MOBERG PHARMA AB (PUBL) Interim Report Jan-Mar 2015 Combining Commercial and Innovation Excellence to Develop Unique Products for Underserved Niches

Transcription

1 MOBERG PHARMA AB (PUBL) Interim Report Jan-Mar 2015 Combining Commercial and Innovation Excellence to Develop Unique Products for Underserved Niches Press conference, May 11, 2015 at 10:30 a.m. (CET) Dial-in number: Sweden , U.S Peter Wolpert, CEO and Founder Anna Ljung, CFO 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 Q115

4 2015 Q1 Highlights Net sales grew by 53% to MSEK 73 Growth across all areas, very strong distribution sales Favorable exchange rate development, 27% growth at fixed rates. Significant profitability improvement EBITDA margin of 24% EBITDA Commercial Operations of 35% Acquisition of Balmex (diaper rash) for $3.9 million Expanded distribution enables future growth Agreement with Menarini expanded to Russia. Approval in China and launch progress in SE Asia Launch of two Kerasal Nail line extensions at CVS / Walgreens Innovation engine progress MOB-015 U.S. and EU patents granted Kerasal Nail U.S. patent granted 3 NOTE: EBITDA Commercial Operations does not include R&D and Business Development expenses for future products outside existing brands 3

5 Growth driving significant improvement in profitability Net Sales, MSEK 73.1 (+53%) EBITDA, MSEK EBITDA Commercial Operations, MSEK Q Q % 24% 24% 35% 17.4 (+131%) 25.6 (+121%) NOTE: EBITDA Commercial Operations does not include R&D and Business Development expenses for future products outside existing brands 4

6 20 consecutive quarters of Sales growth Product Sales, TTM, MSEK MSEK

7 Progress in Commercial Operations and Innovation Engine

8 Outperforming the market through focus on strategic brands Organic growth Q1 15 (Value), % Strategic brands 7% Moberg U.S. 5% U.S. OTC market Kerasal - Foot care Emtrix Domeboro - Derma/Skin irritation Balmex Mature brands Jointflex - Ext. analgesic Vanquish - Int. analgesic Fergon - Iron supplement 7 7

9 Launches of new Kerasal Nail line extensions in line with strategic goal of leadership position in nail fungus No 1 selling product with 22% market share in ) Available at > points of sale, 2014 expansion into food retail segment Two new line extensions drive additional growth 8 1) Retail sales of nail fungus products excluding private label in Multioutlet Stores over the last 52 weeks ending December 28, 2014 as reported by SymphonyIRI 8

10 Closed Balmex acquisition on April 24 Acquired from Chattem (Sanofi) for $3.9 million Sales trending above $4 million annually Deal financed with existing funds Strong heritage in baby diaper rash with broad distribution in major chains: Brand integration fully underway. New consumer campaigns slated for Q3/Q4 Brand Extended into Adult Care in 2013, a small but high potential market for treatment of rash associated with adult incontinence 9 9

11 Distributor Sales key growth driver in Q1 15 with 102% growth Sales in >40 markets Continued growth in Canada Market leader with >50% of OTC sales (value) and 30% of all Rx/OTC units 1) Strong sales in Europe, +55% ROW sales tripled! - Initial launch successes in Malaysia, Hong Kong and Singapore. - Progress in launch preparations in China and additional markets Agreement with Menarini for Russia 10 1) CDH units, IMS. Market share of OTC and Rx products for onychomycosis. 10 Note: Four largest distributors only, not an all inclusive list.

12 Successful start of launch in Malaysia and Hong Kong Excellent distribution and sell-in to pharmacies Positive response from consumers on TV commercials and advertising Good reorders Malaysia: 45% market share 2014 and continued strong sales Q1 15 Hong Kong: Excellent start of sales and reorders 11 11

13 Pipeline assets in phase II - Building on Topical drug delivery know how and IP portfolio Pipeline asset Indication Status Peak sales potential, m$ MOB-015 Onychomycosis Phase II Topical terbinafine with fast visible improvement and superior cure rates BUPI Oral Mucositis and oral pain USP Phase II Lozenge formulation with effective pain relief for 2-3 hrs(vs 0,5 hrs for competition) MOB-015 Strategy and Status update - Superior Target Profile developed vs newly launched US Rx lead competitor (Jublia) - Phase III preparations ongoing to enable start in US patent granted - Discussions ongoing with potential industrial and financial partners - Objective to maintain control of significant rights/value of the asset BUPI status update - Ca 20 patients included in Phase II - Expect study results in H

14 MOB-015 vs Jublia Target Product Profile for mild-moderate affected nails Mycological cure Complete cure Almost cured or cured Clear nail growth % of patients experiencing visual improvement after 1 month Product at 6 months at 12/15 months at 12/15 months at 12/15 months at 12/15 months at 1 month In severely affected nails, 50-75% affected nail area MOB % 1) 54% 0% 28%* 4.5 mm >50% In mild/moderately affected nails, 20-50% affected nail area MOB-015 (Target) >50% 60-70% 20-30% >40% >5 mm >50% Jublia - 54% 15-18% 23-26% mm? Source: 1) Moberg Pharma data on file from phase II study; * Proportion of patients with negative fungal culture, negative direct KOH microscopy and physician s GES=4 (excellent improvement) 13 13

15 Financials

16 P&L summary Sales growth and increased profitability (MSEK) Q Q FY 2014 Revenue Gross profit % 78% 79% 75% SG & A R&D - existing product portfolio 1) Other operating income/operating expenses EBITDA Commercial Operations % 35% 24% 22% R&D & BD - future products 2) EBITDA % 24% 16% 13% 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-015. Due to the rounding component, totals may not tally. 15

17 Majority of revenue from direct OTC sales - RoW product sales tripled Q115 (Y/Y) Distribution of revenue, January March 2015 Direct OTC Sales 65% Sales via distributors 35% JointFlex 17% Kerasal 13% Other 12% Nalox/ Kerasal Nail 59% Americas 67% RoW 14% Europe 19% Channels Products Geography 16 16

18 Revenue growth was 53% in Q1 Revenue by source Jan-Mar Jan-Mar Jan-Mar Full-year (MSEK) Index 2014 Direct sales Sales of products to distributors Milestone payments TOTAL Revenue by product category Jan-Mar Jan-Mar Jan-Mar Full-year (MSEK) Index 2014 Nalox /Kerasal Nail, sales of products Nalox /Kerasal Nail, milestone payments Kerasal JointFlex Other products TOTAL

19 Significant improvement in cash position Q Q Operative cash flow - 5 MSEK - 3 MSEK Cash position 53 MSEK 19 MSEK Note: Many orders in March led to increase in operating receivables to 30 MSEK (5 MSEK) Cash position exclusive of Balmex acquisition in April, consideration 3.9 MUSD, financed with existing funds 18 18

20 Focus next 12 months

21 Focus next 12 months PROVIDING UNIQUE PRODUCTS IN UNDERSERVED NICHES Drive growth and EBITDA improvements Fuel strong U.S growth - Line extensions and new SKUs - Balmex integration Grow Distributor Sales - EU: Extended indication - Launches in China/SE Asia, Mena BD/Innovation Engine - M&A focus on US OTC products - MOB-015 partnering/ Phase III preparations - BUPI: Pll study, pursue sales as unlicensed drug/partner and Orphan Drug designation Long-term target Create shareholder value through a focus on profitable growth, targeting a long-term EBITDA margin of at least 25% from 2016 and onwards