A leader in topical niche...

25
A leader in topical niche categories Nordic-American Life Science Conference 2018 November 29, 2018 Peter Wolpert, CEO and founder

Transcript of A leader in topical niche...

Page 1: A leader in topical niche categoriesd1q0gh225dp9f5.cloudfront.net/sites/default/files/mob_ny...Pipeline –Key milestones achieved with good momentum • Completed enrollment for the

A leader in topical niche categories

Nordic-American Life Science Conference 2018November 29, 2018

Peter Wolpert, CEO and founder

Page 2: A leader in topical niche categoriesd1q0gh225dp9f5.cloudfront.net/sites/default/files/mob_ny...Pipeline –Key milestones achieved with good momentum • Completed enrollment for the

Disclaimer

The purpose of this presentation (the "Presentation") is to provide an overview of Moberg Pharma AB (publ) (the "Company"). For the purposes of this notice, "Presentation" means this document, its contents or any part of it, any oral presentation, any question or answer session and any written or oral material discussed or distributed during the Presentation meeting.

This Presentation is not a prospectus or similar offer document. This Presentation does not purport to contain comprehensive or complete information about the Company and is qualified in its entirety by the business, financial and other information the Company is required to publish in accordance with the rules, regulations and practices applicable to companies listed on Nasdaq Stockholm (the "Exchange Information"). Any decision to invest in any securities of the Company should only be made on the basis of a thorough examination of the Exchange Information and an independent investigation of the Company itself and not on the basis of this Presentation. Neither this Presentation nor any of the Exchange Information has been independently verified by any other person unless expressly stated therein. No representation or warranty, express or implied, is made as to, and no reliance should be placed on, the fairness, accuracy or completeness of the information or opinions contained in this Presentation.

Except where otherwise indicated in this Presentation, the information provided herein is based on matters as they exist at the date of preparation of this Presentation and not as of any future date. All information presented or contained and any opinions expressed in this Presentation are subject to change without notice. None of the Company or any of its directors, officers, employees, agents, affiliates or advisers is under any obligation to update, complete, revise or keep current the information contained in this Presentation to which it relates or to provide the recipient of with access to any additional information that may arise in connection with it.

This Presentation contains "forward-looking" statements. These forward-looking statements can be identified by the fact that they do not relate only to historical or current facts. In particular, forward-looking statements include all statements that express forecasts, expectations, plans, outlook and projections with respect to future matters, including trends in results of operations, margins, growth rates, overall market trends, the impact of interest or exchange rates, the availability or cost of financing, anticipated cost savings or synergies, the completion of strategic transactions and restructuring programmes, anticipated tax rates, expected cash payments, and general economic conditions. By their nature, forward-looking statements involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future and they are subject to change at any time. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements, including 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, the Company’s ability to secure new products for commercialization and/or development and other risks and uncertainties detailed from time to time in the Company’s interim or annual reports, prospectuses or press releases and other factors that are outside the Company's control. Any forward-looking statements made by or on behalf of the Company speak only as of the date they are made. The Company does not undertake to update forward-looking statements to reflect any changes in the Company's expectations with regard thereto or any changes in events, conditions or circumstances on which any such statement is based.

2

Page 3: A leader in topical niche categoriesd1q0gh225dp9f5.cloudfront.net/sites/default/files/mob_ny...Pipeline –Key milestones achieved with good momentum • Completed enrollment for the

Moberg Pharma in brief

Commercial business

Pipeline assets

Focus going forward

Page 4: A leader in topical niche categoriesd1q0gh225dp9f5.cloudfront.net/sites/default/files/mob_ny...Pipeline –Key milestones achieved with good momentum • Completed enrollment for the

Strong commercial business and progressing pipeline assets

4

Direct sales through all major U.S. retailers and distributor sales in 30+ markets, with

400+ MSEK in annual sales

Distributor sales

• #1-3 in many markets• 3 Top-50 partners

Mylan, Menarini, Endo

3 #1-BRANDS

40

IN PHASE 32 PRODUCTS

NAIL FUNGUS LIQUID BANDAGES PAIN RELIEF SPRAYS MOB-015 BUPI

Topical terbinafine against nail fungus

Bupivacaine lozenge against OM

Potential market leaders with $250-500m (MOB-015) and $100-200m

(BUPI) estimated sales potential

COMMERCIAL BUSINESS PIPELINE ASSETS

Page 5: A leader in topical niche categoriesd1q0gh225dp9f5.cloudfront.net/sites/default/files/mob_ny...Pipeline –Key milestones achieved with good momentum • Completed enrollment for the

