M&A - Eton Pharmaceuticals, Inc.

Form Type: 10-K

Filing Date: 2025-03-18

Corporate Action: Acquisition

Type: New

Accession Number: 000143774925008136

Filing Summary: Eton Pharmaceuticals, Inc. focused on developing and commercializing rare disease treatments, has completed the acquisition of INCRELEX®, a biologic product approved in August 2005 for severe primary insulin-like growth factor 1 deficiency. This product is now part of Eton's portfolio following its launch in December 2024. Additionally, the company has positioned itself with multiple product candidates in late-stage development, underscoring its commitment to enhancing its offerings in the rare disease space. Significant inventory valuations and goodwill accounting were discussed, indicating financial maneuvers associated with this acquisition, including capitalizing on intellectual property. The report also outlines prior achievements and plans for submission through FDA pathways to seek regulatory approval for their product candidates, showcasing the company's growth strategies and market ambitions. Furthermore, risk factors associated with legal compliance and market competition were emphasized, along with the necessity for a robust internal control system.

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Form Type: 8-K/A

Filing Date: 2025-03-07

Corporate Action: Acquisition

Type: Update

Accession Number: 000143774925006678

Filing Summary: On December 19, 2024, Eton Pharmaceuticals, Inc. completed its acquisition of the Increlex product from Ipsen S.A. The acquisition is being treated as a business combination rather than an asset purchase, necessitating the filing of separate audited financial statements and unaudited pro forma financial information by March 7, 2025. The company faces issues in providing these financial statements since historical financial data for Increlex is not available as it was included in Ipsen's consolidated financials. Consequently, Eton has requested a waiver from the SEC to relieve them from this filing requirement. Without this waiver, they are non-compliant with reporting obligations under the Securities Exchange Act, affecting their eligibility to use short-form registration statements for capital raising activities and limiting new equity incentive offerings to employees. The amendment also incorporates additional updates under Item 8.01 related to the acquisition and emphasizes the potential material and adverse consequences of their reporting noncompliance.

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Form Type: 8-K

Filing Date: 2025-01-03

Corporate Action: Acquisition

Type: New

Accession Number: 000143774925000109

Filing Summary: On December 31, 2024, Eton Pharmaceuticals, Inc. acquired Galzin® (zinc acetate) from Teva Pharmaceuticals USA, Inc. Galzin® is the only FDA-approved zinc treatment for maintenance therapy in patients with Wilson Disease who were initially treated with a chelating agent. Eton is set to take over the commercialization of Galzin® in the U.S. in the first quarter of 2025 and will employ its metabolic sales force to support healthcare professionals treating Wilson Disease. Additionally, Eton acquired European rights to the product, which is marketed as Wilzin® by a third party, with Eton continuing to supply the product while the third party oversees commercialization efforts. The total purchase price for Galzin® was $7.0 million at closing, with an additional $0.2 million paid for product inventory. Eton will also pay a 10% royalty on U.S. net sales to Teva for a duration lasting until the tenth anniversary of the first commercial sale in the U.S.

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