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The equity ratio measures the proportion of the total assets that are financed by share-holders. Reconciliations of Alternative Performance Measures March 31, December 31, (SEK in thousands or otherwise indicated) 2024 2023 2023 Equity ratio at the end of the period in % Total shareholders' equity at the end of the period 120,151 589,403 334,806 Total assets at the end of the period 1,688,295 1,788,716 1,859,245 Equity ratio at the end of the period in % 7% 33% 18% NOTES
The price per share is to be equivalent to 115% of the weighted average price that the company's shares were traded for on Nasdaq Stockholm during the ten trading days preceding the grant date. The options have, at the time of each issue, been valued according to the Black-Scholes valuation model. March 31, 2024 March 31, 2023 Options Outstanding Share Awards Outstanding Total Outstanding Options Outstanding Share Awards Outstanding Total Outstanding Incentive Programs Board LTIP 2020 - - - - 29,928 29,928 Board LTIP 2021 - 22,882 22,882 - 24,244 24,244 Board LTIP 2022 - 37,136 37,136 - 40,706 40,706 Board LTIP 2023 - 40,957 40,957 - - - ESOP 2020 1,364,730 - 1,364,730 1,364,730 - 1,364,730 ESOP 2021 1,390,500 - 1,390,500 1,479,500 - 1,479,500 ESOP 2022 1,826,000 - 1,826,000 1,548,000 - 1,548,000 ESOP 2023 1,880,000 - 1,880,000 - - - Total Outstanding 6,461,230 100,975 6,562,205 4,392,230 94,878 4,487,108 NOTES Calliditas Therapeutics | Interim Report 2024: January March 30 Definitions and Reconciliations of Alternative Performance Measures Definitions of Alternative Performance Measures Alternative Key Performance Indicator Definitions Reason for Inclusion Equity ratio at the end of the period in % The ratio at the end of respective period is calculated by dividing total shareholders' equity by total assets.
The options have a three-year vesting period calculated from the grant date, provided that, with customary exceptions, the participants remain as employees of, or continue to provide services to, Calliditas. Once the options are vested, they can be exercised within a one-year period. Each vested option entitles the holder to acquire one share in Calliditas at a predetermined price.
The share awards are subject to perfor-mance-based earnings, which are dependent on the development of Calliditas' share price from the date of the 2023 Annual General Meeting to July 1, 2026. ESOP Programs Calliditas implements option programs for employees and key consultants in Calliditas. The options are granted free of charge to participants of the program.
Board LTIP 2022: This is a performance-based long-term incentive program for Calliditas Board members. The share awards are subject to perfor-mance-based earnings, which are dependent on the development of Calliditas' share price from the date of the 2022 Annual General Meeting to July 1, 2025. Board LTIP 2023: This is a performance-based long-term incentive program for Calliditas Board members.
NOTES Calliditas Therapeutics | Interim Report 2024: January March 29 Note 9 - Incentive Programs Board LTIP 2021: This is a performance-based long-term incentive program for Calliditas Board members. The share awards are subject to perfor-mance-based earnings, which are dependent on the development of Calliditas' share price from the date of the 2021 Annual General Meeting to July 1, 2024.
No transfer (sale) of treasury shares have occurred as of March 31, 2024. The total number of issued shares as of March 31, 2024, is disclosed in Note 8. Note 8 - Shareholders' Equity March 31, December 31, (SEK in thousands, except per share amounts and number of shares) 2024 2023 2023 Total registered shares at the beginning of the period 59,580,087 59,580,087 59,580,087 Total registered and subscribed but not registered shares at the end of the period 59,580,087 59,580,087 59,580,087 Shares Ordinary shares 59,580,087 59,157,587 59,580,087 Total 59,580,087 59,157,587 59,580,087 - of which shares are held by Calliditas 5,908,018 5,908,018 5,908,018 Total registered and subscribed but not registered shares at the end of the period, net of shares held by Calliditas 53,672,069 53,249,569 53,672,069 Share capital at the end of the period 2,383 2,383 2,383 Equity attributable to equity holders of the Parent Company 120,151 589,403 334,806 Total equity at the end of the period 120,151 589,403 334,806 Three Months Ended March 31, Year Ended December 31, (SEK in thousands, except per share amounts and number of shares) 2024 2023 2023 Loss per share before and after dilution, SEK (4.59) (3.49) (8.69) Weighted-average number of ordinary shares outstanding for the period, before and after dilution 53,672,069 53,672,069 53,672,069 Reserves for translation from foreign operations amounted to SEK 11.1 million and SEK 10.5 million which are included in retained earnings in equity as of March 31, 2024 and 2023, respectively.
NOTES Calliditas Therapeutics | Interim Report 2024: January March 28 Note 7 - Treasury Shares As of March 31, 2024, Calliditas had 5,908,018 ordinary shares held as treasury shares by the Parent Company. At the Annual General Meeting 2023, authorization was given that Calliditas can transfer (sale) these ordinary shares with the purpose to finance an acquisition of operations, to procure capital to finance the development of projects, repayment of loans or to commercialize Calliditas' products.
The most significant input affecting the valuation of the contingent consideration is the Group's estimate of the probability of the milestones being reached. Calliditas holds a credit agreement that contains customary affirmative and negative covenants for a senior secured loan, such as minimum cash liquidity and minimum product revenue. The fair value at the end of the period amounts to SEK 1,011.4 million.
Contingent consideration is recognized at fair value, measured at Level 3 of the IFRS value hierarchy. The fair value of the contingent consid-eration has been estimated in accordance with the present value method and the probability has been taken into account if and when the various milestones will occur. The calculations are based on a discount rate of 12.2 percent.
The Group's financial liabilities comprise of contingent consideration, non-current interest-bearing liabilities, other non-current liabilities, lease liabilities, accounts payable, other current liabilities, and accrued expenses, all of which except contingent consideration, are recognized at amortized cost. The carrying amount is an approximation of the fair value.
Note 5 - Related-Party Transactions During the reporting period, no significant related-party transactions have occurred. For information about incentive programs please see Note 9. Note 6 - Financial Instruments The Group's financial assets comprise of non-current financial assets, current receivables and cash, which are recognized at amortized cost.
