creating a footprint in underserved niches · due to the rounding component, totals may not tally....
TRANSCRIPT
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Creating a footprint in underserved niches
Carnegie Healthcare Seminar, Stockholm, March 15, 2018Peter Wolpert, CEO & Founder
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Disclaimer
The purpose of this presentation (the "Presentation") is to provide an overview of Moberg Pharma AB (publ) (the "Company"). For the purposes of this notice, "Presentation" means this document, its contents or any part of it, any oral presentation, any question or answer session and any written or oral material discussed or distributed during the Presentation meeting.
This Presentation is not a prospectus or similar offer document. This Presentation does not purport to contain comprehensive or complete information about the Company and is qualified in its entirety by the business, financial and other information the Company is required to publish in accordance with the rules, regulations and practices applicable to companies listed on Nasdaq Stockholm (the "Exchange Information"). Any decision to invest in any securities of the Company should only be made on the basis of a thorough examination of the Exchange Information and an independent investigation of the Company itself and not on the basis of this Presentation. Neither this Presentation nor any of the Exchange Information has been independently verified by any other person unless expressly stated therein. No representation or warranty, express or implied, is made as to, and no reliance should be placed on, the fairness, accuracy or completeness of the information or opinions contained in this Presentation.
Except where otherwise indicated in this Presentation, the information provided herein is based on matters as they exist at the date of preparation of this Presentation and not as of any future date. All information presented or contained and any opinions expressed in this Presentation are subject to change without notice. None of the Company or any of its directors, officers, employees, agents, affiliates or advisers is under any obligation to update, complete, revise or keep current the information contained in this Presentation to which it relates or to provide the recipient of with access to any additional information that may arise in connection with it.
This Presentation contains "forward-looking" statements. These forward-looking statements can be identified by the fact that they do not relate only to historical or current facts. In particular, forward-looking statements include all statements that express forecasts, expectations, plans, outlook and projections with respect to future matters, including trends in results of operations, margins, growth rates, overall market trends, the impact of interest or exchange rates, the availability or cost of financing, anticipated cost savings or synergies, the completion of strategic transactions and restructuring programmes, anticipated tax rates, expected cash payments, and general economic conditions. By their nature, forward-looking statements involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future and they are subject to change at any time. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements, including 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, the Company’s ability to secure new products for commercialization and/or development and other risks and uncertainties detailed from time to time in the Company’s interim or annual reports, prospectuses or press releases and other factors that are outside the Company's control. Any forward-looking statements made by or on behalf of the Company speak only as of the date they are made. The Company does not undertake to update forward-looking statements to reflect any changes in the Company's expectations with regard thereto or any changes in events, conditions or circumstances on which any such statement is based.
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Moberg Pharma - a leader in topical niche categories
3
OTC Sales in the U.S.
• Distribution in all major retailers• #1 in nail fungus
#1 in liquid bandages#1 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
5BRANDS
40+COUNTRIES PIPELINE ASSETS
2 PHASE 3
GLOBAL CONSUMER HEALTH
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Q4 2017 - Highlights
Commercial Operations and Innovation Engine
Focus going forward
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Our major brands grew double-digit in retail sales whichresulted in an improved EBITDA margin to 30%
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Commercial – strong development for Kerasal Nail® increased EBITDA
• Strong fourth quarter, a more streamlined product portfolio resulted in a gross margin of 72% and 30% EBITDA. Results in line with seasonal pattern
• Kerasal Nail® net sales grew by 44% in Q4. Favorable outcome on challenge to NAD will limit main competitor’s marketing in the U.S.
• Underlying demand is strong for Dermoplast® and New Skin®, with double-digit growth in retail sales. Opportunities identified to drive continued growth for both brands
• Balmex under divestment, $4.25m plus inventory, Capital gain $0.5m, close in April.
• Strong cash position
Innovation engine – Extensive action plan implemented to complete recruitment
• MOB-015 – Progressing according to the updated action plan and timeline announced in November, transition to new CRO well underway, with the goal of delivering strong results without further external financing.
• BUPI – Canadian patent approved. Evaluating possibilities to overcome local concern over phase 3 study application in India.
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– Share from Direct sales continue to grow after acquisitions
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Majority of revenue from Consumer Health Sales in the U.S.
