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Swedish Orphan Biovitrum AB (publ)€¦ · Market Cap: SEK 29.7 Billion ($3.6 Billion USD) Share:...

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30 June 2015 ǀ Stockholm Swedish Orphan Biovitrum AB (publ) Annual General Meeting 2015 Geoffrey McDonough, CEO and President
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Page 1: Swedish Orphan Biovitrum AB (publ)€¦ · Market Cap: SEK 29.7 Billion ($3.6 Billion USD) Share: 26 June 2015: SEK 111.20 52-week range: SEK 65.25 –145.90 Listing: NASDAQ OMX (STO:SOBI)

30 June 2015 ǀ Stockholm

Swedish Orphan Biovitrum AB (publ)Annual General Meeting 2015

Geoffrey McDonough, CEO and President

Page 2: Swedish Orphan Biovitrum AB (publ)€¦ · Market Cap: SEK 29.7 Billion ($3.6 Billion USD) Share: 26 June 2015: SEK 111.20 52-week range: SEK 65.25 –145.90 Listing: NASDAQ OMX (STO:SOBI)

Forward Looking Statements

In order to utilize the ‘Safe Harbor’ provisions of the United States Private Securities LitigationReform Act of 1995, Swedish Orphan Biovitrum is providing the following cautionary statement.This presentation contains forward-looking statements with respect to the financial condition,results of operations and businesses of Swedish Orphan Biovitrum. By their nature, forward-looking statements and forecasts involve risk and uncertainty because they relate to events anddepend on circumstances that will occur in the future. There are a number of factors that couldcause actual results and developments to differ materially from that expressed or implied by theseforward-looking statements. These factors include, among other things, the loss or expiration ofpatents, marketing exclusivity or trade marks; exchange rate fluctuations; the risk that R&D willnot yield new products that achieve commercial success; the impact of competition, price controlsand price reductions; taxation risks; the risk of substantial product liability claims; the impact ofany failure by third parties to supply materials or services; the risk of delay to new productlaunches; the difficulties of obtaining and maintaining governmental approvals for products; therisk of failure to observe ongoing regulatory oversight; the risk that new products do not performas we expect; and the risk of environmental liabilities.

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Page 3: Swedish Orphan Biovitrum AB (publ)€¦ · Market Cap: SEK 29.7 Billion ($3.6 Billion USD) Share: 26 June 2015: SEK 111.20 52-week range: SEK 65.25 –145.90 Listing: NASDAQ OMX (STO:SOBI)

An International Healthcare Company Dedicated To Rare Diseases

Our key therapeutic areas are Inflammation, Genetic diseases, and Haemophilia.

We deliver products to specialist physicians and their patients through our integrated and focused team approach to sales and marketing, medical affairs and patient access.

We leverage our world-class capabilities in protein biochemistry and biologics manufacturing to develop next generation biological products.

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Page 4: Swedish Orphan Biovitrum AB (publ)€¦ · Market Cap: SEK 29.7 Billion ($3.6 Billion USD) Share: 26 June 2015: SEK 111.20 52-week range: SEK 65.25 –145.90 Listing: NASDAQ OMX (STO:SOBI)

A Legacy of Biologics Innovation

Pharmacia ReFacto process

development

Kabi/Kabi Pharmacia Heparin

Recombinant FVIIIGenotropin

BiovitrumKineret

KepivanceFIXFc

FVIIIFcKiobrina

SobiSOBI002

Swedish OrphanOrfadin

SPP Model

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Page 5: Swedish Orphan Biovitrum AB (publ)€¦ · Market Cap: SEK 29.7 Billion ($3.6 Billion USD) Share: 26 June 2015: SEK 111.20 52-week range: SEK 65.25 –145.90 Listing: NASDAQ OMX (STO:SOBI)

A Mid-Size International Company

International Presence

• 600+ employees

• Sales and marketing organisation which covers 23 countries in Europe

• Growing organisations in US, Russia, Middle East

Market Cap: SEK 29.7 Billion ($3.6 Billion USD)

Share: 26 June 2015: SEK 111.2052-week range: SEK 65.25 – 145.90

Listing: NASDAQ OMX (STO:SOBI)

Outstanding shares: 270.4 Million

Ownership Summary:

5

USD 1 = SEK 8.25 (26 June 2015)

67%

17%

9%

4% 3%

Sweden

US

UK

Luxemburg

Switzerland

Page 6: Swedish Orphan Biovitrum AB (publ)€¦ · Market Cap: SEK 29.7 Billion ($3.6 Billion USD) Share: 26 June 2015: SEK 111.20 52-week range: SEK 65.25 –145.90 Listing: NASDAQ OMX (STO:SOBI)

