Swedish Orphan Biovitrum AB (publ)€¦ · Market Cap: SEK 29.7 Billion ($3.6 Billion USD) Share:...
Transcript of 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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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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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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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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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:
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USD 1 = SEK 8.25 (26 June 2015)
67%
17%
9%
4% 3%
Sweden
US
UK
Luxemburg
Switzerland
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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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A Diverse, Growing BusinessUnderpinned by Strong Brands
Early StageDevelopment Programmes
Inflammation Genetics &
Metabolism
Partner Products
ReFacto AF®
Haemophilia
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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
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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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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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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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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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Operating Portfolio Momentum
Development Programmes
Inflammation Genetics &
Metabolism
Partner Products
ReFacto AF®
Haemophilia
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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
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Partner Products Annual Growth Trend
MSEK
423
546
682
0
100
200
300
400
500
600
700
800
2012 2013 2014
Revenue
CAGR27%
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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
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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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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
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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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The Share – 1 January 2014 to 26 June 2015
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SEK 111.20
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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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Fc Fusion TechnologyLong-acting Clotting Factors
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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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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
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USD 1 = SEK 8.25 (26 June 2015)
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Fewer than 100 Haemophilia Reference Centres
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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
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Expected Long Acting rFVIIIFc & rFIXFc EU timeline
* Based on publically announced data
26
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
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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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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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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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