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TRANSCRIPT
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Corporate presentation
Swedbank Health Care Seminar, 4 December 2015
Peter Wolpert, CEO & Founder
Moberg Pharma AB PROVIDING UNIQUE PRODUCTS IN UNDERSERVED NICHES
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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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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
Market Cap ca 900 MSEK (OMX:MOB)
M&A strategy – 4 acquisitions in last 3 years
Moberg Pharma PROVIDING UNIQUE PRODUCTS IN UNDERSERVED NICHES
Q3 2015 – Rapid growth and doubled profit
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Net sales grew 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
2015 Q3 Highlights
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Net Sales, MSEK
Growth drives toward long-term target – 25% EBITDA margin
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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
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42 (+95%)
14%
18%
22%
26%
60 (+76%)
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22 consecutive quarters of Sales growth
Product Sales, TTM, MSEK
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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
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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
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Channels Products Geography
Distribution of revenue, January – September 2015
Progress in Commercial Operations
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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.
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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
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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 $4 million annually
– Deal financed with existing funds
Strong heritage in baby diaper rash with broad
distribution in major chains:
Closed Balmex acquisition on April 24
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Distributor Sales well positioned for further growth
Note: Four largest distributors only,
not an all inclusive list.
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Sales in >40 markets
Europe - 9m is flat (+1%)
Asian launches progresses well and rapid
growth of sales:
+171%, incl. inventory build-up
Significant growth potential
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TV commercial in Malaysia – aired from Q4 2014
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Launches in Asia a key growth driver
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Malaysia
Launch Q4 2014, market leader
Hong Kong
Excellent start of sales and reorders
Singapore
Launch started, and ramped up
China
Regional launch started in May
Indonesia
Launch and TV started Aug 17
Other markets
Launch preparations ongoing
Innovation Engine
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Pipeline assets - Building on Topical drug delivery know how
Pipeline
asset
Indication
Status
Peak sales
potential, m$
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)
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MOB-015 – Business Case
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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
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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**
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*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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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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U.S. Rx market growing rapidly
Source: Wolter Kluvers
$ million
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Jublia U.S. launch confirms the potential for new topicals
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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 rather well – added TVC later
24 Source: Wolter Kluvers
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Phase II results indicate that MOB015 have potential to become
best in class (topical drug for Onychomycosis)
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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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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
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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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Example of successful treatment with MOB-015
Before After
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MOB-015 vs Jublia – Target Product Profile for mild-moderate
affected nails
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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
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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 2-3 hours of pain relief
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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, results expected Q4 2015
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Innovation Engine
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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 LAST 36 MONTHS
4 PATENTS APPROVED 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, $4.8 m (1.6x Sales)
Bupizenge, April 2014, dev. project,$1m
Balmex, April 2015, $3.9m (<1x Net Sales)
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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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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 in 36 months
- Team, Systems and infrastructure in place to enable scale-up
Strong Team with track record
Why invest in Moberg Pharma