Moberg Pharma AB Providing Unique Products in Underserved Niches through Commercial and Innovation Excellence

Transcription

1 Moberg Pharma AB Providing Unique Products in Underserved Niches through Commercial and Innovation Excellence Investor presentation, January 18, 2015 Peter Wolpert, CEO & 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 s interim or annual reports, prospectuses or press releases. 1 1

3 2014 TV commercial in the Nordics 2 2

4 Moberg Pharma PROVIDING UNIQUE PRODUCTS IN UNDERSERVED NICHES Vision Build a leading niche player in strategic focus areas, such as: - Topical Foot Care/Dermatology - Topical Pain Management - Additional areas to be added No 1 in Onychomycosis in key regions Financial goal Strategic elements Growth strategy - Organic growth - M&A/Innovation engine Build value through combining Brand/IP Equity Strong focus on shareholder value and achieving EBITDA target 25% EBITDA margin with healthy growth from

5 Moberg Pharma PROVIDING UNIQUE PRODUCTS IN UNDERSERVED NICHES Net Sales grew to 185 MSEK ($25m, TTM) - U.S. OTC Sales operations - Products sold in 40+ countries - 30 employees in Stockholm and NJ Focus in OTC/Dermatology/Topicals - Leading U.S. OTC SKU in Nail Fungus - Superior PII data for MOB015 3 acquisitions in last 24 months - Nov 2012, Alterna LLC - Dec 2013, OTC brands from Bayer - Apr 2014, BUPI, Ph ll for oral pain relief 4 Market Cap 530 MSEK ($ 70m) (OMX:MOB) 4

6 MSEK 18 consecutive quarters of Sales growth Product Sales, TTM, MSEK Q110 Q210 Q310 Q410 Q111 Q211 Q311 Q411 Q112 Q212 Q312 Q412 Q113 Q213 Q313 Q413 Q114 Q214 Q

7 Rapid growth in Net Sales and EBITDA Jan Sep 2013 Jan - Sep 2014 Net Sales, MSEK 156 (+29%) EBITDA, MSEK EBITDA Commercial Operations, MSEK 121 Neg 14% 9% 22% 34 (+240%) NOTE: Commercial EBITDA does not include R&D and Business Development expenses for future products outside existing brands, e.g. Phase II assets 6

8 Launch of Emtrix in Malaysia Strong Q3 35% sales growth US main driver North America grew by 40% - Organic growth and contributions from acquired brands. Rapid growth and >50% market share (OTC) in Canada European sales grew 7% SE Asia launch kicked off with Emtrix in Malaysia Excellent Phase ll results for MOB-015 Mycological cure rate of 54%, exceeded expectations BUPI Phase ll study initiated Strong EBITDA improvement EBITDA for Commercial Operations 1) of 23% for Q3 and 22 % for the past 12 months Expanded cooperation with Emerson Group has potential to further increase efficiency Gross margins remained strong at 72% 7 1) EBITDA Commercial Operations include R&D for marketed products/ line extensions, but not R&D or BD for new products 7

9 Majority of revenue from direct OTC sales, RoW growth starting to pick up Distribution of revenue, Jan September 2014 Direct OTC Sales 71% Sales via distributors 29% Kerasal 15% JointFlex 14% Other 13% Nalox/ Kerasal Nail 58% Americas 75% RoW 7% Europe 18% Channels Products Geography 8 8

10 Commercial Operations & Innovation Engine

11 U.S. retail sales of Kerasal Nail increased 31% in Q314 No 1. SKU in the U.S. Kerasal Nail U.S. market share 1) From 0 23% market share in 3 years Available at all major retailers > stores On Top-50 list of Most Innovative New Products - Drug Store News, 2012 Three clinical studies supporting efficacy and safety (n = ca 600) Q Q ) Retail sales of nail fungus products excluding private label in Multioutlet Stores over the last 52 weeks ending September 7, 2014 as reported by SymphonyIRI 10

12 Efficient infrastructure for building OTC brands in the U.S. CMOs Sales Force Retailers/Wholesalers Sales and marketing/brand Management Logistics Emerson Healthcare 11 11