Royalty income from our partnerships amounted to SEK 13.0 million and SEK 4.4 million for the first quarter of 2024 and 2023, respectively. For the first three months ended March 31, 2024 and 2023, no milestones were recognized. For 2023, outlicensing of product consisted entirely of milestone fees from Everest Medicines. The total liability for expected returns and rebates amounts to SEK 2.7 million and SEK 39.8 million as of March 31, 2024 and 2023, respectively, which are recognized in other current liabilities.
Notes to Condensed Consolidated Financial Statements NOTES Calliditas Therapeutics | Interim Report 2024: January March 27 Note 4 - Revenue from Contracts with Customers Three Months Ended March 31, Year Ended December 31, (SEK in thousands) 2024 2023 2023 Type of goods or services Product sales 282,530 186,940 1,087,418 Outlicensing of product - - 82,712 Royalty income 12,951 4,412 36,758 Total 295,481 191,352 1,206,888 Geographical markets USA 278,276 185,691 1,075,829 Europe 16,859 5,661 39,614 Asia 346 - 91,445 Total 295,481 191,352 1,206,888 Net sales for the periods primarily originate from net sales of TARPEYO in the US, which amounted to SEK 278.3 million and SEK 185.7 million for the three months ended March 31, 2024 and 2023, respectively.
Regarding the Group and the Parent Company's financial risk management, the risks are essentially unchanged compared with the description in the Annual Report for 2023. For more information and full disclosure regarding the operational and financial risks, reference is made to the Annual Report for 2023 and the Annual Report on Form 20-F, filed with the SEC in April 2024.
The Group is primarily affected by foreign exchange risk, since the development costs for Nefecon and setanaxib are mainly paid in USD and EUR. Further, the Group holds account receivables in USD and EUR and cash in USD and EUR to meet future expected costs in USD and EUR in connection with commercialization of TARPEYO in the US and the clinical development programs.
There is a risk that commercialization will not go according to plan or that the uptake of prescribing physicians will be worse than planned or that the drug will not have sufficient effect, or show unwanted side effects, which may affect the sales negatively. The impact on the financial statements is described in the Finan-cial overview. Financial Risks Calliditas' financial policy governing the management of financial risks has been designed by the Board of Directors and represents the framework of guidelines and rules in the form of risk mandated and limits for financial activities.
The operations may also be impacted negatively by regulatory decisions, such as lack of approvals and price changes. Calliditas has a commercialized product, which has received full approval in the US under the brand name TARPEYO and has received conditional marketing authorization in the EU and the UK under the brand name Kinpeygo, and in China under the brand name Nefecon, and are dependent on renewal of the conditional marketing authorizations.
The majority of all initiated projects will never reach market registration due to the technological risks, such as a failure to demonstrate efficacy or a favorable risk/benefit profile, or manufacturing problems. Competing pharmaceuticals can capture market share or reach the market faster, or if competing research projects achieve better product profiles, the future value of the product portfolio may be lower than expected.
For key ratios not defined by IFRS, see the Definitions and reconciliations of alternative performance measures on page 30. Note 3 - Risks and Uncertainties in the Group and the Parent Company Operational Risks Research and drug development up to approved registration and marketing is subject to considerable risk and is a capital-intensive process.
Significant accounting policies can be found in the Annual Report 2023, from pages 45 and onwards including disclosures at respective note. The ESMA (European Securities and Markets Authority) guidelines on alternative key performance ratios are applied, which means disclosure requirements regarding financial measures that are not defined in accordance with IFRS.
The Parent Company applies the Swedish Financial Reporting Board recommendation RFR2, Accounting for legal entities. The accounting policies adopted in the preparation of the interim condensed consolidated financial statements are consistent with those followed in the preparation of the Annual Report for 2023. None of the new or amended standards and interpretations that became effective January 1, 2024, have had a significant impact on the Group's financial reporting.
Actual outcomes may deviate from what has been stated. Internal factors such as successful management of research projects, and intellectual property rights may affect future results. There are also external conditions, (e.g. the economic climate, political changes, and competing research projects) that may affect the Group's results. Note 2 - Accounting Policies These interim condensed consolidated financial statements have been prepared in accordance with International Accounting Standard No. 34 (IAS 34), Interim Financial Reporting .
Calliditas is listed at Nasdaq Stockholm in the Mid Cap segment with ticker CALTX and, in the form of ADSs, on the Nasdaq Global Select Market in the United States with the ticker CALT . These interim condensed consolidated financial statements were approved by the Board of Directors (the Board ) for publication on May 23, 2024. This report may include forward-looking statements.
These interim condensed consolidated financial statements encompass the Group, domiciled in Stockholm, Sweden, and its subsidiaries for the three months ended March 31, 2024 and 2023. Calliditas is a Swedish public limited company registered in and with its registered office in Stockholm. The registered address of the corporate headquarters is Kungsbron 1, D5, Stockholm, Sweden.
