Terclaraor MOB-015 as the product is called in the development context, is now available at the majority of Swedish pharmacies – unless it has sold out. Since the launch towards end consumers began in March, sales have exceeded forecasts, which has led to pharmacy chains increasing their orders. In other words, it is clear that there is a great need for a new and more effective treatment for nail fungus.
Despite the fact that an estimated one in ten people suffer from nail fungus, there has long been a lack of good treatment options. The most common antifungal substance against nail fungus is terbinafine in tablet form. Terbinafine is also available as a topical formulation for other indications, which is well suited for treating, for example, athlete's foot or jock itch. The problem with nail fungus is that a topical formulation does not reach under the nail. Today, the standard treatment for nail fungus patients is therefore terbinafine in tablet form, which is, however, associated with a risk of systemic side effects such as liver damage.
World-leading antifungal effect without the risk of systemic side effects
Moberg Pharma The drug MOB-015 is a topical formulation of terbinafine that has the ability to penetrate the nail and deliver terbinafine directly to the infected area. This provides a 40-fold higher concentration of terbinafine under the nail than with tablets, while avoiding the risk of systemic side effects.
Data from two Phase III studies in a total of 800 patients have shown that MOB-015 has superior antifungal activity compared to other products on the market today. The company was able to report a mycological cure, i.e. the patient becomes free of fungus, in 76 percent of cases, which is a world-leading rate for a topical preparation.
Flying start to sales in Sweden
With this data, Moberg Pharma has secured market approval in 13 EU countries, seven of which have also been granted prescription-free access from the start. The company has now taken its first steps on the Swedish market together with partner Allderma, whose team was also behind the launch of Naloxone, the company's first-generation product, which has until now been the market leader in the Nordic region. The first packages of Terclara were placed on store shelves in February.
In parallel, work was underway during February and March to inform doctors and pharmacists about the benefits of the product. After that, the focus is now on the end consumer, where TV marketing started at the beginning of April, as planned. The goal for the company has been to achieve a market-leading position with its new product, and in Sweden that milestone was already achieved in April. Terclara's market share was then 36 percent, and with the introduction, the total market increased by over 50 percent, compared to the same period last year.
Securing suppliers ahead of broad European launch with Bayer
The company sees the sales figures as a very promising start for the upcoming pan-European market launch, where it has market approval in 13 EU countries. Here Moberg Pharma will work with the partner Bayer, which today has a world-leading position in over-the-counter mushroom products with the brand The canestIn total, the company has 5 commercial partners in place, for territories such as the EU, Canada and Korea.
Before the European rollout, two important items remain on the to-do list. The first and perhaps most critical is to secure sufficient access to terbinafine, as the company's existing supplier has ceased production of the substance. In April, Moberg Pharma submitted an application to the relevant authorities to add a terbinafine manufacturer for MOB-015, with approval expected before the end of the year. In order to further reduce dependence on individual suppliers, work is being done in parallel to secure a third alternative.
Targeting the USA with great sales potential
The second important point going forward is the results of the US phase III study that is currently underway. Good results from there will both open the door to the important US market and strengthen the product's market claims globally. The study tests a shorter treatment period followed by maintenance treatment. The hope is to maintain high antifungal efficacy while achieving better clinical healing, as well as simplifying the process for patients by shortening the period of daily treatment.
Phase III results are expected in January 2025 and in preparation for the reading, Moberg Pharma is working to prepare for commercialization in the US, the largest single nail fungus market, which accounts for approximately half of the product's expected global sales potential of 250-500 million USD annually. Here, Moberg Pharma has enlisted the help of Back Bay Life Science Advisors including finding a good partner for American dermatologists. In addition to the partnership, the plan is to also build its own presence in the US, where the company will benefit greatly from the experience from the launch of the predecessor Kerasal Nail/Nalox.
Redemption in TO 2 finances international launch
Moberg Pharma is currently in the process of exercising the TO 2 warrant, which is part of last year's oversubscribed unit issue. If fully exercised, the cash position will be strengthened by approximately SEK 326 million. For holders of TO 2, it is important to notify their broker of their interest in participating. If you do not want to subscribe for your share, there is the option to sell the warrants. For those who do not already own TO 2, there is the opportunity to purchase these via the stock exchange (MOB TO 2).
Summary of the offer
| Terms & conditions | A warrant of series TO 2 entitles the holder to subscribe for one newly issued share. |
| Redemption period | 5 – 19 June 2024 |
| Subscription price | SEK 18 per share |
| Volume | SEK 326 million before issue costs |
| Pre-money valuation | SEK 511 million |
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