Calliditas Therapeutics(US:CALT)2023-04-27 16:00Financial Performance - Calliditas reported net sales of SEK 802,879,000 in 2022, a significant increase from SEK 229,347,000 in 2021, representing a growth of approximately 250%[12]. - The company incurred a loss before income tax of SEK 409,417,000 in 2022, an improvement from a loss of SEK 513,373,000 in 2021[12]. - Calliditas' total assets increased to SEK 1,952,973,000 in 2022, up from SEK 1,459,910,000 in 2021[12]. - The average number of employees rose to 86 in 2022, compared to 56 in 2021, reflecting the company's growth and expansion efforts[12]. - Calliditas shares on Nasdaq Stockholm closed at SEK 92.5 on December 31, 2022, representing an 18% decrease for the year[181]. - The closing price of Calliditas ADS on Nasdaq USA was USD 17.0 on December 31, 2022, marking a 31% decline during the year[182]. - A total of 79.4 million shares were traded on Nasdaq Stockholm in 2022, with a total trading value of SEK 7,010 million[183]. - The company had 18,585 shareholders as of December 31, 2022, with the top 15 shareholders controlling 53.0% of the capital[191]. - The proportion of shares available for trade (free float) was approximately 69% at year-end 2022[192]. - Calliditas aims to expand its presence in the capital markets across the Nordic region, Europe, and the USA through various investor relations activities[193]. Product Development and Clinical Trials - TARPEYO, the first FDA-approved treatment for IgA nephropathy, generated net sales of SEK 372.2 million ($36.8 million) in the first 11 months of commercialization, with 642 unique prescribers and 1,039 enrollments[16]. - The company initiated two clinical trials for setanaxib in 2022, including a pivotal study in primary biliary cholangitis and a Phase 2 trial in head and neck cancer[19]. - The NeflgArd trial published positive interim results, showing a strong reduction in proteinuria for TARPEYO-treated patients at 9 months, with continued decline off-drug for those reaching 12 months[17]. - Nefecon demonstrated a 27% reduction in UPCR compared to placebo after 9 months of treatment, with a p-value of 0.0003[79]. - The trial showed a statistically significant eGFR treatment benefit of 3.87 mL/min/1.73 m² for Nefecon compared to placebo after 9 months (p = 0.0014)[84]. - Over a two-year period, eGFR was on average 5.05 mL/min/1.73 m² higher with Nefecon compared to placebo (p < 0.0001)[92]. - After 12 months, Nefecon-treated patients exhibited a 52% reduction in proteinuria compared to baseline[83]. - The NeflgArd trial included 364 patients, with a 1:1 randomization into Nefecon 16 mg/day or placebo[88]. - Nefecon was well-tolerated, with treatment-emergent adverse events mostly mild to moderate in severity[86]. - The primary endpoint of the trial was met, showing clinically important improvements in both UPCR and eGFR[88]. - The full NeflgArd trial readout was reported in March 2023, confirming the efficacy of Nefecon[75]. - The trial's positive feedback from nephrologists at the ASN conference highlighted the strong reduction in proteinuria as a differentiating factor[76]. - The NeflgArd trial is expected to conclude in Q3 2023 with the final 29 patients completing their treatment[96]. - Setanaxib achieved a 12% reduction in alkaline phosphatase (ALP) compared to placebo over a 24-week treatment period in a Phase 2 trial[118]. - In patients with liver stiffness ≥9.6 kPa, setanaxib achieved a 24% reduction in ALP and a 22% reduction in liver stiffness compared to a 4% increase for placebo[120]. - Calliditas initiated a pivotal 52-week Phase 2b/3 trial for setanaxib in PBC, targeting approximately 318 patients with elevated liver stiffness[126]. - Setanaxib is also being evaluated in a Phase 2 trial for head and neck cancer, with interim analysis targeted for mid-2023 and final data expected in 2024[136]. - Setanaxib, developed initially for organ fibrosis, shows potential in preventing CAF formation and improving immunotherapy response in mouse cancer models[145]. - Approximately 50% of head & neck cancer patients exhibit high or moderate levels of CAFs, correlating with aggressive cancer behavior[143]. - Only about 15% of head & neck cancer patients respond to checkpoint immunotherapy, indicating a significant need for improved treatment options[149]. - The company aims to combine immunotherapy with setanaxib to enhance response rates in cancers with high CAF levels[149]. - Most solid tumors, including lung, colon, and breast cancers, have a CAF-rich subgroup, suggesting broad potential for CAF-targeting therapies[150]. Market Expansion and Partnerships - Calliditas expanded its sales force from 40 to 60 executives in early Q3 2022 to support the growing interest in TARPEYO[16]. - The European Commission granted conditional marketing authorization for Kinpeygo in July 2022, making it the first approved treatment for IgA nephropathy in Europe[11]. - Calliditas entered into an exclusive license agreement with Viatris Pharmaceuticals for Nefecon in Japan, receiving an upfront payment of $20 million and potential additional payments of up to $80 million[12]. - Calliditas received an upfront payment of EUR 20 million from STADA for the licensing agreement, with potential future payments of up to EUR 65 million linked to regulatory and commercialization milestones[103]. - Calliditas entered a licensing agreement with Everest Medicines for Nefecon in China, receiving an initial payment of USD 15 million and potential future payments up to USD 95 million[107]. - Everest Medicine's NDA for Nefecon was accepted by the NMPA in November 2022, with a regulatory decision expected in 2H 2023[108]. - Calliditas partnered with Viatris to commercialize Nefecon in Japan, receiving an upfront payment of USD 20 million and potential future payments of up to USD 80 million[109]. Marketing and Patient Support - Over 90% of US lives are covered by payers for TARPEYO, with a channel mix of approximately 70% commercially insured patients and 30% government subsidized[34]. - The conversion rate for patients enrolled in TARPEYO Touchpoints is over 80% across various insurance programs[34]. - The sales force expanded from 40 to 60 representatives, enhancing interactions with healthcare providers based on market feedback[26]. - The company achieved unaided awareness of TARPEYO greater than 80% among nephrologists after one year on the market[39]. - The average time to fulfillment for successfully concluded prescriptions is less than 30 days, aiming to exceed industry standards[34]. - The company launched a multimedia campaign to boost TARPEYO's profile, focusing on its unique mechanism of action and clinical efficacy[35]. - The patient support service, TARPEYO Touchpoints™, was fully operational upon approval, providing dedicated case management and support[28]. - The company engaged with key advocacy groups to support the IgAN patient community and raise disease awareness[30]. - The company is committed to continuous improvement in patient support and education to ensure high-quality service as patient load increases[28]. Corporate Responsibility and Sustainability - Calliditas has transitioned from a clinical stage to a commercial stage biotech company, focusing on the commercialization of TARPEYO® in the United States[166]. - The company is committed to ethical business practices and compliance with regulations, particularly in its sales and marketing efforts[166]. - Calliditas has established a Sustainability Manager and an ESG Committee to enhance its sustainability agenda and practices[157]. - The company emphasizes a diverse and inclusive workplace, with a commitment to employee safety and well-being[173]. - Calliditas is focused on minimizing its environmental impact through energy-efficient practices and responsible supply chain management[170].