Q4 and FY Results 2014

Transcription

1 Q4 and FY Results 214 Geoffrey McDonough CEO Alan Raffensperger COO Mats-Olof Wallin CFO Stockholm 19 February 215

2 Highlights Q4 214 Business Received positive CHMP opinion for Xiapex for the treatment of Peyronie's disease Exercised opt-in right for Elocta Marketing Authorisation Application for Elocta filed and validated for review by EMA Orfadin approved in Japan Significant events after the reporting period Xiapex approved by EMA for the treatment of Peyronie's disease Agreement with Exilixis regarding Cometriq has been extended to 219 2

3 Highlights Q4 214 Total revenues: SEK 75 M (611) An increase of 15% In constant exchange rates revenues increased 9 % 8 7 Total Revenue Product revenues: SEK 575 M (448) An increase of 28% ReFacto revenues: SEK 13 (163) A decrease of 2% Product Revenue 2 ReFacto Revenue 1 12Q1 12Q2 12Q3 12Q4 13Q1 13Q2 13Q3 13Q4 14Q1 14Q2 14Q3 14Q4 3

4 Highlights Full Year 214 Total revenues: SEK 2,67 M (2,177) An increase of 2% At constant exchange rates 15% 3, 2,5 2,177 2,67 Product revenues: SEK 1,989 M (1,558) An increase of 28% 2, 1,5 1,284 1,548 Gross margin 59 (59) 1, EBITA: SEK -43 M (211) EBITA excluding Kiobrina/Multiferon write-off SEK 37 M (211) Cash flow operations: SEK 234 M (185) End of quarter cash: SEK 519 M YTD-13 YTD-14 Total revenues Gross profit EBITA EBITA excluding Kiobrina/Multiferon write-downs 4

5 Full Year Revenue by Business Line Early Stage Development Programmes Haemophilia SEK 31 M USD 5 M Total revenue FY 214 SEK 2,67 M +3% * Inflammation SEK 69 M USD 89 M Genetics & Metabolism SEK 666 M USD 97 M +4% * +15% * FY 213 SEK 2,177 M Partner Products SEK 682 M USD 99 M ReFacto AF SEK 618 M USD 9 M -1% * +21% * * Growth at Constant Exchange Rates USD 1 = SEK

6 Divided into Four Regional Platforms EMENAR Haemophilia SCPP North America ReFacto Elocta (& Alprolix) Orfadin, Kineret, Kepivance Orfadin, Kineret, Kepivance ReFacto manufacturing ReFacto Royalty Partner Product portfolio Fuel to build a global rare disease company A leading specialty and rare disease platform A robust platform extension/multiplier A robust platform extension/multiplier SEK 31 M USD 5 M SEK 1,47 M USD 25 M 24% * SEK 551 M USD 8 M 3% * SEK 618 M USD 9 M % * Supporting Corporate Functions CEO and Leadership Team, Commercial Operations, Corporate Development, Development & Medical, Drug Design & Development, External Affairs & Patient Access, Finance, Human Resources, Legal Affairs 6 * Year-on-year growth

7 ReFacto AF Sales (SEK M): ReFacto Q4 revenue for manufacturing and royalty SEK 13 M (163) FY revenue SEK 618 M (619) 213 included validation batches of SEK 66 M Q4 manufacturing revenue SEK 99 M (146) Q4 royalty revenue SEK 31 M (16) Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q Manufacturing Royalty ReFacto 4Q-rolling 7

8 Commercial Results Q4 & FY 214 Alan Raffensperger COO Stockholm 19 February 215

9 Kineret Sales (SEK M): Kineret Revenue SEK 163 M (164) FY revenue 69 (562), an increase of 8% US sales in Q4 213 were positively impacted by a change of wholesaler. Growth driven primarily by price in the US and volume in Europe Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q Quarterly Kineret 4Q-rolling 9

10 Orfadin Sales (SEK M): Orfadin Revenue SEK 169 M (91) FY revenue SEK 548 M (366), an increase of 5% Includes SEK 4.8 M milestone payment from Astellas Continued impact of direct sales model in North America Volume growth particularly in Middle East, North Africa and Russia Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q Quarterly Orfadin 4Q-rolling 1

11 Partner Products Sales (SEK M): Partner Products Revenue SEK 198 M (173) FY revenue SEK 682 M (546), an increase of 25% Increase was driven by new partnerships and by growth of the base portfolio 7 product launches in 21 countries Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q Xiapex approval in February 215 for use in Peyronie s Disease enables launch later this year Partner Products Partner Products 4Q-rolling 11

