Earnings Release • Jul 17, 2020
Earnings Release
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"I am proud of the strategic progress we have achieved during the quarter and the organization's ability to adapt the business to the current circumstances." Emil Billbäck, CEO
| Apr - Jun | Jan - Jun | 12 months | ||||
|---|---|---|---|---|---|---|
| KEY FIGURES | 2020 | 2019 | 2020 | 2019 | LTM | 2019 |
| Net sales, SEKm | 36,2 | 37,3 | 79,6 | 70,1 | 164,9 | 155,5 |
| Sales growth, %¹ | -3,1 | 32,4 | 13,5 | 18,4 | 53,4 | 60,9 |
| Gross profit, SEKm | 31,4 | 32,3 | 69,9 | 60,5 | 145,3 | 135,9 |
| Gross margin, %¹ | 86,7 | 86,5 | 87,8 | 86,2 | 88,1 | 87,4 |
| Operating loss, SEKm | -23,5 | -47,8 | -52,7 | -86,8 | -124,0 | -158,1 |
| Loss for the period, SEKm | -23,6 | -47,9 | -53,0 | -87,0 | -127,1 | -161,1 |
| Equity at period end, SEKm | 442,1 | 192,5 | 442,1 | 192,5 | 442,1 | 124,3 |
| Net debt, SEKm¹ | -383,3 | -161,2 | -383,3 | -161,2 | -383,3 | -81,7 |
| Operating cash flow, SEKm | -31,7 | -42,3 | -59,7 | -84,1 | -139,5 | -163,8 |
| Cash at period end, SEKm | 393,9 | 173,1 | 393,9 | 173,1 | 393,9 | 92,1 |
| Earnings per share, SEK | -0,41 | -0,93 | -0,95 | -1,68 | -2,46 | -3,10 |
1 APM: Alternative performance measures, see definitions on page 23.
The quarter has seen a number of advances related to the future launch of CERAMENT G in the United States. The strong sales growth in the US quarter 2, despite the pandemic impact, displays the potential for both current and future products in this important market.
Emil Billbäck CEO BONESUPPORT

The pandemic has led to a significantly lower priority for non-critical orthopedic surgeries, which many have been deferred to later dates. According to industry estimates, non-critical surgeries have decreased by around 80-90 percent in March and April, compared with the previous year. The number of non-critical surgeries is expected to normalize gradually in the autumn, depending, of course, on how the pandemic develops. Restrictions and quarantine in the second quarter have meant a generally lower mobility of the population, resulting in a reduced amount of trauma cases, which normally accounts for a majority of the critical operations where CERAMENT is used.
The pandemic has led to limitations in meeting with existing and potential customers. Restrictions on larger crowds have led to all major congresses being canceled or moved to later dates. BONESUPPORT has been quick to switch to a more digital way of working. During the quarter, we conducted several virtual events where leading orthopedic surgeons (Key Opinion Leaders) have presented studies and patient cases where CERAMENT has been used successfully. These events have been well attended, with up to 250 participants. The events have also been highly interactive with a large number of questions from an interested audience. We have also ensured procedures that allow us to quickly adapt market activities based on national or regional COVID-19 restrictions.
The transition to digital customer meetings and the measures we have previously reported on, reducing working hours for sales staff and a temporary voluntary salary reduction for the organization, have led to significant cost savings in the second quarter.
Despite the impact of the pandemic, sales in the North America segment grew by 46 percent compared to the second quarter of 2019. A number of major clinics have had fewer surgeries in the quarter as a result of the pandemic. At the same time, we are constantly increasing our customer base in the US as a result of our strategy and growing success with the new distribution network, which more than compensates for the temporary sales decline seen in a number of established customers.
In segment Europe and the rest of the world (EUROW), the regions most affected by COVID-19 have also experienced the largest loss of sales. As a company in its early commercial phase, with a groundbreaking new technology, we are mainly established in university hospitals, which are the hospitals most affected by the pandemic. The upgrade and the shift of distributor partners in Italy and France have also led to temporarily lower sales in these countries.
In the quarter, patient recruitment was completed in the FORTIFY study. The study results are intended to provide support for PMA-application for CERAMENT G by the end of 2021. As the recruitment rate was expected to be affected by the pandemic, after approval from the FDA, the number of study subjects was reduced by 30 to 200. We are confident with the assessment of the study's independent statisticians that the reliability of expected results is only minimally affected by this. In addition, at the beginning of the quarter, we submitted a De Novo application for CERAMENT G in the osteomyelitis (bone infection) indication. We expect an approval from the FDA by the end of 2020.
To finance the upcoming commercialization of CERAMENT G in the USA, we conducted a successful and over subscribed directed new share issue in the quarter, which brought the Company SEK 378 million before issue costs. The funding will also be used for continued market investments in Europe as well as improvements in the manufacturing process to further improve production capacity. I would like to take this opportunity to express my appreciation for the trust given to us by both existing and new shareholders.
The surgeries that are now being postponed add to existing long waiting lists around the world. In the long term, the pandemic has limited impact on the needs for our products, be it in emergency or in planned surgeries. However, the need for an effective healthcare system will be greater than ever before. CERAMENT enables a one-step procedure instead of the multiple surgeries that are currently the prevailing standard. CERAMENT thus makes a unique contribution to the reduction of the healthcare congestion that is now being built up around the world.
The quarter has meant difficult conditions for healthcare, patients and society at large. I am proud of the strategic progress we have achieved during the quarter and the organization's ability to adapt the business to the current circumstances. We have a strong belief in our unique technology and business model. Growth for the full year 2020 remains difficult to predict, but for the following years the target of growing 40 percent per year remains.
The ongoing pandemic has an impact on the Company's sales, which has resulted in lower sales during the first half of 2020. Sales growth for the full year 2020 is currently difficult to predict. Below is an overview of how BONESUPPORT was affected during the quarter and the assessments that can currently be made for the rest of the year, as well as how BONESUPPORT acts to deal with this serious situation.

The American market is the world's largest for synthetic bone graft products and is thereby the most important market for the Company. The focus of the North America segment is the continued development of the distribution structure established at the end of 2018. In addition to this, the preparations for a market introduction of the Company's antibiotic eluting product CERAMENT G has been intensified following a decision to submit a De Novo application for the indication osteomyelitis (bone infection) during April this year. The application could potentially lead to a market approval at the end of the year. Despite the impact of the pandemic, sales in the North America segment grew by 46 percent compared to the second quarter of 2019.
Sales for the period amounted to SEK 21.6 million (14.8), which corresponds to a growth of 46 percent. The new distribution structure means improved geographical coverage and allows for broader market penetration of various indications. The continuously strengthened customer base contributes to a sales increase that exceeds the temporary sales decline of several established customers as a direct effect of the ongoing COVID-19 pandemic.
The contribution from the segment was SEK -4.2 million (-23.4). The reduced loss is due to increased sales as well as savings and lower costs because of the COVID-19 pandemic. The previous year was charged with an item affecting comparability of SEK 11 million regarding the repurchase of inventory items from the former distributor. Sales and marketing expenses during the quarter amounted to SEK 18.6 million (18.8 excluding item affecting comparability expense), of which sales commissions to the distributors amounted to SEK 6.9 million (4.7). The contribution was also burdened by R&D costs amounting to SEK 5.2 million (6.4).
