Q1 Results 2015
Geoffrey McDonough │ CEO
Alan Raffensperger │ COO
Mats-Olof Wallin │ CFO
Stockholm | 6 May 2015
Highlights Q1 2015
Business
• Extended and restructured distribution
agreement with Exelixis for Cometriq™
• Xiapex® approved by the EU Commission for the
treatment of Peyronie's disease
• Announced positive top-line efficacy and safety
results from phase 3 Alprolix® paediatric study
(Kids B-LONG)
Significant events after the reporting period
• Received orphan drug designation for Elocta™ in
Switzerland
• Positive CHMP opinions for Orfadin® liquid
formulation and 20 mg capsule
2
Highlights Q1 2015
• Total revenues: SEK 865 M (573)
• 39% growth at constant exchange rates
• Product revenues: SEK 633 M (406)
• 40% growth at constant exchange rates
• ReFacto® revenues: SEK 232 (168)
• 36% growth at constant exchange rates
1000
900
Total Revenue
800
700
600
500
• Gross margin 60% (56)
400
Product Revenue
300
• EBITA: SEK 172 M (-288)
• 2014 EBITA SEK 37 M excluding Kiobrina®
ReFacto Revenue
200
100
• Cash flow operations: SEK 169 M
(135)
3
0
13Q1 13Q2 13Q3 13Q4 14Q1 14Q2 14Q3 14Q4 15Q1
Q1 2015 Revenue by Business Line
Early Stage
Development Programmes
Haemophilia
+19%*
SEK 17 M USD 2 M
Inflammation
+37%*
SEK 198 M
USD 24 M
Genetics &
Metabolism
SEK 216 M
USD 26 M
+85%*
Partner Products
SEK 202 M
USD 24 M
+14%*
ReFacto AF
SEK 232 M
USD 28 M
+36%*
*Growth
at Constant Exchange Rates
USD 1 = SEK 8,3365
4
ReFacto AF
Sales (SEK M): ReFacto
250
800
• Revenue from manufacturing and
royalty SEK 232 M (168)
• In constant exchange rates 36%
• Concentration of deliveries in the quarter
• Remaining quarters will be lower than Q1
700
200
600
500
150
400
100
300
200
• Manufacturing revenue
SEK 208 M (142)
50
100
0
0
Q1
Q2
Q3
Q4
2013
Manufacturing
5
Q1
Q2
Q3
2014
Royalty
Q4
Q1
2015
4Q-rolling
• Royalty revenue SEK 25 M (26)
•
Commercial Results Q1 2015
Alan Raffensperger │ COO
Stockholm | 6 May 2015
Kineret®
• Revenue SEK 198 M (124)
Sales (SEK M): Kineret
220
800
200
• In constant exchange rates 37%
• Q1 2014 low due to US wholesaler shift
700
180
600
160
140
• Volume growth across Europe and US
500
120
400
100
300
80
60
200
40
100
20
0
0
Q1
Q2
Q3
Q4
Q1
2013
Q3
2014
Quarterly
7
Q2
4Q-rolling
Q4
Q1
2015
• Shift to specialty distribution model
for the US market underway in
second quarter
Orfadin
• Revenue SEK 180 M (76)
Sales (SEK M): Orfadin
200
700
180
• In constant exchange rates 115%
• Q1 2014 low due to US stock buy-back
600
160
500
140
120
400
100
300
80
60
200
40
100
20
0
0
Q1
Q2
Q3
Q4
Q1
2013
Q2
Q3
2014
Quarterly
8
• Last quarter to reflect impact of
direct sales model in North America
4Q-rolling
Q4
Q1
2015
• Positive CHMP opinions for Orfadin
liquid formulation and 20 mg capsule
Partner Products
• Revenue SEK 202 M (165)
• In constant exchange rates 14%
Sales (SEK M): Partner Products
250
800
700
200
600
500
150
• Sales milestone for Cometriq
SEK 18 M
400
100
300
200
50
100
0
0
Q1
Q2
Q3
Q4
Q1
2013
Q3
2014
Quarterly
9
Q2
4Q-rolling
Q4
Q1
2015
• Preparations for a mid-year launch of
Xiapex for Peyronie’s disease ongoing
Haemophilia
• Revenue of SEK 17 M (11)
Revenues (SEK M): Haemophilia
• Based on 2% royalty of sales for Eloctate® and
Alprolix in Biogen territory
18
16
14
• Elocta approval H2 2015
12
10
8
• EU filing for Alprolix on track for H2
2015
6
4
2
0
Q1
Q2
Q3
Q4
Q1
2014
Milestone Alprolix
10
2015
Alprolix
Eloctate
Financial Results Q1 2015
Mats-Olof Wallin │ CFO
Stockholm | 6 May 2015
Profit and Loss Statement
Amounts in SEK M
Q1-15
Q1-14
FY 2014
Total revenues
865
573
2 607
Gross profit
519
320
1 548
Gross Margin
60%
56%
59%
Sales and Administration
-219
-156
-750
Research and development
-132
-127
-501
4
-325
-341
EBITA
172
-288
-43
Amortizations and write-downs
-71
-70
-282
EBIT
102
-358
-325
-1
5
-14
43
6
51
106
-329
-268
Other operating revenues/expenses
Financial income/expenses
Income tax expense
Profit/loss for the period
• One-time write-down in Q1, 2014 for Kiobrina®, SEK 325 M, with limited cash impact
• One-time accrual in Q4, 2014 for Multiferon®, SEK 25 M, with limited cash impact
12
Balance Sheet
Amounts in SEK M
13
March 2015 March 2014
Dec 2014
ASSETS
Intangible
Tangible and financial
Total non-current assets
Inventories
Accounts receivable
Other Receivable
Cash and equivalent
Total current assets
4 192
189
4 380
765
647
133
682
2 226
4 303
159
4 462
678
377
133
574
1 762
4 248
188
4 436
764
480
172
519
1 935
Total Asset
6 606
6 224
6 371
EQUITY AND LIABILITIES
Equity
4 645
4 443
4 523
Long term debt
Long term liabilities
Short term liabilities
Total liabilities
817
282
862
1 961
794
274
713
1 781
816
285
747
1 848
Total equity and liabilities
6 606
6 224
6 371
Net Debt
50%
• End of quarter cash: SEK 682 M
400
40%
• Net debt SEK 136 M
300
30%
200
20%
100
10%
SEK M
500
Net debt
14
Net debt / Equity
Q1-15
Q4-14
Q3-14
Q2-14
Q1-14
Q4-13
Q3-13
Q2-13
0%
Q1-13
0
Summary and Outlook
Geoffrey McDonough │ CEO
Stockholm | 6 May 2015
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
EBITA
EBITA is expected to be in the range SEK 300 – 400 M1
1The
original outlook presented on 19 February 2015 stated that “Sobi expects EBITA to be in line with the adjusted 2014 level”.
The outlook for 2015 is based on exchange rates as of 19 February 2015, and excludes revenue from the potential European launch of Elocta.
The outlook was first published in the 2014 Q4 and FY report on 19 February 2015.
16
Building Our Future
Continued 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 longacting 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
17
Summary
• Strong performance from the
underlying business
• Q1 unusually strong due to ReFacto
deliveries and Cometriq milestone
• Guidance for 2015 reiterated
• EBITA range specified for clarity
• Elocta launch preparations and
Alprolix filing on track
18