New Moberg Pharma ABd1q0gh225dp9f5.cloudfront.net/sites/default/files/moberg... · 2016. 5. 13. ·...
Transcript of New Moberg Pharma ABd1q0gh225dp9f5.cloudfront.net/sites/default/files/moberg... · 2016. 5. 13. ·...
Corporate presentation, Nordic Life Science Days
September 9th 2015
Anna Ljung, CFO
Moberg Pharma AB PROVIDING UNIQUE PRODUCTS IN UNDERSERVED NICHES
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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Net Sales grew to 260 MSEK (TTM, Q215)
- U.S. OTC Sales operations
- Products sold in 40+ countries
- 30 employees in Sthlm and NJ
Focus in OTC/Dermatology/Topicals
- Leading U.S. OTC SKU in Nail Fungus
- Superior PII data for MOB015
Market Cap 800 MSEK (OMX:MOB)
Moberg Pharma PROVIDING UNIQUE PRODUCTS IN UNDERSERVED NICHES
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Strategic elements
Growth strategy
- Organic growth
- M&A/Innovation engine
Build value through combining
Brand/IP Equity
Outlook
Profitable growth, targeting a long-term
EBITDA margin of at least 25% from
2016 and onwards
Moberg Pharma PROVIDING UNIQUE PRODUCTS IN UNDERSERVED NICHES
Q2 2015 – Rapid growth
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Net sales grew by 60% to MSEK 92
(40% at fixed exchange rates)
Profitability and cash flow improvement
Acquisition of Balmex (diaper rash)
Asian launch driving growth in distributor sales
Innovation engine progress
2015 Q2 Highlights
Net Sales, MSEK
Growth driving significant improvement in profitability
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165.3 (+57%)
105.5
EBITDA, MSEK
EBITDA Commercial
Operations, MSEK
H1 2015
H1 2014
NOTE: EBITDA Commercial Operations does not include R&D and Business Development expenses
for future products outside existing brands
14.4
28.5 (+98%)
14%
17%
21%
25%
41.9 (+85%)
22.6
21 consecutive quarters of Sales growth
Product Sales, TTM, MSEK
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0
50
100
150
200
250
300
Other 15%
Nalox/ Kerasal Nail
62%
Kerasal 11%
JointFlex 11%
RoW 13%
Europe 16% Americas
71%
Sales via distributors
31%
Direct OTC Sales 69%
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 – June 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
Kerasal Nail - the OTC market leader in the U.S.
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No 1 with 23% market share in Q2 20151)
Key claim “visible difference in 2 weeks”.
Product supported by 4 clinical studies
Available at >30 000 points of sale
1)Retail sales of nail fungus products excluding private label in Multioutlet Stores over the last 52 weeks
ending June 14, 2015 as reported by SymphonyIRI
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.
Acquired from Chattem (Sanofi) for $3.9 million
(MSEK 33.3)
– Sales trending above $4 million annually
– Deal financed with existing funds
Strong heritage in baby diaper rash with broad
distribution in major chains:
Closed Balmex acquisition on April 24
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Distributor Sales well positioned for further growth
Note: Four largest distributors only,
not an all inclusive list.
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Sales in >40 markets
Europe - H1 growth of 14%
Asian launches progresses well and rapid
growth of sales (incl. inventory build-up)
Large potential for 2015 and beyond
TV commercial in China – aired from May 2015
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Launches in Asia a key growth driver
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Malaysia
Launch Q4 2014, already market
leader
Hong Kong
Excellent start of sales and reorders
Singapore
Launch started, to be ramped up
China
Regional launch started in May
Indonesia
Launch and TV started Aug 17
Other markets
Launch preparations ongoing
Innovation Engine
Pipeline assets - Building on Topical drug delivery know how
Pipeline
asset
Indication
Status
Peak sales
potential, m$
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 – USPs and Strategy
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USPs Targets a superior 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
Ongoing discussions with partners. Objective to maintain control of asset
in key territories through phase III
1
2
3
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, ca 30 patients recruited (target ca 40), results expected Q4 2015
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, K-Nail+ patents granted
4 ACQUISITIONS LAST 30 MONTHS
3 PATENTS APPROVED Q1 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 strong U.S growth
- Kerasal franchise and brand development
- Integration of Balmex
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
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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Q&A
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%
MOB-015 – Recap of the opportunity CONFIDENTIAL
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Medical Need and Current practise
Prevalence in literature ranging from 5-15% ca 10% of the population
A minority of patients are treated
- U.S.: 3-4 million TRx + ca 5m OTC units sold annually vs ca 35 million Americans afflicted
Treatment alternatives
- Oral terbinafine is gold standard, oral itraconazole also used
- Topicals: Generic ciclopirox and amorolfine
- New Topicals: efinaconazole (Jublia) and tavaborole (Kerydin) were launched in 2014 in U.S.
Topicals treat for 48 weeks
Key endpoints are Complete Cure after 52 weeks, i.e.:
- Mycological Cure (Culture and KOH Microscopy)
- Clinical Cure
Commercial
U.S. market is growing from ca $1 billion (2013) to $2-3 billion (MP estimate 2015-2020)
- Key drivers are new launches at high price (ca $600 net price for 10 ml $2400 for 48w cycle)
- Sales of new topicals are incremental to sales of generics
Estimated total potential of $ 0.5 – 1 billion outside U.S. Lower prices and to larger extent OTC
Source: Moberg Pharma analysis, Wolters Kluwer
Jublia U.S. launch confirms the potential
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Source: Valeant Investor Presentation AGM, May 2015
Kerydin trend is following Jublia
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Source: Wolters Kluwer, Note: Gross Dollars
Generic sales maintained after launches of new topicals
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Oral terbinafine is ca 80%
NRx of topicals increased 70% after Jublia launch
Source: Wolters Kluwer, Note: Gross Dollars
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.