Moberg Pharma ABd1q0gh225dp9f5.cloudfront.net/sites/default/files/... · Moberg Pharma’s results...
Transcript of Moberg Pharma ABd1q0gh225dp9f5.cloudfront.net/sites/default/files/... · Moberg Pharma’s results...
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Corporate Presentation – Redeye, September 24, 2014 Peter Wolpert, CEO and Founder
Moberg Pharma AB
Combining Commercial and Innovation Excellence to provide unique products in underserved markets
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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’s interim or annual reports, prospectuses or press releases.
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Presentation of MOB-015 Phase II results
Business update
CONTENT COMBINING COMMERCIAL AND INNOVATION EXCELLENCE
MOB015 Phase II results
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MOB-015B Phase II study
Study design Open-label phase II study in onychomycosis conducted at the Sahlgrenska University Hospital Patients received MOB-015 once daily for 12 months. Last follow-up was at 15 months from inclusion Coordinating Investigator: Professor Jan Faergemann Primary efficacy variable the proportion of patients with mycological cure of target nail, defined as negative fungal culture and negative direct KOH microscopy, at 60 weeks.
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54% MYCOLOGICAL CURE
Excellent Phase II results FINAL RESULTS AT 15 MONTHS
Source: Moberg Pharma data on file from MOB-015 phase II study
29% MYCOLOGICAL CURE AND EXCELLENT CLINICAL IMPROVEMENT OR CURE
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MOB015 phase II results are superior to topical drugs on the market without the safety issues of oral therapy
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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
Ciclopirox Penlac Sanofi Topical - 29-36%2) 20-65% affected
Tavaborole Kerydin Anacor Topical - 31-36% 20-60% affected
Efinaconazole Jublia Valeant Topical - 54% 20-50% affected
Amorolfin Loceryl Galderma Topical - n/a3)
Terbinafine Lamisil Novartis Oral 40%4) 75%4)
Itraconazole Sporanox J&J Oral 25-30%4) 40-50%4)
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;
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Anacor/Sandoz deal – July 2014 CONFIDENTIAL
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Total Deal Value estimated to NPV of 270 m$ (if no exercise of repurchase option) Upfront 65 m$ (whereof 25 m$ by Jan 2015) Payment 2016 45 m$ 50% of gross profits 2017-2025 Source: Anacor press release, MP analysis: estimate at least 100 m$ gross profit per year, based on 2016 terms, potential and expected market share; WACC 12% From Anacor’s press release: The agreement with Sandoz entitles Anacor to upfront payments totaling $40 million and an additional milestone payment of $25 million expected to be paid in January 2015. Under the agreement, Sandoz and Anacor will share equally, under a long-term profit-sharing arrangement, the gross profits (defined as net sales less cost of goods sold) accrued by Sandoz on sales of KERYDIN, except that in 2015 Anacor will start receiving profit-sharing payments after the first $50 million of gross profits have been accrued by Sandoz. The long-term profit-sharing arrangement includes cumulative minimum profit-sharing payments to Anacor in 2016 totaling $45 million. Anacor will also have the option to repurchase all rights in KERYDIN from Sandoz on the later of three years from launch or December 31, 2017, at a price to be determined pursuant to the agreement. Under the terms of the agreement, Anacor will supply product to Sandoz at cost through Anacor's contract manufacturers, and Sandoz will be responsible for all of its selling, marketing, distribution, general and administrative costs related to the commercialization of KERYDIN. Anacor will hold the NDA and will be responsible for any further development of KERYDIN.
Photos from MOB-015 phase II
CONFIDENTIAL
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Pat nr 1005
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Pat nr 1006
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Pat nr 1013
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Pat nr 1018
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Pat nr 1019
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Pat nr 1020
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Pat nr 1021
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Pat nr 1007 No improvement
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Pat nr 1011 Little improvement
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MOB-015 next steps Strategy to select partner for continued
development and commercialization
Potential partners identified
Partner discussions ongoing
Business Update
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2014 TV commercial in the Nordics
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Net Sales grew to 178 MSEK (TTM, Q214) - U.S. OTC Sales operations - Products sold in 40+ countries - 30 employees in Sthlm and NJ
Focus in OTC/Dermatology/Topicals - Leading U.S. OTC SKU in Nail Fungus - Superior PII data for MOB015
3 acquisitions in last 21 months - Nov 2012, Alterna LLC - Dec 2013, OTC brands from Bayer - Apr 2014, BUPI, Ph ll for oral pain relief
Market Cap 450 MSEK, (OMX:MOB)
Moberg Pharma COMBINING COMMERCIAL AND INNOVATION EXCELLENCE
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2014 Highlights
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58% Growth in Direct sales H114
#1 with 25% U.S. Market share last 4w
Stronger claims Expanded indication for Nalox in EU
21%
EBITDA margin for Commercial operations in H114
Strong Ph II data For MOB-015
60 million SEK raised in directed share issue
BUPI - Pipeline boost Acquisition of phase II asset
China/SE Asia Regulatory progress
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17 consecutive quarters of sales growth
Product Sales, TTM, MSEK
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Q12010
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Q42010
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Q22012
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MSE
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Majority of revenue from direct OTC sales – Strong contribution to earnings from both channels
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Sales via distributors
32%
Direct OTC Sales 68%
Other 12%
Nalox/ Kerasal Nail
60%
Kerasal 16%
JointFlex 12%
RoW 4%
Europe 22%
Americas 74%
Channels Products Geography
Distribution of revenue, Jan – June 2014
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Rapid increase in sales and EBITDA
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(MSEK) Net Sales
EBITDA
2011 2012 2013 2014 H1
MilestonesProduct Sales56
112
157
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13 EBITDA
EBITDA excludingmilestone payments
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Commercial EBITDA margin exceeding 20% and EBITDA increased to 14% in H1
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Jan-Jun Jan-Jun Full-year (MSEK) 2014 2013 2013
Revenues - Product Sales - Milestones
105.5 103.7
1.8
83.4 83.4
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157.4 152.6
4.8 EBITDA 14.4 -7.3 -8.0 EBITDA-margin 14% neg neg Operating profit 10.5 -10.3 -14.1 Earnings after Tax 8.1 -7.0 -11.4 Earnings per Share (SEK) 0.67 -0.65 -1.01 EBITDA Commercial Operations 22.6 8.4 17.4 EBITDA-margin Commercial Operations 21% 10% 11%
Cash position June 30 75.6
Progress in Commercial Operations & Innovation Engine
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Organic growth 2014 H1 (Value), percent
5%
31%
U.S. OTC market
Moberg U.S.
