Grundlæggende statistik
LEI | 549300PVPZO8TNT76B58 |
CIK | 1795579 |
SEC Filings
SEC Filings (Chronological Order)
September 23, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13D (Amendment No. 4)* UNDER THE SECURITIES EXCHANGE ACT OF 1934 CALLIDITAS THERAPEUTICS AB (Name of Issuer) Common Shares, quota value SEK 0.04 per Share and American Depositary Shares, each representing two Common Shares, quota value SEK 0.04 per Share (Title of Class of Securities) 13124Q1061 (CUSIP Number) Shinich |
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September 23, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 15F CERTIFICATION OF A FOREIGN PRIVATE ISSUER’S TERMINATION OF REGISTRATION OF A CLASS OF SECURITIES UNDER SECTION 12(g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ITS TERMINATION OF THE DUTY TO FILE REPORTS UNDER SECTION 13(a) OR SECTION 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-39308 CALLID |
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September 18, 2024 |
Exhibit (a)(5)(T) THIS PRESS RELEASE DOES NOT CONSTITUTE AN OFFER TO BUY OR THE SOLICITATION OF AN OFFER TO SELL ANY SHARES OR AMERICAN DEPOSITARY SHARES, WHETHER DIRECTLY OR INDIRECTLY, IN AUSTRALIA, CANADA, HONG KONG, JAPAN, NEW ZEALAND OR SOUTH AFRICA OR IN ANY OTHER JURISDICTION IN WHICH, OR TO ANY PERSON TO OR FROM WHOM, SUCH OFFER OR SOLICITATION PURSUANT TO LEGISLATION AND REGULATIONS IN SUCH RELEVANT JURISDICTION WOULD BE PROHIBITED. |
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September 18, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14D-9 SOLICITATION/RECOMMENDATION STATEMENT UNDER SECTION 14(d)(4) OF THE SECURITIES EXCHANGE ACT OF 1934 (Amendment No. 3) Calliditas Therapeutics AB (publ) (Name of Subject Company) Calliditas Therapeutics AB (publ) (Name of Person Filing Statement) American Depositary Shares, each representing two Common Shares, qu |
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September 18, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(l) or 13(e)(l) of the Securities Exchange Act of 1934 (Amendment No. 4) CALLIDITAS THERAPEUTICS AB (Name of Subject Company (Issuer)) ASAHI KASEI CORPORATION (Offeror) Common Shares (“Shares”), quota value SEK 0.04 per Share American Depositary Shares (“ADSs”), each repres |
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September 17, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13D (Amendment No. 3)* UNDER THE SECURITIES EXCHANGE ACT OF 1934 CALLIDITAS THERAPEUTICS AB (Name of Issuer) Common Shares, quota value SEK 0.04 per Share and American Depositary Shares, each representing two Common Shares, quota value SEK 0.04 per Share (Title of Class of Securities) 13124Q1061 (CUSIP Number) Shinich |
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September 16, 2024 | ||
September 16, 2024 | ||
September 13, 2024 |
As filed with the Securities and Exchange Commission on September 13, 2024 As filed with the Securities and Exchange Commission on September 13, 2024 Registration No. |
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September 13, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 25 NOTIFICATION OF REMOVAL FROM LISTING AND/OR REGISTRATION UNDER SECTION 12(b) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-39308 CALLIDITAS THERAPEUTICS AB The Nasdaq Global Select Market (Exact name of Issuer as specified in its charter, and name of Exchange where security is listed and/or register |
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September 13, 2024 |
As filed with the Securities and Exchange Commission on September 13, 2024 As filed with the Securities and Exchange Commission on September 13, 2024 Registration No. |
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September 13, 2024 |
As filed with the Securities and Exchange Commission on September 13, 2024 As filed with the Securities and Exchange Commission on September 13, 2024 Registration No. |
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September 11, 2024 |
SC 13G/A 1 sc13ga307422calt09112024.htm AMENDMENT NO. 3 TO SCHEDULE 13G UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G (Rule 13d-102) INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO RULES 13d-1(b), (c), AND (d) AND AMENDMENTS THERETO FILED PURSUANT TO RULE 13d-2(b) (Amendment No. 3)1 Calliditas Therapeutics AB (Name of Issuer) Common Shares, quota v |
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September 9, 2024 |
SC 13D/A 1 ea0214027-13da2asahicall.htm AMENDMENT NO. 2 TO SCHEDULE 13D UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13D (Amendment No. 2)* UNDER THE SECURITIES EXCHANGE ACT OF 1934 CALLIDITAS THERAPEUTICS AB (Name of Issuer) Common Shares, quota value SEK 0.04 per Share and American Depositary Shares, each representing two Common Shares, quota value SEK 0.04 pe |
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September 3, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(l) or 13(e)(l) of the Securities Exchange Act of 1934 (Amendment No. 3) CALLIDITAS THERAPETUICS ab (Name of Subject Company (Issuer)) ASAHI KASEI CORPORATION (Offeror) Common Shares (“Shares”), quota value SEK 0.04 per Share American Depositary Shares (“ADSs”), each repres |
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September 3, 2024 |
Exhibit (a)(5)(S) Asahi Kasei Corporation September 3, 2024 Security code: 3407 Notice Regarding Results of Tender Offer for Shares of Calliditas Therapeutics AB and Transfer of Subsidiary Asahi Kasei Corporation (Head office: Chiyoda-ku, Tokyo; President: Koshiro Kudo; hereinafter “Asahi Kasei”) will complete its tender offer (Tender Offer) for shares of Swedish pharmaceutical company Calliditas Therapeutics AB (Head office: Stockholm, Sweden; CEO: Renée Aguiar-Lucander; hereinafter “Calliditas”), offering SEK 208 per ordinary share and SEK 416 per American Depositary Share that was announced on May 28, 2024, and declared unconditional on September 2, 2024 (CEST), as described below. |
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September 3, 2024 |
Exhibit (a)(5)(R) THIS PRESS RELEASE DOES NOT CONSTITUTE AN OFFER TO BUY OR THE SOLICITATION OF AN OFFER TO SELL ANY SHARES OR AMERICAN DEPOSITARY SHARES, WHETHER DIRECTLY OR INDIRECTLY, IN AUSTRALIA, CANADA, HONG KONG, JAPAN, NEW ZEALAND OR SOUTH AFRICA OR IN ANY OTHER JURISDICTION IN WHICH, OR TO ANY PERSON TO OR FROM WHOM, SUCH OFFER OR SOLICITATION PURSUANT TO LEGISLATION AND REGULATIONS IN SUCH RELEVANT JURISDICTION WOULD BE PROHIBITED. |
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September 3, 2024 |
Calliditas Therapeutics Takes Certain Corporate Actions Following Announcement by Asahi Kasei Exhibit 99.1 Calliditas Therapeutics Takes Certain Corporate Actions Following Announcement by Asahi Kasei Stockholm, Sweden, September 3, 2024 – Following the announcement by Asahi Kasei Corporation (“Asahi Kasei”) on September 2, 2024 that it controls more than 90 percent of the outstanding shares of Calliditas Therapeutics AB (Nasdaq: CALT) (“Calliditas” or the “Company”), and declared its offe |
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September 3, 2024 |
Exhibit 99.2 Stockholm 3 September 2024 Notice of extraordinary meeting of Calliditas Therapeutics AB (publ) The shareholders of Calliditas Therapeutics AB (publ) (“Calliditas Therapeutics”), Reg. No. 556659-9766, with registered office in Stockholm, are summoned to the extraordinary general meeting on Monday 30 September 2024 at 12:00 p.m. CEST at Advokatfirman Vinge’s premises on Smålandsgatan 2 |
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September 3, 2024 |
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: September 3, 2024 (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 e |
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September 3, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14D-9 SOLICITATION/RECOMMENDATION STATEMENT UNDER SECTION 14(d)(4) OF THE SECURITIES EXCHANGE ACT OF 1934 (Amendment No. 2) Calliditas Therapeutics AB (publ) (Name of Subject Company) Calliditas Therapeutics AB (publ) (Name of Person Filing Statement) American Depositary Shares, each representing two Common Shares, qu |
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September 3, 2024 |
SC 13D/A 1 ea0213317-13da1asahicall.htm AMENDMENT NO. 1 TO SCHEDULE 13D UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13D (Amendment No. 1)* UNDER THE SECURITIES EXCHANGE ACT OF 1934 CALLIDITAS THERAPEUTICS AB (Name of Issuer) Common Shares, quota value SEK 0.04 per Share and American Depositary Shares, each representing two Common Shares, quota value SEK 0.04 pe |
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August 13, 2024 |
Exhibit 99.2 Stockholm, Sweden August 13, 2024 Calliditas Interim Report January to June 2024 Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX): April to June 2024 (compared to April to June 2023) ● Net sales amounted to SEK 559.8 million, of which TARPEYO® net sales amounted to SEK 493.4 million, for the three months ended June 30, 2024. For the three months ended June 30, 2023, |
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August 13, 2024 |
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: August 13, 2024 (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 exe |
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August 13, 2024 |
Exhibit 99.1 Interim Report January – June 2024 APRIL – JUNE 2024 (COMPARED TO APRIL – JUNE 2023) ● Net sales amounted to SEK 559.8 million, of which TARPEYO® net sales amounted to SEK 493.4 million, for the three months ended June 30, 2024. For the three months ended June 30, 2023 net sales amounted to SEK 269.4 million, of which TARPEYO net sales amounted to SEK 259.2 million. ● Operating loss a |
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August 13, 2024 |
Exhibit (a)(5)(Q) THIS PRESS RELEASE DOES NOT CONSTITUTE AN OFFER TO BUY OR THE SOLICITATION OF AN OFFER TO SELL ANY SHARES OR AMERICAN DEPOSITARY SHARES, WHETHER DIRECTLY OR INDIRECTLY, IN AUSTRALIA, CANADA, HONG KONG, JAPAN, NEW ZEALAND OR SOUTH AFRICA OR IN ANY OTHER JURISDICTION IN WHICH, OR TO ANY PERSON TO OR FROM WHOM, SUCH OFFER OR SOLICITATION PURSUANT TO LEGISLATION AND REGULATIONS IN SUCH RELEVANT JURISDICTION WOULD BE PROHIBITED. |
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August 13, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(l) or 13(e)(l) of the Securities Exchange Act of 1934 (Amendment No. 2) CALLIDITAS THERAPETUICS ab (Name of Subject Company (Issuer)) ASAHI KASEI CORPORATION (Offeror) Common Shares (“Shares”), quota value SEK 0.04 per Share American Depositary Shares (“ADSs”), each repres |
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August 2, 2024 |
DLA Piper LLP (US) 500 Eighth Street, NW Washington, DC 20004 www.dlapiper.com August 2, 2024 United States Securities and Exchange Commission Division of Corporation Finance Office of Mergers & Acquisitions 100 F Street, N.E. Washington, D.C. 20549 Attention: Blake Grady Re: Calliditas Therapeutics AB Schedule 14D-9 Filed July 22, 2024 File No. 005-91523 Ladies and Gentlemen: On behalf of our cli |
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August 2, 2024 |
SC 14D9/A 1 tm2420619d1sc14d9a.htm SC 14D9/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14D-9 SOLICITATION/RECOMMENDATION STATEMENT UNDER SECTION 14(d)(4) OF THE SECURITIES EXCHANGE ACT OF 1934 (Amendment No. 1) Calliditas Therapeutics AB (publ) (Name of Subject Company) Calliditas Therapeutics AB (publ) (Name of Person Filing Statement) American Depositary Sh |
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August 1, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(l) or 13(e)(l) of the Securities Exchange Act of 1934 (Amendment No. 1) CALLIDITAS THERAPeUTICS ab (Name of Subject Company (Issuer)) ASAHI KASEI CORPORATION (Offeror) Common Shares (“Shares”), quota value SEK 0.04 per Share American Depositary Shares (“ADSs”), each repres |
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July 31, 2024 |
