Bonesupport Holding Ab · OMXSTO:BONEX
Bonesupport Holding Ab — Q4 2017 Earnings Presentation
25 slides from Bonesupport Holding Ab's earnings presentation, Feb 20, 2018
Slide 1: Q4 Conference Call Presentation
Q4 Conference Call Presentation 20 February 2018
Slide 2: Presenting Team
Presenting Team RICHARD DAVIES BJÖRN WESTBERG CEO CFO 2
Slide 3: Disclaimer
Disclaimer This presentation, which includes all information and data on the following slides, any oral statements made when presenting these slides, and any other material distributed or statements made at, or in connection with, such presentation (the “Presentation”), relates to BONESUPPORT HOLDIN
Slide 4: Innovative, rapidly growing orthobiologics company
Innovative, rapidly growing orthobiologics company BONESUPPORT – an innovative company focused on developing and commercializing products for the management of bone voids • Commercializing 3 synthetic bone grafts - clinically proven to remodel to host bone • CERAMENT G and V clear differentiation -
Slide 5: Q4 Highlights
Q4 Highlights • Net sales of SEK 27.0 million – decrease of 9% – Strong sales growth in EU and RoW – up 39% to SEK 14.5 million – driven by continued success with antibiotic-eluting products and pick-up in other product sales – Slowdown in North America – Sales decline of 35% – driven by Zimmer Biom
Slide 6: Post-period events
Post-period events • Newly in-licensed CERAMENT based carrier reported to deliver bone active agents to enhance bone formation in prestigious publication – Journal of Controlled Release • Outstanding Kreos loan repaid – EUR 9.5 million • Emil Billbäck appointed as CEO, effective 1 March 2018 6
Slide 7: Bone void management – a sizeable growth market
Bone void management – a sizeable growth market Market Opportunity % US Procedures (2) Further growth for BONESUPPORT will be achieved by Current addressable • Gaining share of market: the synthetic bone EU-5 +US: ~ 650k graft substitute % EU Procedures (2) market driven by procedures p.a. our antib
Slide 8: Our value-generating strategy
Our value-generating strategy • Driving sales of currently approved products in existing markets – Generating further supportive clinical data to drive the adoption of our CERAMENT products for broader range of indications including trauma and revision arthroplasty – Generating compelling HEOR data
Slide 9: Our Commercial Activities
} BONESUBPORT’ Our Commerc ial Activities
Slide 10: Europe
Europe Growing CERAMENT G,V and BVF sales in Europe Our commercial footprint Our activities • European commercial organization • Continue to focus on driving adoption at the top comprises 20 people including the trauma centers in our key European markets leadership team • Black Forest Expert Meeting
Slide 11: CERAMENT BVF sales in the US
US CERAMENT BVF sales in the US Our commercial footprint Our activities • BONESUPPORT US Commercial Team • Sales impacted by Zimmer Biomet hardware drive sales via Zimmer Biomet supply issues and some destocking in Q4 • 2 Area Sales VPs • CERAMENT BVF used in conjunction with Zimmer hardware • 8 Reg
Slide 12: Clinical update
} BONESUBPORT’ Clinical update
Slide 13: Ongoing and Planned Clinical Studies
Ongoing and Planned Clinical Studies POST-MARKETING STUDIES Feasibility1/ Initiated study FPI1/ LPI1/ Publication CERTiFy (DE) – BVF Revision Arthroplasty (IT) – G&V Diabetic Foot (IT) – G Osteomyelitis (FR) – G Regulatory REGULATORY STUDY Feasibility1/ Initiated study FPI1/ LPI1/ Filing FORTIFY (US
Slide 14: Ongoing post-marketing clinical studies
Ongoing post-marketing clinical studies CERTiFy study Italian-Revision Arthroplasty Study • Controlled study investigating the use of • First patient recruited in study evaluating CERAMENT™ BVF in tibial plateau fractures CERAMENT G/V in patients undergoing hip and • CERTiFy enrollment complete – 13
Slide 15: Recruitment on track in FORTIFY study to support approval of CERAMENT G in US
Recruitment on track in FORTIFY study to support approval of CERAMENT G in US FORTIFY trial timeline 2017 2019 2020 2020 Final module FORTIFY submission to FDA First patient enrolled FORTIFY follow- completes for CERAMENT™ G in the FORTIFY study up completed enrollment PMA submission, incl. IDE data
Slide 16: Approval of CERAMENT G in the US Would Create a Significant Commercial Opportunity
Approval of CERAMENT G in the US Would Create a Significant Commercial Opportunity Important large market with no comparable product – bone infections dramatically affect hospital profitability Dr. McKee - Chairman of the Department of Orthopaedic Surgery at the University of Arizona College of Medi
Slide 17: Financial Review
} BONESUBPORT’ Financial Review
Slide 18: 24% increase in 2017 Net sales
24% increase in 2017 Net sales -9% Net Sales Q4 +24% Net Sales FY 18
Slide 19: North America Analysis
North America Analysis Oct-Dec FY (SEKm) 2017 2016 2016 -35% Net Sales Net Sales 12.6 19.2 68.8 Q4 Gross profit 10.7 17.1 59.5 Contribution -3.5 7.3 22.5 +13% Net Sales FY 19
Slide 20: Europe and RoW Analysis
Europe and RoW Analysis Oct-Dec FY (SEKm) 2017 2016 2016 +39% Net Sales 14.5 10.5 35.7 Net Sales Gross profit 11.8 9.0 28.8 Q4 Contribution 0.8 -2.9 -12.2 Direct markets increased by 42% in Q4 +43% Net Sales YTD 20
Slide 21: Operating result development
Operating result development Oct-Dec Jan-Dec FY (SEKm) 2017 2016 2017 2016 2016 Net Sales 27.0 29.6 129.3 104.6 104.6 Cost of sales -4.5 -3.6 -16.9 -16.3 -16.3 Gross profit 22.5 26.0 112.4 88.3 88.3 Selling expenses -21.5 -14.7 -92.9 -79.8 -79.8 Increased activities R&D expenses -19.7 -15.3 -60.6
Slide 22: KPIs
KPIs Oct-Dec Jan-Dec 12M (SEKm) 2017 2016 2017 2016 LTM Net Sales 27.0 29.6 129.3 104.6 131.9 Sales Growth (%)1/ -8.8 28.8 23.6 69.4 34.6 Gross profit 22.5 26.0 112.4 88.3 115.9 Gross margin (%)1/ 83.3 87.8 87.0 84.4 87.9 Operating loss -33.4 -28.4 -99.3 -88.7 -94.3 Loss for the period -51.4 -34.6 -
Slide 23: Wrap up
} BONESUBPORT’ Wrap up
Slide 24: Well positioned to generate shareholder value
Well positioned to generate shareholder value • CERAMENT G and CERAMENT V unrivalled clinical and economic benefits – potential to gain significant share of the global market • Focused on generating further clinical and HEOR data to enhance competitive positioning and drive sales growth • CERTiFy on
Slide 25: Q&A
} BONESUBPORT’ Q&A