5

Double-digit growth in sales and profitability

2010 2011 2012 2013 2014 2015 2016 2017 2018 9M

8

56

112

157

200

286

334

439Net Sales, MSEK

342 342MSEK

70MSEK

20%

NET SALES 9M 2018 (+16%*)

EBITDA 9M 2018 (+32%**)

EBITDA MARGIN 9M 2018

* Current portfolio only, Adjusted for acquisitions, divestments** Excluding capital gains

Page 6: A leader in topical niche categoriesd1q0gh225dp9f5.cloudfront.net/sites/default/files/mob_ny...Pipeline –Key milestones achieved with good momentum • Completed enrollment for the

6

Commercial Operations – Continued strong growth in sales and profitability

• Six separate transactions over the last two years have resulted in a synergistic portfolio of high margin niche brands with leading market positions and continued strong growth, improving the gross margin to 77%

• Distributor sales in line with plan to stabilize 2018 sales. Progress in new potential growth markets - Russia and MEA from 2019

Pipeline – Key milestones achieved with good momentum

• Completed enrollment for the North American phase 3-study. Strong momentum in European screening-process, expected to be finalized in the beginning of 2019

• Signed first license agreement for MOB-015 in Canada with Cipher Pharmaceuticals, confirming the market potential for our lead pipeline asset

• BUPI – U.S. patent approval enabled dialogue with new partners in North America and Europe

Excellent progress commercially as well as in pipeline

Page 7: A leader in topical niche categoriesd1q0gh225dp9f5.cloudfront.net/sites/default/files/mob_ny...Pipeline –Key milestones achieved with good momentum • Completed enrollment for the

Moberg Pharma in brief

Commercial business

Pipeline assets

Focus going forward

Page 8: A leader in topical niche categoriesd1q0gh225dp9f5.cloudfront.net/sites/default/files/mob_ny...Pipeline –Key milestones achieved with good momentum • Completed enrollment for the

Commercial portfolio with double-digit growth

Direct sales – driving organic growth for key brands

Main growth drivers are Kerasal Nail®, New Skin®, and Dermoplast®, accounting for 90% of net sales and an even higher share of profitability

• Kerasal Nail® delivered outstanding sales performance over the past three years and continues to strengthen its #1 position. Consumption growth YTD was +20.3%

• Both Dermoplast® (+14% YTD) and New Skin® (+11.5% YTD) continue to expand their market leading positions, following successful campaigns and enhanced digital marketing including social media

• Continued strong response to Kerasal Intensive Foot Repair re-launch in May. Growth of 37.2% in retail sales (L12W) driven by continued promotion program.

Distributor sales – leading position in Nordics and other prioritized markets

• Distributor sales in line with plan to stabilize full-year levels for 2018. New agreement with Mundipharma in MEA/South Africa and progress in Russia, open new growth markets for Emtrix® in 2019

8

®

Page 9: A leader in topical niche categoriesd1q0gh225dp9f5.cloudfront.net/sites/default/files/mob_ny...Pipeline –Key milestones achieved with good momentum • Completed enrollment for the

9

Underlying EBITDA doubled over the last two years

CONFIDENTIAL

Long-term EBITDA margin target: 25%

– Note significant divestments and acquisitions 2016 - 2018

Page 10: A leader in topical niche categoriesd1q0gh225dp9f5.cloudfront.net/sites/default/files/mob_ny...Pipeline –Key milestones achieved with good momentum • Completed enrollment for the

➢ INVENTORY BUILD-UP

➢ ADVERTISING STARTS

10

Promotion peaks in Q2-Q3, higher profitability in Q4

Q1 Q2 Q3 Q4

Q3 Q4➢ HIGH SEASON/SALES PEAK

➢ HIGH ADVERTISING COSTS

Direct sales

• Many orders each month, advertising increases during high season (Q2-Q3)

Distributor sales

• 2-3 orders/year for each market

➢ HIGH SALES

➢ MID ADVERTISING COSTS

➢ SALES BENEFITING FROM HIGH SEASON ADVERTISING

➢ LOW ADVERTISING COSTS

➢ STRONG CASH FLOW/EBITDA

– The seasonality of our business

Note: Pie charts indicate seasonal variation of anticipated sales & marketing costs as share of revenue

Page 11: A leader in topical niche categoriesd1q0gh225dp9f5.cloudfront.net/sites/default/files/mob_ny...Pipeline –Key milestones achieved with good momentum • Completed enrollment for the