Calliditas Therapeutics | Interim Report 2024: January March 19 Condensed Consolidated Statements of Income Three Months Ended March 31, Year Ended December 31, (SEK in thousands, except per share amounts) Notes 2024 2023 2023 Net sales 4 295,481 191,352 1,206,888 Cost of sales (14,012) (9,028) (60,463) Gross income 281,469 182,323 1,146,425 Research and development expenses (150,613) (126,653) (502,223) Marketing and selling expenses (240,147) (167,224) (727,740) Administrative expenses (102,018) (72,548) (332,991) Other operating income/(expenses), net 7,483 4,027 43,473 Operating income (loss) (203,826) (180,074) (373,055) Net financial income/(expenses) (43,498) (27,944) (83,962) Income (loss) before income tax (247,324) (208,019) (457,017) Income tax 1,164 20,494 (9,168) Net income (loss) for the period (246,160) (187,525) (466,185) Attributable to: Equity holders of the Parent Company (246,160) (187,525) (466,185) (246,160) (187,525) (466,185) Loss per share before and after dilution (SEK) 8 (4.59) (3.49) (8.69) FINANCIAL STATEMENTS Calliditas Therapeutics | Interim Report 2024: January March 20 Condensed Consolidated Statements of Comprehensive Income Three Months Ended March 31, Year Ended December 31, (SEK in thousands) 2024 2023 2023 Net income (loss) for the period (246,160) (187,525) (466,185) Other comprehensive income Other comprehensive income (loss) that may be reclassified to income or loss in subsequent periods: Exchange differences on translation of foreign operations 16,351 1,159 (14,538) Other comprehensive income (loss) that may be reclassified to income or loss in subsequent periods 16,351 1,159 (14,538) Other comprehensive income (loss) that will not be reclassified to income or loss in subsequent periods: Remeasurement gain (loss) on defined benefit plans 12 (662) (3,071) Other comprehensive income (loss) that will not be reclassified to income or loss in subsequent periods 12 (662) (3,071) Other comprehensive income (loss) for the period 16,363 497 (17,609) Total comprehensive income (loss) for the period (229,797) (187,028) (483,794) Attributable to: Equity holders of the Parent Company (229,797) (187,028) (483,794) (229,797) (187,028) (483,794) FINANCIAL STATEMENTS Calliditas Therapeutics | Interim Report 2024: January March 21 March 31, December 31, (SEK in thousands) Notes 2024 2023 2023 ASSETS Non-current assets Intangible assets 424,227 439,180 430,754 Goodwill 47,848 45,911 48,584 Equipment 18,397 8,417 16,053 Right-of-use assets 46,988 34,142 38,186 Non-current financial assets 25,097 13,390 24,201 Deferred tax assets 26,835 27,970 26,315 Total non-current assets 589,392 569,010 584,093 Current assets Inventories 29,303 12,160 20,428 Current receivables 182,824 109,551 196,666 Prepaid expenses and accrued income 76,459 84,396 84,324 Cash 810,317 1,013,600 973,733 Total current assets 1,098,903 1,219,706 1,275,152 TOTAL ASSETS 1,688,295 1,788,716 1,859,245 EQUITY AND LIABILITIES Equity Equity attributable to equity holders of the Parent Company 120,151 589,403 334,806 Total equity 7,8,9 120,151 589,403 334,806 Non-current liabilities Provisions 9 30,463 24,471 36,116 Contingent consideration 6 60,458 78,816 56,561 Deferred tax liabilities 35,152 33,728 41,641 Non-current interest-bearing liabilities 986,390 723,995 939,508 Lease liabilities 30,228 22,903 27,088 Other non-current liabilities 17,282 5,320 16,381 Total non-current liabilities 1,159,973 889,233 1,117,295 Current liabilities Accounts payable 101,384 108,000 100,564 Other current liabilities 33,383 33,158 25,953 Accrued expenses and deferred revenue 273,404 168,922 280,627 Total current liabilities 408,171 310,080 407,144 TOTAL EQUITY AND LIABILITIES 1,688,295 1,788,716 1,859,245 Condensed Consolidated Statements of Financial Position FINANCIAL STATEMENTS Calliditas Therapeutics | Interim Report 2024: January March 22 Condensed Consolidated Statements of Changes in Equity Three Months Ended March 31, Year Ended December 31, (SEK in thousands) 2024 2023 2023 Opening balance equity attributable to equity holders of the Parent Company 334,806 766,264 766,264 Loss for the period (246,160) (187,525) (466,185) Other comprehensive income/(loss) 16,363 497 (17,609) Total comprehensive income/(loss) for the period attributable to equity holders of the Parent Company (229,797) (187,028) (483,794) Transactions with owners: Share-based payments 15,142 10,167 52,337 Total transactions with owners 15,142 10,167 52,337 Closing balance equity attributable to equity holders of the Parent Company 120,151 589,403 334,806 Closing balance equity 120,151 589,403 334,806 FINANCIAL STATEMENTS Calliditas Therapeutics | Interim Report 2024: January March 23 Three Months Ended March 31, Year Ended December 31, (SEK in thousands) 2024 2023 2023 Operating activities Operating loss (203,826) (180,074) (373,055) Adjustment for non-cash items 16,259 27,141 102,478 Interest received 2,516 7 32,905 Interest paid (26,534) (15,460) (94,497) Income taxes paid (244) (1,336) (22,747) Cash flow from (used in) operating activities before changes in working capital (211,829) (169,722) (354,915) Cash flow from (used in) changes in working capital 13,624 (62,218) (79,740) Cash flow from (used in) operating activities (198,205) (231,940) (434,655) Cash flow from (used in) investing activities (3,858) (2,913) (13,745) New borrowings - - 962,889 Costs attributable to new loans - - (26,625) Repayment of borrowing - - (724,479) Repayment of lease liabilities (5,467) (2,969) (12,134) Cash flow from (used in) financing activities (5,467) (2,969) 199,650 Net increase (decrease) in cash (207,530) (237,822) (248,750) Cash at the beginning of the period 973,733 1,249,094 1,249,094 Net foreign exchange gains (loss) in cash 44,114 2,327 (26,611) Cash at the end of the period 810,317 1,013,600 973,733 Condensed Consolidated Statements of Cash Flows FINANCIAL STATEMENTS Calliditas Therapeutics | Interim Report 2024: January March 24 Condensed Parent Company Statements of Income Three Months Ended March 31, Year Ended December 31, (SEK in thousands) 2024 2023 2023 Net sales 138,199 168,370 805,551 Cost of sales (13,976) (9,013) (60,399) Gross income (loss) 124,223 159,358 745,151 Research and development expenses (137,644) (118,789) (456,970) Marketing and selling expenses (109,670) (88,671) (402,436) Administrative expenses (84,160) (59,185) (273,359) Other operating income/(expenses), net 33,286 60,653 219,818 Operating loss (173,965) (46,635) (167,796) Net financial income/(expenses) 10,403 (18,333) (105,722) Loss before income tax (163,562) (64,968) (273,518) Income tax - - - Loss for the period (163,562) (64,968) (273,518) Three Months Ended March 31, Year Ended December 31, (SEK in thousands) 2024 2023 2023 Loss for the period (163,562) (64,968) (273,518) Other comprehensive income (loss) - - - Total comprehensive income (loss) (163,562) (64,968) (273,518) Condensed Parent Company Statements of Comprehensive Income FINANCIAL STATEMENTS Calliditas Therapeutics | Interim Report 2024: January March 25 Condensed Parent Company Balance Sheet March 31, December 31, (SEK in thousands) Notes 2024 2023 2023 ASSETS Non-current assets Intangible assets - 32,132 - Equipment 2,218 511 342 Non-current financial assets 1,168,909 977,553 1,125,186 Total non-current assets 1,171,127 1,010,195 1,125,528 Current assets Inventories 29,303 12,160 20,428 Current receivables 378,450 211,193 223,700 Prepaid expenses and accrued income 47,835 65,046 67,603 Cash 554,834 776,220 817,871 Total current assets 1,010,422 1,064,619 1,129,602 TOTAL ASSETS 2,181,549 2,074,814 2,255,130 SHAREHOLDERS' EQUITY AND LIABILITIES Shareholders' equity Total restricted equity 5,475 5,475 5,475 Total non-restricted equity 755,880 1,070,679 904,299 Total shareholders' equity 7,9 761,355 1,076,155 909,774 Non-current liabilities Provisions 9 21,286 18,769 25,924 Non-current interest-bearing liabilities 986,390 723,995 939,508 Other non-current liabilities 17,387 5,425 16,486 Total non-current liabilities 1,025,063 748,189 981,918 Current liabilities Accounts payable 52,248 53,835 62,562 Other current liabilities 165,949 93,023 113,685 Accrued expenses and deferred revenue 176,934 103,611 187,191 Total current liabilities 395,131 250,470 363,438 TOTAL SHAREHOLDERS' EQUITY AND LIABILITIES 2,181,549 2,074,814 2,255,130 FINANCIAL STATEMENTS Calliditas Therapeutics | Interim Report 2024: January March 26 Note 1 - Description of Business Calliditas Therapeutics AB (publ) ( Calliditas or the Parent Company ), with corporate registration number 556659-9766, and its subsidiaries (collectively, the Group ) conducts commercial and development activities in pharmaceuticals.
