Swedish Orphan Biovitrum Ab · OMXSTO:SOBI
Swedish Orphan Biovitrum Ab — Investor Day (December 2020)
80 slides from Swedish Orphan Biovitrum Ab's investor day presentation, Dec 10, 2020
Slide 1: Sobi Capital Markets Day 2020
Sobi Capital Markets Day 2020 10 December 2020
Slide 2: Welcome
Paula Treutiger Welcome Head of Communications and Investor Relations 2
Slide 3: 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 4: Today's presenters
Today’s presenters Guido Oelkers Henrik Stenqvist CEO CFO Ravi Rao Norbert Oppitz Head of R&D and Head of Immunology CMO and International 4
Slide 5: Today's agenda
Today’s agenda Strategy and realising opportunities Guido Oelkers 13:05 Innovation management at Sobi Ravi Rao 13:30 Break 14:30 Internationalisation strategy Norbert Oppitz 14:45 Financial update Henrik Stenqvist 15:00 Wrap up and Q&A Guido Oelkers 15:15 5
Slide 6: Strategy and realising opportunities
Strategy and realising Guido Oelkers opportunities CEO 6
Slide 7: Five years ago, Sobi looked very different
Five years ago, Sobi looked very different Business largely characterised by in-licensing/ Revenue 2016 distributor agreements Significant dependence on an emerging haemophilia portfolio Pipeline with no big bets in rather early-stage R&D SEK 48% Haemophilia Europe-centric approach without significa
Slide 8: We have accomplished much in the past four years
We have accomplished much in the past four years SEK B Organic growth Inorganic growth Revenue EBITA EBITA % 2016 5 x2.7 1.5 x3.8 30% 2020E 75% 25% 15-15.5 5.7-6.2 39% ~75% of growth is organic1 1. Inorganic growth defined as FY 2018 revenue for Synagis (USD 287M) and Doptelet (USD 10M) Source: Sobi
Slide 9: Committed to a continuous upgrade of our sustainability agenda
Committed to a continuous upgrade of our sustainability agenda Sustainability strategy Commitment to patients Responsible behavior • Our R&D is ethical and focused on medical • We have no tolerance for corruption Commitment need • We are transparent to Agenda • We expand access to treatment 2030 and
Slide 10: In 2017, we set out our strategy to build a regional leader in rare disease
In 2017, we set out our strategy to build a regional leader in rare disease – a strategy on which we have forcefully delivered 1. 2. 3. 4. Drive Develop Grow US business Strengthen Haemophilia Immunology and strengthen late-stage pipeline penetration position in EMENAR Source: Sobi Annual Report 201
Slide 11: 1. We have made a significant impact in the haemophilia market
1. We have made a significant impact in the haemophilia market #1 Ranked leader in haemophilia From 2023 by healthcare professionals3 22% 35% we advance our leadership through BIVV001 as new normal Prophylaxis patient market Prophylaxis patient market #1 in community share1 share2 and scientific eng
Slide 12: 2. Immunology: strong performance since establishment in 2016
2. Immunology: strong performance since establishment in 2016 Immunology revenue share Driven by three major products Immunology Other 19% 2016 Performing well under Growing strongly at Established biology our ownership 27% YTD leading us into new fields 81% Revenue, SEK M Revenue, SEK M 1,781 1,493
Slide 13: 3. US business now a powerful platform for future growth
3. US business now a powerful platform for future growth Revenue by geography, SEK B US Non-US Background 2016 2020E Over the past five years, we have increased our footprint in the US to 9.7-10.0 ~35% of total sales 5.3-5.5 Key drivers for increasing importance 4.3 of US business were acquisitions
Slide 14: 4. Capturing substantial value from our late-stage pipeline
4. Capturing substantial value from our late-stage pipeline1 Phase 2 Phase 3 In registration Gamifant / emapalumab Gamifant / emapalumab Gamifant / emapalumab Secondary HLH malignancy Secondary HLH rheumatology Primary HLH (RoW) Gamifant / emapalumab SEL-212 / pegadricase3 Kineret / anakinra GvHD Ch