11

16% organic growth YTD for Current Portfolio

CONFIDENTIAL

* Fiber Choice® divested Aug 28, 2017 and Balmex® divested April 27, 2018

Net revenue by product Jul-Sep Jan-Sep

Percentage changes Percentage changes

(SEK thousand) 2018 2017Fixed

Rate

FX

effectTotal 2018 2017

Fixed

Rate

FX

effectTotal

Kerasal Nail® 41,638 36,061 3 12 15 140,495 122,010 14 1 15

- of which direct sales 32,630 28,460 0 15 15 111,023 89,210 24 0 24

- of which to distributors 9,008 7,601 14 5 19 29,472 32,800 -13 3 -10

Dermoplast® 31,543 24,893 16 11 27 86,404 72,176 20 0 20

New Skin® 21,634 23,770 -17 8 -9 70,697 65,618 8 0 8

Other products 13,778 8,469 43 20 63 35,999 27,319 31 1 32

CURRENT PORTFOLIO 108,592 93,193 5 12 17 333,594 287,123 16 0 16

Divested products - 15,093 N/A N/A N/A 8,382 61,785 -86 0 -86

TOTAL NET REVENUE 108,592 108,286 -10 10 0 341,976 348,908 -2 0 -2

Page 12: A leader in topical niche categoriesd1q0gh225dp9f5.cloudfront.net/sites/default/files/mob_ny...Pipeline –Key milestones achieved with good momentum • Completed enrollment for the

12

Kerasal Nail®: Strong consumption and net revenue growth

76% → 94%VISIBLE IMPROVEMENT

AFTER 1 WEEKS

*Source: Symphony IRI, MULO, through September 9, 2018.

VISIBLE IMPROVEMENT AFTER 8 WEEKS

#1 Brand in the Fungal Nail category in the U.S.

• Continuing to outperform key competitors across the Nail Fungal Segment.

• YTD, consumption grew by +20%* and net revenue grew by +24%, driven by a successful and more efficient marketing program

• Kerasal Nail Psoriasis test launch in late May on Amazon only. Good learnings but small volumes so far

• Distributor sales in line with strategy to stabilize sales levels for full year, +14% in Q3 vs 2017

• New growth opportunities for Emtrix® in 2019 following new distribution agreement with Mundipharma in three markets in MEA, and the progress towards a registration in Russia.

Page 13: A leader in topical niche categoriesd1q0gh225dp9f5.cloudfront.net/sites/default/files/mob_ny...Pipeline –Key milestones achieved with good momentum • Completed enrollment for the

13

New Skin®: expanding leader in the Liquid Bandage category

Please note that there is about a one-month lag before increased consumer sales produce an effect on net sales. *Source: Symphony IRI, MULO, through September 9, 2018

The #1 OTC liquid bandage brand in the U.S.

• An antiseptic which kills germs and dries rapidly to form a clear protective cover

• Liquid and Spray available

• Distribution for Spray expanded in 2017 to Walmart and Walgreens

Net revenue grew 8% in first 9M and consumtion outpacing last year

• Continues to outpace prior year (+11.5% YTD*)

• YTD revenues grew by +8% , Q3 sales (-17%) were affected by the warehouse move and the optimization of marketing spend

• Marketing mix refined in 2018 with larger share of digital and social and optimized timing of the spend

Page 14: A leader in topical niche categoriesd1q0gh225dp9f5.cloudfront.net/sites/default/files/mob_ny...Pipeline –Key milestones achieved with good momentum • Completed enrollment for the

14

Dermoplast®: Double-digit growth in response to growth plan

The #1 pain relieving spray in U.S. retail

• Contains maximum strength Benzocaine

• No touch application, available with and without an antibacterial

• 60% of sales to Hospitals and 40% in Retail. Used for skin-related pain and itch problems

• Acquired Jan 1, 2017. Distribution expanded at Walmart and CVS

Net revenue grew by 20% YTD, responding well to launched growth plan

• Net revenue increased by 16% in Q3 while retail sales grew by 14%* (L52W: +14.3%, L12W: 14.4%)

• Strong growth in response to growth plan launched In Q2, including a larger share of digital(social campaigns as well as initiatives targeting healthcare professionals

Please note that IRI only track retail sales and ca 60% of the sales for Dermoplast are in Hospitals. *Source: Symphony IRI, MULO, 52 and 12 weeks through June 17, 2018

