sobi update and perspective - jefferies group · we leverage our world-class capabilities in...

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Geoffrey McDonough │ CEO Sobi – Update and Perspective Jefferies Healthcare Conference London| 19 November 2014

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Page 1: Sobi Update and Perspective - Jefferies Group · We leverage our world-class capabilities in protein ... •Paediatric studies underway in Europe •European launch expected 2H 2016

Geoffrey McDonough │ CEO

Sobi – Update and PerspectiveJefferies Healthcare Conference

London| 19 November 2014

Page 2: Sobi Update and Perspective - Jefferies Group · We leverage our world-class capabilities in protein ... •Paediatric studies underway in Europe •European launch expected 2H 2016

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.

Page 3: Sobi Update and Perspective - Jefferies Group · We leverage our world-class capabilities in protein ... •Paediatric studies underway in Europe •European launch expected 2H 2016

An international specialty healthcare company dedicated to rare diseases.

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Our key therapeutic areas are Inflammation and Genetic diseases, with a growing focus on 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.

Page 4: Sobi Update and Perspective - Jefferies Group · We leverage our world-class capabilities in protein ... •Paediatric studies underway in Europe •European launch expected 2H 2016

64%19%

9%4% 3% 1%

Sweden

United States

United Kingdom

Luxemburg

Switzerland

Rest of World

Quick Facts

International Presence

• 550 employees

• Sales and marketing organization which covers about 20 countries in Europe

• Growing organizations in US, Russia, Middle East

Market Cap: $3.48 Billion USD (SEK 23.2 Billion)

Share: 12 November 2014: SEK 86.2052-week range: SEK 63.75 – 94.75

Listing: NASDAQ OMX (STO:SOBI)

Outstanding shares: 272.4 M

Ownership Summary:

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USD 1 = SEK 6.6757 (average rate for the period)

Page 5: Sobi Update and Perspective - Jefferies Group · We leverage our world-class capabilities in protein ... •Paediatric studies underway in Europe •European launch expected 2H 2016

Building Our Future

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1. Diverse, growing, and profitable base business focused on rare diseases

2. Near-term first-to-market long-acting haemophilia factors with exclusive USD 3.7 B in Sobi territories

3. Pipeline of early stage rare disease biologics

Page 6: Sobi Update and Perspective - Jefferies Group · We leverage our world-class capabilities in protein ... •Paediatric studies underway in Europe •European launch expected 2H 2016

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

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Page 7: Sobi Update and Perspective - Jefferies Group · We leverage our world-class capabilities in protein ... •Paediatric studies underway in Europe •European launch expected 2H 2016

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Financial YTD 2014 (YTD 2013)

• Total revenues: SEK 1,902 M (1,566) • An increase of 21%

• An increase of 18% at constant exchange rates

• Product revenues: SEK 1,414 M (1,110)• An increase of 27%

• Gross Margin: 59% (59)

• EBITA: SEK -82 M (146)

• Adj. EBITA: SEK 243 M (146)• excluding Kiobrina write-off

• CF from operations: SEK 232 M (181)

Highlights YTD 2014

1,566

1,902

926

1,121

146

-82

146243

181 232

-100

400

900

1,400

1,900

YTD-13 YTD-14

MSEK

Total revenues

Gross profit

EBITA

EBITA excluding Kiobrina write-downs

Cash flow from operating activities

Page 8: Sobi Update and Perspective - Jefferies Group · We leverage our world-class capabilities in protein ... •Paediatric studies underway in Europe •European launch expected 2H 2016

Revenue Trajectory: Driven by Product Sales

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0

100

200

300

400

500

600

700 • Total revenue driven by double digit growth in product sales

• ReFacto continues to meet our expectations for single digit growth

MSEKTotal Revenue

Product Revenue

ReFacto Revenue

Page 9: Sobi Update and Perspective - Jefferies Group · We leverage our world-class capabilities in protein ... •Paediatric studies underway in Europe •European launch expected 2H 2016

YTD Revenue by Business Line

Early StageDevelopment Programmes

Inflammation SEK 446 MUSD 67 M

Genetics & Metabolism

SEK 465 MUSD 70 M

Partner ProductsSEK 484 MUSD 72 M

ReFacto AF®SEK 488 MUSD 73 M

+37% +12%

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+30%

+7%

HaemophiliaSEK 19 M USD 3 M

USD 1 = SEK 6.6757 (average rate for the period)

Percentage increases at constant exchange rates

Page 10: Sobi Update and Perspective - Jefferies Group · We leverage our world-class capabilities in protein ... •Paediatric studies underway in Europe •European launch expected 2H 2016

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Operating Portfolio Momentum

Page 11: Sobi Update and Perspective - Jefferies Group · We leverage our world-class capabilities in protein ... •Paediatric studies underway in Europe •European launch expected 2H 2016

Partner Products Annual Growth Trend

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MSEK

407

546

484

0

100

200

300

400

500

600

2012 2013 YTD 2014

Revenue

Excluding co-promotion revenues

Page 12: Sobi Update and Perspective - Jefferies Group · We leverage our world-class capabilities in protein ... •Paediatric studies underway in Europe •European launch expected 2H 2016

