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0 Corporate presentation Meetings at JPM, San Francisco, 11 January 2015 Peter Wolpert, CEO & Founder Moberg Pharma AB PROVIDING UNIQUE PRODUCTS IN UNDERSERVED NICHES
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Page 1: Moberg Pharma AB - d1q0gh225dp9f5.cloudfront.netd1q0gh225dp9f5.cloudfront.net/...pharma_jpm_160111.pdf · Efinaconazole Jublia Valeant Topical - 54% 20-50% affected** Amorolfin Loceryl

0

Corporate presentation

Meetings at JPM, San Francisco, 11 January 2015

Peter Wolpert, CEO & Founder

Moberg Pharma AB PROVIDING UNIQUE PRODUCTS IN UNDERSERVED NICHES

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1

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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2

Net Sales grew to 276 MSEK (TTM, Q315)

- U.S. OTC Sales operations

- Products sold in 40+ countries

- 35 employees in Sthlm and NJ

Focus in OTC/Dermatology/Topicals

- Leading OTC SKU in Nail Fungus in North

America and other markets

- Preparing Ph III for MOB015, based on

superior Ph II data

- Jan 11: Positive Ph II data for BUPI

Market Cap ca 900 MSEK (OMX:MOB)

M&A strategy – 4 acquisitions since Nov 2012

Moberg Pharma PROVIDING UNIQUE PRODUCTS IN UNDERSERVED NICHES

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Q3 2015 – Rapid growth and doubled profit

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4

Net sales grew Q3 by 32% to MSEK 67

(8% at fixed exchange rates)

Doubled profit and strong cash flow

Cash position: 43 MSEK, Sep 30, 2015

Asian launch driving growth in distributor sales

Emtrix® rights in six EU markets taken back

Progressing our Innovation engine

- MOB-015 Ph III preparations

- Positive Phase II data for BUPI

2015 H2 Highlights

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Net Sales, MSEK

Growth drives toward long-term target – 25% EBITDA margin

5

232 (+49%)

156

EBITDA, MSEK

EBITDA Commercial

Operations, MSEK

2015 9m

2014 9m

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

for future products outside existing brands

22

42 (+95%)

14%

18%

22%

26%

60 (+76%)

34

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22 consecutive quarters of Sales growth

Product Sales, TTM, MSEK

6

0

50

100

150

200

250

300

Q12010

Q22010

Q32010

Q42010

Q12011

Q22011

Q32011

Q42011

Q12012

Q22012

Q32012

Q42012

Q12013

Q22013

Q32013

Q42013

Q12014

Q22014

Q32014

Q42014

Q12015

Q22015

Q32015

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P&L - Sales growth and doubling of profit

7

1) 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

Jul-Sep Jul-Sep Jan-Sep Jan-Sep Full-year

(MSEK) 2015 2014 2015 2014 2014

Revenue 67 50 232 156 200

Gross profit 49 36 177 119 151

% 73% 72% 76% 76% 75%

SG & A -31 -24 -116 -81 -106

R&D - existing product portfolio1) -1 -2 -5 -6 -7

Other operating income/operating expenses 1 2 4 2 6

EBITDA Commercial Operations 18 12 60 34 43

% 27% 23% 26% 22% 22%

R&D & BD - future products2) -4 -4 -18 -13 -18

EBITDA 14 7 42 22 25

% 21% 14% 18% 14% 13%

Depreciation/amortization -3 -2 -8 -6 -8

Operating profit (EBIT) 11 5 34 16 17

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Other 19%

Nalox/ Kerasal Nail

58%

Kerasal 11%

JointFlex 12%

RoW 15%

Europe 12% Americas

73%

Sales via distributors

29%

Direct OTC Sales 71%

Majority of revenue from direct OTC sales – Launches in Asia

drives RoW product sales

8

Channels Products Geography

Distribution of revenue, January – September 2015

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Progress in Commercial Operations

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10

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 24% market share in Q3 20151)

Key claim “visible difference in 2 weeks”.

Product supported by 4 clinical studies

Available at >30 000 points of sale at all major

U.S retailers

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

ending September 30, 2015 as reported by SymphonyIRI

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Scalable infrastructure for marketing U.S OTC brands

Retailers/

Wholesalers Sales Force

Contract

Manufacturers

Logistics

Sales and marketing/Brand Management

12

Note: Largest retailers and whole-

salers only, not an all inclusive list.