6-K 1 tm2420563d16k.htm FORM 6-K 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: July 31, 2024 (Commission File No. 001-39308) CALLIDITAS THERAPEUTICS AB (Translation of registrant’s name into English) Kungsbron 1, D5 SE-111 22 Stockholm, Sweden (Addres |
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July 31, 2024 |
Number of shares and votes in Calliditas Therapeutics Exhibit 99.1 Stockholm, Sweden July 31, 2024 Number of shares and votes in Calliditas Therapeutics During July, the number of shares and votes in Calliditas Therapeutics AB (publ) has changed due to the exercise of warrants under the company’s long-term incentive program issued in 2020, ESOP 2020 and Board of Directors program LTIP 2021. As of today, the total number of outstanding shares in Calli |
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July 26, 2024 |
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: July 26, 2024 (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 execu |
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July 26, 2024 |
Exhibit 99.2 Stockholm, Sweden July 26, 2024 Calliditas partner STADA receives European Commission decision for full approval of Kinpeygo® for the treatment of IgA Nephropathy Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that the European Commission has granted a full marketing authorization for Kinpeygo for the treatment of adults with primary |
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July 26, 2024 |
Calliditas announces positive TRANSFORM Phase 2b topline data in primary biliary cholangitis Exhibit 99.1 Stockholm, Sweden July 26, 2024 Calliditas announces positive TRANSFORM Phase 2b topline data in primary biliary cholangitis Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that the Phase 2b TRANSFORM trial met its primary endpoint, showing statistically significant improvement in ALP (Alkaline Phosphatase) for both doses tested versus |
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July 22, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14D-9 SOLICITATION/RECOMMENDATION STATEMENT UNDER SECTION 14(d)(4) OF THE SECURITIES EXCHANGE ACT OF 1934 Calliditas Therapeutics AB (publ) (Name of Subject Company) Calliditas Therapeutics AB (publ) (Name of Person Filing Statement) American Depositary Shares, each representing two Common Shares, quota value SEK 0.04 |
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July 18, 2024 |
Exhibit (a)(1)(F) This announcement is neither an offer to purchase nor a solicitation of an offer to sell Offer Securities (as defined below), and the provisions herein are subject in their entirety to the provisions of the U. |
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July 18, 2024 |
Exhibit (a)(1)(C) Application form regarding the public offer from Asahi Kasei to shareholders in Calliditas Therapeutics AB (publ) Acceptance period: 18 July—30 August 2024 The notification must be received by SEB Issues (“SEB”) no later than on 30 August 2024. |
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July 18, 2024 |
EXECUTION VERSION—April 11, 2024 CONFIDENTIAL DISCLOSURE AGREEMENT Exhibit (d)(1) EXECUTION VERSION—April 11, 2024 CONFIDENTIAL DISCLOSURE AGREEMENT This mutual CONFIDENTIAL DISCLOSURE AGREEMENT (“CDA’’) is entered into as of April 11, 2024 (the “Effective Date”), between: CALLIDITAS THERAPEUTICS, AB, a Swedish corporation with its registered office and mailing address at PO Box 70351, SE-107 24 Stockholm, Sweden and its principal office and address for courier delivery at Kungsbron 1, D5, SE 11122 Stockholm, Sweden (“CALLIDITAS”), and VELOXIS PHARMACEUTICALS, INC. |
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July 18, 2024 |
CALCULATION OF FILING FEE TABLE Table 1—Transaction Valuation Exhibit 107 CALCULATION OF FILING FEE TABLE Table 1—Transaction Valuation Transaction Valuation* Fee Rate Amount of Filing Fee** Fees To Be Paid 1,060,428,020 0. |
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July 18, 2024 |
Exhibit (a)(5)(P) THIS PRESS RELEASE DOES NOT CONSTITUTE AN OFFER TO BUY OR THE SOLICITATION OF AN OFFER TO SELL ANY SHARES OR AMERICAN DEPOSITARY SHARES, WHETHER DIRECTLY OR INDIRECTLY, IN AUSTRALIA, CANADA, HONG KONG, JAPAN, NEW ZEALAND OR SOUTH AFRICA OR IN ANY OTHER JURISDICTION IN WHICH, OR TO ANY PERSON TO OR FROM WHOM, SUCH OFFER OR SOLICITATION PURSUANT TO LEGISLATION AND REGULATIONS IN SUCH RELEVANT JURISDICTION WOULD BE PROHIBITED. |
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July 18, 2024 |
Asahi Kasei Commences Tender Offer for Shares of Calliditas Therapeutics AB Exhibit (a)(5)(O) Asahi Kasei Corp. July 18, 2024 Asahi Kasei Commences Tender Offer for Shares of Calliditas Therapeutics AB As published in a previous press release, “Asahi Kasei to Acquire Calliditas Therapeutics AB,” issued on May 28, 2024, Asahi Kasei Corp. (Head office: Chiyoda-ku, Tokyo; President: Koshiro Kudo) announces that on July 18, 2024 (CEST) it commenced a tender offer (Tender Offe |
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July 18, 2024 |
Exhibit (a)(1)(A) U.S. OFFER TO PURCHASE FOR CASH All Outstanding Common Shares and All Outstanding American Depositary Shares, each representing two Common Shares, of Calliditas Therapeutics AB at SEK 208 per Common Share or SEK 416 per ADS by Asahi Kasei Corporation THE U.S. OFFER AND WITHDRAWAL RIGHTS WILL EXPIRE AT 6:00 P.M., EASTERN TIME, ON AUGUST 30, 2024, UNLESS THE U.S. OFFER IS EXTENDED |
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July 18, 2024 |
Exhibit (a)(1)(D) U.S. OFFER TO PURCHASE FOR CASH All Outstanding Common Shares and All Outstanding American Depositary Shares, each representing two Common Shares, of Calliditas Therapeutics AB at SEK 208 per Common Share or SEK 416 per ADS by Asahi Kasei Corporation THE U.S. OFFER AND WITHDRAWAL RIGHTS WILL EXPIRE AT 6:00 P.M., EASTERN TIME, ON AUGUST 30, 2024 (THE “EXPIRATION TIME”), UNLESS THE |
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July 18, 2024 |
Exhibit (a)(1)(B) THIS DOCUMENT IS IMPORTANT AND REQUIRES YOUR IMMEDIATE ATTENTION. |
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July 18, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(1) or 13(e)(1) of the Securities Exchange Act of 1934 CALLIDITAS THERAPeUTICS ab (Name of Subject Company (Issuer)) ASAHI KASEI CORPORATION (Offeror) Common Shares (“Shares”), quota value SEK 0.04 per Share American Depositary Shares (“ADSs”), each representing two Common |
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July 18, 2024 |
Exhibit (a)(1)(E) U.S. OFFER TO PURCHASE FOR CASH All Outstanding Common Shares and All Outstanding American Depositary Shares, each representing two Common Shares, of Calliditas Therapeutics AB at SEK 208 per Common Share or SEK 416 per ADS by Asahi Kasei Corporation THE U.S. OFFER AND WITHDRAWAL RIGHTS WILL EXPIRE AT 6:00 P.M., EASTERN TIME, ON AUGUST 30, 2024 (THE “EXPIRATION TIME”), UNLESS THE |
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June 17, 2024 |
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 17, 2024 (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 execu |
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June 17, 2024 |
Bulletin from the annual general meeting of Calliditas Therapeutics AB (publ) Exhibit 99.1 Stockholm, Sweden 17 June 2024 Bulletin from the annual general meeting of Calliditas Therapeutics AB (publ) The following resolutions were passed at Calliditas Therapeutics AB (publ) (“Calliditas”) annual general meeting held today, on 17 June 2024, in Stockholm. Adoption of income statement and balance sheet for the financial year 2023 and discharge from liability The annual general |
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June 4, 2024 |
* * * [Signature pages follow] Exhibit 2 Strictly confidential Irrevocable undertaking This irrevocable undertaking (the “Undertaking”) is dated 25 May 2024 and made between: (A) Asahi Kasei Corporation (the “Bidder”); and (B) Biotechnology Value Fund, L. |
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June 4, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13D (Amendment No. )* UNDER THE SECURITIES EXCHANGE ACT OF 1934 CALLIDITAS THERAPEUTICS AB (Name of Issuer) Common Shares, quota value SEK 0.04 per Share and American Depositary Shares, each representing two Common Shares, quota value SEK 0.04 per Share (Title of Class of Securities) 13124Q1061 (CUSIP Number) Shinichi |
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June 4, 2024 |
EX-99.1 2 ea020720501ex99-1asahi.htm POWER OF ATTORNEY, DATED MAY 28, 2024 Exhibit 1 POWER OF ATTORNEY The person whose signature appears below, being an authorized representative of the entity beside his name, hereby makes, constitutes and appoints Shinichiro Haga as the true and lawful attorney-in-fact for the entity beside his name, for the purpose of, from time to time, executing in the respec |
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June 4, 2024 |
* * * [Signature pages follow] Exhibit 9 Strictly confidential Irrevocable undertaking This irrevocable undertaking (the “Undertaking”) is dated 25 May 2024 and made between: (A) Asahi Kasei Corporation (the “Bidder”); and (B) Handelsbanken Hälsovård Tema managed by Handelsbanken Fonder AB (registration number 556418-8851) (the “Shareholder”). |
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June 4, 2024 |
* * * [Signature pages follow] Exhibit 4 Strictly confidential Irrevocable undertaking This irrevocable undertaking (the “Undertaking”) is dated 27 May 2024 and made between: (A) Asahi Kasei Corporation (the “Bidder”); and (B) Stiftelsen Industrifonden, foundation registration number 802009-0083 (the “Shareholder”). |
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June 4, 2024 |
* * * [Signature pages follow] Exhibit 8 Strictly confidential Irrevocable undertaking This irrevocable undertaking (the “Undertaking”) is dated 27 May 2024 and made between: (A) Asahi Kasei Corporation (the “Bidder”); and (B) Unionen, 802001-5759 (the “Shareholder”). |
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June 4, 2024 |
* * * [Signature pages follow] Exhibit 6 Strictly confidential Irrevocable undertaking This irrevocable undertaking (the “Undertaking”) is dated 27 May 2024 and made between: (A) Asahi Kasei Corporation (the “Bidder”); and (B) Sofinnova Crossover I SLP, registered with the Paris trade and companies register under number 838 046 035 (the “Shareholder”). |
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June 4, 2024 |
* * * [Signature pages follow] Exhibit 5 Strictly confidential Irrevocable undertaking This irrevocable undertaking (the “Undertaking”) is dated 26 May 2024 and made between: (A) Asahi Kasei Corporation (the “Bidder”); and (B) Polar Capital Funds Plc – Biotechnology Fund (the “Shareholder”). |
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June 4, 2024 |
* * * [Signature pages follow] Exhibit 3 Strictly confidential Irrevocable undertaking This irrevocable undertaking (the “Undertaking”) is dated 25 May 2024 and made between: (A) Asahi Kasei Corporation (the “Bidder”); and (B) Linc AB (publ), company registration number 556232-0811 (the “Shareholder”). |
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June 4, 2024 |
* * * [Signature pages follow] Exhibit 10 Strictly confidential Irrevocable undertaking This irrevocable undertaking (the “Undertaking”) is dated 28 May 2024 and made between: (A) Asahi Kasei Corporation (the “Bidder”); and (B) Mikael Bender, 19560201-0158 (the “Shareholder”). |
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June 4, 2024 |
* * * [Signature pages follow] Exhibit 7 Strictly confidential Irrevocable undertaking This irrevocable undertaking (the “Undertaking”) is dated 28 May 2024 and made between: (A) Asahi Kasei Corporation (the “Bidder”); and (B) Fjärde AP-fonden (the “Shareholder”). |
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May 30, 2024 |