Channel Product Geographies
New Skin20%
Divested 8%
Distributors11%
Direct89%
Other 15%
Nalox / Kerasal Nail
35%
Dermoplast22%
Europe 5%
Americas90%
Distribution of revenue, January – December 2017
ROW5%
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January - December 2017
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Increased sales and EBITDA following acquisitions
31%GROWTH
439MSEKNET SALES
108%UNDERLYING EBITDA GROWTH*
89MSEKEBITDA
20%EBITDA MARGIN
*) Excluding a capital gain in Q3 2017 of SEK 13 million from the divestment of Fiber Choice®. The comparative figures exclude a capital gain in Q2 2016 of SEK 41.1 million from the divestment of the Jointflex®, Fergon® and Vanquish®brands
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October - December 2017
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Strong Q4 results – in line with seasonal pattern
1%GROWTH
90MSEKNET SALES
124%EBITDA GROWTH
27MSEKEBITDA
30%EBITDA MARGIN
12%GROWTH
excluding divested/acquired assets
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Rapid growth
2010 2011 2012 2013 2014 2015 2016 2017
8
56
112
157
200
286
334
439Net Sales, MSEK
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Growth in Sales and EBITDA rolling 12 months
CONFIDENTIAL
• Long-term EBITDA margin target: 25%
Note significant divestments and acquisitions 2016 - 2017
Note significant acquisitions and divestments in 2016-2017:• JointFlex®, Fergon® and Vanquish® divested April 4, 2016• New Skin® PediaCare® and Fiber Choice® acquired July 8, 2016,
and PediaCare® divested Nov 24, 2016 • Dermoplast® acquired Dec 31, 2016• Fiber Choice® divested Aug 28, 2017
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P&L – Strong gross margin and EBITDAQ4 2017
111) 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 Oct-Dec Oct-Dec Full-year Full-year
(MSEK) 2017 2016 2017 2016Revenue 90 89 439 334Gross profit 65 61 314 233% 72% 68% 71% 70%
SG & A -31 -42 -114 -177R&D - existing product portfolio1) -2 -1 -6 -5Other operating income/operating expenses -1 0 13 43EBITDA Commercial Operations 31 18 106 94% 34% 20% 24% 28%
R&D & BD - future products2) -4 -5 -17 -16
EBITDA 27 12 89 78% 30% 13% 20% 23%
Depreciation/amortization -9 -5 -38 -16Operating profit (EBIT) 18 7 51 62
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Balance Sheet and Cash Flow
(MSEK) Dec 31, 2016 Dec 31, 2017
AssetsIntangible fixed assets 1 000 980Property, plant and equipment 1 1Financial assets - -Deferred tax asset 10 9Total non-current assets 1 011 990
Inventories 42 27Trade receivables and other receivables 93 87Cash and bank balances 86 119Total current assets 221 233
TOTAL ASSETS 1 232 1 223
Equity and liabilitiesEquity 562 552Long-term interest-bearing liabilities 589 591Deferred tax liability 7 7Current non-interest-bearing liabilities 75 74
TOTAL EQUITY AND LIABILITIES 1 232 1 223
Stronger cash flow in Q4 thanks to:
• Tied-up capital decreased due to lower inventories after divestments and further optimization of working capital
• Divestment of Balmex for $4.25 million (ca 35 MSEK) plus inventory value, expected to close in April
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Q4 2017 - Highlights
Commercial Operations and Innovation Engine
Focus going forward
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Commercial operations - Focus on major brands
Direct sales – driving organic growth for major brands
Main growth drivers are Kerasal Nail®, New Skin®, and Dermoplast®, representing >80% of net sales and an even higher share of profitability
• Kerasal Nail® +44% in Q4 vs year ago. US retail sales grew 17%.
• Successful invigoration of New Skin® resulted in 21% growth in retail sales Q4 (+18%, L52W)
• Dermoplast® +13% growth in retail sales1). Inventory effects throughout 2017 from the takeover. Targeted growth plan to be launched in 2018
Distributor sales – sales in 40 markets
• Market leader or Top 3-positions in Nordics, several EU and Asian countries
• Strong fourth quarter. Focus to stabilize revenues going forward
1) Note that approximately 60% of sales of Dermoplast® are through hospitals, which means that retail sales data do not provide as complete a picture as for other brands.