A Diverse, Growing BusinessStrategically Complementary Segments

Early StageDevelopment Programmes

Inflammation Genetics &

Metabolism

Partner Products

ReFacto AF®

Haemophilia

Robust biologics foundation

Leading specialty and rare disease platform

Breakthrough franchise fuels a

leading global rare disease company

Next generation rare disease biologics

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Page 7: Swedish Orphan Biovitrum AB (publ)€¦ · Market Cap: SEK 29.7 Billion ($3.6 Billion USD) Share: 26 June 2015: SEK 111.20 52-week range: SEK 65.25 –145.90 Listing: NASDAQ OMX (STO:SOBI)

A Diverse, Growing BusinessUnderpinned by Strong Brands

Early StageDevelopment Programmes

Inflammation Genetics &

Metabolism

Partner Products

ReFacto AF®

Haemophilia

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Page 8: Swedish Orphan Biovitrum AB (publ)€¦ · Market Cap: SEK 29.7 Billion ($3.6 Billion USD) Share: 26 June 2015: SEK 111.20 52-week range: SEK 65.25 –145.90 Listing: NASDAQ OMX (STO:SOBI)

Building Our Future In Three Steps

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Continued strong focus on our business and capabilities within rare diseases

1. Diverse, growing, and profitable base business in Europe and North America focused on rare diseases

2. Launching first-to-market long-acting haemophilia factors in Sobi territories – providing forward cash flow to continue to build company

3. Growing the business organically with new partner products, and with a pipeline of early stage rare disease biologics

Page 9: Swedish Orphan Biovitrum AB (publ)€¦ · Market Cap: SEK 29.7 Billion ($3.6 Billion USD) Share: 26 June 2015: SEK 111.20 52-week range: SEK 65.25 –145.90 Listing: NASDAQ OMX (STO:SOBI)

Partner Products

Inflammation

Genetics & Metabolism

Haemophilia royalties

Haemophilia

ReFacto

Early Programmes

Building a Leading Rare Disease Company

Medium-term

Long-term

2012 - 2013 2014 - 2015 2016 +

Short-termEBITA

TIME

Development Programmes

Inflammation Genetics &

Metabolism

Partner Products

ReFacto AF®

Haemophilia

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Page 10: Swedish Orphan Biovitrum AB (publ)€¦ · Market Cap: SEK 29.7 Billion ($3.6 Billion USD) Share: 26 June 2015: SEK 111.20 52-week range: SEK 65.25 –145.90 Listing: NASDAQ OMX (STO:SOBI)

Important Business Events FY 2014

Speciality Care & Partner Products

• Kiobrina Phase 3 top-line results presented; -primary endpoint not met.

• Direct sales of Orfadin® initiated in North America.

• Orfadin® approved in Japan

• Cometriq® approved in Europe.

• Entered partnership with TiGenix for the commercialisation of ChondroCelect.

• Received positive CHMP opinion for Xiapex® for the treatment of Peyronie's disease

Haemophilia

• US FDA and Health Canada approved Alprolix® and Eloctate®

• Positive top-line results from Kids A-LONG Phase 3 paediatric trial for Eloctate® published

• Marketing Authorisation Application for Elocta™ filed and validated for review by EMA

• Exercised opt-in right for Elocta

• Biogen and Sobi announced their intent to donate 1 billion international units of haemophilia clotting factor therapy for humanitarian aid programmes.

• Elected to include a potentially longer-acting haemophilia A candidate (rFVIIIFc VWF-XTEN Heterodimer) in collaboration agreement with Biogen.

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Page 11: Swedish Orphan Biovitrum AB (publ)€¦ · Market Cap: SEK 29.7 Billion ($3.6 Billion USD) Share: 26 June 2015: SEK 111.20 52-week range: SEK 65.25 –145.90 Listing: NASDAQ OMX (STO:SOBI)

Revenue Trajectory: Driven by Product Sales

• Total revenues: SEK 2,607 M (2,177) • An increase of 20%

• At constant exchange rates 15%

• Product revenues: SEK 1,989 M (1,558)• An increase of 28%

• ReFacto revenues: SEK 618 M (619)

