A majority of all Swedish pharmacies already have Terclara on their shelves. The interest in the new nail fungus drug, which in the development context goes by the name MOB-015, is big. So big that it has sold out at several Swedish pharmacy chains, which have therefore increased their orders.
The fact that the product is now available for sale is of course a milestone for Moberg Pharma, whose shares have had a very strong performance on the stock market so far this year. It is clear that many are hopeful now that it has made it all the way to market – again. With Terclara, Moberg wants to repeat the success of its previous nail fungus product Nalox/Kerasal Nail.
Preparing for European launch
Together with partners Allderma Terclar is now being launched in Sweden. In the next step, the aim is set on the European market, where the launch will take place in collaboration with German BayerWork is currently underway to secure access to terbinafine, which is the product's antifungal ingredient. An application to include an additional terbinafine manufacturer was submitted in April and approval is expected before the end of the year, and Moberg then expects Terclara to be launched in the rest of Europe for the spring 2026 peak season.
In parallel, results are expected from the ongoing phase III study currently being conducted in the US. In previous studies, the drug has been shown to be an effective antifungal agent, with minor discoloration of the nail. A shorter treatment period is now being evaluated prior to launch on the US market, where the expectation is to be able to achieve a good effect without any discoloration.
Current with redemption in TO 2
As part of the financing of the market launch, Moberg is currently exercising the TO 2 warrant, which was issued in connection with last year's unit issue, during the month of June. The subscription rate was a full 130 percent, which can be seen as another clear sign of the interest in the company. The subscription period for TO 2 takes place during the period from June 5 to June 19, and if fully subscribed for TO 2, just over 17 million new shares will be printed and added to today's more than 27 million.
The subscription price will be set between 20 and 31 May and will correspond to 70 percent of the volume-weighted average price at which the common share is traded at that time. At the time of writing, the Moberg share is worth just under SEK 25. For holders of TO 2, it is important to notify their broker of their interest in participating. If you do not wish to subscribe, the alternative is to sell your warrants. For those who do not already own TO 2, they are available for purchase via the stock exchange.
CEO comments
In connection with the impending redemption of TO 2, BioStock has contacted Moberg Pharma's CEO Anna Ljung, to find out more about the launch and future plans.
First of all Anna, after many years of development work, Terclara is now available for purchase in Swedish pharmacies. How does that feel?
– I am extremely proud that as a small Swedish company we have managed to take a drug candidate all the way from idea to approved drug. It feels fantastic that our drug is now available to patients who previously lacked good treatment options. Extensive teamwork has led to market approval in 13 EU countries and that we now have a product on the pharmacy shelf that has the potential to become the market leader in nail fungus.
What feedback do you get from pharmacies, doctors and patients?
– A generally very positive reception from all. Nail fungus is a significant medical need and is common, with more than 100 million patients in the EU and the US. Despite one in ten people having nail fungus, there is currently a lack of good treatment options. Interest in the product is exceeding the pharmacy chains' forecasts, and pharmacies are increasing their orders due to Terclara being temporarily sold out at several of the pharmacy chains.
– However, there is a well-stocked wholesale warehouse. Patients also verify the great need for new treatment options for nail fungus and we receive patient inquiries from many countries, as Sweden is the first country where the drug is launched.
Judging from your communication, the launch in Sweden looks to be going better than expected. What expectations do you have when it comes time to take the plunge into Europe?
– Launching in Europe together with the Consumer Health division of Bayer AG for Europe, the world leader in over-the-counter products for fungal treatment under the Canesten brand is of course a fantastic opportunity. Canesten's strong brand and Bayer's expertise combined with our product profile with MOB-015's antifungal properties, means that our expectation is that MOB-015 will be the market leader.
To enable the launch in Europe, you need a new supplier of terbinafine, so that you can secure product delivery. What does that process look like?
– In April, we submitted an application to add a terbinafine manufacturer for MOB-015, with approval expected before the end of the year. In addition, we are working to secure an additional terbinafine supplier, thus having two parallel tracks to ensure stable long-term supply of terbinafine.
If we turn our attention to the USA and the study that is underway there. What is the background to its implementation and what are your expectations for the results?
– The purpose of the new study is to enable market approval in the US and strengthen the product's clinical evidence and marketing claims globally. Our expectation is that we will be able to maintain the high antifungal effect and show even better clinical healing through modified dosing – where patients only treat daily for 8 weeks and then switch to maintenance treatment once a week.
You are reducing the treatment time compared to previous studies, to avoid the discoloration that has occurred. What risks do you see in that it will affect the antifungal effect?
– In a previous study, we showed that patients treated daily for 24 weeks had 1000 times higher levels of terbinafine (the antifungal substance in Terclara) in the nail, and 40 times higher levels in the nail bed (under the nail) compared to tablet treatment. Converted with the new dosage, this should correspond to in the order of 20 times higher levels of terbinafine than tablet treatment that we know works clinically. The fact that the mycological cure was a full 76 percent in phase III also shows that we manage to deliver sufficient amounts of terbinafine and kill the fungus.
The US market is important for all pharmaceutical companies, given its size and price point. What interest have you seen for your product in the US?
– The interest in our product is global, as there are currently not enough attractive treatment alternatives to meet the need for an effective product with a good safety profile. As we see the US as the company's biggest opportunity, we are intensifying our business development activities ahead of the expected US topline results in January 2025. We have entered into a collaboration with Back Bay Life Science Advisors, who have conducted in-depth interviews with US representatives of pharmacy chains and insurance companies, and are organizing our process to find the best collaboration partner with US dermatologists.
– The in-depth interviews indicate a high willingness to pay per completed treatment cycle from insurance companies, which in combination with the medical need makes the USA a very attractive market for a new nail fungus drug. In order to utilize the full potential in the USA and the knowledge from our first-generation product Kerasal Nail, we want to build our own presence in the American market towards podiatrists and in addition to that, collaborate with a company with an established sales force towards dermatologists. Our intention is to enter into such a collaboration after the topline data has been published.
We have the redemption of TO 2 in June. How is the proceeds intended to be used?
– The proceeds will be used for both clinical and regulatory work for MOB-015 as well as in the launch work. Our expectation is that the company's cash position after the TO 2 conversion is completed is sufficient to take the company through the ongoing Phase III study and to the pan-European launch, after which the company will generate steady revenue.
Why is Moberg Pharma a good investment right now, in your opinion?
– We have begun the launch of the drug Terclara in Sweden with great interest from pharmacists, doctors and end customers. The goal is to make the drug Terclara the leading treatment option for nail fungus globally.
– With strong clinical data, market approval in 13 EU countries and strategic partnerships in place, there is now an investment opportunity in warrants series TO 2 to purchase via the stock exchange with a subscription period of June 5 - 19, which represents an attractive opportunity to enter the company.
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