Moberg Pharma AB Providing Unique Products in Underserved Niches through

Moberg Pharma AB
Providing Unique Products in Underserved Niches through
Commercial and Innovation Excellence
Presentation at Jefferies Global Healthcare Conference, November 20, 2014
Peter Wolpert, CEO & Founder
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Disclaimer
Statements included herein that are not historical
facts are forward-looking statements. Such forwardlooking 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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Moberg Pharma
PROVIDING UNIQUE PRODUCTS IN UNDERSERVED NICHES
Vision
Strategic plan
 Build a mid-size Pharma/Consumer
Health company with direct Sales in:
- U.S. and select countries
- OTC and select specialty areas
 Growth strategy
- Organic growth
- M&A/Innovation engine
 Build value through Brand Equity
and IP Equity
 No 1 in Onychomycosis in key
regions
 Strong focus on shareholder value
and achieving EBITDA target
Financial goal
 25% EBITDA margin with healthy
growth from 2016
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Moberg Pharma
PROVIDING UNIQUE PRODUCTS IN UNDERSERVED NICHES
 Net Sales grew to 185 MSEK ($25m)
- U.S. OTC Sales operations
- Products sold in 40+ countries
- 30 employees in Stockholm and NJ
 Focus in OTC/Dermatology/Topicals
- Leading U.S. OTC SKU in Nail Fungus
- Superior PII data for MOB015
 3 acquisitions in last 24 months
- Nov 2012, Alterna LLC
- Dec 2013, OTC brands from Bayer
- Apr 2014, BUPI, Ph ll for oral pain relief
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 Market Cap 450 MSEK ($ 60m) (OMX:MOB)
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18 consecutive quarters of Sales growth
Product Sales, TTM, MSEK
200
180
160
140
MSEK
120
100
80
60
40
20
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Q110 Q210 Q310 Q410 Q111 Q211 Q311 Q411 Q112 Q212 Q312 Q412 Q113 Q213 Q313 Q413 Q114 Q214 Q314
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Rapid growth in Net Sales and EBITDA
Jan – Sep 2013
Jan - Sep 2014
Net Sales, MSEK
EBITDA, MSEK
EBITDA Commercial
Operations, MSEK
156 (+29%)
121
Neg
14%
9%
22%
34 (+240%)
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-10
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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
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Launch of Emtrix® in Malaysia
Strong Q3
 35% sales growth – US main driver
– US grew by 40% - Organic growth and contributions from
acquired brands
– European sales grew 7%
– Excellent sales and >50% market share (OTC) in Canada
– 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%
1)
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EBITDA Commercial Operations include R&D for marketed products/
line extensions, but not R&D or BD for new products
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Majority of revenue from direct OTC sales, RoW growth starting
Distribution of revenue, Jan – September 2014
Sales via
distributors
29%
Direct OTC
Sales 71%
Channels
JointFlex
14%
Other
13%
RoW
7%
Europe
18%
Kerasal
15%
Nalox/
Kerasal Nail
58%
Products
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Americas
75%
Geography
Commercial Operations & Innovation Engine
U.S. retail sales of Kerasal Nail increased 31% in Q314
No 1. SKU in the U.S.
Kerasal Nail™ – U.S. market share1)
 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
1)Retail
Q3 2013
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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Q3 2014
Efficient U.S infrastructure for building brand equity
CMOs
Sales Force
Retailers/Wholesalers
Sales and marketing/Brand Management
Logistics
Emerson Healthcare
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Outperforming the market through
combining Brand and IP equity
Organic growth YTD (Value), %
Strategic brands
• Kerasal® - Foot care
Emtrix®
17%
• Domeboro® - Derma/Skin irritation
Mature brands
5%
• Jointflex® - Ext. analgesic
• Vanquish® - Int. analgesic
Moberg U.S.
U.S. OTC market
• Fergon® - Iron supplement
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®
Distributor Sales well positioned for further growth
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 to launch in Nov 2014
 Large potential for 2015 and beyond
1)CDH
units, IMS. Market share of OTC and Rx products
for onychomycosis.
Note: Four largest distributors only,
not an all inclusive list.
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Asian launch initiated in Malaysia under our Emtrix® brand
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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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Kerasal Nail ® / Emtrix® – Clinically proven efficacy in 600
patients
Clinical and non-clinical trials:
 Efficacy documented in In vitro study. Hultenby et al.
Mycoses 2014, Volume 57:630-638
 Efficacy and safety confirmed in Post Marketing Study
(n=73). Faergemann et al. Journal of Cosmetics,
Dermatological Sciences and Applications 2011,
Volume 1:59-63
 Efficacy and safety confirmed in Phase III trial (n=493)
Emtestam et al. Mycoses 2012, Volume 55:532-540
 Efficacy and safety demonstrated in Phase II trial
SM13 (n=18, 58 nails)
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Kerasal Nail ® / Emtrix® – an efficacious topical treatment for
fungal nails & nail psoriasis
Properties
 Penetrates nail
 Keratolytic
 Antifungal – physical mode of action
Before treatment
After 2 weeks of treatment
After 2 months of treatment
After 3 months of treatment
Excellent safety profile
 GRAS listed compounds
Competitive positioning
 Unique rapid visible improvement (2-4 weeks)
 First-line, efficacious topical
 Potential to treat severely affected nails
 Once-daily
 Compliance friendly
 High safety margin
Patient history: Onychomycosis since 3 years
Previously treated during 1 year with topical
azolderivate without any effect
Source: Study SM13
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Post-marketing study shows quick visible improvement
Number of patients reporting an improvement, per cent
100%
88%
90%
80%
92%
Design

