Lund, Sweden, 21 December 2016 – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone scaffolds to treat bone voids caused by trauma, infection, disease or related surgery, announces that Björn Westberg is to join the Company as Chief Financial Officer and Director in early 2017.

Mr Westberg brings nearly 30 years’ finance and management experience to BONESUPPORT. He joins from Recipharm AB (publ) - one of the largest pharmaceutical contract manufacturers in the world - where he has been CFO since 2007. Prior to this he was CFO of the listed (Nasdaq Stockholm) software company Jeeves (2001-2007), and before that he held senior roles at AstraZeneca, among those Finance Director ISMO Northern Europe and Controller in Astra Japan. 

Mr Westberg replaces Offer Nonhoff, who is to leave after four-and-a-half-years with the company.

Richard Davies, CEO of BONESUPPORT, said: “I am very pleased to welcome Björn to the BONESUPPORT team. He brings with him a wealth of finance and management experience that I am confident will be crucial to the future growth and development of the company. With our recent strengthening of the Board, with the appointment of Dr. Hakan Björklund as Chairman and Tone Kvåle as a Non-executive Director, and Patrick O’Donnell joining to drive our rapidly growing North American business, we are building a first rate team with the experience and talent that will help us realise the significant potential of our CERAMENT™ platform.

“I would also like to thank Offer for his dedication to BONESUPPORT over the years and wish him all the very best in the future.”

Mr Westberg adds: “I look forward to joining BONESUPPORT, where I am confident that my experience will be important as they grow the sales of CERAMENT™ BVF, CERAMENT™ G and CERAMENT™ V and invest in clinical data that will further differentiate these products in the minds of surgeons and payers. BONESUPPORT also has an exciting product pipeline, based on the unique drug eluting properties of its proprietary CERAMENT™ platform which will be targeting the treatment of a broader range of bone diseases. Given these strengths and the quality of the BONESUPPORT team I am confident that the Company can achieve its strategic goals.” 

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Lund, Sweden, 13 December, 2016 – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone scaffolds to treat bone voids caused by trauma, infection, disease or related surgery, is pleased to announce that its CEO Richard Davies has won the “Best CEO in the Biomaterials Industry” award. The award was presented by European CEO Magazine based on Mr. Davies’ track record at the forefront of major new healthcare trends and the continuing success of BONESUPPORT™ under his leadership.

Mr. Davies became CEO of BONESUPPORT in January 2016, following nearly four years spent at Hospira, where he served as Chief Commercial Officer. While at Hospira, he drove growth, globalization and modernization across the business. Hospira was acquired by Pfizer at the end of 2015. Prior to Hospira, Mr. Davies spent nine years in increasingly senior leadership positions at Amgen in Europe, Australia and the U.S. His roles included leadership of the U.S. Inflammation sales group, which commercialized Enbrel® (etanercept), the most prescribed biologic medicine in the U.S. at that time. Mr. Davies began his career at Eli Lilly, spending 13 years in increasingly senior positions.

Richard Davies, CEO of BONESUPPORT, said: “I am very humbled to have been given this award. I firmly believe that BONESUPPORT has an exciting future based on the significant potential of its unique CERAMENT™ platform. This platform is truly innovative and enables surgeons to improve patient outcomes across a range of orthopaedic indications, enabling a single stage surgical procedure for osteomyelitis, reduce length of stay in hospital and lower the cost of care. These benefits are based on the platform’s important clinical features including its ability to rapidly remodel to host bone in six to 12 months, as well as being a carrier for therapeutics that enhance the bone healing process.”

BONESUPPORT recently raised $37 million (SEK 327 million) to support the execution of its strategy to deliver significant shareholder value, focused on:

- Driving the sales of CERAMENT™ BONE VOID FILLER, CERAMENT™ G and CERAMENT™ V (with the antibiotics gentamicin and vancomycin respectively)

- Generating further clinical data to highlight the compelling benefits that the current CERAMENT™ products deliver

- Conduct the FORTIFY study to support a planned PMA filing in the US for CERAMENT™ G

- Building the Company’s product pipeline by capitalizing on the unique drug-eluting properties of its injectable bioceramic platform 

BONESUPPORT believes that the attractive properties of its CERAMENT™ platform will allow it to develop products that are both osteoconductive and osteoinductive for use managing a range of bone diseases where enhanced bone growth is needed to improve treatment outcomes.

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Lund, Sweden, 7 November, 2016 – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone graft substitutes to treat bone voids caused by trauma, infection, disease or related surgery, is pleased to announce the appointment of Patrick O’Donnell as General Manager and Executive Vice President, North American Commercialization to its leadership team.  Mr O’Donnell will lead the relationship with the company’s partner, Zimmer Biomet, to drive revenue growth of BONESUPPORT’s CERAMENT™|BONE VOID FILLER (BVF). He will also set the strategy for the introduction of CERAMENT™|G, a novel gentamicin eluting bone graft substitute, to the U.S. market pending a positive outcome of the planned FORTIFY PMA trial and subject to FDA approval.

Mr O’Donnell joins BONESUPPORT after serving as CEO of three companies focused on innovative orthopaedic regenerative technologies.  Following his role as CEO of Histogenics Corporation, he was most recently the Co-Founder and CEO of ProteoThera Inc., based in Cambridge, MA.  His experience includes being head of Global Marketing of Confluent Surgical, where he launched and built the DuraSeal™ brand of surgical dural sealant products, currently owned by Integra LifeSciences. In addition, he spent 13 years in sales, sales management and marketing in orthobiologics and medical devices at Johnson & Johnson’s DePuy Spine Division.

Mr O’Donnell said: “I am very pleased about the opportunity and quite fortunate to be joining BONESUPPORT at a very important and exciting tipping point stage for the Company. I look forward to working with the BONESUPPORT team to optimize the significant potential of CERAMENT™|BVF and in time CERAMENT™|G in North America.”

Richard Davies, CEO of BONESUPPORT, said: “We are excited to welcome Patrick to the BONESUPPORT team, particularly after completing the recent financing, which will be crucial to executing our strategy. Patrick brings with him a great breadth of experience ranging from start-ups to small and large companies. He has an in-depth of knowledge of the orthobiologics space and appreciation of the significant potential of our unique CERAMENT™ drug eluting osteoconductive bioceramic platform to develop a pipeline of novel products for a broad range of bone diseases. The clinical value proposition of our products is expected to become increasingly relevant to the U.S. healthcare market which is undergoing a sea change to value based care.” 

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- Dr. Håkan Björklund of Tellacq AB, former CEO of Nycomed, becomes Chairman-Elect   

- CERAMENT™ BVF, CERAMENT™ G AND CERAMENT™ V continue to increase sales rapidly driven by a growing body of compelling clinical data

Lund, Sweden, 27 October, 2016 - BONESUPPORT AB an emerging leader in innovative injectable bioceramic bone scaffolds to treat bone voids caused by trauma, infection, disease or related surgery, announces that it has raised $37 million (SEK 327 million) in a combination of equity and debt finance. These new funds will be used to deliver further value from its unique CERAMENT™ platform. The oversubscribed equity financing was led by Tellacq AB and was supported by the Company's current major shareholders, including HealthCap, Lundbeckfond Ventures, Industrifonden, AP3 (The Third Swedish National Pension Fund) and Carl Westin. The debt finance was provided by Kreos Capital.

Dr. Håkan Björklund of Tellacq AB will be joining the BONESUPPORT Board as Chairman in conjunction with the fund raising, subject to shareholder approval. Dr. Björklund has a long and successful track record in the healthcare industry, including as the former CEO of Nycomed, which he grew from a small Scandinavian company into a global business before its acquisition by Takeda in 2011. He is currently chairman of the board of Swedish Orphan Biovitrum AB and an Industry Executive at Avista Capital Partners.

Richard Davies, CEO of BONESUPPORT said, "I am delighted that we have been able to complete this new financing to help us to execute our strategy to deliver the significant potential of our unique CERAMENT™ drug eluting osteoconductive/osteoinductive bioceramic platform. I am also pleased that the equity element reflects the significant progress that we have made during the course of 2016. With our sales on a strong growth trajectory, an increasing body of compelling clinical data and a drug eluting platform that will allow us to develop a pipeline of novel products to treat a broad range of bone diseases, BONESUPPORT can look to the future with great confidence."

"We are delighted to welcome Håkan Björklund to the board at this exciting time for the company and look forward to benefiting from his extensive experience in the years ahead. I would also like to take this opportunity to thank the departing chairman Dr. Örn Stuge for his significant contribution to BONESUPPORT over many years" says Björn Odlander, Managing Partner at HealthCap and board member.

Håkan Björklund, said: "Our decision to invest in BONESUPPORT was driven by the important progress that has been made over recent years. The CERAMENT™ drug eluting platform offers multiple opportunities to generate significant value by providing much needed and cost-efficient treatment options for patients with a broad range of bone diseases. I look forward to working with the management team and the Board to deliver BONESUPPORT's potential to become a global leader in the management and treatment of bone disease." 

The new funds will be used to support the execution of BONESUPPORT's strategy to deliver significant shareholder value, focused on:

- Driving the sales of CERAMENT™ BVF, CERAMENT™ G and CERAMENT™ V in existing and new markets

- Generating further clinical data to highlight the compelling benefits that the current CERAMENT™ products deliver and to conduct the FORTIFY study to support a planned PMA filing in the US for CERAMENT™ G

- Building the Company's product pipeline by capitalizing on the unique drug eluting properties of its injectable osteoconductive/osteoinductive bioceramic platform.

In the first half of 2016, BONESUPPORT's overall sales have continued to grow rapidly driven by the European success of CERAMENT™ G and CERAMENT™ V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products are used for the management of problematic bone infections including osteomyelitis and prophylactically in patients who are at risk for developing infection. Sales of CERAMENT™ BVF have also shown good growth as the product has continued to gain traction in the US where it is marketed by BONESUPPORT's partner Zimmer Biomet.

BONESUPPORT is also continuing to generate the clinical data needed to drive the adoption of its products. A recent paper in The Bone and Joint Journal[1] provided follow up data from the first 100 patients in a prospective study evaluating CERAMENT™ G for dead space (void) management in patients with chronic osteomyelitis (bone infection) using a single stage surgical procedure. These data showed that this approach, augmented by the use of CERAMENT™ G, was highly effective, delivering a 96% prevention of infection recurrence rate, a 3.0% fracture rate and a total wound leakage rate of 6.0%. This represents a significant improvement in both the infection recurrence and fracture rates when compared to published results evaluating alternative bone graft substitutes that deliver antibiotics locally.

The Company has also recently received approval from the US Food and Drug Administration (FDA) to begin an IDE (Investigational Device Exemption) study with CERAMENT™ G. The FORTIFY study, a randomized multicenter controlled trial, which will evaluate the safety and efficacy of CERAMENT™ G as part of surgical repair of open diaphyseal tibial fractures. The first patient is expected to be recruited into this prophylactic study before the end of 2016.

BONESUPPORT will also use the funds to develop its product pipeline. The Company believes that the attractive properties of its CERAMENT™ platform will allow it to develop products that will deliver a broad range of drugs to the bone to manage indications including osteoporosis, cancer and pain.

References

1. McNally et al, The Bone and Joint Journal, 2016, Vol. 98-B, No. 9, p1289-9

2. Raina, D. et al. A Biphasic Calcium Sulfate Hydroxapatite Carrier Bone Morphogenic Protein -2 and Zoledronic Acid Generates Bone (2016) Nature Scientific Reports

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Single stage surgical procedure achieves 96% infection eradication rate

Lund, Sweden, 1 September 2016 – BONESUPPORT AB, an emerging leader in innovative injectable bioresorbable bone graft substitute products to treat bone voids caused by trauma, infection, disease or related surgery, today announced the publication of a paper in The Bone and Joint Journal: Single-stage treatment of chronic osteomyelitis with a new absorbable gentamicin-loaded, calcium sulphate/hydroxyapatite biocomposite - A prospective series of 100 cases. McNally et al, The Bone and Joint Journal, 2016, Vol. 98-B, No. 9, p1289-96.

