Calliditas Therapeutics(CALT) - 2024 Q2 - Quarterly Report

Financial Performance - Net sales for Q2 2024 amounted to SEK 559.8 million, with TARPEYO® net sales contributing SEK 493.4 million, representing a 90% growth compared to Q2 2023[2][5] - Adjusted operating profit for Q2 2024 was SEK 70.2 million, excluding SEK 101.7 million in expenses related to the Asahi Kasei offer and social security contributions[2] - Cash position as of June 30, 2024, was SEK 797.3 million, compared to SEK 866.2 million in the same period in 2023[3] - Net sales for the first six months of 2024 totaled SEK 855.3 million, with TARPEYO net sales contributing SEK 771.6 million, a significant increase from SEK 460.7 million in the same period in 2023[3] - Adjusted operating loss for the first six months of 2024 was SEK 133.6 million, excluding SEK 101.7 million in expenses related to the Asahi Kasei offer and social security contributions[3] - Calliditas expects total net sales from the Nefecon franchise, including milestones, to be USD 165-185 million for the year ending December 31, 2024[8] - Calliditas' cash position remains strong with SEK 797 million ($75 million) on the balance sheet at the end of the quarter, reflecting very limited cash burn[22] - Calliditas adjusts its 2024 net revenue guidance for the Nefecon franchise to $165–185 million[22] - Net sales for the three months ended June 30, 2024, amounted to SEK 559.8 million, a significant increase from SEK 269.4 million in the same period in 2023[59] - TARPEYO® net sales in the US for the three months ended June 30, 2024, were SEK 493.4 million, up from SEK 259.2 million in 2023[59] - Royalty income for the three months ended June 30, 2024, increased to SEK 38.9 million from SEK 8.8 million in 2023[59] - Research and development expenses for the three months ended June 30, 2024, rose to SEK 120.7 million from SEK 89.0 million in 2023, driven by increased costs for Nefecon manufacturing scale-up and higher pharmacovigilance costs[62] - Marketing and selling expenses for the three months ended June 30, 2024, increased to SEK 253.0 million from SEK 191.5 million in 2023, primarily due to intensified marketing activities for TARPEYO and an expanded US salesforce[63] - The company's cash position as of June 30, 2024, was SEK 797.3 million, down from SEK 866.2 million in 2023[69] - Calliditas expects total net sales from the Nefecon franchise, including milestones, to be USD 165-185 million for the year ending December 31, 2024, up from the previously communicated USD 150-180 million[78] - Q2 2024 net sales reached SEK 559.78 million, a 107.8% increase compared to SEK 269.38 million in Q2 2023[91] - Six-month net sales for 2024 totaled SEK 855.26 million, up 85.6% from SEK 460.74 million in the same period in 2023[91] - Operating loss for Q2 2024 was SEK 31.50 million, a 58.1% improvement from SEK 75.17 million in Q2 2023[91] - Total assets decreased from SEK 1,859,245 thousand in December 2023 to SEK 1,747,205 thousand in June 2024[93] - Cash decreased from SEK 973,733 thousand in December 2023 to SEK 797,278 thousand in June 2024[93] - Net sales for the six months ended June 2024 were SEK 551,270 thousand, compared to SEK 273,987 thousand in the same period in 2023[97] - Operating loss for the six months ended June 2024 was SEK 168,740 thousand, compared to SEK 164,723 thousand in the same period in 2023[97] - Research and development expenses increased to SEK 239,871 thousand for the six months ended June 2024, up from SEK 196,609 thousand in the same period in 2023[97] - Marketing and selling expenses increased to SEK 243,065 thousand for the six months ended June 2024, up from SEK 195,739 thousand in the same period in 2023[97] - Administrative expenses increased to SEK 235,820 thousand for the six months ended June 2024, up from SEK 121,033 thousand in the same period in 2023[97] - Loss for the period was SEK 171,976 thousand for the six months ended June 2024, compared to SEK 187,041 thousand in the same period in 2023[98] - Cash flow from operating activities was negative SEK 205,248 thousand for the six months ended June 2024, compared to negative SEK 394,971 thousand in the same period in 2023[95] - Total equity decreased from SEK 334,806 thousand in December 2023 to SEK 106,789 thousand in June 2024[93] - Total assets increased to SEK 2,258,059 thousand in June 2024, up from SEK 1,991,423 thousand in June 2023[99] - Net sales of TARPEYO in the US reached SEK 493.4 million for Q2 2024, compared to SEK 259.2 million in Q2 2023[106] - Royalty income for Q2 2024 was SEK 38.9 million, up from SEK 8.8 million in Q2 2023[106] - Total revenue for the six months ended June 30, 2024, was SEK 855.3 million, compared to SEK 460.7 million in the same period in 2023[106] - Cash holdings decreased to SEK 469,114 thousand in June 2024 from SEK 754,802 thousand in June 2023[99] - Non-current financial assets increased to SEK 1,223,814 thousand in June 2024 from SEK 1,049,716 thousand in June 2023[99] - Current receivables rose significantly to SEK 449,745 thousand in June 2024 from SEK 71,974 thousand in June 2023[99] - Total liabilities increased to SEK 1,065,636 thousand in June 2024 from SEK 778,363 thousand in June 2023[99] - The total value of the public cash offer by Asahi Kasei Corporation is SEK 11,164 million[102] - The fair value of the contingent consideration is estimated using a discount rate of 13.4%[110] - Total registered shares at the end of the period increased to 59,918,583 from 59,580,087 at the beginning of the period, with 338,496 shares issued but not registered[112] - Equity attributable to equity holders of the Parent Company decreased to SEK 106,789 thousand from SEK 504,367 thousand in the same period last year[112] - Loss per share before and after dilution was SEK (0.88) for the six months ended June 30, 2024, compared