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 Presentation at Jefferies Global Healthcare Conference, November 20, 2014 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 mid-size Pharma/Consumer Health company with direct Sales in: - U.S. and select countries - OTC and select specialty areas No 1 in Onychomycosis in key regions Financial goal Strategic plan Growth strategy - Organic growth - M&A/Innovation engine Build value through Brand Equity and 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 ($25m) - U.S. OTC Sales operations - Products sold in 40+ countries - 30 employees in Stockholm and NJ Focus in OTC/Dermatology/Topicals - Leading U.S. OTC SKU in Nail Fungus - Superior PII data for MOB015 3 acquisitions in last 24 months - Nov 2012, Alterna LLC - Dec 2013, OTC brands from Bayer - Apr 2014, BUPI, Ph ll for oral pain relief 4 Market Cap 450 MSEK ($ 60m) (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 US grew by 40% - Organic growth and contributions from acquired brands European sales grew 7% Excellent sales and >50% market share (OTC) in Canada 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 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 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 U.S infrastructure for building brand equity 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 to 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 Distribution in >1000 pharmacies in Malaysia (97%) 15 15

17 Counter Top 16 16

18 Window stickers in pharmacy 17 17

19 Pharmacy training 18 18

20 Kerasal Nail / Emtrix Clinically proven efficacy in 600 patients Clinical and non-clinical trials: Efficacy documented in In vitro study. Hultenby et al. Mycoses 2014, Volume 57: Efficacy and safety confirmed in Post Marketing Study (n=73). Faergemann et al. Journal of Cosmetics, Dermatological Sciences and Applications 2011, Volume 1:59-63 Efficacy and safety confirmed in Phase III trial (n=493) Emtestam et al. Mycoses 2012, Volume 55: Efficacy and safety demonstrated in Phase II trial SM13 (n=18, 58 nails) 19 19

21 Kerasal Nail / Emtrix an efficacious topical treatment for fungal nails & nail psoriasis Properties Penetrates nail Keratolytic Antifungal physical mode of action Excellent safety profile GRAS listed compounds Before treatment After 2 weeks of treatment Competitive positioning Unique rapid visible improvement (2-4 weeks) First-line, efficacious topical Potential to treat severely affected nails Once-daily Compliance friendly High safety margin After 2 months of treatment Patient history: Onychomycosis since 3 years Previously treated during 1 year with topical azolderivate without any effect Source: Study SM13 After 3 months of treatment 20 20

22 Post-marketing study shows quick visible improvement Number of patients reporting an improvement, per cent 100% 92% 88% 90% 80% 77% 70% 60% 50% 40% 30% 20% 10% 0% 2 weeks 4 weeks 8 weeks Design Open clinical study with the purpose to document early visible effects of Emtrix 75 patients with 25 75% affected nail in big toe or thumb Result Primary efficacy variable: number of patients experiencing improvement after 8 weeks treatment: 92% (CI: 83% - 97%) 52% of the patients reported large or very large improvement* Other secondary efficacy variables also improved with 45 75% of the patients No product related side affects * The patients estimation was graded in four steps: no improvement, some improvement, large improvement and very large improvement 21 Source; Journal of Cosmetics, Dermatological Sciences and Applications, 2011, Vol. 1:

23 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) 22 22

24 MOB-015 Excellent Phase II results 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 MYCOLOGICAL CURE AT 15 MONTHS MYCOLOGICAL CURE AND EXCELLENT CLINICAL IMPROVEMENT OR CURE* 23 * Means 10% or less clinical involvement Source: Moberg Pharma data on file from MOB-015 phase II study 23

25 Phase II results indicate that MOB015 have 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% 24 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; 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 Phase II results provide evidence of efficacy and safety 54% 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 Target Product Profile in mild/moderate Onychomycosis (25-50% nail involvement) > 60% mycological cure 20-30% complete cure >50% of patients report visible improvement after 1 month 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 Share, Shareholders, Team

32 The Share last 3 years (Nov 19, 2014) Analysts Klas Palin, Redeye Christian Lee, Remium Additional coverage expected H

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 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 Steve Cagle VP North America (to Dec 31) Mats Pettersson (Chair) Wenche Rolfsen Geert Cauwenbergh Kjell Rensfeldt VP R&D Anna Ljung CFO Jeff Vernimb joining Dec 15 as new GM for US operations (Ex Insight, Pfizer/Warner Lambert) Thomas Thomsen Torbjörn Koivisto 33 33

35 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 34 BD/Innovation Engine - M&A focus on US OTC products - MOB-015 partner process and Phase III preparations - BUPI: Pll study, evaluate/pursue sales as unlicensed drug/partner and Orphan opps 34