The paper provides 12-34 month follow up data from the first 100 patients in a prospective study evaluating CERAMENT™ G for dead space (void) management in patients with chronic osteomyelitis (bone infection) using a single stage surgical procedure. These data showed that this approach, augmented by the use of CERAMENT™ G, was highly effective, delivering a 96% prevention of infection recurrence rate, a 3.0% fracture rate and a total wound leakage rate of 6.0%.  This is significantly lower than published results with alternative bone graft substitutes that deliver antibiotics locally.

These results highlight the essential properties of CERAMENT™ G in the management of chronic osteomyelitis. The very encouraging infection recurrence prevention rate is supported by CERAMENT™ G’s attractive local delivery properties, which enable it to provide an initial targeted ultra-high concentration of gentamicin into the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) of the bacteria that initially caused the osteomyelitis. This unique antibiotic-eluting profile helps protect the bone healing process and promote bone remodeling.

The bone healing and bone remodeling properties of CERAMENT™ G, when combined with gentamicin, make it an ideal solution for dead space management in patients with chronic osteomyelitis. It is able to fill the void completely due to its injectability and to provide initial structural stability due to its self-setting properties.

The use of CERAMENT™ G to deliver gentamicin locally could play an important role in improving antibiotic stewardship in hospitals by increasing compliance and reducing the need for patients with chronic osteomyelitis to receive long term systemic antibiotics.

Mr Martin McNally, Consultant Bone Infection and Limb Reconstruction Surgeon at Oxford University Hospitals (Oxford, UK) and lead author of the paper said, “The results that we have achieved with the single stage surgical procedure using CERAMENT™ G for the dead space management of patients with chronic osteomyelitis are a significant improvement on past experience. These results reflect CERAMENT™ G’s unique local antibiotic delivery profile and its attractive bone remodeling capabilities. We are increasingly using CERAMENT™ G in the treatment of patients with chronic osteomyelitis and infected fractures. It allows a more patient-friendly treatment, preventing repeated operations and recurrent infections. We expect it to become the mainstay of our dead space management, given the major clinical and health economic benefits that it supports.”

The paper covers the first 100 patients in a prospective cohort study utilising CERAMENT™ G for dead space management in a single stage surgical procedure for chronic osteomyelitis. The mean duration of chronic osteomyelitis in this patient group was 10.4 years (0.5 to 68 years). All surgeries were performed by two surgeons and were completed in a single operative session. All patients were given similar systemic antibiotic therapy and rehabilitation. Patients were followed up for at least 12 months (mean 19.5 months, range 12 -34 months) with infection recurrence, fracture rate and wound leakage rate as the primary outcome measure. The study showed that the single stage surgical procedure with CERAMENT™ G, was highly effective delivering a 96% infection recurrence prevention rate, a 3.0% fracture rate and a total wound leakage rate of 6.0%.

Richard Davies, CEO of BONESUPPORT said, “The results that have been published today highlight the clear clinical benefits with CERAMENT™ G’s ability to deliver sustained bactericidal levels of gentamicin locally to support the eradication of underlying infections in patients with chronic osteomyelitis. By using CERAMENT™ G in a single stage procedure to help patients with chronic osteomyelitis return to a normal life, we can deliver significant health economic benefits to payors who are struggling to contain the significant and growing costs of treating severely debilitating bone infection.”

Reference

1. McNally et al, The Bone and Joint Journal, 2016, Vol. 98-B, No. 9, p1289-96.

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Lund, Sweden, 30 August 2016 – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery, today announced that presentations and posters covering research with its CERAMENT™ G and CERAMENT™ V will feature extensively at the upcoming 35^th Annual Meeting of the European Bone & Joint Infection Society (EBJIS) taking place September 1-3 in Oxford, UK - which is a key congress for physicians and surgeons managing patients with bone infections. CERAMENT™ G and CERAMENT™ V are the only CE-marked injectable antibiotic eluting bone graft substitutes which provide local sustained delivery of gentamicin and vancomycin, respectively.

The EBJIS annual meeting will feature 25 abstracts highlighting research and clinical findings with CERAMENT™ G and CERAMENT™ V. This is a significant increase in the number of presentations and posters that were made at the 34^th Annual EBJIS meeting reflecting the impressive clinical performance reported, the launch of CERAMENT™ V in 2016 and the growing interest in the only injectable antibiotic eluting bone graft substitutes that are available in Europe. Both CERAMENT™ G and CERAMENT™ V are able to deliver an initial high concentration of antibiotic to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to promote and protect bone healing and remodeling.

Richard Davies, CEO of BONESUPPORT, said: “The broad range of research and clinical data on CERAMENT™ G and CERAMENT™ V being presented at this year’s EBJIS Annual meeting highlights the significant increase in interest in these novel injectable antibiotic eluting bone graft substitutes. The new data also underscores BONESUPPORT’s commitment to supporting high-quality research that will help improve the management of important bone diseases. We are confident that the growing body of clinical evidence in support of both CERAMENT™ G and CERAMENT™ V will allow them to be used increasingly in patients with problematic bone infections including osteomyelitis, as well as prophylactically in patients at risk for developing an infection.”

BONESUPPORT recently received approval from the US Food and Drug Administration (FDA) to begin the FORTIFY study, an IDE (Investigational Device Exemption) study, with CERAMENT™ G.  This study is a randomized multicenter controlled trial that will evaluate the safety and efficacy of CERAMENT™ G as part of surgical repair of open diaphyseal tibial fractures. The first patient is expected to be recruited into the FORTIFY study by the end of 2016. Data from the FORTIFY study will be an important component of BONESUPPORT’S planned PMA to gain US approval for CERAMENT™ G.

EBJIS is a European association of orthopedic surgeons, trauma surgeons, infection specialists and microbiologists. The aim of the Society is to promote the knowledge of all infections affecting the Musculoskeletal system (bone and joint infections) and to promote the prevention and treatment of these infections. The complete program of the EBJIS meeting is available at http://ebjis.org/.

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FORTIFY Study to Assess CERAMENT™|G as part of Surgical Repair of Open Diaphyseal Tibial Fractures

Lund, Sweden, 9 August – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery, today announced that it has received approval from the US Food and Drug Administration (FDA) to begin an IDE (Investigational Device Exemption) study with CERAMENT™ G. CERAMENT™ G is an injectable antibiotic-eluting bone graft substitute that provides local sustained delivery of gentamicin. CERAMENT™ G received CE mark approval in February 2013 and is now marketed in 19 countries outside the US.

The FORTIFY study, a randomized multicenter controlled trial, will evaluate the safety and efficacy of CERAMENT™ G as part of surgical repair of open diaphyseal tibial fractures. The trial will enrol up to 230 patients at up to 30 centers globally, with the aim of having at least 50% of the study data coming from US subjects. In addition to evaluating the safety of CERAMENT™ G use, primary endpoints of the study include

- Absence of deep infection at the fracture site

- Absence of secondary procedures (surgical or nonsurgical) intended to promote fracture union

BONESUPPORT anticipates starting the FORTIFY trial by the end of 2016.

CERAMENT™ G combines the bone healing and bone remodeling properties of CERAMENT™ with the antibiotic, gentamicin. CERAMENT™ G drug-eluting properties enable it to provide an initial ultra-high concentration of gentamicin to the environment of the bone fracture and then a longer sustainable dose above the minimum inhibitory concentration (MIC) of many of the bacteria which could cause a deep bone infection at the fracture site. This unique antibiotic-eluting profile helps protect the bone healing process and to promote bone remodeling.

Richard Davies, CEO of BONESUPPORT, said, “The FDA approval of our planned IDE study with CERAMENT G is a key corporate milestone for BONESUPPORT. We are looking forward to beginning the FORTIFY study before the end of 2016. The results of this study will form a key component of our planned PMA to gain US approval for this novel antibiotic-eluting bone graft substitute.”

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Lund, Sweden, 1 June, 2016 – BONESUPPORT AB, an emerging leader in innovative injectable bioresorbable bone graft substitute products to treat bone voids caused by trauma, infection, disease or related surgery today announced  the publication of a paper in  Nature Scientific Reports: A Biphasic Calcium Sulphate Hydroxyapatite Carrier Containing Bone Morphogenic Protein-2 and Zoledronic Acid Generates Bone (Raina, D et al., reference below). The paper covers a pre-clinical study which demonstrated that CERAMENT™ loaded with a combination of recombinant human bone morphogenic protein 2 (“rhBMP-2”) plus zoledronic acid (“ZA”) in very low doses was able to quantitatively and qualitatively generate a higher amount of mineralized bone volume. The study also showed In vivo that the mineralized volume was significantly higher when CERAMENT™ was combined with rhBMP-2 and ZA (21.4±5.5mm³) as compared to CERAMENT™ in combination with just rhBMP-2 (10.9±2.1mm³). Raina, D. et al.

The findings highlight the attractive properties of CERAMENT™ as an injectable carrier material that can mimic natural bone matrix. CERAMENT™ benefits from several advantages such as a high degree of protein encapsulation, sustained release behavior and improved surgical handling. The biocompatibility and bioresorbability of the biphasic microporous material which sets in situ make it suitable as a carrier with a controlled release of encapsulated or chemically bound additives. Raina, D. et al.

Authors of the publication stated, “There is a clear need for bone substitutes that can safely and effectively replace autograft via a combination of bone growth and remodeling. There is increasing demand and the absence of a viable solution for replacing large volumes of bone that clearly requires new innovative bone graft solutions. The results that we have published shows that it could be possible to develop a single stage method based on the unique properties of CERAMENT™|BONE VOID FILLER (BVF) to deliver a combination of the rhBMP-2 and ZA locally at the site where significant new bone formation is needed”. Raina, D. et al.

The authors note that previously BMPs have not been proven to induce better bone healing than autograft suggesting that there is a clear need for an improved delivery platform, and that the limitations of delivery methods used to-date have led to varying clinical outcomes. These include carboxymethyl cellulose, bovine particle carriers and collagen sponges, which additionally can cause local inflammatory reaction. The study findings suggest that using CERAMENT™ as a platform to co-deliver a combination of rhBMP-2 and ZA with a synergistic effect can potentially improve the standard of care for patients afflicted with bone disease. Raina, D. et al.

Richard Davies, CEO of bonesupport.commenting on today’s announcement said, “The pre-clinical results in this prestigious publication highlight an unmet medical need for a single-stage delivery platform with properties that not only foster bone healing, but also enable local delivery of a range of therapeutics. It discusses the advantageous properties of CERAMENT™ as a drug eluting material which we have been demonstrating in clinical practice with antibiotic containing CERAMENT™ G & V. We have received favourable physician feedback about the efficacy of these products in the management of patients with osteomyelitis. We are encouraged about the potential of our platform to develop further products to treat specific groups of patients with bone disease. “

Reference

Raina, D. et al. A Biphasic Calcium Sulfate Hydroxapatite Carrier Bone Morphogenic Protein -2 and Zoledronic Acid Generates Bone (2016) Nature Scientific Reports. http://bit.ly/22xgU84. 

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CERAMENT™|G 5 mL to be utilized for infection management and prophylaxis in diabetic foot procedures and small extremities

Lund, Sweden, (PRNEWSWIRE) March 1, 2016 – BONESUPPORT™, an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, today announced an extension to the CERAMENT™|G product portfolio, adding a 5 mL volume to further develop the management of osteomyelitis (OM) and infection prophylaxis in diabetic foot and small extremities. CERAMENT™|G, which releases Gentamicin, received CE-mark in 2013, and is the first injectable antibiotic eluting bone substitute indicated to promote and protect bone healing in the management of bone infection. CERAMENT™|G is now available in 5 mL and 10 mL in CE-mark countries.

The new smaller 5 mL volume further expands the application of CERAMENT™|G in small joint and extremity indications, including osteomyelitis in the Diabetic Foot.  The efficacy of CERAMENT™|G in the management of this indication was recently demonstrated in two studies presented at the 34th Annual Meeting of the European Bone and Infection Society.

“CERAMENT™|G has demonstrated efficacy in the management of bone infections, and the new 5 mL volume will allow us to utilize this product in a larger number of patients with extremity infections as well as prophylactically in indications where a high risk of infection exists,” said Professor Lars Jens Perlick, Chief of Trauma and Orthopaedics, Asklepios Paulinen Klinik Wiesbaden, in Germany.

