Moberg Pharma ABd1q0gh225dp9f5.cloudfront.net/sites/default/files/moberg... · 2016-08-09 · 3...
Transcript of Moberg Pharma ABd1q0gh225dp9f5.cloudfront.net/sites/default/files/moberg... · 2016-08-09 · 3...
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Conference call, August 9, 2016 at 3:00 p.m. (CET) Dial-in number: SE: +46 8 566 426 95, US: +1 646 502 51 20 Peter Wolpert, CEO and Founder
Moberg Pharma AB Interim report, January – June 2016
CREATING A FOOTPRINT IN UNDERSERVED NICHES
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Disclaimer
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Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Moberg Pharma’s results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with the inherent uncertainty of pharmaceutical research and product development, manufacturing and commercialization, the impact of competitive products, patents, legal challenges, government regulation and approval, Moberg Pharma’s ability to secure new products for commercialization and/or development and other risks and uncertainties detailed from time to time in Moberg Pharma AB’s interim or annual reports, prospectuses or press releases.
Highlights – Q2 2016
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Highlights – Q2 2016
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Net sales of MSEK 71 – Sales (excl. divested brands) declined by 13%,
due to discontinued product variants and lower European sales
– 28% market share in the U.S. for Kerasal Nail – All Time High
– Launches initiated in Japan, Taiwan and UK (2nd Direct market)
Acquisition doubles operations in U.S. – Acquisition of three brands from Prestige Brands in the U.S. for $40
million (transaction completed July 7th)
– Financed by bond loan (incl. Q2 tap issue of SEK 85m) and divestment of non-core brands for $10m, incl. SEK 41m cap. gain
MOB-015 advances – Phase 3 applications submitted to the U.S. FDA and authorities in
Germany, Poland and Canada
– Patents granted in several territories, including the U.S., Canada, the EU and Japan
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Three brands acquired for $40 million – Expected contribution of ca $5 million to EBITDA for 12 months following
closing
– Expected to double sales of our U.S. franchise
– Non-dilutive financing. Financed by available cash resources and bond loan
Sold through our established sales channels in the U.S, primarily through chain drugstores and mass retailers, such as:
– New Skin is the #1 OTC liquid bandage brand in the U.S. An antiseptic which kills germs and dries rapidly to form a clear protective cover
– Fiber Choice is focusing on digestive health with many product options for daily fiber supplementation
– PediaCare has a strong equity amongst moms based on highly effective products for children, primarily within cough cold and analgesics segments
Acquisition of brands from Prestige closed on July 7
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Rapid growth over the last 6 years – divestment affects Q216 Product Sales, TTM, MSEK
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Product Sales, TTM, MSEK
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P&L summary
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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. 3) Including a capital gain on divested brands of 41 MSEK
Due to the rounding component, totals may not tally.
P&L Summary Apr-Jun Apr-Jun Jan-Jun Jan-Jun Full-year
(MSEK) 2016 2015 2016 2015 2015 Revenue 71 92 141 165 286 Gross profit 51 72 100 128 214 % 72% 78% 71% 78% 75%
SG & A -55 -51 -94 -85 -142 R&D - existing product portfolio1) -1 -3 -3 -4 -6 Other operating income/operating expenses 413) -2 403) 3 4 EBITDA Commercial Operations 36 16 43 42 68 % 51% 18% 31% 25% 24%
R&D & BD - future products2) -3 -5 -7 -13 -22 EBITDA 33 11 37 29 46 % 47% 12% 26% 17% 16%
Depreciation/amortization -2 -3 -5 -5 -11 Operating profit (EBIT) 31 8 32 23 35
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Revenues by channel and product category
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Revenue by channel Apr-Jun Apr-Jun Jan-Jun Jan-Jun Full-year (KSEK) 2016 2015 2016 2015 2015 Direct sales 54 67 103 114 207 Sales of products to distributors 18 25 38 49 76 Milestone payments - 0 - 2 3 TOTAL 71 92 141 165 286
Revenue by product category Apr-Jun Apr-Jun Jan-Jun Jan-Jun Full-year (KSEK) 2016 2015 2016 2015 2015 Nalox/Kerasal Nail®, sales of products 49 61 81 102 154 Nalox/Kerasal Nail®, milestone payments - 0 - 2 3 Jointflex®, Fergon®, Vanquish® (divested April 1) - 10 16 26 52 Other products 22 21 43 35 77 TOTAL 71 92 141 165 286
Due to the rounding component, totals may not tally.