Open clinical study with the purpose to
document early visible effects of Emtrix

75 patients with 25 – 75% affected nail in big
toe or thumb
77%
70%
Result
60%

Primary efficacy variable: number of patients
experiencing improvement after 8 weeks
treatment: 92% (CI: 83% - 97%)

52% of the patients reported large or very
large improvement*

Other secondary efficacy variables also
improved with 45 – 75% of the patients

No product related side affects
50%
40%
30%
20%
10%
0%
2 weeks
4 weeks
8 weeks
* The patients estimation was graded in four steps: no improvement, some improvement, large improvement and very large improvement
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Source; Journal of Cosmetics, Dermatological Sciences and Applications, 2011, Vol. 1: 59-63
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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
250-500
completed
Topical terbinafine with fast
visible improvement and
superior cure rates
BUPI
Lozenge formulation with
effective pain relief for 2-3
hrs(vs 0,5 hrs for
competition)
Oral Mucositis
and oral pain
Phase II
started
50-100
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MOB-015
Excellent Phase II results
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%
29%
MYCOLOGICAL CURE AT 15
MONTHS
MYCOLOGICAL CURE AND
EXCELLENT CLINICAL
IMPROVEMENT OR CURE*
Well tolerated
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* Means 10% or less clinical involvement
Source: Moberg Pharma data on file from MOB-015 phase II study
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Phase II results indicate that MOB015 have potential to become
best in class (topical drug for Onychomycosis)
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)
*Mean affected nail area was 60%
**Mean affected nail area was 36%
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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;
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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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Phase II results provide evidence of efficacy and safety
 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)
- In nail:
1610 µg/g (median value)
40x Oral TBF
1000x Oral TBF
 Safe – low plasma levels of TBF
1/1000 Oral TBF
Target Product Profile in mild/moderate Onychomycosis (25-50% nail involvement)
 > 60% mycological cure
 20-30% complete cure
 >50% of patients report visible improvement after 1 month
Next Steps
 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
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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Share, Shareholders, Team
The Share last 3 years (Nov 19, 2014)
Analysts
 Klas Palin, Redeye
 Christian Lee, Remium
 Additional coverage
expected H2 2014
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Increasing high quality institutional investors (SW, US, FR)
Shareholders
ÖSTERSJÖSTIFTELSEN
HANDELSBANKEN FONDER
JPM CHASE NA (Altaris Capital Partners)
FÖRSÄKRINGSAKTIEBOLAGET, AVANZA PENSION
GRANDEUR PEAK
TREDJE AP-FONDEN
WOLCO INVEST AB (Peter Wolpert, CEO)
SIX SIS AG, W8IMY
GOLDMAN SACHS INTERNATIONAL LTD, W8IMY
BANQUE CARNEGIE LUXEMBOURG S A (FUNDS)
DEUTSCHE BANK AG LDN-PRIME BROKER, AGE FULL TAX
SOCIETE GENERALE
STATE STREET BANK & TRUST COM, BOSTON
ML, PIERCE, FENNER & SMITH INCH
SYNSKADADES STIFTELSE
AB TRACTION
MATTSSON, MICHAEL
J P MORGAN CLEARING CORP, WP
LUNDMARK, ANDERS
DEUTSCHE BANK AG, LONDON BRANCH, W-8BEN
SUMMA, 20 STÖRSTA ÄGARNA
Övriga aktieägare
TOTAL
No of shares
Capital and votes, %
2 245 179
834 477
825 652
798 417
720 680
656 000
600 000
580 386
512 419
326 494
281 633
258 621
225 000
172 414
172 201
165 000
154 708
149 896
135 000
133 396
9 947 573
4 014 964
13 962 537
16,1
6,0
5,9
5,7
5,2
4,7
4,3
4,2
3,7
2,3
2,0
1,9
1,6
1,2
1,2
1,2
1,1
1,1
1,0
1,0
71,2
28,8
100
Source: Euroclear Sweden AB per 2014-09-30
Stock options to Management
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 Outstanding stock options correspond to 8.1% of shares (6% to Management/Employees)
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Management and Board with strong track record
Management experience
Board experience
McKinsey, AZ, Q-Med, Biogen Idec,
Insight, Pfizer
Pharmacia/Pfizer, Lundbeck, Genmab, Quintiles, J&J,
Barrier Therapeutics, NCH
Peter Wolpert
Martin Ingman
CEO and Founder VP Sales &
marketing, ROW
Kjell Rensfeldt
VP R&D
Anna Ljung
CFO
Steve Cagle
VP North America
(to Dec 31)
Mats Pettersson
(Chair)
Wenche Rolfsen
Jeff Vernimb
joining Dec 15
as new GM for
US operations
(Ex Insight,
Pfizer/Warner
Lambert)
Thomas Thomsen Torbjörn Koivisto
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Geert Cauwenbergh
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 partner process and Phase III
preparations
- BUPI: Pll study, evaluate/pursue sales as
unlicensed drug/partner and Orphan opps
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