Any forward-looking statements contained in this Interim Report represent Calliditas' views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. This Interim Report has been prepared in a Swedish original and has been translated into English. In case of differences between the two, the Swedish version shall apply.
Calliditas cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Calliditas disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
The words may, will, could, would, should, expect, plan, anticipate, intend, believe, estimate, predict, project, potential, continue, target and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this Interim Report are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this Interim Report, including, without limitation, any related to Calliditas' business, operations, commercialization of TARPEYO, Kinpeygo and Nefecon, clinical trials, supply chain, strategy, goals and anticipated timelines for development and potential approvals, competition from other biopharmaceutical companies, revenue and product sales projections or forecasts, including 2024 total net sales guidance and cash runway and preliminary net sales for the second quarter of 2024 to date, and other risks identified in the section entitled Risk Factors in Calliditas' reports filed with the Securities and Exchange Commission.
The information in the report is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was sent for publication, through the agency of the contact persons set out above, on May 23, 2024, at 7:00 a.m. CET. Registered office Calliditas Therapeutics AB Kungsbron 1 SE 111 22 Stockholm, Sweden calliditas.com / ir@calliditas.com Forward looking statements This Interim Report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding Calliditas' strategy, business plans, revenue and other financial projections, and focus.
Via the telephone conference, there is an opportunity to ask oral questions. Calliditas R&D Day 2024 V stra Tr dg rdsgatan 19, Stockholm 30 May ANNUAL GENERAL MEETING 2024 Klarabergsviadukten 90, Stockholm 17 June INTERIM REPORT Q2 January June 2024 13 August INTERIM REPORT Q3 January September 2024 11 November Ren e Aguiar-Lucander / CEO +46 (0)8 411 30 05 renee.lucander@calliditas.com sa Hillsten / Head of IR & Sustainability +46 (0) 764 03 35 43 asa.hillsten@calliditas.com Supplemental Information This interim report has not been reviewed or audited by the Company's auditors.
The presentations will be given in English. - Time: Thursday 14:30 p.m. CET on 23 May, 2024 - Link to webcast https://ir.financialhearings.com/calliditas-therapeutics-q1-report-2024 - To participate via conference call register via this link: https://conference.financialhearings.com/teleconference/?id=50047214 After registration, you will receive a phone number and a conference ID to log in to the conference call.
Calliditas Therapeutics | Interim Report 2024: January March 18 Presentation to investors, analysts and press For further information please contact Upcoming events - Calliditas invites investors, analysts and press to a presentation of the Q1 Report 2024 at 14:30 p.m. CET on 23 May, 2024. The report was published on 23 May at 7:00 a.m. CET. - Calliditas' CEO Ren e Aguiar-Lucander will present the report together with CFO Fredrik Johansson, CMO Richard Philipson and President North America Maria T rns n.
The analysis showed statistically significant improvements in progres-sion-free survival (PFS), as well as in overall survival (OS), with statistically significant changes in tumor biology consistent with the mechanism of action of setanaxib. - On 14 May, Calliditas announced that its partner Everest Medicines launched Nefecon in China, which is estimated to have up to 5 million patients suffering from the progressive autoimmune disease. - Preliminary net sales from TARPEYO for the second quarter up until the date of this report amounts to USD 25.5 million.
Significant Events After the end of the Period - On 8 April, Calliditas announced that the Company received a Notice of Allowance from the United States Patent and Trade-mark Office (USPTO) for patent application no. 16/760,910 entitled Use of NOX Inhibitors for Treatment of Cancer . This Notice of Allowance is expected to result in the issuance of a U.S. patent once administrative processes are completed. - On 24 April, Calliditas announced that the global open-label extension (OLE) study to the Phase 3 NefIgArd study showed a treatment response consistent with the NefIgArd study across endpoints of urine protein to creatinine ration (UPCR) and estimated glomerular filtration rate (eGFR) at 9 months across all IgAN patients, including those who had previously received Nefecon in the NefIgArd study. - On 6 May, Calliditas announced topline data from the proof-of-concept Phase 2 trial evaluating setanaxib, its lead NOX enzyme inhibitor, in combination with pembrolizumab, in patients with squamous cell carcinoma of the head and neck (SCCHN).
Ms. T rns n is responsible for all US based operations and reports to the CEO. - On 13 February, Calliditas announced that the United States Patent and Trademark Office (USPTO) issued patent no. 11896719, entitled New Pharmaceutical Compositions , on 24 January, 2024 with validity 13 February, 2024. This is Calliditas' second patent for TARPEYO in the United States, and provides product protection until 13 February 2043. - On 6 March, Calliditas announced that the FDA granted an orphan drug exclusivity period of seven years for TARPEYO , expiring in December 2030, based on when the company obtained full approval with an expanded indication for this drug product.
The event is available online and also possible to attend live. To attend, live or online, please register at: https://financialhearings.com/event/49948/register/live_event Auditor's Review This interim report has not been subject to review by the company's auditors. Stockholm 23 May, 2024 Ren e Aguiar-Lucander CEO Calliditas Therapeutics | Interim Report 2024: January March 17 Significant Events FINANCIAL COMMENTS Significant Events During the Period 1 January 31 March, 2024 - On 7 January, Calliditas announced that Maria T rns n was appointed to the position of President North America.
