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
CONTACT:
FOR ADDITIONAL INFORMATION
Anna Ljung, CEO, Phone: +46 70 766
60 30, e-mail: anna.ljung@mobergpharma.se
Mark Beveridge, VP Finance, Phone:
+46 76 805 82 88, e-mail: mark.beveridge@mobergpharma.se
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SOURCE Moberg Pharma