Moberg Pharma´s Interim report January - March 2022
EUROPEAN MARKETING AUTHORIZATION APPLICATION SUBMITTED AND NORTH AMERICAN PHASE 3 STUDY STARTED
FIRST QUARTER JAN-MAR 2022
- EBITDA SEK -4.8 million (-5.4) *
- Operating profit (EBIT) SEK -5.4 million (-6.1) *
- Profit after tax SEK -4.4 million (-5.0) *
- Total profit SEK -4,4 million (18.6)
- Diluted earnings per share SEK -0.10 (0.46) *
- Cash and cash equivalents amounted to SEK 73.4 million (133.6)
* All comparative figures refer to continuing operations
SIGNIFICANT EVENTS IN THE FIRST QUARTER
- Moberg Pharma submitted a marketing authorization application for MOB-015. The company has submitted the registration application in Europe through the decentralized process, and market approval is expected in 2023.
- Moberg Pharma submitted regulatory filing for the next clinical Phase 3 study to the FDA. The purpose of the new study is to facilitate market approval in the U.S. as well as strengthen the product’s clinical evidence and marketing claims globally.
- The Nomination Committee proposed Kerstin Valinder Strinnholm as the new Chairman of the Board of Moberg Pharma and Anders Lundmark as a new Director on the Board.
- Exercise of warrants of series 2020:1 provided the company with approximately SEK 7.6 million before issue costs.
SIGNIFICANT EVENTS AFTER THE QUARTER
- The Board of Directors has resolved to carry out a fully guaranteed issue of new ordinary shares with preferential rights for existing shareholders of approximately SEK 121 million before transaction costs. The Board of Directors’ rights issue resolution was approved at the Extraordinary General Meeting on 3 May 2022. The net proceeds will be used for registration activities and clinical work for MOB-015.
- Enrollment of patients has begun for the Phase 3 study for MOB-015. The randomized, multicenter, vehicle-controlled Phase 3 study will include approximately 350 patients in North America.
STATEMENT FROM THE CEO
In March, the company submitted a marketing authorization application for MOB-015 in Europe – a key milestone in our journey to launch a new and improved nail fungus drug. The new North American Phase 3 study has started and is fully financed thanks to the guaranteed rights issue.
The submission of the marketing authorization application for MOB-015 to the Swedish Medical Products Agency was the most important event in the quarter. The company submitted the application in Europe through the decentralized procedure with the Swedish Medical Products Agency as the reference member state. Moberg Pharma submitted a full application, which offers the possibility of data exclusivity in Europe for up to 10 years following market approval. Our goal remains unchanged: to receive the first market approval and launch MOB-015 in 2023.
Concurrent with the marketing authorization application, an additional Phase 3 study in North America has been launched. Moberg Pharma submitted regulatory filing for the new study to the FDA in March of this year and has begun enrolling patients in the study. The randomized, multicenter, vehicle-controlled Phase 3 study will include approximately 350 patients in the U.S. and Canada. The patients will be 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. Moberg Pharma will cooperate with the same CRO, lead investigator and successful sites from the previous North American study. The purpose of the new study is to facilitate market approval in the U.S. as well as strengthen the product’s clinical evidence and marketing claims globally.
The submission of the marketing authorization application in Europe and start of the Phase 3 study in North America are two key milestones this year, and now that they have been achieved it is the perfect time to welcome Kerstin Valinder Strinnholm, who has been proposed as the new Chairman of the Board, and Anders Lundmark, one of our major shareholders and proposed as a new Board Director by the Nomination Committee. Current Chairman and founder Peter Wolpert is leaving the Board but will remain one of our major owners. Fredrik Granström is also stepping down from the Board but will retain his role as our legal advisor. I want to take this opportunity to warmly thank Peter and Fredrik for the invaluable efforts on behalf of Moberg Pharma.
The Board of Directors’ resolution on a fully guaranteed rights issue in May will provide the company with approximately SEK 121 million before transaction costs. The financing we have secured gives us the opportunity to fully exploit MOB-015’s potential. With financing secured, the team can now fully focus on the registration process, the clinical study and the preparations together with our partners ahead of the 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 May 10th, 2022.