As of 28 March, 2024, the closing price for the Calliditas Therapeutics share CALTX was SEK 113.4. The total number of shareholders as of 31 March, 2024 was approximately 18,000. Shareholder Structure Ten largest shareholders as of March, 2024 % BVF Partners LP 10,51 Linc AB 10,01 Stiftelsen Industrifonden 5,28 Polar Capital 3,94 Unionen 3,60 Avanza Pension 3,24 Handelsbanken Fonder 2,95 Fj rde AP-fonden 2,94 Sofinnova Partners 2,36 hman Fonder 2,23 Subtotal, 10 largest shareholders 47,06 Treasury shares 9,92 Other shareholders 43,02 Total 100.00 Calliditas R&D Day On 30 May Calliditas will hold an R&D Day at Inderes Event Studio, V stra Tr dg rdsgatan 19, Stockholm at 15.00 p.m CET.
All docu-mentation will be published on the company's website. Unchanged Outlook 2024 For 2024, Calliditas expects continued revenue growth: Total net sales from the Nefecon franchise, including milestones, are estimated to be USD 150-180 million for the year ending 31 December, 2024. The Share As of 31 March 2024, the number of shares amounted to 59,580,087 ordinary shares, of which, 5,908,018 are held as treasury shares by the Parent Company.
Nomination Committee AGM 2024 The nomination committee for the AGM 2024 consists of: Patrick Sobocki, appointed by Stiftelsen Industrifonden, Karl Tobieson, appointed by Linc AB and Spike Loy, appointed by BVF. Annual General Meeting 2024 The 2024 Annual General Meeting will be held 17 June at 14.00 p.m. CET, Klarabergsviadukten 90, Stockholm, Sweden.
Executive Management The Executive Management of Calliditas Therapeutics AB consists of: CEO Ren e Aguiar-Lucander, CFO Fredrik Johansson, CMO Richard Philipson, Group General Counsel Brian Gorman, President North America Maria T rns n, Vice President Regulatory Affairs Frank Bringstrup, Head of Technical Operations Lars Stubberud and Head of Human Resources Sandra Frithiof.
The decrease is primarily attributable to change in the price mix of product sales compared to previous year. Operating loss amounted to SEK 174.0 million and SEK 46.6 million for the three months ended March 31, 2024 and 2023, respectively. The decrease of SEK 127.4 million was primarily related to higher costs related to intensified marketing activities, increased regulatory requirements, and the larger organization.
No transfer (sale) of treasury shares have occurred as of March 31, 2024. See Note 7 and 8 for further information. Incentive Programs During the three months ended March 31, 2024, 555,000 options have been allocated for the ESOP 2023 Program. For more information on incentive programs, see Note 9. Parent Company Net sales for the Parent Company, Calliditas Therapeutics AB, amounted to SEK 138.2 million and SEK 168.4 million for the three months ended March 31, 2024 and 2023, respectively.
Treasury Shares As of March 31, 2024, Calliditas had 5,908,018 ordinary shares held as treasury shares by the Parent Company. At the Annual General Meeting 2023, authorization was given that Calliditas can transfer (sale) these ordinary shares with the purpose to finance an acquisition of operations, to procure capital to finance the development of projects, repayment of loans or to commer-cialize Calliditas' products.
Calliditas Therapeutics | Interim Report 2024: January March 16 FINANCIAL OVERVIEW Changes in Shareholders' Equity and Number of Shares Equity attributable to equity holders of the Parent Company amounted to SEK 120.2 million and SEK 589.4 million as of March 31, 2024 and 2023, respectively. The number of regis-tered shares amounted to 59,580,087 and 59,580,087 as of March 31, 2024 and 2023, respectively.
Net decrease in cash amounted to SEK 207.5 million and SEK 237.8 million for the three months periods ended March 31, 2024 and 2023, respectively. Cash amounted to SEK 810.3 million and SEK 1,013.6 million as of March 31, 2024 and 2023, respectively. Personnel The average number of employees were 219 and 170 for the three months ended March 31, 2024 and 2023, respectively.
The decrease is mainly attrib-utable to the change in current receivables. Cash flow used in investing activities amounted to SEK 3.9 million and SEK 2.9 million for the three months ended March 31, 2024 and 2023, respectively. The change was primarily explained by acquisition of equipment. Cash flow used in financing activities amounted to SEK 5.5 million and SEK 3.0 million for the three months ended March 31, 2024 and 2023, respectively.
Result for the period For the three months ended March 31, 2024 and 2023, loss for the period amounted to SEK 246.2 million and SEK 187.5 million, and the corresponding loss per share before and after dilution amounted to SEK 4.59 and SEK 3.49, respectively. Cash Flow and Cash Position Cash flow used in operating activities amounted to SEK 198.2 million and SEK 231.9 million for the three months ended March 31, 2024 and 2023, respectively.
Tax Total income tax (expense) amounted to SEK 1.2 million and SEK 20.5 million for the three months ended March 31, 2024 and 2023, respectively. The change in income tax was primarily explained by carried-forward losses recognized regarding U.S. subsidiaries in the first quarter of 2023. The Group's tax losses carried-forward have not been recognized as deferred tax assets, other than to the extent such tax losses can be used to offset temporary differences.
The improvement was primarily attributable to movements in exchange rates related to operating receivables and liabilities. Net Financial Income and Expenses Net financial income (expenses) amounted to (SEK 43.5 million) and (SEK 27.9 million) for the three months ended March 31, 2024 and 2023, respectively. The change in the net amount of (SEK 15.5 million) was primarily derived from interest expenses and currency effects primarily related to translation effects.
Administrative Expenses Administrative expenses amounted to SEK 102.0 million and SEK 72.5 million for the three months ended March 31, 2024 and 2023, respectively. The increase of SEK 29.5 million for the period was primarily related to increased costs from a larger organization and increased regulatory requirements. Other Operating Incomes/Expenses, net Other operating income (expenses), net amounted to SEK 7.5 million and SEK 4.0 million for the three months ended March 31, 2024 and 2023, respectively.