0

100

200

300

400

500

600

700

800

12

Q1

12

Q2

12

Q3

12

Q4

13

Q1

13

Q2

13

Q3

13

Q4

14

Q1

14

Q2

14

Q3

14

Q4

Total Revenue

Product Revenue

ReFacto Revenue

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Page 12: Swedish Orphan Biovitrum AB (publ)€¦ · Market Cap: SEK 29.7 Billion ($3.6 Billion USD) Share: 26 June 2015: SEK 111.20 52-week range: SEK 65.25 –145.90 Listing: NASDAQ OMX (STO:SOBI)

Full Year Revenue 2014 by Business Line

Early StageDevelopment Programmes

Inflammation SEK 609 MUSD 89 M

Genetics & Metabolism

SEK 666 MUSD 97 M

Partner ProductsSEK 682 MUSD 99 M

ReFacto AF®SEK 618 MUSD 90 M

+3%*

+21%*

-1%*

HaemophiliaSEK 31 M USD 5 M

*Growth at Constant Exchange Rates

USD 1 = SEK 6.8577

+40%*

FY 2013SEK 2,177 M

FY 2014SEK 2,607 M

+15%*

Total revenue

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Page 13: Swedish Orphan Biovitrum AB (publ)€¦ · Market Cap: SEK 29.7 Billion ($3.6 Billion USD) Share: 26 June 2015: SEK 111.20 52-week range: SEK 65.25 –145.90 Listing: NASDAQ OMX (STO:SOBI)

Operating Portfolio Momentum

Development Programmes

Inflammation Genetics &

Metabolism

Partner Products

ReFacto AF®

Haemophilia

13

0

50

100

150

200

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

2012 2013 2014

Orfadin (SEK M)

Quarterly

Orfadin 4Q-Rolling average

020406080

100120140160180200

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

2012 2013 2014

Kineret (SEK M)

Quarterly

Kineret 4Q-Rolling average

0

50

100

150

200

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

2012 2013 2014

ReFacto (SEK M)

Royalty

manufacturing

ReFacto 4Q-Rolling average

0

50

100

150

200

250

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

2012 2013 2014

Partner Products (SEK M)

Co-promotion revenues

Base portfolio

Base portfolio 4Q-Rolling average

Page 14: Swedish Orphan Biovitrum AB (publ)€¦ · Market Cap: SEK 29.7 Billion ($3.6 Billion USD) Share: 26 June 2015: SEK 111.20 52-week range: SEK 65.25 –145.90 Listing: NASDAQ OMX (STO:SOBI)

Partner Products Annual Growth Trend

MSEK

423

546

682

0

100

200

300

400

500

600

700

800

2012 2013 2014

Revenue

CAGR27%

14

Page 15: Swedish Orphan Biovitrum AB (publ)€¦ · Market Cap: SEK 29.7 Billion ($3.6 Billion USD) Share: 26 June 2015: SEK 111.20 52-week range: SEK 65.25 –145.90 Listing: NASDAQ OMX (STO:SOBI)

Growth Across Four Regional Platforms

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Supporting Corporate FunctionsCEO and Leadership Team, Commercial Operations, Corporate Development, Development & Medical,

Drug Design & Development, External Affairs & Patient Access, Finance, Human Resources, Legal Affairs

EMENAR

ReFacto

• ReFacto manufacturing

• ReFacto Royalty

A robust platform extension/multiplier

SEK 618 MUSD 90 M

0%*

*Year-on-year growth

North America

• Orfadin, Kineret, Kepivance

A robust platform extension/multiplier

SEK 551 M USD 80 M

30%*

SCPP

• Orfadin, Kineret®, Kepivance®

A leading specialty and rare disease platform

• Partner Product portfolio

SEK 1,407 M USD 205 M

24%*

Haemophilia

• Elocta (& Alprolix)

Fuel to build a global rare disease company

SEK 31 MUSD 5 M

Page 16: Swedish Orphan Biovitrum AB (publ)€¦ · Market Cap: SEK 29.7 Billion ($3.6 Billion USD) Share: 26 June 2015: SEK 111.20 52-week range: SEK 65.25 –145.90 Listing: NASDAQ OMX (STO:SOBI)

Haemophilia

• Q4 2014 revenue of SEK 12 M (0)

• FY was SEK 31 M (0)

• SEK 11 M relates to a milestone revenue for the BLA approval of Alprolix® in Q1 2014

Sales (SEK M): Haemophilia

0

2

4

6

8

10

12

14

Q1 Q2 Q3 Q4

2014

Milestone Alprolix Alprolix Eloctate

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Page 17: Swedish Orphan Biovitrum AB (publ)€¦ · Market Cap: SEK 29.7 Billion ($3.6 Billion USD) Share: 26 June 2015: SEK 111.20 52-week range: SEK 65.25 –145.90 Listing: NASDAQ OMX (STO:SOBI)

