Q4 and FY Results 2013

Q4 and FY Results 2013
Geoffrey McDonough │ CEO
Alan Raffensperger │ COO
Mats-Olof Wallin │ CFO
Stockholm | 20 February 2014
Highlights Q4 2013
Business
Financial Q4 2013 (Q4 2012)
• Received approval for Kineret® for
treatment of rare disease CAPS in the EU
• Total revenues: SEK 611 M (472)
• Sobi to take direct responsibility for
Orfadin® in the Americas
• Product revenues: SEK 448 M (356)
• Announced novel complement C5
inhibitor program to enter phase 1
(SOBI002)
• Gross Margin: 59% (57)
• Gained rights to distribute Ravicti® in
Middle East from Hyperion Therapeutics,
Inc.
• EBITA: SEK 65 M (35)
• Awarded Best Biotech Pipeline at World
Orphan Drug Congress
2
• An increase of 29%
• An increase of 26%
• End of quarter cash position: SEK 445 M
• Earnings per share: SEK -0.05 (-0.54)
Consolidated Results Q4
Financial Highlights
700
SEK M
500
• Total Revenues: SEK 611 M (472)
611
600
• an increase of 29%
472
• Gross Margin: 59% (57)
400
300
358
• EBITA: SEK 65 M (35)
267
• Cash Flow from operating activities:
SEK 4 M (157)
200
157
100
65
35
4
0
Q4-12
Total revenues
3
Gross profit
Q4-13
EBITA
Cash flow from operating activities
Consolidated Results Full Year
Financial Highlights
2 500
• Total revenues: SEK 2,177 M (1,923)
2,177
2 000
• an increase of 13%
1,923
• Product revenues: SEK 1,558 M (1,344)
• an increase of 16%
1 500
SEK M
1,284
• Gross Margin: 59% (54)
1,040
• EBITA: SEK 211 M (367)
1 000
500
• Cash Flow from operations:
SEK 185 M (406)
367 406
211 185
0
YTD -12
Total revenues
4
Gross profit
YTD -13
EBITA
Cash flow from operating activities
• Year-end cash position: SEK 445 M
FY Revenue by Business Line
Early Stage
Development Programmes
Haemophilia
+16%
Inﬂammation
SEK 562 M
Neonatology
Genetics &
Metabolism
SEK 450 M
Partner Products
SEK 546 M
ReFacto AF®
SEK 619 M
+9%
5
+29%
+3%
ReFacto®
Sales (SEK M): ReFacto
250
1 000
• Q4 revenue for manufacturing and royalty
was SEK 163 M (116)
• an increase of 40%
200
800
150
600
100
400
50
200
ReFacto Manufacturing
ReFacto 4Q rolling
6
Q4-13
Q3-13
Q2-13
Q1-13
Q4-12
Q3-12
Q2-12
Q1-12
Q4-11
Q3-11
Q2-11
0
Q1-11
0
ReFacto Royalty
• FY revenue: SEK 619 M (566)
• an increase of 9%
• Q4 manufacturing revenue was
SEK 146 M (93)
• Q4 includes validation batches of SEK 43 M
• FY includes validation batches of SEK 66 M
• Q4 royalty revenue was SEK 16 M (23)
Results Q4 2013
Alan Raffensperger │ COO
Stockholm | 20 February 2013
Kineret
• Q4 revenue was SEK 164 M (131)
Sales (SEK million): Kineret
200
600
• an increase of 25%
• FY revenue: SEK 562 M (485)
150
400
• an increase of 16% (CER 19%)
100
• Strong US performance
200
50
• Received EU approval for Kineret for
treatment of rare disease CAPS
2011
2013
Kineret 4Q rolling
Q4-13
Q3-13
Q2-13
Q1-13
Q4-12
Q3-12
2012
Quarterly
8
Q2-12
Q1-12
Q4-11
Q3-11
Q2-11
0
Q1-11
0
Orfadin
• Q4 revenue was SEK 91 M (91)
Sales (SEK M): Orfadin
120
400
350
100
300
80
• an increase of 3% (CER 5%)
250
60
200
• Volume continues to grow in all markets
150
40
100
20
50
• Higher rebates in the US under the
Affordable Care Act
Quarterly
Orfadin 4Q rolling
Q4-13
Q3-13
Q2-13
Q1-13
Q4-12
Q3-12
Q2-12
Q1-12
Q4-11
Q3-11
Q2-11
0
Q1-11
0
9
• FY revenue: SEK 366 M (357)
• Sobi to take direct responsibility for
Orfadin in North America effective 1
April 2014
Partner Products
• Q4 revenue was SEK 173 M (113)
Sales (MSEK): Partner Products
200
600
• an increase of 53%
• FY revenue: SEK 546 M (423)
150
400
• an increase of 29% (CER 31%)
100
200
50
2011
10
2012
Q4-13
Q3-13
Q2-13
Q1-13
Q4-12
Q3-12
Q2-12
Q1-12
Q4-11
Q3-11
Q2-11
0
Q1-11
0
2013
Current portfolio
Co-promotion revenues
Discontinued products
Current portfolio 4Q rolling
• Growth from new products (e.g.