Exhibit 99.2 Accelerating Growth as a Global Healthcare Company Acquisition of Calliditas Therapeutics AB Transcript, Asahi Kasei — Analyst Conference 28th May 2024 6:30 — 7:30pm Tomoo Otsubo — Investor Relation Officer Thank you very much for coming to this business briefing regarding acquisition of Calliditas Therapeutics AB hosted by Asahi Kasei. I am Otsubo from IR office. I’ll be serving as a |
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May 30, 2024 |
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: May 30, 2024 (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 execut |
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May 30, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(1) or 13(e)(1) of the Securities Exchange Act of 1934 (Amendment No. )* CALLIDITAS THERAPeUTICS ab (Name of Subject Company (Issuer)) ASAHI KASEI CORPORATION (Names of Filing Persons (Offeror)) Common Shares, quota value SEK 0.04 per Share and American Depositary Shares (“ |
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May 30, 2024 |
Exhibit 99.1 |
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May 30, 2024 |
Exhibit 99.1 Stockholm, Sweden May 30, 2024 Calliditas partner STADA receives positive CHMP opinion recommending full approval for Kinpeygo® for the treatment of IgA nephropathy Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opi |
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May 28, 2024 |
Exhibit 99.2 Asahi Kasei Corp. May 28, 2024 Security code: 3407 Asahi Kasei to Acquire Calliditas Therapeutics AB to Accelerate Growth as a Global Healthcare Company Asahi Kasei Corp. (Head office: Chiyoda-ku, Tokyo; President: Koshiro Kudo; hereinafter “Asahi Kasei”) today announces that Asahi Kasei will offer the shareholders of Calliditas Therapeutics AB (Head office: Stockholm, Sweden.; CEO: R |
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May 28, 2024 |
Email to all staff of Calliditas sent at 8:35 AM CEST on May 28, 2024 Exhibit 99.2 Email to all staff of Calliditas sent at 8:35 AM CEST on May 28, 2024 Dear Colleagues, I am writing to inform you that this morning Asahi Kasei, a leading Japanese pharmaceutical company and conglomerate, has announced a cash offer to acquire Calliditas Therapeutics AB, and that the Board has unanimously recommended that shareholders accept this offer. This offer represents a premium |
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May 28, 2024 |
Stockholm on May 28, 2024 Calliditas Therapeutics AB (publ) The Board of Directors Exhibit 99.1 Stockholm, Sweden May 28, 2024 Statement by the Board of Directors of Calliditas Therapeutics AB (publ) in relation to the public offer by Asahi Kasei Corporation The Board of Directors of Calliditas Therapeutics AB (publ) unanimously recommends that the shareholders and holders of American Depositary Shares (“ADS”) of Calliditas Therapeutics AB (publ) (jointly the “Securityholders”) |
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May 28, 2024 |
Exhibit 99.1 THIS PRESS RELEASE DOES NOT CONSTITUTE AN OFFER TO BUY OR THE SOLICITATION OF AN OFFER TO SELL ANY SHARES OR AMERICAN DEPOSITARY SHARES, WHETHER DIRECTLY OR INDIRECTLY, IN THE UNITED STATES, AUSTRALIA, CANADA, HONG KONG, JAPAN, NEW ZEALAND OR SOUTH AFRICA OR IN ANY OTHER JURISDICTION IN WHICH, OR TO ANY PERSON TO OR FROM WHOM, SUCH OFFER OR SOLICITATION PURSUANT TO LEGISLATION AND REG |
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May 28, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14D-9 (Rule 14d-101) SOLICITATION/RECOMMENDATION STATEMENT UNDER SECTION 14(d)(4) OF THE SECURITIES EXCHANGE ACT OF 1934 Calliditas Therapeutics AB (publ) (Name of Subject Company) Calliditas Therapeutics AB (publ) (Name of Person Filing Statement) American Depositary Shares, each representing two Common Shares, quota |
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May 28, 2024 |
Stockholm on May 28, 2024 Calliditas Therapeutics AB (publ) The Board of Directors Exhibit 99.1 Stockholm, Sweden May 28, 2024 Statement by the Board of Directors of Calliditas Therapeutics AB (publ) in relation to the public offer by Asahi Kasei Corporation The Board of Directors of Calliditas Therapeutics AB (publ) unanimously recommends that the shareholders and holders of American Depositary Shares (“ADS”) of Calliditas Therapeutics AB (publ) (jointly the “Securityholders”) |
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May 28, 2024 |
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: May 28, 2024 (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 execut |
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May 28, 2024 |
Email to partners and suppliers sent at 1:00 PM CEST on May 28, 2024 Exhibit 99.3 Email to partners and suppliers sent at 1:00 PM CEST on May 28, 2024 Dear Partners and Collaborators, I am writing to inform you that this morning Asahi Kasei, a leading Japanese pharmaceutical company and conglomerate, has announced a cash offer to acquire Calliditas Therapeutics AB, and that the Board has unanimously recommended that shareholders accept this offer. This offer repres |
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May 28, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(1) or 13(e)(1) of the Securities Exchange Act of 1934 (Amendment No. )* CALLIDITAS THERAPeUTICS ab (Name of Subject Company (Issuer)) ASAHI KASEI CORPORATION (Names of Filing Persons (Offeror)) Common Shares, quota value SEK 0.04 per Share and American Depositary Shares (“ |
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May 28, 2024 |
Asahi Kasei’s recommended offer for Calliditas 28 May 2024 Exhibit 99.4 Asahi Kasei’s recommended offer for Calliditas 28 May 2024 2 About Asahi Kasei’s recommended offer Asahi Kasei has offered SEK [ ● ] in cash for each share and SEK [ ● ] in cash for each ADS – The Offer values the company on a fully diluted basis at SEK [ ● ] – The Offer represents a premium of [ ● ] per cent compared to the closing price of the shares on 27 May 2024 of SEK [ ● ]* The |
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May 23, 2024 |
Calliditas Q1 report, January – March 2024 Exhibit 99.2 Stockholm, Sweden May 23, 2024 Calliditas Q1 report, January – March 2024 Calliditas Therapeutics AB (Nasdaq Stockholm: CALTX): Target market expansion following full approval in the US JANUARY – MARCH 2024 (COMPARED TO JANUARY – MARCH 2023) · Net sales amounted to SEK 295.5 million, of which TARPEYO® net sales amounted to SEK 278.3 million, for the three months ended March 31, 2024. |
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May 23, 2024 |
Exhibit 99.1 INTERIM REPORT JANUARY – MARCH 2024 Q1 Calliditas Therapeutics | Interim Report 2024: January – March 2 278 50% 810 Key takeaways from Q1, 2024 Outlook 2024: Unchanged JANUARY – MARCH 2024 (COMPARED TO JANUARY – MARCH 2023) “In Q1 we generated another record JAN – MAR 2024 quarter in terms of demand with 705 enrollments and 354 new prescribers. We are very excited over this positive t |
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May 23, 2024 |
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: May 23, 2024 (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 execut |
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May 16, 2024 |
Exhibit 99.1 Stockholm 15 May 2024 Notice of annual general meeting of Calliditas Therapeutics AB (publ) The shareholders of Calliditas Therapeutics AB (publ) (“Calliditas Therapeutics”), Reg. No. 556659-9766, with registered office in Stockholm, are summoned to the annual general meeting on Monday 17 June 2024 at 2.00 p.m. CEST at Klara, Klarabergsviadukten 90, SE-111 64 Stockholm, Sweden. Regist |
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May 16, 2024 |
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: May 15, 2024 (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 execut |
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May 6, 2024 |
Exhibit 99.1 Stockholm, Sweden May 6, 2024 Calliditas announces positive topline results of Phase 2 head and neck cancer trial with lead NOX inhibitor candidate, setanaxib Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced data from the proof-of-concept Phase 2 trial evaluating setanaxib, its lead NOX enzyme inhibitor, in combination with pembrolizuma |
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May 6, 2024 |
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: May 6, 2024 (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 executi |
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April 25, 2024 |
Calliditas Therapeutics’ 2023 Annual Report Published Exhibit 99.2 Stockholm, Sweden April 24, 2024 Calliditas Therapeutics’ 2023 Annual Report Published Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announces that the Annual Report for 2023 now is available at the company’s website: www.calliditas.com For further information, please contact: Åsa Hillsten, Head of IR & Sustainability, Calliditas Tel.: +46 76 |
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April 25, 2024 |
Calliditas Announces Positive NefIgArd Open Label Extension Results Exhibit 99.3 Stockholm, Sweden April 24, 2024 Calliditas Announces Positive NefIgArd Open Label Extension Results Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today 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 creatinin |
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April 25, 2024 |
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: April 25, 2024 (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 exec |
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April 25, 2024 |
Exhibit 99.1 ANNUAL REPORT 2023 02Calliditas Therapeutics | Annual Report 2023 About Calliditas 03 2023 in Breif 04 CEO Statement 06 Our Pipeline 08 Key Events 09 The Share 10 TARPEYO: Full Approval 12 Commerical Overview 14 Patient interview 16 IGA Nephropathy 18 Our Commercial Partnerships 20 Interview with Mr Rogers, CEO Everest Medicines 21 Expanding TARPEYO's IP 22 IgAN Market Opportunity 23 |
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April 24, 2024 |
Exhibit 13.2 CERTIFICATION OF CFO PURSUANT TO 18 U.S.C. SECTION 1350 AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Fredrik Johansson, Chief Financial Officer of |
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April 24, 2024 |
Product Agreement for Nefecon 4mg Exhibit 4.24 CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. INFORMATION THAT WAS OMITTED HAS BEEN NOTED IN THIS DOCUMENT WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[***]”. Product Agreement for Nefecon 4mg This Product Agreement (this “Product Agreement”) is issued under the M |
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April 24, 2024 |
Exhibit 12.2 SECTION 302 CERTIFICATION I, Fredrik Johansson, certify that: 1. I have reviewed this annual report on Form 20-F of Calliditas Therapeutics AB; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not mis |
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April 24, 2024 |
Exhibit 4.23 CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. INFORMATION THAT WAS OMITTED HAS BEEN NOTED IN THIS DOCUMENT WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[***]”. Master Manufacturing Services Agreement Effective Date: December 30, 2020 PARTIES PATHEON PHARMACEUTICALS |
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April 24, 2024 |
Exhibit 4.22 Certain identified information has been excluded from this exhibit because it is both not material and is the type that the registrant treats as private or confidential. Information that was omitted has been noted in this document with a placeholder identified by the mark “[***]”. CREDIT AGREEMENT Dated as of December 27, 2023 among CALLIDITAS THERAPEUTICS AB, as the Borrower, CERTAIN |
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April 24, 2024 |
Exhibit 2.4 DESCRIPTION OF SECURITIES The following description of the capital stock of Calliditas Therapeutics AB (“us,” “our,” “we” or the “Company”) is a summary of the rights of our ordinary shares and C-shares and certain provisions of our articles of association in effect as of May 30, 2023. This summary does not purport to be complete and is qualified in its entirety by the provisions of ou |
