Moberg Pharma ABd1q0gh225dp9f5.cloudfront.net/sites/default/files/moberg... · 2016-08-09 · 3...

18
0 Conference call, August 9, 2016 at 3:00 p.m. (CET) Dial-in number: SE: +46 8 566 426 95, US: +1 646 502 51 20 Peter Wolpert, CEO and Founder Moberg Pharma AB Interim report, January – June 2016 CREATING A FOOTPRINT IN UNDERSERVED NICHES

Transcript of Moberg Pharma ABd1q0gh225dp9f5.cloudfront.net/sites/default/files/moberg... · 2016-08-09 · 3...

Page 1: Moberg Pharma ABd1q0gh225dp9f5.cloudfront.net/sites/default/files/moberg... · 2016-08-09 · 3 Highlights – Q2 2016 3 Net sales of MSEK 71 – Sales (excl. divested brands) declined

0

Conference call, August 9, 2016 at 3:00 p.m. (CET) Dial-in number: SE: +46 8 566 426 95, US: +1 646 502 51 20 Peter Wolpert, CEO and Founder

Moberg Pharma AB Interim report, January – June 2016

CREATING A FOOTPRINT IN UNDERSERVED NICHES

Page 2: Moberg Pharma ABd1q0gh225dp9f5.cloudfront.net/sites/default/files/moberg... · 2016-08-09 · 3 Highlights – Q2 2016 3 Net sales of MSEK 71 – Sales (excl. divested brands) declined

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 AB’s interim or annual reports, prospectuses or press releases.

Page 3: Moberg Pharma ABd1q0gh225dp9f5.cloudfront.net/sites/default/files/moberg... · 2016-08-09 · 3 Highlights – Q2 2016 3 Net sales of MSEK 71 – Sales (excl. divested brands) declined

Highlights – Q2 2016

Page 4: Moberg Pharma ABd1q0gh225dp9f5.cloudfront.net/sites/default/files/moberg... · 2016-08-09 · 3 Highlights – Q2 2016 3 Net sales of MSEK 71 – Sales (excl. divested brands) declined

3

Highlights – Q2 2016

3

Net sales of MSEK 71 – Sales (excl. divested brands) declined by 13%,

due to discontinued product variants and lower European sales

– 28% market share in the U.S. for Kerasal Nail – All Time High

– Launches initiated in Japan, Taiwan and UK (2nd Direct market)

Acquisition doubles operations in U.S. – Acquisition of three brands from Prestige Brands in the U.S. for $40

million (transaction completed July 7th)

– Financed by bond loan (incl. Q2 tap issue of SEK 85m) and divestment of non-core brands for $10m, incl. SEK 41m cap. gain

MOB-015 advances – Phase 3 applications submitted to the U.S. FDA and authorities in

Germany, Poland and Canada

– Patents granted in several territories, including the U.S., Canada, the EU and Japan

Page 5: Moberg Pharma ABd1q0gh225dp9f5.cloudfront.net/sites/default/files/moberg... · 2016-08-09 · 3 Highlights – Q2 2016 3 Net sales of MSEK 71 – Sales (excl. divested brands) declined

4

Three brands acquired for $40 million – Expected contribution of ca $5 million to EBITDA for 12 months following

closing

– Expected to double sales of our U.S. franchise

– Non-dilutive financing. Financed by available cash resources and bond loan

Sold through our established sales channels in the U.S, primarily through chain drugstores and mass retailers, such as:

– New Skin is the #1 OTC liquid bandage brand in the U.S. An antiseptic which kills germs and dries rapidly to form a clear protective cover

– Fiber Choice is focusing on digestive health with many product options for daily fiber supplementation

– PediaCare has a strong equity amongst moms based on highly effective products for children, primarily within cough cold and analgesics segments

Acquisition of brands from Prestige closed on July 7

4

Page 6: Moberg Pharma ABd1q0gh225dp9f5.cloudfront.net/sites/default/files/moberg... · 2016-08-09 · 3 Highlights – Q2 2016 3 Net sales of MSEK 71 – Sales (excl. divested brands) declined

5

Rapid growth over the last 6 years – divestment affects Q216 Product Sales, TTM, MSEK

5

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

Q42015

Q12016

Q22016

Product Sales, TTM, MSEK

Page 7: Moberg Pharma ABd1q0gh225dp9f5.cloudfront.net/sites/default/files/moberg... · 2016-08-09 · 3 Highlights – Q2 2016 3 Net sales of MSEK 71 – Sales (excl. divested brands) declined

6

P&L summary

6

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. 3) Including a capital gain on divested brands of 41 MSEK

Due to the rounding component, totals may not tally.

