STOCKHOLM, Sept. 3, 2024 /PRNewswire/ -- The shareholders of Calliditas Therapeutics AB (publ) ("Calliditas Therapeutics"), Reg. No. 556659-9766, with registered office in Stockholm, are summoned to the extraordinary general meeting on Monday 30 September 2024 at 12:00 p.m. CEST at Advokatfirman Vinge's premises on Smålandsgatan 20, SE-111 46, Stockholm, Sweden. Registration starts at 11:30 a.m. CEST. Background Asahi Kasei Corporation ("Asahi Kasei"), which has announced that the public offer made regardin ...

Core Viewpoint - Asahi Kasei Corporation has acquired over 90% of Calliditas Therapeutics' outstanding shares and intends to initiate compulsory redemption of the remaining shares, prompting Calliditas' Board of Directors to take corporate actions [1]. Delisting and Deregistration - Calliditas' Board has resolved to apply for the delisting of its common shares from Nasdaq Stockholm and its American Depositary Shares (ADSs) from the Nasdaq Global Select Market at Asahi Kasei's request [2]. - The last trading day for Calliditas' common shares on Nasdaq Stockholm will be announced once confirmed by Nasdaq Stockholm [3]. - The company plans to file a Form 25 with the U.S. Securities and Exchange Commission (SEC) around September 13, 2024, with the delisting of the ADSs expected to take effect around September 23, 2024 [4]. Extraordinary General Meeting - An Extraordinary General Meeting has been convened by Calliditas' Board at Asahi Kasei's request, scheduled for September 30, 2024, to elect a new Board of Directors [5]. Company Overview - Calliditas Therapeutics is a biopharma company based in Stockholm, Sweden, focused on developing treatments for orphan indications with significant unmet medical needs. Its common shares are listed on Nasdaq Stockholm and its ADSs on the Nasdaq Global Select Market [6].

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]

Calliditas Therapeutics AB (publ) (NASDAQ:CALT) Q2 2024 Earnings Conference Call August 13, 2024 8:30 AM ET Company Participants Renée Aguiar-Lucander - CEO Richard Philipson - CMO Maria Tornsen - President, North America Fredrik Johansson - CFO Conference Call Participants Operator Welcome to Calliditas Q2 2024 Report. [Operator Instructions] And there will be no Q&A session after the presentation. Now I will hand the conference over to the speakers. Please go ahead. Renée Aguiar-Lucander Thank you very mu ...

STOCKHOLM, Aug. 13, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (STO: CALTX) : April to June 2024 (compared to April to June 2023) Net sales amounted to SEK 559.8 million, of which TARPEYO® net sales amounted to SEK 493.4 million, for the three months ended June 30, 2024. For the three months ended June 30, 2023, net sales amounted to SEK 269.4 million, of which TARPEYO net sales amounted to SEK 259.2 million. Operating loss amounted to SEK 31.5 million and SEK 75.2 million for the three ...

Company Overview - Calliditas Therapeutics AB is a biopharma company headquartered in Stockholm, Sweden, focused on identifying, developing, and commercializing novel treatments for rare diseases with significant unmet medical needs [4]. Leadership and Representation - CEO Renée Aguiar-Lucander will participate in a panel at the Women in Nephrology Leadership Conference, emphasizing the importance of female representation and leadership in the industry [2]. - Aguiar-Lucander acknowledges the progress women have made in leadership positions but highlights that the industry remains male-dominated, indicating a need for continued efforts to promote diversity and support women in leadership roles [2]. Conference Details - The panel titled "How to be Efficient as a Leader in Academia and Industry" will take place on August 9-10 in Los Angeles, CA, focusing on the achievements of female leaders and the importance of mentorship [2][3]. - The Women in Nephrology organization was founded in 1983 to provide mentorship and guidance to nephrologists and scientists, particularly those who have been historically underrepresented [2].

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Core Points - The European Commission has granted full marketing authorization for Kinpeygo, a treatment for adults with primary immunoglobulin A nephropathy (IgAN) [3] - This approval triggers a milestone payment of ten million EUR to Calliditas, which will be recognized as revenue in the third quarter [2] - Kinpeygo's status as an orphan drug for a rare disease has been confirmed, providing 10-year market exclusivity until 2032 [4] Group 1 - The full marketing authorization covers EU member states, Iceland, Norway, and Liechtenstein [4] - Kinpeygo is the first fully approved medication for IgAN, representing a significant advancement for patients [5] - The expanded label for Kinpeygo allows for a broader patient population, changing the urine protein excretion limitation from > 1.5g/g to ≥ 0.8g/g [7] Group 2 - The approval is based on data from the Phase 3 NefIgArd clinical trial, which demonstrated high statistical significance in meeting its eGFR endpoint [5][7] - The results of the trial were published in The Lancet, highlighting the efficacy and safety of the treatment [6] - The approval is seen as a crucial development for the treatment landscape of IgAN in Europe [5]

Core Insights - The TRANSFORM trial demonstrated that setanaxib significantly improved alkaline phosphatase (ALP) levels in patients with primary biliary cholangitis (PBC) compared to placebo, meeting its primary endpoint [3][4][7] Group 1: Trial Details - The TRANSFORM trial is a double-blind, randomized, placebo-controlled Phase 2b study involving 76 patients with PBC and elevated liver stiffness [1] - Two treatment arms were tested: 1200 mg (800 mg AM + 400 mg PM) and 1600 mg (800 mg BID) over 24 weeks [1] - The treatment groups were well-balanced with no significant differences at baseline [2] Group 2: Efficacy Results - Patients receiving setanaxib showed a statistically significant improvement in ALP levels: 19% in the 1600 mg arm and 14% in the 1200 mg arm [2][3] - Positive trends were observed in liver stiffness assessed by FibroScan® at 24 weeks [2] Group 3: Safety and Tolerability - Setanaxib treatment was generally well tolerated, with similar rates of treatment-emergent adverse events (TEAEs) between active treatment and placebo [2] - However, the frequency of TEAEs leading to study discontinuation was higher in the active treatment group [2] Group 4: Future Developments - The company is conducting additional clinical trials with setanaxib, including a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) expected to report data in Q4 2024/Q1 2025 [5] - An ongoing Phase 2 proof of concept trial in Alport syndrome is anticipated to deliver data in 2025 [5]