STOCKHOLM, Feb. 11, 2020 /PRNewswire/ --
Period (Jul-Dec 2019)
- Net revenue SEK 50.5 million
(15.6) *
- EBITDA SEK 38.2 million (-3.0)
*
- Operating profit (EBIT) SEK 37.0
million (-4.2) *
- Profit after tax SEK 28.7 million
(-4.7) *
- Comprehensive income SEK 28.7
million (499.4)
- Diluted earnings per share SEK
1.53 (-0.27) *
- Cash and cash equivalents amounted to SEK 64.7 million (919.1)
* All comparative figures refer to continuing
operations
Second Quarter (Oct-Dec
2019)
- Net revenue SEK 2.7 million (0.0)
*
- EBITDA SEK -4.2 million (-10.3)
*
- Operating profit (EBIT) SEK -4.8
million (-9.2) *
- Profit after tax SEK -4.0 million
(-7.6) *
- Comprehensive income SEK -4.0
million (-5.1)
- Diluted earnings per share SEK
-0.21 (-0.43)
- Cash and cash equivalents amounted to SEK 64.7 million (919.1)
The Annual General Meeting on October
30 resolved to extend the company's financial year to the
following period, July 1, 2019 -
December 31, 2020. This interim
report covers the first six months of the extended fiscal year from
July 1, 2019. The comparative figures
refer to the abbreviated financial year from January 1, 2019 to June
30, 2019.
Significant Events In The Second Quarter
The Annual General Meeting resolved on October 30 to pay shareholders SEK 46.50 per share through an automatic
redemption procedure, in accordance with the Board of Directors'
proposal. Payment was issued in November.
In October, a distribution agreement was signed with DongKoo for
MOB-015 in the Republic of Korea.
Mark Beveridge, VP Finance,
reassumed responsibility for the finance function and replaced the
previous CFO Sarah Hellerfelt.
In December, the topline results were presented from the phase 3
study in North America. MOB-015
met both the primary endpoint and key secondary endpoints. No
serious side effects were identified in the study.
Significant Events After The End Of The Second
Quarter
Expert analysis confirms the validity of the results from the
phase 3 study in North America,
including:
i) Treatment with MOB-015 results in a mycological cure that
compares favorably to oral onychomycosis drugs and with the added
advantage of earlier onset of action;
ii) The proprietary vehicle technology increases the hydration and
permeability of the nail plate enabling efficient terbinafine
delivery, however it also confounds the assessment of
clinical cure and complete cure; and
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.
Statement From The CEO
In December 2019, the results
of the first of two clinical studies in the phase 3 program for
MOB-015 were presented. The study met both the primary endpoint and
key secondary endpoints and no safety issues were identified. The
study and subsequent expert analysis showed that MOB-015 has the
potential to become the future market leader in onychomycosis.
Seventy percent of the patients were fungus free, which is world
leading, but increased hydration causes temporary whitening of the
nail, which makes the assessment of clinical cure more challenging.
A shorter treatment period is a likely solution to the problem of
whitening.
The North American study was conducted at 32 clinics in the U.S.
and Canada and included a total of
365 patients, where 246 patients were treated with MOB-015 and 119
patients in a control group received the vehicle. At 52 weeks,
significantly more MOB-015 patients reached complete cure compared
to the vehicle (p=0.019) and mycological cure (fungus-free samples)
was reached in 70 percent of the patients, which is significantly
higher than has been reported for other topical treatments and
compares with, but with an earlier onset of action than, oral
terbinafine treatment. In addition, 80 percent of the patients
reported an improvement by the first follow-up visit. Provided that
the European study also produces positive results, both studies can
be used as a basis for product registration.
On the whole, the outcome of the study was surprising, given the
clinical cure rate (restoration of normal looking nails) of 4.5
percent was lower than expected based on the high mycological cure.
Since the results were made public, the company, in collaboration
with leading experts (Key Opinion Leaders, KOL), has analyzed the
outcome to validate and better understand the unexpected results.
The conclusion of the analysis was that the company's technology
enables high delivery of terbinafine through the nail plate, but
its hydrating properties also cause whitening/discoloration in
nails. This phenomenon is transient but makes the assessment of
clinical cure challenging, which contributed to the low complete
cure rate observed. The KOLs as well as the company's own experts
concluded that a higher complete cure is likely to be achieved with
a shorter treatment period followed by maintenance dosing. This
should maintain high concentrations of terbinafine in the nail
tissue, while there is sufficient time for the hydration level to
normalize.
From a medical and commercial perspective, a dosing regimen with
daily treatment for a maximum of three months, followed by
maintenance dosing once weekly, is highly attractive and further
improves the target product profile of MOB-015. This is further
supported by prescription data from the U.S., which shows that the
actual use of existing topical treatments usually lasts between 3
to 4 months, despite intended daily treatment for 48 weeks. The
improved product profile with a shorter treatment period also
creates key competitive advantages compared to oral terbinafine. If
MOB-015 shows the same antifungal effect as oral treatment and can
show a high complete cure rate, there would be no medical reason to
choose oral treatment over topical treatment.
In the U.S., around 4.5 million onychomycosis prescriptions are
written, of which 3 million are for oral terbinafine. Previous
launches of novel topical products have not significantly affected
oral terbinafine prescriptions. With the improved product profile,
MOB-015 will be an attractive alternative to other topical products
as well as oral terbinafine.
We are very grateful for the thorough analysis of the key
opinion leaders, which not only validated and gave us a better
understanding of the reasons for the phase 3 results, but also
strengthened our conviction that MOB-015 has the potential to
become the future market leader in onychomycosis. Four key
licensing agreements are currently in place for MOB-015: in
Europe, Japan and Canada, plus the addition of the Republic of
Korea in the latest quarter.
The share redemption in November
2019 resulted in an extraordinary payment to our
shareholders of SEK 46.50 per share.
After the redemption, the company has SEK 65
million in cash reserves and has sufficient funds to
finalize the phase 3 studies for MOB-015.
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 look
forward to the topline data from the EU study by the end of the
second quarter 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 - February 11,
2020 At 3:00 P.M. CET
CEO Anna Ljung will present the
report at a telephone conference on February
11, 2020 at 3:00 p.m. CET.
Dial in: SE: +46-8-505-583-69, US: +1-833-526-83-82.
About This Information
Moberg Pharma discloses this information pursuant to the Swedish
Securities Markets Act and/or the Financial Instruments Trading
Act. The information was submitted for publication through the
agency of the contact person set out below at 8.00 a.m. (CET) on February 11th 2020.
Contact:
For Additional Information, Please Contact:
Anna Ljung, VD, phone:
+46-707-66-60-30, e-post: anna.ljung@mobergpharma.se
Mark Beveridge, VP Finance, phone:
+46-768-05-82-88, e-post: mark.beveridge@mobergpharma.se
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Moberg Pharma AB
Interim report October - December 2019
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SOURCE Moberg Pharma