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Acquired from Chattem (Sanofi) for $3.9 million

(MSEK 33.3)

– Sales trending above $4 million annually

– Deal financed with existing funds

Strong heritage in baby diaper rash with broad

distribution in major chains:

Closed Balmex acquisition on April 24

13

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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

Europe - 9m is flat (+1%)

Asian launches progresses well and rapid

growth of sales:

+171%, incl. inventory build-up

Significant growth potential

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Launches in Asia a key growth driver

15

Malaysia

Launch Q4 2014, market leader

Hong Kong

Excellent start of sales and reorders

Singapore

Launch started, and 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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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)

17

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MOB-015 – Business Case

18

Peak Sales $250 – 500 million (Total market > $3 billion)

Ph III costs $10 – 15 million

ROI case IRR > 100%

rNPV > $100 – 200 million (risk-adjusted 50-100%)

Conservative assumptions on

Market share, upfronts, milestones, royalties & WACC

Source: Moberg Pharma analysis, Wolters Kluvers, IMS

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MOB-015 – USPs and Strategy

19

USPs Superior target 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

Maintain control of asset in key territories through phase III

Closed a development/risk sharing deal with Supply partner Colep

U.S. Market TRx: +25% L52 weeks*

Dollar: +72% L52 weeks*

Branded OTC market declined 8% YTD**

1

2

3

*Wolters Kluver, data ending week of Oct 16, 2015

** U.S. retail sales, branded nail fungus products in MULO Stores over L52 weeks ending Sept 30, 2015, SymphonyIRI

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20

Annual TRx from ca 3m in 2014 to 4.5m in last 18 months

U.S. Rx market growing rapidly TRx +50% in L18M

Source: Wolter Kluvers

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21

U.S. Rx market growing rapidly

Source: Wolter Kluvers

$ million

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Jublia U.S. launch confirms the potential for new topicals

22

Source: Valeant Investor Presentation AGM, May 2015, 3Q Earnings Deck, Oct 2015

3Q 2015 Sales = $106 million

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Kerydin launch tracking Jublia – added TVC later

23 Source: Wolter Kluvers

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Phase II results indicate that MOB015 have potential to become

best in class (topical drug for Onychomycosis)

24

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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25

25

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

26

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Example of successful treatment with MOB-015

Before After

27

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

affected nails

31

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 N/A

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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Anacor/Sandoz deal – July 2014 CONFIDENTIAL

32

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

Source: Anacor press release, MP analysis: estimate at least 100 m$ 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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BUPI targets to provide additional and prolonged pain relief

33

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

Positive topline Phase II data, Additional analyses in Q116

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Positive Phase II data - BUPI provided additional pain relief CONFIDENTIAL

34

Controlled Phase II study, conducted in Denmark

• 32 patients completed the phase II-study, conducted at two hospitals in Denmark

• Efficacy of BUPI vs Control (Standard Treatment for pain in the oral cavity)

• Control could also use lidocaine gel/mouthwash

Topline results - Statistically significant reduction in pain

• Primary endpoint met: Pain in the mouth or pharynx 60 minutes post administration of

BUPI compared to the average pain during the day for the control group

BUPI group had 23% reduction in pain compared to the control group

VAS 37.47 in BUPI vs. 48.94 in control, p = 0.0326

• Difference in the mouth (pharynx excluded) was even more pronounced

BUPI group had 46% reduction in pain

VAS 17.74 in BUPI group vs. 33.03, p = 0.0027

• No serious adverse events reported in BUPI group

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Innovation Engine

35

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 (2032), K-Nail+ (2034)

4 ACQUISITIONS SINCE NOV 2012

4 PATENTS APPROVED 2015

Acquisitions/inlicensing

Brands - Focus on US OTC market

Pipeline assets enabling new products

Completed Acquisitions

Alterna LLC, Nov 2012

Bayer brands, Dec 2013

Bupizenge, April 2014

Balmex, April 2015

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36

Focus next 12 months PROVIDING UNIQUE PRODUCTS IN UNDERSERVED NICHES

Drive growth and EBITDA improvements

Fuel U.S growth

- Execution of Kerasal brand strategy

- Integration of Balmex

Grow Distributor Sales

- Asia is key growth driver, additional launches

BD/Innovation Engine

- M&A focus on US OTC products

- MOB-015 Phase III preparations

- BUPI: Pll study, pursue sales as unlicensed

drug/partner and Orphan Drug designation

Long-term target

Create shareholder value

through a focus on

profitable growth, targeting

a long-term EBITDA

margin of at least 25%

from 2016 and onwards.

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37

Commercial niche strategy enables a growing and profitable base business

Pipeline with large potential and at reasonable risk

- Proven molecules limit development risk, cost and TTM

Acquisition strategy with substantial value potential

- 4 acquisitions since Nov 2012

- Team, Systems and infrastructure in place to enable scale-up

Strong Team with track record

Why invest in Moberg Pharma


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