P&L Summary Apr-Jun Apr-Jun Jan-Jun Jan-Jun Full-year

(MSEK) 2016 2015 2016 2015 2015 Revenue 71 92 141 165 286 Gross profit 51 72 100 128 214 % 72% 78% 71% 78% 75%

SG & A -55 -51 -94 -85 -142 R&D - existing product portfolio1) -1 -3 -3 -4 -6 Other operating income/operating expenses 413) -2 403) 3 4 EBITDA Commercial Operations 36 16 43 42 68 % 51% 18% 31% 25% 24%

R&D & BD - future products2) -3 -5 -7 -13 -22 EBITDA 33 11 37 29 46 % 47% 12% 26% 17% 16%

Depreciation/amortization -2 -3 -5 -5 -11 Operating profit (EBIT) 31 8 32 23 35

Page 8: Moberg Pharma ABd1q0gh225dp9f5.cloudfront.net/sites/default/files/moberg... · 2016-08-09 · 3 Highlights – Q2 2016 3 Net sales of MSEK 71 – Sales (excl. divested brands) declined

7

Revenues by channel and product category

7

Revenue by channel Apr-Jun Apr-Jun Jan-Jun Jan-Jun Full-year (KSEK) 2016 2015 2016 2015 2015 Direct sales 54 67 103 114 207 Sales of products to distributors 18 25 38 49 76 Milestone payments - 0 - 2 3 TOTAL 71 92 141 165 286

Revenue by product category Apr-Jun Apr-Jun Jan-Jun Jan-Jun Full-year (KSEK) 2016 2015 2016 2015 2015 Nalox/Kerasal Nail®, sales of products 49 61 81 102 154 Nalox/Kerasal Nail®, milestone payments - 0 - 2 3 Jointflex®, Fergon®, Vanquish® (divested April 1) - 10 16 26 52 Other products 22 21 43 35 77 TOTAL 71 92 141 165 286

Due to the rounding component, totals may not tally.

Note that brand divestments April 1 and product discontinuations affect comparisons Direct sales, excluding divested brands, declined by 7% in the second quarter (decline by 5% at fixed

exchange rates) due to discontinued product variants and a decline for Kerasal Ointment. All other products delivered growth

Distributor sales, excluding divested brands, declined by 27% (decline by 26% at fixed exchange rates). The majority of the decline originates from lower sales in Europe.

Page 9: Moberg Pharma ABd1q0gh225dp9f5.cloudfront.net/sites/default/files/moberg... · 2016-08-09 · 3 Highlights – Q2 2016 3 Net sales of MSEK 71 – Sales (excl. divested brands) declined

8

RoW 17%

Europe 9%

Americas 74%

Other 31%

Nalox / Kerasal Nail

58%

Divested products

12% Sales via distributors

27%

Direct OTC Sales 73%

Majority of revenue from direct OTC sales – Launches in Asia drive RoW product sales

8

Channels Products Geography

Distribution of revenue, January – June 2016

Page 10: Moberg Pharma ABd1q0gh225dp9f5.cloudfront.net/sites/default/files/moberg... · 2016-08-09 · 3 Highlights – Q2 2016 3 Net sales of MSEK 71 – Sales (excl. divested brands) declined

Progress in Commercial Operations and Innovation Engine

Page 11: Moberg Pharma ABd1q0gh225dp9f5.cloudfront.net/sites/default/files/moberg... · 2016-08-09 · 3 Highlights – Q2 2016 3 Net sales of MSEK 71 – Sales (excl. divested brands) declined

10

10

Strategic brands

Kerasal® - Foot care Emtrix®

Balmex® - Diaper rash

Domeboro® - Derma/Skin irritation

New Skin - Antiseptic liquid

Mature brands

PediaCare® - Pediatric cough cold

Fiber Choice® - Prebiotic fiber supplements

Focus on strategic brands

Page 12: Moberg Pharma ABd1q0gh225dp9f5.cloudfront.net/sites/default/files/moberg... · 2016-08-09 · 3 Highlights – Q2 2016 3 Net sales of MSEK 71 – Sales (excl. divested brands) declined

11

11

All-Time High market share in U.S. for Kerasal Nail following successful relaunch

* Last 12 weeks ending June 15, 2016 vs same period 2015 Source: Symphony IRI, U.S. retail sales of nail fungus products excluding private label in Multi Outlet Stores

New packaging, commercial and website launched in March Very positive reception from consumers and trade, all-time high market share

Note: there is a lag of at least one month between growth in consumer sales and effects on net sales

23% 28% 25% +2%

MARKET SHARE* VALUE GROWTH* CATEGORY GROWTH*

Page 13: Moberg Pharma ABd1q0gh225dp9f5.cloudfront.net/sites/default/files/moberg... · 2016-08-09 · 3 Highlights – Q2 2016 3 Net sales of MSEK 71 – Sales (excl. divested brands) declined

12

Growth potential in Asia for Distributor Sales

Note: Three largest distributors only, not an all inclusive list.