to SEK (1.71) for the same period in 2023[112] - Total outstanding options and share awards under incentive programs increased to 5,701,470 from 4,895,205 in the previous year[113] - The equity ratio at the end of the period decreased to 6% from 30% in the same period last year, with total shareholders' equity at SEK 106,789 thousand and total assets at SEK 1,747,205 thousand[119] - Adjusted operating loss for the six months ended June 30, 2024, was SEK (133,579) thousand, compared to SEK (255,246) thousand in the same period last year[120] - Provisions for social security contributions for incentive programs amounted to SEK 70,532 thousand, and advisor fees for the Asahi Kasei public offer were SEK 31,218 thousand[120] - Reserves for translation from foreign operations amounted to SEK 11.6 million as of June 30, 2024, compared to SEK 6.4 million in the same period last year[112] TARPEYO Performance and Market Impact - In Q2 2024, Calliditas reported 750 new enrolments for TARPEYO in the US, generating record revenues of SEK 493 million, a 90% growth over Q2 2023[16] - TARPEYO achieved a quarterly record with 750 new patient enrollments in Q2 2024, adding 343 new prescribers, bringing the total to 2,336 prescribers[40] - Over 80% of commercial lives are covered by payers in alignment with TARPEYO's updated label[40] - Calliditas' lead product, TARPEYO, is the first fully FDA-approved treatment for IgAN, based on protection of kidney function[36] - Calliditas' marketing efforts for TARPEYO have driven increased demand, with full approval based on eGFR data in December 2023[51] - The Phase 3 NefIgArd trial demonstrated a significant kidney protective effect, with a treatment benefit of 3 mL/min/year in favor of TARPEYO[28] - Initial data from the open-label extension study showed positive results with consistent treatment response across UPCR and eGFR endpoints at 9 months for all patients, including those previously treated with TARPEYO[42] - Global open-label extension (OLE) study for NefIgArd showed consistent treatment response across endpoints of UPCR and eGFR at 9 months for all IgAN patients[82] - FDA granted TARPEYO® a 7-year orphan drug exclusivity period, expiring in December 2030[85] Clinical Trials and Drug Development - Calliditas reported positive topline data from the Phase 2 Head and Neck cancer trial, showing statistically significant results in progression-free survival (PFS) and overall survival (OS)[18] - Positive topline data from the Phase 2b PBC trial showed statistically significant improvement in Alkaline Phosphatase (ALP) for both doses of setanaxib[19] - Setanaxib demonstrated statistically significant improvement in ALP reduction for PBC patients with elevated liver stiffness in a Phase 2b trial, meeting its primary endpoint[47] - Phase 2 trial of setanaxib in SCCHN showed statistically significant improvements in PFS (median 5 months vs. 2.9 months) and OS (92% vs. 68% at 6 months; 88% vs. 58% at 9 months) compared to placebo[50] - Setanaxib-treated patients in the SCCHN trial showed a 70% disease-control rate compared to 52% in the placebo arm[50] - Calliditas received FDA Fast Track Designation for setanaxib in PBC in August 2021 and orphan drug designation for Alport syndrome in September 2023[45][46] - The company estimates approximately 67,000 people in the US have Alport syndrome, contributing to 1.5% to 3.0% of children on renal replacement therapies in the EU and US[44] - Calliditas launched a Phase 2 study in Alport syndrome with around 20 patients, evaluating safety and impact on proteinuria, with data readout expected to inform a full regulatory program[45] - The company received a US patent in June 2024 for the use of NOX inhibitors in treating solid tumors resistant to PD-1 inhibitor immunotherapy, with an expiration date in 2039[49] - Setanaxib Phase 2 trial in SCCHN showed statistically significant improvements in PFS and OS, with significant changes in tumor biology[82] - TRANSFORM Phase 2b trial for setanaxib in PBC met its primary endpoint with statistically significant ALP improvement[85] Market and Regulatory Developments - The global IgA nephropathy (IgAN) market is estimated to grow to $5–8 billion as availability and familiarity of approved drugs increase[31] - Nefecon received conditional approval in China in November 2023 and was commercially launched in mainland China in May 2024[34] - The Chinese cohort in the Phase 3 NefIgArd trial showed a 66% reduction in loss of kidney function (eGFR) with Nefecon compared to a 50% reduction in the global dataset[35] - Calliditas' partner STADA received full approval from the European Commission for Kinpeygo in July 2024[30] - Calliditas secured an additional EUR 10 million milestone payment from STADA in Q3 2024 related to the full approval of Kinpeygo[16] - European Commission granted full marketing authorization for Kinpeygo for treating primary IgAN in adults[85] - Everest Medicines launched Nefecon® in China, targeting up to 5 million patients with the autoimmune disease[83] - The United States Patent and Trademark Office issued a new patent for TARPEYO, providing product protection until February 13, 2043[81] Corporate and Strategic Developments - Asahi Kasei Corporation made a public cash offer to acquire all shares in Calliditas for SEK 208 per share, valuing the offer at approximately SEK 11,164 million[77] - Calliditas' Board of Directors unanimously recommended shareholders accept Asahi Kasei Corporation's public tender offer[83] - The company's average number of employees increased to 224 for the three months ended June 30, 2024, from 174 in 2023[70] - The company is developing sustainability policies and processes, focusing on climate change mitigation, circular economy, employee health, and business ethics, with reporting to align with CSRD from FY 2025[57][58]