Cash and Net Debt

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0%

10%

20%

30%

40%

50%

0

100

200

300

400

500

Q1

-12

Q2

-12

Q3

-12

Q4

-12

Q1

-13

Q2

-13

Q3

-13

Q4

-13

Q1

-14

Q2

-14

Q3

-14

SEK

M

Net debt Net debt / Equity

• End of quarter cash position: SEK 611 M

• Net debt SEK 206 M

• Expected one-time cost in Q4 for Multiferon®• SEK 25 to 30 M, with limited cash impact

• Expected larger payments in Q4• XTEN payment Q4, USD 7M

• Elocta opt-in Q4, USD 10 M

Page 13: Sobi Update and Perspective - Jefferies Group · We leverage our world-class capabilities in protein ... •Paediatric studies underway in Europe •European launch expected 2H 2016

Revenues MSEK 2,300 to 2,500

Gross Margin 58-60%

Operating costs Operating costs are expected to increase as the company continues to prepare for the planned launch of the Haemophilia programmes

Outlook 2014 (Unchanged)

The outlook was first published in the 2013 Q4 report on 20 February 2014.

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Page 14: Sobi Update and Perspective - Jefferies Group · We leverage our world-class capabilities in protein ... •Paediatric studies underway in Europe •European launch expected 2H 2016

Significant events after the reporting period

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• Biogen Idec filed a marketing authorisation application for Elocta™ in Europe

• Decided to discontinue the production of Multiferon

• Placed the phase 1 study of SOBI002 on clinical hold

• Decided not to pursue an additional indication for Kepivance®

Page 15: Sobi Update and Perspective - Jefferies Group · We leverage our world-class capabilities in protein ... •Paediatric studies underway in Europe •European launch expected 2H 2016

Building a Leading European Haemophilia Platform

Haemophilia

• Factor IX – Fc (Alprolix in the US)• Approved in Canada

• Approved in US

• Paediatric studies underway in Europe

• European launch expected 2H 2016

• Factor VIII – Fc (Eloctate in the US)• Positive KIDS-A-LONG data Q1 2014

• Approved in the US

• European file validated October 2014

• European launch expected 2H 2015

• Potential future hemophilia candidate (XTEN) added to partnership with Biogen Idec

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Page 16: Sobi Update and Perspective - Jefferies Group · We leverage our world-class capabilities in protein ... •Paediatric studies underway in Europe •European launch expected 2H 2016

Expected Long Acting FVIII EU timeline

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EU MAA filing

2014 2015 2016 2017 2018

Possible EMA approval

Sobi

Elocta launch in EU (Sobi territory)

Sobi opt-in

Page 17: Sobi Update and Perspective - Jefferies Group · We leverage our world-class capabilities in protein ... •Paediatric studies underway in Europe •European launch expected 2H 2016

Expected Long Acting FVIII EU timeline

* Based on publically announced data

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EU MAA filing

2014 2015 2016 2017 2018

Possible EMA approval

Sobi

CompetitorsFirst potential

long-acting FVIII

competitors*

Elocta launch in EU (Sobi territory)

Sobi opt-in

Page 18: Sobi Update and Perspective - Jefferies Group · We leverage our world-class capabilities in protein ... •Paediatric studies underway in Europe •European launch expected 2H 2016

Haemophilia A in Sobi Territory

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Size of Market in Sobi Territories*

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

$ 3,3 Billion

Page 19: Sobi Update and Perspective - Jefferies Group · We leverage our world-class capabilities in protein ... •Paediatric studies underway in Europe •European launch expected 2H 2016

Haemophilia A in Sobi Territory

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

46%

26%

17%

11%

Baxter

Bayer

Pfizer

CSL Behring

Recombinant Market in Europe* Plasma:Recombinant in European Market*

57%

43% Recombinant

Plasma

Page 20: Sobi Update and Perspective - Jefferies Group · We leverage our world-class capabilities in protein ... •Paediatric studies underway in Europe •European launch expected 2H 2016

Fewer than 100 Haemophilia Reference Centres

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Page 21: Sobi Update and Perspective - Jefferies Group · We leverage our world-class capabilities in protein ... •Paediatric studies underway in Europe •European launch expected 2H 2016

Sobi Launch Team on Track

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• Preparation has been ongoing for two years

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

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

Headcount

0

20

40

60

80

100

120

H2 2014 H1 2015 H2 2015 H1 2016

Anticipated EU ApprovalElocta Q4 2015

Page 22: Sobi Update and Perspective - Jefferies Group · We leverage our world-class capabilities in protein ... •Paediatric studies underway in Europe •European launch expected 2H 2016

Contractual Milestones EMA filing/

Sobi Opt-in

2013 2014 2015 2016 2017 2018 2019 2020

Sobi/Biogen CollaborationFinancial Flows for Eloctate/Elocta Programme

Royalties

2%

7%

12%

17%

BIIB royalty to Sobi

Sobi royalty to BIIB

Base rate cross royalty

EMA approval

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BIIB first commercial sale

After Sobi’s share of development cost is paid back

Sobi first commercial sale

Page 23: Sobi Update and Perspective - Jefferies Group · We leverage our world-class capabilities in protein ... •Paediatric studies underway in Europe •European launch expected 2H 2016

Building Our Future

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1. Diverse, growing, and profitable base business focused on rare diseases

2. Near-term first-to-market long-acting haemophilia factors with exclusive USD 3.7 B in Sobi territories

3. Pipeline of early stage rare disease biologics

Page 24: Sobi Update and Perspective - Jefferies Group · We leverage our world-class capabilities in protein ... •Paediatric studies underway in Europe •European launch expected 2H 2016

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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