Note that brand divestments April 1 and product discontinuations affect comparisons Direct sales, excluding divested brands, declined by 7% in the second quarter (decline by 5% at fixed
exchange rates) due to discontinued product variants and a decline for Kerasal Ointment. All other products delivered growth
Distributor sales, excluding divested brands, declined by 27% (decline by 26% at fixed exchange rates). The majority of the decline originates from lower sales in Europe.
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RoW 17%
Europe 9%
Americas 74%
Other 31%
Nalox / Kerasal Nail
58%
Divested products
12% Sales via distributors
27%
Direct OTC Sales 73%
Majority of revenue from direct OTC sales – Launches in Asia drive RoW product sales
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Channels Products Geography
Distribution of revenue, January – June 2016
Progress in Commercial Operations and Innovation Engine
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Strategic brands
Kerasal® - Foot care Emtrix®
Balmex® - Diaper rash
Domeboro® - Derma/Skin irritation
New Skin - Antiseptic liquid
Mature brands
PediaCare® - Pediatric cough cold
Fiber Choice® - Prebiotic fiber supplements
Focus on strategic brands
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All-Time High market share in U.S. for Kerasal Nail following successful relaunch
* Last 12 weeks ending June 15, 2016 vs same period 2015 Source: Symphony IRI, U.S. retail sales of nail fungus products excluding private label in Multi Outlet Stores
New packaging, commercial and website launched in March Very positive reception from consumers and trade, all-time high market share
Note: there is a lag of at least one month between growth in consumer sales and effects on net sales
23% 28% 25% +2%
MARKET SHARE* VALUE GROWTH* CATEGORY GROWTH*
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Growth potential in Asia for Distributor Sales
Note: Three largest distributors only, not an all inclusive list.
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Sales in >40 markets
Decline in Europe – expecting lower level vs 2015
Asian launches progresses well - 20% volume growth H116 - Volume discounts provided to support further growth
Launches initiated in Japan and Taiwan
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MOB-015 update - Phase 3 applications submitted to relevant authorities, aim to start patient enrollment in Q3 - Patent granted in multiple territories, incl U.S., EU, Japan and Canada
BUPI update - Positive Phase 2 results for BUPI in Q116 - License/Dev Agreement with Cadila. Cadila conducts a Phase 3 trial in India, rights in India/Africa - Moberg sponsors one Phase 3 trial in Europe, co-financed by Eurostars grant
Pipeline assets - Building on Topical drug delivery know how
Pipeline asset
Indication
Status
Peak sales potential, m$
USP
MOB-015 Onychomycosis Phase 3 applications submitted
250-500 Topical terbinafine with fast visible improvement and superior cure rates
BUPI Oral Mucositis and oral pain
Phase 3 preparation
50-100 Lozenge formulation with effective pain relief for 2-3 hrs(vs 0,5 hrs for competition)
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MOB-015 update
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Concept Builds on Emtrix/Kerasal nail, adds terbinafine Phase 2 demonstrated efficacy and safety:
- Delivers high μg-levels of terbinafine into nail bed and nail - 54% mycological cure in severe nails and ca 4-5 mm of clear nail growth
Progress Patents approved in EU, US, CA and several other territories. Term to at least 2032. June 2016: Submitted IND in U.S. and CTAs to start Phase 3 in DE, PL and CA. Clinical Trial Material produced by Colep (Colep co-invests in MOB-015 project) Leading Derm CROs manage Phase 3 studies:
- ProInnovera (EU) and - TKL (US/CA)
Design/Timeline: - Primary endpoint: Complete Cure after 52w - Start enrollment in Q3 2016 of in total ca 675 patients
Focus next 12 months
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Focus next 12 months PROVIDING UNIQUE PRODUCTS IN UNDERSERVED NICHES
Making significant investments in 2016 - Acquiring additional brands/products - Initiating phase 3 studies for MOB-015 - Strengthening strategic brands in U.S. - Broadening international distribution
U.S: Execution of Kerasal brand strategy
Asia key growth driver, additional launches
BD/Innovation Engine - M&A focus on US OTC products - MOB-015 Initiating Phase 3 - BUPI: Preparations for Phase 3
Long-term target Create shareholder value through profitable growth targeting a long-term EBITDA margin of at least 25%
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Commercial niche strategy enables a growing and profitable base business
Pipeline with large potential and at reasonable risk - Proven molecules limit development risk, cost and TTM
Acquisition strategy with substantial value potential - 6 transactions in last 40 months - Team, systems and infrastructure in place to enable scale-up - Capacity to finance deals
Strong Team and track record
Why invest in Moberg Pharma – Strategy for Shareholder value