Annual General Meeting 2018

Transcription

1 Annual General Meeting May 2018 Guido Oelkers

2 Forward looking statements In order to utilize the Safe Harbor provisions of the United States Private Securities Litigation Reform Act of 1995, Swedish Orphan Biovitrum AB (publ) 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 AB (publ), By their nature, forward-looking statements and forecasts involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future, There are a number of factors that could cause actual results and developments to differ materially from that expressed or implied by these forward-looking statements, These factors include, among other things, the loss or expiration of patents, marketing exclusivity or trade marks; exchange rate fluctuations; the risk that R&D will not yield new products that achieve commercial success; the impact of competition, price controls and price reductions; taxation risks; the risk of substantial product liability claims; the impact of any failure by third parties to supply materials or services; the risk of delay to new product launches; the difficulties of obtaining and maintaining governmental approvals for products; the risk of failure to observe ongoing regulatory oversight; the risk that new products do not perform as we expect; and the risk of environmental liabilities. 1

3 Our strategic direction Further internationalisation and commercialisation of Haemophilia Build Specialty Care as the preferred partner Strengthen position in the US and EMENAR Build pipeline and self-sustained R&D Vision To be recognised as a global leader in providing innovative treatments that transform lives for individuals with rare diseases 2

4 New leadership Central functions Business Science/Medical FREDRIK WETTERLUNDH HENRIK STENKVIST HENRIK STENKVIST As of May 16, 2018

5 The orphan market has been very attractive and will likely continue to be so The orphan drug market has grown at 10+% p.a.

6 Sustainability factors important to Sobi Material issues Value creation Improving global access to treatments for rare care diseases Quality and supply chain management Strategic research and development Compliance and ethics Regulatory and legal environment Developing our people Ethical practices and collaborations Responsibility Environmental impact Patient and customer integrity Responsible tax Anti-corruption Anti-competitive practices 5

7 Our value creation

8 Share development May 2018 SEK All-time high 30 April, closing at Swedish Orphan Biovitrum OMX Stockholm Pharmaceuticals & Biotechnology PI OMX Stockholm PI Nasdaq Biotech Index 7

9 Financial highlights FY 2017 Total Revenue (SEK M) FY 2017 FY 2016 Change Revenue (SEK M) 6,511 5, % Gross margin 72% 70% EBITA (SEK M) 2,053 1, % 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q Cash flow from operations (SEK M) 1, % Revenues One-time credits 8

10 Financial highlights Q Total Revenue (SEK M) Q Q Change Revenue (SEK M) 1,964 1, % Gross margin 72% 74% EBITA (SEK M) % 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q Cash flow from operations (SEK M) % Revenues One-time credits 9

11 Haemophilia growth based on innovation Safety established in thousands of patients Unique use of Fc fusion technology in haemophilia utilising a natural pathway in the body Provides opportunities for individualised treatment For all age groups, in prophylaxis, on-demand and surgery Mode of action a natural way of replacing factor Evidence shows improved joint health Prophylactic treatment with Elocta demonstrates improved joint health 10

12 Haemophilia delivering stellar growth FY 2017 revenue SEK 3,682 M (2,509) SEK 1,920 M (327) in sales revenue SEK 1,202 M (1,613) in royalty revenue SEK 559 M in manufacturing revenue (569) Increase of SEK 1,881 M when one-time credits in 2016 are excluded Sales Revenues (SEK M): Haemophilia 1,400 1,200 1, Q revenue of SEK 1,222 M (698) SEK 801 M (300) in product sales revenue SEK 301 M (277) in royalty revenue ReFacto royalty for the US ceased 1 Feb 2018 SEK 120 M (121) in manufacturing revenue Starting from 2018, the ReFacto manufacturing business will be included in the Haemophilia business area Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q Sales Royalty Manufacturing One-time items 11

13 Elocta becoming the standard of care Sales Revenues FY 2017 (SEK M): Elocta Reimbursed in 24 countries (Q1 2018) IE PT ES UK FR NL BE NO DK DE CH IT SE PO CZ SK AT HU SL HR FI GR FI EE LV RO BG Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Algeria Saudi Arabia Kuwait UAE Quarterly Reimbursement granted Pricing & reimbursement decision-making in process

14 Effective commercialisation of Elocta SUCCESFULL NEGOTIATIONS in tender markets, e.g UK, RoI, Saudi Arabia LEADING POSTITION in key markets, e.g France COST COST EFFECTIVENESS EFFECTIVENESS recognised recognised by by payers payers FAST LAUNCH SEQUNCE beating benchmarks by 5 months EVIDENCE GENERATION Inhibitor patients enrolled in the ReITIrate study