“We are pleased to be able to address the market’s demand for CERAMENT™|G in a smaller volume,” said Richard Davies, CEO of BONESUPPORT™.  “Physicians in Europe are clearly recognizing the benefits of our novel antibiotic eluting CERAMENT™ technology, and we continue to look forward to initiating a pivotal U.S. clinical trial for CERAMENT™|G in the second quarter of 2016.” 

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CERAMENT™|G registry now includes 230 cases conducted in 18 hospitals across 9 countries

Registry now updated to include CERAMENT™ V procedures

Lund, Sweden, (PRNEWSWIRE) February 2, 2016 – BONESUPPORT™, an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, today provided an update on the Company’s CERAMENT™ procedure registry, established by BONESUPPORT™ in February 2014 as part of the proactive post-market surveillance process for the Company’s novel antibiotic eluting injectable bone substitutes. The CERAMENT™|G registry now includes 230 cases conducted in 18 hospitals across 9 countries. In addition, the registry has recently been updated to include CERAMENT™ V procedures.

The CERAMENT™|G registry includes a variety of complex procedures, including bone tumors, primary and revision hip and knee prostheses, osteomyelitis and infected diabetic foot.  Moreover, the registry participants include a number of world-renowned surgeons, including Professor Carlo Romanò, Istituto Ortopedico Galeazzi, Milan Italy, Mr. Martin McNally, Nuffield Orthopaedic Centre in Oxford, United Kingdom and Professor Guido Wanner, University Hospital of Zurich, Switzerland.  The CERAMENT™ registry provides the ability to add more hospitals, more indications and more product line extensions and is one of the most robust registries in the industry.

“This important registry offers hospitals the opportunity to share CERAMENT™ data with a view to analyzing inter-country or cross-country trends,” said Professor McNally. “I am pleased to be participating in, and contributing to this registry.  We have shown that CERAMENT™|G is a safe and effective addition to the management of many complex indications, including chronic osteomyelitis, and look forward to generating further data to confirm this.”

“We are excited about the diverse set of procedures and compelling data being generated in our CERAMENT™ registry,” said Richard Davies, CEO of BONESUPPORT™. “This registry both ensures vigilance in the post-marketing surveillance for our products, and allows the data generated from these complex procedures to be collected and stored in a central location. We intend to work with our surgeon participants to ensure publication of this data in the future.”

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Mr. Davies Brings over 25 Years of Life Sciences Industry Experience to BONESUPPORT™

Current Chief Executive Officer, Lloyd Diamond, to Transition to Role of Chief Business Officer

Lund, Sweden, (PRNEWSWIRE) January 22, 2016 – BONESUPPORT™, an emerging leader in both injectable bone substitutes and innovative drug eluting bone scaffold technology for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, announced today that the Company has appointed Richard Davies as BONESUPPORT™’s new Chief Executive Officer, effective immediately. Mr. Davies is a senior commercial leader in the life sciences industry with 25 years of global experience in all aspects of sales / marketing and country / regional leadership, a track record of devising and executing growth strategies and delivering successful results in complex situations.

BONESUPPORT™’s current Chief Executive Officer, Lloyd Diamond, will transition to the role of Chief Business Officer, effective immediately. Mr. Diamond will re-locate back to the U.S., establishing an executive level presence for the Company’s largest market. During his time with BONESUPPORT™, Mr. Diamond secured an important distribution agreement in the U.S. with the world’s largest orthopedic market player, Zimmer Biomet, and transformed the Company from a Research and Development organization to a fully commercial group, with more than 20,000 CERAMENT™ procedures performed worldwide.

“I am proud of the transition BONESUPPORT™ has made from an R&D organization to a global commercial company in the four years I have had the pleasure of serving as CEO,” said Mr. Diamond. “My new role as Chief Business Officer will allow me to focus on further driving CERAMENT™ commercial growth, particularly in the U.S. market."

Mr. Davies previously spent nearly four years at Hospira, where he served as Chief Commercial Officer. While at Hospira, he drove growth, globalization and modernization across the business. Mr. Davies’ efforts led the company to an acceleration of revenue growth to 12% per year. Hospira was acquired by Pfizer at the end of 2015. Prior to Hospira, Mr. Davies spent nine years in increasingly senior leadership positions at Amgen in Europe, Australia and the U.S. His roles encompassed a start up of clinical and commercial operations in CEE, leadership of Australia and New Zealand and leadership of the U.S. Inflammation sales group, commercializing Enbrel, the most prescribed biologic medicine in the U.S. at that time. His most recent position at Amgen was General Manager, Japan and Asia Pacific.  Mr. Davies began his career at Eli Lilly, spending 13 years in increasingly senior positions.

“First, on behalf of the entire Board, I’d like to thank Lloyd for his dedication and numerous achievements as BONESUPPORT™’s CEO over the past four years,” said Oern R. Stuge, M.D., BONESUPPORT™’s Chairman of the Board. “We are delighted to welcome Richard to BONESUPPORT™. His vast pharmaceutical experience will be key to leveraging the drug eluting capabilities of CERAMENT™. I look forward to working closely with Richard as we focus on the many opportunities ahead of BONESUPPORT™ in the coming years.”

“I am pleased to be joining BONESUPPORT™ as CEO at such a critical juncture in the Company’s history,” said Mr. Davies. “The technology BONESUPPORT™ has developed offers important health benefits to patients and represents significant upside value potential for investors. Lloyd has done a tremendous job in advancing the Company and I look forward to working with him and the team to continue to accelerate this growth.”

Mr. Davies is currently Chairman of the Board of Alvotech Iceland and has previously served on the Board of Zydus Hospira Oncology Products Ltd., and of several trade associations in Poland and Australia. He holds a B.Sc. in Applied Chemistry from Portsmouth University, and an MBA from Warwick Business School.

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Lund, Sweden, (PRNEWSWIRE) January 11, 2016 – BONESUPPORT™, an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, announced today the Company has reached a significant milestone with more than 20,000 patients treated worldwide with CERAMENT™, a novel injectable and moldable bone substitute with unique drug eluting capabilities. Adoption of the CERAMENT™ product portfolio continues to grow and gain momentum globally.

“In the past four years, we have transitioned from a Research and Development focused company to a commercial phase company,” said Lloyd Diamond, CEO of BONESUPPORT™. “In the U.S., CERAMENT™ procedure growth is being driven by the continued commercial progress BONESUPPORT™ and our U.S. distribution partner, Zimmer Biomet, continue to achieve.  In Europe, the strong physician demand for BONESUPPORT’s first to market injectable antibiotic eluting products, CERAMENT™|G (gentamicin) and CERAMENT™ V (vancomycin), indicated to promote and protect bone healing in the management of bone infections, is fueling significant procedure growth in this region and in new markets with new indications.”

“Achieving this milestone of 20,000 CERAMENT™ procedures is not only recognition that our commercialization strategy is working, but validation that the utility of our novel technologies is resonating well with the global market place,” continued Mr. Diamond. “We look forward to expanding our product portfolio and extending the benefits to additional surgeons and patients worldwide.”

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Rigshospitalet to evaluate CERAMENT™ platform for use in bone tumors

Lund, Sweden, (PRNEWSWIRE) January 7, 2016 – BONESUPPORT™, an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, today announced that the Company has signed a research collaboration with Rigshospitalet, Copenhagen University Hospital, the largest hospital in Denmark, whereby the institution will evaluate BONESUPPORT™’s platform technology, CERAMENT™, in the management of bone tumors. 

The study will retrospectively evaluate clinical results using bone allografts, and prospectively evaluate clinical results using CERAMENT™lBONE VOID FILLER and gentamicin eluting CERAMENT™lG, for prophylactic use in bone tumor patients. CERAMENT™ will also be evaluated in combination with different substances in order to achieve enhanced bone healing. 

Surgical management of bone tumors can create a residual bone defect in highly compromised patients, which requires void filling to prevent infection or fracture. Synthetic bone substitutes offer significant advantages over traditional autograft and allograft, which are associated with high morbidity and risk of disease transmission.

“We are excited to evaluate the CERAMENT™ technology platform in this research collaboration,” said Michael Mørk-Petersen, Professor, MD, DMSc, Rigshospitalet, who will oversee the study. “Both autologous bone and allograft have some disadvantages and risks associated with their use.  We believe CERAMENT™ can provide a safe and effective alternative long-term solution to these technologies.”

“BONESUPPORT™ is pleased to enter into this collaboration with such a prestigious medical institution,” said Dr. Eva Lidén, VP of Research and Development of BONESUPPORT™. “Our CERAMENT™ technology platform continues to gain momentum with the physician community in Europe, and we will continue to invest in important research to validate our technology and improve upon the standard of care.”

CERAMENT™|G is CE-mark approved and is commercially available in parts of Europe, SE Asia and the Middle East.  CERAMENT™|BONE VOID FILLER is FDA cleared and CE-mark approved and is commercially available in the U.S., Canada, parts of Europe, SE Asia and the Middle East.  Zimmer Biomet is the exclusive distributor of CERAMENT™|BONE VOID FILLER in the U.S.

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Two separate studies confirm efficacy of CERAMENT™|G, an antibiotic eluting bone substitute, as a new option in the surgical management of osteomyelitis in the infected diabetic foot.

Lund, Sweden, (PRNEWSWIRE) January 5, 2016 – BONESUPPORT™, an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, today announced data from two studies confirming the efficacy of the Company’s CERAMENT™ antibiotic eluting bone substitute technology as a step in the management of osteomyelitis (OM) in infected diabetic foot. CERAMENT™|G, which releases Gentamicin, received CE-mark in 2013, and is the first approved antibiotic eluting bone substitute indicated to promote and protect bone healing in the management of bone infections.

Contiguous bone infection is a common complication of diabetic foot ulcers, and overall approximately 20% of patients with a diabetic foot infection (and over 60% of those with severe infections) have underlying osteomyelitis.¹. Prevalence of diabetes is growing rapidly and is the most common cause of non-traumatic lower limb amputation, with approximately 30% of patients with a diabetic foot ulcer leading to amputation. The risk for amputation in acute diabetic infections is four times higher with OM than with soft tissue infection alone². Additionally 50% of patients will go on to another amputation within 3-5 years, and 70% percent of patients die within 5 years of an amputation for diabetes.

Overall, the studies confirmed previously unpublished experience with CERAMENT™|G and published off label clinical use of CERAMENT™ which was shown to induce bone and soft tissue healing and preservation of proper anatomy in the infected diabetic foot. Of significance, 11 of 12 patients who had mid-foot or hind foot partial resections healed rapidly, with the other patient follow up ongoing.  In the second study six patients with OM of the metatarsal head were managed with CERAMENT™|G, with none requiring additional surgery.

“The results of these studies confirm that CERAMENT™|G has the potential to be an effective new surgical option for patients with osteomyelitis,” said Enrico Brocco, Chief, Diabetic Foot Unit, Policlinico Abano Terme, Diabetic Foot Referral Center, Italy, and author of one of the studies. “In these studies, CERAMENT™|G was associated with the rapid resolution of osteomyelitis, rapid soft tissue closure and preservation of the foot structure. We are very optimistic that CERAMENT™|G holds great promise in the management of osteomyelitis in diabetic foot ulcers.”

“The data generated from these studies support the feedback we’ve received from European physicians regarding the efficacy of CERAMENT™|G,” said Lloyd Diamond, CEO of BONESUPPORT™. “Importantly, our physician adoption rate in Europe continues to grow significantly, and we anticipate initiating a pivotal U.S. clinical trial for CERAMENT™|G in the second quarter of 2016.” 

The results from these studies were presented at the 34th Annual Meeting of the European Bone and Infection Society in September.  BONESUPPORT™ is currently pursuing a pathway for FDA clearance in order to bring this novel treatment to the U.S.

References

1. Eneroth M, Larsson J, Apelqvist J.  Deep foot infections in patients with diabetes and foot ulcer: an entity with different characteristics, treatments, and prognosis. J Diabetes Complications 1999;13:254–263.

2. Mutluoglu M, Sivrioglu AK, Eroglu M, Uzun G, Turhan V, Ay H, et al. The implications of the presence of osteomyelitis on outcomes of infected diabetic foot wounds. Scand J Infect Dis. 2013;45:497–503.

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The English text is an unofficial translation. In case of any discrepancies between the Swedish text and the English translation, the Swedish text shall prevail.