13 Outperforming the market through combining Brand and IP equity Organic growth YTD (Value), % 17% Strategic brands Kerasal - Foot care Emtrix Domeboro - Derma/Skin irritation 5% Mature brands Jointflex - Ext. analgesic Moberg U.S. U.S. OTC market Vanquish - Int. analgesic Fergon - Iron supplement 12 12

14 Distributor Sales well positioned for further growth Nalox /Kerasal Nail Sales in >40 markets Stronger claims recently approved Potential for further growth Strong sales in Canada as response to launch of consumer advertising, Market leader with >50% of OTC sales (value) and 30% of all Rx/OTC units 1) Preparations for launches in China and SE Asia progressing well Malaysia 1 st launch in Nov 2014 Large potential for 2015 and beyond 13 1) CDH units, IMS. Market share of OTC and Rx products for onychomycosis. 13 Note: Four largest distributors only, not an all inclusive list.

15 Asian launch initiated in Malaysia under our Emtrix brand 14 14

16 2014 H2 TV commercial in Malaysia 15 15

17 Distribution in >1000 pharmacies in Malaysia (97%) 16 16

18 Counter Top 17 17

19 Window stickers in pharmacy 18 18

20 Pharmacy training 19 19

21 Pipeline assets in phase II - Building on Topical drug delivery know how and IP portfolio Pipeline asset Indication Status MOB-015 Onychomycosis Phase II completed Peak sales potential, m$ USP Topical terbinafine with fast visible improvement and superior cure rates BUPI Oral Mucositis and oral pain Phase II started Lozenge formulation with effective pain relief for 2-3 hrs(vs 0,5 hrs for competition) 20 20

22 MOB-015 Excellent Phase II results 21 Study design Open label, n=25, 24 patients completed Once daily for 48w Last follow-up at 60w Severely affected nails, 60% mean nail involvement 54% 29% Well tolerated * 54% of patients completing the treatment (13 of 25), 52% of FAS (13 of 24) and 60% of PPAS ** Means 10% or less clinical involvement Source: Moberg Pharma data on file, MOB-015 phase II study 21 MYCOLOGICAL CURE AT 15 MONTHS* MYCOLOGICAL CURE AND EXCELLENT CLINICAL IMPROVEMENT OR CURE**

23 Phase II results indicate that MOB015 has potential to become best in class (topical drug for Onychomycosis) Mycological cure Active Product Company Form at 6 months at 12/15 months Comment Terbinafine MOB-015 Moberg Pharma Topical 40% 1) 54% 25-75% affected* Efinaconazole Jublia Valeant Topical - 54% 20-50% affected** Tavaborole Kerydin Anacor/Sandoz Topical % 20-60% affected Ciclopirox Penlac Valeant Topical % 2) 20-65% affected Amorolfin Loceryl Galderma Topical - n/a 3) Terbinafine Lamisil Novartis Oral 40% 4) 75% 4) Itraconazole Sporanox J&J Oral 25-30% 4) 40-50% 4) *Mean affected nail area was 60% **Mean affected nail area was 36% 22 Source: 1) Moberg Pharma data on file from ongoing phase II study; 2) Gupta AK, Fleckman P, Baran R. Ciclopirox nail lacquer topical solution 8% in the treatment of toenail onychomycosis. J Am Acad Dermatol 43(4 Suppl):S70-80 (2000 Oct); 3) Mycological cure rates have not been published for Loceryl using the standard definition, which is the combination of negative fungal culture and KOH microscopy; 4) Double blind, randomized study of continous terbinafine compared with intermittent itraconazole in the treatment of toenail Onychomycosis, BMJ 1999; 22