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April 24, 2024 |
Exhibit 1.1 N.B. The English text is an in-house translation of the original Swedish text. Should there be any disparities between the Swedish and the English text, the Swedish text shall prevail. ARTICLES OF ASSOCIATION OF CALLIDITAS THERAPEUTICS AB Reg. no. 556659-9766 Adopted at the annual general meeting held on 30 May 2023. 1 § Business name The business name of the company is Calliditas Ther |
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April 24, 2024 |
Consent of Independent Registered Public Accounting Firm Exhibit 15.1 Consent of Independent Registered Public Accounting Firm We consent to the incorporation by reference in the following Registration Statements: (1) Registration Statement (Form S-8 333-240126) pertaining to the ESOP 2020 United States Sub-Plan (the “U.S. Sub-Plan”) and the Long-term Performance Based Incentive Program (the “Board LTIP 2020”) of Calliditas Therapeutics AB, (2) Registra |
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April 24, 2024 |
Exhibit 97.1 Standard Operating Procedure Executive Officer Incentive Compensation Clawback Document No. Version Lifecycle State Effective Date 1 December 2023 Document Owner Owning Department Finance Contents 1. Purpose 1 2. Scope 1 3. Responsibilities 2 4. Definitions 2 5. Procedure 4 6. Supporting Documents 7 7. Literature References 7 8. Attachments 7 9. Revision History 7 1. Purpose The Remun |
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April 24, 2024 |
SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F Table of Contents 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, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES |
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April 24, 2024 |
Exhibit 12.1 SECTION 302 CERTIFICATION I, Renée Aguiar-Lucander, certify that: 1. I have reviewed this annual report on Form 20-F of Calliditas Therapeutics AB; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not |
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April 24, 2024 |
Exhibit 13.1 CERTIFICATION OF CEO PURSUANT TO 18 U.S.C. SECTION 1350 AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Renée Aguiar-Lucander, Chief Executive Office |
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April 24, 2024 |
Exhibit 4.16 Resolution on adoption of a long-term incentive program for the company’s management and key personnel (item 21) The Board of Directors of Calliditas Therapeutics proposes the introduction of a long-term incentive program for the company’s management and key personnel (including employees and consultants) in accordance with the following. The Board of Directors proposes that the annua |
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March 6, 2024 |
Calliditas announces extended orphan drug exclusivity period for TARPEYO Exhibit 99.1 Stockholm, Sweden March 6, 2024 Calliditas announces extended orphan drug exclusivity period for TARPEYO® in U.S. Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that the FDA has granted a new orphan drug exclusivity period of seven years for TARPEYO®, starting from Dec 20, 2023, when the company obtained full approval with a new indic |
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March 6, 2024 |
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: March 6, 2024 (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 execu |
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February 21, 2024 |
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: February 21, 2024 (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 e |
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February 21, 2024 |
Exhibit 99.2 YEAR-END REPORT JANUARY – DECEMBER 2023 Q4 Calliditas Therapeutics | Year-End Report 2023: January – December 2 347 108% 974 Key takeaways from Q4, 2023 Outlook 2024 OCTOBER – DECEMBER 2023 (COMPARED TO OCTOBER – DECEMBER 2022) JANUARY – DECEMBER 2023 (COMPARED TO JANUARY –DECEMBER 2022) “In December we were granted full OCT – DEC 2023 approval by the FDA for TARPEYO – a crowning ach |
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February 21, 2024 |
Calliditas Year-end report, January – December 2023 Exhibit 99.1 Stockholm, Sweden February 21, 2024 Calliditas Year-end report, January – December 2023 Calliditas Therapeutics AB (Nasdaq Stockholm: CALTX) 2023: Full approval for TARPEYO in the US; a year of successes OCTOBER – DECEMBER 2023 (COMPARED TO OCTOBER – DECEMBER 2022) ● Net sales amounted to SEK 451.6 million, of which TARPEYO® net sales amounted to SEK 347.3 million, for the three month |
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January 8, 2024 |
Exhibit 99.1 Stockholm, Sweden January 7, 2024 Calliditas Therapeutics appoints Maria Törnsén as President North America Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”), a commercial biopharma company focused on rare diseases today announced that Maria Törnsén has been appointed to the position of President North America. Ms Törnsén will be responsible for all US |
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January 8, 2024 |
Calliditas Therapeutics provides business update ahead of JP Morgan conference Exhibit 99.2 Stockholm,Sweden January 8, 2024 Calliditas Therapeutics provides business update ahead of JP Morgan conference Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”), a commercial biopharma company focused on rare diseases today provided a business update for the fourth quarter of 2023 and certain preliminary, unaudited key financial information for the fou |
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January 8, 2024 |
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: January 8, 2024 (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 exe |
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December 27, 2023 |
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: December 27, 2023 (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 e |
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December 27, 2023 |
Exhibit 99.1 Stockholm, Sweden December 27, 2023 Calliditas refinances existing term loan with Euro 92 million senior secured facility with Athyrium Capital Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that the company has signed and fully drawn a term loan of 92 million Euros with funds managed by Athyrium Capital Management, LP (“Athyrium”). P |
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December 20, 2023 |
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: December 20, 2023 (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 e |
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December 20, 2023 |
Exhibit 99.1 Stockholm, Sweden December 20, 2023 Calliditas Therapeutics announces full FDA approval of TARPEYO®, the only FDA- approved treatment for IgA nephropathy to significantly reduce the loss of kidney function Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”), today announced that the U.S. Food and Drug Administration (FDA) has approved TARPEYO (budesonide) |
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December 11, 2023 |
Calliditas Receives Notice of Allowance for United States Patent Application Covering TARPEYO® Exhibit 99.1 Stockholm, Sweden December 11, 2023 Calliditas Receives Notice of Allowance for United States Patent Application Covering TARPEYO® Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no. 18/100,396 entitled “New Phar |
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December 11, 2023 |
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: December 11, 2023 (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 e |
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November 30, 2023 |
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: November 30, 2023 (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 e |
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November 30, 2023 |
Calliditas initiates clinical study to evaluate setanaxib in Alport Syndrome Exhibit 99.1 Stockholm, Sweden November 30, 2023 Calliditas initiates clinical study to evaluate setanaxib in Alport Syndrome Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced the initiation of a Phase 2 clinical study to evaluate setanaxib in Alport syndrome. Calliditas is a company focused on developing and commercializing novel treatments in rare |
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November 24, 2023 |
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: November 24, 2023 (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 e |
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November 24, 2023 |
Exhibit 99.1 Stockholm, Sweden November 24, 2023 Calliditas’ partner Everest Medicines announces China NMPA’s approval of Nefecon® for the treatment of primary IgA nephropathy Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that its partner Everest Medicines (HKEX: 1952.HK) ("Everest") announced that China's National Medical Products Administration |
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November 7, 2023 |
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: November [ ], 2023 (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 |
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November 7, 2023 |
Calliditas Interim Report January – September 2023 Exhibit 99.2 Stockholm, Sweden November 7, 2023 Calliditas Interim Report January – September 2023 The Lancet publication of full Phase 3 data set In August we were excited to see the full data set from our Phase 3 clinical trial, NefIgArd, published in The Lancet and we are looking forward to a potential full approval of TARPEYO for treatment of IgA Nephropathy, for which the PDUFA date is Decemb |
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November 7, 2023 |
Exhibit 99.1 INTERIM REPORT JANUARY – SEPTEMBER 2023 Q3 2 Calliditas Therapeutics | Interim Report Q3: January - September 2023 284 130% 787 Key Takeaways from Q3 JULY – SEPTEMBER 2023 (COMPARED TO JULY – SEPTEMBER 2022) JANUARY – SEPTEMBER 2023 (COMPARED TO JANUARY – SEPTEMBER 2022) JUL – SEP 2023 “We are looking forward to a potential full approval of TARPEYO for the treatment of IgA Nephropath |
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October 23, 2023 |
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: October 23, 2023 (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 ex |
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October 23, 2023 |
Calliditas Therapeutics’ nomination committee composition for the AGM 2024 Exhibit 99.1 Stockholm, Sweden October 23, 2023 Calliditas Therapeutics’ nomination committee composition for the AGM 2024 It is hereby announced that Calliditas Therapeutics´s major owners have appointed a nomination committee for the AGM 2024. The nomination committee, which is appointed in accordance with the principles adopted by the extraordinary general meeting in 2017, consists of: • Patric |
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October 5, 2023 |
Exhibit 99.1 Stockholm, Sweden October 5, 2023 European Medicines Agency Committee for Orphan Medicinal Products provides positive opinion on Calliditas’ application for setanaxib in Alport syndrome Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has issued a po |
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October 5, 2023 |
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: October 5, 2023 (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 exe |
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September 27, 2023 |
Exhibit 99.1 Stockholm, Sweden September 27, 2023 Calliditas Therapeutics granted orphan drug designation by the FDA for the treatment of Alport syndrome with setanaxib Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for the treatment of Alport syndrome with se |
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September 27, 2023 |