The shareholders in BONESUPPORT HOLDING AB, Reg. No. 556802-2171, are hereby invited to attend the annual shareholders’ meeting (Sw. årsstämma) to be held at Elite Hotel Ideon, Scheelevägen 27 in Lund, Sweden on Tuesday 22 May 2018 at 10.00 a.m.

Right to participate and notice of participation

Shareholders wishing to attend the annual shareholders’ meeting must:

• partly be registered in the company’s share register kept by Euroclear Sweden AB (the Swedish Securities Register Center) as of Wednesday 16 May 2018; and
• partly notify the company of their intention to participate in the annual shareholders’ meeting no later than on Wednesday 16 May 2018, by mail to address BONESUPPORT HOLDING AB, att: Bolagsstämma, Scheelevägen 19, SE-223 70 Lund, by e-mail to legal@bonesupport.com or by phone to +46 (0) 286 53 70. The notice shall specify the shareholder’s complete name, personal or company registration number, registered shareholding, address, telephone number during work hours and, when applicable, information on the number of advisors (two at the most). 

Trustee registered shares

Shareholders who have their holdings trustee-registered must temporarily register the shares in their own name in order to be entitled to participate in the annual shareholders’ meeting. Such temporary re-registration of ownership must be implemented no later than as of Wednesday 16 May 2018, meaning that the shareholders must well in advance before this date request their trustees thereof.

Proxies etc.

A proxy representing a shareholder must bring a written, dated and by the shareholder signed power of attorney to the annual shareholders’ meeting. The power of attorney must not be older than one year, unless a longer validity term (maximum five years) have been stipulated. Should the power of attorney be issued by a legal entity, a certified copy of a registration certificate (Sw. registreringsbevis) or equivalent document shall be presented at the meeting. In order to facilitate the preparations before the annual shareholders’ meeting, a copy of the power of attorney and other proof of authority should be attached to the notice of participation. A template power of attorney can be found at the company website (www.bonesupport.com), and will be sent to the shareholders who request it and state their address. 

Proposed agenda

0. Opening of the meeting.

1. Election of chairman of the meeting.

2. Preparation and approval of voting list.

3. Approval of the agenda.

4. Election of one or two persons to approve the minutes.

5. The question as to whether the meeting has been duly convened.

6. Address by the CEO.

7. Presentation of the annual report and the auditor’s report and the annual report for the group and the auditor’s report for the group.

8. Resolutions in respect of

a. adoption of the profit and loss statement and balance sheet and the group profit and loss statement and the group balance sheet;

b. allocation of the company’s profit in accordance with the adopted balance sheet; and

c. the discharge from liability of the members of the board of directors and the CEO.

9. Determination of the number of members of the board and the number of auditors.

10. Determination of fees to the board of directors and the auditors.

11. Election of members of the board, chairman of the board as well as election of auditors and deputy auditors.

12. Resolution on instruction and charter for the Nomination Committee.

13. Determination of Remuneration Policy for senior executives.

14. Resolution on implementation of a long-term incentive program for senior executives by way of (A) directed issue of warrants; and (B) approval of transfer of warrants.

15. Resolution on amendment of the Articles of Association.

16. Resolution on implementation of a long-term incentive program for employees by way of (A) implementation of a performance-based share saving program; (B) authorization on a directed issue of series C shares; (C) authorization for repurchase of series C shares; and (D) resolution on transfer of own ordinary shares.

17. Resolution on implementation of a long-term incentive program for certain members of the board of directors by way of (A) implementation of a performance-based share saving program; (B) authorization on a directed issue of series C shares; (C) authorization for repurchase of series C shares; and (D) resolution on transfer of own ordinary shares.

18. Closing of the meeting.

Resolution proposals

Item 1: Election of chairman of the meeting

The Nomination Committee, consisting of Jacob Gunterberg (chairman), representing HealthCap V L.P, Johan Kördel, representing Lundbeckfonden Invest A/S, Jonas Jendi, representing Stiftelsen Industrifonden, and the chairman of the board, Håkan Björklund, proposes that attorney Ola Grahn is elected as chairman of the meeting.

Item 8 b: Resolution in respect of allocation of the company’s profit in accordance with the adopted balance sheet 

The board of directors proposes that no dividends are paid and that available total funds of SEK 889,317,383 are carried forward to a new account. 

Item 9: Determination of the number of members of the board and the number of auditors

The Nomination Committee proposes to the annual shareholders’ meeting that the number of the members of the board shall be seven. Furthermore, it is proposed that one registered accounting firm is appointed as auditor until the end of the next annual shareholders’ meeting

Item 10: Determination of fees to the board of directors and the auditors 

The Nomination Committee proposes to the annual shareholders’ meeting that board remuneration shall be paid with a total of SEK 1,565,000 (SEK 1,415,000 previous year). The proposal means that remuneration shall be paid with SEK 325,000 to the chairman of the board (unchanged since previous year) and with SEK 150,000 to each of the other board members who are not employed by the company (unchanged since previous year). It is further proposed that remuneration for committee work shall be paid with SEK 125,000 to the chairman of the audit committee (unchanged since previous year), with SEK 70,000 to each of the other members of the audit committee (unchanged since previous year), with SEK 50,000 to the chairman of the remuneration committee (unchanged since previous year) and with SEK 25,000 to each of the other members of the remuneration committee (unchanged since previous year).

Remuneration to the auditor is proposed to be paid in accordance with invoiced amounts in accordance with customary charging standards. 

Item 11: Election of members of the board, chairman of the board as well as election of auditors and deputy auditors

The Nomination Committee proposes to the annual shareholders’ meeting that Håkan Björklund, Björn Odlander, Nina Rawal, Lars Lidgren, Tone Kvåle and Lennart Johansson are re-elected as ordinary board members and that Simon Cartmell is elected as new ordinary board member. The Nomination Committee further proposes to the annual shareholders’ meeting that Håkan Björklund is re-elected as chairman of the board. 

Information on the board members proposed for re-election can be found at the company website and in the Annual Report (www.bonesupport.com). Information on the candidate proposed for new election can be found in the Nomination Committee’s reasoned statement. 

Furthermore, the Nomination Committee proposes to the annual shareholders’ meeting, in accordance with the recommendation from the audit committee, that Ernst Young AB is re-elected as accounting firm. Ernst & Young AB has announced that Johan Thuresson will continue to be the auditor in charge.

Item 12: Resolution on instruction and charter for the Nomination Committee 

The Nomination Committee proposes that that an instruction and charter for the Nomination Committee is adopted in accordance with the following main content. 

The Nomination Committee shall consist of four members, representing the three largest shareholders as per the end of September, together with the chairman of the board of directors. The “three largest shareholders” refer to the ownership grouped registered or in any other way known shareholders as per the end of September. 

The chairman of the board of directors shall as soon as possible when the information regarding the three shareholders as per the end of September is known, contact the three largest shareholders to find out whether they wish to appoint a representative to the Nomination Committee. In case one of the three largest shareholders refrain from appointing a representative, or such representative resign prior to completion of the assignment and without the shareholder who has appointed the representative appointing a new member, the chairman of the board of directors shall encourage the next owner in size (i.e. in the first place the fourth largest shareholder) to appoint a representative. The procedure shall go on until the Nomination Committee is composed of four members including the chairman of the board of directors.  

The chairman of the board of directors shall as soon as possible when the information regarding the three shareholders as per the end of September is known, contact the three largest shareholders to find out whether they wish to appoint a representative to the Nomination Committee. In case one of the three largest shareholders refrain from appointing a representative, or such representative resign prior to completion of the assignment and without the shareholder who has appointed the representative appointing a new member, the chairman of the board of directors shall encourage the next owner in size (i.e. in the first place the fourth largest shareholder) to appoint a representative. The procedure shall go on until the Nomination Committee is composed of four members including the chairman of the board of directors.  

The members of the Nomination Committee shall be announced no later than six months before the annual shareholders’ meeting. When significant changes in the ownership occur after the date the Nomination Committee was appointed, the Nomination Committee may, if it considers it necessary, decide to offer a new owner a position in the Nomination Committee in accordance with the principles above. Changes in the Nomination Committee shall be made public immediately. 

The Nomination Committee’s term shall run until such time as a new Nomination Committee has been elected. 

No fees shall be paid to the members of the Nomination Committee. 

The Nomination Committee shall prepare and propose the following to the coming annual shareholders’ meeting:

(a) election of chairman at the shareholders’ meeting; 

(b) election of chairman of the board of directors and other members of the board of directors; 

(c) fees to the board of directors, divided between the chairman and other members, and any fees for committee work; 

(d) election of auditor and fees to the auditor; and 

(e) principles for appointment of the Nomination Committee.

Item 13: Determination of Remuneration Policy for senior executives

The board of directors proposes to the annual shareholders’ meeting that the following guidelines for remuneration to senior executives are adopted. 

The company shall offer remuneration levels and employment terms at market terms, aimed at facilitating the recruitment and retention of senior executives with high competence and capacity, in order to achieve established targets. It is noted that the company is highly international with employees in several countries. When determining the remuneration level and other employment terms, the starting point should be that the terms should be competitive considering the situation in the country in which the employee is employed. The guidelines shall apply to employment agreements entered into after the adoption of these guidelines by the shareholders’ meeting or amendments to existing agreements made after the adoption of the guidelines.  

The remuneration to the CEO and other senior executives can be comprised of fixed salary, variable remuneration, pension benefits, share-based incentive programs resolved by the shareholders’ meeting and other benefits. Senior executives refer to the CEO and the other persons forming part of the company’s management team.   

Remuneration and other employment terms for the CEO and other senior executives are prepared by the Remuneration Committee and resolved by the board of directors.  

The fixed salary shall take into consideration the individual’s competence, area of responsibility and performance. A review should generally be made annually.

The variable remuneration is to be based on the outcome of predetermined well defined objectives. The variable consideration is to be limited and may not exceed 75 per cent of the fixed annual salary for the CEO and 40 per cent of the fixed annual salary for other senior executives, whereby the individual highest level should be based on factors such as the position held by the specific individual. 

The company’s commitments in reference to variable remuneration for the CEO and other senior executives who can be entitled to variable remuneration targets are for 2018 calculated to amount to, if all targets are met in full and based on the current exchange rates, at the highest approximately SEK 10 million (excluding social charges). The calculation is based on the persons currently being senior executives and who can be entitled to variable remuneration.  

In addition to what follows from law or collective bargain agreements or other agreements, the CEO and other senior executives may be entitled to arrange individual pension schemes. Refrained salaries and variable remuneration can be used for increased pension contributions, provided that the total cost for the company is unchanged over time. 

Share-based incentive programs shall, where applicable, be resolved by the shareholders’ meeting.  

The senior executives may be awarded other customary benefits, such as a company car, occupational health services, etc.

In case of termination of the CEO’s employment by the company, the notice period should not exceed 6 months. In case the Company terminates the CEO without cause the CEO shall, in addition to salary during the notice period, be entitled to severance payment corresponding to 12 months’ base salary. The notice period for other senior executives shall not exceed 12 months. In case of termination from the company, in addition to salary during the notice period, severance payment corresponding to an amount equal to up to 12 months base salary may be paid.  

At the time of the annual shareholders’ meeting on 22 May 2018, the company has no outstanding remuneration commitments towards senior executives except for running commitments. 

To the extent that a member of the board of directors performs consultancy work on behalf of the company, in addition to the assignment as member of the board of directors, consultancy fees and other remuneration for such consultancy work should be payable. Such remuneration shall be paid on market terms and the remuneration as well as other terms shall be resolved upon by the board of directors. 

The board of directors shall be entitled to deviate from the guidelines in individual cases if there are special reasons for doing so.

Item 14: Resolution on implementation of a long-term incentive program for senior executives by way of (A) directed issue of warrants; and (B) approval of transfer of warrants 

The board of directors proposes that the annual shareholder’s meeting resolves to implement a long-term incentive program for senior executives (the ”Warrants Program 2018/2021”). 

To implement the Warrants Program 2018/2021, the board of directors proposes that the annual shareholders’ meeting resolves on (A) directed issue of warrants; and (B) approval of transfer of warrants, on the following terms and conditions:

A. Directed issue of warrants 

A maximum of 1,175,000 warrants shall be issued for the Warrants Program 2018/2021.

