Bonesupport Holding Ab · OMXSTO:BONEX
Bonesupport Holding Ab — Investor Day (September 2022)
79 slides from Bonesupport Holding Ab's investor day presentation, Sep 1, 2022
Slide 1: BONESUPPORT Capital Market Day
BONESUPPORT Capital Market Day September 1st, 2022 Introduction Emil Billback, CEO
Slide 2: Agenda
Agenda 14.00 Introduction Emil Billbäck, CEO Clinician Evidence 14.15 Clinical overview put into context Dr Michael Diefenbeck, Chief Medical Officer, EVP clinical affairs 14.35 CERAMENT in clinical practice Prof. Anand Pillai 15.00 Q&A 15.15 Break 15.30 CERAMENT G Launch US Mike Roth, General Manag
Slide 3: Recap on the BONESUPPORT journey -2022
Recap on the BONESUPPORT journey -2022 • Origin − Invented in Lund, Sweden, by orthopedic clinicians seeking a solution to a well-known problem − Unique technology, mimicking natural healing, through bi-phasic remodeling − Addition of antibiotic (2013) created a market disruptive breakthrough soluti
Slide 4: Eight consecutive all-time-high, strong traction in both regions
Eight consecutive all-time-high, strong traction in both regions LTM Quarterly Sales per Segment 275,0 275,0 257 250,0 250,0 234 225,0 213 225,0 205 197 200,0 200,0 180 181 Transition in U.S. 173 175,0 166165 175,0 distributor 155 Net Sales SEK m structure 150,0 150,0 132 129 128 132 126 119 125,0 1
Slide 5: EUROPE – rapid market share gains in early-stage market entries
EUROPE – rapid market share gains in early-stage market entries Top EU5 total: 335 k Direct markets: 000 procedures/ year CERAMENT total market share : 4% UK 70 (procedures) Germany 80 Nordics 25 CERAMENT (G/V) Market share local antibiotics: 8% 175 (procedures) Market penetration with proven model:
Slide 6: BONESUPPORT Strategy
BONESUPPORT Strategy Commercial platform Clinical and Health Clinician Innovation Evidence Evidence Economic evidence interactions • 3 levels of innovation: • Over 160 peer-to-peer • Market access − Tactical reviewed clinical publications o Ancillary offerings to support • Medical education CERAMENT
Slide 7: Clinical overview
BONESUPPORT Capital Market Day September 1st, 2022 Clinical overview Michael Diefenbeck, Chief Medical Officer
Slide 8: Introduction: Michael Diefenbeck
Introduction: Michael Diefenbeck, MD, PhD Orthopaedic Surgeon Chief Medical Officer, BONESUPPORT AB since April 2017 EVP Clinical and Medical Affairs since Jul 2018 Honorary Consultant, Nuffield Orthopaedic Centre, Oxford University Hospitals, NHS in 2016 Founder of “Scientific Consulting in Orthope
Slide 9: Strong clinical evidence for CERAMENT builds strong foundation
Strong clinical evidence for CERAMENT builds strong foundation 1 27 13 11 Case RCT 2 series Cohort Case studies 5 report Animal Cell Model 181 Material cultures Science Abstracts Reference: Clinical Evaluation Reports 2021
Slide 10: CERTiFy further strengthens CERAMENT's clinical evidence
CERTiFy further strengthens CERAMENT’s clinical evidence 1 9 5 11 Case RCT 2 series Cohort Case studies 5 report Animal Cell Model 181 Material cultures Science Abstracts Reference: Clinical Evaluation Reports 2021 Basic evidence for C BVF or CG or combination of both
Slide 11: CERTiFy paves the way for CERAMENT BONE VOID FILLER
CERTiFy paves the way for CERAMENT BONE VOID FILLER Design: Randomized Clinical Trial Outcome: Patients: 135 (18 to 65 Y) Primary: SF-12 Physical Component Summary at 26 weeks Indication: Tibia plateau fractures Co-primary: Pain level at 26 weeks Treatment: Autologous Iliac Bone Graft vs. CERAMENT B
Slide 12: CERTiFy paves the way for CERAMENT BONE VOID FILLER