Net sales amounted to SEK 42.8 million (26.3), corresponding to an increase of 63 percent. The increase should be seen in light of the transition to a new distribution structure.
1 APM: Alternative performance measures, see definitions on page 23.
The contribution amounted to SEK -16.4 million (-39.2). The contribution has improved by SEK 11.8 million, excluding the item affecting comparability last year. The improved contribution is mainly due to the increase in sales.
| Apr - Jun | Jan - Jun | |||||
|---|---|---|---|---|---|---|
| 2020 | 2019 | 2020 | 2019 | 2019 | ||
| Net sales | 21,6 | 14,8 | 42,8 | 26,3 | 68,0 | |
| Gross profit | 19,6 | 13,4 | 39,3 | 23,7 | 62,4 | |
| Contribution | -4,2 | -23,4 | -16,4 | -39,2 | -56,5 |


In Europe, CERAMENT is sold by both the Company's own sales organization and by distributors. Germany, the United Kingdom, Switzerland, Sweden and Denmark are key markets where BONESUPPORT has its own sales staff. During the quarter, recruitment of own sales staff to the Dutch market was initiated. In other European markets and in other parts of the world (ROW), the Company cooperates with specialist distributors. In 2020, the focus will be on accelerating sales and use of CERAMENT in established and new markets through increased market access through, above all, the provision of published clinical and health economic evidence. Sales in the quarter are a direct effect of a reduced number of orthopedic surgeries as an effect of the COVID-19 pandemic.
Sales for the segment decreased, as a direct impact of the COVID-19 pandemic, by 35 percent compared with the previous year and amounted to SEK 14.6 million (22.5). Sales in key markets accounted for 84 percent (85) of the segment's sales. Sales of the antibiotic-releasing products CERAMENT G and CERAMENT V decreased by 34 percent.
The contribution from the segment was SEK 2.3 million (3.8). The reduced contribution is explained by lower sales and a lower gross profit of SEK 11.7 million, partly offset by lower costs and savings. Sales and marketing expenses decreased by SEK 5.7 million compared with the corresponding period last year and amounted to SEK 9.4 million (15.1). The decrease is partly due to a lower level of activity in the market, as a direct effect of the pandemic and the restrictions on physical meetings that have been applied, and partly due to lower staff costs as a result of the working time reductions and voluntary salary reductions implemented during the period.
Net sales amounted to SEK 36.8 million (43.9), a decrease of 16 percent compared with the previous year. The decreased sales during the period are a direct effect of a reduced number of orthopedic surgeries as a direct effect of the COVID-19 pandemic. Sales of the antibiotic release products CERAMENT G and CERAMENT V decreased by 15 percent.
1 APM: Alternative performance measures, see definitions on page 23.
The contribution amounted to SEK 6.2 million (4.7). Lower costs and implemented savings have meant a better contribution than last year.
| Apr - Jun | Jan - Jun | Full year | |||
|---|---|---|---|---|---|
| 2020 | 2019 | 2020 | 2019 | 2019 | |
| Net sales | 14,6 | 22,5 | 36,8 | 43,9 | 87,4 |
| Gross profit | 11,7 | 18,8 | 30,6 | 36,8 | 73,5 |
| Contribution | 2,3 | 3,8 | 6,2 | 4,7 | 8,0 |


BONESUPPORT's clinical development program focuses on further developing CERAMENT's properties, broadening clinical application areas and utilizing CERAMENT's unique drug-releasing properties through the development of combination products that promote bone healing.
Several different combinations with CERAMENT have been investigated to add osteoinductive properties, meaning the ability to actively stimulate bone healing. Among other things, the Company has conducted research in the form of preclinical candidates that have combined CERAMENT with bisphosphonates, bone morphogenic proteins (BMP), bone marrow aspirate (BMA) and demineralized bone matrix (DBM). Prioritized product candidates for own development are CERAMENT with bisphosphonate and CERAMENT with DBM, while CERAMENT with BMP is a candidate for potential partner development.
Bisphosphonate is a well-established substance in the treatment of osteoporosis and is used to limit the activity of osteoclasts, resulting in improved bone remodeling and bone density. Demineralized bone matrix (DBM) is based on allograft reduced on minerals. The material has been shown to have a wide use in conditions and situations where there is weak natural bone remodeling.
One of the three cornerstones of the strategy is to provide industry-leading scientific and clinical evidence that validates the many benefits of CERAMENT. Already today there is a comprehensive database of more than 160 research publications and abstracts of preclinical and clinical studies with CERAMENT. In December 2019, the CERTiFy study was published in the highly regarded JB&JS, The Journal of Bone & Joint Surgery. With regards to future clinical data, BONESUPPORT has high expectations for the FORTIFY and the SOLARIO studies. In March, following a dialogue with the US Food and Drug Administration (FDA), BONESUPPORT decided to submit a De Novo application which could potentially lead to a market approval for CERAMENT G for the indication osteomyelitis (chronic bone infection) at the end of 2020.
CERTiFy is a randomized, controlled clinical trial conducted at 20 trauma centers in Germany with 135 patients. The study, which was done on tibia plateau fractures, shows that CERAMENT BVF can replace autograft as a standard of care. The study confirmed that CERAMENT has the ability to be converted to bone. In addition, treatment with CERAMENT BVF resulted in significantly lower patient-experienced post-operative pain and a significantly lower blood loss. BONESUPPORT expects the results of the study published in The Journal of Bone & Joint Surgery in December 2019 to represent a milestone in driving change in the standard of care and that more clinics in consultation with the patient will choose CERAMENT over autograft.
In mid-March, CERAMENT G received the FDA's "Breakthrough Device" status, a category exclusively for therapies that provide more effective treatment or diagnosis of life-threatening or severely irreversible diseases and at the same time represent a breakthrough technology. In April, BONESUPPORT submitted a so-called De Novo application to the FDA, based on already published clinical evidence from the Nuffield Orthopaedic Centre, Oxford, among others, for the indication osteomyelitis. Studies from the Nuffield Orthopaedic Centre have shown that the use of CERAMENT G significantly reduces the frequency of re-infections and the need for further surgery. A De Novo application can be made when there is no comparable established alternative ("predicate device") on the market. The application could potentially lead to a market approval for the indication bone infection by the end of 2020.
The FORTIFY study evaluates the ability of CERAMENT G to improve the treatment outcome of patients with open tibia fractures. That the fracture is "open" means that the skin has been penetrated in conjunction with the trauma. These fractures run a high risk of infection, with inadequate bone healing as a result. The primary effects to be measured in the study include the absence of deep infection at the fracture site, the absence of additional surgical procedures to promote healing and patient-reported improvement.
The patient enrollment to FORTIFY ended in June following the FDA approval of a request from BONESUPPORT to reduce the number of study subjects by 30, due to expected difficulties in recruiting during the COVID-19 pandemic. The request was submitted after a blinded review conducted by the study's independent statisticians, showed that a reduction in study subjects only minimally affects the statistical strength of the study. The study, which includes patients in clinics in both the United States and Europe, will form the basis for supporting a planned PMA (pre-market approval) application to the FDA, for a wide range of indications for CERAMENT G, including trauma. The PMA application is expected to be submitted by the end of 2021. This process continues according to plan regardless of the company's De Novo application.