With deviation from the shareholders’ preferential rights, the right to subscribe for the warrants shall only vest in a wholly owned subsidiary within the group (the “Subsidiary”). The reason for the deviation from the shareholders’ preferential rights is that the warrants shall be used within the Warrants Program 2018/2021.  

The Subsidiary’s subscription shall be made at the latest on 30 June 2018, with a right for the board of directors to prolong the subscription period. 

Over subscription cannot occur.

The warrants shall be issued to the Subsidiary free of charge. The reason for the warrants being issued to the Subsidiary free of charge is that the warrants are issued as part of the implementation of the Warrants Program 2018/2021. 

Each warrant shall entitle to subscription of one new ordinary share in the company. 

The subscription price per share shall correspond to 125 per cent of the volume weighted average price according to Nasdaq Stockholm’s official price list for shares in the company during the period as from 14 May 2018 to and including 18 May 2018. The subscription price shall be rounded to the nearest whole öre, whereupon 0.5 öre shall be rounded upwards. 

Subscription of shares by virtue of the warrants may be effected as from 1 June 2021 up to and including 30 June 2021. 

A share that has been issued upon subscription will entitle to dividends for the first time on the first record date for dividend occurring after subscription of shares through exercise of warrants has been executed. 

The subscription price and the number of shares that each warrant confers right to subscribe for shall be subject to recalculation in consequence of a bonus issue, split, rights issue, and/or other similar company actions. 

In case all warrants are exercised for subscription of new shares, the share capital will increase with SEK 734,375. 

The chairman of the board of directors, or anyone appointed by him, shall be authorized to make minor formal adjustments of the resolution which may be required for registration with the Swedish Companies Registration Office (Sw. Bolagsverket) or Euroclear Sweden AB. 

B. Transfer of warrants 

The Warrants Program 2018/2021 shall principally be carried out in accordance with what is stated below. 

The Subsidiary shall be entitled to transfer warrants against payment to participants in the Warrants Program 2018/2021 in accordance with the guidelines set out below. 

Transfer of warrants to participants in the Warrants Program 2018/2021 shall be made at fair market value at the time of the transfer which shall be established by Öhrlings Pricewaterhouse Coopers AB, as an independent valuation institute, in accordance with the Black Scholes formula. 

The board of directors of the company shall resolve upon allotment to participants in the Warrants Program 2018/2021 in accordance with the following guidelines: 

Allotment to the participants in the Warrants Program 2018/2021 shall occur no later than on 30 June 2018.

A participant can subscribe for a lower number of warrants compared to what is offered to the participant. Over subscription cannot occur.  

Right to allotment in the Warrants Program 2018/2021 requires that the participant at the time of allotment holds a position in the company (or another company in the group) or has signed an agreement regarding it and has not, at such time, informed or been informed that the employment will be terminated. 

For participants in other jurisdictions than Sweden, it is implied that transfer of the warrants is legally possible and that transfer, in the board of director’s opinion, can be carried out with reasonable administrative and financial efforts at the established market value of the warrants. The board of directors shall have the right to adjust the terms of the Warrants Program 2018/2021 to the extent required in order for allotment of warrants to participants in other jurisdictions, to the extent practically possible, to be carried out under the same conditions imposed by the Warrants Program 2018/2021. 

Reasons for the Warrants Program 2018/2021 and the deviation from the shareholders’ preferential rights

The reasons for the implementation of the Warrants Program 2018/2021 and the deviation from the shareholders’ preferential rights for subscription of the new warrants are to be able to create possibilities for the company to retain senior executives by offering a long term ownership engagement. Such ownership engagement is expected to contribute to an increased alignment of interests between the participating senior executives and the shareholders, and also promote a long-term commitment to the company’s development.

Costs, impact on key ratios, existing incentive programs and dilution 

Since the warrants in the Warrants Program 2018/2021 will be transferred to the participants at market value, the company’s assessment is that the company will not incur any social costs in relation to the Warrants Program 2018/2021. The company’s costs related to the Warrants Program 2018/2021 will hence only be composed of limited costs for implementation and administration of the program.

As per the date of the notice, the number of shares in the company amounts to 50,811,866. In addition thereto, warrants have been issued in connection with a previous financing agreement which could result in a maximum of 599,114 additional shares being issued. 

In case all warrants issued in connection with the Warrants Program 2018/2021 are exercised for subscription of new shares, a total of 1,175,000 new shares will be issued, which corresponds to a dilution of approximately 2.26 per cent of the company’s share capital and votes after full dilution, calculated on the number of shares that will be added upon full utilization of all warrants issued under the Warrants Program 2018/2021. The key figure earnings per share for the full year 2017 had then been changed in such way that the result per share had been changed from SEK – 3.24 to SEK –3.14. The dilution calculation as described above does not consider the shares that may be issued in connection with an exercise of the warrants which have been issued in connection with the previous financing agreement. In case these warrants are to be considered as well, the maximum total dilution from the Warrants Program 2018/2021 amounts to approximately 2.23 per cent.

There are currently incentive programs in the form of three employee option programs and one warrant program outstanding in the company. In case all warrants issued in connection with the outstanding programs, and which still can be exercised, are exercised for subscription of new shares, a total amount of 2,564,710 new shares will be issued. In addition to the Warrants Program 2018/2021, the board of directors has also proposed that the annual shareholders’ meeting resolves to implement a long-term incentive program for employees in the form of a performance-based share saving program in connection with which a total of 500,000 new shares may be issued and the Nomination Committee has proposed that the annual shareholders’ meeting also resolves to implement a long-term incentive program for certain members of the board of directors in the form of a performance-based share saving program in connection with which a total of 120,000 new shares may be issued. In case all outstanding incentive programs as well as the incentive programs proposed for resolution by the annual shareholders’ meeting are exercised in full, a total of 4,359,710 new shares will be issued, which corresponds to a total dilution of approximately 7.90 per cent of the company’s share capital and votes after full dilution, calculated on the number of shares that will be added upon full utilization of all outstanding and proposed incentive programs. The dilution calculation as described above does not consider the shares that may be issued in connection with an exercise of the warrants which have been issued in connection with the previous financing agreement. In case these warrants are to be considered as well, the maximum total dilution from existing and proposed incentive programs amounts to approximately 7.82 per cent.

The above calculations regarding dilution and impact on key ratios are subject to re-calculation of the warrants in accordance with the customary recalculation terms set out for the programs. 

Preparation of the proposal 

The proposal of the Warrants Program 2018/2021 has been prepared by the Remuneration Committee with advice from external consultants. The final proposal has been resolved by the board of directors.

Item 15: Resolution on amendment of the Articles of Association 

The board of directors of proposes that the annual shareholders’ meeting resolves, in order to enable issuance of series C shares under share saving programs, to incorporate a new § 6 in the company’s Articles of Association in accordance with the following wording. Following the incorporation of the new section in the Articles of Association, the already existing shares shall be ordinary shares.

“6 § Classes of shares 

Shares may be issued in two classes, ordinary shares and series C shares. The ordinary shares shall carry one vote per share and series C shares shall carry one-tenth of a vote per share. Shares of either share class may be issued up to an amount corresponding to the full share capital. 

Series C shares do not entitle to dividends. Upon the dissolution of the company, series C shares shall carry equivalent right to the company’s assets as other shares, however, not to an amount exceeding the quota value of the share. 

If the company resolves to issue new ordinary shares and series C shares, against payment other than contribution in kind, owners of ordinary shares and series C shares shall have pre-emption rights to subscribe for new shares of the same class pro rata to the number of shares previously held by them (primary pre-emption right). Shares which are not subscribed for pursuant to the primary pre-emption rights shall be offered to all shareholders for subscription (secondary preemption right). If the shares thus offered are not sufficient for the subscription pursuant to the secondary pre-emption rights, the shares shall be allocated between the subscribers pro rata to the number of shares previously held and, to the extent such allocation cannot be effected, by the drawing of lots.

If the company resolves to issue new shares of either solely ordinary shares or series C shares, against payment other than contribution in kind, all shareholders shall, irrespective of whether their shares are ordinary shares or series C shares, have pre-emption rights to subscribe for new shares pro rata to the number of shares previously held by them. 

What is set out above with regard to pre-emption rights shall apply mutatis mutandis in the event of issues of warrants and convertible bonds, and shall not limit the right to resolve upon an issue with deviation from the shareholders’ pre-emption rights. 

In the event of a bonus issue, new shares of each class shall be issued pro rata to the number of shares of the same class previously issued. In connection therewith, the owners of existing shares of a certain class shall entitle the holder to new shares of the same class. This shall not entail any restrictions on the possibility of issuing new shares of a new class by means of a bonus issue, following the required amendments of the Articles of Association. 

Reduction of share capital, which in any case shall not fall below the minimum share capital, may, at the request of a holder of a series C share and after resolution by the company’s board of directors or a shareholders’ meeting, take place through redemption of series C shares. A request from a shareholder must be submitted in writing. When a resolution on reduction has been passed, an amount corresponding to the reduction amount shall be transferred to the company’s reserve fund, if the required funds are available. The redemption amount per series C share shall be the quota value of such share. 

Following receipt of the redemption resolution, holders of shares subject to redemption shall promptly receive payment for the shares, or, if authorization for the redemption from the Swedish Companies Registration Office (Sw. Bolagsverket) or a court is required, following the receipt of notice that the final and effected resolution has been registered. 

Series C shares held by the company may, upon resolution of the board of directors be reclassified into ordinary shares. Immediately thereafter, the board of directors shall register the reclassification with the Swedish Companies Registration Office. The reclassification is effected when it has been registered and the reclassification been reflected in the central securities depository register.”

As a result of the incorporation of the new section, the existing sections 6 – 11 of the Articles of Association will be renumbered. 

Item 16: Resolution on implementation of a long-term incentive program for employees by way of (A) implementation of a performance-based share saving program; (B) authorization on directed issues of series C shares; (C) authorization on repurchase of series C shares; and (D) resolution on transfer of own ordinary shares 

The board of directors proposes that the annual shareholder’s meeting resolves to implement a long-term incentive program in the form of a performance-based share saving program (the “LTI 2018”) for employees in accordance with A below. The resolution shall be conditional upon that the annual shareholders’ meeting also resolves to amend the Articles of Association in accordance with a separate proposal whereby the possibility to issue series C shares is introduced and that the annual shareholders’ meeting also resolves on hedging measures in accordance with B – D below.

A. Implementation of a performance-based share saving program 

Background 

The overall purpose with LTI 2018 is to align the interests of the employees with those of the shareholders and thus ensure a maximum long-term value adding commitment. LTI 2018 is also considered to create a long-term focus on increase in earnings and growth among the participants. LTI 2018 is further considered to facilitate for the company to recruit and retain employees.

Terms and conditions for LTI 2018 

As a starting point, LTI 2018 shall comprise employees who do not participate in any outstanding share-related incentive programs in the company prior to the annual shareholders’ meeting on 22 May 2018. However, the company’s CFO shall have the right to participate in LTI 2018 even though he is a participant in a share-related incentive program since previously, and the board of directors may in addition to that, in exceptional cases, also resolve that up to five employees in the category “Other employees” who participate in share-related incentive programs since previously shall be entitled to participate in LTI 2018. 

In total, LTI 2018 is considered to comprise up to approximately 25 employees. In order to be entitled to participate in LTI 2018, it is required that the participant has been employed by the company or another company within the Group at the latest on the date of expiration of the Investment Period in accordance with the below. 

LTI 2018 means that the participants will invest in ordinary shares in the company (”Saving Shares”). In order to be entitled to participate in LTI 2018, each participant must at least acquire the number of Savings Shares which has been specified for each category below (which amount also corresponds to the maximum number of Saving Shares that each participant in each category may acquire within the framework of LTI 2018). The investment in Saving Shares shall be made through acquisition of ordinary shares on the stock market on 31 December 2018 at the latest (the "Investment Period").

If the Saving Shares are retained as from the expiration of the Investment Period to and including 31 December 2021 (the “Saving Period”) and the participant has continued to be employed by the company throughout the Saving Period, the participant is entitled to allotment of additional ordinary shares in the company free of charge (the “Performance Shares”), provided that the performance targets (the “Performance Targets”) mentioned below are achieved or exceeded. 