Slide 15: M&A continues to be a key driver for our transformation
M&A continues to be a key driver for our transformation 2018 2019 2020 Novimmune AstraZeneca Dova Sanofi Selecta Apellis Gamifant Synagis Doptelet BIVV001 SEL-212 Systemic (NI-1701/ nirsevimab/ (opt-in) pegcetacoplan NI-1801) MEDI8897 BIVV001 is developed and, if approved, will be commercialised in
Slide 16: How we will grow beyond today's core
How we will grow beyond today’s core 2 Deliver on our late-stage 3 Go global pipeline and launch (20-30% of growth) New (60-70% of growth) • China • 12 late-stage programs • Japan • Develop Gamifant beyond pHLH • Russia • Make Doptelet TPO-RA of choice • Australia, South Korea Portfolio • Long-term
Slide 17: For the coming five years, our new ambition is '25 by 25'
For the coming five years, our new ambition is ‘25 by 25’ Revenue Go global1 Capture value of pipeline2 Grow the core3 in SEK B 25±2 3 10 6 15-15.5 10 16 5 2016 17 18 19 20 2025 1. Growth from core and pipeline in international markets 2. Growth from pipeline in current markets 3. Growth from core i
Slide 18: 1. Committed to develop Elocta in a challenging environment
1. Committed to develop Elocta in a challenging environment YTD product sales1 Opportunities SEK M Headwinds • New launches, such as 4,000 • Increasing competition Russia, opportunity of 3,514 from new EHLs and NFT SEK 500 million 3,274 • Price pressure as a result 3,000 • Penetration upside in of i
Slide 19: 1. Creating material growth from a strong trajectory and clear differentiation
1. Creating material growth from a strong trajectory and clear differentiation US TPO-RA1 market Sobi's market share in the US Doptelet is a small molecule USD B Adult ITP only thrombopoietin receptor agonist used to treat thrombo- cytopenia in ITP2 and CLD3 +19% +350% 1.4 6.3% As a cost-effective o
Slide 20: 2. Developing Gamifant: a strong trajectory into the future
2. Developing Gamifant: a strong trajectory into the future Development of Gamifant over time, in thousands of mg HLH HSCT 126 +61% 78 Move to the next Maximise in pHLH Expand into sHLH frontier: GF & GvHD Expand Develop sHLH from Develop GF with geographically rHLH and mHLH to companion Drive disea
Slide 21: 2. We opted in early for BIVV001
2. We opted in early1 for BIVV001 – to drive our leadership in haemophilia into the future Improving patient QoL through Overcoming current limitations Extending half-life by factor of 3-4 once-weekly dosing in haemophilia treatments Illustrative BIVV001 used as 130% monotherapy, whereas NFT require
Slide 22: 2. SEL-212 gives us a substantial opportunity in immunology
2. SEL-212 gives us a substantial opportunity in immunology SEL-212’s unique value proposition Patient population US (2030) Reduced immunogenicity Diagnosed prevalent gout patients ~6.7M Sustained efficacy Refractory gout patients ~200K Greater reduction in SUA levels Chronic ~190K Better control in
Slide 23: 2. The partnership with Apellis expanded our late-stage pipeline
2. The partnership with Apellis is a great example of how we have expanded our late-stage pipeline with multiple opportunities C3 has a central role in the complement cascade Indications Patient opportunity ex-US (Sobi territory) PNH ~9,000-11,000 pegcetacoplan CAD ~7,000-9,000 HSCT-TMA ~8,000-10,00
Slide 24: 2. Estimated peak sales of our portfolio
2. Estimated peak sales of our portfolio Estimated peak sales1, SEK B 5-12 8-10 7 4-5 4-5 3-5 3-4 ~3 5 Indications Haemophilia A+B ITP pHLH HSCT-TMA Chronic RSV RA CLD sHLH ALS refractory prevention CAPS Graft failure CAD gout Still’s GvHD PNH NOMID IC-MPGN & C3G BIVV0012 pegceta- SEL-2123 coplan ME
Slide 25: 2. Capturing substantial value from our late-stage pipeline