BONESUPPORT invests in the SOLARIO study (Short or Long Antibiotic Regimes in Orthopaedic), with the aim of investigating if synthetic bone graft substitutes containing antibiotics can lead to shorter treatment times compared to systemic antibiotics and thereby reduce risk of antibiotic resistance, side effects and costs. The study is led by the Oxford University Hospital's NHS Foundation Trust in collaboration with EBJIS (European Bone and Joint Infection Society). SOLARIO is a randomized unblinded European multicenter study that is expected to include 500 patients. The first patient was recruited in February 2019 and the study is expected to be closed by the first half of 2022. A positive result of the study may mean a paradigm shift in the protocol for treating bone infections.
The French CRIOAc1 Network has initiated CONVICTION, a randomized controlled trial to evaluate the efficacy of CERAMENT G in the treatment of osteomyelitis. The French Ministry of Health has decided to fund the study with a research grant from BONESUPPORT to partially finance the products used in the study.
The study will evaluate the effectiveness of CERAMENT G in the treatment of osteomyelitis. The study is a national multicenter study and will be conducted by clinics that are part of the CRIOAc network.
A positive outcome of the study would mean that a large commercial opportunity is enabled in the French market and that improved reimbursement status is obtained.
Global measures against COVID-19 and the need to prioritize healthcare resources are likely to impact on ongoing clinical trials beyond FORTIFY. At present, BONESUPPORT has no information on any consequences of COVID-19. Updates will be provided when applicable.
1 CRIOAc (Reference Center for Osteoarticular Infections) is a healthcare network in France that is implemented through a nationwide health ministry program to improve outcomes in the management of bone and joint infections.

One of the largest challenges when introducing new and innovative healthcare technology is to ensure that healthcare systems around the world understand the value of the technology and include the technology in the care offered. The value of a technology is determined in various ways in different countries. BONESUPPORT undertakes a variety of activities to ensure that the Company's products are included in the remuneration systems where our products are marketed. An example of this is a health economic analysis in conjunction with Nuffield Orthopaedic Centre to investigate how the previously published positive clinical results can be translated into patient benefit and improved healthcare system efficiency.
When CERAMENT G was introduced in the UK in 2013, the Nuffield Orthopaedic Centre was one of the first clinics to implement CERAMENT G into its treatment algorithm. Nuffield Orthopaedic Centre is one of the leading clinics in Europe for orthopedics and treatment of bone infections.
In 2016, Professor Martin McNally presented the clinical results of his first 100 osteomyelitis patients treated with single-stage surgery and CERAMENT G. The results showed an impressive 56 percent reduction in the degree of re-infection compared with results from previous treatment methods.
The positive experience with CERAMENT led to a collaboration between Nuffield Orthopaedic Centre and BONESUPPORT to study the health economic benefits of the improved clinical results.
The study is based on data from the official statistics database for healthcare in England, NHS's Hospital Episode Statistics (HES). The database shows the total health history and treatment costs for each patient.
All patients who underwent surgical treatment for osteomyelitis during 2013-2017 (over 25,000 patients) were analyzed. Patients were followed for two years before and after surgical treatment.
The analysis compared patients treated at Nuffield after the introduction of CERAMENT G or CERAMENT V in a single-stage procedure with all patients cared for at other hospitals in Great Britain.
In September 2019, the first preliminary results were presented by the EBJIS European Bone and Joint Infection Society study. The data showed that the hospital stay associated with osteomyelitis surgery was reduced by a third - an average of five days per patient - which meant that patients could go home earlier; and the hospitals freed up beds, and reduced costs. The data presented at EBJIS also showed that patients treated at Nuffield Orthopaedic Centre had, on average, eleven days fewer hospital stay in the following two years after surgery. The average cost of care per patient per day at a hospital in England is GBP 437.
These preliminary data show significant health economic benefits in single-stage surgery with CERAMENT G or CERAMENT V in the treatment of osteomyelitis. The total savings in reductions in length of stay associated with surgery and subsequent care could amount to approximately GBP 44 million annually, calculated on 6,250 treated patients per year. BONESUPPORT awaits publication of the study for final and conclusive results.
Net sales
Net sales amounted to SEK 36.2 million (37.3), a decrease of 3 percent compared to the previous year. In March 2020, COVID-19 reached a pandemic level and BONESUPPORT was affected by a decline in primarily elective surgery in both NA and Europe.
In the North America segment, sales amounted to SEK 21.6 million (14.8), which corresponds to growth of 46 percent. A number of larger clinics have had fewer operations in the quarter as a result of the ongoing pandemic. At the same time, the customer base in the US has expanded as a result of the Company's strategy and growing success with the new distribution network, which offsets the temporary decline in sales seen at a number of established customers.
In the Europe & Rest of the World (EUROW) segment, the regions most affected by COVID-19 also had the largest sales decline. BONESUPPORT is mainly established at the larger university hospitals, which are the hospitals most affected during the pandemic period. EUROW reported a decrease in sales of 35 percent to SEK 14.6 million (22.5).
The currency translation effect was negative with SEK -0.0 million (+1.9).
Cost of goods sold amounted to SEK 4.8 million (5.0), giving a gross margin of 86.7 percent (86.5). Increased sales in the US had a positive impact on gross profit. The gross margin was suppressed by fixed production costs in combination with lower net sales.
Selling expenses including commissions amounted to SEK 29.9 million (52.7), a decrease of 43 percent. The previous year included a one-off charge of SEK 11 million regarding the repurchase of inventory items from the previous distributor in the North America segment. Personnel costs reduced to SEK 17.7 million (21.1) as an effect of reduced working hours and voluntary salary waivers. In contrast, costs for sales commissions in NA increased to SEK 6.9 million (4.8). Other sales costs amounted to SEK 5.3 million (15.8), driven by reduced travel costs as well as canceled congresses and meetings, as an effect of the ongoing pandemic.
The NA segment reported a cost reduction to SEK 18.6 million (30.0), mainly driven by an item affecting comparability last year. In EUROW, expenses amounted to SEK 9.4 million (15.1). Unallocated costs decreased to SEK 1.9 million (7.6), driven by reduced market activities as a result of the ongoing pandemic.

Research and development expenses amounted to SEK 14.0 million (16.0). Personnel costs were reduced to SEK 5.6 million (9.6) which can partly be explained by vacancies that are covered by temporary staff. Other expenses totaled SEK 8.4 million (6.4) which was due to the above mentioned temporary staff but also to quarterly variations related to projects and clinical studies.
The NA segment reported expenses amounting to SEK 5.2 million (6.4).
Administrative expenses amounted to SEK 10.3 million (10.4). Personnel costs amounted to SEK 6.7 million (5.6). Excluding provisions within the framework of active incentive programs, staff costs amounted to SEK 3.9 million. Other expenses amounted to SEK 3.6 million (4.8).
Other operating income and expenses consisted primarily of exchange rate gains and losses on operating assets and liabilities.
Operating result amounted to SEK -23.5 million (-47.8), where the decreased loss is mainly explained by higher sales, reduced direct operating costs and that the previous year included a oneoff charge of SEK 11 million regarding repurchase of inventory items from the former distributor in the NA segment.
For the reasons described above, the loss for the quarter amounted to SEK -23.6 million (-47.9), which corresponds to earnings per share of SEK -0.41 (-0.93).