The increase of SEK 23.9 million for the period was primarily due to increased clinical activities for the Nox-platform, including the ongoing setanaxib trials. Marketing and Selling Expenses Marketing and selling expenses amounted to SEK 240.1 million and SEK 167.2 million for the three months ended March 31, 2024 and 2023, respectively. The increase of SEK 72.9 million was primarily related to intensified marketing activities of TARPEYO and increased US salesforce due to the TARPEYO full approval in the US.
Cost of Sales Cost of sales amounted to SEK 14.0 million and SEK 9.0 million for the three months ended March 31, 2024 and 2023, respectively. Total Operating Expenses Total operating expenses amounted to SEK 485.3 million and SEK 362.4 million for the three months ended March 31, 2024 and 2023, respectively. Research and Development Expenses Research and development expenses amounted to SEK 150.6 million and SEK 126.7 million for the three months ended March 31, 2024 and 2023, respectively.
Net sales primarily originated from net sales of TARPEYO in the US, which amounted to SEK 278.3 million and SEK 185.7 million for the three months ended March 31, 2024 and 2023, respectively. Royalty income from our partnerships amounted to SEK 13.0 million and SEK 4.4 million for the three months ended March 31, 2024 and 2023, respectively. For additional information see Note 4.
In addition, Calliditas will grad-ually add key performance indicators to increase progress in the sustainability work and the implementation of CSRD. 14 Environmental matters - Climate change mitigation and adaptation - Circular economy and waste Social matters - Employee health and safety - Access to products - Health and safety of end-users Governance matters - Anti-corruption and anti-bribery - Animal protection Calliditas' material sustainability areas The sustainability matters that are most important for Calliditas to work with, monitor and report on are gathered in seven main areas divided as follows: Calliditas Therapeutics | Interim Report 2024: January March 15 January March 2024 FINANCIAL OVERVIEW Revenue Net sales amounted to SEK 295.5 million and SEK 191.4 million for the three months ended March 31, 2024 and 2023, respectively.
The selection was made based on the metrics and targets included in a number of the ESRS on which Calliditas will report starting in fiscal year 2025. An overview: Environment - Share of all purchased electricity from renewable sources Social - Number of incidents linked to work-related injuries, ill health cases and fatalities - Number of days lost due to work-related ill health - Number of employees who left Calliditas/Employee turnover Governance - Percentage of employees trained in Calliditas' Code of Conduct - Percentage of business partners who have signed Calliditas' Code of Conduct Continued work to drive transition For Calliditas, the long-term work to develop policies, processes, targets, and activities continues.
To ensure that the right priorities are set in the long-term sustainability work, a roadmap was developed during the first quarter. It defines what Calliditas needs to work on in order to drive its sustainability work forward, together with how the work is to be done, the timeline, as well as who, alternatively which function, is responsible. SUSTAINABILITY Key figures for continuous follow-up With the ambition to increase the pace of sustainability work and data collection, several selected key performance indicators were developed during the first quarter to continuously monitor the progress of some of Calliditas' material sustainability matters.
During the first quarter, Calliditas continued the efforts to develop its sustainability work with a focus on the issues that, in accordance with the double materiality assessment, will guide the strategic sustainability work and reporting going forward. Based on current sustainability reporting, an analysis was made to get a clear picture of the information and data that is avail-able, and what needs to be added to comply with CSRD and its associated standards.
Calliditas Therapeutics | Interim Report 2024: January March 14 Continued focus on CSRD implementation Calliditas Therapeutics | Interim Report 2024: January March During the first quarter, Calliditas took further steps in the implementation of the upcoming legal requirement, CSRD, by establishing a roadmap for the project and preparing several key performance indicators to ensure progress in its sustainability work.
Our national account team, alongside our field based medical team, have been engaging with payors since the full approval was granted. This has included multiple scientific presentations on the new label, providing payors with a summary of the differences compared to the previous label, and answering their questions. With this information in hand, we are expecting the major payors to update their policies over the next six months, which should facilitate access to TARPEYO.
Our focus in Q1 has been on educating payors on the new label for TARPEYO. We have invested in our field-based team, both in terms of national account managers, whose focus is commercial and govern-ment payors, and our field reimbursement managers, who are focused on educating nephrology offices on the prior authorization process and facilitating patient access.
We know that many nephrologists use these guidelines as they make decisions on how to treat their patients with IgAN. We are anticipating that the updated guidelines will include TARPEYO, and that they may also expand the definition of the at risk population who should be treated. What can you share with regards to progress related to payor interactions on the new label in the first quarter of the year?
The data from our open label extension (OLE) study is also important in helping us better understand the potential benefit of providing a second 9-month treatment of TARPEYO. Another important milestone we are anticipating this year is the update of the KDIGO guidelines. These guidelines were last updated in 2021, prior to the full approval of TARPEYO.
What key events and milestones in the upcoming year do you think might drive TARPEYO sales and profile? The full approval in December 2023 was the most important milestone for Calliditas. This full approval provides access to a broader IgAN population. During the first half of 2024, our focus is on educating payors and healthcare providers on the new label, to ensure broader access to TARPEYO.
We can not underestimate the importance of this full approval, as it gives healthcare providers an opportunity to not only manage proteinuria, but also tell their patients it can help preserve their kidney function. It will also facilitate discussions with payors and improve patient access. This is a benefit for IgAN patients, as many are diagnosed before the age of 40 and will live with this disease for many decades.
This may allow us an opportunity to potentially help other patients in the future. What do you think the full approval and expanded label will mean for TARPEYO in the context of standard of care? For many years, the IgAN community has not had an approved therapy which has shown to reduce the loss of kidney function. Since the full approval of TARPEYO, they now have that.
I am excited about the opportunity to engage with healthcare providers, patient organizations and payors to educate on the new indication for TARPEYO and ensure appropriate patients can have access to our therapy. I am equally excited about our clinical programs and our NOX enzyme inhib-itors platform. Over the next twelve months, we will have multiple data read-outs in disease areas with high unmet need.
What excited you about the prospect of leading Calliditas' commercial efforts in the US? In December 2023, we gained full approval for TARPEYO for the treatment of IgAN. This was a pivotal moment for Calliditas, but most importantly for the IgAN community. This is the first time a product has proven to reduce the loss of kidney function in IgAN, which is something the community has been waiting for, for a long time.
Finally, I would also highlight the aspect of community support and how important that is for someone living with a rare disease. As rare diseases are not well known to most people, a person diagnosed with a rare disease may be challenged with finding accurate information and get the support they need. That's why the patient organizations play such a critical role for rare disease patients, and I am proud that Calliditas is working with multiple patient organizations supporting people living with IgAN and other kidney diseases.