12

Sales in >40 markets

Decline in Europe – expecting lower level vs 2015

Asian launches progresses well - 20% volume growth H116 - Volume discounts provided to support further growth

Launches initiated in Japan and Taiwan

Page 14: Moberg Pharma ABd1q0gh225dp9f5.cloudfront.net/sites/default/files/moberg... · 2016-08-09 · 3 Highlights – Q2 2016 3 Net sales of MSEK 71 – Sales (excl. divested brands) declined

13

MOB-015 update - Phase 3 applications submitted to relevant authorities, aim to start patient enrollment in Q3 - Patent granted in multiple territories, incl U.S., EU, Japan and Canada

BUPI update - Positive Phase 2 results for BUPI in Q116 - License/Dev Agreement with Cadila. Cadila conducts a Phase 3 trial in India, rights in India/Africa - Moberg sponsors one Phase 3 trial in Europe, co-financed by Eurostars grant

Pipeline assets - Building on Topical drug delivery know how

Pipeline asset

Indication

Status

Peak sales potential, m$

USP

MOB-015 Onychomycosis Phase 3 applications submitted

250-500 Topical terbinafine with fast visible improvement and superior cure rates

BUPI Oral Mucositis and oral pain

Phase 3 preparation

50-100 Lozenge formulation with effective pain relief for 2-3 hrs(vs 0,5 hrs for competition)

13

Page 15: Moberg Pharma ABd1q0gh225dp9f5.cloudfront.net/sites/default/files/moberg... · 2016-08-09 · 3 Highlights – Q2 2016 3 Net sales of MSEK 71 – Sales (excl. divested brands) declined

14

MOB-015 update

14

Concept Builds on Emtrix/Kerasal nail, adds terbinafine Phase 2 demonstrated efficacy and safety:

- Delivers high μg-levels of terbinafine into nail bed and nail - 54% mycological cure in severe nails and ca 4-5 mm of clear nail growth

Progress Patents approved in EU, US, CA and several other territories. Term to at least 2032. June 2016: Submitted IND in U.S. and CTAs to start Phase 3 in DE, PL and CA. Clinical Trial Material produced by Colep (Colep co-invests in MOB-015 project) Leading Derm CROs manage Phase 3 studies:

- ProInnovera (EU) and - TKL (US/CA)

Design/Timeline: - Primary endpoint: Complete Cure after 52w - Start enrollment in Q3 2016 of in total ca 675 patients

Page 16: Moberg Pharma ABd1q0gh225dp9f5.cloudfront.net/sites/default/files/moberg... · 2016-08-09 · 3 Highlights – Q2 2016 3 Net sales of MSEK 71 – Sales (excl. divested brands) declined

Focus next 12 months

Page 17: Moberg Pharma ABd1q0gh225dp9f5.cloudfront.net/sites/default/files/moberg... · 2016-08-09 · 3 Highlights – Q2 2016 3 Net sales of MSEK 71 – Sales (excl. divested brands) declined

16

16

Focus next 12 months PROVIDING UNIQUE PRODUCTS IN UNDERSERVED NICHES

Making significant investments in 2016 - Acquiring additional brands/products - Initiating phase 3 studies for MOB-015 - Strengthening strategic brands in U.S. - Broadening international distribution

U.S: Execution of Kerasal brand strategy

Asia key growth driver, additional launches

BD/Innovation Engine - M&A focus on US OTC products - MOB-015 Initiating Phase 3 - BUPI: Preparations for Phase 3

Long-term target Create shareholder value through profitable growth targeting a long-term EBITDA margin of at least 25%

Page 18: Moberg Pharma ABd1q0gh225dp9f5.cloudfront.net/sites/default/files/moberg... · 2016-08-09 · 3 Highlights – Q2 2016 3 Net sales of MSEK 71 – Sales (excl. divested brands) declined

17 17

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 - 6 transactions in last 40 months - Team, systems and infrastructure in place to enable scale-up - Capacity to finance deals

Strong Team and track record

Why invest in Moberg Pharma – Strategy for Shareholder value