Net sales amounted to SEK 79.6 million (70.1), an increase of 14 percent. The NA segment increased by 63 percent to SEK 42.8 million (26.3) and the EUROW segment decreased by 16 percent to SEK 36.8 million (43.9).
Operating result amounted to SEK -52.7 million (-86.8), where the previous year was charged with an item affecting comparability of SEK 11 million. The increase in sales contributed positively to improved gross profit while operating costs reduced as a result of the pandemic and implemented savings.
For the reasons described above, the loss for the period amounted to SEK -53.0 million (-87.0), which corresponds to earnings per share of SEK -0.95 (-1.68).
| SEKm | Jun 30 | Dec 31 | |
|---|---|---|---|
| Financial position | 2020 | 2019 | 2019 |
| Cash and cash equivalents | 393,9 | 173,1 | 92,1 |
| Interest bearing debt¹ | 10,6 | 11,9 | 10,4 |
| Net debt¹ | -383,3 | -161,2 | -81,7 |
| Equity | 442,1 | 192,5 | 124,3 |
1 APM: Alternative performance measures, see definitions on page 23.
| SEKm | Apr - Jun | Jan - Jun | Full year | ||
|---|---|---|---|---|---|
| Cash flow | 2020 | 2019 | 2020 | 2019 | 2019 |
| Operating activities | -31,7 | -42,3 | -59,7 | -84,1 | -163,8 |
| Investing activities | -0,8 | -1,7 | -1,8 | -2,3 | -4,4 |
| Financing activities | 359,3 | -1,3 | 363,6 | -2,6 | -1,8 |
Cash and cash equivalents at the end of the period amounted to SEK 393.9 million (173.1), an increase of SEK 301.8 million since the beginning of the year. The change mainly consists of the cash flow from the directed share issue that was carried out in May, amounting to SEK 361.9 million after transaction costs. The change is also explained by cash flow from operating activities amounting to SEK -59.7 million (-84.1), mainly attributable to operating result of SEK -52.7 million (-86.8). This also explains the change in net debt.
The Parent Company BONESUPPORT HOLDING AB (publ) is a holding company. The Parent Company generated SEK 11.1 million (10.3) in sales of internal services to subsidiaries during the quarter. The result for the quarter was SEK 0.4 million (3.6). No investments were made during the quarter.
On average, the Group had 83 (78) employees (full-time equivalent) during the quarter, of whom 22 (20) worked within Research and Development.
For significant events, see page 1.
No significant events have occurred after the end of the period.
The Company has ordinary shares and C shares, see Note 4. The quotient value of the shares is SEK 0.625 per share. The ordinary shares entitle to one vote each and the C shares entitle to one tenth of a vote each. According to the Articles of Association, the number of shares shall be at least 29,000,000 and at most 116,000,000.
As of June 30, 2020, the total number of common shares amounted to 63,246,824, distributed among 3,965 shareholders. The major shareholders are shown in the table below. During the year, the number of shares increased as a result of converted employee stock options, but mainly due to the directed share issue that was carried out in May.
| HealthCap V LP | 10.4% |
|---|---|
| Swedbank Robur Fonder | 8.4% |
| Stiftelsen Industrifonden | 7.6% |
| Tredje AP-fonden | 6.6% |
| Fjärde AP-Fonden | 4.9% |
| Avanza Pension | 4.7% |
| Tellacq AB | 4.7% |
| Other shareholders | 52.7% |
As of June 30, 2020, the total number of C shares amounted to 1,235,000. BONESUPPORT HOLDING AB holds all C shares. During the year, the number of shares increased as a result of issued C shares.
BONESUPPORT has three employee stock option programs, three performance share programs and two warrant programs. These are described in Note 8.
• November 5, 2020 - Interim report Q3 2020
This report has been prepared in both a Swedish-language and an English-language version. If the versions do not conform, the Swedish-language version shall prevail.
The Board and the CEO assure that this interim report gives a true and fair view of the development and the Group's and the Parent Company's operations, position and results and describes significant risks and uncertainties faced by the companies that form part of the Group.
Lund July 17, 2020
Lennart Johansson Lars Lidgren Håkan Björklund Björn Odlander
Chairman Board member Board member Board member
Tone Kvåle Simon Cartmell Emil Billbäck Board member Board member CEO
| Apr - Jun | Jan - Jun | Full year | ||||
|---|---|---|---|---|---|---|
| SEKt | Note | 2020 | 2019 | 2020 | 2019 | 2019 |
| Net sales | 7 | 36,175 | 37,320 | 79,607 | 70,148 | 155,462 |
| Cost of sales | 7 | -4,813 | -5,047 | -9,713 | -9,678 | -19,587 |
| Gross profit | 7 | 31,362 | 32,273 | 69,894 | 60,470 | 135,875 |
| Selling expenses | -22,957 | -48,011 | -57,952 | -85,309 | -160,139 | |
| Sales commissions | -6,916 | -4,678 | -13,997 | -8,213 | -22,184 | |
| Research and development expenses | -13,994 | -15,987 | -29,777 | -32,902 | -68,878 | |
| Administrative expenses | 3, 8 | -10,341 | -10,482 | -21,204 | -20,840 | -43,280 |
| Other operating income | 1,971 | 2,434 | 6,421 | 4,610 | 10,667 | |
| Other operating expenses | -2,598 | -3,369 | -6,064 | -4,631 | -10,163 | |
| Operating loss | 7 | -23,473 | -47,820 | -52,679 | -86,815 | -158,102 |
| Net financial items | 7 | -195 | -53 | -223 | -97 | -177 |
| Loss before income tax | 7 | -23,668 | -47,873 | -52,902 | -86,912 | -158,279 |
| Income tax | 34 | -67 | -116 | -109 | -2,781 | |
| Loss for the period | -23,634 | -47,940 | -53,018 | -87,021 | -161,060 | |
| Earnings per share before dilution, SEK | -0.41 | -0.93 | -0.95 | -1.68 | -3.10 | |
| Earnings per share after dilution, SEK | -0.41 | -0.93 | -0.95 | -1.68 | -3.10 | |
| Average number of shares, thousands | 57,950 | 51,796 | 55,972 | 51,796 | 51,889 |
Loss for the period is attributable to equity holders of the Parent.
| Apr - Jun | Jan - Jun | Full year | |||
|---|---|---|---|---|---|
| SEKt | 2020 | 2019 | 2020 | 2019 | 2019 |
| Loss for the period | -23,634 | -47,940 | -53,018 | -87,021 | -161,060 |
| Other comprehensive income: | |||||
| Items to be reclassified to profit or loss in subsequent periods | |||||
| Exchange differences on translation of foreign | |||||
| operations | -640 | -1 | -83 | 94 | 115 |
| Total comprehensive income for the period | -24,274 | -47,941 | -53,101 | -86,927 | -160,945 |
Total comprehensive income for the period is in its entirety attributable to equity holders of the Parent.