Participants shall acquire the following number of Saving Shares and shall have the opportunity to be allotted with up to the following number of Performance Shares per Saving Share. 

The total number of Performance Shares shall not exceed 500,000.  

The Performance Targets that have to be achieved or exceeded relate to (i) the share price development of the company’s shares (the “Share Price Target”), (ii) the net sales for each respective financial year of 2018-2021 (the “Sales Target”), and (iii) the EBITDA for each respective financial year of 2018-2021 (the “EBITDA Target”), whereby each Performance Target is weighted by 1/3 and with regard to the Sales Target and EBITDA Target, each respective financial year is weighted by 1/4.

The Share Price Target relates to the development of the company’s share price over the period from the date of the annual shareholders’ meeting 2018 to and including 31 December 2021. The share price development will be measured based on the volume weighted average share price 30 trading days immediately following the annual general meeting 2018 and 30 trading days immediately preceding 31 December 2021. An increase in the share price with less than 25 per cent does not entitle to any vesting of any of the Performance Shares pertaining to the Share Price Target and an increase in the share price with 100 per cent or more does entitle a vesting of all of the Performance Shares pertaining to the Share Price Target. In the event of an increase in the share price of between 25 and 100 per cent, vesting of the Performance Shares pertaining to the Share Price Target will occur linearly. 

The Sales Target and the EBITDA Target for each respective financial year shall be determined by the board of directors annually and with regard to the financial year 2018, before LTI 2018 is of fered to the participants. For each respective target, a minimum level and a maximum target level shall be determined for each respective financial year. If the minimum level is not achieved, no Performance Shares are vested in relation to the actual Performance Target for the financial year and if the maximum target level is achieved, full vesting shall take place of the Performance Shares pertaining to the actual Performance Target for the financial year. If the minimum level is exceeded but the maximum target level is not achieved, vesting of the Performance Shares pertaining to the actual Performance Target for the financial year will occur linearly. The board of directors intends to present the determined targets regarding the Sales Target and the EBITDA Target as well as the achievement of these in connection with the expiration of LTI 2018 at the latest.

The final number of Performance Shares vested by each participant shall be rounded downwards to the nearest whole number. 

Before the number of Performance Shares to be allocated is finally determined, the board of directors shall evaluate if allocation pursuant to the principles set out above is reasonable, having regard to the company’s results and financial standing, to conditions on the stock market and to other circumstances in general. If the board of directors finds that it is not reasonable, then the board of directors may decrease the number of Performance Shares to be allocated to the lower number of shares that the board of directors finds reasonable. 

The number of Performance Shares that may be allotted by virtue of Saving Shares shall be subject to recalculation in consequence of a bonus issue, split, rights issue, and/or other similar company actions.

Allotment of Performance Shares shall take place within 30 days from the publication of the yearend report for the financial year 2021. 

Participation in LTI 2018 presupposes that the participation is legally possible and that the participation in the company’s sole opinion can be made with reasonable administrative costs for the company.

The board of directors shall be responsible for the details and management of LTI 2018 within the framework of the main conditions as set out above, and the board of directors shall be authorized to make minor adjustments to these conditions as required by law or for administrative reasons. The board of directors shall also be authorized to adjust or deviate from the terms and conditions as required by local laws and regulations as well as existing market practices. Furthermore, in the event of a public take-over offer, a sale of the company’s business, liquidation, merger or any other such transaction affecting the company, the board of directors shall, at its sole discretion, be entitled to resolve that the Performance Shares (partially or in full) shall vest and be allotted on completion of such transaction. The board of directors will make this resolution based on the level of achievement of the Performance Targets, the remainder of the Saving Period and any other factors deemed relevant by the board of directors.

B. Authorization on directed issues of series C shares 

The board of directors proposes that the annual shareholders’ meeting resolves to authorize the board of directors, for the period up until the next annual shareholders’ meeting, on one or several occasions, to issue a maximum of 500,000 series C shares. The new shares may, with deviation from the shareholders' preferential rights, only be subscribed for by a bank or a securities company at a subscription price which corresponds to the quota value of the shares. The purpose of the authorization and the reason for the deviation from the shareholders' preferential rights in connection with an issue of shares is to secure delivery of Performance Shares under LTI 2018, which shall be effected through the company repurchasing the series C shares issued pursuant to the authorization in section C below and thereafter, when the series C shares have been converted to ordinary shares, by transferring ordinary shares to the participants in LTI 2018 in accordance with section D below. 

C. Authorization on repurchase of series C shares

The board of directors proposes that the annual shareholders’ meeting resolves to authorize the board of directors, for the period up until the next annual shareholders’ meeting, on one or several occasions, to repurchase its own series C shares. Repurchase may only be effected through a public offer directed to all holders of series C shares and shall comprise all outstanding series C shares. Repurchase may also be made of so-called interim shares, by Euroclear Sweden AB designated as a Paid Subscribed Share (Sw. Betald Tecknad Aktie (BTA)), regarding a series C share. Repurchase shall be made at a purchase price per share which corresponds to the quota value of the share. The purpose of the proposed repurchase authorization is to secure delivery of Performance Shares under LTI 2018.

D. Resolution on transfer of own ordinary shares

In order to fulfil the company’s obligations towards participants in LTI 2018, the board of directors proposes that the annual shareholders’ meeting resolves that the company shall be entitled to transfer the company’s own ordinary shares as follows: 

The company shall have the right to transfer the number of ordinary shares that the Company has a maximum obligation to allocate as Performance Shares to participants in LTI 2018, at most 500,000 shares. 

The number of shares that may be transferred pursuant to LTI 2018 shall be subject to recalculation in consequence of a bonus issue, split, rights issue, and/or other similar corporate action which affects the number of shares in the company. 

The right to acquire ordinary shares shall, with deviation from the shareholders’ preferential rights, vest in participants in LTI 2018 who are entitled to be allotted Performance Shares in accordance with the terms and conditions of the program. 

Transfer of shares to participants in LTI 2018 shall be made free of charge and be executed at the relevant time specified in the terms and conditions for LTI 2018. 

The reason for the deviation from the shareholders' preferential rights in connection with the transfers of own ordinary shares is to enable the company’s delivery of Performance Shares to participants in LTI 2018. 

Costs, impact on key ratios, existing incentive programs and dilution 

LTI 2018 will be accounted for in accordance with IFRS 2 which stipulates that the right to receive Performance Shares shall be expensed as a personnel cost over the vesting period.

The board of directors has made a preliminary cost calculation for LTI 2018, which is based on a price per share of SEK 30 at the final allocation, that each participant makes an investment in Saving Shares which qualifies for participation in LTI 2018 and that the maximum number of Performance Shares is allotted. The value of the Performance Shares has been calculated based on a share price of SEK 15 per share in connection with the implementation of LTI 2018. Based on the above assumptions, the value of each Performance Share related to the Sales Target and the EBITDA Target, respectively has been calculated to SEK 15 and the value of each Performance Share related to the Share Price Target has been calculated to SEK 5.67. 

Overall, this results in a maximum cost for LTI 2018 of approximately SEK 5.9 million, excluding costs for social security contributions. The total costs for social security contributions, based on the assumption of a 100 per cent share price increase until the time of allocation of Performance Shares, is estimated to amount to a maximum of approximately SEK 4.7 million.

As per the date of the notice, the number of shares in the company amounts to 50,811,866. In addition thereto, warrants have been issued in connection with a previous financing agreement which could result in a maximum of 599,114 additional shares being issued. 

The maximum number of Performance Shares amounts to 500,000, which corresponds to a dilution of approximately 0.97 per cent of the company’s share capital and votes after full dilution, calculated on the number of shares that will be added upon full issuance of Performance Shares in connection with LTI 2018. 

Based on the calculation of cost and the dilution as per the above, the key figure earnings per share for the full year 2017 had been changed from SEK –3.24 to SEK –3.28. 

The dilution calculation as described above does not consider the shares that may be issued in connection with an exercise of the warrants which have been issued in connection with the previous financing agreement. In case these warrants are to be considered as well, the maximum total dilution from LTI 2018 amounts to approximately 0.96 per cent.

Information on existing incentive programs and dilution effects are presented above in the proposal under item 14. 

Preparation of the proposal 

The proposal for LTI 2018 has been prepared by the Remuneration Committee together with external consultants. The final proposal has been resolved upon by the board of directors. 

Item 17: Resolution on implementation of a long-term incentive program for certain members of the board of directors by way of (A) implementation of a performance-based share saving program; (B) authorization on directed issues of series C shares; (C) authorization on repurchase of series C shares; and (D) resolution on transfer of own ordinary shares 

The Nomination Committee proposes that the annual shareholder’s meeting resolves to implement a long-term incentive program in the form of a performance-based share saving program (the “Board LTI 2018”) for certain members of the board of directors in accordance with A below. The resolution shall be conditional upon that the annual shareholders’ meeting also resolves to amend the Articles of Association in accordance with a separate proposal whereby the possibility to issue series C shares is introduced and that the annual shareholders’ meeting also resolves on hedging measures in accordance with B – D below.

A. Implementation of a performance-based share saving program 

Background

Board LTI 2018 has been initiated and prepared by the Nomination Committee, considering that the company competes for qualified board members in an internationally competitive market. The overall purpose with Board LTI 2018 is to align the interests of the members of the board of directors with those of the shareholders and thus ensure a maximum long-term value adding commitment. Board LTI 2018 is also considered to create a long-term focus on increase in earnings and growth among the participants.

Terms and conditions for Board LTI 2018 

Board LTI 2018 shall comprise the members of the board of directors, Simon Cartmell, Tone Kvåle and Lennart Johansson. The members of the board of directors, Håkan Björklund, Björn Odlander and Nina Rawal, who are linked to the company’s principal shareholders Tellacq AB, HealthCap V L.P. and Stiftelsen Industrifonden, and the member of the board of directors, Lars Lidgren, who is the founder of the company, shall not be comprised of Board LTI 2018. 

Board LTI 2018 means that the participants will invest in ordinary shares in the company (”Saving Shares”). In order to be entitled to participate in Board LTI 2018, each participant must at least acquire the number of Savings Shares which has been specified for each participant below (which amount also corresponds to the maximum number of Saving Shares that each participant may acquire within the framework of Board LTI 2018). The investment in Saving Shares shall be made through acquisition of ordinary shares on the stock market on 31 December 2018 at the latest (the "Investment Period").

If the Saving Shares are retained as from the expiration of the Investment Period to and including 31 December 2021 and the participant has continued to be a member of the board of directors of the company until the date of when the annual shareholders’ meeting 2021 is held (i.e. most likely in May 2021), the participant is entitled to allotment of additional ordinary shares in the company free of charge (the “Performance Shares”), provided that the performance target (the “Performance Target”) mentioned below is achieved or exceeded. 

Participants shall acquire the following number of Saving Shares and shall have the opportunity to be allotted with up to the following number of Performance Shares per Saving Share. 

The total number of Performance Shares shall not exceed 120,000. 

The Performance Target that has to be achieved or exceeded relates to the development of the company’s share price over the period from the date of the annual shareholders’ meeting 2018 to and including 31 December 2021. The share price development will be measured based on the volume weighted average share price 30 trading days immediately following the annual general meeting 2018 and 30 trading days immediately preceding 31 December 2021. An increase in the share price with less than 25 per cent does not entitle to any vesting of Performance Shares and an increase in the share price with 100 per cent or more does entitle a vesting of all Performance Shares. In the event of an increase in the share price of between 25 and 100 per cent, vesting of Performance Shares will occur linearly. 

The final number of Performance Shares vested by each participant shall be rounded downwards to the nearest whole number. 

The number of Performance Shares that may be allotted by virtue of Saving Shares shall be subject to recalculation in consequence of a bonus issue, split, rights issue, and/or other similar company actions.

Allotment of Performance Shares shall take place within 30 days from the publication of the yearend report for the financial year 2021. 

Participation in Board LTI 2018 presupposes that the participation is legally possible and that the participation in the company’s sole opinion can be made with reasonable administrative costs for the company. 

The company’s Remuneration (excluding the participants, if applicable) shall be responsible for the management of Board LTI 2018 within the framework of the conditions as set out above, and the board of directors shall be authorized to make minor adjustments to these conditions as required by law or for administrative reasons. The Remuneration Committee shall also be responsible for any recalculations in accordance with the above. 

