STOCKHOLM, May 12, 2020 /PRNewswire/ -- FINANCING
AGREEMENT OF UP TO SEK 216
MILLION
PERIOD (JUL 2019-MAR
2020)
- Net revenue SEK 50.5 million
(15.6) *
- EBITDA SEK 34.6 million (-3.0)
*
- Operating profit (EBIT) SEK 32.7
million (-4.2) *
- Profit after tax SEK 25.3 million
(-4.7) *
- Comprehensive income SEK 25.3
million (499.4)
- Diluted earnings per share SEK
1.35 (-0.27) *
- Cash and cash equivalents amounted to SEK 51.6 million (919.1)
Comparative figures for the period refer to January 2019 - June
2019 (Note: 9 months vs. 6 months due to shortened
financial year)
* All comparative figures refer to continuing
operations
THIRD QUARTER (JAN-MAR
2020)
Net revenue SEK 0.0 million (15.6)
*
- EBITDA SEK -3.6 million (7.3)
*
- Operating profit (EBIT) SEK -4.2
million (5.0) *
- Profit after tax SEK -3.4 million
(2.9) *
- Comprehensive income SEK -3.4
million (504.5)
- Diluted earnings per share SEK
-0.18 (0.26) *
- Cash and cash equivalents amounted to SEK 51.6 million (1,596.9)
Comparative figures for the third quarter refer to
January 2019 - March 2019
SIGNIFICANT EVENTS IN THE THIRD QUARTER (JAN-MAR 2020)
- All patients in the ongoing European MOB-015 study completed
their last visit in the study. The data collection was completed
without any negative impact from COVID-19. The timeline remains
unchanged with topline results expected by the end of Q2 2020.
- Moberg Pharma entered into a convertible note agreement with
Nice & Green S.A. of up to SEK 216
million for further investments in MOB-015. The agreement
enables Moberg Pharma to conduct an additional clinical study,
depending on the outcome of the EU study.
- The expert evaluation confirmed the validity of the results of
the phase 3 study in North
America, including:
- i) treatment with MOB-015 results in a mycological cure that
compares favorably with oral antifungal drugs with the added
advantage of an earlier onset of action;
- ii) the proprietary vehicle technology increases the hydration
and permeability of the nail plate, enabling efficient terbinafine
delivery, but it also confounds the assessment of clinical cure and
complete cure
- iii) a likely solution to the problem - a shorter dosing
regimen with the potential to deliver superior complete cure rates
at 52 weeks.
- The Swedish Tax Agency declared that for the redemption of
shares in Moberg Pharma for cash proceeds of SEK 46.50 per share, 60 percent the original
acquisition cost will represent the redemption shares and 40
percent the remaining ordinary shares.
SIGNIFICANT EVENTS AFTER THE END OF THE THIRD QUARTER
- An Extraordinary General Meeting on May
28 resolved, among other things, to authorize the Board of
Directors to resolve to issue convertibles and to introduce a
long-term incentive program.
- To date, Moberg Pharma's operation have not been significantly
impacted by COVID-19.
STATEMENT FROM THE CEO
In December 2019, Moberg Pharma
reported that the primary endpoint for MOB-015 had been met in the
North American phase 3 study. The evaluation of the study results
showed that the rapid and high cure rate for MOB-015 is world
leading, but that the dosing regimen can be optimized. Based on
these data, MOB-015 has the potential to become the future market
leader in onychomycosis. The financing agreement signed in March of
up to SEK 216 million enables Moberg
Pharma to exploit this potential and conduct an additional clinical
study, depending on the outcome of the EU study expected by the end
of Q2 2020.
EXPERT EVALUATION CONFIRMS THE VALIDITY OF THE RESULTS OF THE
NORTH AMERICAN STUDY
The North American study was conducted at 32 clinics in the U.S.
and Canada and included a total of
365 patients, 246 of whom received MOB-015 and 119 patients in a
control group received the vehicle. The results of the study were
surprising because the high mycological cure was not followed by a
correspondingly high complete cure rate.
