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Presentation at SEB - Bolagsdagen September 18, 2015 Peter Wolpert, CEO & Founder Moberg Pharma AB PROVIDING UNIQUE PRODUCTS IN UNDERSERVED NICHES
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Page 1: Moberg Pharma ABd1q0gh225dp9f5.cloudfront.net/sites/default/files/moberg...250-500 Topical terbinafine with fast visible improvement and superior cure rates BUPI Oral Mucositis and

Presentation at SEB - Bolagsdagen

September 18, 2015

Peter Wolpert, CEO & Founder

Moberg Pharma AB PROVIDING UNIQUE PRODUCTS IN UNDERSERVED NICHES

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Disclaimer

1

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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TV commercial in Malaysia – aired from Nov/Dec 2014

2

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3

Strategic elements

Growth strategy

- Organic growth

- M&A/Innovation engine

Build value through combining

Brand/IP Equity

Strong focus on shareholder value

and achieving EBITDA target

Vision

Build a leading niche player in

strategic focus areas, such as:

- Topical Foot Care/Dermatology

- Topical Pain Management

- Additional areas to be added

No 1 in Onychomycosis in key regions

Outlook

Profitable growth, targeting a long-term

EBITDA margin of at least 25% from

2016 and onwards

Moberg Pharma PROVIDING UNIQUE PRODUCTS IN UNDERSERVED NICHES

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Q2 2015 – Rapid growth

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5

Net sales grew by 60% to MSEK 92

(40% at fixed exchange rates) – Growth across all areas of the business

– Strong U.S. growth and launches in Asia key drivers

Profitability and cash flow improvement – EBITDA margin of 12% / 15%*

– EBITDA Commercial Operations of 18% / 21%* for Q2

– 17 MSEK in Operative cash flow

Acquisition of Balmex (diaper rash) – Sales exceeds $4M annually

– Consideration 33.3 MSEK ($3.9M), financed by existing funds

Asian launch driving growth in distributor sales – China launch initiated

Innovation engine progress – Kerasal Nail EU patent granted

– Eurostars grant of MSEK 8.4 for BUPI

2015 Q2 Highlights

*Excluding accounting provisions related to incentive schemes

NOTE: EBITDA Commercial Operations does not include R&D and Business Development expenses

for future products outside existing brands

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Net Sales, MSEK

Growth driving significant improvement in profitability

6

165.3 (+57%)

105.5

EBITDA, MSEK

EBITDA Commercial

Operations, MSEK

H1 2015

H1 2014

NOTE: EBITDA Commercial Operations does not include R&D and Business Development expenses

for future products outside existing brands

14.4

28.5 (+98%)

14%

17%

21%

25%

41.9 (+85%)

22.6

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21 consecutive quarters of Sales growth

Product Sales, TTM, MSEK

7

0

50

100

150

200

250

300

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Other 15%

Nalox/ Kerasal Nail

62%

Kerasal 11%

JointFlex 11%

RoW 13%

Europe 16% Americas

71%

Sales via distributors

31%

Direct OTC Sales 69%

Majority of revenue from direct OTC sales – Launches in Asia

drives RoW product sales

8

Channels Products Geography

Distribution of revenue, January – June 2015

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Progress in Commercial Operations

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10

Strategic brands

Kerasal® - Foot care

Emtrix®

Balmex ® - Diaper rash

Domeboro® - Derma/Skin irritation

Mature brands

Jointflex® - External analgesic

Vanquish® - Internal analgesic

Fergon® - Iron supplement

®

Focus on strategic brands

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Kerasal Nail - the OTC market leader in the U.S.

11

No 1 with 23% market share in Q2 20151)

Key claim “visible difference in 2 weeks”. Product supported by 4 clinical studies

Available at >30 000 points of sale, 2014 expansion into food retail segment

Two new line extensions launched Q2 15

1)Retail sales of nail fungus products excluding private label in Multioutlet Stores over the last 52 weeks

ending June 14, 2015 as reported by SymphonyIRI

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Acquired from Chattem (Sanofi) for $3.9M

(MSEK 33.3)

– Sales trending above $4M annually

– Deal financed with existing funds

Strong heritage in baby diaper rash with broad

distribution in major chains:

Brand integration fully underway. New

consumer campaigns slated for Q3/Q4

Brand extended into Adult Care in 2013, a small

but high potential market for treatment of rash

associated with adult incontinence

Closed Balmex acquisition on April 24

12

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Scalable infrastructure for marketing U.S OTC brands

Retailers/

Wholesalers Sales Force

Contract

Manufacturers

Logistics

Sales and marketing/Brand Management

13

Note: Largest retailers and whole-

salers only, not an all inclusive list.