2. Capturing substantial value from our late-stage pipeline Examples of indications (illustrative) x Cumulated number of planned launches in key geographies avatrombopag, ITP avatrombopag, CLD 32 5 19 27 Graph illustrative pegcetacoplan2, PNH pegcetacoplan2, CAD pegcetacoplan2, IC-MPGN / C3G pegceta
Slide 26: 3. We are building the next geographic growth platforms
3. We are building the next geographic growth platforms Sobi core markets Russia Sobi extended markets Fully fledged organisation set up Sobi future markets Orfadin launched Elocta approved Japan Management team successfully Sobi currently has ramped up sales of SEK Australia ~800M outside China Pla
Slide 27: In summary: transitioning Sobi from a regional to a global leader
In summary: we are now transitioning Sobi from a regional to a global leader in rare disease Grow Lead in Immunology Haematology Capture the Go global value of our pipeline 27
Slide 28: Innovation management at Sobi
Innovation Ravi Rao management Head of R&D and CMO at Sobi 28
Slide 29: Building on Sobi's rare strength so we can transform patients' lives
Building on Sobi’s rare strength so we can transform patients’ lives Innovative and differentiated medicines • Medicines with novel mechanisms of action: first in class or best in disease • Enabling a step change in therapy for unmet medical need At the intersection of haematology and immunology • L
Slide 30: We currently have 6 products in development, with 12 programs
We currently have 6 products in development, with 12 programs1 Phase 2 Phase 3 in Registration Gamifant / emapalumab Gamifant / emapalumab Gamifant / emapalumab Secondary HLH malignancy Secondary HLH rheumatology Primary HLH RoW Gamifant / emapalumab SEL-212 / pegadricase3 Kineret / anakinra GvHD Ch
Slide 31: Six innovative and differentiated medicines
Six innovative and differentiated medicines to adress patient need across the spectrum of haematology and immunology Lead in haematology Overlap between haematology Grow in immunology and immunology pegcet- SEL-212 BIVV001 acoplan MEDI8897 Bioengineered Convenient oral First-in-class First-in-class
Slide 32: BIVV001 is designed for more normal FVIII levels in HA
BIVV001 BIVV001 is designed for more normal FVIII levels in HA Mode of Action • Built on Fc fusion technology with added • von Willebrand factor domains SEL 212 • XTEN1 polypeptides • To result in high and sustained factor levels in circulation MEDI 8897 Designed profile First product with once week
Slide 33: BIVV001 has the potential to normalise FVIII levels
BIVV001 has the potential to normalise FVIII levels Normalisation of factor VIII levels Disease Background: • Haemophilia A is a genetic deficiency in 50 IU/kg rFVIII (n=28)1 50 IU/kg BIVV001 (n=9)2,3 clotting factor VIII • Results in extensive bleeds, joint damage, low QoL 130 130 Differentiation:
Slide 34: Two major phase 3 studies underway - BIVV001
Two major phase 3 studies underway - BIVV001 expected to be submitted in US in 2022 Study timeline Key design aspects Expected launch1 Phase 3 in 2019 2020 2021 2022 2023 Arms: Multi-centre, open-label, 2023 Haemophilia A adults & non-randomized 2-arm (prophylaxis adolescents and on-demand); previou
Slide 35: Doptelet could be a best-in-class treatment for CLD and ITP
BIVV001 Doptelet could be a best-in-class treatment for CLD and ITP Mode of Action • Second-generation small-molecule thrombopoietin receptor agonist (TPO- RA) stimulating platelet production SEL-212 • Stimulates proliferation and differentiation of megakaryocytes from bone marrow progenitor cells r
Slide 36: Doptelet can increase platelet numbers to reduce need for transfusions
Doptelet can increase platelet numbers to significantly reduce need for platelet transfusions Disease background: Median platelet counts during trial2 • Low levels of blood platelets can cause spontaneous Titration Concomitant ITP Med Reduction Maintenance bleeding avatrombopag Placebo • Thrombocyto