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: September 27, 2023 (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 |
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August 18, 2023 |
FDA grants priority review for full approval of TARPEYO for the treatment of IgA Nephropathy Exhibit 99.1 Stockholm, Sweden August 18, 2023 FDA grants priority review for full approval of TARPEYO for the treatment of IgA Nephropathy Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”), today announced that the U.S. Food and Drug Administration (FDA) has accepted the submission for the supplemental New Drug Application (sNDA) for TARPEYO® (budesonide) delayed r |
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August 18, 2023 |
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: August 18, 2023 (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 exe |
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August 17, 2023 |
Exhibit 99.1 INTERIM REPORT JANUARY 1 – JUNE 30, 2023 Filing for full approval of TARPEYO Group Financial Summary Key Figures April 1 - June 30, 2023 ● Net sales amounted to SEK 269.4 million, of which TARPEYO® net sales amounted to SEK 259.2 million, for the three months ended June 30, 2023. For the three months ended June 30, 2022 net sales amounted to SEK 64.0 million, of which TARPEYO net sale |
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August 17, 2023 |
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: August 17, 2023 (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 exe |
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August 17, 2023 |
Exhibit 99.2 Stockholm, Sweden August 17, 2023 Interim Report Q2, 2023 Filing for full approval of TARPEYO FINANCIAL SUMMARY FOR THE GROUP Key Figures April 1 - June 30, 2023 - Net sales amounted to SEK 269.4 million, of which TARPEYO® net sales amounted to SEK 259.2 million, for the three months ended June 30, 2023. For the three months ended June 30, 2022, net sales amounted to SEK 64.0 million, |
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July 17, 2023 |
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: July 17, 2023 (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 execu |
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July 17, 2023 |
Exhibit 99.1 Stockholm, Sweden July 13, 2023 Calliditas announces supportive interim data from Phase 2 head and neck cancer trial with lead NOX inhibitor candidate, setanaxib Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced interim data from the proof-of-concept Phase 2 trial in patients with squamous cell carcinoma of the head and neck (SCCHN) with |
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June 21, 2023 |
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 21, 2023 (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 execu |
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June 21, 2023 |
Exhibit 99.1 Stockholm, Sweden June 21, 2023 Calliditas Therapeutics Submits Supplemental New Drug Application to U.S. Food and Drug Administration for Full Approval of TARPEYO® Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced the submission of a supplemental New Drug Application (“sNDA”) to the U.S. Food and Drug Administration (“FDA”) seeking full |
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June 12, 2023 |
Exhibit 4.1 BOLAGSORDNING FÖR CALLIDITAS THERAPEUTICS AB ARTICLES OF ASSOCIATION OF CALLIDITAS THERAPEUTICS AB Org.nr 556659-9766 Reg. no. 556659-9766 Antagen på årsstämma den 30 maj 2023. Adopted at the annual general meeting held on 30 May 2023. 1 § Företagsnamn / Business name Bolagets företagsnamn är Calliditas Therapeutics AB. Bolaget är publikt (publ). The business name of the company is Cal |
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June 12, 2023 |
Board LTIP 2023 in Calliditas Therapeutics AB (publ) GRANT NOTICE & AGREEMENT Exhibit 99.6 Board LTIP 2023 in Calliditas Therapeutics AB (publ) GRANT NOTICE & AGREEMENT On 30 May 2023, the annual general meeting in Calliditas Therapeutics AB (publ) (the “Company”) resolved to introduce a long-term performance-based incentive program for members of the Board of Directors (“Board LTIP 2023”). In summary, the resolution entails that the members of the Board of Directors (each |
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June 12, 2023 |
As filed with the Securities and Exchange Commission on June 12, 2023 As filed with the Securities and Exchange Commission on June 12, 2023 Registration No. |
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June 12, 2023 |
Exhibit 107 Calculation of Filing Fee Tables Form S-8 (Form Type) Calliditas Therapeutics AB (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered Securities Security Type Security Class Title(1) Fee Calculation Rule Amount Registered(2) Proposed Maximum Offering Price Per Share Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Fees to Be Paid Equity Common shares, quota value SEK 0. |
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June 12, 2023 |
CALLIDITAS THERAPEUTICS AB ESOP 2023 UNITED STATES SUB-PLAN Exhibit 99.3 CALLIDITAS THERAPEUTICS AB ESOP 2023 UNITED STATES SUB-PLAN 1. PURPOSE; DEFINITIONS The purpose of the ESOP 2023 United States Sub-Plan (the “Sub-Plan”) is to establish certain rules and limitations applicable to Options granted under the T&C’s to Employees and Consultants who are or are expected to become United States residents or otherwise subject to the feder |
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June 8, 2023 |
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 8, 2023 (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 execut |
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May 30, 2023 |
Bulletin from the annual general meeting of Calliditas Therapeutics AB (publ) Exhibit 99.1 Stockholm, Sweden 30 May 2023 Bulletin from the annual general meeting of Calliditas Therapeutics AB (publ) The following resolutions were passed at Calliditas Therapeutics AB (publ) (“Calliditas”) annual general meeting held today, on 30 May 2023, in Stockholm. Adoption of income statement and balance sheet for the financial year 2022 and discharge from liability The annual general m |
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May 30, 2023 |
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: May 30, 2023 (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 execut |
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May 16, 2023 |
EX-99.2 3 tm2315949d1ex99-2.htm EXHIBIT 99.2 Exhibit 99.2 Stockholm, Sweden May 16, 2023 Interim Report Q1, 2023 Strong eGFR Data from Positive NefIgArd Phase 3 Trial Readout “In March we announced that the global NefIgArd Phase 3 trial successfully met its primary endpoint, estimated glomerular filtration rate (eGFR), with a p value < 0.0001. Achieving this clinically relevant endpoint of kidney |
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May 16, 2023 |
Exhibit 99.1 Significant Events in Q1 2023, in Summary In February 2023, Calliditas announced that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom granted Conditional Marketing Authorization (CMA) for Kinpeygo® for the treatment of primary immunoglobulin A (IgA) nephropathy in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio |
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May 16, 2023 |
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: May 16, 2023 (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 execut |
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April 28, 2023 |
Calliditas Therapeutics’ 2022 Annual Report Published Exhibit 99.2 Stockholm, Sweden April 26, 2023 Calliditas Therapeutics’ 2022 Annual Report Published Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) today announces that the Annual Report for 2022 now is available at the company’s website: www.calliditas.com For further information, please contact: Åsa Hillsten, Head of Investor Relations, Calliditas Therapeutics AB Phone: +46 76 |
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April 28, 2023 |
Exhibit 99.3 Stockholm 28 April 2023 Notice of annual general meeting of Calliditas Therapeutics AB (publ) The shareholders of Calliditas Therapeutics AB (publ) (“Calliditas Therapeutics”), Reg. No. 556659-9766, with registered office in Stockholm, are summoned to the annual general meeting on Tuesday 30 May 2023 at Klara, Klarabergsviadukten 90, Stockholm, Sweden. Registration starts at 10.00 CES |
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April 28, 2023 |
Exhibit 99.1 ANNUAL REPORT 2022 Contents The Annual Report of Calliditas Therapeutics AB (publ), 556659-9766, is comprised of directors report, the Group's and the Parent Company's financial statements with notes and audit report (pages 36-91). About Calliditas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 03 January – |
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April 28, 2023 |
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: April 28, 2023 (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 exec |
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April 26, 2023 |
CALLIDITAS THERAPEUTICS AB ESOP 2022 UNITED STATES SUB-PLAN Exhibit 4.15 CALLIDITAS THERAPEUTICS AB ESOP 2022 UNITED STATES SUB-PLAN 1.PURPOSE; DEFINITIONS The purpose of the ESOP 2022 United States Sub-Plan (the “Sub-Plan”) is to establish certain rules and limitations applicable to Options granted under the T&C’s to Employees and Consultants who are or are expected to become United States residents or otherwise subject to the federal tax laws of the Unit |
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April 26, 2023 |
Articles of Association Articles of Association of Calliditas Therapeutics AB. Reg. no. 556659-9766. Exhibit 1.1 Articles of Association Articles of Association of Calliditas Therapeutics AB. Reg. no. 556659-9766. Adopted at the annual general meeting held on 19 May 2022. 1 § Business name The business name of the company is Calliditas Therapeutics AB. The company is a public company (publ). 2 § Registered office of the company The registered office of the company is situated in Stockholm, Sweden |
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April 26, 2023 |
SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F Table of Contents 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, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES |
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April 26, 2023 |
Exhibit 12.2 SECTION 302 CERTIFICATION I, Fredrik Johansson, certify that: 1. I have reviewed this annual report on Form 20-F of Calliditas Therapeutics AB; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not mis |
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April 26, 2023 |
Exhibit 2.4 DESCRIPTION OF SECURITIES The following description of the capital stock of Calliditas Therapeutics AB (“us,” “our,” “we” or the “Company”) is a summary of the rights of our ordinary shares and C-shares and certain provisions of our articles of association in effect as of May 19, 2022. This summary does not purport to be complete and is qualified in its entirety by the provisions of ou |
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April 26, 2023 |
Exhibit 13.2 CERTIFICATION OF CFO PURSUANT TO 18 U.S.C. SECTION 1350 AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Fredrik Johansson, Chief Financial Officer of |
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April 26, 2023 |
LICENSE AGREEMENT CALLIDITAS THERAPEUTICS AB (PUBL) VIATRIS PHARMACEUTICALS JAPAN INC. Exhibit 4.26 EXECUTION VERSION Certain identified information has been excluded from this exhibit because it is both not material and is the type that the registrant treats as private or confidential. Information that was omitted has been noted in this document with a placeholder identified by the mark “[***]”. LICENSE AGREEMENT between CALLIDITAS THERAPEUTICS AB (PUBL) and VIATRIS PHARMACEUTICALS |
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April 26, 2023 |
