Swedish Orphan Biovitrum AB · OMXSTO:SOBI
Swedish Orphan Biovitrum AB — Q1 2011 Earnings Presentation
24 slides from Swedish Orphan Biovitrum AB's earnings presentation, Apr 20, 2011
Slide 1: Interim Report First Quarter 2011
Interim Report First Quarter 2011 Stockholm April 20, 2011
Slide 2: Summary of Q1 2011
Summary of Q1 2011 • Good volume growth, revenues up 10% and 17% adjusted for currency • Negative impact from FX and full effect of price cuts in 2010 • Increased number of product price approvals • Continued efforts to strengthen Sobi long-term -Decision on cost savings -Increased business developm
Slide 3: Q1 Report, January – March 2011 – Lars Sandström, CFO
Q1 Report, January – March 2011 Lars Sandström, CFO 3
Slide 4: Highlights Q1 2011
Highlights Q1 2011 600 SEKm • Revenues up 10% as reported, and 17% adjusted for FX 500 -Higher revenues from ReFacto 400 • Product sales +4%, adjusted for FX and discontinued products 300 • Gross margin declined to 52.8% (64.1) 200 • Lower administrative and R&D expenses 100 • EBITA before non-recur
Slide 5: Revenues trend
Revenues trend Total revenues Q1 2010 – Q1 2011 600 Comments 500 • High Manufacturing volumes 400 • Product sales excl currency and discontinued products +4% 300 • Milestone last year 200 • Negative currency effects 100 0 Q1 2010 Q2 2010 Q3 2010 Q4 2010 Q1 2011 Product revenues Other revenues 5
Slide 6: EBITA trend Q1 2010 – Q1 2011
EBITA trend Q1 2010 – Q1 2011 250 50% Comments 45% • EBITA before non recurring items MSEK 200 40% 35% 59,7 (55,1) 150 30% • EBITA Margin 11,1 % (11,3%) 25% 100 20% 15% 50 10% 5% 0 0% Q1 Q2 Q3 Q4 Q1 2010 2010 2010 2010 2011 SEK M. % 6
Slide 7: Gross profit
Gross profit Deliveries of Refacto • Gross profit MSEK Royalties 283,9 vs. 313,1 Underlying product volumes Milstone last year • Gross margin Manufacturing prices 52,8% vs 64,1% Tech transfer Currency 7
Slide 8: EBITA
EBITA Refacto volume • EBITA Q1 2011: Cost containment +4,6 mSEK • EBITA margin 11,1% (11,3) Milstone last year Manufacturing prices Tech transfer Currency 8
Slide 9: Cash Flow before financing (excl Acq)
Cash Flow before financing (excl Acq) Q1 2010 – Q1 2011 50 Comments • Cash flow before financing (excl 0 acquisitions) -26,4 mSEK (-32,9) -50 -100 • Net investments -150 • 4,5 mSEK (20,3) -200 -250 • Working Capital -300 • -75,3 mSEK (-74,1) Q1 2010 Q2 2010 Q3 2010 Q4 2010 Q1 2011 Cash flow incl op
Slide 10: Working Capital impact on Cash Flow
Working Capital impact on Cash Flow Q1 2010 – Q1 2011 0 Comments -50 • Working Capital • -75,3 mSEK (-74,1) -100 • Kineret inventory build up and payment -150 • Q1-11 -200 • Stock reduction -250 • High Refacto revenues -300 • Last payments of Kineret Q1 2010 Q2 2010 Q3 2010 Q4 2010 Q1 2011 Change in
Slide 11: Net debt Q1 2010 – Q1 2011
Net debt Q1 2010 – Q1 2011 1 400 30% Comments 1 200 25% • Net debt SEK 1 174 m 1 000 20% 800 15% 600 10% • Net debt to equity 27% 400 200 5% 0 0% Q1 Q2 Q3 Q4 Q1 2010 2010 2010 2010 2011 SEK M. Net debt / EQ 11
Slide 12: Rights issue terms
Rights issue terms Offering type • Fully underwritten rights issue of common shares Size • Gross proceeds of SEK 600 million Envisaged timetable • Rights issue announced: 29 March • Q1 report: changed from 28 April to 20 April • Rights issue terms announced: 27 April • AGM decision on proposed trans
Slide 13: Q1 Report, January – March 2011 – Kennet Rooth, CEO
Q1 Report, January – March 2011 Kennet Rooth , CEO 13
Slide 14: Markets - Europe
Markets -Europe • 60 pricing cases in Europe, prices established in 32 cases since November 2010 • Kineret - strong volume growth in most countries, but reported sales growth hampered by strong SEK and mandatory price decreases in 2010 • Parallel export primarily from UK Parallell import primarily t
Slide 15: Markets – USA and RoW
Markets – USA and RoW Contract organization and distribution partner In North America • Strong development in North America + 15% in spite of the weak USD • Growth in volume for all products in USA • Low orders from Middle East during Q1 Distribution partner in Australia and New Zeeland Distribution
Slide 16: Revenues
Revenues • No further price reductions in Q1. Willfact Other • Product launches progress as Yondelis planned in most countries Ammonaps ReFacto • Orfadin - number of packs sold show Orfadin strong increase – but less 10 mg packages than expected • Yondelis - strong monthly volume Kepivance Kineret g
Slide 17: Operations
Operations ReFacto® Kineret® • High delivery volumes • Transfer of production ongoing • Validation batches • Stock build up 2010 of active substance to be turned to finished goods • Increased full year volume Cost reduction measures • Most of the planned reduction of staff reversed due to manufactur
Slide 18: Cost-reduction measures
Cost-reduction measures Provision of SEK 70 M in the quarter • Reduction of 55-60 positions instead of 70 -Affecting all functions -Mostly within preclinical research, CMC and manufacturing,Quality/Control/Assurance • Cost savings estimated at approx. SEK 90 M instead of SEK 100 M • Full effect as o
Slide 19: Research & Development
Research & Development Indication Product/Project Partner Phase I Phase II Phase III Reg phase Hemophilia A rFVIIIFc BiogenIdec Hemophilia B rFIXFc BiogenIdec Prevent growth retardation in premature infants Kiobrina® CAPS Kineret® Pernicious anemia Nascobal® Strativa Activity Expected timing Kiobrin
Slide 20: R&D Projects
R&D Projects • Long acting F IXfc – pivotal phase II/III registration study – According to plan – Fully recruited 2011 – Data available 2012 • Long acting F VIIIfc – pivotal phase II/III registration study – According to plan – Fully recruited 2011 – Data available 2012 20
Slide 21: R&D Projects
R&D Projects • Kiobrina – Two phase II studies successfully completed – Pivotal phase III study decided to start – First prematurely born child planned to be included into the study Q2 2011 • Nascobal – Small study for EU regulatory purpose ongoing – First regulatory filing planned H2, 2011 • Produc
Slide 22: Business Development
Business Development Products Geographies • Priority 1 • BD function significantly strengthened – Asia (New business, primarily China, • Several products being evaluated in Japan) parallell – Middle East (expansion) • Priority 2 – South/Middle America (Brazil, Argentina, Chile, Mexico) • Temporary s
Slide 23: Outlook 2011
Outlook 2011 • Continued uncertainty about the macroeconomy and exchange rates • No major impact from further price changes foreseen • Good volume growth and 1-5 % sales growth as reported • Increased manufacturing and shipments of Refacto during 2011 • Gross margin lower than 2010 • Continued focus
Slide 24: Disclaimer
DISCLAIMER 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,
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