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14-May-2018 / 11:03 GMT/BST
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Kuros Biosciences AG (KURN-CH): Differentiated orthobiologics for spinal fusion
2017 was an eventful year during which Kuros closed the acquisition of Dutch orthobiologics company Xpand Biotechnology, received US approval for synthetic bone graft substitute (“BGS”) MagnetOs, and appointed a new CEO, Dr. Joost de Bruijn. Following a strategic review, Kuros will focus on its potentially best-in-class orthobiologics portfolio for spinal fusion, the largest BGS market. In the next 12-18 months, the focus will be on launching MagnetOs in the US to obtain clinical and commercial validation and starting a Phase II trial for growth factor-based BGS KUR-113 in early 2019, paving the way for launch in 2024E. We forecast peak sales of $195m for MagnetOs (2027E) and $660m for KUR-113 (2032E), based on their differentiated profiles, underlying market growth, and the continued shift from the gold standard autograft to BGS. We set a new target price of CHF29 per share and maintain our OUTPERFORM recommendation.
Spinal fusion the largest segment within the c.$3.2bn orthobiologics market
Orthobiologics include bone grafts harvested from the same patient (autograft) or obtained from a donor cadaver (allograft), and BGS, such as synthetics, growth factors, stem cells and others. They are used in c.2.2 million orthopaedic procedures p.a., with BGS used in nearly 40% of these. The orthobiologics market reached c.$3.2bn in 2017 and is growing at 4% – 6% p.a. Spinal fusion procedures in particular have experienced very high growth in the last two decades, particularly in the US, more than doubling between 1998 and 2011, due to advances in technology, continued adoption of BGS, the ageing of the population, and increased quality of life expectations.
Synthetic MagnetOs has been approved in the US and Europe
Acquired through the purchase of Xpand, MagnetOs has been approved for posterolateral spinal fusion in the US and orthopaedics, craniomaxillofacial and dental procedures in Europe. It will be positioned as best-in-class synthetic as a replacement for autograft, differentiated by (1) its unique surface structure, (2) robust preclinical data in clinically relevant animal models, and (3) clinical data from a post-market clinical trial expected to start this year.
Growth factor-based KUR-113 (fibrin/PTH) to enter Phase II in early 2019E
KUR-113 has shown comparable efficacy and robust safety compared to autograft / InFuse in a highly relevant preclinical model, and has successfully completed a Phase II trial in open tibial shaft fractures, generating strong safety and efficacy data in 200 patients. A dose-finding Phase II trial in lumbar interbody fusion comparing KUR-113 to autograft is due to start enrolling patients in early 2019E. We conservatively forecast launch by YE2024E and expect KUR-113 to take share both from other growth factor-based products including market leader InFuse, as well as autograft.
Brigitte de Lima, PhD, CFA | Analyst
goetzpartners Healthcare Research Team | Research Team
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