Exhibit 4.14 Resolution on the introduction of a long-term incentive program for the company’s management and key personnel (item 18) The Board of Directors of Calliditas Therapeutics proposes the introduction of a long-term incentive program for the company’s management and key personnel (including employees and consultants) in accordance with the following. The Board of Directors proposes that t |
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April 26, 2023 |
Exhibit 13.1 CERTIFICATION OF CEO PURSUANT TO 18 U.S.C. SECTION 1350 AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Renée Aguiar-Lucander, Chief Executive Office |
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April 26, 2023 |
Exhibit 12.1 SECTION 302 CERTIFICATION I, Renée Aguiar-Lucander, certify that: 1. I have reviewed this annual report on Form 20-F of Calliditas Therapeutics AB; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not |
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April 26, 2023 |
Consent of Independent Registered Public Accounting Firm Exhibit 15.1 Consent of Independent Registered Public Accounting Firm We consent to the incorporation by reference in the following Registration Statements: (1) Registration Statement Form S-8 (333-240126) pertaining to the ESOP 2020 United States Sub-Plan (the “U.S. Sub-Plan”) and the Long-term Performance Based Incentive Program (the “Board LTIP 2020”) of Calliditas Therapeutics AB, and (2) Regi |
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April 26, 2023 |
Board LTIP 2022 in Calliditas Therapeutics AB (publ) GRANT NOTICE & AGREEMENT Exhibit 4.9 Board LTIP 2022 in Calliditas Therapeutics AB (publ) GRANT NOTICE & AGREEMENT On 19 May 2022, the annual general meeting in Calliditas Therapeutics AB (publ) (the “Company”) resolved to introduce a long-term performance-based incentive program for members of the Board of Directors (“Board LTIP 2022”). In summary, the resolution entails that the members of the Board of Directors (each a |
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March 13, 2023 |
Nef - 301 Summary of Full Phase 3 Trial Results March 13, 2023 Exhibit 99.1 Nef - 301 Summary of Full Phase 3 Trial Results March 13, 2023 2 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 Calliditas’ strategy, planned regulatory submissions, anticipated regulat ory approvals and |
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March 13, 2023 |
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: March 13, 2023 (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 exec |
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March 13, 2023 |
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: March 13, 2023 (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 exec |
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March 13, 2023 |
Exhibit 99.1 Stockholm, Sweden March 12, 2023 Calliditas Announces Primary Endpoint Successfully Met in Phase 3 NefIgArd Trial Evaluating Nefecon® in IgA Nephropathy Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced positive topline results from the global, randomized, double-blind, placebo-controlled Phase 3 clinical trial NefIgArd, which investigat |
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February 23, 2023 |
Exhibit 99.2 Significant Events in Q4 2022, in Summary In October 2022, Calliditas announced that Kidney International published the successful results from Part A of the NefIgArd pivotal Phase 3, randomized, double-blind, placebo-controlled, multicenter study, on the basis of which the accelerated approval by the FDA for TARPEYO and the conditional marketing authorization by the European Commissi |
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February 23, 2023 |
Exhibit 99.1 Stockholm, Sweden February 23, 2023 Year-End Report, 2022 2022: Successful transformation into a commercial stage company “2022 was a fantastic year for Calliditas as we launched TARPEYO® in the US, the first approved drug for IgA nephropathy and a medication with the potential to be disease modifying based on the early stabilization of eGFR in patients at risk of rapid disease progre |
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February 23, 2023 |
6-K 1 tm237694d16k.htm FORM 6-K 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: February 23, 2023 (Commission File No. 001-39308) CALLIDITAS THERAPEUTICS AB (Translation of registrant’s name into English) Kungsbron 1, D5 SE-111 22 Stockholm, Sweden (Add |
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February 14, 2023 |
SC 13G/A 1 sc13ga207422calt02142023.htm AMENDMENT NO. 2 TO THE SCHEDULE 13G UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G (Rule 13d-102) INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO RULES 13d-1(b), (c), AND (d) AND AMENDMENTS THERETO FILED PURSUANT TO RULE 13d-2(b) (Amendment No. 2)1 Calliditas Therapeutics AB (Name of Issuer) Common Shares, quo |
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February 2, 2023 |
Calliditas Receives Conditional Marketing Authorization from UK MHRA for Kinpeygo in IgA nephropathy EX-99.1 2 tm235246d1ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Stockholm, Sweden February 2, 2023 Calliditas Receives Conditional Marketing Authorization from UK MHRA for Kinpeygo in IgA nephropathy Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom has granted Conditi |
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February 2, 2023 |
6-K 1 tm235246d16k.htm FORM 6-K 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: February 2, 2023 (Commission File No. 001-39308) CALLIDITAS THERAPEUTICS AB (Translation of registrant’s name into English) Kungsbron 1, D5 SE-111 22 Stockholm, Sweden (Addr |
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February 1, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G/A UNDER THE SECURITIES EXCHANGE ACT OF 1934 (Amendment No. 1)* Calliditas Therapeutics AB (Name of Issuer) Common Shares, quota value SEK 0.04 per share (Title of Class of Securities) 13124Q106 (CUSIP Number) December 31, 2022 (Date of Event Which Requires Filing of This Statement) Check the appropriate box to des |
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January 31, 2023 |
Number of shares and votes in Calliditas Therapeutics EX-99.1 2 tm235038d1ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Stockholm, Sweden January 31, 2023 Number of shares and votes in Calliditas Therapeutics During January, Calliditas Therapeutics AB (publ) has issued 7,500 common shares connected to the company’s long term incentive program 2019/2022. Thus, as of January 31, 2023, the number of shares and votes in the company amounts to 59,580,087 shares an |
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January 31, 2023 |
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: January 31, 2023 (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 ex |
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December 30, 2022 |
6-K 1 tm2233740d16k.htm FORM 6-K 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: December 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 (Ad |
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December 30, 2022 |
Number of shares and votes in Calliditas Therapeutics Exhibit 99.1 Stockholm, Sweden December 30, 2022 Number of shares and votes in Calliditas Therapeutics During December, Calliditas Therapeutics AB (publ) has issued 415,000 common shares connected to the company?s long term incentive program 2019/2022. Thus, as of December 30, 2022, the number of shares and votes in the company amounts to 59,572,587 shares and 59,572,587 votes. For further informa |
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December 30, 2022 |
China CDE/NMPA Recommends Priority Review for Nefecon for the Treatment of Primary IgA Nephropathy Exhibit 99.2 Stockholm, Sweden December 30, 2022 China CDE/NMPA Recommends Priority Review for Nefecon for the Treatment of Primary IgA Nephropathy Calliditas Therapeutics AB (publ) (?Calliditas?) partner Everest Medicines (HKEX 1952.HK) today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has recommended Priority Review for the New |
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December 13, 2022 |
Exhibit 99.1 Stockholm, Sweden December 13, 2022 Calliditas Therapeutics announces license agreement with Viatris to register and commercialize specialty therapy for IgA nephropathy in Japan Calliditas announces that it has entered into an agreement with Viatris to bring Nefecon?, a specialty therapy focused on downregulating IgA1, to Japanese patients. The agreement, worth up to $100M in upfront |
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December 13, 2022 |
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: December 13, 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 e |
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November 15, 2022 |
6-K 1 tm2230630d16k.htm FORM 6-K 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: November 15, 2022 (Commission File No. 001-39308) CALLIDITAS THERAPEUTICS AB (Translation of registrant’s name into English) Kungsbron 1, D5 SE-111 22 Stockholm, Sweden (Ad |
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November 15, 2022 |
Exhibit 99.1 Stockholm, Sweden November 15, 2022 Calliditas’ partner Everest Medicine’s New Drug Application for Nefecon is accepted by the China NMPA Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that the Chinese regulatory authority National Medical Products Administration (“NMPA”) has accepted Everest Medicines’ (HKEX 1952.HK, “Everest") New D |
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November 14, 2022 |
6-K 1 tm2230450d16k.htm FORM 6-K 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: November 14, 2022 (Commission File No. 001-39308) CALLIDITAS THERAPEUTICS AB (Translation of registrant’s name into English) Kungsbron 1, D5 SE-111 22 Stockholm, Sweden (Ad |
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November 14, 2022 |
Exhibit 99.1 Q3 2022 INTERIM REPORT JANUARY 1ST ? SEPTEMBER 30TH 2022 in Summary nephropathy (IgAN) in adults at risk of rapid disease progression with a urine product and became the first and only approved treatment for IgAN in EU. STADA Arzneimittel AG. Subsequently, in September 2022, Calliditas transferred partner, STADA Arzneimittel AG, who will initially launch in Germany, with Investor Pres |
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November 14, 2022 |
Exhibit 99.2 Stockholm, Sweden November 14, 2022 Interim Report Q3, 2022 Conditional Marketing Authorization in EU Granted for Kinpeygo? ?On July 15th the European Commission issued the conditional marketing authorization for Kinpeygo, which marked the first time that any drug has achieved approval for this rare disease in EU. We immediately started the process of transferring the market authoriza |
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October 21, 2022 |
Calliditas Therapeutics’ nomination committee composition for the AGM 2023 Exhibit 99.1 Stockholm, Sweden October 21, 2022 Calliditas Therapeutics? nomination committee composition for the AGM 2023 Calliditas Therapeutics AB (publ.) publishes the nomination committee?s composition for the AGM in 2023. The nomination committee, which is appointed in accordance with the principles adopted by the extraordinary general meeting in 2017, consists of: ? Patrick Sobocki, appoint |
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October 21, 2022 |
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: October 21, 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 ex |
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September 20, 2022 |
Exhibit 99.1 Stockholm, Sweden September 20, 2022 Calliditas? partner STADA launches the first medicine authorized in the EU for treating primary IgA nephropathy Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (?Calliditas?) today announced that its European commercial partner, STADA Arzneimittel AG, has launched the first and only approved treatment in the EU for primary immuno |
