Moberg Pharma´s Interim report January - September 2023

Moberg Pharma´s Interim report January - September 2023

MOB-015 HAS RECEIVED NATIONAL APPROVALS IN 10 EU COUNTRIES, ANOTHER 3 APPROVALS ARE EXPECTED

NINE-MONTH PERIOD (JAN-SEP 2023)

·      EBITDA SEK -17.4 million (-13.7)

·      Operating profit (EBIT) SEK -19.2 million (-15.6)

·      Profit after tax SEK -14.6 million (-12.6)

·      Total profit SEK -14.6 million (-12.6)

·      Diluted earnings per share SEK -1.24 (-1.84)

·      Cash and cash equivalents amounted to SEK 101.5 million (142.5)

THIRD QUARTER (JUL-SEP 2023)

·    EBITDA SEK -6.6 million (-4.6)

·    Operating profit (EBIT) SEK -7.3 million (-5.3)

·    Profit after tax SEK -5.8 million (-4.3)

·    Total profit SEK -5.8 million (-4.3)

·    Diluted earnings per share SEK -0.36 (-0.43)

·    Cash and cash equivalents amounted to SEK 101.5 million (142.5)

SIGNIFICANT EVENTS IN THE THIRD QUARTER

·      National approvals have been received in the following countries: Austria, Czech Republic, Denmark, Finland, France, Hungary, Ireland, Norway, Spain and Sweden.

·      Moberg Pharma’s rights issue of SEK 100 million was oversubscribed – subscription rate 130%. The rights issue of units comprised of shares and warrants was resolved by the Board of Directors on June 28. The Board of Directors also resolved on a directed issue to guarantors in the rights issue. The Board of Directors’ resolutions were approved by the Extraordinary General Meeting on August 8 and the Extraordinary General Meeting on October 9.

SIGNIFICANT EVENTS AFTER THE QUARTER

·      Enrollment to the North American study is now 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 Pharmaceutical Innovation & Development.

STATEMENT FROM THE CEO

Both the regulatory process, with additional national approvals during the quarter, and the North American study where patient enrollment was completed by a wide margin in 2023 are important achievements for the company.

The completion of enrollment in North America in early October, by a wide margin within 2023, is an important milestone and the result of an outstanding effort by the team and engaged investigators. I am very pleased with the progress of the study, where a thorough screening process and collaborative climate increase the probability of strong Phase 3 data. A total of 384 patients have been randomized at 33 study centers in the U.S. and Canada. The timing when the last patient is enrolled in the study also determines the timeline when data can be presented, and because enrollment was completed in October we expect to be able to present topline results as early as January 2025.

We have now received national approvals in a total of ten countries, and are awaiting approval in the three remaining countries included in the DCP process. Czech Republic, Denmark, Finland, France, Ireland and Spain have issued national approvals for prescription sales (Rx), while Austria, Hungary, Norway and Sweden have issued approvals for over-the-counter sales (OTC). It is important that we obtain approvals for OTC sales of the medication in as many markets as possible, since the largest sales volumes in Europe are expected to come from the markets where the product has OTC status – which will take different lengths of time for different markets and will not be implementable everywhere. The decisions by Swedish and Norwegian authorities to make the product available from the start at pharmacies without a prescription is therefore a key achievement, since the commercial launch is planned to start in our home market and we are working with launch preparations for Sweden together with our partner Allderma. This early launch enables us to gain valuable insights into consumer behavior, collect patient feedback and provide user data to support a direct RX to OTC switch in more countries.

One of our focus areas is 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 API supplier, which we expect to apply to include in the file in H1 2024. We are also actively looking for an additional API source and have commenced discussions with potential candidates through our manufacturer to secure a stable long-term supply of terbinafine.

The rights issue that we completed during the quarter despite the challenging market climate was oversubscribed and provided the company with proceeds of SEK 100 million before transaction costs. The net proceeds will mainly be used for clinical and regulatory activities for MOB-015 and preparations ahead of launch. We are pleased to have secured financing and look forward to devoting our time on executing on our business with full force.

In summary, the third quarter was a productive quarter in which we continued to deliver according to plan with the national approvals, progress in the North American study and preparations for the forthcoming launch. We continue to work diligently 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 November 7, 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