| Jun 30 | Dec 31 | |||
|---|---|---|---|---|
| SEKt | Note | 2020 | 2019 | 2019 |
| ASSETS | ||||
| Non-current assets | ||||
| Intangible assets | 8,471 | 6,950 | 7,679 | |
| Tangible assets | 14,255 | 15,786 | 14,585 | |
| Other non-current assets | 883 | 282 | 951 | |
| Total non-current assets | 23,609 | 23,018 | 23,215 | |
| Current assets | ||||
| Inventories | 47,218 | 30,625 | 39,331 | |
| Trade receivables | 6 | 21,877 | 28,518 | 29,848 |
| Other operating receivables | 6 | 9,584 | 7,453 | 11,873 |
| Cash and cash equivalents | 6 | 393,871 | 173,096 | 92,065 |
| Total current assets | 472,550 | 239,692 | 173,117 | |
| TOTAL ASSETS | 496,159 | 262,710 | 196,332 | |
| EQUITY AND LIABILITIES | ||||
| Equity attributable to equity holders of the Parent | 4 | 442,082 | 192,487 | 124,309 |
| Non-current liabilities | ||||
| Leasing debt | 5,599 | 6,693 | 5,703 | |
| Provisions | 305 | 289 | 305 | |
| Total non-current liabilities | 5,904 | 6,982 | 6,008 | |
| Current liabilities | ||||
| Leasing debt | 6 | 5,011 | 5,189 | 4,682 |
| Trade payables | 6 | 11,583 | 13,118 | 13,649 |
| Other operating liabilities | 6 | 31,579 | 44,934 | 47,684 |
| Total current liabilities | 48,173 | 63,241 | 66,015 | |
| TOTAL EQUITY AND LIABILITIES | 496,159 | 262,710 | 196,332 |
| Accumulated | |||||||
|---|---|---|---|---|---|---|---|
| Paid but not registered |
Other paid in | Translation | Fund for development |
losses inclu ding loss for |
|||
| SEKt | Share capital | share issue | capital | reserve | expenses | the period | Total equity |
| As at January 1, 2019 | 32,373 | 0 | 1,187,895 | -175 | 1,801 | -943,363 | 278,531 |
| Loss January - June 2019 | 94 | -87,021 | -86,927 | ||||
| Change in fund for development | |||||||
| expenses | 536 | -536 | 0 | ||||
| Share-based payment transactions | 883 | 883 | |||||
| As at June 30, 2019 | 32,373 | 0 | 1,187,895 | -81 | 2,337 | -1,030,037 | 192,487 |
| Loss July - December 2019 | 21 | -74,039 | -74,018 | ||||
| Change in fund for development | |||||||
| expenses | 1,215 | -1,215 | 0 | ||||
| New share issue, employee stock | |||||||
| options | 137 | 137 | |||||
| New share issue under process, | |||||||
| employee stock options | 100 | 3,880 | 3,980 | ||||
| New share issue and repurchase of own | |||||||
| C-shares | 316 | -316 | 0 | ||||
| Share-based payment transactions | 1,723 | 1,723 | |||||
| As at January 1, 2020 | 32,826 | 100 | 1,191,775 | -60 | 3,552 | -1,103,884 | 124,309 |
| Loss January - June 2020 | -83 | -53,018 | -53,101 | ||||
| Change in fund for development | |||||||
| expenses | 1,153 | -1,153 | 0 | ||||
| New share issue, employee stock | |||||||
| options and warrants | 457 | -96 | 6,508 | 6,869 | |||
| Directed share issue | 6,563 | 371,438 | 378,000 | ||||
| Transaction costs, directed share issue | -16,142 | -16,142 | |||||
| New share issue and repurchase of own | |||||||
| C-shares | 456 | -456 | 0 | ||||
| Share-based payment transactions | 2,147 | 2,147 | |||||
| As at June 30, 2020 | 40,301 | 4 | 1,553,579 | -143 | 4,705 | -1,156,364 | 442,082 |
| Apr - Jun | Jan - Jun | Full year | |||
|---|---|---|---|---|---|
| SEKt | 2020 | 2019 | 2020 | 2019 | 2019 |
| Operating loss | -23,473 | -47,820 | -52,679 | -86,815 | -158,102 |
| Non-cash adjustments: | |||||
| -Share-based payments | 1,303 | 441 | 2,147 | 883 | 2,606 |
| -Provision for repurchase of items from previous | |||||
| distributor | 0 | 11,000 | 0 | 11,000 | 11,000 |
| -Other | 6,016 | 2,074 | 6,272 | 1,369 | 3,950 |
| Interests received | 4 | 7 | 4 | 31 | 98 |
| Interests paid | -32 | -60 | -1 | -128 | -36 |
| Income tax paid | -2,956 | -298 | -2,390 | -400 | -5,210 |
| Net cash flows from operating activities before | |||||
| changes in working capital | -19,138 | -34,656 | -46,647 | -74,060 | -145,694 |
| Changes in working capital | -12,571 | -7,623 | -13,064 | -9,998 | -18,134 |
| Net cash flows from operating activities | -31,709 | -42,279 | -59,711 | -84,058 | -163,828 |
| Investments in intangible assets | -459 | -1,514 | -1,340 | -1,758 | -2,915 |
| Investments in equipment and tools | -375 | -232 | -449 | -617 | -1,510 |
| Disposals of financial assets | 0 | 57 | 0 | 95 | 0 |
| Net cash flows from investing activities | -834 | -1,689 | -1,789 | -2,280 | -4,425 |
| New share issue, employee stock options and warrants | 102 | 0 | 6,869 | 0 | 137 |
| Directed share issue | 378,000 | 0 | 378,000 | 0 | 0 |
| Transaction costs, directed share issue | -16,142 | 0 | -16,142 | 0 | 0 |
| Allotted warrants | 0 | 0 | 0 | 0 | 3,980 |
| Repayments of borrowings | -2,628 | -1,284 | -5,098 | -2,562 | -5,933 |
| Net cash flows from financing activities | 359,332 | -1,284 | 363,629 | -2,562 | -1,816 |
| Net cash flows | 326,789 | -45,252 | 302,129 | -88,900 | -170,069 |
| Cash and cash equivalents as at beginning of period | 67,951 | 219,141 | 92,065 | 261,468 | 261,468 |
| Net exchange difference | -869 | -793 | -323 | 528 | 666 |
| Cash and cash equivalents as at end of period | 393,871 | 173,096 | 393,871 | 173,096 | 92,065 |
| Apr - Jun | Jan - Jun | Full year | |||
|---|---|---|---|---|---|
| SEKt | 2020 | 2019 | 2020 | 2019 | 2019 |
| Net sales | 11,138 | 10,313 | 22,276 | 20,625 | 48,290 |
| Administrative expenses | -13,086 | -13,933 | -29,218 | -27,821 | -65,568 |
| Other operating income | 1,493 | 149 | 1,710 | 254 | 961 |
| Other operating expenses | -75 | -402 | -1,486 | -740 | -1,357 |
| Operating loss | -530 | -3,873 | -6,718 | -7,682 | -17,674 |
| Net financial items | 909 | 226 | 2,067 | 10 | 1,767 |
| Result after financial items | 379 | -3,647 | -4,651 | -7,672 | -15,907 |
| Income tax | 0 | 0 | 0 | 0 | 0 |
| Result for the period | 379 | -3,647 | -4,651 | -7,672 | -15,907 |
Parent Company result for the period equals comprehensive income.