Slide 37: Focus on ongoing lifecycle studies for Doptelet
We have finished the majority of the development with focus on ongoing lifecycle studies Study timeline Key design aspects Expected launch Early use 2019 2020 2021 2022 2023 2024 Arms: Pbo – 2:1 randomization with 6- 2021 ITP study adults month duration of treatment ITP Primary endpoint: Continuous
Slide 38: SEL-212 is a novel combination product candidate for chronic refractory gout
BIVV001 SEL-212 is a novel combination product candidate to improve treatment of chronic refractory gout ImmTOR™1 has the potential to enable sustained therapeutic activity of biologic therapies and unlock their potential SEL-212: ImmTOR™ co- administered with pegadricase Mode of Action ImmTOR™ • Im
Slide 39: Phase 2 results show potential for greater reduction of SUA
Phase 2 results show potential for COMPARE trial results (SEL-212 vs pegloticase)1 greater reduction of SUA Patients with <6 mg/dl SUA for at least 80% of the evaluation time Disease Background: • Chronic gout: serum uric acid levels remain elevated and SEL-212 pegloticase p-value flares continue de
Slide 40: Patients with tophi have higher responder rates for SEL-212
Patients with tophi have significantly higher responder rates for SEL-212 as compared to pegloticase based on phase 2 data Chronic refractory gout patients Study results for tophi patients1 >70% have visible tophi US (2030) Treatment response rates2 Serum Uric Acid (SUA) percent reduction3 (PP, mont
Slide 41: Two phase 3 studies on SEL-212 launched this year
Two phase 3 studies on SEL-212 have been launched this year Study timeline Key design aspects Expected launch Dissolve 1 2020 2021 2022 2023 Arms: Randomized 1:1:1 to receive 2023 Chronic Refractory either one of two SEL-212 dose Gout Study 1 N= 105 levels or placebo every 28 days for 6 months 08/20
Slide 42: About Synagis and MEDI8897
BIVV001 About Synagis and MEDI8897 • The 2018 acquisition from AstraZeneca included rights to Synagis® (palivizumab) in the US as well as rights to participate in 50 per cent of the future earnings of MEDI SEL-212 8897 the candidate drug MEDI8897 in the US • Synagis is a medicine for the prevention
Slide 43: Gamifant targets and neutralises IFNγ
BIVV001 Gamifant is the only treatment to target and neutralise IFNγ – a major proinflammatory cytokine Mode of action IL-1β IL-1R IL-18 IL-18R • Monoclonal antibody to neutralise SEL-212 Disease progression IFNγ IL-33/ST2 interferon gamma (IFNγ) Vesicular protein • Aberrant IFNγ expression is assoc
Slide 44: pHLH is a life-threatening disease caused by genetic mutations
pHLH is a life-threatening disease NI-0501-04 Study: response at wk 8 (end of treatment)2 Percent of patients caused by genetic mutations Patients with inadequate response to therapy (N= 27) 80 63.0 60 40 26.0 30.0 Disease Background1: 20 7.0 • Caused by multiple genetic mutations, 0 Overall Complet
Slide 45: Expanding emapalumab in HLH and beyond
We are expanding emapalumab in HLH and beyond into diseases of high unmet need Expected launch 2021-2022 pHLH 2023 sHLH Move to the next frontier: Maximize pHLH Expand into sHLH GF and GvHD post-HSCT 2024 GvHD Expand geographically Development of secondary Precision medicine: Development Continue to
Slide 46: Many cases of HLH lie on a spectrum between sHLH and pHLH
Many cases of HLH lie on a spectrum between sHLH and pHLH We are gaining a deeper understanding of the impact of unknown genetic mutations and infectious triggers in the pathogenesis of HLH Infection, Rheumatologic, Malignancy Genetic mutation “Primary” HLH “Secondary” HLH Known Genetic Unknown Gene
Slide 47: Emapalumab could be a breakthrough treatment for rheumatologic HLH