CERTiFy paves the way for CERAMENT BONE VOID FILLER Design: Randomized Clinical Trial Outcome: Patients: 135 (18 to 65 Y) Primary: SF-12 Physical Component Summary at 26 weeks Indication: Tibia plateau fractures Co-primary: Pain level at 26 weeks Treatment: Autologous Iliac Bone Graft vs. CERAMENT B
Slide 13: CERTiFy paves the way for CERAMENT BONE VOID FILLER
CERTiFy paves the way for CERAMENT BONE VOID FILLER Hofmann A, Gorbulev S, Guehring T, et al. Autologous Iliac Bone Graft Compared with Biphasic Hydroxyapatite and Calcium Sulfate Cement for the Treatment of Bone Defects in Tibial Plateau Fractures: A Prospective, Randomized, Open-Label, Multicenter
Slide 14: Solid clinical evidence for CERAMENT G
Solid clinical evidence for CERAMENT G 17 4 11 Case 2 series Cohort Case studies 5 report Animal Cell Model 181 Material cultures Science Abstracts Reference: Clinical Evaluation Reports 2021 Basic evidence for C BVF or CG or combination of both
Slide 15: Solid clinical evidence for CERAMENT G
Solid clinical evidence for CERAMENT G 17 4 Fracture related Infection 11 Case Diabetic Foot Osteomyelitis 2 series Cohort Case studies 5 report Animal Trauma - Open Fracture Cell Model 181 Material cultures Science Abstracts Other indications Reference: Clinical Evaluation Reports 2021 Basic eviden
Slide 16: Fracture-related Infection
Fracture-related Infection Fracture related infection In 2018 the Fracture Related Infection Consensus Group (an international group of experts) published a consensus definition: Confirmatory Criteria Infection related to a previous internal fixation that is Clinical Signs confirmed by at least one
Slide 17: Key clinical evidence for CERAMENT G - Fracture-related Infection
Key clinical evidence for CERAMENT G - Fracture-related Infection Fracture related infection Design: Prospective case series Prospective case series Patients: 52 patients, mean age 53 years [range 22-81] 35 patients, mean age 56 years [range 37-75] Treatment: Surgical debridement, application of CER
Slide 18: Diabetic Foot Osteomyelitis a hard-to-treat indication
Diabetic Foot Osteomyelitis a hard-to-treat indication Diabetic Foot Osteomyelitis Diabetic Foot Osteomyelitis (DFO) is mostly a consequence of a soft tissue infection (e. g. Diabetic foot ulcer) that spreads into the bone, first involving the cortex and then the marrow The typical sequence is usual
Slide 19: Strong clinical evidence in Diabetic Foot Osteomyelitis
Strong clinical evidence in Diabetic Foot Osteomyelitis Diabetic Foot Osteomyelitis Design: Retrospective case series Retrospective case series Patients: 70 patients mean age 68 years [range 22-88] 48 patients, mean age 55 years [range 34-83] Treatment: Debridement and Dead Space Management with Deb
Slide 20: Trauma: Open Fracture
Trauma: Open Fracture Trauma - Open Fracture • Open fracture is a fracture with an open wound or break in the skin near the site of the broken bone • Most often caused by a fragment of bone breaking through the skin at the moment of injury • Once the skin is broken, bacteria from dirt and other cont
Slide 21: Strong clinical evidence in open fracture
Strong clinical evidence in open fracture Trauma - Open Fracture Design: Prospective case series Prospective case series Patients: 51 patients, mean age 40.9 years [range 11-90] 80 patients, mean age 41.28 years [range 10-96] Treatment: One stage protocol including debridement, One stage protocol in
Slide 22: US market approval based on very extensive clinical data
US market approval based on very extensive clinical data • Clinical data was collected mainly at the Bone Infection Unit, Nuffield Orthopaedic Centre, Oxford University Hospitals, NHS, UK. • A total of 16950 clinical data points submitted. • Treatment group bone infection etiology: Trauma (Fracture-
