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Interim report January – March 2017 Conference call, May 9 th , 2017 at 3:00 p.m. (CET) Dial-in number: SE: +46 8 566 426 95, US: +1 646 502 51 20 Peter Wolpert, CEO & Founder Anna Ljung, CFO
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Interim report January – March 2017d1q0gh225dp9f5.cloudfront.net/.../moberg...tc_presentation_170509.pdfThe purpose of this presentation ... MOB.ST) • Net sales run ... Source

Jun 13, 2018

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Page 1: Interim report January – March 2017d1q0gh225dp9f5.cloudfront.net/.../moberg...tc_presentation_170509.pdfThe purpose of this presentation ... MOB.ST) • Net sales run ... Source

Interim reportJanuary – March 2017

Conference call, May 9th, 2017 at 3:00 p.m. (CET) Dial-in number: SE: +46 8 566 426 95, US: +1 646 502 51 20Peter Wolpert, CEO & FounderAnna Ljung, CFO

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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.

2

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Creating shareholder value – investment case

3

Commercial niche player• Portfolio of 6 brands• 7 transactions since 2012

Growing and profitable business• 40+ countries• 3 #50 partners

Late-stage pipeline • Sales potential of $300-600 million peak• Proven molecules limit TTM, cost & risk

Strong team and track record• 40 employees• Offices in Stockholm and NJ (US)

TMTM

TM

Organic and M&A, leader in 3 niches

Distributors and Direct Sales

Innovation Engine

Aligned interests and diversity

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Moberg Pharma - a leader in topical niche categories

4

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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Q1 2017 - Highlights

Commercial Operations and Innovation Engine

Focus next 12 months

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Continued strong growth in EBITDA– Q1 2017

6

Commercial – continuing to drive organic growth for our major brands

• Growth is mainly driven by New Skin® and Dermoplast® and Kerasal Nail®, with additional distribution secured for new brands

• Kerasal Nail® continues to develop strongly while maintaining its market share

• Three major brands account for well above 2/3 of revenue and an even higher share of profitability. Slightly weaker development for the smaller brands

• Expanded launch of Zanmira® Nail in Japan together with CMIC Group. Japan could become one of our largest distribution markets

• Distributor sales decreased slightly due to higher inventory levels in Asia, while sales to distributors in Europe increased

Innovation engine - advancing according to plan

• Applications to launch the Phase 3 program for BUPI will be submitted

• Patient recruitment to the Phase 3 studies for MOB-015progressing and expected to be completed during the year

• Recent physician survey supports strong demand for MOB-015

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– Q1 2017

7

Increased sales and EBITDA following acquisitions

51%GROWTH

105MSEKNET SALES

5XGROWTH

16.7MSEKEBITDA

16%EBITDA MARGIN

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8

Rapid growth

2010 2011 2012 2013 2014 2015 2016

8

56

112

157

200

286

334

~450

2016 runrate incl H2 acquisitions

Net Sales, MSEK

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P&L summaryQ1 2017

91) 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 -16EBITDA 17 3 78% 16% 5% 23%

Depreciation/amortization -10 -3 -16Operating profit (EBIT) 7 1 62

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– Share from Direct sales continue to grow after acquisitions

10

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

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• 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

11

Revenue segmentation

Revenue by channel Jan-Mar Jan-Mar Full-year(MSEK) 2017 2016 2016Direct sales, organic 36 39 173Direct sales, acquisitions and divestments 56 10 94Sales of products to distributors, organic 13 14 61Sales of products to distributors, acquisitions and divestments - 7 7Milestone payments 0 - -TOTAL 105 69 334

Revenue by product category Jan-Mar Jan-Mar Full-year(MSEK) 2017 2016 2016Kerasal Nail®/Nalox 33 32 151Dermoplast® 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.

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No major changes in Balance Sheet during Q1

12

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

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Q1 2017 - Highlights

Commercial Operations and Innovation Engine

Focus next 12 months

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Commercial operations - Focus on major brands

14

Direct sales – driving organic growth for major brands• Main growth drivers: Kerasal Nail®, New Skin®,

Dermoplast® - accounting for >2/3 of revenue and an even higher share of profitability

• Kerasal Nail® develops well, maintaining 27% market share (U.S.), stronger claims in 2017

• UK Direct sales launch progresses well, limited revenues to date

Distributor sales – sales in 40 markets • Market leader or #3-position in Nordics, several

EU and Asian countries

• Growth potential in Asia - Taiwan and Japan 2016 launches

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Nationwide launch initiated in Japan end of March

15

• National TV

• Social media

• Distribution in 8,000 stores

• Managed by localpartner CMIC Group

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Pipeline assets – target leadership in two niches– building on topical drug delivery know-how

16Source: 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

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17Note: 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: Lifesci Capital Equity Research, Survey of Physicians on the Treatment of Onychomycosis, April 4, 2017

MOB-015: Our asset with the greatest potential

67%“TOPICAL AGENTS IS THE BIGGEST UNMET NEED”

65%

MOB-015: based on Emtrix/Kerasal nail, adds terbinafine • Phase 2 demonstrated efficacy and safety• Phase 3: recruitment expected to be completed in 2017

Recent prescriber survey confirms strong preference for MOB-015• Survey included 89 U.S. prescribers

- podiatrists and dermatologists

Superior Target Product profile vs Jublia• Jublia reached $334m sales within 18 months after launch• MOB-015 target :

”Superior cure rates” “Rapid visible improvement” Potential for “Shorter treatment”

“PREFER MOB-015, SOLELY OR COMBINED WITH ORAL TREATMENT”

3%“COMPLETELY SATISFIED WITH LEAD

TOPICAL COMPETITOR”

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18

BUPI – phase 3 preparations underway

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%

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)

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Q1 2017 - Highlights

Commercial Operations and Innovation Engine

Focus next 12 months

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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

20

2017 is a consolidation year

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Creating shareholder value – investment case

21

Commercial niche player

Growing and profitable business

Late-stage pipeline

Strong team and track record

TMTM

TM

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Moberg Pharma AB (Publ)Gustavslundsvägen 42, 5 tr.

167 51 Brommamobergpharma.se