Moberg Pharmas Year-end report 2022

REGISTRATION PROCESS AND THE PHASE 3 STUDY ONGOING

THE YEAR (JAN-DEC 2022)

• EBITDA SEK -17.6 million (-17.1) *
• Operating profit (EBIT) -20.2 million (-19.7) *
• Profit after tax SEK -15.7 million (-16.2) *
• Total profit SEK -15.7 million (7.4)**
• Diluted earnings per share SEK -0.21 (0.17)**
• Cash and cash equivalents amounted to SEK 125.6 million (102.7)

FOURTH QUARTER (OCT-DEC 2022)

• EBITDA SEK -3.9 million (-4.2) *
• Operating profit (EBIT) SEK -4.6 million (-4.9) *
• Profit after tax SEK -3.1 million (-4.0) *
• Total profit SEK -3.1 million (-4.0)
• Diluted earnings per share SEK -0.03 (-0.09)
• Cash and cash equivalents amounted to SEK 125.6 million (102.7)

* These comparative figures refer to continuing operations
**Note that the spin‐off of BUPI had a positive effect on earnings of SEK 24 million, which affects total profit and earnings per share for the period

SIGNIFICANT EVENTS IN THE FOURTH QUARTER

• Anders Bröijersén was appointed the new Chief Medical Officer as well as a member of the management team.
• Progress according to plan for regulatory interactions in the EU
• The North American study is progressing as planned.

SIGNIFICANT EVENTS AFTER THE FOURTH QUARTER

• The management team added Jesper Lind, Head of Supply.

STATEMENT FROM THE CEO

REGISTRATION PROCESS AND THE PHASE 3 STUDY ONGOING

THE YEAR (JAN-DEC 2022)

• EBITDA SEK -17.6 million (-17.1) *
• Operating profit (EBIT) -20.2 million (-19.7) *
• Profit after tax SEK -15.7 million (-16.2) *
• Total profit SEK -15.7 million (7.4)**
• Diluted earnings per share SEK -0.21 (0.17)**
• Cash and cash equivalents amounted to SEK 125.6 million (102.7)

FOURTH QUARTER (OCT-DEC 2022)

• EBITDA SEK -3.9 million (-4.2) *
• Operating profit (EBIT) SEK -4.6 million (-4.9) *
• Profit after tax SEK -3.1 million (-4.0) *
• Total profit SEK -3.1 million (-4.0)
• Diluted earnings per share SEK -0.03 (-0.09)
• Cash and cash equivalents amounted to SEK 125.6 million (102.7)

* These comparative figures refer to continuing operations
**Note that the spin‐off of BUPI had a positive effect on earnings of SEK 24 million, which affects total profit and earnings per share for the period

SIGNIFICANT EVENTS IN THE FOURTH QUARTER

• Anders Bröijersén was appointed the new Chief Medical Officer as well as a member of the management team.
• Progress according to plan for regulatory interactions in the EU
• The North American study is progressing as planned.

SIGNIFICANT EVENTS AFTER THE FOURTH QUARTER

• The management team added Jesper Lind, Head of Supply.

STATEMENT FROM THE CEO

We remain fully focused on our two most important activities: the registration process for the nail fungus treatment MOB-015 in Europe and patient enrollment in the North American Phase 3 study. Both the registration process and the clinical study are progressing as planned and we are now intensifying the preparations ahead of expected approval this year.

A dialogue is now underway with the Medical Products Agency in Sweden, which is the reference member state for the registration application in Europe for MOB-015. Moberg Pharma had previously received the preliminary assessment report from the Medical Products Agency in Sweden and all the comments from other countries in the registration process. Moberg Pharma has submitted a full registration application through the decentralized process, which offers the possibility of data exclusivity in Europe for up to 10 years following market approval. Our goal is to receive the first market approval and initiate launch of MOB-015 in 2023.

Our work managing regulatory issues and pre-launch preparations are fully underway. In addition to interactions with our commercial partners, the collaboration with our primary manufacturer in Germany is intensifying and we are also closely dialoguing with component and raw material manufacturers. In connection with the company’s preparations for the commercial phase, we strengthened the management team by adding Jesper Lind, Head of Supply, and also welcomed Anders Bröijersén as the new Chief Medical Officer and member of the management team.

The North American Phase 3 study with MOB-015 is progressing as planned. The randomized, vehicle-controlled, multicenter study will include a total of 350 patients with nail fungus. The patients are being evaluated over 52 weeks and the primary endpoint will be the proportion of subjects achieving complete cure of their target nail. The study design builds on the experience gained from the previous Phase 3 studies and Moberg Pharma is cooperating with the same CRO, same lead investigator and high-performance clinics from the previous North American study.

In 2022, we took important steps towards the commercial phase, including the submission of the registration application in Europe and the start of the North American study to enable registration in the U.S. market. We have also added another commercial partner through the collaboration with Perrigo for the Israeli market. All in all, we are advancing towards the company’s goal to create the future market leader in the treatment of nail fungus, and I look forward with confidence to 2023 with approval expected later in the year.

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 7th, 2023.

goal is to receive the first market approval and initiate launch of MOB-015 in 2023.

Our work managing regulatory issues and pre-launch preparations are fully underway. In addition to interactions with our commercial partners, the collaboration with our primary manufacturer in Germany is intensifying and we are also closely dialoguing with component and raw material manufacturers. In connection with the company’s preparations for the commercial phase, we strengthened the management team by adding Jesper Lind, Head of Supply, and also welcomed Anders Bröijersén as the new Chief Medical Officer and member of the management team.

The North American Phase 3 study with MOB-015 is progressing as planned. The randomized, vehicle-controlled, multicenter study will include a total of 350 patients with nail fungus. The patients are being evaluated over 52 weeks and the primary endpoint will be the proportion of subjects achieving complete cure of their target nail. The study design builds on the experience gained from the previous Phase 3 studies and Moberg Pharma is cooperating with the same CRO, same lead investigator and high-performance clinics from the previous North American study.

In 2022, we took important steps towards the commercial phase, including the submission of the registration application in Europe and the start of the North American study to enable registration in the U.S. market. We have also added another commercial partner through the collaboration with Perrigo for the Israeli market. All in all, we are advancing towards the company’s goal to create the future market leader in the treatment of nail fungus, and I look forward with confidence to 2023 with approval expected later in the year.

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 7th, 2023.