Significantly faster growth than the market
Growth driver
Combination of Brand and IP equity:
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Acquired mature brands contribute to cash-flow
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• Domeboro is a astringent solution that provides fast, soothing itch relief for skin irritations - Brand update - Skin Center launched - Reminding Dermatologists - Line extension opportunities
• Vanquish provides strong headcache relief with lower safety risk profile vs. Competitors - Launched integrated marketing plan
• Fergon is a high potency iron supplement - Solid cash generator
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Domeboro - Brand modernization CONFIDENTIAL
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New web - Skin Care Center
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Distributor Sales well positioned for further growth Nalox™/Kerasal Nail™
10% growth in Europe – implementation of new stronger claims only started. Potential for further growth in 2015
Strong sales in Canada as response to launch of consumer advertising, Market leader with 25% market share Jan - May1)
Preparations for launches in China and SE Asia progressing well Large potential for 2015
Note: Four largest distributors only, not an all inclusive list.
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1)CDH units, IMS. Market share of OTC and Rx products for onychomycosis.
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Innovation engine
8 patent families - MOB015 – entering licensing - BUPI – Ph II expected Sept – Q115 - Kerasal Nail+/Nalox+
Focus to strengthen OTC pipeline
>100 BD OPPORTUNITIES EVALUATED IN LAST 12 MONTHS
3 ACQUISITIONS LAST 21 MONTHS
Acquisitions/inlicensing
Focus on OTC assets for U.S. market Completed Acquisitions Alterna LLC, Nov 2012, 20 m$ (1.8x Sales) Bayer brands, Dec 2013, 4.8 m$ (1.6x Sales) Bupizenge, April 2014, Dev. project,1m$
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The Share last 3 years (Sept 19 2014)
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Analysts
Klas Palin, Redeye
Christian Lee, Remium
Additional coverage expected H2 2014
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Additional institutional investors after share issue in May CONFIDENTIAL
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Shareholders No of shares Capital and votes, % ÖSTERSJÖSTIFTELSEN 2 248 478 16,1 SIX SIS AG, W8IMY 890 645 6,4 JPM CHASE NA (Altaris Capital Partners) 825 652 5,9 BURE EQUITY AB (PUBL) 811 151 5,8 FÖRSÄKRINGSAKTIEBOLAGET, AVANZA PENSION 773 472 5,5 GRANDEUR PEAK 703 780 5,0 HANDELSBANKEN FONDER AB RE JPMEL 612 777 4,4 WOLCO INVEST AB (Peter Wolpert, CEO) 600 000 4,3 TREDJE AP-FONDEN 486 000 3,5 J P MORGAN CLEARING CORP, W9 446 410 3,2 DEUTSCHE BANK AG LDN-PRIME BROKER, AGE FULL TAX 415 029 3,0 BANQUE CARNEGIE LUXEMBOURG S.A, (FUNDS) 386 494 2,8 SOCIETE GENERALE (AltoInvest (FR)) 258 621 1,9 STATE STREET BANK & TRUST COM., BOSTON 222 703 1,6 ML, PIERCE, FENNER & SMITH INC 172 414 1,2 SYNSKADADES STIFTELSE 172 201 1,2 MOBEDERM AB 154 215 1,1 BNY GCM CLIENT ACCOUNTS (E) ILM 130 257 0,9 LUNDMARK, ANDERS 130 000 0,9 KAUFMANN, PETER 120 800 0,9 SUMMA, 20 STÖRSTA ÄGARNA 10 561 099 75,6 Övriga aktieägare 3 401 438 24,4 TOTAL 13 962 537 100 Source: Euroclear Sweden AB per 2014-06-30
Warrants to Management (SW: PersonaloptionerI)
Outstanding warrants correspond to 8.1% of shares (6% to Management/Employees)
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Focus next 12 months COMBINING COMMERCIAL AND INNOVATION EXCELLENCE
Improving EBITDA!
Fuel strong U.S growth - K-Nail and Neurocream launch - Line extensions and new SKUs
Grow Distributor Sales - EU: Extended indication - China registration, SE Asia, Mena
BD focus - US OTC products
MOB-015 licensing process
Bupi: Pll study, evaluate/pursue early sales and Orphan Drug opportunities