Net Debt

• End of year cash: SEK 519 M

• Net debt SEK 298 M

• Significant payments to partner in Q4• XTEN payment Q4, USD 7 M

• Elocta opt-in Q4, USD 10 M

0%

10%

20%

30%

40%

50%

0

100

200

300

400

500Q

1-1

2

Q2

-12

Q3

-12

Q4

-12

Q1

-13

Q2

-13

Q3

-13

Q4

-13

Q1

-14

Q2

-14

Q3

-14

Q4

-14

SEK

M

Net debt Net debt / Equity

17

Page 18: Swedish Orphan Biovitrum AB (publ)€¦ · Market Cap: SEK 29.7 Billion ($3.6 Billion USD) Share: 26 June 2015: SEK 111.20 52-week range: SEK 65.25 –145.90 Listing: NASDAQ OMX (STO:SOBI)

Outlook 2015 - EBITA expectations clarified

Revenues Sobi expects total revenues for the full year to be in the range of SEK 2,800 to 3,000 M

Gross Margin Gross margin is expected be in the range of 58-60 percent.

Operating Costs Operating costs are projected to increase as the company continues to prepare for the planned launch of Elocta

EBITAEBITA is expected to be in the range SEK 300 – 400 M1

The outlook was first published in the 2014 Q4 and FY report on 19 February 2015.

The outlook for 2015 is based on exchange rates as of 19 February 2015, and excludes revenue from the potential European launch of Elocta.

1The original outlook presented on 19 February 2015 stated that “Sobi expects EBITA to be in line with the adjusted 2014 level”.

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Page 19: Swedish Orphan Biovitrum AB (publ)€¦ · Market Cap: SEK 29.7 Billion ($3.6 Billion USD) Share: 26 June 2015: SEK 111.20 52-week range: SEK 65.25 –145.90 Listing: NASDAQ OMX (STO:SOBI)

The Share – 1 January 2014 to 26 June 2015

19

SEK 111.20

Page 20: Swedish Orphan Biovitrum AB (publ)€¦ · Market Cap: SEK 29.7 Billion ($3.6 Billion USD) Share: 26 June 2015: SEK 111.20 52-week range: SEK 65.25 –145.90 Listing: NASDAQ OMX (STO:SOBI)

Strategic Priorities

1. Near-term focus on growth in our base business, with sustainable positive cash flow from operations.

2. Medium-term investments to ensure successful commercialisation of our haemophilia programmes.

3. Long-term growth will come organically and through acquisitions.

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Page 21: Swedish Orphan Biovitrum AB (publ)€¦ · Market Cap: SEK 29.7 Billion ($3.6 Billion USD) Share: 26 June 2015: SEK 111.20 52-week range: SEK 65.25 –145.90 Listing: NASDAQ OMX (STO:SOBI)

Fc Fusion TechnologyLong-acting Clotting Factors

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Page 22: Swedish Orphan Biovitrum AB (publ)€¦ · Market Cap: SEK 29.7 Billion ($3.6 Billion USD) Share: 26 June 2015: SEK 111.20 52-week range: SEK 65.25 –145.90 Listing: NASDAQ OMX (STO:SOBI)

Biogen launch progress for Alprolix & EloctateAlprolix Revenue ($M) Eloctate Revenue ($M)

Q3 2014 Q4 2014 Q1 2015

Eloctate (mUSD) 22 37 (+41%) 54 (+31%)Alprolix (mUSD) 25 40 (+38%) 43 (+8%)

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Page 23: Swedish Orphan Biovitrum AB (publ)€¦ · Market Cap: SEK 29.7 Billion ($3.6 Billion USD) Share: 26 June 2015: SEK 111.20 52-week range: SEK 65.25 –145.90 Listing: NASDAQ OMX (STO:SOBI)

Haemophilia A in Sobi Territory

Size of Market (M) in Sobi Territories*

*Source: MRB, 2011, includes all patients (mild, moderate, severe)

USD 3.3 B

SEK 27 B

23

USD 1 = SEK 8.25 (26 June 2015)

Page 24: Swedish Orphan Biovitrum AB (publ)€¦ · Market Cap: SEK 29.7 Billion ($3.6 Billion USD) Share: 26 June 2015: SEK 111.20 52-week range: SEK 65.25 –145.90 Listing: NASDAQ OMX (STO:SOBI)