Slide 23: Strong and convincing clinical evidence in key indications
Strong and convincing clinical evidence in key indications for management and prophylaxis of bone infection 1 ▪ Only BGS with proven bone remodelling 27 ▪ Only BGS with convincing clinical evidence for safety and efficacy in bone infections 13 ▪ First cleared gentamicin-eluting BGS in the USA 11 Cas
Slide 24: § BONESUPPORT
§ BONESUPPORT
Slide 25: CERAMENT Clinical Experience
BONESUPPORT Capital Market Day September 1st 2022 CERAMENT® Clinical Experience Prof Anand Pillai Manchester University Hospitals
Slide 26: Scenario 1 Fracture Related Infections (FRI)
Scenario 1 Fracture Related Infections (FRI)
Slide 27: Red dot
Red dot Horizontal beam
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Slide 29: HB LATERAL @)
HB LATERAL @) RED DOT
Slide 30: «S BONESUPPORT
«S BONESUPPORT
Slide 31: «S BONESUPPORT
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Slide 32: CROSS-TABLE ©)
CROSS-TABLE ©)
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Slide 34: «S BONESUPPORT
«S BONESUPPORT
Slide 35: INESUPPORT
INESUPPORT
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Slide 37: Ǥ BONESUPPORT
Ǥ BONESUPPORT
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Slide 40: Scenario 2 Diabetic Foot Osteomyelitis (DFO)
Scenario 2 Diabetic Foot Osteomyelitis (DFO)
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Slide 42: «f BONESUPPOR
«f BONESUPPOR
Slide 43: 30NESUPPORT
30NESUPPORT
Slide 44: «S BONESUPPORT
«S BONESUPPORT
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Slide 46: Ǥ BONESUPPORT
Ǥ BONESUPPORT
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Slide 49: Scenario 3 Open Fractures
Ǥ BONESUPPORT Scenario 3 Open Fractures (Contents lists available at ScenceDirec CObntents lists available at ScenceDirect Journal of Orthopaedics E Doers OB Orthopaedics journal homepage: www elsevier.com ELSEVIER journal homepage: www.elsevier.com/locate/jor Original Article The use of adjuvant l
Slide 50: «S BONESUPPORT
«S BONESUPPORT
Slide 51: NES
NES S|
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Slide 53: «S BONESUPPORT
«S BONESUPPORT
Slide 54: «S BONESUPPORT
«S BONESUPPORT
Slide 55: Ǥ BONESUPPORT
Ǥ BONESUPPORT
Slide 56: Ǥ BONESUPPORT
Ǥ BONESUPPORT
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Slide 59: Ǥ BONESUPPORT
Ǥ BONESUPPORT
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Slide 61: Ǥ BONESUPPORT
Ǥ BONESUPPORT
Slide 62: Ǥ BONESUPPORT
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Slide 63: CERAMENT Clinical Experience
BONESUPPORT Capital Market Day September 1st, 2022 CERAMENT® Clinical Experience Prof Anand Pillai Manchester University Hospitals
Slide 64: CERAMENT G launch US
BONESUPPORT Capital Market Day September 1st, 2022 CERAMENT G launch US Mike Roth, General Manager & Executive Vice President North America
Slide 65: Strong sales team ready to expand
Strong sales team ready to expand U.S. Commercial Organization GM & EVP Distribution Partner VP Sales VP Marketing Finance Operations Clinical 12 Direct Region Team of 1 + OrthoPediatrics Team of 4 Team of 2 Team of 3 Managers Global Non-exclusive Distribution for CERAMENT BONE VOID FILLER 40+ Distr
Slide 66: CERAMENT G expected to accelerate strong underlying growth
CERAMENT G expected to accelerate strong underlying growth • Strong sales growth in USA since independence (Q4 2018), despite negative impact from COVID 2022 June 2022 Growth vs LTM Growth vs LTM • Strong sales momentum June 2021 June 2019 • High Gross Margin (93.5%) Sales LTM 87.2 mSEK 40% 216% • S
Slide 67: US bone graft market
