Moberg Pharma´s interim report January - March 2024

LAUNCH INITIATED IN SWEDEN

FIRST QUARTER (JAN-MAR 2024)

·        Net revenue SEK 0.8 million (0)

·        EBITDA SEK -7.6 million (-6.1)

·        Operating profit (EBIT) SEK -7.9 million (-6.7)

·        Profit after tax SEK -6.5 million (-5.0)

·        Diluted earnings per share SEK -0.23 (-0.51)

·        Cash and cash equivalents amounted to 38.6 million (84.5)

SIGNIFICANT EVENTS IN THE FIRST QUARTER

·        The sale of MOB-015 in Sweden under the brand name Terclara® has begun in collaboration with the company’s partner Allderma and the majority of pharmacies around the country have decided to sell the product.

·        In February, the Nomination Committee presented its proposal to the Annual General Meeting 2024, where Jonas Ekblom was proposed for election as a new board member.

SIGNIFICANT EVENTS AFTER THE QUARTER

·        National approvals have been received in the following countries: Belgium, Italy and the Netherlands. In all three countries MOB-015 has been approved for OTC sales and with this, national approvals have been received for all countries included in the decentralized procedure. 

·        An application to include the intended terbinafine supplier in the company’s registration file for MOB-015 has been submitted. Approval is expected before the end of the year.

·        TV marketing started on April 1 and a majority of Swedish pharmacies have the product available on the shelf.

STATEMENT FROM THE CEO

The launch to pharmacies was initiated in February. A majority of ~1,400 Swedish pharmacies now have MOB-015 available on the shelf under the brand name Terclara® and interest is exceeding the chains’ forecasts. The pharmacy chains are increasing their orders after consumer marketing began around the end of March due to the fact that the product occasionally has sold out at several of the pharmacy chains. However, there is a well-stocked wholesale warehouse.

We have now received national approvals in all 13 countries in the decentralized procedure. The three countries added since last report - Belgium, Italy and the Netherlands – all decided to approve the product for over-the-counter (OTC) sales right from the start. It is important for us to obtain approval as an OTC pharmaceutical in as many markets as possible, since the largest sales volumes in Europe are expected to come from markets where the product has OTC status. It is therefore gratifying that 7 of the 13 countries have granted OTC approval.

In the North American study, half of the patients have now completed their treatment. After patient enrollment was finalized in October 2023, cash flow has improved through lower expenditure as we are now nearing the end of the study. The North American study is a double-blind, randomized, vehicle-controlled, multicenter Phase 3 study being conducted at 33 study centers in the U.S. and Canada. The study will be unblinded after the fungal sample from the last patient’s last visit has been analyzed, with topline results expected in January 2025. Ahead of this data, we are intensifying our business development activities and have entered into a collaboration with Back Bay Life Science Advisors, which has conducted in-depth interviews with U.S. payer representatives and is organizing our process to find the best partner for targeting U.S. dermatologists. The in-depth interviews indicate a strong willingness on the part of insurance companies to pay per completed treatment cycle, which in combination with the medical need makes the U.S. a very attractive market for a new nail fungus medication. To capture the full potential in the U.S. and capitalize on the knowledge we gained from our first-generation product Kerasal Nail®, we want to build our own footprint in the U.S. market vis-à-vis podiatrists, while also collaborating with a company with an established sales force targeting dermatologists. Our intent is to enter into such a collaboration after the topline data has been made public.

During the quarter, we together with our partner Allderma worked to ensure that the preconditions for a successful launch are in place and Terclara® started to appear on shelves at Swedish pharmacies in February of this year. In parallel with the pharmacies filling up the shelves, work was ongoing in February and March to inform physicians and pharmacists about the unique benefits of Terclara®. The focus has now shifted to end consumers, with TV marketing started on April 1 as planned. This means that MOB-015 is available to Swedish patients ahead of high season for those who want to begin the journey towards attractive, fungus-free nails before sandal season and the summer holiday.

Sales in the quarter mainly reflect the initial pharmacy orders. It is not until consumer marketing begins that demand from patients will affect the sales figures. Sweden is initially the priority market for Moberg Pharma as we have limited access to terbinafine (the active substance in Terclara®) in the near term. We continue to deliver on our plan to secure a long-term supply of terbinafine ahead of the planned pan-European rollout. 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 actively working to secure another terbinafine supplier and thus have two parallel tracks to ensure a stable supply of terbinafine.

Preparations ahead of the pan-European rollout and commercialization in the U.S. are the company’s biggest value drivers. During the quarter, we continued to deliver according to plan for all key activities: the North American study, long-term terbinafine access and the rollout of Terclara® in Sweden. The Swedish launch is an important springboard to realize our vision – to make MOB-015 the leading nail fungus treatment worldwide.

Anna Ljung, CEO of Moberg Pharma