Fewer than 100 Haemophilia Reference Centres

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Page 25: Swedish Orphan Biovitrum AB (publ)€¦ · Market Cap: SEK 29.7 Billion ($3.6 Billion USD) Share: 26 June 2015: SEK 111.20 52-week range: SEK 65.25 –145.90 Listing: NASDAQ OMX (STO:SOBI)

Sobi Launch Team on Track

• Preparation has been ongoing for two years

• On track to reach launch readiness in 2015 with fully dedicated organisation

• Sequential build of Market Access, Medical Affairs, and Commercial teams

Headcount

Anticipated EU ApprovalElocta Q4 2015

25

0

20

40

60

80

100

120

H2 2014 H1 2015 H2 2015 H1 2016

Page 26: Swedish Orphan Biovitrum AB (publ)€¦ · Market Cap: SEK 29.7 Billion ($3.6 Billion USD) Share: 26 June 2015: SEK 111.20 52-week range: SEK 65.25 –145.90 Listing: NASDAQ OMX (STO:SOBI)

Expected Long Acting rFVIIIFc & rFIXFc EU timeline

* Based on publically announced data

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EU MAA filing Elocta

2014 2015 2016 2017 2018

Possible EC approval Elocta

Sobi opt-in Elocta

rFVIIIFc

First potential long-acting FVIII

competitors*

Possible start of Elocta launch in EU (Sobi territory)

EU MAA filing Alprolix

Possible EC approval Alprolix

Possible start of Alprolix launch in EU (Sobi territory)

Possible Sobi opt-in Alprolix

First potential long-acting FIX competitors*

rFIXFc

Page 27: Swedish Orphan Biovitrum AB (publ)€¦ · Market Cap: SEK 29.7 Billion ($3.6 Billion USD) Share: 26 June 2015: SEK 111.20 52-week range: SEK 65.25 –145.90 Listing: NASDAQ OMX (STO:SOBI)

Long-Term Commitment to Haemophilia

• Working toward developing next-generation factors: • rFVIIIFc-VWF-XTEN

• Included in the Sobi-Biogen Idec collaboration Q4 2014: • Similar terms to Elocta and Alprolix

for development and commercialisation rFVIIIFc-VWF-XTEN

A1

A2

A3

C1C2

D’D3

Fc

Fc

XTEN insertions:

• Prolong half-life by increasing hydrodynamic radius and blocking receptor-mediated clearance

VWF D’D3 fusion:

• Utilises D’D3 domain from FVIII endogenous binding partner von Willebrand Factor (VWF) to stabilize molecule and decouple from VWF clearance pathways

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Page 28: Swedish Orphan Biovitrum AB (publ)€¦ · Market Cap: SEK 29.7 Billion ($3.6 Billion USD) Share: 26 June 2015: SEK 111.20 52-week range: SEK 65.25 –145.90 Listing: NASDAQ OMX (STO:SOBI)

Summary

1. Diversified commercial portfolio focused on improving cash flow and profitability

2. Working to efficiently commercialise our proprietary innovative medicines for rare disease patients globally

3. Business model oriented to building value through partnerships from global early stage biologics development to late stage specialty distribution in Europe

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Page 29: Swedish Orphan Biovitrum AB (publ)€¦ · Market Cap: SEK 29.7 Billion ($3.6 Billion USD) Share: 26 June 2015: SEK 111.20 52-week range: SEK 65.25 –145.90 Listing: NASDAQ OMX (STO:SOBI)

2014 2015 2016 2017 2018 2019 2020

Royalty Mechanism RevenuesEloctate/Elocta Programme

12%Base rate cross royalty

Base cross royalty rates between Sobi and Biogen Idec are set to 12% • Sobi earns 12% royalty on Biogen Idec sales• Biogen Idec earns 12% royalty on Sobi sales

17%

7%

2%

Presently• Starting from Biogen Idec’s first commercial sale, Sobi earns 2%

royalty on Biogen Idec sales

• Sobi receives a one-time credit corresponding to 10% royalty on Biogen Idec sales pre-Sobi launch (12%-2%). Deducted against opt-in debt (non-cash item).

Starting from Sobi first commercial sales• Sobi earns 12% royalty on Biogen Idec sales post-Sobi launch.

7% received as cash and 5% deducted against Opt-in debt.

Royalty deducted against opt-in debt Royalty received in cash

PnL impact at Sobi first commercial sales:• One-time credit and

royalty booked as revenue

• 7% of royalty revenue will impact cash-flow

• 5% of royalty revenue and one-time credit will be deducted against opt-in debt

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