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Press conference, August 11, 2015 at 15:00 a.m. (CET)
Pipeline assets - Building on Topical drug delivery know how
Pipeline
asset
Indication
Status
Peak sales
potential, m$
USP
MOB-015 Onychomycosis Ph III
preparation
250-500 Topical terbinafine with fast visible
improvement and superior cure rates
BUPI Oral Mucositis
and oral pain
Phase II 50-100 Lozenge formulation with effective
pain relief for 2-3 hrs(vs 0,5 hrs for
competition)
10
MOB-015 update - Phase II results enable a superior target profile vs U.S. Rx lead competitor (Jublia)
- US and EPO patents granted
- Phase III preparations progressing to enable start in 2016
- Discussions advancing with potential industrial/development partners.
Objective to maintain control of significant rights/value of the asset
BUPI update - 30 patients included in Phase II
- Topline results expected Q4 2015
MOB-015 – USPs, Strategy and market update
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USPs Targets a superior profile, in mild to moderate onychomycosis
based on phase II data and experience from the OTC product
(>600 patients in clinical trials and >5 million units sold to date):
Superior cure rates – Mycological and Clinical
Shorter treatment time – potentially 6 months
First visible improvement within 2-4 weeks
Strategy Prepare Phase III to start in 2016
Ongoing discussions with partners. Objective to maintain control of asset
in key territories through phase III
U.S. Market Total market growing rapidly, driven by intense marketing of new Rx drugs
- TRx: +27% L52 weeks*
- Dollar: +46% L52 weeks*
Branded OTC market declined 11% in Q2 y/y**
1
2
3
*Wolters Kluver, data ending week of July 31, 2015
** U.S. retail sales of branded nail fungus products in Multioutlet Stores over L52 weeks ending June 14 , 2015,
SymphonyIRI
Financials
P&L summary – Sales growth and increased profitability
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1) Research and development expenses – existing product portfolio includes R&D expenses for new product variants under existing brands, regulatory work and quality.
2) Research and development expenses - future products includes R&D expenses for new product candidates, for example MOB-015.
Due to the rounding component, totals may not tally.
P&L Summary
Apr-Jun Apr-Jun Jan-Jun Jan-Jun Full-year
(MSEK) 2015 2014 2015 2014 2014
Revenue 92 57 165 105 200
Gross profit 72 45 128 83 151
% 78% 78% 78% 78% 75%
SG & A -51 -32 -85 -56 -106
R&D - existing product portfolio1) -3 -2 -4 -4 -7
Other operating income/operating expenses -2 0 3 0 6
EBITDA Commercial Operations 16 11 42 23 43
% 18% 19% 25% 21% 22%
R&D & BD - future products2) -3 -3 -10 -5 -12
EBITDA 11 7 29 14 25
% 12% 12% 17% 14% 13%
Depreciation/amortization -3 -2 -5 -4 -8
Operating profit (EBIT) 8 5 23 11 17
Other 15%
Nalox/ Kerasal Nail
62%
Kerasal 11%
JointFlex 11%
RoW 13%
Europe 16% Americas
71%
Sales via distributors
31%
Direct OTC Sales 69%
Majority of revenue from direct OTC sales – Launches in Asia
drives RoW product sales
14
Channels Products Geography
Distribution of revenue, January – June 2015
Revenue growth was 60% in Q2, Kerasal Nail and new products
main growth drivers
15
Revenue by channel Apr-Jun Apr-Jun Jan-Jun Jan-Jun Full-year
(KSEK) 2015 2014 2015 2014 2014
Direct sales 67 38 114 72 139
Sales of products to distributors 25 20 49 32 59
Milestone payments 0 - 2 2 2
TOTAL 92 58 165 105 200
Revenue by product category Apr-Jun Apr-Jun Jan-Jun Jan-Jun Full-year
(KSEK) 2015 2014 2015 2014 2014
Nalox/Kerasal Nail®, sales of products 61 36 102 62 113
Nalox/Kerasal Nail®, milestone payments 0 - 2 2 2
Kerasal® 9 8 18 17 29
JointFlex® 6 7 19 13 31
Other products 16 7 24 12 25
TOTAL 92 58 165 105 200
Due to the rounding component, totals may not tally.
Solid cash position, positive cash flow and low debt
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Jan-Jun 2015 Jan-Jun 2014
Operative cash flow
+17 MSEK +3 MSEK
Cash position 35 MSEK 76 MSEK
Cash position inclusive of Balmex acquisition in April, consideration 33 MSEK (3.9 MUSD),
financed with existing funds
Focus next 12 months
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Focus next 12 months PROVIDING UNIQUE PRODUCTS IN UNDERSERVED NICHES