| Jun 30 | Dec 31 | ||||
|---|---|---|---|---|---|
| SEKt | Note | 2020 | 2019 | 2019 | |
| ASSETS | |||||
| Non-current financial assets | 967,339 | 704,652 | 726,652 | ||
| Other receivables | 6 | 0 | 68,143 | 125,245 | |
| Prepaid expenses | 6 | 1,419 | 1,344 | 651 | |
| Cash | 6 | 375,004 | 146,475 | 73,549 | |
| TOTAL ASSETS | 1,343,762 | 920,614 | 926,097 | ||
| EQUITY AND LIABILITIES | |||||
| Equity | |||||
| Restricted equity | 4 | 40,301 | 32,372 | 32,926 | |
| Unrestricted equity | 1,220,668 | 866,980 | 862,277 | ||
| Total equity | 1,260,969 | 899,352 | 895,203 | ||
| Non-current liabilities | 76,319 | 0 | 19,203 | ||
| Current liabilities | 6 | 6,474 | 21,262 | 11,691 | |
| TOTAL EQUITY AND LIABILITIES | 1,343,762 | 920,614 | 926,097 |
| 2020 | 2019 | 2018 | |||||||
|---|---|---|---|---|---|---|---|---|---|
| SEKt | Q2 | Q1 | Q4 | Q3 | Q2¹ | Q1 | Q4 | Q3 | |
| Net sales | 36,175 | 43,432 | 46,199 | 39,115 | 37,320 | 32,828 | 23,108 | 14,246 | |
| Cost of sales | -4,813 | -4,900 | -5,114 | -4,795 | -5,047 | -4,631 | -3,460 | -2,587 | |
| Gross profit | 31,362 | 38,532 | 41,085 | 34,320 | 32,273 | 28,197 | 19,648 | 11,659 | |
| Gross margin, % | 86.7% | 88.7% | 88.9% | 87.7% | 86.5% | 85.9% | 85.0% | 81.8% | |
| Selling expenses | -22,957 | -34,995 | -41,322 | -33,508 | -48,011 | -37,298 | -37,606 | -35,086 | |
| Selling commissions | -6,916 | -7,081 | -7,970 | -6,001 | -4,678 | -3,535 | -1,154 | 0 | |
| Research and development expenses | -13,994 | -15,783 | -18,527 | -17,449 | -15,987 | -16,915 | -17,607 | -16,426 | |
| Administrative expenses | -10,341 | -10,863 | -11,566 | -10,874 | -10,482 | -10,358 | -9,343 | -17,531 | |
| Other operating income | 1,971 | 4,450 | 3,080 | 2,977 | 2,434 | 2,176 | 1,251 | 1,818 | |
| Other operating expenses | -2,598 | -3,466 | -3,379 | -2,153 | -3,369 | -1,262 | -226 | -2,851 | |
| Operating loss | -23,473 | -29,206 | -38,599 | -32,688 | -47,820 | -38,995 | -45,037 | -58,417 | |
| Net financial items | -195 | -28 | -64 | -16 | -53 | -44 | 41 | -4 | |
| Loss before income tax | -23,668 | -29,234 | -38,663 | -32,704 | -47,873 | -39,039 | -44,996 | -58,421 | |
| Income tax | 34 | -150 | -2,186 | -486 | -67 | -42 | -629 | -377 | |
| Loss for the period | -23,634 | -29,384 | -40,849 | -33,190 | -47,940 | -39,081 | -45,625 | -58,798 |
Loss for the period is attributable to equity holders of the Parent.
1 The period was affected by a non comparability item with a negative impact of SEK 11.0 million. The item is a provision related to repurchase of stock items from the previous US distributor.
This quarterly report was prepared in accordance with IAS 34 Interim Financial Reporting and the Swedish Annual Accounts Act. The Parent Company's reporting has been prepared in accordance with RFR 2, Reporting for Legal Entities, and the Swedish Annual Accounts Act. The accounting principles mentioned in the Annual Report for 2019 have also been applied in this quarterly report. New or amended standards or interpretations of standards effective as of January 1, 2020 have not had any significant impact on BONESUPPORT's financial statements.
When preparing the Company's financial statements, a number of assessments and estimates are made, as well as assumptions that affect the application of the accounting principles and the reported amounts in the income statement and balance sheet. The actual outcome may deviate from these estimates and assessments. Estimates and assessments are evaluated on the basis of historical experience and other factors, including expectations of future events. The Parent Company examines annually or more frequently whether there is an indication of a decline in value and whether there is a need for impairment in shares in Group Companies. As a result of the COVID-19 pandemic, examination has been carried out in the half-yearly financial statements showing that there is no need for impairment of shares in Group Companies. How the assets are assessed is explained in Note 3 of the Annual Report for 2019.
The Group is exposed to various financial risks. The business is impacted by many factors that could affect the Group's result and financial position. It is BONESUPPORT's strategy to continuously identify and manage risks. Financial risk management is described in Note 2, Annual Report 2019.
See page 3 regarding risks relating to COVID-19.
The financial reports include costs related to the following transactions between BONESUPPORT and related parties.
| SEKt | Apr - Jun | Jan - Jun | Full year | |||
|---|---|---|---|---|---|---|
| Related party | Service | 2020 | 2019 | 2020 | 2019 | 2019 |
| Route 2 Advisors Ltd (Simon Cartmell, Board member) | Consultancy | 110 | 110 | 221 | 289 | 615 |
| Purchase of | ||||||
| Seagles AB (Lars Lidgren, Board member) | patent | 0 | 0 | 0 | 0 | 900 |
| Ordinary shares | Number of shares | Potential shares |
|---|---|---|
| December 31, 2019 | 52,016,342 | 2,205,614 |
| New share issue | 10,500,000 | 0 |
| Converted employee stock options | 480,482 | -480,482 |
| Converted warrants | 250,000 | -250,000 |
| Returned employee stock options | 0 | -5,000 |
| June 30, 2020 | 63,246,824 | 1,470,132 |
| Series C shares | ||
| December 31, 2019 | 505,000 | 730,000 |
| Issued shares | 730,000 | -730,000 |
| June 30, 2020 | 1,235,000 | 0 |
The US subsidiary BONESUPPORT Inc. has provided a guarantee of USD 56 thousand (56), corresponding to SEK 521 thousand (520) for rented premises. The Parent Company, BONESUPPORT HOLDING AB, guarantees a corresponding amount.
The Group has pledged collateral for capital-invested direct pensions amounting to SEK 979 thousand (979).
Fair values of current financial assets and liabilities are assessed to agree with values accounted for.
The Group manages and monitors operations in the North America (NA) and Europe & Rest of the World (EUROW) segments. Other comprises other items, mainly costs for Group functions. Contribution per segment is calculated as net sales minus directly attributable operating costs. Such costs are related to cost of sales, selling expenses including commissions and research & development expenses. Assets and liabilities are not reported by segment, these are managed and monitored on Group level by mangement and the board of directors.
