creating a footprint in underserved niches · organic and m&a, leader in 3 niches distributors...
TRANSCRIPT
Creating a footprint in underserved niches
Presentation at Redeye, May 23, 2017 Anna Ljung, CFO
Disclaimer
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 and Moberg Pharma does not undertake to update, complete, revise or keep current the information or statements contained herein. 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.
The information in this presentation does not constitute an offer to sell or an invitation to buy securites in Moberg Pharma.
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Creating shareholder value – investment case
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Commercial niche player
Growing and profitable business
Late-stage pipeline
Strong team and track record
TMTM
TM
Organic and M&A, leader in 3 niches
Distributors and Direct Sales
Innovation Engine
Aligned interests and diversity
Moberg Pharma in brief
Commercial business
Pipeline assets
Focus the coming year
Moberg Pharma - a leader in topical niche categories
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Financial Overview
• Market Cap ~0.9 BSEK ($100m, MOB.ST)• Net sales run rate 2016: ~450 MSEK ($50m), incl. H216 acquisitions
Note: Acquisition of DermoPlast from Prestige Brands closed December 30, 2016
OTC Sales in the U.S.
• Distribution in all major retailers• #1 in nail fungus
#1 in liquid bandages#2 in pain relief sprays
Distributor sales
• #1-3 in many markets• 3 Top-50 partners
Mylan, Menarini, Endo
Innovation Engine
• MOB-015 - $250-500m• BUPI - $50-100m • Future market leaders in
their respective niches
25%LONG-TERM EBITDA MARGIN
6BRANDS
40+COUNTRIES PIPELINE ASSETS
PHASE3
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2016 – a transformative year
CONFIDENTIAL
Portfolio
• Acquisition of Dermoplast®, New Skin®, Fiber Choice® and PediaCare® for 88 MUSD
• Divestment of four non-core brands for 15 MUSD
Pipeline assets
• Patent for MOB-015 in multiple territories and for BUPI in the EU
• Initiated Phase 3 program for MOB- 015 in Europe and N.A.
• BUPI - positive Phase 2 data, license and development agreement with Cadila Pharmaceutical
2/3SHARE OF REVENUE AND PROFITABILITY
Phase32 PRODUCTS IN/ENTERING PHASE 3
Commercial business
• Successful re-launch of KerasalNail® in the U.S. - all time high market share
• Continued expansion in Asia with a launch in Taiwan and a successful test launch in Japan
27%23%
KERASAL NAIL MARKET SHARE*
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A journey towards half a billion SEK
2010 2011 2012 2013 2014 2015 2016
8
56
112
157
200
286
334
~450
2016 runrate incl H2 acquisitions
Net Sales, MSEK
EBITDA, MSEK
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Scale increases profitability
2010 2011 2012 2013 2014 2015 2016
-30
-8
13
25
46
78
-8
9
Q117 - Increased sales and EBITDA following acquisitions
51%GROWTH
105MSEKNET SALES
5XGROWTH
16.7MSEKEBITDA
16%EBITDA MARGIN
11%
Note: Underlying EBITDA (excluding capital gain)
P&L summaryQ1 2017
101) 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.
P&L Summary Jan-Mar Jan-Mar Full-year
(MSEK) 2017 2016 2016Revenue 105 69 334Gross profit 73 49 233% 70% 70% 70%
SG & A -50 -40 -177R&D - existing product portfolio1) -2 -2 -5Other operating income/operating expenses 0 0 43EBITDA Commercial Operations 21 7 94% 20% 10% 28%
R&D & BD - future products2) -4 -4 -16
EBITDA 17 3 78% 16% 5% 23%
Depreciation/amortization -10 -3 -16Operating profit (EBIT) 7 1 62
– Share from Direct sales continue to grow after acquisitions
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Majority of revenue from direct OTC sales
Channel Product Geographies
Distributors12%
Direct88% Other
49%
Nalox / Kerasal Nail
31%
Dermoplast20%
ROW5%
Europe 8%
Americas88%
Distribution of revenue, January – March 2017
➢ INVENTORY BUILD-UP
➢ ADVERTISING STARTS
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Seasonality in our commercial business
Q1 Q2 Q3 Q4
Q3 Q4➢ HIGH SEASON/SALES PEAK
➢ HIGH ADVERTISING COSTS
Direct sales
• Many orders each month, advertising increases during high season
Distributor sales
• 2-3 orders/year for each market
➢ HIGH SALES
➢ HIGH ADVERTISING COSTS
➢ SALES BENEFITING FROM HIGH SEASON ADVERTISING
➢ LOW ADVERTISING COSTS
➢ STRONG CASH FLOW/EBITDA
• Q1 2017 revenues increased by 51% fuelled by recent acquisitions
• The three biggest brands Kerasal Nail®, Dermoplast®, and New Skin® account for well above 2/3 of revenue
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Revenue segmentation
Revenue by channel Jan-Mar Jan-Mar Full-year
(MSEK) 2017 2016 2016
Direct sales, organic 36 39 173Direct sales, acquisitions and divestments 56 10 94
Sales of products to distributors, organic 13 14 61
Sales of products to distributors, acquisitions and divestments - 7 7
Milestone payments 0 - -
TOTAL 105 69 334
Revenue by product category Jan-Mar Jan-Mar Full-year
(MSEK) 2017 2016 2016
Kerasal Nail®/Nalox 33 32 151
Dermoplast® 21 - -Divested products (JointFlex®, Fergon®, Vanquish®, PediaCare®) - 16 33Other products 51 21 150TOTAL 105 69 334
Due to the rounding component, totals may not tally.
