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Geoffrey McDonough (CEO) and Lars Sandström (CFO) Interim Report January September 2011 Stockholm, 20 October 2011 We provide valuable medicines to patients with rare diseases

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Page 1: Interim Report January September 2011 · Interim Report January – September 2011 Stockholm, 20 October 2011 ... Market Share 0.5% Source: Datamonitor 2010, Schiff et al 2004 and

Geoffrey McDonough (CEO) and Lars Sandström (CFO)

Interim Report January – September 2011 Stockholm, 20 October 2011

We provide valuable medicines to patients with rare diseases

Page 2: Interim Report January September 2011 · Interim Report January – September 2011 Stockholm, 20 October 2011 ... Market Share 0.5% Source: Datamonitor 2010, Schiff et al 2004 and

Disclaimer

2

In order to utilize the ‘Safe Harbor’ provisions of the United States Private Securities Litigation Reform 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 and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially from that expressed or implied by these forward-looking statements. These factors include, among other things, the loss or expiration of patents, marketing exclusivity or trade marks; exchange rate fluctuations; the risk that R&D will not yield new products that achieve commercial success; the impact of competition, price controls and price reductions; taxation risks; the risk of substantial product liability claims; the impact of any failure by third parties to supply materials or services; the risk of delay to new product launches; the difficulties of obtaining and maintaining governmental approvals for products; the risk of failure to observe ongoing regulatory oversight; the risk that new products do not perform as we expect; and the risk of environmental liabilities.

Page 3: Interim Report January September 2011 · Interim Report January – September 2011 Stockholm, 20 October 2011 ... Market Share 0.5% Source: Datamonitor 2010, Schiff et al 2004 and

Agenda

3

•Introduction Geoffrey McDonough, CEO

•Financial Review Lars Sandström, CFO

•Business Review Geoffrey McDonough, CEO

•Q & A

Page 4: Interim Report January September 2011 · Interim Report January – September 2011 Stockholm, 20 October 2011 ... Market Share 0.5% Source: Datamonitor 2010, Schiff et al 2004 and

Key Points

4

•Sobi is an integrated, innovative biopharmaceutical company

•We have a unique position in the rare disease space

•Our focus today:

1. Growth – reaching the potential of our key products

2. Profitability – operating efficiency and discipline

3. Building value for our future – executing on our pipeline

Page 5: Interim Report January September 2011 · Interim Report January – September 2011 Stockholm, 20 October 2011 ... Market Share 0.5% Source: Datamonitor 2010, Schiff et al 2004 and

Lars Sandström, CFO

Financial Review

We provide valuable medicines to patients with rare diseases

Page 6: Interim Report January September 2011 · Interim Report January – September 2011 Stockholm, 20 October 2011 ... Market Share 0.5% Source: Datamonitor 2010, Schiff et al 2004 and

Financial performance YTD

0

500

1 000

1 500

2010 YTD 2011 YTD

SEK

M Total revenues

EBITA before non-recurring items

6

Page 7: Interim Report January September 2011 · Interim Report January – September 2011 Stockholm, 20 October 2011 ... Market Share 0.5% Source: Datamonitor 2010, Schiff et al 2004 and

Revenues by quarter

7

0

100

200

300

400

500

600 Q

3-1

0

Q4

-10

Q1

-11

Q2

-11

Q3

-11

SEK

M

Product sales & Co-promotion Other revenues

•Total revenues SEK 447 M (444) • Currency effects SEK -13 M

• Discontinued products SEK -26 M

•Product sales and Co-promotion +8% y/y adjusted for currency effects and discontinued products

Page 8: Interim Report January September 2011 · Interim Report January – September 2011 Stockholm, 20 October 2011 ... Market Share 0.5% Source: Datamonitor 2010, Schiff et al 2004 and

Revenues Q3-11 vs. Q3-10

8

0

100

200

300

400

500

Q3 2010 Discontinued products

Currency Growth from product portfolio

Growth from other revenues

Q3 2011

SEK

M

-26 -13

+26 +15

Page 9: Interim Report January September 2011 · Interim Report January – September 2011 Stockholm, 20 October 2011 ... Market Share 0.5% Source: Datamonitor 2010, Schiff et al 2004 and

EBITA before non-recurring items by quarter

9

•EBITA before non-recurring items SEK 3.0 M (65.6)

•EBITA margin 0.7% (12.8)

0%

10%

20%

30%

40%

50%

0

50

100

150

200

250 Q

3-1

0

Q4

-10

Q1

-11

Q2

-11

Q3

-11

SEK

M

EBITA before non-recurring items % of sales

Page 10: Interim Report January September 2011 · Interim Report January – September 2011 Stockholm, 20 October 2011 ... Market Share 0.5% Source: Datamonitor 2010, Schiff et al 2004 and

EBITA Q3-11 vs. Q3-10

10

EBITA

SEK 3 M (66)

+ Volume

+ Lower operating expenses

− Gross margin 52% (64%)

− Scheduled plant maintenance

− Currency

− Royalty

Page 11: Interim Report January September 2011 · Interim Report January – September 2011 Stockholm, 20 October 2011 ... Market Share 0.5% Source: Datamonitor 2010, Schiff et al 2004 and

Cash flow before financing (excl. acquisitions) by quarter

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•Cash flow before financing (excl. acquisitions) SEK -3.2 M (+3.4)

•Working capital SEK -13.7 M (-32.4)

•Net investments SEK -28.7 (-5.0)

-150

-100

-50

0

50 Q

3-1

0

Q4

-10

Q1

-11

Q2

-11

Q3

-11

SEK

M

Cash flow before financing (excl. acq.)

Whereof working capital

Page 12: Interim Report January September 2011 · Interim Report January – September 2011 Stockholm, 20 October 2011 ... Market Share 0.5% Source: Datamonitor 2010, Schiff et al 2004 and

Total inventory value by quarter

12

0

200

400

600

800

1 000

1 200

Q4

-08

Q1

-09

Q2

-09

Q3

-09

Q4

-09

Q1

-10

Q2

-10

Q3

-10

Q4

-10

Q1

-11

Q2

-11

Q3

-11

SEK

M

Tech Transfer Kineret

Page 13: Interim Report January September 2011 · Interim Report January – September 2011 Stockholm, 20 October 2011 ... Market Share 0.5% Source: Datamonitor 2010, Schiff et al 2004 and

Net debt by quarter

13

•Net debt SEK 613 M (1,131)

•Net debt to equity 12%

0%

10%

20%

30%

0

500

1 000

1 500 Q

3-1

0

Q4

-10

Q1

-11

Q2

-11

Q3

-11

SEK

M

Net debt Net debt / Equity

Page 14: Interim Report January September 2011 · Interim Report January – September 2011 Stockholm, 20 October 2011 ... Market Share 0.5% Source: Datamonitor 2010, Schiff et al 2004 and

Outlook 2011

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•Reiterate revenue growth of 1-5 % and lower gross margin compared to last year

•Expect to evaluate possible write-down of balance sheet items in Q4 of up to SEK 350 M • Inventory positions

• Intangible assets

•Other items including finalization of restructuring announced in Q1 2011

Page 15: Interim Report January September 2011 · Interim Report January – September 2011 Stockholm, 20 October 2011 ... Market Share 0.5% Source: Datamonitor 2010, Schiff et al 2004 and

Geoffrey McDonough, CEO

Business Overview

We provide valuable medicines to patients with rare diseases

Page 16: Interim Report January September 2011 · Interim Report January – September 2011 Stockholm, 20 October 2011 ... Market Share 0.5% Source: Datamonitor 2010, Schiff et al 2004 and

Sales Driven by a Diverse Portfolio

0

100

200

300

400

500

600 Q

3-1

0

Q4

-10

Q1

-11

Q2

-11

Q3

-11

SEK

M

Product sales & Co-promotion Other revenues

54 Products

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Page 17: Interim Report January September 2011 · Interim Report January – September 2011 Stockholm, 20 October 2011 ... Market Share 0.5% Source: Datamonitor 2010, Schiff et al 2004 and

Portfolio Dominated by Three Lines

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ReFacto 37%

Kineret 21%

Orfadin 16%

Other products 26%

Revenues YTD

Page 18: Interim Report January September 2011 · Interim Report January – September 2011 Stockholm, 20 October 2011 ... Market Share 0.5% Source: Datamonitor 2010, Schiff et al 2004 and

Revenues YTD growth @ CER

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0

100

200

300

400

500

600

Kineret Orfadin ReFacto Other products excl. discontinued

SEK

M

2010 2011 @ CER

+8%

+6%

+29%

+1%

Page 19: Interim Report January September 2011 · Interim Report January – September 2011 Stockholm, 20 October 2011 ... Market Share 0.5% Source: Datamonitor 2010, Schiff et al 2004 and

Kineret Potential in RA Segment (Europe example)

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•Role of Kineret in RA is re-emerging as an option for patients

•We are gaining momentum as we learn more about the appropriate clinical role for Kineret in the rheumatology community

Total RA patients 4.7 million (approx. 1% of population)

Diagnosed patients 3 million (approx. 60% of total)

Treated with biologics 820 000

Eligible Kineret patients 200 000

Current Kineret Market Share

0.5%

Source: Datamonitor 2010, Schiff et al 2004 and Sobi assumptions

Page 20: Interim Report January September 2011 · Interim Report January – September 2011 Stockholm, 20 October 2011 ... Market Share 0.5% Source: Datamonitor 2010, Schiff et al 2004 and

0

25

50

75

100 Q

1-1

0

Q2

-10

Q3

-10

Q4

-10

Q1

-11

Q2

-11

Q3

-11

SEK

M

Orfadin @ CER

Growth Drivers for Orfadin

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•Potential in existing markets as awareness of newborn screening and adolescent compliance increases

•New markets • First commercial sales in Russia

• Working to build our presence in the Middle East region

Page 21: Interim Report January September 2011 · Interim Report January – September 2011 Stockholm, 20 October 2011 ... Market Share 0.5% Source: Datamonitor 2010, Schiff et al 2004 and

Revenues* YTD by region

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Europe 52%

Nordic 8%

North America

36%

RoW 4%

Kineret and Orfadin

* Product sales and Co-promotion

Europe 25%

Nordic 62%

North America

12%

RoW 1%

Other products

Page 22: Interim Report January September 2011 · Interim Report January – September 2011 Stockholm, 20 October 2011 ... Market Share 0.5% Source: Datamonitor 2010, Schiff et al 2004 and

Revenues* YTD growth @ CER

22

0

100

200

300

400

500

Europe Nordic excl. discontinued products

North America RoW

SEK

M

2010 2011 @ CER

+4%

+13% +6%

+5%

* Product sales and Co-promotion

Page 23: Interim Report January September 2011 · Interim Report January – September 2011 Stockholm, 20 October 2011 ... Market Share 0.5% Source: Datamonitor 2010, Schiff et al 2004 and

Research & Development

23

Indication Product/ Project

Partner Phase I Phase II Phase III Reg. phase

Hemophilia A rFVIIIFc Biogen Idec

Hemophilia B rFIXFc Biogen Idec

Prevent growth restriction in premature infants

Kiobrina

Page 24: Interim Report January September 2011 · Interim Report January – September 2011 Stockholm, 20 October 2011 ... Market Share 0.5% Source: Datamonitor 2010, Schiff et al 2004 and

Communications Calendar

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29 November 2011

• Capital Markets Day – Stockholm

9-12 January 2012

• JP Morgan Presentation – San Francisco

23 February 2012

• Q4 Earnings Call – Stockholm

For details please contact: Asa Stenqvist – [email protected]

Page 25: Interim Report January September 2011 · Interim Report January – September 2011 Stockholm, 20 October 2011 ... Market Share 0.5% Source: Datamonitor 2010, Schiff et al 2004 and

Summary

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•Sobi is an integrated, innovative biopharmaceutical company

•We have a unique position in the rare disease space

•Our focus today:

1. Growth – reaching the potential of our key products

2. Profitability – operating efficiency and discipline

3. Building value for our future – executing on our pipeline

Page 26: Interim Report January September 2011 · Interim Report January – September 2011 Stockholm, 20 October 2011 ... Market Share 0.5% Source: Datamonitor 2010, Schiff et al 2004 and

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