Second, once a patient has received a diagnosis, there are in most cases no treatments available, or access is challenging. More than 95% of rare diseases have no treatments available today, so the healthcare provider may be limited to offering supportive care. At Calliditas, we can provide a treatment for one of the rare diseases, TARPEYO for IgA nephropathy (IgAN) and we also have an experienced access team who can help ensure eligible patients gain access to TARPEYO.
First, patients with rare diseases typically face a long journey to diag-nosis which sometimes includes a misdiagnosis and seeing multiple specialists. This is why understanding the patient journey is critical, to ensure we put in place the right type of education, to the right stakeholders, at the right time to shorten time to diagnosis and raise the urgency to treat.
What experiences from your previous positions do you think have been most valuable as you have taken over as President, North America at Calliditas? While all rare diseases are unique, I have through working on over fifteen different rare diseases learned that there are many similarities, which I have been able to bring from one organization to the next one.
Since 2011, I have almost exclusively spent my career in rare diseases at organizations such as Shire, Sanofi Genzyme and Sarepta in global, European and US roles. I have had the opportunity to work in diseases where there is no therapy available, in areas with several approved therapies and with programs at all stages of development and commercialization.
Looking back, I would say this was a bit of by luck, as I met represen-tatives from Eli Lilly Sweden at a career day at Lund University as I was finishing up my Master's degree. Little did I know that this initial meeting would bring me the career I have enjoyed over the last 22 years and the majority spent outside my home country of Sweden. From early days of sales and marketing with Eli Lilly and Merck Serono in Sweden, I emigrated in 2008 when I got the opportunity to move into a global role with Merck Serono in Switzerland.
Calliditas Therapeutics | Interim Report 2024: January March 13 INTERVIEW WITH MARIA T RNS N Calliditas President North America Maria T rns n You have joined Calliditas with over 20 years of experience in the pharmaceutical industry. Can you talk about your career and your experiences in the industry thus far? I started my career as a sales representative in the north of Sweden.
It is very encouraging to see statistical significance on important clinical outcomes in this relatively small study, which provides an excellent basis for advancing setanaxib in this hard-to-treat population. Kevin Harrington, Professor in Biological Cancer Therapies at The Institute of Cancer Research (ICR) London, Consultant Clinical Oncologist at The Royal Marsden NHS Foundation, London, and Investigator on the trial.
This Notice of Allowance is expected to result in the issuance of a U.S. patent once administrative processes are completed. The allowed claims cover a method of treating a solid tumor presenting resistance to PD-1 inhibitor immunotherapy by administering setanaxib in combination with a PD-1 inhibitor. The patent, when issued, will have an antici-pated expiration date in 2038.
There was also an improvement in disease-control rate in seta-naxib-treated patients, with 70% in the setanaxib arm showing a best response of at least stable disease compared to 52% in the placebo arm. Expanded patent protection In April 2024, Calliditas received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no. 16/760,910 entitled Use of NOX Inhibitors for Treatment of Cancer .
Patients treated with pembrolizumab and setanaxib showed statistically significant improvements in the key secondary endpoints of progression-free survival, (PFS median 5 months versus 2.9 months; Hazard ratio= 0.58) and overall survival (OS at 6 months 92% vs 68%; OS at 9 months 88% vs 58%; Hazard ratio=0.45) compared to patients treated with pembrolizumab and placebo.
The basis for the analysis consisted of 55 enrolled patients with recurrent or metastatic SCCHN and moderate or high CAF-density tumors. A tumor biopsy was taken prior to randomization and then again after at least 9 weeks of treatment. Pipeline: NOX Inhibitor platform Phase 2 data readout The treatment groups were well-balanced with no clinically relevant differences between the groups observed at baseline.
Setanaxib in squamous cell carcinoma of the head and neck In May 2024, Calliditas read out topline data from its proof-of-concept Phase 2 trial evaluating setanaxib in combination with pembrolizumab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). The trial is a randomized, placebo-controlled, double-blind Phase 2 study investigating the effect of setanaxib 800mg twice daily in conjunction with pembrolizumab 200mg IV, administered every 3 weeks, (a standard treatment regimen for SCCHN) with the full dataset reflecting all patients having had the opportunity to complete at least 15 weeks of treatment.
Transcriptomic analysis of tumor biopsy samples showed a statistically significant increase in CD8+ T-cells in tumor tissue from patients treated with setanaxib, indicating an increase in tumor immunological activity consistent with the mechanism of action of setanaxib. The tolerability of setanaxib when given with pembrolizumab was generally good, with no new safety signals identified.
Calliditas is conducting a randomized, placebo-controlled, double-blind Phase 2b trial in PBC patients with elevated liver stiffness We are expecting to read out data from approximately 75 patients in Q3 2024. Calliditas Therapeutics | Interim Report 2024: January March 12 BUSINESS OVERVIEW No significant difference in the primary endpoint of best percentage change from baseline in tumor size was observed.
Phase 2 data from a trial with setanaxib in 111 patients with PBC demonstrated that setanaxib had a more pronounced effect on fibrosis and ALP reduction (alkaline phosphatase, an established independent predictor of prognosis in PBC) in patients with an estimated liver fibrosis stage of F3 or higher. Patients with elevated liver stiffness are at greater risk of disease progression.
Calliditas received FDA Fast Track Designation for setanaxib in PBC in August 2021. Ursodeoxycholic acid, a generic drug also known as ursodiol or UDCA, and obeticholic acid, known as Ocaliva, are the only treat-ments for PBC approved by the FDA. However, despite these treatment options, there is still an unmet medical need among PBC patients, in particular when it comes to important quality of life outcomes.
Calliditas was granted orphan drug designation for the treatment of Alport syndrome with setanaxib by the FDA in September 2023, and by the EMA in November 2023. Primary biliary cholangitis PBC is a progressive and chronic autoimmune disease of the liver that causes immune injury to biliary epithelial cells, resulting in cholestasis and fibrosis. It is an orphan disease and, based on its known prevalence rates, we estimate that there are approxi-mately 140,000 patients in the United States, where the annual incidence ranges from 0.3 to 5.8 cases per 100,000.
Pipeline: NOX Inhibitor platform Based on supportive pre-clinical work, Calliditas launched a randomized, placebo-controlled Phase 2 study in Alport syndrome including around 20 patients. The study will eval-uate overall safety as well as impact on proteinuria. The study was initiated in November 2023 and on the basis of the data readout we will decide on a full regulatory program in Alport.
