Swedish Orphan Biovitrum Ab · OMXSTO:SOBI
Swedish Orphan Biovitrum Ab — Q2 2019 Earnings Presentation
25 slides from Swedish Orphan Biovitrum Ab's earnings presentation, Jul 17, 2019
Slide 1: Sobi Q2 results presentation
Sobi Q2 results presentation 17 July 2019
Slide 2: Forward looking statements
Forward looking statements In order to utilise 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
Slide 3: Presenters
Guido Oelkers, CEO Presenters Henrik Stenqvist, CFO Milan Zdravkovic, Head of R&D and CMO 3
Slide 4: Strong performance, sharper focus
Strong performance, sharper focus • Total revenue of SEK 3,163 M (2,289). 38 per cent revenue growth in the quarter compared with Q2 2018 (32 per cent at CER) • Organic growth (adjusted for Synagis and measured at CER) amounted to 25 per cent compared with Q2 2018 • Adjusted EBITA1,2 was SEK 1,193 M
Slide 5: Business Review
Business Review 5
Slide 6: Haemophilia – strong position with substantial potential
Haemophilia – strong position with substantial potential Continued exceptional momentum - Future growth driven by penetration and internationalisation Individualised therapy only possible with factor replacement - Ensuring best outcome for patients Significant promise now and for the future - Factor
Slide 7: Alprolix – impressive performance continues
Alprolix – impressive performance continues Sales revenue (SEK M) • Q2 product sales of SEK 382 M (263) 500 2 000 • Sales growth of 45 per cent (40 per cent at CER) • Majority of the growth derived from France, Italy 400 1 600 and Germany 300 1 200 • Reimbursed in 23 countries 200 800 • Debate on cl
Slide 8: Elocta – factor replacement therapies keep up momentum
Elocta – factor replacement therapies keep up momentum Sales revenue (SEK M) • Q2 product sales of SEK 1,127 M (794) 1 250 5 000 ▪ Revenue growth of 42 per cent (37 per cent at CER) 1 000 4 000 ▪ Majority of the growth derived from France, Italy and Germany 750 3 000 ▪ Sales positively impacted by o
Slide 9: Single 65 IU/kg dose of BIVV001 extends FVIII half-life to 43 h
Single 65 IU/kg dose of BIVV001 extends FVIII half-life to 43 h and shows 17% activity seven days post-infusion • Mean t1/2 for BIVV001 at a dose of 65 IU/kg was longer than for rFVIII (43 vs 13 h) • Average FVIII activities at 5 and 7 days post 65 IU/kg BIVV001 were 38% and 17% respectively Konkle
Slide 10: Interim results from a prospective study of first-time ITI with Elocta
Interim results from a prospective study of first‐time ITI with Elocta • Immune Tolerance Induction (ITI) is the standard of therapy for eradication of inhibitors Background • Experimental data suggests immunomodulatory effects of Fc-fused factor therapy • Encouraging retrospective clinical data in
Slide 11: Driving growth in Immunology
Driving growth in Immunology Strong base business with Kineret – back to double-digit growth Gamifant – high unmet medical need driving growth Continuously reviewing opportunities for external growth 11
Slide 12: Immunology – strong overall growth
Immunology – strong overall growth Sales revenue (SEK M) • Total Immunology revenue of SEK 773 M 1 500 • Synagis sales impacted by seasonal variations 1 200 • Purchase agreement of CHF 515 M (SEK 4,897 M) for the global rights to emapalumab and 900 related assets was signed 600 • Double-digit growth
Slide 13: Kineret – continued solid growth
Kineret – continued solid growth Sales revenue (SEK M) • Revenue of SEK 419 M (340 M) 500 2 000 ▪ Increase of 23 per cent (16 per cent at CER) compared with Q2 2018 400 1 600 • Double-digit growth seen across all regions 300 1 200 • High demand in the US related to: ▪ Changed distribution channel pr
Slide 14: Synagis opportunity
Synagis opportunity • Q2 sales of SEK 148 M - Sales strongly influenced by seasonal effects - Virus season lasted longer this year - Increased focus on achieving full adherence among patients. - Sales also include one-offs of SEK 81 M • Underlying demand increasing (2.5%) • Ongoing activities to unl
Slide 15: Gamifant – strong US growth
Gamifant – strong US growth • Q2 sales of SEK 205 M • Growth mainly driven by high demand due to unmet medical need • The regulatory dialogue and process ongoing with CHMP in Europe for the potential approval of emapalumab for primary HLH • Based on current estimates and anticipated timelines for qu
Slide 16: Emapalumab clinical trial programme (as of June 2019)
Emapalumab clinical trial programme (as of June 2019) 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 NI-0501-03 Emapalumab Phase 1 in healthy volunteers1 NI-0501-06 Phase 2 MAS/sHLH in sJIA2 NI-0501-04 primary HLH3 NI-0501-05 Long-term follow-up4 Phase 2/3 Phase 3 NI-0501-09 pHLH Bridging st
Slide 17: Emapalumab leads to complete response in patients with secondary HLH (MAS) induced by sJIA
Emapalumab leads to complete response in patients with secondary HLH (MAS) induced by sJIA – interim results from a pilot phase 2 study emapalumab • Complete response to emapalumab was observed in 6 out of 6 patients, all of 6 mg/kg/ 3 mg/kg/ whom had failed conventional therapy every 3 twice • Rapi
Slide 18: Financial Results
Financial Results 18
Slide 19: Financial results
Financial results Total revenue (SEK M) 3 500 Q2 Q2 H1 H1 FY Amounts in SEK M 2019 2018 Change 2019 2018 Change 2018 3 000 Total revenue 3,163 2,289 38% 6,427 4,253 51% 9,139 2 500 Gross profit 2,413 1,677 44% 4,907 3,089 59% 6,723 Gross margin 76% 73% 76% 73% 74% 2 000 EBITA adjusted1 1,193 951 25%
Slide 20: Q2 Adjusted EBITA walk-through
Q2 Adjusted EBITA1 walk-through Total EBITA (SEK M) 736 -377 1 193 -115 -2 951 Q2 2018 EBITA Gross Profit Sales and Research and Other Q2 2019 EBITA Administrative development adjusted 1 expenses expenses This is non-IFRS financial information. For an IFRS income statement, please refer to Consolida
Slide 21: Important events – financial impact
Important events – financial impact Intention to discontinue early research and programmes outside of core areas: • Restructuring costs for the quarter amounted to SEK 175 M, whereof SEK 157 M impacted EBITA and SEK 18 M related to impairment of intangible assets • Expected to generate annual saving
Slide 22: Summary
Summary 22
Slide 23: Key messages
Key messages • Committed to our strategic direction • Develop Immunology and expand within Haematology - Drive Haemophilia penetration - Grow US business and strengthen position in EMENAR - Strengthen late-stage pipeline - Committed to M&A • Updated 2019 guidance: - Sobi expects revenue for the full
Slide 24: Q&A
Q&A 24
Slide 25: Sobi is a trademark of Swedish Orphan Biovitrum AB (publ)
Sobi is a trademark of Swedish Orphan Biovitrum AB (publ). © 2019 Swedish Orphan Biovitrum AB (publ) – All rights reserved Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm • Sweden www.sobi.com
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