Extended fiscal year July 2019 - December 2020 Interim report July - September 2020
STOCKHOLM, Nov. 10, 2020 /PRNewswire/ -- Registration preparations in Europe, Financing for MOB-015 secured and spin-off of BUPI
PERIOD (JUL 2019-SEP 2020)
- Net revenue SEK 50.5 million (15.6) *
- EBITDA SEK 24.4 million (-3.0) *
- Operating profit (EBIT) SEK 21.2 million (-4.2) *
- Profit after tax SEK 15.4 million (-4.7) *
- Total comprehensive income SEK 15.4 million (499.4)
- Diluted earnings per share SEK 0.81 (-0.27) *
- Cash and cash equivalents amounted to SEK 30.0 million (919.1)
Comparative figures for the period refer to January 2019 - June 2019 (Note: 15 months vs. 6 months due to shortened fiscal year)
FIFTH QUARTER (JUL-SEP 2020)
- Net revenue SEK 0.0 million (15.6) *
- EBITDA SEK -4.6 million (5.6) *
- Operating profit (EBIT) SEK -5.2 million (5.0) *
- Profit after tax SEK -4.7 million (2.9) *
- Total comprehensive income SEK -4.7 million (504.5)
- Diluted earnings per share SEK -0.25 (0.26) *
- Cash and cash equivalents amounted to SEK 30.0 million (1.596.9)
Comparative figures for the fifth quarter refer to January 2019 - March 2019
* All comparative figures refer to continuing operations
SIGNIFICANT EVENTS IN THE FIFTH QUARTER (JUL-SEP 2020)
- Dr. Cindy Wong was appointed Chief Medical Officer and a member of the Executive Management. Dr. Wong comes most recently from Metz Pharmaceuticals, where she was Vice President and Head of Global Clinical Development.
- To date, Moberg Pharma's operations have not been materially affected by COVID-19.
SIGNIFICANT EVENTS AFTER THE END OF THE FIFTH QUARTER
- Moberg Pharma intends to submit a registration application in Europe in 2021. With a normal processing time of about 1.5 years, approval is expected in early 2023 and launch in Europe by the end of 2023.
- In November, the company's Board of Directors resolved to carry out a fully guaranteed rights issue of approximately SEK 150 million for further financing of MOB-015. When the rights issue is completed, the company intends to terminate the current convertible note agreement. The rights issue requires the approval of an extraordinary general meeting, which will be held on December 1, 2020.
- The BUPI project has been transferred to the subsidiary OncoZenge AB, whose shares shall in turn be distributed to Moberg Pharma's shareholders and listed separately on Nasdaq First North Growth Martket in Q1 2021.
STATEMENTS FROM THE CEO
In June, the results were presented from the second of two clinical studies in the Phase 3 program for MOB-015. As with the North American study, the European the study met the primary endpoint and no serious side effects were identified. The high mycological cure rate for MOB-015 has now been demonstrated in two pivotal studies, strengthening our conviction that MOB-015 has the potential to be the future market leader in the treatment of nail fungus. After dialogue with our partners, we have a clear path forward, targeting to submit a marketing authorization application in Europe in the second half of 2021. We are carrying out a fully guaranteed rights issue in Moberg Pharma and are also preparing to spin off and separately list the BUPI project through the subsidiary OncoZenge AB.
Moberg Pharma's primary asset is MOB-015, where preparations are underway for registration in Europe, based on two large Phase 3 studies totaling more than 800 patients. Since the primary endpoint was met in the North American and European studies, both studies are expected to be used as a basis for product registration in Europe. We have chosen a registration route that could provide valuable data exclusivity for up to 10 years after market approval. This sets the timetable for our plan to submit a registration application in Europe in the second half of 2021. We expect the application to be approved within 18 months, indicating that MOB-015 could be launched in Europe by the end of 2023.
For the U.S., we intend to discuss the next step in an advice meeting with the FDA after presubmission meetings have been completed with regulatory authorities in the EU, with the assumption that an additional study may be needed for registration in the U.S.
Since a clear strategy to take MOB-015 to market has been agreed upon with our partners, we can now choose a suitable financing solution. The secured rights issue announced in November means that long-term financing is secured for MOB-015. We intend to capture the potential in BUPI and create value for our shareholders by spinning off and listing the project in the subsidiary OncoZenge AB, with Erik Penser Bank as advisor. When this is in place, BUPI can progress at full speed with a dedicated team and its own financing, under the leadership of OncoZenge's CEO, Pirkko Tamsen. OncoZenge's focus is to carry out a clinical Phase 3 study for BUPI, which is expected to be used as a basis for product registration in Europe as well as additional markets and create attractive commercial opportunities.
The secured financing facilitates not only the registration application for MOB-015 in Europe, but also an additional clinical study for the U.S. to capture the product's full potential. The need for treatment alternatives that truly can cure the fungal infection is high, which means that MOB-015 can achieve a unique market position through its high antifungal effect.
Anna Ljung, CEO of Moberg Pharma
CONFERENCE CALL - November 10, 2020 at 3:00 p.m. CET
CEO Anna Ljung will present the report at a telephone conference on November 10, 2020 at 3:00 p.m. CET.
Dial-in: SE: +46 8 505 583 69 US: +1 833 249 84 04
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 November 10th, 2020
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The following files are available for download:
Interim report July â€" September 2020
SOURCE Moberg Pharma
Company Codes: OTC-PINK:MBGRF, Stockholm:MOB, Frankfurt:MB8, LSE:0P48, ISIN:SE0003613090, RICS:MOB.ST