Eventually, patients present with proteinuria, hypertension, progressive loss of kidney function (gradual decline in GFR), and ESRD. It is estimated that approximately 67,000 people in the United States have this disorder, and it is a significant cause of chronic kidney disease (CKD), leading to ESRD in adolescents and young adults and accounting for 1.5% to 3.0% of children on renal replacement therapies in EU and the US.
Setanaxib, which is the first NOX inhibitor to reach the clinical stage, inhibits NOX1 and NOX4, enzymes that are implicated in fibrosis and inflammation pathways and that represent a high-potential therapeutic target. Alport syndrome Alport syndrome is a genetic disorder arising from the muta-tions in the genes that code for type IV collagen. The type IV collagen alpha chains are primarily located in the kidneys, eyes, and cochlea, and thus the condition is characterized by kidney disease, loss of hearing, and eye abnormalities.
The disruption of redox homeostasis has been implicated in multiple disease pathways, with oxidative stress caused by excess ROS being a likely underlying mechanism for many disorders, including cardiovascular diseases, neurodegenerative disorders, and cancer. As such, NOX enzyme inhibitors emerged as promising novel experimental drugs in a new therapeutic class.
NOX Enzyme Inhibitors NOX enzymes, also known as nicotinamide adenine dinucleotide phosphate (NADPH) oxidases, are the only known enzymes that are solely dedicated to producing reactive oxygen species (ROS). At appropriate concentrations, ROS help regulate cell proliferation, differentiation, and migration, as well as modulate the innate immune response, inflammation, and fibrosis.
Calliditas Therapeutics | Interim Report 2024: January March 11 BUSINESS OVERVIEW Calliditas' pipeline consists of development programs based on a first-in-class NOX inhib-itor platform. Calliditas is presently running clinical trials with lead compound setanaxib in squamous cell carcinoma of the head & neck (SCCHN), which read out positive topline data data in May 2024, as well as in primary biliary cholangitis (PBC) and Alport syndrome.
Continue US promotional efforts to drive TARPEYO s positioning as a disease modifying foundational therapy in IgAN. Drive scientific exchange and data dissemination at major scientific congress and programs (e.g. ERA, NKF,ASN). Leverage KDIGO guidelines expected in 2024. Educate and inform US payors on the full approval to ensure TARPEYO payor policies are reflecting new label.
The estimated negative impact on Q1 revenues of this unexpected disruption is ~$4.7m, which we anticipate will be recorded over the next several months. Importantly, this does not impact our revenue guidance for 2024. We are also highly encouraged by a strong start to Q2 in terms of TARPEYO net sales, which to the date of this report already amount to approximately $25.5m with an additional 5 weeks remaining in the quarter.
New Label Promotional Launch First and only product FDA-approved to reduce the loss of kidney function. Patient Educational Webinar with IgAN Foundation & TARPEYO Patient Ambassadors. 4 Presentations at WCN with analysis from NeflgArd Phase 3 trial and QoL data. QUARTERLY HIGHLIGHTS Q1 New Patients enrolled in Q1 27% QoQ growth New Prescribers in Q1 LTD Prescribers: 1,993 17% QoQ growth Net sales of TARPEYO in Q1 2024 KEY METRICS Q1 2024 705 354 $26.8M EXCITING JOURNEY AHEAD The Q1 revenue was impacted by two factors: the seasonal effect of the open enrollment period in the US, with insurance changes for many patients, and a cyber-attack on the IT network of our exclusive specialty pharmacy's insurance claims processor in the US, Change Healthcare.
In Q1 2024, TARPEYO set another quarterly record with 705 new patient enrollments, marking a substantial 27% quarter-over-quarter increase, following the 51% quarterly increase seen in Q4. The increase in new prescribers of 354 was also a quarterly record, which is another clear indicator of market acceptance and demand for TARPEYO. The positive momentum is expected to persist throughout 2024, supported by the new label and indica-tion, further reinforcing TARPEYO's positioning as the backbone treatment option in IgAN.
PMID: 34692885; PMCID: PMC8410133. Calliditas Therapeutics | Interim Report 2024: January March 10 Strong Demand for TARPEYO in Q1 BUSINESS OVERVIEW During the first quarter, the Calliditas US team focused on leveraging TARPEYO's full FDA approval and new label to inform and engage nephrology healthcare professionals, payors and patient communities regarding the latest clinical data.
Long-Term Outcomes in IgA Nephropathy. Clin J Am Soc Nephrol. 2023;18(6):727-738. doi:10.2215/CJN.000000000000013 Kwon CS, Daniele P, Forsythe A, Ngai C. A Systematic Literature Review of the Epidemiology, Health-Related Quality of Life Impact, and Economic Burden of Immunoglobulin A Nephropathy. J Health Econ Outcomes Res. 2021 Sep 1;8(2):36-45. doi: 10.36469/001c.26129.
TARPEYO is the only fully FDA-approved treatment for IgAN and the only treatment approved based on protection of kidney function. - A genetic predisposition is required but not sufficient; most patients are diagnosed in their 20s and 30s - More than 50% are at risk of developing ESRD within 10-20 years, leading to kidney transplant - The treatment goal is to preserve eGFR kidney function - Recently published longitudinal data imply that disease progression is faster and outlook worse than previously thought1 IgAN Patients: 1 Pitcher D, Braddon F, Hendry B, et al.
(Nasdaq: VTRS). Viatris is a global healthcare company which is headquartered in the United States and has a presence in over 165 countries. 1Veeva OpenData for 2023, including all active HCPs where the primary specialty is Nephrology 2Spherix RealWorld Dynamix Calliditas Therapeutics | Interim Report 2024: January March 9 TARPEYO: Moving from supportive care to treating IgAN BUSINESS OVERVIEW Targeted B cell immunomodulator designed to local-ly target origin of disease In combination with optimized RASi ther-apy; option of inter-mittent, rather than chronic treatment Durable eGFR benefit and sustained pro-teinuria disease-mod-ifying effects in IgAN Well characterized active ingredient and safety profile Mechanism of action Patient focus Efficacy Safety TARPEYO and Kinpeygo were the first-ever medications approved for IgAN by the FDA and European Commission, respectively, and the only treatments specifically designed to target the origin of IgAN and to be disease-modifying.