Emapalumab could be a break- Study NI-0501-06 MAS in SJIA/AOSD • Gamifant started on day 0: through treatment for - 14/14 patients had a clinical response rheumatologic HLH - Improvement in multiple lab parameters CXCL9 (pg/ml) AST (IU/L) Disease Background: 5e+04 5000 • Severe, potentially fatal co
Slide 48: Extensive development plan for sHLH
We are carrying out an extensive development plan for sHLH Timeline Key design aspects rHLH 2019 2020 2021 2022 2023 2024 Pilot Arms: Single-arm, open label N= 14 FDA meeting Endpoints: MAS remission, duration of response Data for US Data for ROW Pivotal Arms: Single-arm, open label, observational r
Slide 49: Development of emapalumab for graft failure to start in Q1 2021
Development of emapalumab for graft failure to start in Q1 2021 Disease Background: • Primary GF: lack of engraftment of donor cells Three possible complications following HSCT could be treated with emapalumab following Hematopoietic stem cell transplantation (HSCT); high mortality 1.Primary GF (pGF
Slide 50: Collaboration with bioMérieux to develop a Companion Diagnostic
Collaboration with bioMérieux to Increased serum levels of IFNγ and CXCL9 are predictors of graft failure develop a Companion Diagnostic • As early as day 3 post-transplantation, patients developing GF had elevated serum CXCL9 • Serum CXCL9 appears to be an early biomarker for the Research collabora
Slide 51: Enabling development of emapalumab in GvHD to start in 2021
Enabling development of emapa- lumab in GvHD to start in 2021 CXCL9 levels at d28 post transplant are predictive of 1 year cumulative incidence of aGvHD Disease Background: • GvHD is a potentially serious complication of allogeneic HSCT • Donor T cells attack the host which leads to multi-organ dama
Slide 52: Development program for GvHD with expected launch in 2024
Development program for GvHD to start in 2021 with expected launch in 2024 Timeline Key design aspects Companion 2020 2021 2022 2023 2024 2025 2026 2027 Diagnostic Deliver investigational use only device ready for clinical VIDAS validation prior to phase 3 GvHD 2020 2021 2022 2023 2024 2025 2026 202
Slide 53: Anakinra & emapalumab in COVID-19 CSS
Anakinra & emapalumab have the potential to address key pathways in COVID-19 CSS1 Immuno-101 POC study of anakinra or emapalumab vs. SOC has been stopped Ongoing clinical trial activity with anakinra: • 18+ ongoing or planned RCT studies of anakinra in moderate-severe disease • 10 studies supported
Slide 54: Pegcetacoplan is a targeted C3 therapy
BIVV001 Pegcetacoplan is a targeted C3 therapy – it is therefore modulating a key component of the complement system Proximal complement Mode of Action Classical Lectin Alternative Initiation pathway pathway pathway • Investigational, targeted C3 therapy designed to SEL-212 regulate excessive comple
Slide 55: The complement system underlies many diseases
The complement system underlies many diseases; in addition to PNH, 3 others are part of the initial focus for pegcetacoplan Neurology Pegcetacoplan PNS/CNS focus indications AD, MS, NMO, gMG, GBS, Parkinson's Disease, Schizophrenia ALS EYE MOUTH AMD, Uveitis, Glaucoma Periodontitis HEART LUNGS Asthm
Slide 56: PNH: Superior improvement in Hb compared to eculizumab
Paroxysmal Nocturnal Haemoglobinuria (PNH): Superior improvement in Hb compared to eculizumab1 Disease Background (PNH): • Acquired, rare, chronic, life-threatening blood PEGASUS Study vs eculizumab: Week 16 disorder associated with abnormally low hemo- Change from baseline hemoglobin in patients wi
Slide 57: Highly targeted treatment in Cold Agglutinin Disease
Highly targeted treatment in Cold Agglutinin Disease (CAD) Interim Results: PLAUDIT Study, a phase 2 study n=24 Disease Background: Rapid, sustained, and durable increase in • Chronic and severe red blood disorder driven hemoglobin in response to pegcetacoplan by extravascular hemolysis (IgM) CAD he