No major changes in Balance Sheet during Q1
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Balance Sheet
(MSEK) Dec 31, 2016 Mar 31, 2017
AssetsIntangible fixed assets 1 000 997Property, plant and equipment 1 1Financial assets - -Deferred tax asset 10 11Total non-current assets 1 011 1 009
Inventories 42 54Trade receivables and other receivables 93 90Cash and bank balances 86 74Total current assets 221 218
TOTAL ASSETS 1 232 1 227
Equity and liabilitiesEquity 562 555Long-term interest-bearing liabilities 589 590Long-term non-interest-bearing liabilities 7 8Current non-interest-bearing liabilities 75 75
TOTAL EQUITY AND LIABILITIES 1 232 1 227
Moberg Pharma in brief
Commercial business
Pipeline assets
Focus the coming year
Attractive portfolio - Main brands are niche leaders
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Direct sales – three major brands drive growth
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2016 and Q1 2017
• Successful re-launch of Kerasal Nail® in 2016 increased U.S. market share to 27%
• Recent launch of 1-week claim in the U.S. drives growth for Kerasal Nail
• Entered the UK in 2016, our second direct sales market
• In Q117, three largest brands Kerasal Nail®, New Skin® and Dermoplast® are main growth drivers, accounting for >2/3 of revenue and an even higher share of profitability.
• New distribution at Walmart, CVS and Walgreens
27%23%
KERASAL NAILMARKET SHARE*
2/3SHARE OF REVENUE AND PROFITABILITY
2016 – a year of transformative acquisitions
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Transactions in 2016
• Acquisition of Dermoplast®, New Skin®, Fiber Choice® and PediaCare® for 88 MUSD
• Divestment of non-core brands Joint ex®, Fergon®, Vanquish® and PediaCare® for 15 MUSD
2 major brands acquired driving growth as of 2017
Source: Symphony IRI, Brand ranking according to Pharmacy Times Prestige Brands Earnings call, Nov 3, 2016
Dermoplast
• Net sales $12m, growing high single digit, EBITDA margin 45%
• #1 pharmacist recommended brand, #2 with 21% market share in retail pain relief market, significant hospital business
• Acquired for 8.9X EBITDA
• Integration to be finalized H1 2017
New Skin
• #1 liquid bandage in U.S. retail
• Integration finalized Q4 2016
• High EBITDA margin
• Portfolio acquired for 8x EBITDA
Commercial operations - scalable infrastructure in the U.S.– Consumer Healthcare Focus
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Retailers/WholesalersContract Manufacturers Sales Force
Logistics
Sales and marketing/Brand Management
Note: Largest retailers, contract manufacturers and wholesalers only, not an all inclusive list.
Emerson Healthcare
Distributor sales – focus on Asia-Pacific
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2016 and Q1 2017• Focus on launches in Asia-Pacific• Successful 2016 launches in Taiwan and
one city in Japan
Nationwide launch initiated in Japan • Started end of March• Managed by local partner CMIC Group• National TV • Social media• Distribution in 8,000 stores
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TV Commercial in Japan
Moberg Pharma in brief
Commercial business
Pipeline assets
Focus the coming year
Pipeline assets – target leadership in two niches– building on topical drug delivery know-how
23Source: Moberg Pharma analysis and estimate
Nail fungus• Topical terbinafine
• Target profile: Rapid, visible improvement and superior cure rate (among topical medications)
Pain relief for oral mucositis• Lozenge with bupivacaine
• Target profile: Better and longer pain relief than with existing products
Status: Phase 3 program initiated in Q3, 2016• Recruitment of 750–800 patients for two Phase-3 studies in
North America and Europe to be completed H217
Status: Preparations for Phase-3 application underway• Application for phase 3 to be submitted in Q217 by partner
Cadila Pharmaceuticals.
