Year-end report 2023

LAUNCH INITIATED IN SWEDEN

THE YEAR (JAN-DEC 2023)

• EBITDA SEK -25.4 million (-17.6)
• Operating profit (EBIT) SEK -27.5 million (-20.2)
• Profit after tax SEK -21.1 million (-15.7)
• Total profit SEK -21.1 million (-15.7)
• Diluted earnings per share SEK -1.33 (-2.07)
• Cash and cash equivalents amounted to SEK 60.6 million (125.6)

FOURTH QUARTER (OCT-DEC 2023)

• EBITDA SEK -8.0 million (-4.0)
• Operating profit (EBIT) SEK -8.2 million (-4.6)
• Profit after tax SEK -6.4 million (-3.1)
• Total profit SEK -6.4 million (-3.1)
• Diluted earnings per share SEK -0.23 (-0.32)
• Cash and cash equivalents amounted to SEK 60.6 million (125.6)

SIGNIFICANT EVENTS IN THE FOURTH QUARTER

• Enrollment to the North American study is completed by a wide margin in 2023; 384 patients have been randomized at 33 study centers in the U.S. and Canada. Topline results are expected in January 2025.
• Management changes where Robert Ehrl succeeds Jesper Lind as Head of Supply and Christina Erixon succeeds Agneta Larhed as Vice President Vice President Pharmaceutical Innovation & Development.
• Manufacture and transport of MOB-015 ahead of launch has been completed according to schedule.

SIGNIFICANT EVENTS AFTER THE QUARTER

• The sale of MOB-015 in Sweden under the brand name Terclara® has begun and the product is now available at the majority of pharmacies around the country.

STATEMENT FROM THE CEO

MOB-015 is now on the shelves of pharmacies around Sweden under the brand name Terclara® – a milestone we have been working towards at Moberg Pharma for some time. It is especially gratifying to see the great interest in the product among the pharmacies.

We are now in the midst of the rollout to pharmacies of Terclara®, the brand name that MOB-015 is being launched under in Sweden by our partner Allderma. Production and inselling to pharmacy chains has been completed on schedule, so that the pharmacies can get the product now during the “February window,” one of three times during the year when the chains reset their shelves. At the same time as pharmacies fill up the shelves, work is ongoing to inform doctors and pharmacy staff about the unique advantages of Terclara®. We're also conducting tests and fine-tuning marketing materials to ensure that it effectively communicates the product's superior features to our target groups. This is followed by targeted marketing to consumers, including digital marketing starting from March and TV commercials from April onwards. This means that MOB-015 is now available to Swedish patients ahead of high season in Q2 for those who want to begin the journey towards attractive, fungus-free nails before sandal season and the summer holiday.

We have received national approvals in a total of ten countries to date and are awaiting approvals in the remaining three countries included in the DCP process. We are dialoguing with the countries - Italy, Belgium and the Netherlands - that have not yet approved the product, where the approval decisions are taking time mainly due to the limited resources and heavy workload of the regulatory authorities. It is worth noting that all the countries have approved the product within the DCP process. National approvals affect only national adjustments, such as the translation of the product literature to the national language and whether the product will be approved for over-the-counter (OTC) or prescription (Rx) sales in each country.   

Sweden is the priority market for Moberg Pharma as we have limited access to terbinafine in the near term. We have made progress in our efforts to secure a long-term supply of terbinafine ahead of the planned pan-European rollout together with our partner Bayer. We continue to work together with our intended terbinafine supplier, with an anticipated application submission expected shortly. In addition, we are actively working to secure another terbinafine supplier and have ordered terbinafine from alternative manufacturers. Upon delivery, we will have a small batch of MOB-015 manufactured for the stability studies required for the regulatory process to include a new terbinafine manufacturer. We thus have two parallel tracks to ensure a stable supply of terbinafine.

An important event during the quarter was the conclusion of patient enrollment in North America in early October by a wide margin thanks to the outstanding efforts of the team and engaged investigators. A total of 384 patients have been randomized at 33 study centers in the U.S. and Canada. The completion of the recruitment has also resulted in an outflow of cash linked to this milestone and we expect lower expenses for the study going forward. The timing when the last patient is enrolled in the study determines the timeline when data can be presented, and thanks to the fact that enrollment was completed in October, we expect to be able to present topline results as soon as January 2025. Maintaining a dialogue with the investigators in the study and key opinion leaders is important to both our ongoing clinical work and so that medical personnel will receive the product in the best way, and we look forward to again meeting many of our investigators at the annual meeting of the American Academy of Dermatology (AAD) in March.  

Now in the first quarter we see that the preconditions for a successful launch are in place, with pharmacies filling up their shelves, and we look forward to launching our marketing to the consumer when high season is approaching and interest in treating nail fungus peaks. 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

ABOUT THIS INFORMATION
This information is information that Moberg Pharma is Obliged to make public persuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out below, at 8.00 a.m. CET on February 13th, 2024.

FOR ADDITIONAL INFORMATION
Anna Ljung, CEO, Phone: +46 70 766 60 30, e-mail: anna.ljung@mobergpharma.se
Mark Beveridge, VP Finance, Phone: +46 76 805 82 88, e-mail: mark.beveridge@mobergpharma.se

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