In the event of a public take-over offer, a sale of the company’s business, liquidation, merger or any other such transaction, all Performance Shares shall be deemed to be immediately vested and shall be allotted on completion of such transaction provided that the participant at the relevant point of time of such transaction (i) still is a member of the board of directors; and (ii) still holds all Saving Shares. 

B. Authorization on directed issues of series C shares  

The Nomination Committee proposes that the annual shareholders’ meeting resolves to authorize the board of directors, for the period up until the next annual shareholders’ meeting, on one or several occasions, to issue a maximum of 120,000 series C shares, wherein the final number of series C shares that may be issued shall be determined to correspond with the maximum amount of Performance Shares that may need to be issued in relation to Board LTI 2018. The new shares may, with deviation from the shareholders' preferential rights, only be subscribed for by a bank or a securities company at a subscription price which corresponds to the quota value of the shares. The purpose of the authorization and the reason for the deviation from the shareholders' preferential rights in connection with an issue of shares is to secure delivery of Performance Shares under Board LTI 2018, which shall be effected through the company repurchasing the series C shares issued pursuant to the authorization in section C below and thereafter, when the series C shares have been converted to ordinary shares, by transferring ordinary shares to the participants in Board LTI 2018 in accordance with section D below. 

C. Authorization on repurchase of series C shares 

The Nomination Committee proposes that the annual shareholders’ meeting resolves to authorize the board of directors, for the period up until the next annual shareholders’ meeting, on one or several occasions, to repurchase its own series C shares. Repurchase may only be effected through a public offer directed to all holders of series C shares and shall comprise all outstanding series C shares. Repurchase may also be made of so-called interim shares, by Euroclear Sweden AB designated as a Paid Subscribed Share (Sw. Betald Tecknad Aktie (BTA)), regarding a series C share. Repurchase shall be made at a purchase price per share which corresponds to the quota value of the share. The purpose of the proposed repurchase authorization is to secure delivery of Performance Shares under Board LTI 2018. 

D. Resolution on transfer of own ordinary shares

In order to fulfil the company’s obligations towards participants in Board LTI 2018, the Nomination Committee proposes that the annual shareholders’ meeting resolves that the company shall be entitled to transfer the company’s own ordinary shares as follows:

The company shall have the right to transfer the number of ordinary shares that the company has a maximum obligation to allocate as Performance Shares to participants in Board LTI 2018, at most 120,000 shares. 

The number of shares that may be transferred pursuant to Board LTI 2018 shall be subject to recalculation in consequence of a bonus issue, split, rights issue, and/or other similar corporate action which affects the number of shares in the company. 

The right to acquire ordinary shares shall, with deviation from the shareholders’ preferential rights, vest in participants in Board LTI 2018 who are entitled to be allotted Performance Shares in accordance with the terms and conditions of the program. 

Transfer of shares to participants in Board LTI 2018 shall be made free of charge and be executed at the relevant time specified in the terms and conditions for Board LTI 2018. 

The reason for the deviation from the shareholders' preferential rights in connection with the transfers of own ordinary shares is to enable the company’s delivery of Performance Shares to participants in Board LTI 2018. 

Costs, impact on key ratios, existing incentive programs and dilution 

Board LTI 2018 will be accounted for in accordance with IFRS 2 which stipulates that the right to receive Performance Shares shall be expensed as a personnel cost over the vesting period. 

The Nomination Committee has made a preliminary cost calculation for Board LTI 2018, which is based on a price per share of SEK 30 at the final allocation, that each participant makes an investment in Saving Shares which qualifies for participation in Board LTI 2018 and that the maximum number of Performance Shares is allotted. The value of the Performance Shares has been calculated based on a share price of SEK 15 per share in connection with the implementation of Board LTI 2018. Based on the above assumptions, the value of each Performance Share has been calculated to SEK 5.67.

Overall, this results in a maximum cost for Board LTI 2018 of approximately SEK 0.7 million, excluding costs for social security contributions. The total costs for social security contributions, based on the assumption of a 100 per cent share price increase until the time of allocation of Performance Shares, is estimated to amount to a maximum of approximately SEK 1.1 million. 

As per the date of the notice, the number of shares in the company amounts to 50,811,866. In addition thereto, warrants have been issued in connection with a previous financing agreement which could result in a maximum of 599,114 additional shares being issued. 

The maximum number of Performance Shares amounts to 120,000, which corresponds to a dilution of approximately 0.24 per cent of the company’s share capital and votes after full dilution, calculated on the number of shares that will be added upon full issuance of Performance Shares in connection with Board LTI 2018. 

Based on the calculation of cost and the dilution as per the above, the key figure earnings per share for the full year 2017 would have been unchanged. 

The dilution calculation as described above does not consider the shares that may be issued in connection with an exercise of the warrants which have been issued in connection with the previous financing agreement. In case these warrants are to be considered as well, the maximum total dilution from Board LTI 2018 amounts to approximately 0.23 per cent. 

Information on existing incentive programs and dilution effects are presented above in the proposal under item 14. 

Preparation of the proposal 

The proposal for Board LTI 2018 has been prepared by the Nomination Committee together with external consultants. However, the chairman of the board of directors, Håkan Björklund, has not participated in the Nomination Committee’s preparation of the proposal.  

Particular majority requirements 

For a valid resolution on the proposal pursuant to item 15, the proposal has to be supported by shareholders representing at least two-thirds of the votes cast as well as of all shares represented at the annual shareholders’ meeting. For a valid resolution on the proposals pursuant to items 14, 16 and 17, the proposals have to be supported by shareholders representing at least nine-tenths of the votes cast as well as of all shares represented at the annual shareholders’ meeting. 

Duty of disclosure at the annual shareholders' meeting

The board and the CEO shall at the annual shareholders’ meeting, if any shareholder so requests and the board believes that it can be done without significant harm to the company, provide information regarding circumstances that may affect the assessment of items on the agenda, circumstances that can affect the assessment of the company’s or its subsidiaries financial position and the company’s relation to other companies within the group.

Accounting documents and complete proposals 

Accounting documents, the audit report, the statement by the auditor on the compliance of the applicable guidelines for remuneration to senior executives as well as complete proposals for resolutions and the board of directors’ statement pursuant to Chapter 19, Section 22 of the Swedish Companies Act will be made available for the shareholders at the company’s office at Scheelevägen 19, SE-223 70 Lund, Sweden and at the company website (www.bonesupport.com) as from no later than three weeks prior to the annual shareholders’ meeting. Copies of the documents will be sent to the shareholders upon their request to the company, provided that such shareholders state their address, and will also be made available at the annual shareholders’ meeting. 

Number of shares and votes in the company 

As per the date of this notice, the total number of shares and votes in the company amounts to 50,811,866. The company does not hold any own shares.

Lund, Sweden, 08.00 CET, 21 March 2018 – BONESUPPORT^TM, an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT^® platform announces that three papers based on the successful use of CERAMENT^® G to treat bone infections were presented at the British Limb Reconstruction Society (BLRS) Meeting 2018, which took place from the 15-16th March in Southampton.

One of the papers, entitled ‘The choice of local antibiotic carrier significantly affects outcome in treatment of chronic bone infection’ by J Ferguson, M Mifsud, D Stubbs and MA McNally, compared the use of CERAMENT^® G in 160 patients with chronic bone infection (mean follow-up 1.4 years) vs the use of Osteoset^® T in 137 patients with chronic bone infection (mean follow-up 2.5 years).The data presented showed that CERAMENT^® G demonstrates significantly better bone healing and is associated with a lower rate of recurrent infection, wound leakage and subsequent fracture risk.

A second of the papers was ‘Internal Fixation and Local Antibiotics for Infected Non-unions; technique and outcome at over one year’ by MA McNally, J Ferguson, M Mifsud and D Stubbs. In a series of 12 cases of infected non-union and segmental bone loss up to 1cm treated by intramedullary nails/plates and CERAMENT^® G, all patients were infection free at a mean follow-up of 23 months and union was achieved in 92% of patients with primary surgery alone.  

The final paper presented was ‘Outcomes of simultaneous Ilizarov frame reconstruction and free muscle flaps in the management of complex limb infection’ by M Mifsud, J Ferguson, D Stubbs, A Ramsden and MA McNally. In a series of 56 patients (34 osteomyelitis and 22 infected non-unions) treated by Ilizarov reconstruction (a type of external fixation), muscle flaps and CERAMENT^® G, at a mean follow-up of 22 months, 97.7% had achieved bony union. Recurrence rate of infection in this very challenging subgroup of patients was 8.9%.

Mr Martin McNally, Consultant Bone Infection and Limb Reconstruction Surgeon at Oxford University Hospitals (Oxford, UK) and co-author on all papers presented, said: “The papers we have presented at BLRS continue to emphasise the important benefits that CERAMENT^® G can provide in various bone infection situations across large numbers of patients. Its ability to prevent infection recurrence through local antibiotic delivery whilst simultaneously allowing for bone remodelling offers advantages including reduced readmission rates and number of operations for patients.”

BLRS brings together surgeons and associated professionals with the aim of advancing education and research in the field of limb reconstruction.

Lund, Sweden, 08.00 CET, 13 March 2018 – BONESUPPORT^TM, an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT^® platform announces that Emil Billbäck, its recently appointed Chief Executive Officer, purchased 60,000 shares in the Company at a price of SEK 15.07 per share on Friday 9 March.

Björn Westberg, the Company’s Chief Financial Officer,  bought 20,000 BONESUPPORT shares yesterday at a price of SEK 14.80 per share. Mr Westberg has purchased a total of 60,000 BONESUPPORT shares since the Company’s IPO in June 2017. In addition to his shareholding he holds warrants, which he purchased when he joined the Company in early 2017.

Lund, Sweden, 08.00 CET, 9 March 2018 – BONESUPPORT^TM, an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT^® platform announces that it will give two oral presentations and a poster presentation at the upcoming Orthopaedic Research Society (ORS) 2018 Annual Meeting. The meeting takes place from March 10-13 at the Hyatt Regency New Orleans in New Orleans, LA and is the leading forum for the presentation of high-quality, innovative and transformative orthopaedic research.

The research to be presented was undertaken by BONESUPPORT^TM in collaboration with Lund University in Sweden.

Jerry Chang, Executive Vice President R&D, Regulatory and Clinical, commented:

“We are extremely pleased to be covering important new data via these three presentations at ORS. The data further highlights the benefits of our CERAMENT^® platform due to its ability to remodel to host bone, as well as its capability to effectively deliver bone growth factors locally to aid bone formation. This research reaffirms our confidence in the potential of our preclinical pipeline, focused on exploiting the drug eluting properties of CERAMENT^® based carriers, in meeting global unmet needs in both fracture repair and prevention.”

The details of the presentations are as follows:

Oral presentations

1. Paper Title: An Injectable Calcium Sulphate/Hydroxyapatite Biomaterial Delivering rhBMP-2 and ZA for Bone Regeneration in the Femoral Canal of Osteoporotic Rats
   

   Authors: Aurimas Širka, Deepak Bushan Raina, Hanna Isaksson, Elizabeth Tanner, Alfredas Smailys, Šarūnas Tarasevičius, Magnus Tägil, Lars Lidgren

   Date & Time: Saturday, March 10, 2018. 3:00 PM - 3:10 PM

   Presenter: Aurimas Širka (Orthopaedic Surgeon, combined PhD program at the Lithuanian University of Health Sciences and Lund University, Sweden)

    

2. Paper title: The Effect Of A Biphasic Apatite/Calcium Sulfate Bone Graft Substitute Conjugated With Different Dosages Of Bisphosphonate On Bone Defect Healing In Rats
   

   Authors: Christina Perdikouri, Eva Lidén, Michael Diefenbeck

   Date & Time: Tuesday March 13, 2018. 8:14 AM – 8:21 AM

   Presenter: Christina Perdikouri (BONESUPPORT R&D Scientist, PhD)

    

Poster presentation

Poster and paper title: In-vitro And In-vivo Carrier Properties Of A Macroporous Composite Biomaterial For Sustained Delivery Of Bone Morphogenic Protein-2 And Zoledronic Acid

Authors: Deepak Raina, David Larsson, Filip Mrkonjic, Hanna Isaksson, Ashok Kumar, Lars Lidgren, Magnus Tägil

The paper will be presented in poster session “Biomaterials – Technologies” and as a 1-minute poster teaser presentation.