US bone graft market: 360 k surgical procedures per year in the US with bone grafts used to manage bone injuries CERAMENT G Approval 50 • 48% fracture/ trauma etiology2 for infected cases Infected. Treated with local antibiotics • All current use of bone grafts + local antibiotics in the US, are 220
Slide 68: CERAMENT G fills an obvious unmet market need
CERAMENT G fills an obvious unmet market need R E I N F E C T I O N R AT E 1. The Problem: Bone infections are difficult to treat 1. Patients are complex On average 24% of US bone 2. Lack of innovation in treatment options 24% infection cases result in 3. High reinfection rates, low patient QOL rein
Slide 69: Focused sales strategy securing success
Focused sales strategy securing success • Quality not quantity – High volume users based on data • Secure early adopters and success with CERAMENT G ➢ Identify & qualify surgeon champions ➢ Drive local hospital approvals ➢ Focus on Customer Care/onboarding ➢ Gather product/clinical feedback • Target
Slide 70: Accelerated market access secures future growth
Accelerated market access secures future growth National Account Status Reimbursement Status • Weighted (5mL and 10mL) price of CERAMENT G ~ $5,600 USD • Limited discounting 5% - 15% • Currently bone grafts fall under DRG (bundled pay.) Premier On Contract • 2,501 hospital members • CERAMENT G award
Slide 71: US Booster Program accelerates market access
US Booster Program accelerates market access Push Develop Invest in resources that help Add resources to support the generate US sales growths > 50% increase in anticipated sales Anticipated Impact ➢ Drive aggressive market penetration with NTAP and GPO listing (Healthtrust and Premier) ➢ Full year
Slide 72: Key hirings further develops the business
Key hirings further develops the business Push Develop ➢ US Medical Advisor(s) ✓ Customer Service Rep to help support • Orthopedic surgeon(s) as “Head of incremental increase in volume clinical and medical affairs US” ✓ Financial Controller to assist with sales ➢Interacting with KOLs reports to supp
Slide 73: Poised to expand…
Poised to expand… • Well oiled organization • Strong and growing customer base • Approvals granted and in motion • Reimbursement in place • Booster Program in place
Slide 74: THANK YOU
BONESUPPORT Capital Market Day September 1st, 2022 THANK YOU
Slide 75: Future outlook and market guidance
Future outlook and market guidance
Slide 76: Significant growth vector in favorable post-pandemic environment
Significant growth vector in favorable post-pandemic environment 2018 2019 2020 2021 2022 2023 2024 2025 2026 Segment NA US New Distribution platform Segment EUROW Improved sales efficiency (Scaling on FTE investments) COVID head wind COVID Back-log tail wind 100 k proc EU Hybrid markets US Booster
Slide 77: First and only of its kind - CERAMENT G US
First and only of its kind - CERAMENT G US Superiority of CERAMENT G shown in peer-reviewed clinical studies US Market penetration rate with CERAMENT BVF since late 2018 CERAMENT G being only product on the market NTAP of 4920 kUSD for Medicaid patients Market insight/ market research GPO presence G
Slide 78: Guidance message
Guidance message 40%1 sales growth for the next three years (2023-2025) 1. Average and normalized sales growth CAGR from 2023 – 2025
Slide 79: Strong financial position and outlook
Strong financial position and outlook Sales growth and profitability + Efficient use of funds = Strong cash flow • Leverage from sales growth • Low level of Net Working Capital • Substantial headroom in funding • Improved gross margin • 1 bn SEK in tax losses carried forward • Cash at end of Q2-22 w