24 Rationale for the superiority of MOB % mycological cure, in patients with severe onychomycosis (60% mean involvement) Excellent clinical improvement, full photo documentation High terbinafine levels in patients: - In nail bed: 45 µg/g (median value) 40x Oral TBF - In nail: 1610 µg/g (median value) 1000x Oral TBF Safe low plasma levels of TBF 1/1000 Oral TBF A reasonable assumption is that a Phase III strategy to include patients with only 20-50% nail involvement, will increase mycological and clinical cure rates, supported by: Experience from previous trial with K101 (Nalox) (n=493) indicated a 40% higher mycological cure rate in stratum with 25-50% affected nail area (27,1%) vs stratum with 50-75% affected nail area (19,1%). In the MOB-015B trial: Significantly higher myc cure (70%) in the 10 patients with <60% affected nail area (post-hoc analysis) If significant clear nail growth is observed, it is obvious that complete cure rates increase in a stratum with less affected nail area 23 23

25 CONFIDENTIAL 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) 24 24

26 Example of successful treatment with MOB-015 Before After 25 25

27 Example of successful treatment with MOB-015 Before After 26 26

28 Example of successful treatment with MOB-015 Before After 27 27

29 MOB-015 Next steps Dual track Discussion with industrial/financial partners ongoing Refine Ph III program and CMC preparations 28 28

30 BUPI Long-acting lozenge with bupivacaine - Phase II started Oct 2014 Product & Indication Bupivacaine lozenge for oral pain relief (mouth and throat) 1 st indication: Oral Mucositis in cancer patients. Large unmet need Other indications: Burning Mouth Syndrome, Sjögren s syndrome, Upper gastrointestinal endoscopy. Phase II study started data expected H Up to 40 patients in radiation therapy for Head-Neck Cancer Controlled study Standard pain treatment with/without BUPI lozenge VAS scale Target: Demonstrate 2-3 hours of pain relief and superior to control 29 29

31 Team

32 Management and Board with strong track record Management experience McKinsey, AZ, Q-Med, Biogen Idec, Insight, Pfizer Board experience Pharmacia/Pfizer, Lundbeck, Genmab, Quintiles, J&J, Barrier Therapeutics, NCH Peter Wolpert Martin Ingman CEO and Founder VP Sales & marketing, ROW Jeff Vernimb GM North America Mats Pettersson (Chair) Wenche Rolfsen Geert Cauwenbergh Kjell Rensfeldt VP R&D Anna Ljung CFO Thomas Thomsen Torbjörn Koivisto 31 31

33 Increasing high quality institutional investors (SW, US, FR) Shareholders No of shares Capital and votes, % ÖSTERSJÖSTIFTELSEN ,1 HANDELSBANKEN FONDER ,0 JPM CHASE NA (Altaris Capital Partners) ,9 FÖRSÄKRINGSAKTIEBOLAGET, AVANZA PENSION ,7 GRANDEUR PEAK ,2 TREDJE AP-FONDEN ,7 WOLCO INVEST AB (Peter Wolpert, CEO) ,3 SIX SIS AG, W8IMY ,2 GOLDMAN SACHS INTERNATIONAL LTD, W8IMY ,7 BANQUE CARNEGIE LUXEMBOURG S A (FUNDS) ,3 DEUTSCHE BANK AG LDN-PRIME BROKER, AGE FULL TAX ,0 SOCIETE GENERALE ,9 STATE STREET BANK & TRUST COM, BOSTON ,6 ML, PIERCE, FENNER & SMITH INCH ,2 SYNSKADADES STIFTELSE ,2 AB TRACTION ,2 MATTSSON, MICHAEL ,1 J P MORGAN CLEARING CORP, WP ,1 LUNDMARK, ANDERS ,0 DEUTSCHE BANK AG, LONDON BRANCH, W-8BEN ,0 SUMMA, 20 STÖRSTA ÄGARNA ,2 Övriga aktieägare ,8 TOTAL Source: Euroclear Sweden AB per Stock options to Management 32 Outstanding stock options correspond to 8.1% of shares (6% to Management/Employees) 32

34 Focus next 12 months PROVIDING UNIQUE PRODUCTS IN UNDERSERVED NICHES Drive growth and EBITDA improvements Fuel strong U.S growth - K-Nail and Neurocream launch - Line extensions and new SKUs 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 33 33