Moberg Pharma AB Interim report January - March 2021
Moberg Pharma AB Interim report January - March 2021
REGISTRATION PREPARATIONS FULLY UNDERWAY
FIRST QUARTER (JAN-MAR 2021)
· EBITDA SEK -5.4 million (-3.6) *
· Operating profit (EBIT) SEK -6.1 million (-4.2) *
· Profit after tax SEK -5.0 million (-3.4) *
· Total profit SEK 18.6 million (-3.4)
· Diluted earnings per share SEK 0.46 (-0.18) *
· Cash and cash equivalents amounted to SEK 133.6 million (51.6)
· Cash and cash equivalents SEK 142 million adjusted for effects of OncoZenge divestment (reversed in Q2)
* All comparative figures refer to continuing operations
SIGNIFICANT EVENTS IN THE FIRST QUARTER
· A patent was granted for MOB-015 in India, adding to previously granted patents in major markets such as the U.S., Canada, the EU, China and Japan. Patent term until 2032.
· Moberg Pharma’s rights issue of SEK 150 million was carried out and registered. The rights issue was approved by the Extraordinary General Meeting in December 2020 and was fully subscribed without issue guarantees.
· The Lex Asea distribution of OncoZenge shares was completed. Ten ordinary shares in Moberg Pharma entitled one share in OncoZenge AB. OncoZenge was listed with February 12 as the first day of trading on Nasdaq First North Growth Market.
· OncoZenge was granted a new European patent for BUPI. The new patent provides broad protection for sustained-release lozenges containing bupivacaine, for treatment or alleviation of pain in the oral cavity, and is based on a previously granted patent providing protection for pain treatment of oral mucositis in cancer patients.
SIGNIFICANT EVENTS AFTER THE FIRST QUARTER
· On April 19, 2021, the Nomination Committee proposed Nikolaj Sörensen, President and CEO of Orexo, as a new member of the Board of Directors.
STATEMENT FROM THE CEO
Registration preparations for MOB-015 are progressing at full speed, including recently received final comments on our pediatric plan from EMA, compilation of a single safety database with data from all MOB-015 studies and development of the product label in collaboration with our partners. We remain on plan to submit the registration application in Europe in the second half of 2021.
Preparations for registration in Europe are fully underway, based on two Phase 3 studies that combined included more than 800 patients. Since the primary endpoint was reached in both the North American and European studies, we are using this data as the basis for product registration in Europe. We intend to choose a registration route that offers the possibility of valuable data exclusivity for up to 10 years following market approval, which means that regulatory approval of a pediatric plan will be the determining factor when we can submit the registration application. We have recently received final comments on our pediatric plan from the EMA and see a good chance of coming to agreement with authorities on a realistic pediatric plan with a clinical study including a limited number of children. We expect a final decision from the EMA’s Paediatric Committee this autumn. After discussions with authorities, we feel there is a strong likelihood that we can utilize this registration route and obtain data exclusivity. Regardless of the outcome of the pediatric plan, we intend to submit a registration application in Europe in the second half of the year, notwithstanding data exclusivity, since we have strong IP protection by the granted patents for MOB-015. We expect the registration application to be granted within 18 months after submission, which means that MOB-015 could be launched in Europe by the end of 2023.
Regarding intellectual property rights, we were recently granted a patent in India, adding to previously granted patents in all 38 member states of the European Patent Office (EPO), the U.S., Canada, Japan, China, the Republic of Korea and eight other countries. We also added a number of approvals to our trademark portfolio during the quarter. Our branding strategy includes securing global trademark and domain protection for five separate trademark families. The trademarks are required for registration application in various countries, but we also see opportunities for our own trademark in certain markets to complement our partners’ established trademarks in other regions or markets.
In February, BUPI was spun off via a distribution of shares in OncoZenge to Moberg Pharma’s shareholders and a successful IPO of OncoZenge on Nasdaq First North Growth Market which provided visibility of the value of the BUPI project. In connection with the listing, OncoZenge secured SEK 70 million in capital to conduct a registration study in Europe. The spin-off also resulted in a positive earnings effect of SEK 24 million, which is included in the total profit for Moberg Pharma in Q1 of SEK 19 million.
Altogether, I am very pleased with the team and progress made in the quarter. It is a significant commitment for a small company to get a new medication to market approval in multiple markets, and it is gratifying to see how the pieces are getting into place for the EU submission. Based on two completed phase 3 studies, MOB-015 has significant opportunity to create value at limited risk, which over time will provide increasing awareness of the potential within Moberg Pharma. I look forward to an exciting year!
Anna Ljung, CEO of Moberg Pharma
CONFERENCE CALL - May 11, 2021 at 3.00 p.m. CET
CEO Anna Ljung will present the report at a teleconference on May 11, 2021, at 3:00 p.m. CET.
Dial in: SE: +46 8 566 427 03, US: +1 833 823 05 86
ABOUT THIS INFORMATION
This information is information that Moberg Pharma AB 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 11th, 2021.