Moberg Pharma ABmobergpharma.com/sites/default/files/moberg_presenta… ·  · 2016-05-13Moberg...

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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

Transcript of Moberg Pharma ABmobergpharma.com/sites/default/files/moberg_presenta… ·  · 2016-05-13Moberg...

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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

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Disclaimer

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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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2014 TV commercial in the Nordics

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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

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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

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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

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Rapid growth in Net Sales and EBITDA

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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%

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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

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Majority of revenue from direct OTC sales,

RoW growth starting to pick up

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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

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Commercial Operations & Innovation Engine

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

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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

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

Retailers/Wholesalers Sales Force CMOs

Logistics

Sales and marketing/Brand Management

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Emerson Healthcare

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Organic growth YTD (Value), %

5%

17%

U.S. OTC market

Moberg U.S.

Outperforming the market through

combining Brand and IP equity

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Strategic brands

• Kerasal® - Foot care

Emtrix®

• Domeboro® - Derma/Skin irritation

Mature brands

• Jointflex® - Ext. analgesic

• Vanquish® - Int. analgesic

• Fergon® - Iron supplement

®

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Distributor Sales well positioned for further growth

Note: Four largest distributors only,

not an all inclusive list.

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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

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Asian launch initiated in Malaysia under our Emtrix® brand

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2014 H2 TV commercial in Malaysia

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Distribution in >1000 pharmacies in Malaysia (97%)

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Counter Top

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Window stickers in pharmacy

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Pharmacy training

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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)

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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

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Phase II results indicate that MOB015 has potential to become

best in class (topical drug for Onychomycosis)

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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%

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Rationale for the superiority of MOB-015

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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

<60% affected nail area (post-hoc analysis)

If significant clear nail growth is observed, it is obvious that complete cure rates

increase in a stratum with less affected nail area

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

affected nails

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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)

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Example of successful treatment with MOB-015

Before After

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Example of successful treatment with MOB-015

Before After

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Example of successful treatment with MOB-015

Before After

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MOB-015 – Next steps

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Dual track – Discussion with industrial/financial partners ongoing

Refine Ph III program and CMC preparations

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BUPI – Long-acting lozenge with bupivacaine

- Phase II started Oct 2014

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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

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Team

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Management and Board with strong track record

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

Insight, Pfizer

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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

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

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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)

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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