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
For the month of December 2020
(Commission File No. 001-39308)
CALLIDITAS THERAPEUTICS AB
(Translation of registrant’s name into English)
-
Kungsbron 1, C8
SE-111 22
Stockholm, Sweden
(Address of registrant’s principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F x Form 40-F ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨
As previously reported, Calliditas Therapeutics AB (the “Company”) entered into a Share Purchase Agreement (the “Purchase Agreement”) with certain of the largest shareholders and management team (collectively, the “Sellers”) of Gentyotex SA, a French limited liability company (“Genkyotex”) to purchase a 62.7% interest in Genkyotex. Genkyotex’s ordinary shares, nominal value of €1.00 trade on Euronext Paris and Euronext Brussels under ISIN code FR0013399474 (the “Genkyotex Shares”). Genkyotex is a leader in NOX inhibition therapies, and its lead clinical candidate, Setanaxib (GKT831), is in development for Primary Biliary Cholangitis, a chronic orphan liver disease resulting from progressive destruction of the bile ducts in the liver.
On November 3, 2020, having received clearance from the French Minister of Economy and Finance regarding foreign investments into France, the Company closed the off-market block trade of the Genkyotex Shares (the “Acquisition”) pursuant to the Purchase Agreement for a total consideration of €19.8M in cash (€2.73 per ordinary share, after deducting certain transaction costs) plus contingent rights payable upon regulatory approvals of Setanaxib. In addition, in November 2020, Calliditas commenced a simplified mandatory cash tender offer (the “Tender Offer”) for the remaining Genkyotex ordinary shares on the same terms as the Acquisition.
On December 16, 2020, Calliditas announced the results of the Tender Offer following the acceptance period. As a result of the Tender Offer, 2,885,161 shares have been tendered and as a result Calliditas controls a total of 10,121,676 shares in Genkyotex, corresponding to 86.2 percent of the share capital and the total number of votes in Genkyotex. A copy of the Company announcement is attached hereto as Exhibit 99.1, and is incorporated by reference herein.
EXHIBIT INDEX
| Exhibit | Description | |
| 99.1 | Company announcement dated December 16, 2020 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| CALLIDITAS THERAPEUTICS AB | ||||
| Date: December 16, 2020 | By: | /s/ Fredrik Johansson | ||
|
Fredrik Johansson Chief Financial Officer |
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Exhibit 99.1
| Stockholm, Sweden | December 16, 2020 |
Calliditas announces final outcome of simplified mandatory offer to the shareholders of Genkyotex
Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX - CALTX; NASDAQ - CALT) submitted a simplified public mandatory offer to the shareholders of Genkyotex on 26 November 2020. After the end of the acceptance period on December 11, Calliditas now controls 86.2 percent of the shares in Genkyotex.
Calliditas acquired 7,236,515 ordinary shares in Genkyotex SA (“Genkyotex”) (Euronext Paris & Brussels: FR0013399474 - GKTX) on November 3, 2020, corresponding to 62.7 percent of the share capital and voting rights, from Genkyotex's largest shareholders and management group. On November 26, 2020, Calliditas submitted a simplified public mandatory cash offer of EUR 2.80 and non-transferable contingent rights, per share to the remaining shareholders in Genkyotex. In the final outcome after the acceptance period, 2,885,161 shares have been tendered into the offer. As result Calliditas controls a total of 10,121,676 shares in Genkyotex, which corresponds to 86.2 percent of the share capital and the total number of votes in Genkyotex.
For further information, please contact:
Marie Galay, IR Manager, Calliditas
Tel.: +44 7955129845, email: marie.galay@calliditas.com
The information was sent for publication, through the agency of the contact persons set out above, on December 16, 2020 at 5.45 p.m. CET.
About Calliditas
Calliditas Therapeutics is a specialty pharmaceutical company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas’ lead product candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 trial within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (ticker: CALTX) and the Nasdaq Global Select Market (ticker: CALT). Visit www.calliditas.com for further information.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the regulatory pathway for Nefecon, plans for submissions for marketing approvals, plans and strategies for commercialization of Nefecon, if approved, the conduct of Part B of the NefIgArd clinical trial, Calliditas’ strategy, business plans and focus. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, any related to regulatory filings submissions for Nefecon, the continuation of Part B of the NefIgArd study, Calliditas’’ business, operations, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other biopharmaceutical companies, and other risks identified in the section entitled “Risk Factors” in Calliditas’ reports and other filings filed with the Securities and Exchange Commission. Calliditas cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Calliditas disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Calliditas’’ views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.