Slide 58: One of the first targeted therapies in HSCT-associated TMA
One of the first targeted therapies in HSCT-associated Thrombotic Microangiopathy (TMA) C3b (ng/mL) Disease Background: Mean Median 455 394 • HSCT-TMA is a rare inflammatory and +/-224 (300-519) thrombotic condition characterized by hemolytic anemia, thrombocytopenia, and evidence of multiorgan dama
Slide 59: First line treatment in IC-MPGN and C3 Glomerulopathy
First line treatment in IC-MPGN and C3 Glomerulopathy1 Disease Background: • Rare kidney diseases caused by excessive complement activation that can lead to kidney failure DISCOVERY Study: Week 48* • C3G is associated with a need for recurrent Baseline Week 48 transplant in as many as 85% Mean (SE)
Slide 60: Potentially registrational phase 2 study design laid out for ALS
Potentially registrational phase 2 study design laid out for ALS1 Disease Background: Potentially Registrational Phase 2 Study Design • Neurodegenerative disease that results in CAFS primary endpoint progressive muscle weakness and paralysis due readout to the death of nerve cells in the brain and s
Slide 61: Clinical development program to launch pegcetacoplan in 5 indications by 2024
Our clinical development program is on the way to launch pegcetacoplan in 5 indications by 2024 Sobi leads development Category Disease Phase 2 Phase 3 Expected launch 2021 PNH Haematology PNH CAD Initiate phase 3 study in 2021 HSCT-TMA Initiate phase 2 study in 2021 Nephrology IC-MPGN / C3G Initiat
Slide 62: Capturing substantial value from our late-stage pipeline
Capturing substantial value from our late-stage pipeline Examples of indications (illustrative) x Cumulated number of planned launches in key geographies avatrombopag, ITP avatrombopag, CLD 32 5 19 27 Graph illustrative pegcetacoplan2, PNH pegcetacoplan2, CAD pegcetacoplan2, IC-MPGN / C3G pegcetacop
Slide 63: Building our rare strength in R&D
4 Centers of excellence with ~250 team members • deepening experience of haematology and immunology Building our rare strength in R&D Stockholm A portfolio across a broad range of rare haematologic and immunologic diseases Innovative and differentiated medicines Basel Asset development in multiple i
Slide 64: Internationalisation Strategy
Internationalisation Norbert Oppitz Strategy 64
Slide 65: The rare disease market represents opportunities outside Europe and US
The rare disease market represents compelling opportunities outside Europe and US Key facts Rare disease market, USD B Strong double-digit International Europe US X CAGR market growth for rare 7,000+ diseases outside current More than 7,000 designated Sobi core territories rare diseases exist 223 >2
Slide 66: Our Mission 2025 goal is to go global
Our Mission 2025 goal is to go global and make our products available to twice as many patients as today 2017-2020 Mission 2025 Becoming a regional leader Global leader in in rare disease rare disease Establish US as a second pillar next to Presence established in key markets China, Europe Japan, Ru
Slide 67: We have already expanded our market presence outside Europe and the US
We have already expanded our market presence outside Europe and the US Sobi core markets Sobi extended markets Sobi future markets Russia Fully fledged Sobi has already organisation set up established presence Orfadin launched in Middle East, Russia Elocta approved and China Current sales of SEK ~80
Slide 68: International will ramp up value with a high cadence of launches
International will ramp up value with a high cadence of launches Examples of indications (illustrative) eloctate, HA 18+ nitisinone, HT-1 Graph illustrative emapalumab, pHLH emapalumab, sHLH Potential launches emapalumab, GvHD in international avatrombopag, ITP regions1 by 2025 avatrombopag, CLD peg