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September 20, 2022 |
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: September 20, 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 |
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August 19, 2022 |
Exhibit 99.1 ? ? ? ? INTERIM REPORT JANUARY 1ST ? JUNE 30TH 2022 European approval for Kinpeygo? Financial Summary For the Group Key Figures April 1 - June 30, 2022 ? Net sales amounted to SEK 64.0 million, whereof TARPEYO? net sales amounted to SEK 63.6 million, for the three months ended June 30, 2022. No net sales were recognized for the three months ended June 30, 2021. ? Operating loss amount |
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August 19, 2022 |
Exhibit 99.2 ? ? Stockholm, Sweden August 18, 2022 ? Interim Report Q2, 2022 European approval for Kinpeygo? ?On May 19th, the European Medicines Agency (EMA) announced that it had adopted a positive opinion regarding the application for conditional approval of Kinpeygo? for the treatment of IgA nephropathy, and on July 15th the European Commission issued the market authorization for Kinpeygo in t |
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August 19, 2022 |
? ? 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: August 19, 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 |
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July 29, 2022 |
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: July 29, 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 execu |
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July 29, 2022 |
Number of shares and votes in Calliditas Therapeutics Exhibit 99.1 Stockholm, Sweden July 29, 2022 Number of shares and votes in Calliditas Therapeutics During July, Calliditas Therapeutics AB (publ) has issued 51,399 ordinary shares as part of the company?s long-term incentive program for certain members of the board of directors issued in 2019, Board LTIP 2019, and converted 5,908,018 class C-shares to 5,908,018 ordinary shares as part of the estab |
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July 15, 2022 |
European Commission approves Kinpeygo® for adults with primary IgA nephropathy Exhibit 99.1 Stockholm, Sweden July 15, 2022 European Commission approves Kinpeygo? for adults with primary IgA nephropathy Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (?Calliditas?) today announced that the European Commission (EC) has granted conditional marketing authorization for Kinpeygo? for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults a |
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July 15, 2022 |
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: July 15, 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 execu |
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July 12, 2022 |
Calliditas announces additions to the management team Exhibit 99.1 Stockholm, Sweden July 11, 2022 Calliditas announces additions to the management team Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (?Calliditas?) today announced that the company has added two members to its management team, Head of Human Resources Sandra Frithiof and Group General Counsel Jonathan Schur. Jonathan Schur has over 40 years of experience as a lawyer |
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July 12, 2022 |
6-K 1 tm2220835d16k.htm FORM 6-K 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: July 12, 2022 (Commission File No. 001-39308) CALLIDITAS THERAPEUTICS AB (Translation of registrant’s name into English) Kungsbron 1, D5 SE-111 22 Stockholm, Sweden (Addres |
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July 7, 2022 |
July 7, 2022 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Ada D. Sarmento Re: Calliditas Therapeutics AB Registration Statement on Form F-3 Filed June 28, 2022 File No. 333-265881 Acceleration Request Requested Date: July 8, 2022 Requested Time: 4:00 p.m. Eastern Time Ladies and Gentlemen: In accordance with Rule |
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June 30, 2022 |
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 execu |
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June 30, 2022 |
Number of shares and votes in Calliditas Therapeutics Exhibit 99.1 Stockholm, Sweden June 30, 2022 Number of shares and votes in Calliditas Therapeutics During June, Calliditas Therapeutics AB (publ) has issued 5,908,018 class C-shares as part of the establishment of the company?s at-the-market program. Thus, as of June 30, 2022, the number of shares and votes in the company amounts to 59,106,188 shares and 53,788,971.8 votes. For further information |
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June 29, 2022 |
Supplemental intellectual property disclosure EX-4 4 tm2219399d3ex4.htm EXHIBIT 4 Exhibit 4 SUPPLEMENTAL INTELLECTUAL PROPERTY DISCLOSURE The following disclosure should be read in conjunction with, and amends and supplements, the disclosure in Item 4.B, “Business Overview—Intellectual Property—Patents” included in the Annual Report on Form 20-F filed by the Company on April 27, 2022 (the “Form 20-F”). The terms “we,” “us” and “our” refer to |
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June 29, 2022 |
Company announcement dated June 28, 2022 Exhibit 2 Stockholm, Sweden June 28, 2022 Calliditas Therapeutics establishes a U. |
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June 29, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 OF THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: June 28, 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 princip |
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June 29, 2022 |
Exhibit 3 RISK FACTORS The following risk factors should be read in conjunction with, and amends and supplements, those included in the Annual Report on Form 20-F filed by the Company on April 27, 2022 (the ?Form 20-F?). |
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June 28, 2022 |
As filed with the Securities and Exchange Commission on June 28, 2022 F-3 1 tm2219399-1f3.htm F-3 TABLE OF CONTENTS As filed with the Securities and Exchange Commission on June 28, 2022 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM F-3 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Calliditas Therapeutics AB (Exact name of Registrant as specified in its charter) Sweden 2834 N/A (State or other juris |
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June 28, 2022 |
, dated June 28, 2022, by and between and between Calliditas Therapeutics AB and Jefferies LLC EX-1.2 2 tm2219399d2ex1-2.htm EXHIBIT 1.2 Exhibit 1.2 OPEN MARKET SALE AGREEMENTSM June 28, 2022 JEFFERIES LLC 520 Madison Avenue New York, New York 10022 Ladies and Gentlemen: Calliditas Therapeutics AB (publ), a Swedish public limited liability company (the “Company”), proposes, subject to the terms and conditions stated herein, to issue and sell from time to time through Jefferies LLC, as sales |
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June 28, 2022 |
Calculation of Filing Fee Tables. Exhibit 107 Calculation of Filing Fee Tables Form F-3 (Form Type) Calliditas Therapeutics AB (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered and Carry Forward Securities Security Type Security Class Title Fee Calculation or Carry Forward Rule Amount Registered Proposed Maximum Offering Price Per Unit Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Carry Forward Form Type Carry Forward File Number Carry Forward Initial effective date Filing Fee Previously Paid In Connection with Unsold Securities to be Carried Forward Newly Registered Securities Equity Common shares, quota value SEK 0. |
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June 28, 2022 |
Form of Senior or Subordinated Indenture. Exhibit 4.3 Calliditas Therapeutics AB (publ), Issuer AND [TRUSTEE], Trustee INDENTURE Dated as of [?], 20 Debt Securities TABLE OF CONTENTS PAGE article 1 DEFINITIONS 1 Section 1.01 Definitions of Terms 1 article 2 ISSUE, DESCRIPTION, TERMS, EXECUTION, REGISTRATION AND EXCHANGE OF SECURITIES 5 Section 2.01 Designation and Terms of Securities 5 Section 2.02 Form of Securities and Trustee?s Certifi |
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June 21, 2022 |
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 21, 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 execu |
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June 21, 2022 |
Issuance and repurchase of C-shares to establish an at-the-market program Exhibit 99.1 Stockholm, Sweden June 20, 2022 Issuance and repurchase of C-shares to establish an at-the-market program The Board of Directors of Calliditas Therapeutics AB (publ) today resolved to carry out a new issue of 5,908,018 C-shares and to subsequently immediately repurchase the 5,908,018 newly issued C-shares which are subsequently intended to be converted into ordinary shares in accordan |
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May 20, 2022 |
? ? 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: May 20, 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 ex |
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May 20, 2022 |
Exhibit 99.4 Stockholm, Sweden May 17, 2022 First patient randomized in Phase 2 trial in head and neck cancer Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (?Calliditas?) today announced that the first patient has been randomized in the company?s proof-of-concept Phase 2 study in patients with squamous cell carcinoma of the head and neck (SCCHN) with the NOX 1 and 4 inhibitor, |
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May 20, 2022 |
Exhibit 99.1 ? ? ? ? INTERIM REPORT JANUARY 1ST ? MARCH 31ST 2022 Start of TARPEYO? Commercial Launch Financial summary for the Group Key Figures ? January 1 - March 31, 2022 ? Net sales amounted to SEK 49.7 million, whereof TARPEYO net sales amounted to SEK 18.0 million, for the three months ended March 31, 2022. No net sales were recorded for the three months ended March 31, 2021. ? Operating lo |
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May 20, 2022 |
Exhibit 99.2 Stockholm, Sweden May 18, 2022 Interim Report Q1, 2022 Start of TARPEYO? Commercial Launch in the US ?During the first quarter Calliditas launched its first commercial product, TARPEYO, in the US, supported by 40 experienced specialty sales executives who were trained and in the field in late January. Our commercial product was already available to ship to patients at the end of Janua |
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May 20, 2022 |
Exhibit 99.5 ? Stockholm, Sweden May 19, 2022 ? Calliditas receives positive CHMP opinion in IgA nephropathy Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (?Calliditas?) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the granting of a conditional marketing authorisati |
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May 20, 2022 |
Exhibit 99.6 ? Stockholm, Sweden 19 May 2022 ? Bulletin from the annual general meeting of Calliditas Therapeutics AB (publ) The meeting was held in accordance with sections ?? 20 and 22 of the Act (2022:121) on temporary exceptions to facilitate the execution of general meetings in companies and other associations and the shareholders solely exercised their voting rights at the general meeting th |
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May 20, 2022 |
Exhibit 99.3 ? ? ? Q1 2022 REPORT May 18, 2022 ? ? 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 commercializa |
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April 29, 2022 |
Exhibit 99.1 ANNUAL REPORT 2021 Calliditas Therapeutics is a commercial stage biopharma company based in Stock- holm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic dis- eases with significant unmet medical needs. Calliditas? lead product, TARPEYO, has been approved by the FDA as the first and only tr |
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April 29, 2022 |
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: April 29, 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 exec |