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Distributor Sales well positioned for further growth

Note: Four largest distributors only,

not an all inclusive list.

14

Sales in >40 markets

Continued growth in Canada, >50%

market share in OTC

Europe - H1 growth of 14%

Asian launches progresses well and rapid

growth of sales (incl. inventory build-up)

Large potential for 2015 and beyond

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Launches in Asia a key growth driver

15

Malaysia

45% market share 2014

and continued strong sales in H1

Hong Kong

Excellent start of sales and reorders

Singapore

Launch started, to be ramped up

China

Regional launch started in May

Indonesia

Launch and TV started Aug 17

Other markets

Launch preparations ongoing

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Innovation Engine

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Innovation Engine

17

Organic growth

Current products growing, adding new markets

Line extensions adding incremental growth

- Focus on strategic brands

5 patent families enable additional products

- MOB-015, K-Nail+ patents granted

4 ACQUISITIONS LAST 30 MONTHS

3 PATENTS APPROVED Q1 2015

Acquisitions/inlicensing

Brands - Focus on US OTC market

Pipeline assets enabling new products

Completed Acquisitions

Alterna LLC, Nov 2012, $20M (1.8x Sales)

Bayer brands, Dec 2013, $4.8M (1.6x Sales)

Bupizenge, April 2014, dev. project,$1M

Balmex, April 2015, $3.9M (<1x Net Sales)

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Pipeline assets - Building on Topical drug delivery know how

Pipeline

asset

Indication

Status

Peak sales

potential, m$

USP

MOB-015 Onychomycosis Ph III

preparation

250-500 Topical terbinafine with fast visible

improvement and superior cure rates

BUPI Oral Mucositis

and oral pain

Phase II 50-100 Lozenge formulation with effective

pain relief for 2-3 hrs(vs 0,5 hrs for

competition)

18

MOB-015 update - Phase II results enable a superior target profile vs U.S. Rx lead competitor (Jublia)

- US and EPO patents granted

- Phase III preparations progressing to enable start in 2016. FDA and EU MPA meetings in Q415

- Strategy to maintain control of significant rights/value of the asset,

partner discussions ongoing, for non-core territories and for manufacturing

BUPI update - 30 patients included in Phase II

- Topline results expected Q4 2015

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Pipeline assets provide significant upside potential

19

Peak Sales potential:

Risk assessment:

Phase 3 investment:

Peak Sales potential:

Risk assessment:

Phase 3 investment:

MOB-015

$250 – 500M

Based on proven molecule

Strong Phase 2 data in severe patients, but small

study

Very high terbinafine levels in nail bed and nail

< $10M

(pending feedback from FDA and EU agencies)

$50 – 100M

Proven molecule, TBE: Phase 2 data in Q415

< $5M

BUPI

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MOB-015 – USPs, Strategy and market update

20

USPs Targets a superior profile, in mild to moderate onychomycosis

based on phase II data and experience from the OTC product

(>600 patients in clinical trials and >5 million units sold to date):

Superior cure rates – Mycological and Clinical

Shorter treatment time – potentially 6 months

First visible improvement within 2-4 weeks

Strategy Prepare Phase III to start in 2016

Ongoing discussions with partners. Objective to maintain control of asset

in key territories through phase III

U.S. Market Total market growing rapidly, driven by intense marketing of new Rx drugs

- TRx: +27% L52 weeks*

- Dollar: +46% L52 weeks*, Jublia trending at $450M

Rx took share of branded OTC market in Q2 y/y (declined 11%**)

1

2

3

*Wolters Kluver, data ending week of July 31, 2015

** U.S. retail sales of branded nail fungus products in Multioutlet Stores over L52 weeks ending June 14 , 2015,

SymphonyIRI

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MOB-015 – Recap of the opportunity CONFIDENTIAL

21

Medical Need and Current practise

Prevalence in literature ranging from 5-15% ca 10% of the population

A minority of patients are treated

- U.S.: 3-4 million TRx + ca 5m OTC units sold annually vs ca 35 million Americans afflicted

Treatment alternatives

- Oral terbinafine is gold standard, oral itraconazole also used

- Generic Topicals: Generic ciclopirox and amorolfine

- New Topicals: efinaconazole (Jublia) and tavaborole (Kerydin) were launched in 2014 in U.S.

