STOCKHOLM, Dec. 20, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas"), today announced that the U.S. Food and Drug Administration (FDA) has approved TARPEYO (budesonide) delayed release capsules to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. TARPEYO was first approved in December 2021 under accelerated approval, based on the surrogate marker of proteinuria. Marking a signi ...

Financial Performance - As of June 30, 2023, equity attributable to equity holders of the Parent Company amounted to SEK 504.4 million, down from SEK 721.1 million in the same period of 2022[5]. - For the six months ended June 30, 2023, net sales reached SEK 460.7 million, a significant increase from SEK 113.8 million in the same period of 2022, with TARPEYO net sales contributing SEK 444.9 million[9]. - The operating loss for the six months ended June 30, 2023, was SEK 255.2 million, reduced from SEK 418.2 million in the same period of 2022[23]. - In Q2 2023, net sales amounted to SEK 269.4 million, with TARPEYO net sales at SEK 259.2 million, compared to SEK 64.0 million and SEK 63.6 million, respectively, in Q2 2022[21]. - The loss per share before and after dilution for the six months ended June 30, 2023, was SEK 5.21, compared to SEK 7.57 in the same period of 2022[10]. - The total comprehensive loss for the six months ended June 30, 2023, was SEK 283.6 million, compared to SEK 366.9 million in the same period of 2022, reflecting a decrease of approximately 22.7%[173]. - The loss for the three months ended June 30, 2023, was SEK 91.9 million, compared to a loss of SEK 192.4 million in the same period of 2022, showing an improvement of about 52%[161]. - Cash flow used in operating activities for the three months ended June 30, 2023, was SEK 163.0 million, down from SEK 225.2 million in 2022, indicating a reduction of approximately 27.7%[162]. Market and Sales Outlook - Calliditas expects net TARPEYO revenues for 2023 to be revised to USD 100 – 120 million due to market access challenges[28]. - Net sales from TARPEYO are estimated to be USD 100-120 million for the year ending December 31, 2023[47]. - The estimated net sales from TARPEYO for the year ending December 31, 2023, are projected to be between USD 100-120 million, down from the previous estimate of USD 120-150 million[165]. - Calliditas expects revenue growth in the U.S. for 2023, driven by continued sales of TARPEYO[188]. Clinical Trials and Approvals - The company submitted a supplemental New Drug Application (sNDA) to the FDA in June 2023 for full approval of TARPEYO based on positive Phase 3 trial data[24]. - The Phase 3 NefIgArd trial demonstrated a 5.05 mL/min/1.73 m² eGFR treatment benefit for Nefecon compared to placebo over two years, with a highly statistically significant p value < 0.0001[37]. - The Phase 3 NefIgArd trial demonstrated a statistically significant benefit in eGFR over placebo (p value < 0.0001) after 9 months of treatment and 15 months of follow-up[54]. - The Phase 3 NefIgArd trial met its primary endpoint with Nefecon demonstrating a highly statistically significant benefit over placebo (p value < 0.0001) in estimated glomerular filtration rate (eGFR) over a two-year period[122]. - Calliditas submitted a supplemental New Drug Application (sNDA) to the FDA seeking full approval for TARPEYO based on the Phase 3 trial data[73]. - Calliditas received FDA Fast Track Designation for setanaxib in PBC in August 2021, indicating progress in its pipeline development[140]. - The company is conducting a 52-week, randomized, placebo-controlled, double-blind trial for setanaxib, with an adaptive Phase 2b/3 design currently under review[142]. - Calliditas plans to launch a clinical trial for setanaxib in Alport syndrome in the second half of 2023[83]. - Calliditas plans to initiate a randomized, placebo-controlled clinical trial in Alport syndrome involving around 20 patients in the second half of 2023[112]. Research and Development - Calliditas is conducting a Phase 2 study of setanaxib in head and neck cancer, with interim data read out in July 2023[83]. - Research and development expenses for Q2 2023 were SEK 89.0 million, down from SEK 96.3 million in Q2 2022, a decrease of 7.3 million due to the completion of the NefIgArd study[179]. - Setanaxib, the first NOX inhibitor to reach clinical trials, is being studied for its potential in treating inflammation and fibrosis pathways[133]. Financial Position and Cash Flow - Calliditas reported a strong cash position of SEK 866.2 million as of June 30, 2023, which is expected to support operations until profitability[8]. - Cash at the end of Q2 2023 was SEK 866.2 million, slightly up from SEK 846.8 million at the end of Q2 2022[178]. - The increase in non-current financial assets to SEK 1,049.7 million as of June 30, 2023, was primarily due to intercompany transactions, reflecting a growth of SEK 162.3 million since December 31, 2022[167]. Marketing and Sales Efforts - Over 90% of patients enrolled in TARPEYO Touchpoints received TARPEYO in Q2, with a 14% improvement in average time-to-fill compared to Q1[74]. - Calliditas added 232 new prescribers during Q2 2023, contributing to a total of 831 enrollments year-to-date, reflecting over 180% growth compared to the first half of 2022[97]. - Calliditas anticipates engaging with nephrologists at upcoming national conferences to educate them on TARPEYO's benefits for IgAN patients[101]. - The company has received conditional marketing authorization for Nefecon in Europe and is expanding its market presence with launches in various countries[102]. Expenses and Liabilities - Operating expenses for the three months ended June 30, 2023, totaled SEK 330.3 million, up from SEK 271.5 million in 2022, reflecting a year-over-year increase of approximately 22%[155]. - Marketing and selling expenses increased to SEK 191.5 million in Q2 2023 from SEK 113.3 million in Q2 2022, reflecting a rise of 68% driven by intensified marketing for TARPEYO[180]. - Administrative expenses rose to SEK 77.2 million in Q2 2023 from SEK 58.9 million in Q2 2022, an increase of 31% attributed to a larger organization and regulatory requirements[181]. - Total current liabilities as of June 30, 2023, were SEK 290.3 million, compared to SEK 178.5 million in the same period last year, an increase of 62%[178]. Employee Growth - The average number of employees increased to 174 in Q2 2023 from 81 in Q2 2022, reflecting the company's growth and expansion efforts[186].