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April 29, 2022 |
Number of shares and votes in Calliditas Therapeutics Exhibit 99.3 Stockholm, Sweden April 29, 2022 Number of shares and votes in Calliditas Therapeutics During April, Calliditas Therapeutics AB (publ) has allotted 830,586 common shares within the company?s warrant program issued in 2018. Thus, as of April 29, 2022, the number of shares and votes in the company amounts to 53,172,170. For further information, please contact: Mikael Widell, Investor re |
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April 29, 2022 |
Calliditas Therapeutics’ 2021 Annual Report Published Exhibit 99.2 Stockholm, Sweden April 27, 2022 Calliditas Therapeutics? 2021 Annual Report Published Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) today announces that the Annual Report for 2021 now is available at the company?s website: www.calliditas.com. This information is information that Calliditas Therapeutics AB is obliged to make public pursuant to the Securities Marke |
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April 27, 2022 |
SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F 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 1 |
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April 27, 2022 |
ESOP 2021 United States Sub-Plan Exhibit 4.12 CALLIDITAS THERAPEUTICS AB ESOP 2021 UNITED STATES SUB-PLAN 1.PURPOSE; DEFINITIONS The purpose of the ESOP 2021 United States Sub-Plan (the ?Sub-Plan?) is to establish certain rules and limitations applicable to Options granted under the T&C?s to Employees and Consultants who are or are expected to become United States residents or otherwise subject to the federal tax laws of the Unit |
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April 27, 2022 |
Exhibit 4.11 Resolution on the introduction of a long-term incentive program for the Company?s management and key personnel (item 16) The Board of Directors of Calliditas Therapeutics AB (publ) proposes the introduction of a long-term incentive program for the Company?s management and key personnel (including employees and consultants) in accordance with the following. The Board of Directors propo |
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April 27, 2022 |
Exhibit 4.2 ? [***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) customarily and actually treated by the registrant as private or confidential. ? Supplemental Agreement and First Amendment to License Agreement regarding NEFECONTM between Calliditas Therapeutics AB (Publ) and Everest Medicines II Limited This SUPPLEMENTAL AGREE |
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April 27, 2022 |
Consent of independent registered public accounting firm EXHIBIT 15.1 Consent of Independent Registered Public Accounting Firm We consent to the incorporation by reference in the following Registration Statements: (1) Registration Statement Form S-8 (333-240126) pertaining to the ESOP 2020 United States Sub-Plan (the ?U.S. Sub-Plan?) and the Long-term Performance Based Incentive Program (the ?Board LTIP 2020?) of Calliditas Therapeutics AB, and (2) Regi |
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April 27, 2022 |
Exhibit 12.1 SECTION 302 CERTIFICATION I, Renée Aguiar-Lucander, certify that: 1. I have reviewed this annual report on Form 20-F of Calliditas Therapeutics AB; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not |
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April 27, 2022 |
Board Long Term Incentive Program 2021 Exhibit 4.8 Board LTIP 2021 in Calliditas Therapeutics AB (publ) GRANT NOTICE & AGREEMENT On 27 May 2021, the annual general meeting in Calliditas Therapeutics AB (publ) (the ?Company?) resolved to introduce a long-term performance-based incentive program for members of the Board of Directors (?Board LTIP 2021?). In summary, the resolution entails that the members of the Board of Directors (each a |
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April 27, 2022 |
Exhibit 13.2 CERTIFICATION OF CFO PURSUANT TO 18 U.S.C. SECTION 1350 AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Fredrik Johansson, Chief Financial Officer of |
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April 27, 2022 |
Exhibit 12.2 SECTION 302 CERTIFICATION I, Fredrik Johansson, certify that: 1. I have reviewed this annual report on Form 20-F of Calliditas Therapeutics AB; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not mis |
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April 27, 2022 |
EX-2.4 3 calt-20211231xex2d4.htm EXHIBIT-2.4 Exhibit 2.4 DESCRIPTION OF SECURITIES The following description of the capital stock of Calliditas Therapeutics AB (“us,” “our,” “we” or the “Company”) is a summary of the rights of our ordinary shares and certain provisions of our articles of association in effect as of May 27, 2021. This summary does not purport to be complete and is qualified in its |
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April 27, 2022 |
Articles of Association of the Registrant (English translation) EX-1.1 2 calt-20211231xex1d1.htm EXHIBIT-1.1 Exhibit 1.1 This document is a free translation. In case of discrepancy between the Swedish and the English version, the Swedish version shall prevail. BOLAGSORDNING FÖR CALLIDITAS THERAPEUTICS AB ARTICLES OF ASSOCIATION OF CALLIDITAS THERAPEUTICS AB Org.nr 556659-9766 Reg. no. 556659-9766 Antagen på årsstämma den 27 maj 2021. Adopted at the annual gene |
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April 27, 2022 |
Exhibit 13.1 CERTIFICATION OF CEO PURSUANT TO 18 U.S.C. SECTION 1350 AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Renée Aguiar-Lucander, Chief Executive Office |
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April 14, 2022 |
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: April 14, 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 exec |
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April 14, 2022 |
Exhibit 99.1 Stockholm 14 April 2022 Notice of annual general meeting of Calliditas Therapeutics AB (publ) The shareholders of Calliditas Therapeutics AB (publ), Reg. No. 556659-9766, with registered office in Stockholm, are summoned to the annual general meeting on Thursday 19 May 2022. With reference to the Swedish Act (2022:121) on temporary exceptions to facilitate the execution of general mee |
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March 22, 2022 |
6-K 1 tm229181d36k.htm FORM 6-K 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: March 22, 2022 (Commission File No. 001-39308) CALLIDITAS THERAPEUTICS AB (Translation of registrant’s name into English) Kungsbron 1, D5 SE-111 22 Stockholm, Sweden (Addres |
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March 22, 2022 |
Calliditas provides a regulatory update on EMA process for Nefecon Exhibit 99.1 Stockholm, Sweden March 22, 2022 Calliditas provides a regulatory update on EMA process for Nefecon Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (?Calliditas?) today announced that the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) can be expected in Q2, 2022. In its review of the marketing authorisatio |
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March 18, 2022 |
6-K 1 tm229181d26k.htm FORM 6-K 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: March 18, 2022 (Commission File No. 001-39308) CALLIDITAS THERAPEUTICS AB (Translation of registrant’s name into English) Kungsbron 1, D5 SE-111 22 Stockholm, Sweden (Addres |
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March 18, 2022 |
Updated regulatory plans for NEFECON in China Exhibit 99.1 Stockholm, Sweden March 18, 2022 Updated regulatory plans for NEFECON in China Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (?Calliditas?) today announced that partner Everest Medicines (HKEX 1952.HK) plans to submit an NDA for NEFECON in China in the second half of 2022. Everest received Breakthrough Therapy Designation (BTD) from the China Center for Drug Evalu |
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March 14, 2022 |
Expansion of Everest Medicine’s licence agreement to include South Korea EX-99.1 2 tm229181d1ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Stockholm, Sweden March 14, 2022 Expansion of Everest Medicine’s licence agreement to include South Korea Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that the company has expanded its licensing agreement with Everest Medicines II Limited (HKG: 1952) (“Everest”) to extend the territory cov |
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March 14, 2022 |
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: March 14, 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 exec |
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March 2, 2022 |
SE:CALTX / Calliditas Therapeutics AB / Linc AB - SC 13G Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G UNDER THE SECURITIES EXCHANGE ACT OF 1934 (Amendment No. )* Calliditas Therapeutics AB (Name of Issuer) Common Shares, quota value SEK 0.04 per share (Title of Class of Securities) 13124Q106 (CUSIP Number) December 31, 2021 (Date of Event Which Requires Filing of This Statement) Check the appropriate box to design |
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February 24, 2022 |
6-K 1 tm227319d16k.htm FORM 6-K 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: February 24, 2022 (Commission File No. 001-39308) CALLIDITAS THERAPEUTICS AB (Translation of registrant’s name into English) Kungsbron 1, D5 SE-111 22 Stockholm, Sweden (Add |
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February 24, 2022 |
Exhibit 99.1 Stockholm, Sweden February 24, 2022 Year-End Report, 2021 Calliditas became the first Company to receive accelerated approval in IgA Nephropathy. ?The accelerated approval of TARPEYO was for the indication of reduction of proteinuria, which was the endpoint of Part A of the trial, in adult patients with IgA nephropathy with risk of rapid progression, which is characterized as generall |
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February 24, 2022 |
EX-99.2 3 tm2212345dex99-2.htm EXHIBIT 99.2 Exhibit 99.2 Significant events in Q4 2021 In December 2021, Calliditas announced that the US Food and Drug Administration (FDA) had granted accelerated approval for TARPEYO (budesonide) delayed release capsules indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a uri |
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February 14, 2022 |
SC 13G 1 tm226050-10sc13g.htm SC 13G UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G UNDER THE SECURITIES EXCHANGE ACT OF 1934 (Amendment No. )* Calliditas Therapeutics AB (Name of Issuer) Common Shares, quota value SEK 0.04 per share (Title of Class of Securities) 13124Q106 (CUSIP Number) December 31, 2021 (Date of Event Which Requires Filing of This Statement |
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January 14, 2022 |
Exhibit 13.2 ? CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 ? In connection with the Annual Report of Calliditas Therapeutics AB (the ?Company?) on Form 20-F for the period ended December 31, 2020, as filed with the Securities and Exchange Commission on the date hereof (the ?Report?), I, Fredrik Jo |
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January 14, 2022 |
Exhibit 13.1 CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 In connection with the Annual Report of Calliditas Therapeutics AB (the “Company”) on Form 20-F for the period ended December 31, 2020, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Renée Aguiar-L |
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January 14, 2022 |
Table of Contents Exhibit 15.1 ? INDEX TO FINANCIAL STATEMENTS ? ? Consolidated Statements of Income 3 Consolidated Statements of Comprehensive Income 4 Consolidated Statements of Financial Position 5 Consolidated Statements of Changes in Equity 6 Consolidated Statements of Cash Flow 7 Notes to Consolidated Financial Statements 8 ? ? ? Table of Contents REPORT OF INDEPENDENT REGISTERED PUBLIC ACCO |