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• #1 Brand in the Fungal Nail category in the U.S.
• Retail sales grew 17% in Q4 as well as L52W, excellent impact also in Q4 from Q2-Q3 focused marketing/sales plan
• December NAD outcome resulted in major limitations of the marketing for main competitor
• 2018 test launch of Kerasal Nail® for psoriasis patients with nail problems
• Excellent clinical data published in 20171 supports stronger claims and use for nail psoriasis, to be launched in select other markets
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17% growth for Kerasal Nail in the U.S. in Q4
76% 94%VISIBLE IMPROVEMENT
AFTER 1 WEEKS
1Title: Early visible improvements during K101-03 treatment: an open-label multicenter clinical investigation in patients with onychomycosis and/or nail psoriasis Link: http://www.karger.com/DOI/10.1159/000478257
VISIBLE IMPROVEMENT AFTER 8 WEEKS
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• The #1 OTC liquid bandage brand in the U.S. An antiseptic which kills germs and dries rapidly to form a clear protective cover
– Liquid and Spray available
– Distribution for Spray expanded in 2017 to Walmart and Walgreens
• Retail sales grew 21% in Q4 and 18% L52W, excellent impact also in Q4 from Q2-Q3 focused marketing/sales plan
– A nationwide television campaign “Mr Cut” was launched in June, which drove strong growth and effects lasting through Q4
– For 2018, we intend to leverage the 2017 success, optimize marketing, and increase digital presence
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New Skin retail sales grew by 21% in Q4
Please note that there is about a one-month lag before increased consumer sales produce an effect on net sales.
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Double-digit growth just made Dermoplast the #1 selling pain relieving spray in U.S. retail
• The #1 pain relieving spray in U.S. retailContains maximum strength Benzocaine
– No touch application, available with and without antibacterial
– 60% of sales to Hospitals and 40% in Retail. Used for skin-related pain and itch problems
– Acquired Jan 1, 2017. Distribution expanded at Walmart and CVS
• Retail sales grew by 14% in Q4 (+13%, L52W)
– In 2017, detailed market analysis of opportunities in hospital and retailchannels and a growth strategy has been developed. Consumers arepassionate about the product as evident from high social media activity
– In 2018, will launch a targeted marketing plan, with digital focus to leverage the strong interest and strengthened positioning
Please note that there is about a one-month lag before increased consumer sales produce an effect on net sales.
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MOB-015 – targeting leadership in onychomycosis
18Source: Moberg Pharma analysis and estimate
• Topical formulation delivering high concentrations of terbinafine through the nail
• Target profile: Rapid visible improvement, superior cure rates and safe
• Two Phase-3 studies ongoing in North America and Europe, enrolling in total 800 patients
• Progressing towards target to complete enrollment in North American study in the summer of 2018 and European study in H2 2018
• Patent protection until 2032, granted in USA, EU, and Japan
• Estimated annual sales potential: USD 250–500 million
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0
1 000 000
2 000 000
3 000 000
4 000 000
5 000 000
6 000 000
2022E2021E2020E2019E2018E20172016201520142013
Market – 5m TRx expected in US Rx Onychomycosis by 2022
Generics
Branded Topicals(Jublia, Kerydin)
All products
Jublia & Kerydin launched in 2014 and peaked in 2015 with extensive promotion, Jublia at $338m
Source: Symphony Health, Moberg Pharma analysis, assuming 3% growth 2018E-2022E
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MOB-015 – Net Sales potential of $250-500 million
X
Market potential for MOB-015
• US Rx potential: $170-300+ million (5 million units à $1700/unit for WAC branded topicals before GTN discount)
• Other Rx markets, e.g. Japan and Canada: $50-100 million
• OTC markets in EU and RoW: Ca $50-100 million (3.5-7 million units à $15/unit)
$million 60% 50% 40% 30%
5% 170 213 255 298
7.5% 255 319 383 446
10% 340 425 510 595
15% 510 638 765 893Mar
ket
shar
e, T
Rx
Gross-to-Net discount
5-7.5% market share of 5 million x $1700 with 50-60% discount off
= $170-300+ million in net sales for the US market
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Results from Phase 2 - 24/25 completed study
• 45 µg/g TBF in nail bed (Median) = 40 x Oral
• 1610 µg/g TBF in nail (Median) = 1000 x Oral
