This material has been prepared for marketing purposes and is not and shall not be considered to constitute a prospectus under applicable laws and regulations. The full terms and conditions of the rights issue and further information about the company have been set out in a prospectus which was published and published on mobergpharma.se on August 14, 2023.
The basis for Moberg Pharma business has always been to commercialize drugs against nail fungus that are based on well-proven substances. With MOB-015 The company aims to consolidate its position in nail fungus treatment and surpass the successes the company had with its previous flagship product. Kerasal Nail.
Nail fungus, or onychomycosis, is a fungal infection that affects about one in ten adults and attacks the nails, most commonly on the toes. The infection often starts as a white or yellow spot under the tip of the nail. Over time, nail fungus can cause the nail to become thick, discolored, and cracked.
Developing next-generation treatment
Traditional treatments for nail fungus can be roughly divided into two categories. On the one hand, there are tablet treatments with terbinafine, which are powerful but carry the risk of serious side effects. On the other hand, there are topical preparations, which are less risky but also less effective.
Moberg Pharma has developed MOB-015 to combine the best of both worlds. By using a patented formulation technology, which allows application directly to the nail, the product manages to deliver terbinafine in much higher concentrations directly where it is needed most – on and under the nail – while minimizing the risks associated with tablet treatment. This has been shown to provide significant advantages in combating nail fungus compared to existing topical products.
Sees great market potential
If we look at the market for nail fungus treatments, according to the analysis firm, it is expected Future Market Insights amount to approximately 4,7 billion USD in 2023. The market is expected to grow by just over 8 percent per year to reach over USD 10 billion in ten years. Moberg Pharma itself estimates that MOB-015 has a sales potential of approximately USD 250 – 500 million per year.
So how does MOB-015 compare to existing treatments? In the two phase III studies conducted by Moberg Pharma to date, MOB-015 has shown mycological cure, i.e. the patient becomes fungus-free, in 76 percent of patients. This compares to the 30–54 percent reported for other topical medications.
Received market approval
It was with these data that the company applied for market approval in Europe last year. Earlier this summer, it was announced that the drug was recommended for approval in 13 European countries, including Sweden, Denmark, Norway, France, Italy and Spain. In order for MOB-015 to be sold, approvals are now needed at the national level. Here, Moberg Pharma has managed to get the green light in Sweden and Ireland and the company expects other approvals in the coming months.
Launching in two phases
Moberg Pharma plans to launch MOB-015 in two phases. The first phase will start in the Scandinavian market and is a collaboration with Allderma, who was previously responsible for the Nordic launch of Moberg Pharma's first generation nail fungus product, NaloxoneThe second step will be a pan-European launch in collaboration with the German pharmaceutical giant Bayer.
Before that launch gets underway, Moberg Pharma will focus on securing the supply chain. When market approval was obtained, only one of the company's two suppliers of terbinafine was approved. That manufacturer will cease production of terbinafine later this year. To ensure the availability of terbinafine in the future, Moberg Pharma is now looking for more terbinafine manufacturers.
Study to further strengthen the product
The company will also await the results of a Phase III study currently underway in North America. The study aims to evaluate a shortened treatment period, which Moberg Pharma believes will demonstrate a significantly higher rate of complete healing compared to that used in the previous Phase III studies.
The background is that the hydrating properties of the drug candidate can cause temporary whitish discoloration of the nails. This makes it difficult to assess the clinical healing, where both the mycological healing and the final appearance of the nail are looked at. The results are seen as an important part of MOB-015 being able to reach its full potential. Moberg Pharma expects the study to be fully recruited before the end of the year, with topline results expected in the first quarter of 2025.
Carry out a rights issue of units
As the launch is taking place in two stages, significant expected revenues are being postponed. The Board of Directors of Moberg Pharma has therefore decided to carry out a rights issue of a total of approximately SEK 100 million. The issue is intended to finance clinical and regulatory work, as well as preparations for the market launch. It is 50 percent secured, of which 16 percent is covered by subscription commitments and 34 percent by guarantees.
The offer in summary
| Terms & conditions | The issue is a unit issue, where each unit contains one common share and one warrant of series 2023:1. Each warrant gives the right to subscribe for one new common share during the period June 5 – June 19, 2024, at a price corresponding to 70 percent of the volume-weighted average price paid for the company's share during the period May 20 – May 31, 2024. |
| Subscription period | 16 August – 30 August 2023 |
| Subscription price | SEK 5,75 per unit. |
| Issue volume | SEK 100 million |
| Dilution | Upon full subscription of the initial issue, the dilution amounts to approximately 63 percent. Upon full exercise of the warrants, the total dilution amounts to approximately 77 percent for shareholders not participating in the rights issue. |
Information and subscription
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