• Advisory meetings held Q117 with health agencies in Sweden and Germany.
Patents: Patent protection until 2032• Patents granted in large markets, incl. USA, EU, and Japan.
Patents: Patent protection until 2031• Patents granted in the EU.
• Applications in progress in the USA and Canada.
Estimated annual sales potential: USD 250–500 million Estimated annual sales potential: USD 50–100 million
MOB-015 BUPI
• MOB-015 is based on Emtrix/Kerasal nail, adds terbinafine
• Phase 3:
– Primary end-point: Complete Cure after 52w
– Manufacturing partner Colep co-invests in MOB-015
• Phase 2 demonstrated efficacy and safety
– building on topical drug delivery know-how
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Targeting market leadership with MOB-015
Source: An open, single center pilot study of efficacy and safety of topical MOBO15B in the treatment of distal subungual onychomycosis, Faergemann et al, poster presentation at American Academy of Dermatology, March 2016; 54% of the patients completing the study were mycologically cured. Mycological cure for FAS was 52% and for PPAS 60%
1000X 40X54%
MYCOLOGICAL CURE MORE TERB IN NAIL BED VS ORALMORE TERB IN NAIL VS ORAL
Target Product Profile for mild-moderate nails vs Jublia- Jublia peaked at $338m sales in 2015 (Launch June 2014)
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Myc. Cure Complete cure Visual improvement
24W 52W 52W 4W
MOB-015Target
>50% 60-70% 20-30% >50%
Jublia - 54% 15-18% N/A
Penlac and Current OTCs*
Ca 30% 6-8% or less N/A
Superior Cure Rates
Rapid Visible Improvement
Potential for Shorter TreatmentNote: For MOB-015, the above describes the outcome Management targets in ongoing Phase 3 trials. Source for Jublia data is Jublia Prescriber Information, Rev 09/2016* Refers to publications on ciclopirox and amorolfine. Many other OTC products have not conducted or published 52w trials
TRx Million, U.S. prescription market for nail fungus
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Onychomycosis market growth after recent launches ofnew topicals
CAGR 2012-2016 = 9.2%
Source: IMS, Moberg Pharma estimate for Q4 2016
BUPI - Providing better pain relief in the oral cavity
Product & Indication
• BUPI (bupivacaine lozenge) for oral pain relief (mouth and throat)
– 1st indication: Oral Mucositis in cancer patients. Large unmet need.
– Potential for other indications: Burning Mouth, Sjögren’s, Endoscopy
– EU patent with term to 2031, pending in U.S. and Canada
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Sales potential and Next steps
• Peak Sales potential estimated to $50-100m (whereof OM $20-25m)
• Phase 3 preparations in Europe (Moberg) and India (Cadila Pharmaceuticals)
“In Phase 2, BUPI provided 50% better pain relief in the mouth than standard pain treatment”
Source: Poster presentation at International Association for the Study of Pain (IASP), Japan, September 2016.Moberg Pharma analysis and estimate
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BUPI – phase 3 preparations underway
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BUPI Control
baseline average max VAS
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BUPI Control
baseline average max VAS
VAS Score (Highest of Mouth/Pharynx) VAS Score in Mouth only
-40% -49%
BUPI: Strong Phase 2 data, significantly better pain relief than standard treatment
• Control group had access to oral painkillers, morphine and lidocain mouthwash
• Primary endpoint: 31% less pain in BUPI group (Highest VAS score in mouth/pharynx, p=0,0032)
• In Mouth only: 50% less pain in BUPI group (p=0,0002)
Moberg Pharma in brief
Commercial business
Pipeline assets
Focus the coming year
Continuing the positive momentum in 2017
Focus in Q2 – preparing for high season
• Supporting the Japanese launch
• Broader distribution for our recent acquisitions New Skin® and Dermoplast®
• Launching stronger claims for Kerasal Nail® ahead of the high season in the U.S.
Focus in 2017 – a consolidation year
• Integrate acquired brands and strengthen brand positions
• Complete Phase 3 enrolment for MOB-015
• Gain approval to start BUPI Phase 3
• Engage with potential commercialization partners for MOB-015 and BUPI
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2017 is a consolidation year
Why invest in Moberg Pharma– Strategy for Shareholder value
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Commercial niche strategy enables a growing and profitable base business
Pipeline with large potential and at reasonable risk- Proven molecules limit TTM, cost and risk
Acquisition strategy with substantial value potential- 6 transactions since 2012
Strong Team and track record
Moberg Pharma AB (Publ)Gustavslundsvägen 42, 5 tr.
167 51 Bromma
mobergpharma.se