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0 Investor presentation, January 18, 2015 Peter Wolpert, CEO & Founder Moberg Pharma AB Providing Unique Products in Underserved Niches through Commercial and Innovation Excellence

Moberg Pharma AB · 2016. 5. 13. · Ciclopirox Penlac Valeant 2)Topical - 29-36% 20-65% affected Amorolfin 3)Loceryl Galderma Topical - n/a Terbinafine Lamisil Novartis 4)Oral 4)40%

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    Investor presentation, January 18, 2015

    Peter Wolpert, CEO & Founder

    Moberg Pharma AB Providing Unique Products in Underserved Niches through

    Commercial and Innovation Excellence

  • 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.

  • 2

    2014 TV commercial in the Nordics

    2

  • 3

    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

    Financial goal

    25% EBITDA margin with healthy

    growth from 2016

    Moberg Pharma PROVIDING UNIQUE PRODUCTS IN UNDERSERVED NICHES

  • 4

    4

    Net Sales grew to 185 MSEK ($25m, TTM)

    - U.S. OTC Sales operations

    - Products sold in 40+ countries

    - 30 employees in Stockholm and NJ

    Focus in OTC/Dermatology/Topicals

    - Leading U.S. OTC SKU in Nail Fungus

    - Superior PII data for MOB015

    3 acquisitions in last 24 months

    - Nov 2012, Alterna LLC

    - Dec 2013, OTC brands from Bayer

    - Apr 2014, BUPI, Ph ll for oral pain relief

    Market Cap 530 MSEK ($ 70m) (OMX:MOB)

    Moberg Pharma PROVIDING UNIQUE PRODUCTS IN UNDERSERVED NICHES

  • 5

    18 consecutive quarters of Sales growth

    Product Sales, TTM, MSEK

    5

    0

    20

    40

    60

    80

    100

    120

    140

    160

    180

    200

    Q110 Q210 Q310 Q410 Q111 Q211 Q311 Q411 Q112 Q212 Q312 Q412 Q113 Q213 Q313 Q413 Q114 Q214 Q314

    MSE

    K

  • 6

    Rapid growth in Net Sales and EBITDA

    6

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

    for future products outside existing brands, e.g. Phase II assets

    Net Sales, MSEK

    156 (+29%)

    121

    34 (+240%)

    10

    -10

    22

    EBITDA, MSEK

    EBITDA Commercial

    Operations, MSEK

    Jan – Sep 2013

    Jan - Sep 2014

    Neg

    14%

    9%

    22%

  • 7

    7

    35% sales growth – US main driver

    – North America grew by 40% - Organic growth and

    contributions from acquired brands.

    Rapid growth and >50% market share (OTC) in Canada

    – European sales grew 7%

    – SE Asia launch kicked off with Emtrix® in Malaysia

    Excellent Phase ll results for MOB-015

    – Mycological cure rate of 54%, exceeded expectations

    BUPI Phase ll study initiated

    Strong EBITDA improvement

    – EBITDA for Commercial Operations1) of 23% for Q3 and

    22 % for the past 12 months

    – Expanded cooperation with Emerson Group has potential

    to further increase efficiency

    Gross margins remained strong at 72%

    Strong Q3

    1) EBITDA Commercial Operations include R&D for marketed products/

    line extensions, but not R&D or BD for new products

    Launch of Emtrix® in Malaysia

  • 8

    Majority of revenue from direct OTC sales,

    RoW growth starting to pick up

    8

    Sales via distributors

    29%

    Direct OTC Sales 71%

    Other 13%

    Nalox/ Kerasal Nail

    58%

    Kerasal 15%

    JointFlex 14%

    RoW 7%

    Europe 18%

    Americas 75%

    Channels Products Geography

    Distribution of revenue, Jan – September 2014

  • Commercial Operations & Innovation Engine

  • 10

    U.S. retail sales of Kerasal Nail increased 31% in Q314

    10

    Q3 2013 Q3 2014

    Kerasal Nail™ – U.S. market share1) No 1. SKU in the U.S.

    From 0 23%

    market share in 3 years

    Available at all

    major retailers

    >30 000 stores

    On Top-50 list of ”Most

    Innovative New

    Products” - Drug Store News, 2012

    Three clinical studies

    supporting efficacy and

    safety (n = ca 600)

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

    ending September 7, 2014 as reported by SymphonyIRI

  • 11

    Efficient infrastructure for building OTC brands in the U.S.

