Calliditas Therapeutics(US:CALT)2023-08-16 16:00Financial 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].