Key CERTiFy study confirms CERAMENT’s properties

Update | 19 November 2018

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The proof that CERAMENT BVF is equivalent to autologous bone graft, the current gold standard, in treating complex fractures is a major step in the marketing strategy developed to properly differentiate the CERAMENT platform from other synthetic bone void fillers. Management focus is now on ensuring the positive data is used to exploit the renewed commercialisation organisation, especially the new distribution partnerships in the important US market. We maintain our valuation at SEK2,042m or SEK37/share as we await greater visibility on successful execution of the strategy.

Year-end: December 31201620172018E2019E
Sales (SEKm)104.6129.3102.1228.0
Adj. PBT (SEKm)(109.6)(127.9)(176.7)(133.9)
Net Income (SEKm)(110.2)(128.9)(177.8)(134.4)
EPS (SEK)(4.3)(3.2)(3.4)(2.4)
Cash (SEKm)141.5533.4267.4 114.2
EBITDA (SEKm)(87.4)(98.1)(174.9)(130.7)
Source: Trinity Delta
  • CERTiFy proven as good as bone graft  The important CERTiFy (CERAMENT Treatment of Fracture Defects) study demonstrates that CERAMENT BVF is non-inferior to autograft in treating fracture defects. This prospective, randomised controlled study evaluated 137 patients across 20 centres with CERAMENT compared with autologous bone graft in treating tibial plateau fractures. Autograft (patient derived bone) is considered the gold standard, with high efficacy and safety; however, the need for two surgical procedures (harvest and the transplant itself), increases its cost vs the alternatives, is painful, and is associated with infection risk.
  • Differentiation from other synthetic fillers A number of synthetic bone substitutes have been developed to overcome the disadvantages of autograft (and allograft). CERAMENT differs in that it provides optimal conditions for healing; it consists of a blend of 40% hydroxyapatite (HA) and 60% α-calcium sulphate hemihydrate in a ratio designed to balance the rates of implant resorption and new bone growth. CERTiFy is the first trial to demonstrate non-inferiority to autograft and was specifically performed to demonstrate CERAMENT’s clear clinical benefits and to support its marketing to clinicians, buyers, and payors.
  • Commercialisation infrastructure now in place Following the termination of the Zimmer Biomet agreement Bonesupport sells CERAMENT BVF directly in the US. This is via 25 independent distributors, supported by a larger US commercial team (increased from 14 to 23) and has resulted in a greater marketing presence. This platform enables it to access 100% of the US synthetic bone substitute market (vs c30% under Zimmer Biomet), lifting sales and margins, and improving penetration ahead of potential US launch of CERAMENT G in 2021. In Europe, a headcount doubling strengthens the presence in key markets (eg Germany), improving penetration and is driving use of higher margin CERAMENT G/V in trauma.
  • Valuation currently unchanged at SEK37/share We maintain our valuation of SEK2,042bn or SEK37/share, which is based on a three-phase DCF that employs conservative assumption. Near-term upside potential comes from greater visibility of strategic execution and US sales acceleration; longer-term it is data from the pivotal FORTIFY study that we view as the key growth driver.


19 November 2018

Market CapSEK1,026m
Enterprise ValueSEK713m
Shares in issue55.6m
12 month rangeSEK9.04-26.5
Free float88.7%
Primary exchangeOMX Stockholm
Other exchangesN/A
Company CodeBONEX
Corporate clientYes

Company description

Bonesupport is a Swedish ortho-biologics company focused on developing and commercialising a pipeline of unique injectable drug eluting bioceramic bone graft substitutes based on its proprietary CERAMENT technology.


Lala Gregorek
+44 (0) 20 3637 5043

Mick Cooper PhD
+44 (0) 20 3637 5042

Exhibit 1: Summary of financials
Source: Company, Trinity Delta Note: Historical adjustment of number of shares following 5:1 consolidation in 2017.


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