Moberg Pharma´s Interim report January - September 2022

PROGRESS IN THE REGISTRATION PROCESS AND LAUNCH PREPERATIONS

NINE-MONTH PERIOD (JAN-SEP 2022)

• EBITDA SEK -13.7 million (-12.9) *
• Operating profit (EBIT) -15.6 million (-14.8) *
• Profit after tax SEK -12.6 million (-12.2) *
• Total profit SEK -12.6 million (11.4)**
• Diluted earnings per share SEK -0.18 (0.26)**
• Cash and cash equivalents amounted to SEK 142.5 million (111.4)

THIRD QUARTER (JUL-SEP 2022)

• EBITDA SEK -4.6 million (-4.0) *
• Operating profit (EBIT) SEK -5.3 million (-4.7) *
• Profit after tax SEK -4.3 million (-3.9) *
• Total profit SEK -4.3 million (-3.9)
• Diluted earnings per share SEK -0.04 (-0.09)
• Cash and cash equivalents amounted to SEK 142.5 million (111.4)

* These comparative figures refer to continuing operations 
** Note that the spin-off of BUPI resulted in a positive earnings effect of SEK 24 million, which affects total profit and earnings per share in the comparable figures

SIGNIFICANT EVENTS IN THE THIRD QUARTER

• Progress was made in interactions with regulatory authorities in the EU and in patient recruitment for the North American study.
• In August, a distribution agreement was signed with Padagis Israel Agencies Ltd. for MOB-015 in Israel. Padagis will finance the registration activities in Israel and will have marketing, distribution and sales responsibility in Israel and the Palestinian territories after product registration. 

SIGNIFICANT EVENTS AFTER THE THIRD QUARTER

• Anders Bröijersén was appointed the new Chief Medical Officer and a member of the management team.

STATEMENT FROM THE CEO

The two most important activities in the near term for the company – the registration process for MOB-015 in Europe and patient enrollment in the new North American Phase 3 study – are progressing according to plan. Together with our partners, we are continuing preparations ahead of the expected approval and initiation of launch next year.

During the quarter, the company received the preliminary assessment report from the Medical Products Agency in Sweden as well as all comments from other countries in the registration process. Moberg Pharma has submitted a registration application in Europe through the decentralized process, with the Medical Products Agency in Sweden as the reference member state for the application. Moberg Pharma has submitted a full application, 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.

In August, Moberg Pharma signed its sixth distribution agreement for MOB-015, this time with Padagis for the Israeli market. Under the agreement Padagis is granted exclusive rights to market and sell MOB-015 in Israel and the Palestinian territories. Moberg Pharma assumes production and supply responsibility.

Our work managing regulatory issues and pre-launch preparations intensifies this autumn, in close collaboration with our partners. In addition to interactions with our commercial partners, we for example visited our primary manufacturer in Germany in October and are also regularly in dialogue with component and raw material manufacturers.

The North American study with MOB-015 is progressing as planned. We now have 30 different clinics in the U.S. and Canada which are treating patients in the study. The randomized, vehicle-controlled, multicenter Phase 3 study will enroll 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.

We are advancing toward the company’s goal to create the future market leader in the treatment of nail fungus. The company has now received questions from all countries in the registration process and continues to deliver according to plan ahead of the expected approval and launch in 2023.

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 8th, 2022.