Poster Session:

Date & Time: Monday March 12, 3:15 PM – 4:15 PM

Presenter: Deepak Raina (Department of Orthopaedics, Medical Faculty, Lund University, Sweden)

Poster Teaser Presentation:

Date & Time: Saturday March 10. Presentation as part of poster teaser session 2:15 PM - 3:20 PM; presentation time: 2:47pm - 2:48pm

Presenter(s): Deepak Raina (Department of Orthopaedics, Medical Faculty, Lund University, Sweden)

Lund, Sweden, 08.00 CET, 5 March 2018 – BONESUPPORTTM, an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT^® platform announces that it will present at the Canaccord Musculoskeletal Conference on Tuesday 6 March at 10.00 am EST in New Orleans, US

Patrick O’Donnell, General Manager & Executive Vice President of Commercial Operations US, will present at the Conference. His presentation will provide an overview of the Company’s proprietary CERAMENT platform and its products which provide clear benefits to patients, surgeons and payors through their ability to remodel to host bone and to protect the healing process from infection in the case of CERAMENT^® G&V*. Reducing infection rates in orthopedic surgery is a key objective in order to decrease the patient’s length of stay and the number of readmissions following the primary procedure.

The presentation will also cover recent progress made with the Company’s growth strategy which is focused on driving the sales of BONESUPPORT’s currently marketed products, generating further clinical data to drive their adoption in major indications such as trauma and revision arthroplasty and completing the FORTIFY study which is designed to support a planned Premarket Approval (PMA) filing with CERAMENT G in 2020.

BONESUPPORT™ intends to have a number of one on one investor meetings at the Canaccord Musculoskeletal Conference.

BONESUPPORT™ will also be exhibiting at the American Academy of Orthopaedic Surgeons 2018 Annual Meeting, which takes place from 6-10 March in New Orleans, US.

Lund, Sweden, 18:00 CET 28 February 2018 - During February, the number of shares and votes in BONESUPPORT HOLDING AB (publ) has increased due to the exercise of warrants. As of
28 February 2018, the number of shares and votes in BONESUPPORT HOLDING AB (publ) amounts to 50,811,866.

Lund, Sweden, 08.00 CET, 20 February 2018 – BONESUPPORT^TM, an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT^® platform today announces the publication of its Q4 and Year-End Report - January – December 2017.

2017 net sales increased by 24%

FINANCIAL HIGHLIGHTS

OCTOBER – DECEMBER 2017

Net Sales amounted to SEK 27.0 million (29.6), a decrease of 9%

Gross margin of 83.3% (87.8)

Operating loss of SEK ‐33.4 million (‐28.4) 

Earnings per share, before and after dilution was SEK ‐1.03 (‐1.24)

JANUARY – DECEMBER 2017

Net Sales amounted to SEK 129.3 million (104.6), an increase of 24%

Gross margin of 87.0% (84.4)

Operating loss of SEK ‐99.3 million (‐88.7)

Earnings per share, before and after dilution was SEK ‐3.24 (‐4.26)

BUSINESS HIGHLIGHTS

OCTOBER – DECEMBER 2017

CERTiFy study completed (136 patients) in this important level 1 trauma study comparing CERAMENT bone void filler with autograft.

BONESUPPORT signed distribution agreement for the Italian market with Citieffe Srl.

Ms Helena L Brandt appointed Head of Human Resources.

SIGNIFICANT EVENTS AFTER PERIOD END

BONESUPPORT announced 23 January the appointment of Emil Billbäck as CEO, effective as of 1 March.

BONESUPPORT repaid the outstanding debt of EUR 9.5 million to Kreos.

Richard Davies, CEO of BONESUPPORT, said: “In Europe and the rest of the world we delivered our best-ever quarterly sales performance in the region with sales increasing by 39% vs Q4 2016 to SEK 14.5 million. This was due to the continued success of our drug eluting products, CERAMENT G and CERAMENT V driven by surgeon preference.  The increasing level of clinical evidence supporting CERAMENT’s ability to remodel to host bone and to deliver antibiotics to protect bone healing is key to this choice.

We are also making good progress with our key clinical studies, CERTiFy has completed patient recruitment and results are expected later in 2018. Patient recruitment in the FORTIFY study, with CERAMENT G, is on track to support our goal of filing a PMA with FDA in 2020.

“Over the last 2 years we have positioned BONESUPPORT to become a leading player in orthobiologics. We have invested in our sales and marketing capabilities, and in the clinical data needed to drive the sales of our highly differentiated drug eluting products. We have also built a strong management team and raised the funds needed to execute our value enhancing strategy through to 2020.

“Given this progress, it is the right time for me to hand over the reins to Emil Billbäck, who will become BONESUPPORT’s new CEO on 1 March. I wish him every success and am confident that the Company will deliver significant shareholder value in the years to come based on its unique CERAMENT platform.”

The full Report is available by clicking on the links below:

Outside the US: https://www.bonesupport.com/en-eu/financial-reports-inv/

US: https://www.bonesupport.com/en-us/financial-reports-us/

The report will be available on BONESUPPORT’s website from 08:00 am CET the same day and the presentation from the webcast will be uploaded during the day on 20 February.

Conference Call/Webcast Details

The Company will host a conference call and an online presentation at 10.00am CET today.

The dial-in numbers for the conference call are:

UK: +442030089808

SE: +46850639549

US: +18557532235

Webcast

The presentation will also be webcast and can be accessed from the following web address: https://financialhearings.com/event/10530

Hosts: Richard Davies, CEO, and Björn Westberg, CFO

Lund, Sweden, 08.00 CET, 6 February 2018 – BONESUPPORT^TM, an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT^® platform, will publish its Year-end Report for January-December 2017 on Tuesday 20 February 2018 at 08.00am CET.

The Company will also host a conference call and an online presentation on the same day at 10am CET.

The dial-in numbers for the conference call are:

UK: +442030089808

SE: +46850639549

US: +18557532235

The presentation will also be webcast and can be accessed from the following web address:

https://financialhearings.com/event/10530

Hosts: BONESUPPORT AB Management

Notes to Editor

Lund, Sweden, 18:00 CET 1 February 2018 – BONESUPPORT HOLDING AB’s subsidiary BONESUPPORT AB has repaid the remaining debt under the loan facility from Kreos Capital V (UK) Ltd. The original loan agreement, which was signed in September 2016 included two tranches, one of EUR 13.4 million and one of EUR 8.9 million. BONESUPPORT has only drawn down the first tranche of EUR 13.4 million, which was disbursed to BONESUPPORT on 30 September 2016. The outstanding amount of the first tranche at the end of January 2018 was EUR 9.5 million, which was repaid today. In addition, the Company paid an early termination fee of EUR 0.7 million plus costs for legal counsel.

Björn Westberg, CFO of BONESUPPORT, commented: “Given our strong financial position and the high interest expense associated with this loan facility, we believe that the decision to repay it early is the right thing to do from a financial perspective.”

Lund, Sweden, 18:00 CET 31 January 2018 - During January, the number of shares and votes in BONESUPPORT HOLDING AB (publ) has increased due to the exercise of warrants. As of
31 January 2018, the number of shares and votes in BONESUPPORT HOLDING AB (publ) amounts to 50,368,766.

Lund, Sweden 08.30 CET, 23 January 2018 – BONESUPPORT (Nasdaq Stockholm: BONEX), an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique CERAMENT^® platform, announces that the Board of Directors has appointed Emil Billbäck as the new CEO of BONESUPPORT HOLDING AB. Mr. Billbäck has over 20 years management experience from the life science industry and the Board of Directors is of the opinion that he has the ideal profile to implement the Company’s strategy and to deliver shareholder value. He will join BONESUPPPORT on 1^st March 2018 when he will replace Richard Davies who has been the Company’s CEO since January 2016.

Mr. Billbäck, who lives in Malmö and is a Swedish citizen, will join from Essity where he was Senior Advisor following its acquisition of BSN Medical from the Swedish private equity group EQT in 2017. Prior to this, he was a member of the Group Executive Board/Management Committee at BSN Medical, where he held the position of Executive Vice President EMEA and Head of Global Commercial Operations. Mr. Billbäck spent over 13 years in senior management roles at BSN Medical, including Interim President of North America and Group Director Commercial Operations and R&D. BSN Medical develops, manufactures, markets and sells products within wound care, compression therapy and orthopedics.

Håkan Björklund, Chairman of BONESUPPORT, commenting on today’s announcement said: “I would like to thank Richard Davies for the significant contributions he has made to the company which have included an impressive growth of the business as well putting the company in a strong financial position following its IPO on Nasdaq Stockholm in June 2017.  As the company is becoming much bigger and more complex, it will benefit from a full time leadership presence at the headquarters in Lund. I am very pleased that we have attracted someone of Emil’s caliber to become the CEO of BONESUPPORT. He has extensive experience in areas of the healthcare market which are central to BONESUPPORT’s future success and will provide excellent leadership under which BONESUPPORT can continue to realize its significant potential.”

Emil Billbäck, commenting on his appointment said: “I am looking forward to becoming the CEO of BONESUPPORT. It is clear that the Company has an exciting future based on the significant growth potential of its current commercial products for the management of bone voids. These products, which are based on the Company’s highly differentiated CERAMENT platform, deliver important clinical and economic benefits to surgeons, patients and payers based on their ability to remodel to host bone and to elute antibiotics to protect the healing process by preventing infection. I also believe that BONESUPPORT’s pipeline, which is focused on novel products designed to enhance bone growth, will contribute to the Company’s longer term success.”

Richard Davies commented: “I am very proud of what we have built over the last two years and I am confident that success will endure going forward. I would like to thank my colleagues for their contributions and fellowship and I wish Emil the best of success for the future.”

Lund, Sweden, 08.00 CET, 22 January 2018 – BONESUPPORT^TM, an emerging leader in innovative injectable bio-ceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery based on its unique platform  announces that a paper “Gelatin- hydroxyapatite-calcium sulphate based biomaterial for long term sustained delivery of bone morphogenic protein-2 and zoledronic acid for increased bone formation: In-vitro and in-vivo carrier properties, - D Raina et al 2018- has been published online in the Journal of Controlled Release.

The paper* can be viewed here: https://authors.elsevier.com/a/1WPE7cI2~mAUJ

The publication shows that a novel macro-porous biomaterial, Gelatin/CERAMENT, is an efficient carrier for the long-term, sustained delivery of recombinant bone morphogenic protein (rhBMP-2) and zoledronic acid (ZA) leading to increased bone formation in a pre-clinical animal model when compared to commercially available carrier for rhBMP-2.

BONESUPPORT has acquired the IP to the novel Gelatin/CERAMENT biomaterial from Seagles AB, a company owned by Lars Lidgren, who is one of the members of the Swedish/Indian research group that developed the new material and the founder of BONESUPPORT. A first patent application covering a macro porous biopolymer ceramic biomaterial as a carrier for bone active agents was submitted to the European Patent Office in September 2017.

Mr Deepak Raina, Department of Orthopedics, Medical Faculty, Lund University, Sweden, and lead author of the publication, said: “In this study, we produced and characterized a novel macroporous gelatin/CERAMENT-based cryogel scaffold for the delivery of rhBMP-2 and ZA. In-vivo experiments showed that the scaffold enabled increased bone formation compared to a currently approved carrier with BMP. We believe that it is a crucial step in the development of biomaterials that are needed to facilitate the co-delivery of rhBMP-2 and ZA, to enhance bone growth in demanding clinical situations where bone regeneration is essential but difficult to achieve.”

Dr Jerry Chang, Executive Vice President and Head of Research and Development at BONESUPPORT, said: "The Journal of Controlled Release publication clearly shows the potential of a novel CERAMENT-based biomaterial as a carrier of bioactives designed to enhance bone growth. We believe the acquisition of this technology is an important addition to our product pipeline which is focused on meeting the growing clinical need for novel osteoinductive synthetic bone graft substitutes for a broad range of orthopedic indications and, in particular in the spine.”

*Link valid until 8^th March 2018