    Retailers/Wholesalers Sales Force CMOs

    Logistics

    Sales and marketing/Brand Management

    11

    Emerson Healthcare

    http://www.google.com/imgres?imgurl=http://hunt4freebies.com/coupons/wp-content/uploads/2009/08/meijer.gif&imgrefurl=http://hunt4freebies.com/coupons/meijers-free-danimal-yougurt/&usg=__NMcoOsxrpz4cCK_lPT--H9rfjSs=&h=255&w=575&sz=5&hl=en&start=2&um=1&itbs=1&tbnid=NE0UgnU6b047uM:&tbnh=59&tbnw=134&prev=/images?q=meijer&um=1&hl=en&sa=N&rlz=1T4GFRB_enUS240US241&tbs=isch:1http://images.google.com/imgres?imgurl=http://www.listphile.com/Fortune_500_Logos/Rite_Aid/image/Rite_Aid.png&imgrefurl=http://www.listphile.com/Fortune_500_Logos/Rite_Aid&h=375&w=375&sz=7&hl=en&start=2&sig2=He858RgNAgGQ9ZznpSZ1Uw&usg=__0_-0kCd1tTZVSob98k39lYZh4V0=&tbnid=gvM3pueYwpiRVM:&tbnh=122&tbnw=122&ei=6bvaSPLgJ6DAeoq7tb4G&prev=/images?q=Rite+Aid+company+logo&gbv=2&hl=enhttp://www.publix.com/Home.dohttp://www.google.se/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&docid=ug_LQtdybz_IAM&tbnid=aLZoskAwn_rezM:&ved=0CAUQjRw&url=http://www.ecodesk.com/sustainability/mckesson&ei=c7A4UYrgHOuO4gTinIC4Bg&bvm=bv.43287494,d.bGE&psig=AFQjCNHa3hGGLYmVtVFeH7bUuTeVUm3f1g&ust=1362756078124735http://www.google.se/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&docid=WRv0kMFapnrLqM&tbnid=cE3yubxAZJhbLM:&ved=0CAUQjRw&url=http://westchesternewsonline.com/elmsford-company-receives-750k-grant-expansion-and-job-creation&ei=-7A4UcDiH8WI4AT5rIG4BQ&bvm=bv.43287494,d.bGE&psig=AFQjCNGwd-szUiHlKXbijSkxw14EbjqRpg&ust=1362756213754673

  • 12

    Organic growth YTD (Value), %

    5%

    17%

    U.S. OTC market

    Moberg U.S.

    Outperforming the market through

    combining Brand and IP equity

    12

    Strategic brands

    • Kerasal® - Foot care

    Emtrix®

    • Domeboro® - Derma/Skin irritation

    Mature brands

    • Jointflex® - Ext. analgesic

    • Vanquish® - Int. analgesic

    • Fergon® - Iron supplement

    ®

  • 13

    Distributor Sales well positioned for further growth

    Note: Four largest distributors only,

    not an all inclusive list.

    13

    1)CDH units, IMS. Market share of OTC and Rx products

    for onychomycosis.

    Nalox™/Kerasal Nail®

    Sales in >40 markets

    Stronger claims recently approved

    Potential for further growth

    Strong sales in Canada as response to

    launch of consumer advertising,

    Market leader with >50% of OTC sales

    (value) and 30% of all Rx/OTC units1)

    Preparations for launches in China and

    SE Asia progressing well

    Malaysia 1st launch in Nov 2014

    Large potential for 2015 and beyond

    http://meda.se/english/http://www.leosonsinternational.com/default.asp

  • 14

    Asian launch initiated in Malaysia under our Emtrix® brand

    14

  • 15

    2014 H2 TV commercial in Malaysia

    15

  • 16

    Distribution in >1000 pharmacies in Malaysia (97%)

    16

  • 17

    Counter Top

    17

  • 18

    Window stickers in pharmacy

    18

  • 19

    Pharmacy training

    19

  • 20

    Pipeline assets in phase II -

    Building on Topical drug delivery know how and IP portfolio

    Pipeline

    asset

    Indication

    Status

    Peak sales

    potential, m$

    USP

    MOB-015 Onychomycosis Phase II

    completed

    250-500 Topical terbinafine with fast

    visible improvement and

    superior cure rates

    BUPI Oral Mucositis

    and oral pain

    Phase II

    started

    50-100 Lozenge formulation with

    effective pain relief for 2-3

    hrs(vs 0,5 hrs for

    competition)

    20

  • 21

    21

    54%

    29%

    Well tolerated

    MOB-015

    Excellent Phase II results

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

    MYCOLOGICAL CURE AT 15 MONTHS*

    MYCOLOGICAL CURE AND EXCELLENT CLINICAL IMPROVEMENT OR CURE**

    Study design Open label, n=25,

    24 patients completed

    Once daily for 48w

    Last follow-up at 60w

    Severely affected nails,

    60% mean nail involvement

    * 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

  • 22

    Phase II results indicate that MOB015 has potential to become

    best in class (topical drug for Onychomycosis)

    22

    Mycological cure

    Active Product Company Form at 6 months at 12/15

    months

    Comment

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

    Efinaconazole Jublia Valeant Topical - 54% 20-50% affected**

    Tavaborole Kerydin Anacor/Sandoz Topical - 31-36% 20-60% affected

    Ciclopirox Penlac Valeant Topical - 29-36%2) 20-65% 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 affected nail area was 60%