Net sales in Sweden (part of EUROW) was SEK 1.6 million (2.6) in the quarter. US, Germany and UK were the only markets that delivered more than ten percent of consolidated net sales.
| SEKt | Apr - Jun 2020 | Apr - Jun 2019 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Profit and loss items | NA | EUROW | Other | Totalt | NA | EUROW | Other | Total | ||
| Net sales | 21,565 | 14,610 | 0 | 36,175 | 14,776 | 22,544 | 0 | 37,320 | ||
| of which CERAMENT BVF | 21,161 | 2,148 | 0 | 23,309 | 14,776 | 3,735 | 0 | 18,511 | ||
| of which CERAMENT drug eluting¹ | 0 | 12,462 | 0 | 12,462 | 0 | 18,809 | 0 | 18,809 | ||
| of which other | 404 | 0 | 0 | 404 | 0 | 0 | 0 | 0 | ||
| Cost of sales | -1,925 | -2,888 | 0 | -4,813 | -1,347 | -3,700 | 0 | -5,047 | ||
| Gross profit | 19,640 | 11,722 | 0 | 31,362 | 13,429 | 18,844 | 0 | 32,273 | ||
| Operative costs | -23,820 | -9,422 | 0 | -33,242 | -36,838 | -15,088 | 0 | -51,926 | ||
| Contribution | -4,180 | 2,300 | 0 | -1,880 | -23,409 | 3,756 | 0 | -19,653 | ||
| Other operating items | 0 | 0 | -21,593 | -21,593 | 0 | 0 | -28,167 | -28,167 | ||
| Operating result | -4,180 | 2,300 | -21,593 | -23,473 | -23,409 | 3,756 | -28,167 | -47,820 | ||
| Net financial items | 0 | 0 | -195 | -195 | 0 | 0 | -53 | -53 | ||
| Result before income tax | -4,180 | 2,300 | -21,788 | -23,668 | -23,409 | 3,756 | -28,220 | -47,873 |
| SEKt | Jan - Jun 2020 | Jan - Jun 2019 | ||||||
|---|---|---|---|---|---|---|---|---|
| Profit and loss items | NA | EUROW | Other | Totalt | NA | EUROW | Other | Total |
| Net sales | 42,813 | 36,794 | 0 | 79,607 | 26,295 | 43,853 | 0 | 70,148 |
| of which CERAMENT BVF | 41,613 | 5,862 | 0 | 47,475 | 26,295 | 6,956 | 0 | 33,251 |
| of which CERAMENT drug eluting¹ | 0 | 30,932 | 0 | 30,932 | 0 | 36,897 | 0 | 36,897 |
| of which other | 1,200 | 0 | 0 | 1,200 | 0 | 0 | 0 | 0 |
| Cost of sales | -3,473 | -6,240 | 0 | -9,713 | -2,588 | -7,090 | 0 | -9,678 |
| Gross profit | 39,340 | 30,554 | 0 | 69,894 | 23,707 | 36,763 | 0 | 60,470 |
| Operative costs | -55,720 | -24,354 | 0 | -80,074 | -62,860 | -32,070 | 0 | -94,930 |
| Contribution | -16,380 | 6,200 | 0 | -10,180 | -39,153 | 4,693 | 0 | -34,460 |
| Other operating items | 0 | 0 | -42,499 | -42,499 | 0 | 0 | -52,355 | -52,355 |
| Operating result | -16,380 | 6,200 | -42,499 | -52,679 | -39,153 | 4,693 | -52,355 | -86,815 |
| Net financial items | 0 | 0 | -223 | -223 | 0 | 0 | -97 | -97 |
| Result before income tax | -16,380 | 6,200 | -42,722 | -52,902 | -39,153 | 4,693 | -52,452 | -86,912 |
1 CERAMENT drug eluting includes CERAMENT G and CERAMENT V.
At the period end, there are three different employee stock option programs, three performance share programs and two warrant programs.
Of the three employee stock option programs, two run over ten years and expire 2022 and 2025 and one program runs over eight years and expires 2024. Each stock option gives the holder the right to acquire 0.2 ordinary shares in BONESUPPORT when exercising the option. This at a price in the first two programs of SEK 0.125 per option, equivalent to SEK 0.625 per share, and in the third program of SEK 5.30 per option, equivalent to SEK 26.50 per share. The employee stock options are vested according to a schedule in each program. A condition for allotment of options is employment or a contractual relationship with the Company at each vesting date. Of the allocated 25.7 million options, 21.4 million (20.8) options were fully vested before the end of the period.
There are two programs for newly recruited employees and one program for three Directors. All programs run over four years; one of the programs that is aimed at employees runs until 2022, the other programs run until 2021. Each savings share gives the opportunity to be allotted to the employees a maximum of two, three or four performance shares without payment depending on share price development and the Company's development in terms of sales and EBITDA during the duration of the program. The performance shares were issued in the form of class C-shares with a subscription price and quota value of SEK 0.625 per share.
Employee stock options and performance shares are valued at fair value at the date of allocation.The total cost is distributed over the vesting period. The cost is accounted for as personnel cost and is credited to equity. The social security cost is revalued at fair value. When the options are exercised, the Company issues new shares. Payments received on behalf of the shares issued are credited to equity.
There are two warrant programs. One of these was executed in 2016 and gives the holder the right to acquire 0.2 ordinary shares per warrant. The second program was executed in 2018 and gives the holder the right to acquire 1 share per warrant.
Further information on these programs is presented in Notes 12 and 23 in the Annual Report 2019.
| Employee stock option programs | No of options¹ | Equal to no of shares | |
|---|---|---|---|
| Balance January 1, 2020 | 4,977,020 | 995,404 | 12.12 |
| Exercised | -2,402,416 | -480,482 | 1.04 |
| Returned | -25,000 | -5,000 | 0.63 |
| Balance June 30, 2020 | 2,549,604 | 509,922 | 13.16 |
| Performance share programs | Right to no of shares |
|---|---|
| Balance January 1, 2020 | 1,225,000 |
| Returned | -45,000 |
| Balance June 30, 2020 | 1,180,000 |
| Warrant programs | No of warrants | Equal to no of shares | WAEP² | |
|---|---|---|---|---|
| Balance January 1, 2020 | 4,606,664 | 1,210,210 | 20.87 | |
| Exercised | -1,250,000 | -250,000 | 26.50 | |
| Balance June 30, 2020 | 3,356,664 | 960,210 | 19.41 |
1 Not allocated options amounted to 3,950,380 (3,824,338).
2 Weighted Average Exercise Price per share (SEK).
During the year, the cost of employee stock option and performance share programs, excluding social security contributions, was recognized as operating expenses amounting to SEK 2,147 thousand (851). Accrued social security contributions amounts to SEK 3,581 thousand (2,431).
Allograft. The transplant of an organ or tissue from one individual to another of the same species, with a different genotype.
Autograft. A bone graft harvested from the patient's own skeleton, usually from the iliac crests.
Bisphosphonate. A type of drugs that inhibits resorption of bone tissue.
BMA. Bone marrow aspirate.
BMP. Bone Morphogenic Protein.
Bone graft substitute. Synthetic material used as bone grafts instead of biological bone tissue.
C-shares. Performance shares within the Performance share programs issued in the form of C-shares
CERAMENT BVF. CERAMENT BONE VOID FILLER
CERAMENT G. CERAMENT G, CERAMENT with gentamicin
CERAMENT V. CERAMENT V, CERAMENT with vancomycin
CERTiFy. A prospective, randomized, controlled clinical trial with 137 patients in 20 leading trauma centers in Germany, aimed to compare treatment of CERAMENT BVF with autologous bone graft (autograft) transplantation
Clinical study. Study on humans of e.g. a medical device or a pharmaceutical product.
CONVICTION. A randomized controlled trial to evaluate the efficacy of CERAMENT G in the treatment of osteomyelitis (chronic bone infection).