Financial 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].

Product Development and Clinical Trials - Nefecon, the first approved treatment for IgAN in the US and EU, reported commercial availability in January 2022, with a urine protein-to-creatinine ratio (UPCR) ≥1.5 gram/gram as the indication for use [594]. - The pivotal NefIgArd trial demonstrated a statistically significant benefit of Nefecon over placebo in eGFR (p value < 0.0001) over a two-year period [595]. - Setanaxib, a NOX inhibitor, is currently in a Phase 2b/3 clinical trial with approximately 318 patients, focusing on primary biliary cholangitis (PBC) [599]. - The FDA granted fast track designation to Setanaxib in August 2021, with an interim analysis expected in the first half of 2024 [599]. - The company plans to develop Budenofalk for autoimmune hepatitis in the US, with a definitive clinical development plan targeted for 2023 [600]. Financial Performance - As of December 31, 2022, the company reported a net loss of SEK 412.3 million, with an accumulated loss of SEK 1,836.3 million since inception [601]. - Net sales increased by SEK 573.5 million for the year ended December 31, 2022, primarily due to SEK 372.2 million in net sales of TARPEYO in the US and SEK 427.4 million in milestones and royalties from partnerships in Europe, China, and Japan [655]. - Gross profit for the year ended December 31, 2022, was SEK 787.7 million, compared to SEK 229.3 million in 2021 [654][657]. - Operating loss for the year ended December 31, 2022, was SEK 421.9 million, an improvement from a loss of SEK 524.5 million in 2021 [654]. - Financial income increased by SEK 29.9 million for the year ended December 31, 2022, primarily due to currency effects relating to internal loans [663]. Expenses and Cost Management - Research and development expenses increased by SEK 57.3 million for the year ended December 31, 2022, mainly due to increased costs related to the setanaxib and Nefecon clinical trials [658]. - Marketing and selling expenses rose by SEK 335.6 million for the year ended December 31, 2022, driven by the commercialization of TARPEYO [659]. - Administrative expenses increased by SEK 48.8 million for the year ended December 31, 2022, primarily due to higher costs in finance and IT functions [661]. - The company expects marketing and administrative expenses to increase in the future to support the commercialization of Nefecon and other product candidates [643][646]. Funding and Capital Structure - The company has received net proceeds of SEK 2,523.8 million from equity securities issuance through December 31, 2022 [601]. - The company financed its operations primarily through equity offerings, debt financings, and milestone payments from licensing agreements [601]. - The company signed a loan agreement for up to USD 75 million with Kreos Capital, with the first two tranches drawn down in 2021 and 2022 [724]. Compliance and Regulatory Risks - The company is subject to extensive healthcare regulations, including HIPAA and the FDCA, which impose significant compliance costs and risks of penalties for violations [670]. - The company faces scrutiny from federal and state enforcement bodies regarding interactions with healthcare providers, leading to investigations and potential sanctions [672]. - Compliance with anti-corruption laws, such as the UK Bribery Act and the US Foreign Corrupt Practices Act, presents challenges and could result in significant legal expenses and penalties if violated [679]. - The company is subject to the EU Corporate Sustainability Reporting Directive, which mandates enhanced ESG disclosures starting from 2025 [628]. Intellectual Property and Competitive Position - The company may face limitations on patent