December 31, 2023, compared to SEK 46.6 million in 2022[868] - A 10% stronger Euro against the Swedish Krona would negatively impact profit after tax and equity by approximately SEK 29.3 million for the year ended December 31, 2023[870] - A 10% stronger US dollar against the Swedish Krona would positively impact profit after tax and equity by approximately SEK 0.1 million for the year ended December 31, 2023[870] - The company's transaction exposure in foreign currency has been increasing year by year, with primary exposure in Euros and US dollars[917] TARPEYO and Nefecon Clinical Data - TARPEYO received full FDA approval on December 20, 2023, for reducing kidney function loss in adults with IgAN at risk for disease progression[537] - In the Phase 3 NefIgArd trial, Nefecon showed a 31% reduction in UPCR compared to a 5% reduction in placebo-treated patients after nine months of treatment[979] - Proteinuria reduction was 52% from baseline in Nefecon-treated patients compared to 7% in placebo-treated patients at 12 months[979] Disease Prevalence and Patient Impact - IgAN affects approximately 130,000 to 150,000 people in the United States and approximately 200,000 people in Europe, with a significantly higher prevalence in Asia, particularly Greater China, affecting around 5 million people[539] - The company estimates approximately 140,000 patients in the United States are affected by PBC, with an annual incidence ranging from 0.3 to 5.8 cases per 100,000[992] Remediation and Internal Controls - The company has initiated a remediation plan to address material weaknesses, including increasing dedicated resources and improving reporting processes[914]

STOCKHOLM, April 24, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT), (NASDAQ STOCKHOLM: CALTX) ("Calliditas") today announces that the Annual Report for 2023 now is available at the company's website: www.calliditas.com For further information, please contact: Åsa Hillsten, Head of IR & Sustainability, CalliditasTel.: +46 76 403 35 43, Email: [email protected] This information is information that Calliditas Therapeutics AB is obliged to make public pursuant to the Securities Markets Act. The ...

STOCKHOLM, April 24, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT), (NASDAQ STOCKHOLM: CALTX) ("Calliditas") today announced that the global open-label extension (OLE) study to the Phase 3 NefIgArd study showed a treatment response consistent with the NefIgArd study across endpoints of urine protein to creatinine ration (UPCR) and estimated glomerular filtration rate (eGFR) at 9 months across all IgAN patients, including those who had previously received Nefecon in the NefIgArd study. NefIg ...