Topicals treat for 48 weeks

Key endpoints are Complete Cure after 52 weeks, i.e.:

- Mycological Cure (Culture and KOH Microscopy)

- Clinical Cure

Commercial

U.S. market is growing from ca $1 billion (2013) to $2-3 billion (MP estimate 2015-2020)

- Key drivers are new launches at high price (ca $600 net price for 10 ml $2400 for 48w cycle)

- Sales of new topicals are incremental to sales of generics

Est. market potential of $0.5-1 billion outside U.S. Lower prices, to large extent OTC

Source: Moberg Pharma analysis, Wolters Kluwer

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Jublia U.S. launch confirms the potential

22

Source: Valeant Investor Presentation AGM, May 2015

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Kerydin trend is following Jublia

23

Source: Wolters Kluwer, Note: Gross Dollars

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Generic sales maintained after launches of new topicals

24

Oral terbinafine is ca 80%

NRx of topicals increased 70% after Jublia launch

Source: Wolters Kluwer, Note: Gross Dollars

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Anacor/Sandoz deal – July 2014 CONFIDENTIAL

25

Total Deal Value estimated to NPV of $270M (if no exercise of repurchase option)

Upfront $65M (whereof 25 m$ by Jan 2015)

Payment 2016 $45M

50% of gross profits

Source: Anacor press release, MP analysis: estimate at least $100M gross profit per year 2017-2025, 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.

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Phase II results indicate that MOB015 have potential to become

best in class (topical drug for Onychomycosis)

26

Mycological cure

Active Product Company Form at 6 months at 52/60

weeks

Comment

Terbinafine MOB-015 Moberg Pharma Topical 40%1) 54% 25-75% affected*

Ciclopirox Penlac Valeant 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;

*Mean involvement was ca 60%

**Mean involvement was 36%

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27

54%

40%

100%

29%

>4.5 mm jkjkj

45 µg/g

1610 µg/g

Source: Moberg Pharma data on file, MOB-015 phase II study

MYCOLOGICAL CURE AT 60 WEEKS*

MYC CURE AT 24 WEEKS

NEGATIVE CULTURE AT 60 WEEKS MYC CURE AND ALMOST CURED OR CURED** CLEAR NAIL GROWTH***

TBF IN NAIL BED (MEDIAN)

TBF IN NAIL (MEDIAN)

* 54% of patients completing the treatment (13 of 25), 52% of FAS (13 of 24) and 60% of PPAS

** Means 10% or less clinical involvement

*** Post-hoc analysis

MOB-015

Excellent results in Phase 2 demonstrated efficacy and safety

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Example of successful treatment with MOB-015

Before After

28

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Example of successful treatment with MOB-015

Before After

29

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Example of successful treatment with MOB-015

Before After

30

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Example of successful treatment with MOB-015

Before After

31

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Example of successful treatment with MOB-015

Before After

32

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MOB-015 vs Jublia – Target Product Profile for mild-moderate

affected nails

33

Mycological cure Complete

cure

Almost

cured or

cured

Clear nail

growth

% of patients

experiencing visual

improvement after 1

month

Product at 6

months

at 12/15

months

at 12/15

months

at 12/15

months

at 12/15

months

at 1 month

In severely affected nails, 50-75% affected nail area

MOB-015 40%1) 54% 0% 28%* 4.5 mm >50%

In mild/moderately affected nails, 20-50% affected nail area

MOB-015

(Target)

>50% 60-70% 20-30% >40% >5 mm >50%

Jublia - 54% 15-18% 23-26% 3.8-5 mm ?