enforceability in certain countries, potentially impairing its competitive position and adversely affecting business operations [618]. - Intellectual property rights may not adequately protect the company's competitive advantage, as similar products could be developed without infringing existing patents [620]. - Enforcement proceedings for patent rights could incur substantial costs and divert focus from core business activities, risking invalidation of patents [619]. Operational Challenges and Management - The company expects to continue incurring significant expenses and operating losses as it develops and commercializes its product candidates [602]. - Retaining key personnel is critical for the company's success, as the loss of management or scientific staff could delay development activities [636]. - Anticipated growth in operations will require effective management of resources and recruitment of qualified personnel to avoid disruptions [638]. Market and Economic Factors - The company’s operations may be impacted by geopolitical events, such as the war in Ukraine, affecting relationships with collaborators and suppliers [634]. - The price of the company's equity securities may be volatile and influenced by factors beyond its control, impacting investor confidence and market perception [689]. - Fluctuations in exchange rates between the US dollar and Swedish Krona may impact the value of ADSs and common shares, leading to potential trading discrepancies [711]. Shareholder Rights and Corporate Governance - The rights of shareholders under Swedish corporate law differ from those typically offered to shareholders of US corporations, potentially providing less protection [782]. - Holders of American Depositary Shares (ADSs) will not be able to exercise pre-emptive subscription rights related to the underlying shares, which may lead to dilution of their equity holdings [785]. - The concentration of ownership among executive officers and major shareholders (27.5%) may influence corporate decisions and discourage unsolicited acquisition proposals [708].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 OF THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: June 30, 2022 (Commission File No. 001-39308) CALLIDITAS THERAPEUTICS AB (Translation of registrant's name into English) Kungsbron 1, D5 SE-111 22 Stockholm, Sweden (Address of registrant's principal executive office) Indicate by check mark whether the registrant files or will file annual reports under cover of Form ...

Exhibit 99.1 calliditas 2021 | --- | --- | --- | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ...

SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIE ...

Calliditas Therapeutics AB (NASDAQ:CALT) Q1 2021 Earnings Conference Call May 18, 2021 8:30 AM ET Company Participants Renée Lucander - CEO Richard Philipson - Chief Medical Officer Fredrik Johansson - CFO Andrew Udell - President, North America Conference Call Participants Yigal Nochomovitz - Citigroup Maury Raycroft - Jefferies Edwin Zhang - H.C. Wainwright Nicholas Rubino - Stifel Rami Katkhuda - LifeSci Capital Operator Ladies and gentlemen, welcome to the Calliditas Therapeutics Q1 2021 Conference. [Op ...

Q1 2021 REPORT May 18, 2021 Disclaimers Important information This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the regulatory pathway for Nefecon, plans for submissions for marketing approvals, plans and strategies for commercialization of Nefecon, if approved, the conduct of Part B of the NefIgArd clinical trial, Calliditas' strategy, business plans and focus. The ...

SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ¨ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ OR ¨ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR ...