sobi update and perspective - jefferies group · we leverage our world-class capabilities in...
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Geoffrey McDonough │ CEO
Sobi – Update and PerspectiveJefferies Healthcare Conference
London| 19 November 2014
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.
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.
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)
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
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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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
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
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
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Operating Portfolio Momentum
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
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
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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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®
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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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
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
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
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
Fewer than 100 Haemophilia Reference Centres
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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
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
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
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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