Page 15: A leader in topical niche categoriesd1q0gh225dp9f5.cloudfront.net/sites/default/files/mob_ny...Pipeline –Key milestones achieved with good momentum • Completed enrollment for the

Moberg Pharma in brief

Commercial business

Pipeline assets

Focus going forward

Page 16: A leader in topical niche categoriesd1q0gh225dp9f5.cloudfront.net/sites/default/files/mob_ny...Pipeline –Key milestones achieved with good momentum • Completed enrollment for the

MOB-015 – targeting leadership in onychomycosis

16Source: Moberg Pharma analysis and estimate

Target profile: Better cure rates, fast visible improvement and shorter treatment

• Topical delivering high concentrations of terbinafine through the nail

• Efficacy and safety demonstrated in Phase 2, incl. terbinafine levels in nail and nail bed

Two Phase-3 studies ongoing in North America and Europe (n = 750 - 800)

• In September, the enrollment of 365 patients to the North American study was completed

• Recruitment in Europe is expected to be completed by the beginning of 2019

Patent protection until 2032, granted in all key markets, including US, EU, Japan and China

Estimated annual sales potential: USD 250 - 500 million – first agreement signed

X

MYCOLOGICAL CURE AT 60 W54%

100%NEGATIVE CULTURE AT 60 W

>40XMORE TERBINAFINE IN NAIL BED

VS ORAL THERAPY

Page 17: A leader in topical niche categoriesd1q0gh225dp9f5.cloudfront.net/sites/default/files/mob_ny...Pipeline –Key milestones achieved with good momentum • Completed enrollment for the

17

MOB-015 – Attractive license agreement signed in Q3 for Canada

Confirming significant market potential for our key pipeline asset

• In mid-September, an exclusive license agreement was signed with Cipher Pharmaceuticals in Canada

• Cipher will commercialize MOB-015 in Canada upon completed clinical studies and registration of the product, with responsibility for marketing, distribution and sales

• Moberg Pharma will receive development and regulatory milestones totaling USD 4.6 million, whereof USD 0.5 million is an up-front fee at the time of signing

• Pending commercial targets, Moberg Pharma is entitled to further milestone payments of USD 10 million as well as royalties and supply fees for delivered products, enabling an industry standard gross margin for Cipher

• The Canadian market for onychomycosis prescription drugs amounted to CDN 58 million in 2017, 72% of which were topical drugs, growing steady at 18.3% in 2017 and at a CAGR of 25.4% for the period 2014-2017

Page 18: A leader in topical niche categoriesd1q0gh225dp9f5.cloudfront.net/sites/default/files/mob_ny...Pipeline –Key milestones achieved with good momentum • Completed enrollment for the

18

MOB-015 – Net Sales potential of $250-500 million

X

Market potential for target profile: Better cure rates, fast visible improvement and shorter treatment

• US Rx potential: $170-300+ million (WAC $1700/unit, branded topicals before discount)

• Other Rx markets, e.g. Japan and Canada: $50-100 million

• OTC markets in EU and RoW: Ca $50-100 million (3.5-7 million units à $15/unit)

$million 60% 50% 40% 30%

5% 170 213 255 298

7.5% 255 319 383 446

10% 340 425 510 595

15% 510 638 765 893Mar

ket

shar

e, T

Rx

Gross-to-Net discount

5-7.5% market share of 5m units x $1700

with 50-60% discount → $170-300+ million in net

sales for the US market

Page 19: A leader in topical niche categoriesd1q0gh225dp9f5.cloudfront.net/sites/default/files/mob_ny...Pipeline –Key milestones achieved with good momentum • Completed enrollment for the

19

Prescribers prefer MOB-015 target profile vs competition

Superior Cure Rates, Rapid Visible Improvement and Safety are key factors for prescribers (n=89)**:

• 62% would prefer MOB-015 vs 6-15% for other topicals

• 65% would prefer MOB-015 alone or in combination with oral terbinafine, vs 24% oral terbinafine only

• 72% try to avoid using oral terbinafine due to patient concerns over liver toxicities

Note: For MOB-015, the above describes the Target Product Profile for mild/moderated patients meeting inclusion criteria in ongoing Phase 3 trials. Source for Jublia data is Jublia Prescriber Information, Rev 09/2016* Refers to publications on ciclopirox and amorolfine. Many other OTC products have not conducted or published 52w trials** Source: HCP survey with 89 prescribers, dermatologists and podiatrists in the U.S., April 4, 2017