The expert evaluation in January of this year clarified the
discrepancy and confirmed the validity of the results of the phase
3 study in North America,
including:
i) treatment with MOB-015 results in a mycological cure rate of
70 percent, which is substantially higher than reported for other
topical treatments and compares favorably with oral antifungal
drugs with the added advantage of an earlier onset of action;
ii) the proprietary vehicle technology increases the hydration
and permeability of the nail plate, enabling efficient terbinafine
delivery, but it also confounds the assessment of clinical cure and
complete cure, since its hydrating properties also cause temporary
whitening/discoloration in the nail
iii) a likely solution to the problem - a shorter dosing regimen
with the potential to deliver superior complete cure rates at 52
weeks. A higher complete cure rate can probably be obtained with a
shorter dosing regimen followed by maintenance dosing. This should
maintain sufficiently high concentrations of terbinafine in the
tissue, while allowing the hydration of the nail plate to
normalize.
From a medical and commercial perspective, a regimen with daily
dosing for up to three months followed by less frequent treatment
is highly attractive and further improves the target product
profile of MOB-015. This is further supported by U.S. market data
indicating that real-life usage of current topicals on average is
3-4 months, despite being labeled for 48 weeks' daily treatment.
The improved product profile with a shorter treatment period offers
key competitive advantages versus oral terbinafine; if MOB-015 can
show the same mycological cure rate as the oral treatment and can
show a high complete cure rate, there is no medical reason to
choose oral rather than topical treatment.
ALL PATIENTS HAVE COMPLETED THEIR LAST VISIT IN STUDY DESPITE
COVID-19
We are now in the final phase of the European study and all
patient visits have been completed without any negative impact from
COVID-19 in Europe, thanks in
large part to the intensive work by our medical team and our CRO
partner. In the European study, 452 patients were initially
randomized and 379 patients completed the study, a drop-out rate of
only 16 percent. All planned patient visits were completed despite
the current COVID-19 situation in Europe. After the patients completed their
last visit, nail samples were sent to a central lab for mycological
testing. Data base lock and statistical analysis are on schedule
and will be completed by the CRO partner. The timeline remains
unchanged and we expect the topline results from the study by the
end of the second quarter of 2020.
FINANCING AGREEMENT OF UP TO SEK 216
MILLION FOR FURTHER INVESTMENTS IN MOB-015In March, the
company entered into a convertible note agreement with Nice &
Green S.A., which has committed to subscribe for convertible notes
with a nominal value of up to SEK 216
million, in tranches of initially SEK
3 million per month for the first six months and thereafter,
depending on market conditions, with possibility to increase to
SEK 6 million per month. According to
the agreement, Moberg Pharma has only committed to draw the first
two tranches and can then decide if and when the remaining tranches
will be drawn. This financing can cover the company's capital
requirements to product registration following a positive outcome
in the European phase 3 study and can secure financing for an
additional study if needed before registration. The agreement
provides Moberg Pharma access to flexible financing at a reasonable
cost under current market conditions. The financing solution does
not preclude other financing solutions, contains a profit sharing
program and does not entail any fixed costs. As part of the
agreement, Nice & Green will introduce Moberg Pharma to its
wide network of biotech investors in Switzerland, Germany and France.
CLEAR PLAN TO CREATE THE FUTURE MARKET LEADER
To fully capitalize on MOB-015's potential, the advantages of a
shorter treatment period will have to be documented in another
study. The timing of such a study depends on whether the outcome of
the EU study provides a basis for product registration. We and our
commercial partners look forward to the topline data from the EU
study by the end of the second quarter 2020 and are fully committed
to creating the future market leader in onychomycosis. The earlier
onset of action and exceptional ability to eliminate the fungus as
well as the outlook for a shorter treatment period are very
promising.
Anna Ljung, CEO of Moberg
Pharma
CONFERENCE CALL - MAY 12, 2020
AT 3:00 P.M CET
CEO Anna
Ljung will present the report at a telephone conference on
May 12, 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 pursuant 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 12, 2020.
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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The following files are available for download:
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SOURCE Moberg Pharma