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Investment Agreement between Santhera Pharmaceuticals Holding AG and Catalyst Pharmaceuticals, Inc. | | 3 | 3 |
SCHEDULE 4.1(l)
MATERIAL CHANGES SINCE DECEMBER 31, 2022
(As per page 84 of the Company’s Annual Report for 2022)
31. Events after the Reporting Date
In January 2023, the FDA formally accepted the submission of the NDA for vamorolone in DMD for review and notified that it has set the target date for its decision on the NDA to October 26, 2023. Following the acceptance of NDA submission, the Company has received USD 2.0 million milestone payment in relation to China license.
In January 2023, the Company entered into a share exchange agreement with Idorsia, pursuant to which ldorsia transferred 346,500 of its registered shares to Santhera, As consideration, Santhera delivered 5,529,016 Shares, valued at CHF 0.9043 to Idorsia and issued 2,211,607 warrants to ldorsia, each of which is exercisable for one Share at an exercise price of CHF 0.9043 at any time until January 9, 2025. The purpose of such share exchange was to obtain short-term liquidity by selling the Idorsia Shares. As of the date of issuing these consolidated financial statements, all these Idorsia Shares have been sold generating net proceeds of CHF 5.6 million
In February 2023, the Company secured a final pricing reimbursement agreement with the French authorities related to Raxone for the treatment of LHON. The newly agreed price for Raxone in France is lower than the price applied under the temporary pricing scheme, leading to a settlement payment in the amount of approximately EUR 25.4 million, with 30% due around mid-2024 and the remainder one year later. The first payment is currently expected to be covered by sales generated until mid-2024, while the majority of the second payment will be covered by sales beyond mid-2025,
In February 2023, Santhera secured additional funding through a private placement of shares and an amendment of its existing financing arrangement with funds managed by Highbridge to provide up to CHF 22.2 million, subject to certain milestones and conditions. This is intended to cover the capital requirements of the Company through to the PDUFA date in October 2023, when an FDA decision on vamorolone is expected. Concomitant with this transaction, Santhera has formed Strategy Committee focusing on evaluating all strategic options for the Company and plans to nominate Bradley Meyer for election as a new member of its Board of Directors at the Company’s upcoming AGM until when he will serve as a Board Observer. In addition, Santhera issued 40 million shares, 37 million of which were transferred to treasury, in the ordinary capital increase resolved by its $ shareholders on November 29, 2022.
In March 2023, the Company announced that it has submitted a marketing authorization application (MAA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for vamorolone for the treatment of DMD.