    **Mean affected nail area was 36%

  • 23

    Rationale for the superiority of MOB-015

    23

    54% mycological cure, in patients with severe onychomycosis (60% mean involvement)

    Excellent clinical improvement, full photo documentation

    High terbinafine levels in patients:

    - In nail bed: 45 µg/g (median value) 40x Oral TBF

    - In nail: 1610 µg/g (median value) 1000x Oral TBF

    Safe – low plasma levels of TBF 1/1000 Oral TBF

    A reasonable assumption is that a Phase III strategy to include patients with only

    20-50% nail involvement, will increase mycological and clinical cure rates, supported by:

    – Experience from previous trial with K101 (Nalox) (n=493) indicated a 40% higher

    mycological cure rate in stratum with 25-50% affected nail area (27,1%) vs stratum

    with 50-75% affected nail area (19,1%).

    – In the MOB-015B trial: Significantly higher myc cure (70%) in the 10 patients with

  • 24

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

    affected nails

    24

    CONFIDENTIAL

    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)

  • 25

    Example of successful treatment with MOB-015

    Before After

    25

  • 26

    Example of successful treatment with MOB-015

    Before After

    26

  • 27

    Example of successful treatment with MOB-015

    Before After

    27

  • 28

    MOB-015 – Next steps

    28

    Dual track – Discussion with industrial/financial partners ongoing

    Refine Ph III program and CMC preparations

  • 29

    BUPI – Long-acting lozenge with bupivacaine

    - Phase II started Oct 2014

    29

    Product & Indication

    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.

    Phase II study started – data expected H1 2015

    Up to 40 patients in radiation therapy for Head-Neck Cancer

    Controlled study – Standard pain treatment with/without BUPI lozenge

    VAS scale

    Target: Demonstrate 2-3 hours of pain relief and superior to control

  • Team

  • 31

    Management and Board with strong track record

    Management experience McKinsey, AZ, Q-Med, Biogen Idec,

    Insight, Pfizer

    31

    Anna Ljung

    CFO Thomas Thomsen Torbjörn Koivisto

    Board experience Pharmacia/Pfizer, Lundbeck, Genmab, Quintiles, J&J,

    Barrier Therapeutics, NCH

    Peter Wolpert

    CEO and Founder Mats Pettersson

    (Chair)

    Wenche Rolfsen Geert Cauwenbergh

    Kjell Rensfeldt

    VP R&D

    Martin Ingman

    VP Sales &

    marketing, ROW

    Jeff Vernimb

    GM North America

  • 32

    Increasing high quality institutional investors (SW, US, FR)

    32

    Shareholders No of shares Capital and votes, %

    ÖSTERSJÖSTIFTELSEN 2 245 179 16,1

    HANDELSBANKEN FONDER 834 477 6,0

    JPM CHASE NA (Altaris Capital Partners) 825 652 5,9

    FÖRSÄKRINGSAKTIEBOLAGET, AVANZA PENSION 798 417 5,7

    GRANDEUR PEAK 720 680 5,2

    TREDJE AP-FONDEN 656 000 4,7

    WOLCO INVEST AB (Peter Wolpert, CEO) 600 000 4,3

    SIX SIS AG, W8IMY 580 386 4,2

    GOLDMAN SACHS INTERNATIONAL LTD, W8IMY 512 419 3,7

    BANQUE CARNEGIE LUXEMBOURG S A (FUNDS) 326 494 2,3

    DEUTSCHE BANK AG LDN-PRIME BROKER, AGE FULL TAX 281 633 2,0

    SOCIETE GENERALE 258 621 1,9

    STATE STREET BANK & TRUST COM, BOSTON 225 000 1,6

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

    SYNSKADADES STIFTELSE 172 201 1,2

    AB TRACTION 165 000 1,2

    MATTSSON, MICHAEL 154 708 1,1

    J P MORGAN CLEARING CORP, WP 149 896 1,1

    LUNDMARK, ANDERS 135 000 1,0

    DEUTSCHE BANK AG, LONDON BRANCH, W-8BEN 133 396 1,0

    SUMMA, 20 STÖRSTA ÄGARNA 9 947 573 71,2

    Övriga aktieägare 4 014 964 28,8

    TOTAL 13 962 537 100

    Source: Euroclear Sweden AB per 2014-09-30

    Stock options to Management

    Outstanding stock options correspond to 8.1% of shares (6% to Management/Employees)

  • 33

    33

    Focus next 12 months PROVIDING UNIQUE PRODUCTS IN UNDERSERVED NICHES

    Drive growth and EBITDA improvements

    Fuel strong U.S growth

    - K-Nail and Neurocream launch

    - Line extensions and new SKUs

    Grow Distributor Sales

    - EU: Extended indication

    - Launches in China/SE Asia, Mena

    BD/Innovation Engine

    - M&A focus on US OTC products

    - MOB-015 partnering/ Phase III preparations

    - BUPI: Pll study, pursue sales as unlicensed

    drug/partner and Orphan Drug designation