• 1520 pg/mL TBF in plasma (Max) = 1000 x lower than Oral
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Phase 2 – results demonstrated efficacy and safety
X
MYCOLOGICAL CURE
40%
MYCOLOGICAL CURE AT 60 W*
54%
100%
MYCOLOGICAL CURE AT 24 W
NEGATIVE CULTURE AT 60 W
* 54% of patients completing the treatment (13 of 24), 52% of FAS (13 of 25) and 60% of PPAS (12 of 20)** Means 10% or less clinical involvement *** Post-hoc analysisSource: Moberg Pharma data on file, MOB-015 phase II study
Results 24 weeks 60 weeks
Mycological cure and almost cured or cured** 29%
Mycological cure 40% 54%*
Negative culture 100%
Clear nail growth*** >4,5 mm
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Aiming at a superior product profile
Superior Cure Rates, Rapid Visible Improvement and safety is key to prescribers (n=89)**:
• 62% would prefer MOB-015 vs 6-15% for other topicals
• 65% would prefer MOB-015 alone or in combination with oral terbinafine, vs 24% oral terbinafine only
• 72% try to avoid using oral terbinafine due to patient concerns over liver toxicities
Note: 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** Source: HCP survey with 89 prescribers, dermatologists and podiatrists in the U.S., April 4, 2017
X
MYCOLOGICAL CURE
Mycologicalcure
Complete cure
Visible improvement
24W 52W 52W 4W
MOB-015 Target >50% 60-70% 20-30% >50%
Jublia - 54% 15-18% N/A
Penlac & Current OTCs* Ca 30% 6-8% or less N/A
Target Product Profile for mild-moderate nails vs Jublia
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Current Rx treatment alternatives in the U.S.
X
TreatmentFDA
Approval Complete cure rate
Ciclopirox (Penlac) 1999 5.5-8.5%
Efinaconazole (Jublia) 2014 15-18%*
Tavaborole (Kerydin) 2014 7-9%
Terbinafine (Lamisil) 1996 38-54%
Itraconazole 1995 14-26%
Fluconazole Off-label 37-48%
Main topical branded competitor
Adverse events associated with oral treatments
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% Source: Dermatology World, August 2017
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Example of successful treatment with MOB-015
Before After
Source: Moberg Pharma data on file, MOB-015 phase II study
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Example of successful treatment with MOB-015
Before After
Source: Moberg Pharma data on file, MOB-015 phase II study
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Example of successful treatment with MOB-015
Before After
Source: Moberg Pharma data on file, MOB-015 phase II study
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BUPI - Providing better pain relief in the oral cavity
27
“In Phase 2, BUPI provided 50% better pain relief in the mouth than standard pain treatment”
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Targeting leadership in managing oral mucositis pain
28Source: Moberg Pharma analysis and estimate
• BUPI: Lozenge with bupivacaine, taste-masked
• Target profile: Better and longer pain relief than existing products
• Phase 3 application submitted by partner Cadila Pharmaceuticals.
• Patent protection until 2031, granted in EU and Canada
• Applications in progress in the USA
• Estimated annual sales potential: USD 50–100 million
• Cadila funds one Phase 3 trial
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BUPI demonstrated efficacy and safety in Phase 2
0
10
20
30
40
50
60
70
BUPI Control
baseline average max VAS
0
5
10
15
20
25
30
35
40
BUPI Control
baseline average max VAS
VAS Score (Highest of Mouth/Pharynx) VAS Score in Mouth only
-40% -49%
Strong Phase 2 data recently published, significantly better pain relief than standard treatment, n=39
• 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)
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Q4 2017 - Highlights
Commercial Operations and Innovation Engine
Focus going forward
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Continued focus to deliver on Strategy
We focus on maximizing the potential in our portfolio; through organic growth as well as realizing the substantial value of our pipeline
Commercial
➢ Building on strong 2017 growth for Kerasal Nail and New Skin in the U.S., and test launch Kerasal® for nail psoriasis. Stabilize nail fungus sales in EU/RoW.
➢ Launching growth plan for Dermoplast®
➢ Increase digital presence for key brands
Pipeline assets
➢ MOB-015 – Finalizing Phase 3 studies and preparing commercialization
➢ BUPI – Evaluating strategies to solve local concern over phase 3 study in India
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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