MYCOLOGICAL CURE

Target Product Profile, mild-moderate nails vs Jublia Mycological cure Complete cure Visible improvement

24W 52W 52W 4W

MOB-015 Target >50% 60-70% 20-30% >50%

Jublia - 54% 15-18% N/A

Penlac & Current OTCs* Ca 30% 6-8% or less N/A

Page 20: A leader in topical niche categoriesd1q0gh225dp9f5.cloudfront.net/sites/default/files/mob_ny...Pipeline –Key milestones achieved with good momentum • Completed enrollment for the

BUPI - Providing better pain relief in the oral cavity

20Source: Moberg Pharma analysis and estimates

Lead indication is Oral Mucositis after radio- or chemotherapy• BUPI: Lozenge with bupivacaine, taste-masked

• Target profile: Better and longer pain relief than existing products

Superior Phase 2 data published• Phase 3 preparations ongoing

• Expanding partnering effort

Patent protection until 2032-2033 granted in USA, EU and Canada

Estimated annual sales potential: USD 100 – 200 million

Page 21: A leader in topical niche categoriesd1q0gh225dp9f5.cloudfront.net/sites/default/files/mob_ny...Pipeline –Key milestones achieved with good momentum • Completed enrollment for the

21

BUPI demonstrated efficacy and safety in Phase 2

0

10

20

30

40

50

60

70

BUPI Control

baseline average max VAS

0

5

10

15

20

25

30

35

40

BUPI Control

baseline average max VAS

VAS Score (Highest of Mouth/Pharynx) VAS Score in Mouth only

-40% -49%

Strong Phase 2 data published, significantly better pain relief than standard treatment, n=39

• Control group had access to oral painkillers, morphine and lidocain mouthwash

• Primary endpoint: 31% less pain in BUPI group (Highest VAS score in mouth/pharynx, p=0,0032)

• In Mouth only: 50% less pain in BUPI group (p=0,0002)

Page 22: A leader in topical niche categoriesd1q0gh225dp9f5.cloudfront.net/sites/default/files/mob_ny...Pipeline –Key milestones achieved with good momentum • Completed enrollment for the

Moberg Pharma in brief

Commercial business

Pipeline assets

Focus going forward

Page 23: A leader in topical niche categoriesd1q0gh225dp9f5.cloudfront.net/sites/default/files/mob_ny...Pipeline –Key milestones achieved with good momentum • Completed enrollment for the

Continued focus to drive growth and deliver pipeline value

We focus on maximizing the potential in our portfolio; through organic growth as well as realizing the substantial value of our pipeline.

Commercial niche player – continuing to strengthen a growing and profitable business

• The streamlining of our portfolio has resulted in sustained growth as well as consistent improvements in profitability, as reflected in our EBITDA margin more than doubling from 10% to 22% over the last two years, excluding capital gains.

• We currently focus on the 2019 growth planning, maintaining the strong momentumfor all key brands

Pipeline assets – continuing to realize the potential

• Pipeline has progressed significantly in 2018 with completed Phase 3 enrollment in the U.S., attractive license agreement in Canada and additional patents in key markets

• We continue to progress our phase 3-studies and commercialization plans for MOB-015 as well as broadening dialogues with current and new partners

23

Page 24: A leader in topical niche categoriesd1q0gh225dp9f5.cloudfront.net/sites/default/files/mob_ny...Pipeline –Key milestones achieved with good momentum • Completed enrollment for the

Moberg Pharma AB (Publ)Gustavslundsvägen 42, 5 tr.

167 51 Bromma

mobergpharma.se

Page 25: A leader in topical niche categoriesd1q0gh225dp9f5.cloudfront.net/sites/default/files/mob_ny...Pipeline –Key milestones achieved with good momentum • Completed enrollment for the

P&L – Strong gross margin and EBITDAQ3 2018

251) 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 Jan-Sep Full-year

(MSEK) 2018 2017 2018 2017 2017Revenue 109 108 342 349 439Gross profit 84 77 262 249 314% 77% 71% 77% 71% 71%

SG & A -57 -52 -183 -184 -214R&D - existing product portfolio1) -2 -1 -6 -4 -6Other operating income/operating expenses 3 16 13 14 13EBITDA Commercial Operations 28 40 86 75 106% 26% 37% 25% 22% 24%

R&D & BD - future products2) -5 -4 -16 -13 -17EBITDA 23 36 70 62 89% 21% 33% 20% 18% 20%

Depreciation/amortization -9 -9 -28 -29 -38Operating profit (EBIT) 14 27 42 33 51