Quarterly Report • Oct 26, 2023
Quarterly Report
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• In October 2023, BONESUPPORT received Breakthrough device designation from the FDA for CERAMENT V for the indication of bone infection.
| Jul - Sep | Jan - Sep | 12 months | ||||
|---|---|---|---|---|---|---|
| KEY FIGURES | 2023 | 2022 | 2023 | 2022 | LTM | 2022 |
| Net sales, SEKm | 158.2 | 84.6 | 418.3 | 225.6 | 521.6 | 328.8 |
| Sales growth, %¹ | 87.0 | 54.2 | 85.4 | 48.9 | 81.7 | 54.5 |
| Gross profit, SEKm | 145.8 | 76.8 | 382.3 | 203.3 | 476.7 | 297.7 |
| Gross margin, %¹ | 92.1 | 90.8 | 91.4 | 90.1 | 91.4 | 90.5 |
| Operating result, SEKm | 14.9 | -13.9 | 21.6 | -45.3 | 2.3 | -64.5 |
| Result for the period, SEKm | 228.8 | -15.0 | 234.3 | -47.6 | 213.8 | -68.2 |
| Equity at period end, SEKm | 529.7 | 283.4 | 529.7 | 283.4 | 529.7 | 268.9 |
| Net debt, SEKm¹ | -151.0 | -194.1 | -151.0 | -194.1 | -151.0 | -183.8 |
| Operating cash flow, SEKm | 16.4 | -9.8 | -31.1 | -41.3 | -20.9 | -47.0 |
| Cash at period end, SEKm | 164.1 | 212.6 | 164.1 | 212.6 | 164.1 | 201.3 |
| Earnings per share before dilution, SEK | 3.52 | -0.23 | 3.61 | -0.74 | 3.30 | -1.06 |
| Earnings per share after dilution, SEK | 3.47 | -0.23 | 3.56 | -0.74 | 3.26 | -1.06 |
This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to EU's regulation on market abuse (MAR).

BONESUPPORT's sales continue to display a strong positive trend. Sales for the quarter amounted to SEK 158 million, corresponding to a growth of 87 percent (76 percent in constant currency) compared with the corresponding period last year. The strong sales development was driven by increased CERAMENT usage among existing and new customers in EUROW and North America, as well as a continued successful launch of CERAMENT G in the US.
The combination of a doctors' strike in the UK, the European vacation season and staff shortages in hospitals across Europe led to slightly lower volumes of orthopedic procedures in general, versus previous quarter. Despite this, BONESUPPORT's sales in EUROW increased compared to both the previous year and the previous quarter this year. Sales in the quarter increased by 31 percent compared to the previous year. The increase in market share comes at the expense of both autograft and traditional bone cement. In several European markets, we note that the authorities selectively are deciding on increased funding to cope with the healthcare backlog that has been built up in recent years.
Sales of CERAMENT G in the US during the quarter amounted to SEK 63 million, corresponding to a sequential growth of 22 percent compared to the previous quarter. We have started to see some cannibalization of CERAMENT BVF, but at the same time new customers are being added at a high pace for CERAMENT G. These include clinics and surgeons who have previously not been users of CERAMENT Bone Void Filler (BVF). We are encouraged by the strong sales to these new customers.
A previously published health economic model (fourth quarter 2022) has shown a cost advantage of approximately USD 28,000, over two years, for CERAMENT G compared to standard treatment in the US, for patients with bone infection. This data, in addition to strong clinical documentation and local leading surgeons' early positive experiences with CERAMENT G, contributes to the rapid penetration rate.
CERAMENT G has contracts with most major Group Purchasing Organizations (GPOs), as well as administrative approvals already from approximately 82 hospital systems, with over 1,000 affiliated
hospitals. The approval process is progressing at a rapid pace. Sales penetration at member-affiliated hospitals is still in its infancy. The focus of the US sales force is on training surgeons in application techniques and the added benefits of local antibiotic-elution. Total sales in the US during the quarter amounted to SEK 121 million, representing growth of 115 percent (102 percent in constant currency).
The strong sales and the scalability in the business model resulted in an operating profit (before the accounting effects of incentive programs) in the quarter of SEK 25 million, as well as a positive cash flow from operations.
The clinical trial team under the European Bone and Joint Infection Society (EBJIS), that manages the SOLARIO trial, decided to include one last patient in August. The follow-up period is approximately twelve months, and we can therefore expect the study to be completed in the third quarter of 2024.
The work on the 510(k) application for the extended indication (trauma/open fracture), for CERAMENT G in the US, is progressing. We intend to submit the application to the FDA in the fourth quarter of 2023. The FDA's communicated lead time target is three months.
Over the past few years, there has been a significant upgrade of the Company's regulatory deliverables and commercial infrastructure. Great progress has also been made in clinical documentation as well as with research and development. We intend to provide in-depth information about our clinical progress and innovations during a Capital Markets Day that we plan to hold at the end of November 2023.
BONESUPPORT delivers a quarterly result that confirms the strong momentum in the business. The sales growth is a clear indicator that more and more healthcare providers are experiencing the patient outcome benefits CERAMENT can contribute to. We continue to rapidly expand in the US and European markets and are proud to contribute to a positive change for patients with bone injuries and to replace an outdated standard of care.
INTERIM REPORT BONESUPPORT JULY– SEPTEMBER 2023 2