12 Partner Products Annual Growth Trend MSEK Revenue Significant turnaround over past three years CAGR 27% Driven by a combination of portfolio growth and new deals

13 Haemophilia Sales (SEK M): Haemophilia Q4 214 revenue of SEK 12 M () FY was SEK 31 M () SEK 11 M relates to a milestone revenue for the BLA approval of Alprolix in Q Q1 Q2 Q3 Q4 214 Milestone Alprolix Alprolix Eloctate 13

14 Expected Long Acting FVIII EU timeline EU MAA filing Sobi opt-in Sobi Possible EMA approval Elocta launch in EU (Sobi territory) Competitors First potential long-acting FVIII competitors* 14 * Based on publically announced data

15 Haemophilia A in Sobi Territory Size of Market (M) in Sobi Territories* USD 3.3 B SEK 23 B 15 *Source: MRB, 211, includes all patients (mild, moderate, severe)

16 Sobi Launch Team on Track Headcount Anticipated EU Approval Elocta Q4 215 Preparation has been ongoing for two years On track to reach launch readiness in 215 with fully dedicated organisation Sequential build of Market Access, Medical Affairs, and Commercial teams H2 214 H1 215 H2 215 H

17 Financial Results Q4 & FY 214 Mats-Olof Wallin CFO Stockholm 19 February 215

18 Profit and Loss Statement Amounts in SEK M Q4-14 Q4-13 FY 214 FY 213 Total revenues ,67 2,177 Gross profit ,548 1,284 Gross Margin 6% 59% 59% 59% Sales and Administration Research and development Other operating revenues/expenses EBITA Amortisations and write-downs EBIT Financial income/expenses Income tax expense Profit/loss for the period One-time write-down in Q1 for Kiobrina, SEK 325 M, with limited cash impact One-time write-down in Q4 for Multiferon, SEK 25 M, with limited cash impact 18

19 Balance Sheet Amounts in SEK M Dec 214 Dec 213 ASSETS Intangible 4,248 4,637 Tangible and financial Total non-current assets 4,436 4,789 Inventories Accounts receivable Other Receivable Cash and equivalent Total current assets 1,935 1,73 Total Asset 6,371 6,519 EQUITY AND LIABILITIES Equity 4,523 4,769 Long term debt Long term liabilities Short term liabilities Total liabilities 1,848 1,75 Total equity and liabilities 6,371 6,519 19

20 Net Debt 5 5% End of quarter cash: SEK 519 M 4 4% Net debt SEK 298 M SEK M 3 2 3% 2% Significant payments to partner in Q4 XTEN payment Q4, USD 7 M Elocta opt-in Q4, USD 1 M 1 1% Q1-12 Q2-12 Q3-12 Q4-12 Q1-13 Q2-13 Q3-13 Q4-13 Q1-14 Q2-14 Q3-14 Q4-14 % Net debt Net debt / Equity 2

21 Royalty Mechanism Revenues Eloctate/Elocta Programme 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 Presently Starting from Biogen Idec s first commercial sale, Sobi earns 2% royalty on Biogen Idec sales 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. Sobi receives a one-time credit corresponding to 1% royalty on Biogen Idec sales pre-sobi launch (12%-2%). Deducted against opt-in debt (non-cash item). 17% 12% 7% 2% 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 Base rate cross royalty Royalty deducted against opt-in debt Royalty received in cash 21

22 Summary and Outlook Geoffrey McDonough CEO Stockholm 19 February 215

23 Outlook 214 The company exceeded its revenue outlook for 214, which estimated the total revenues for the full year to be in the range of SEK 2,3 to 2,5 M. The gross margin met the range of 58-6 per cent at 59 per cent. The outlook was first published in the 213 Q4 report on 2 February

24 Outlook 215 Revenues Sobi expects total revenues for the full year to be in the range of SEK 2,8 to 3, M Gross Margin Gross margin is expected be in the range of 58-6 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 line with the adjusted 214 level The outlook for 215 is based on current exchange rates, and excludes revenue from the European launch of Elocta. 24 The outlook was first published in the 214 Q4 and FY report on 19 February 215.

25 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 25

26 Building a Leading Rare Disease Company EBITA Short-term Mediumterm Long-term Development Programmes Haemophilia Inflammation Genetics & Metabolism Partner Products Haemophilia Early Programmes ReFacto AF Haemophilia royalties Genetics & Metabolism Inflammation Partner Products ReFacto TIME 26

27 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. 27