15 Alprolix first EHL for haemophilia B in France Sales Revenues FY 2017 (SEK M): Alprolix Reimbursed in 16 countries (Q1 2018) IE PT ES FI NO SE DK UK NL PO DE BE CZ SK AT FR CH HU SL RO IT BG GR 50 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Algeria Saudi Arabia Kuwait UAE Quarterly Reimbursement granted Pricing & reimbursement decision-making in process

16 Commitment to the global haemophilia community Supporting leadership programmes, youth fellowship, and new technologies workshops in collaboration with the European Haemophilia Consortium (EHC) To provide predictable, sustainable access to people with haemophilia in developing healthcare systems Regular donations through WFH Emergency aid through Direct Relief One billion international units over ten years* *Donation programme started in July 2015

17 Reaching patients in 40 countries Donation statistics July 2015 to December 2017 By year-end 2017, Sobi and Bioverativ had donated 262 million IUs of Elocta and Alprolix enabling the treatment of 15,000+ people in 40 countries by addressing 79,400 bleeds and almost 1,500 surgical procedures 16

18 Specialty Care core strengths World-class commercialisation platform Lifecycle management & indication expansion Partner product portfolio with expansion possibilities 17

19 Specialty Care strong business platform for continued growth FY 2017 revenue SEK 2,829 M (2,695) +5% Revenues (SEK M): Specialty Care Double-digit growth for Kineret and Orfadin 1,000 4, ,000 Q revenue of SEK 742M (698) An increase of 6 per cent (9 per cent at CER) 500 2,000 Growth driven by Kineret and Orfadin Ravicti launched in major European markets 250 1,000 Solid growth for Xiapex An increase of 4 per cent 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q Quarterly 4Q-rolling 18

20 Orfadin increased market share for new formulations FY 2017 revenue SEK 862 M (770) +12% Double digit growth in North America and EMENAR Q revenue SEK 224 M (216) increase of 4 per cent (7 per cent at CER) Growth across EMENAR and North America driven by the new formulations No impact from generics realised Revenues (SEK M): Orfadin , Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q Quarterly 4Q-rolling 19

21 Kineret double digit growth driven by continued investment in development FY 2017 revenue SEK 1,142 M (1,001) +14% Strong double digit value and volume growth in both North America and EMENAR Q revenue SEK 297 M (277) increase of 7 per cent (12 per cent at CER) Revenues (SEK M): Kineret ,600 1, Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q Quarterly 4Q-rolling 20

22 Supply chain security and sustainability We distribute to 60 countries world wide Serialisation project to ensure that products are not falsified Sobi has implemented due diligenceprocesses to reduce the risk for corruption and bribery

23 SPECIALTY CARE HAEMOPHILIA A rare disease pipeline with increasing value Therapeutic area/indication Product/Project Pre-clinical Phase 1 Phase 2 Phase 3 Phase 4 Haemophilia A Elocta/A-SPIRE Haemophilia A Elocta/PUP A Haemophilia A Haemophilia A Haemophilia A Haemophilia A Haemophilia A and B Haemophilia B Haemophilia B Haemophilia B Acute gout Still s disease Alkaptonuria MPS IIIA Anti-C5 XTEN*/BIVV001 Elocta/ASURE Elocta/reITIrate Elocta/verITI8 EIocta/ Alprolix/PREVENT Alprolix/B-YOND Alprolix/PUP B XTEN*/BIVV002 Kineret/anaGO Kineret/anaSTILLs Orfadin/SONIA2 SOBI003 SOBI Anti-IL-1 SOBI006 * XTEN are Bioverativ development program, Sobi has elected to add programs to the collaboration agreement but not yet opted-in

24 Relative levels (% vs. Placebo) Pipeline progress 23 FPI in phase 2 study anago to evaluate anakinra for the treatment of acute gout Kineret approved in the EU for the treatment of Still s disease FPI in the phase 3 anastill s study evaluating anakinra for the treatment of Still s disease in the US Fast Track status and IND for SOBI003 for the treatment of MPS IIIA. FPI expected in H FPI in the phase 4 reitirate study to evaluate ITI with Elocta FPI in the phase 1 BIVV001/XTEN for haemophilia A Dose dependent reduction of tetrasaccharide storage in the brain of MPS IIIA mice following treatment with SOBI Placebo Distinct intracellular SOBI003 fluorescence (Green) indicates uptake into lysosomes in nerve cells in the CNS. SOBI003 treated MPS IIIA mice Increasing SOBI003 dose Untreated Healthy mice 20µm

25 Compliance with GDPR Data privacy framework and organisation established Training / awareness Conduct inventory of processing

26 Our strategic direction Further internationalisation and commercialisation of Haemophilia Build Specialty Care as the preferred partner Strengthen position in the US and EMENAR Vision To be recognised as a global leader in providing innovative treatments that transform lives for individuals with rare diseases Build pipeline and self-sustained R&D 25

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