Xiapex®, Cometriq™, Megace®) and base
portfolio (e.g. Yondelis®, Ruconest® and
Defibrotide)
Financials Q4 and FY 2013
Mats-Olof Wallin │ CFO
Stockholm | 20 February 2013
Income Statement
Q4-13
Q4-12
Full year 2013
Full year 2012
611
472
2,177
1,923
Gross profit
Gross Margin
358
59%
267
57%
1,284
59%
1,040
54%
Sales and Administration
-192
-130
-621
-540
Research and development
-102
-99
-456
-402
2
-1
3
305
65
38
211
404
–
-3
–
-37
65
34
211
367
-70
-227
-278
-422
Financial income/expenses
Income tax expense
-5
-6
-3
-193
-17
67
-67
-57
31
-55
-51
4
Profit/loss for the period
-13
-143
-93
-101
Amounts in SEK M
Total revenues
Other operating revenues/expenses
Adjusted EBITA
Non-recurring items
EBITA
Amortizations and write-downs
EBIT
12
Balance Sheet
Dec
Dec
Amounts in SEK M
2013
2012
ASSETS
Intangible
Tangible and financial
4 637
152
4 533
130
Total non-current assets
4 789
4 663
Inventories
Accounts recievable
Other Receivable
Cash and equivalent
726
415
145
445
700
343
143
457
Total current assets
1 730
1 643
Total Asset
6 519
6 307
4 769
4 838
796
307
647
588
372
509
Total liabilities
1 750
1 469
Total equity and liabilities
6 519
6 307
EQUITY AND LIABILITIES
Equity
Long term debt
Long term liabilities
Short term liabilities
13
Cash Flow and Net Debt
500
50%
400
40%
300
30%
200
20%
100
10%
300
SEK M
SEK M
200
100
0
Cash flow from operations
14
Q4-13
Q3-13
Q2-13
Q1-13
Q4-12
Q3-12
Q2-12
Q1-12
-100
Change in working capital
Net debt
Net debt / Equity
Q4-13
Q3-13
Q2-13
Q1-13
Q4-12
Q3-12
Q2-12
0%
Q1-12
0
Summary and Outlook
Geoffrey McDonough │ CEO
Stockholm | 20 February 2013
Two Years Ago
16
Today
2011: Adjusted EBITA SEK -21 M
• 2 500
Non-recurring SEK 78 M
(restructuring)
• Multiferon SEK -149 M
2 000
2012: Adjusted EBITA SEK 97 M
• Non-recurring SEK 37 M (Arexis)
• Co-promotion Pfizer SEK -307 M
1 000
2 177
900
1 923
1 911
800
700
1 500
600
M SEK
GM 59%
500
1 000
GM 54%
GM 51%
400
300
367
500
211
100
50
0
0
2011
2012
Total revenues
17
200
Gross profit
2013
EBITA
Adjusted EBITA
Planned Key Events* 2014 -- 2016
Sobi’s Key Milestones
Kineret
Orfadin
NOMID approval US
NOMID launch US
CAPS approval EU
1 European launch
CAPS
Kepivance
Filling of liquid
formulation in US
and EU
1 Assume direct
Orfadin sales in NA
Factor VIII
Kiobrina
SOBI002
Phase I
Phase I
Phase I
Phase I
1
Phase I begins
Phase II
Phase II
Phase II
Phase II
2
Phase I data
Phase III
Phase III
Phase III
1 US launch
1 US launch
1 Results of
European phase III
trial
2 EMA filing + opt-in
2 EMA filing + opt-in
2 Beginning US
Phase III trial
3 European approval
3 European approval
1 Discussion with
FDA on possible
label expansion for
Head/Neck CA
2 Decision on
approval of liquid
formulation in EU
Factor IX
3 Decision on
approval of liquid
formulation in US
3 File for EU
approval
4 European launch
Sobi’s Milestones by Timeline
Completed
2014
1
1
1
1
1
2
1
2015
1
2
3
*Timing within years is illustrative – no event sequence is implied.
18
2
3
3
2
2016
4
2
3
Strategic Priorities
1.
Near-term focus on growth in key
therapeutic areas, with sustainable
positive cash flow from operations.
We are here
2.
Medium-term investments to ensure
successful commercialization of our
late-stage pipeline.
3.
Long-term growth will come
organically and through acquisitions in
key therapeutic areas.
19
Outlook 2014
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 three phase 3 pipeline projects.
The outlook was first published in the 2013 Q4 report on 20 February 2014.
20
Summary
1. Diversified commercial portfolio
focused on improving cash flow
and profitability
2. Working to efficiently commercialize
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
21

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