CRIOAc. A healthcare network in France that is implemented through a nationwide health ministry program to improve outcomes in the management of bone and joint infections.
DBM. Demineralized bone matrix. A bone substitute biomaterial.
FDA. US Food and Drug Administration.
FORTIFY. A prospective, randomized, multicentercontrolled test of CERAMENT G that evaluates the ability of CERAMENT G to improve treatment outcome of patients with open shin fractures
Hematoma. A localized collection of blood outside the blood vessels.
HEOR. Health Economics and Outcomes Research. Scientific discipline that quantifies the economic and clinical outcomes of medical technology.
LTM. Latest twelve months.
Micro-CT. Micro Tomography, uses X-ray scanning to recreate a 3D-model without destroying the object.
Osteoinduction. A bone graft material or a growth factor can stimulate the differentiation of osteoblasts, forming new bone tissues.
Osteomyelitis. A bacterial infection affecting bones.
PMA. Premarketing Approval is the FDA process to review Class III medical devices.
SOLARIO is a randomized unblinded European multicenter study with the aim of investigating if synthetic bone graft substitutes containing antibiotics can lead to shorter treatment times compared to systemic antibiotics.
Toxicity. The degree to which substance (a toxin or poison) can harm humans or animals.
Alternative Performance Measures are key figures not defined in financial reports prepared according to IFRS. The following key figures are used:
The difference in net sales between two periods in relation to net sales for the earlier period. Shows the operations sales performance.
Net sales minus cost of sales. Shows the profit to cover other costs and profit margin.
Net sales minus cost of sales, in relation to net sales. Shows the margin to cover costs and profit.
Net sales minus cost of sales, minus directly attributable selling expenses and research & development expenses. A measure of result showing the performance of segments and their contribution to cover other Group costs.
Borrowings from banks, financial institutions and lease liabilities, short and long term. Shows the debt level of the Group and forms the base for interest expenses.
Interest bearing debt minus cash and cash equivalents. Shows the Group's net debt and is used to measure the leverage level of the Group and future funding needs.
| Apr - Jun | Jan - Jun | Full year | |||
|---|---|---|---|---|---|
| SEKm | 2020 | 2019 | 2020 | 2019 | 2019 |
| Net sales | 36.2 | 37.3 | 79.6 | 70.1 | 155.5 |
| Sales growth, % | -3.1 | 32.4 | 13.5 | 18.4 | 60.9 |
| Cost of sales | -4.8 | -5.0 | -9.7 | -9.7 | -19.6 |
| Gross profit | 31.4 | 32.3 | 69.9 | 60.5 | 135.9 |
| Gross margin, % | 86.7 | 86.5 | 87.8 | 86.2 | 87.4 |
| Directly attributable selling expenses | -27.7 | -45.5 | -67.1 | -81.9 | -159.6 |
| Selling expenses, not directly attributable | -2.2 | -7.2 | -4.9 | -11.6 | -22.7 |
| Selling expenses including commissions | -29.9 | -52.7 | -71.9 | -93.5 | -160.1 |
| Directly attributable research & development expenses | -5.6 | -6.4 | -13.0 | -13.0 | -24.8 |
| Research & development expenses, not directly attributable | -8.4 | -9.6 | -16.8 | -19.9 | -44.0 |
| Research & development expenses | -14.0 | -16.0 | -29.8 | -32.9 | -68.9 |
| Contribution | -1.9 | -19.6 | -10.2 | -34.5 | -48.6 |
| Jun 30 | |||
|---|---|---|---|
| SEKm | 2020 | 2019 | 2019 |
| Non-current borrowings | 5.6 | 6.7 | 5.7 |
| Current borrowings | 5.0 | 5.2 | 4.7 |
| Interest bearing debt | 10.6 | 11.9 | 10.4 |
| Cash and cash equivalents | 393.9 | 173.1 | 92.1 |
| Net debt | -383.3 | -161.2 | -81.7 |

BONESUPPORT HOLDING AB (publ), reg id. 556802-2171, with registered office in Lund, is the Parent Company of BONESUPPORT AB. BONESUPPORT is a fast growing orthobiologics company in the commercial phase that targets the major orthopedic markets in the US and Europe. BONESUPPORT has its registered office in Lund with wholly owned subsidiaries in the US, UK, Germany, Sweden, Denmark, Switzerland, Spain and the Netherlands and a branch office in France.
BONESUPPORT is active in orthobiological products, developing and commercializing innovative injectable bioceramic bone graft substitutes which remodel to host bone and have the capability of eluting drugs directly into the bone void. BONESUPPORT's marketed synthetic bone graft substitutes are CERAMENT BVF, CERAMENT G and CERAMENT V, all of which are based on the novel and proprietary CERAMENT technology platform. To date, all BONESUPPORT's marketed products have undergone the medical device approval process in the markets in which they are currently available. The Company is not aware of any other commercially available products with the same properties as CERAMENT G and CERAMENT V, i.e. an injectable antibiotic-eluting bone graft substitute with proven rapid remodeling into host bone.
BONESUPPORT's products represent an innovative technology backed by an intellectual property portfolio of approximately 100 registered and/or pending patents.
BONESUPPORT has 13 years of documented experience of safety and efficacy and, based on sales data, estimates that more than 50,000 treatments have been performed with its products worldwide. There is a great market potential in trauma, chronic osteomyelitis, revision arthroplasty, bone tumors and diabetic foot infections. The Company's research focuses on continuing to further develop and refine the current technology.
The CERAMENT portfolio is currently commercially available in several European markets, Colombia, Saudi Arabia, Oman and Singapore. In addition, CERAMENT BVF is commercially available in the US and CERAMENT G in Canada.
The Company started as a research company in the early 2000s by Professor Lars Lidgren, with the vision of developing a synthetic product that could replace autograft. CERAMENT BVF received the CE mark in 2009, CERAMENT G in 2013 and CERAMENT V in 2015. BONESUPPORT's mission is to improve the quality of life for patients suffering from bone diseases that cause skeletal injuries and can lead to pain and a reduced quality of life.
The Company invites investors, analysts and media to a web conference (in English) on July 17 at 11.00 CEST, where CEO Emil Billbäck and CFO Håkan Johansson will present and comment on the report and also answer questions. The report will be available on BONESUPPORT's website from 08.00 CEST on the same day and the presentation from the webcast will be uploaded during the day on July 17, 2020. For further details regarding participation, see the investor pages at www.bonesupport.com
The report contains certain forward looking information that reflects BONESUPPORT's current views of future events and financial and operational performance. Words such as "intends", "anticipates", "expects", "can", "plans", "estimates" and similar expressions regarding indications or forecasts of future developments or trends, and which are not based on historical facts, constitute forward looking information. Forward looking information is inherently associated with both known and unknown risks and uncertainties because it is dependent on future events
Emil Billbäck, CEO T: +46 46 286 53 70
Håkan Johansson, CFO T: +46 46 286 53 70
E: [email protected] www.bonesupport.com and circumstances. Forward-looking information is not a guarantee of future results or developments and actual results may differ materially from results referred to in forward looking information. Forward looking information in the report is only applicable on the date of issue of the report. BONESUPPORT does not commit to publishing updates or revision of any forward- looking statements as a result of new information, future events or similar circumstances other than those required by applicable legislation.
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