Moberg Pharma AB. Interim report, January June 2016 CREATING A FOOTPRINT IN UNDERSERVED NICHES

Transcription

1 Moberg Pharma AB Interim report, January June 2016 CREATING A FOOTPRINT IN UNDERSERVED NICHES Conference call, August 9, 2016 at 3:00 p.m. (CET) Dial-in number: SE: , US: Peter Wolpert, CEO and Founder 0

2 Disclaimer Statements included herein that are not historical facts are forward-looking statements. Such forwardlooking 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. 1 1

3 Highlights Q2 2016

4 Highlights Q 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 (2 nd 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 7 th ) 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 3 3

5 Acquisition of brands from Prestige closed on July 7 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 4 4

6 Rapid growth over the last 6 years divestment affects Q216 Product Sales, TTM, MSEK 300 Product Sales, TTM, MSEK Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q

7 P&L summary P&L Summary Apr-Jun Apr-Jun Jan-Jun Jan-Jun Full-year (MSEK) Revenue Gross profit % 72% 78% 71% 78% 75% SG & A R&D - existing product portfolio 1) Other operating income/operating expenses 41 3) ) 3 4 EBITDA Commercial Operations % 51% 18% 31% 25% 24% R&D & BD - future products 2) EBITDA % 47% 12% 26% 17% 16% Depreciation/amortization Operating profit (EBIT) ) 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 ) Including a capital gain on divested brands of 41 MSEK 6 Due to the rounding component, totals may not tally. 6

8 Revenues by channel and product category 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. Revenue by channel Apr-Jun Apr-Jun Jan-Jun Jan-Jun Full-year (KSEK) Direct sales Sales of products to distributors Milestone payments TOTAL Revenue by product category Apr-Jun Apr-Jun Jan-Jun Jan-Jun Full-year (KSEK) Nalox/Kerasal Nail, sales of products Nalox/Kerasal Nail, milestone payments Jointflex, Fergon, Vanquish (divested April 1) Other products TOTAL Due to the rounding component, totals may not tally. 7

9 Majority of revenue from direct OTC sales Launches in Asia drive RoW product sales Distribution of revenue, January June 2016 Sales via distributors 27% Divested products 12% Other 31% RoW 17% Europe 9% Direct OTC Sales 73% Nalox / Kerasal Nail 58% Americas 74% Channels Products Geography 8 8

10 Progress in Commercial Operations and Innovation Engine

11 Focus on strategic brands 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 10 10

12 All-Time High market share in U.S. for Kerasal Nail following successful relaunch New packaging, commercial and website launched in March Very positive reception from consumers and trade, all-time high market share 23% 28% 25% +2% MARKET SHARE* VALUE GROWTH* CATEGORY GROWTH* Note: there is a lag of at least one month between growth in consumer sales and effects on net sales 11 * Last 12 weeks ending June 15, 2016 vs same period 2015 Source: Symphony IRI, U.S. retail sales of nail fungus products excluding 11 private label in Multi Outlet Stores

13 Growth potential in Asia for Distributor Sales 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 Note: Three largest distributors only, not an all inclusive list

14 Pipeline assets - Building on Topical drug delivery know how Pipeline asset Indication Status MOB-015 Onychomycosis Phase 3 application s submitted BUPI Oral Mucositis and oral pain Phase 3 preparation Peak sales potential, m$ USP Topical terbinafine with fast visible improvement and superior cure rates Lozenge formulation with effective pain relief for 2-3 hrs(vs 0,5 hrs for competition) 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 13 13

15 MOB-015 update 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 14 Progress Patents approved in EU, US, CA and several other territories. Term to at least 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 Q of in total ca 675 patients 14

16 Focus next 12 months

17 Focus next 12 months PROVIDING UNIQUE PRODUCTS IN UNDERSERVED NICHES Making significant investments in Acquiring additional brands/products - Initiating phase 3 studies for MOB 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% 16 16

18 Why invest in Moberg Pharma Strategy for Shareholder value 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 17 17