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Moberg Pharma AB is a pharmaceutical company based in Bromma, Sweden, specializing in the development and commercialization of medical products. Established in March 2006 by Peter Gunnar Maurits Wolpert and Marie Moberg, the company offers a range of products under brands such as Kerasal, Kerasal Nail, Balmex, NewSkin, Dermoplast, Domeboro, and Fiber Choice.
The company recently announced positive outcomes from the Decentralized Procedure for MOB-015, a treatment for fungal nail infections. The program is recommended for national approval in 13 European countries, including Austria, Belgium, Italy, and Spain. The launch strategy involves a two-step process starting in Scandinavia and followed by a pan-European rollout in collaboration with partner Bayer.
Moberg Pharma announces that MOB-015 (topical terbinafine) did not meet the primary endpoint in its North American phase 3 study using 8 weeks of daily dosing followed by weekly maintenance dosing. The study, conducted at 33 centers in the US and Canada with 384 patients, showed that the shorter treatment regimen was insufficient compared to the daily dosing throughout treatment period approved in 13 EU countries.
Following these results and strategic considerations, Bayer Consumer Health has decided to stop the upcoming launch of MOB-015, leading to a mutual termination of the license agreement. Moberg Pharma will regain full rights for MOB-015 in EU while retaining previously paid milestone revenues. The company will shift focus to the European market, where MOB-015 (branded as Terclara®) is already successful in Sweden, growing the market by 44% and achieving 76% mycological cure with daily dosing.
Moberg Pharma AB (OMX: MOB) has announced lower-than-expected clinical cure rates in a subset of patients in its ongoing North American Phase 3 study for MOB-015, a nail fungus treatment. This development has significantly increased the risk of not being able to commercialize the product in the US based on this study. The trial involves 384 patients across 33 study centers in the US and Canada, using a reduced dosage compared to previous studies. The company emphasizes the importance of protecting data integrity and will not speculate on outcomes. Moberg Pharma expects to release topline results before year-end, potentially earlier than previously communicated. A Q&A session with company executives is scheduled for September 13th, 2024, at 15:00 (CET) to address questions regarding this development.
Moberg Pharma has successfully raised SEK 336 million through the exercise of TO 2 warrants and a directed share issue to top guarantors. The TO 2 warrants, amounting to 17,776,856, were exercised at a subscription rate of 98%, adding SEK 320 million. An additional 863,333 shares were issued to top guarantors for SEK 16 million. This capital influx is intended to support the growth and shareholder value, particularly focusing on the launch of MOB-015, approved in 13 EU countries. The new shares will be registered by July 5th, 2024, leading to a total share count of 47,879,854 and a share capital of SEK 47,879,856.39, with a dilution of approximately 39%.
Moberg Pharma AB has signed a distribution agreement with Padagis Israel Agencies Ltd. for MOB-015 in Israel and the Palestinian territories, granting Padagis exclusive rights to market and sell the product. Moberg Pharma will handle production and supply responsibilities, while Padagis manages registration, marketing, and distribution following approval. The Israeli market for topical drugs for onychomycosis is valued at approximately €6.5 million. This marks the sixth commercial agreement for MOB-015, underscoring Moberg's goal to establish it as a leading treatment for nail fungus.
Moberg Pharma AB has submitted a marketing authorization application for MOB-015, a new treatment for nail fungus, as of March 28, 2022. The application is part of a decentralized procedure in Europe, with market approval anticipated in 2023. By receiving this approval, Moberg aims for up to ten years of data exclusivity. The Swedish Medical Products Agency will lead the review process. CEO Anna Ljung emphasized the importance of this submission, highlighting the need for an effective treatment for nail infections.
Moberg Pharma AB has received approval from the Medical Products Agency in Sweden to act as the reference member state for its registration application of MOB-015, a treatment for nail fungus. The company will initiate the registration application process in Europe via a decentralized procedure, expected to be completed by March 2022, aiming for market approval in 2023. This application could secure data exclusivity for up to 10 years post-approval, positioning MOB-015 as a potential leader in antifungal treatments.
Moberg Pharma AB has received approval for its pediatric plan for MOB-015 from the EMA's pediatric committee (PDCO), paving the way for a full marketing authorization application. This approval allows Moberg to conduct a pediatric study involving 30 children aged 6-17, expected to commence in the latter half of 2022. The company anticipates submitting the registration application for MOB-015 in Europe this year, with market approval expected in 2023. This decision enhances data exclusivity in Europe for up to ten years, bolstering Moberg's intellectual property protection.
Moberg Pharma reported a net revenue of SEK 50.5 million for the period from July 2019 to December 2020. The operating profit was SEK 16.0 million, with profit after tax at SEK 10.2 million. However, the sixth quarter saw a net revenue of SEK 0.0 million with losses in EBITDA and EBIT. A significant rights issue raised SEK 150 million for financing the registration of MOB-015, expected to launch in Europe by 2023. The company also announced a spin-off of the BUPI project into OncoZenge AB, which will be listed soon.
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