Source: 1)Moberg Pharma data on file from phase II study;

* Proportion of patients with negative fungal culture, negative direct KOH microscopy and physician’s GES=4 (excellent improvement)

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BUPI targets to provide 2-3 hours of pain relief

34

Product & Indication

BUPI (Bupivacaine lozenge) for oral pain relief (mouth and throat)

1st indication: Oral Mucositis in cancer patients. Large unmet need

Other indications: Burning Mouth Syndrome, Sjögren’s syndrome, Upper

gastrointestinal endoscopy. Long-term also OTC potential

Value and Next steps

Peak Sales potential $50-100m, whereof the OM indication is $20-25m

Phase II ongoing, ca 30 patients recruited (target ca 40), results expected Q4 2015

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Team and shareholders

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Management with strong track record

36

Anna Ljung

CFO

10 years experience,

joined from start in 2006

CFO at start-ups from

Karolinska Institutet

Peter Wolpert

CEO and Founder

15 years experience,

founded the

company in 2006

McKinsey & Co,

CEO at start-ups

from Karolinska, co-

Founder Ibility AB

and Viscogel AB

Kjell Rensfeldt

VP R&D

>20 years experience,

joined in 2007

Clinical practise,

Q-Med, BiogenIdec

Martin Ingman

VP Sales & marketing,

ROW

>20 years experience,

joined in 2008

AstraZeneca, Q-Med,

Carema

Jeff Vernimb

GM North America

>20 years experience,

joined in 2014

Pfizer, Novartis,

Insight Pharma-

ceuticals

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Experienced Board

Thomas Thomsen Torbjörn Koivisto

Board experience Pharmacia/Pfizer, Lundbeck, Genmab, Quintiles, J&J, Barrier Therapeutics, NCH, Reckitt Benkiser

Investor Growth Capital, Östersjöstiftelsen

Mats Pettersson

(Chair)

Thomas Eklund

Wenche Rolfsen

Mattias Klintemar

(Östersjöstiftelsen)

Geert Cauwenbergh

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Increasing number of institutional investors (SW, US, FR)

38

Shareholders No of shares Capital and votes, %

ÖSTERSJÖSTIFTELSEN 2 274 179 16,3

HANDELSBANKEN FONDER AB RE JPMEL 1 236 414 8,9

FÖRSÄKRINGSAKTIEBOLAGET, AVANZA PENSION 1 078 893 7,7

J P MORGAN CLEARING CORP, W9 725 533 5,2

WOLCO INVEST AB 600 000 4,3

GRANDEUR PEAK INTERNATIONAL 371 800 2,7

SOCIETE GENERALE 298 897 2,1

NORDNET PENSIONSFÖRSÄKRING AB 296 046 2,1

BANQUE CARNEGIE LUXEMBOURG S.A, (FUNDS) 281 494 2,0

DEUTSCHE BANK AG, LONDON BRANCH, W-8BEN 248 256 1,8

GRANDEUR PEAK GLOBAL, OPPORTUNITIES 245 880 1,8

STATE STREET BANK & TRUST COM., BOSTON 180 000 1,3

ML, PIERCE, FENNER & SMITH INC 172 414 1,2

SYNSKADADES STIFTELSE 172 201 1,2

ANDRA AP-FONDEN 150 000 1,1

STATE STREET BANK & TRUST COM., BOSTON 150 000 1,1

LUNDMARK, ANDERS 142 000 1,0

MORGAN STANLEY & CO INTL PLC, W-8BEN 121 874 0,9

TOLVPLUS4 AB 113 304 0,8

GRANDEUR PEAK GLOBAL REACH, FUND 111 100 0,8

SUMMA, 20 STÖRSTA ÄGARNA 8 970 285 64,3

Övriga aktieägare 4 992 252 35,8

TOTALT 13 962 537 100

Source: Euroclear Sweden AB per 2015-06-30

Stock options to Management

Stock options corresponding to 8.1% of shares (6% in programs to Management/Employees)

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39

Focus next 12 months PROVIDING UNIQUE PRODUCTS IN UNDERSERVED NICHES

Drive growth and EBITDA improvements

Fuel strong U.S growth

- Kerasal franchise and brand development

- Integration of Balmex

- Additional accretive acquisitions of brands

Grow Distributor Sales

- EU: Extended indication

- Launches in China/SE Asia, Mena

BD/Innovation Engine

- M&A focus on US OTC products

- MOB-015 Phase III preparations

- BUPI: Pll study, prepare sales as unlicensed

drug/partner and Orphan Drug designation

Financial target

Create shareholder value

through a focus on

profitable growth, targeting

a long-term EBITDA

margin of at least 25%

from 2016 and onwards.