Slide 69: Example: China – fast-tracking emapalumab and nitisinone
Example: China – we are fast-tracking to enable patients to access emapalumab and nitisinone in 2022 HLH patients in China HT-1 patients in China Legal entity established 660 5.600 720 360 GM with 530 20+ years of 410 experience 130 + pHLH 4.500 <6y >6y Medical sHLH support 2020 2030 2020 2030 2020
Slide 70: Example: Japan – en route to introduce four products
Example: Japan – en route to introduce emapalumab, anakinra, avatrombopag and pegcetacoplan Patient pools by indication 2019 2030 Launch year emapalumab anakinra avatrombopag pegcetacoplan Total 870 1,024 Total 7,005 7,910 Total 14,000 17,297 Total 185 228 Well-established markets already 2023 AOSD
Slide 71: By 2025, International is expected to contribute 15% of revenue
By 2025, International is expected to contribute 15% of Sobi's revenue Sobi core markets Sobi extended markets Sobi future markets Revenue in SEK B +40% p.a. >4 0.8 International revenue 2020 2025 Share ~5% ~15% of total revenue Source: Sobi 71
Slide 72: Financial update
Henrik Stenqvist Financial update CFO 72
Slide 73: Operational performance 2016–2020 has generated strong revenue, EBITA and cash flow
Operational performance in 2016 – 2020 has generated strong revenue, EBITA and cash flow Total Revenue, SEK B Haematology Achieved continued growth in Haemophilia Specialty Care Immunology Haematology x Adj. EBITA Realised successful launch of Doptelet 15.0-15.5 Immunology 14.2 Impact from Synagis a
Slide 74: Sobi is in a new stage as a company
Sobi is in a new stage as a company Mission 2025 Global leader in rare disease Competitive situation within Haemophilia We now have a significant pipeline of late-stage assets to be brought to approval Commercial success will be driven by realizing the potential of launches on a global scale We will
Slide 75: Bringing assets to approval and realising commercial potential globally
Bringing assets to approval and realising commercial potential on a global scale R&D spend – pipeline of late-stage assets to SG&A spend – realising the potential of launches on be brought to approval a global scale • Moving forward in 2021-2022, will • Continued investments in Doptelet and Gamifant
Slide 76: Growth acceleration from 2023 onwards
Growth acceleration from 2023 onwards 2023 – 2025: 2021 – 2022: • Continuous potential double-digit revenue growth • Single-digit revenue growth • Mid-term revenue aspiration of 25B SEK by 2025 • Investment into the future related • EBITA margin acceleration to R&D, launches and internationalisation
Slide 77: Continued strong cash flow will support growth through M&A
A continued strong cash flow will support growth through M&A Net debt, SEK B 20 Continued strong cash generation with seasonality -2.7B driven by Synagis Net debt / EBITDA will likely be 10 below 3 in short-term Ability to lever up to 3-4x range 0 Q1 2019 Q2 2019 Q3 2019 Q4 2019 Q1 2020 Q2 2020 Q3 2
Slide 78: Focus M+A in strategic areas – derisk where possible
Focus M+A in strategic areas – derisk where possible Majority of obligations relate to Example actions to de-risk commercial milestones Pegceta- Limited upfront payment; future payments contingent Regulatory coplan on R&D and commercial success 30% Limited upfront payment; future payments contingent
Slide 79: Wrap-up and Q&A
Guido Oelkers Wrap-up and Q&A CEO 79
Slide 80: Conclusion
Conclusion Proven track record - since 2016 we have created a strong foundation with regard to revenue, EBITA and cash flow, whilst building the organisation and our pipeline Next phase requires investment into development, pre-launch and launches of our pipeline to propel mid- to long-term growth O
Swedish Orphan Biovitrum AB (Sobi) — Investor Day (December 2020) on 6ix