Moberg Pharma´s Interim report January - June 2023

Moberg Pharma´s Interim report January - June 2023

MOB-015 IS RECOMMENDED FOR APPROVAL IN 13 EUROPEAN COUNTRIES

 SIX-MONTH PERIOD (JAN-JUN 2023)

·      EBITDA SEK -10.7 million (-9.1)

·      Operating profit (EBIT) SEK -12.0 million (-10.4)

·      Profit after tax SEK -8.9 million (-8.3)

·      Total profit SEK -8.9 million (-8.3)

·      Diluted earnings per share SEK -0.90 (-1.34)

·      Cash and cash equivalents amounted to SEK 52.0 million (160.0)

SECOND QUARTER (APR-JUN 2023)

·    EBITDA SEK -4.7 million (-4.3)

·    Operating profit (EBIT) SEK -5.3 million (-4.9)

·    Profit after tax SEK -3.9 million (-3.9)

·    Total profit SEK -3.9 million (-3.9)

·    Diluted earnings per share SEK -0.39 (-0.62)

·    Cash and cash equivalents amounted to SEK 52.0 million (160.0)

SIGNIFICANT EVENTS IN THE SECOND QUARTER

·      The Decentralized Procedure ended with a positive outcome and MOB-015 is recommended for national approval in 13 European countries for the treatment of mild to moderate fungal infections of the nails in adults

o Approval in the European Union represents the first marketing authorizations for Moberg Pharma´s new onychomycosis treatment worldwide

o Approval is supported by two Phase 3 trials where MOB-015 demonstrated superior levels of mycological cure (76% vs up to 42% for comparators) and a significantly better complete cure rate compared to vehicle, without any serious adverse reactions

o MOB-015 is a topical formulation of terbinafine, enabling effective concentrations of terbinafine to the nail and nail bed while avoiding the risk of systemic exposure seen with oral terbinafine use

·      The commercialization rollout will be a two-step process, planned to start in the company’s home market of Scandinavia. Step 2 of the launch will be a pan-European rollout, following the results of the ongoing North American study. Short term the company has limited supply of the active substance terbinafine as only one of the two original terbinafine manufacturers included in the registration file was approved. The launch in two stages means that significant expected revenues are postponed and the Board of Directors of Moberg Pharma has therefore resolved on a rights issue of approximately SEK 100 million

·      The Annual General Meeting on May 16 resolved on among other things to implement a long-term incentive plan as well as a reverse share split. Håkan Wallin was elected as a new board member

SIGNIFICANT EVENTS AFTER THE QUARTER

·      The North American study is progressing as planned and patient enrollment is expected to be completed by the end of the year

·      First national approval was received in Ireland in July

STATEMENT FROM THE CEO

We are incredibly proud that the Decentralized Procedure has ended with a positive outcome and that we will be able to bring a new efficacious treatment option with a favorable safety profile to people living with onychomycosis in Europe.

The approval in the European Union represents the first marketing authorizations for our new onychomycosis treatment worldwide. National approvals are now underway in each country along with OTC approvals when applicable. The national approvals are expected to follow during upcoming months and timelines may vary between countries. We have already now received national approval for Ireland.

In connection with the approval, it was found that only one of our two suppliers of the active substance terbinafine was approved, and this supplier will stop its production of terbinafine later this year. Short term we therefore have a limited supply of terbinafine and the rollout will be a two-step process. The launch is planned to start in our home market Scandinavia. Step 2 will be a pan-European rollout, following the results of the ongoing Phase 3 North American study. The launch in two stages means that significant expected revenues are postponed and the Board of Directors has therefore resolved on a rights issue of approximately SEK 100 million.

We will begin the Scandinavian launch as soon as possible after the national approval and expect to initiate launch preparations in Sweden before the end of the year. The exact choice of countries will depend on time to national approval - which may vary.

This early Scandinavian launch enables us to gain valuable insights into consumer behavior, collect patient feedback and provide user data to support direct to OTC/OTC switches in more countries. The launch in Scandinavia will take place in collaboration with our partner Allderma, managed by the commercial leaders who were responsible for the successful Nordic launch of Nalox®, Moberg Pharma’s first-generation nail fungus product.

Step 2 of the launch will be a pan-European rollout together with our partner Bayer, a world leader in OTC fungus treatments with the Canesten® brand. Bayer is already closely involved in the project and will co-invest in development work such as packaging improvements ahead of the pan-European launch.

One priority going forward will be to ensure long-term supply of terbinafine. We expect to be able to include the second API supplier post approval. We are also looking for an additional API source and have identified several possible suppliers to commence discussions to secure long-term supply of terbinafine.

Approval in the EU is an extremely important milestone for Moberg Pharma, and it is a fantastic accomplishment for our team. I would like to express my sincere gratitude, especially to our fantastic employees and partners, who have worked diligently to get this done, but also to you shareholders for your support along this journey. We have now laid the foundation 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 August 3, 2023.

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