The US market is the world's largest for synthetic bone graft products and thus the Company's most important market. In May 2022, the Company received market approval from the US Food and Drug Administration (FDA), for the Company's antibiotic-eluting product CERAMENT G, for the indication bone infection (osteomyelitis). Launch took place during October 2022. Work is being undertaken for an extension of the indication area to also include orthopedic surgeries where there is a high risk of infection, such as in e.g. infection prevention at trauma operations.
Sales for the period amounted to SEK 121.0 million (56.3), which corresponds to a growth of 115 percent (102 percent in constant exchange rate). The strong growth in the quarter comes from strong sales of CERAMENT G, new customers and increased use among existing customers. Sales of CERAMENT G in the quarter amounted to SEK 62.6 million (0.0).
The contribution from the segment was SEK 46.5 million (11.2). The increased sales led to an increase in gross profit of SEK 61.3 million compared to previous year. Sales and marketing expenses during the quarter amounted to SEK 67.6 million (37.7), of which sales commissions to distributors and fees amounted to SEK 42.2 million (21.1). The increase, excluding sales commissions and fees, was driven by positive currency effects of SEK 1.5 million and an increased activity level, including expenses for the earlier communicated US booster program and for the launch of CERAMENT G. The contribution was also influenced by R&D costs related to clinical studies amounting to SEK 0.3 million (3.2).
Net sales for the period amounted to SEK 310.8 million (143.5), which corresponds to a growth of 117 percent (103 percent in constant exchange rate).
The contribution from the segment was SEK 103.1 million (24.9). The improved contribution is mainly due to the increase in sales.

| Full | |||||
|---|---|---|---|---|---|
| Jul - Sep | Jan - Sep | year | |||
| 2023 | 2022 | 2023 | 2022 | 2022 | |
| Net sales | 121.0 | 56.3 | 310.8 | 143.5 | 216.9 |
| Gross profit | 114.4 | 53.1 | 294.2 | 134.6 | 204.0 |
| Contribution | 46.5 | 11.2 | 103.1 | 24.9 | 42.3 |

In Europe, CERAMENT is sold either by the Company's own sales organization or by distributors. Germany, the UK, Sweden, Denmark and the BENELUX countries are key markets where BONESUPPORT has its own sales representatives. In Italy and Spain, the Company has established a hybrid model, with qualified local staff from BONESUPPORT working side by side with the local distributors' sales representatives. In other European markets and in other parts of the world (ROW), the Company cooperates with specialist distributors. The focus is on accelerating the sales and the use of CERAMENT in established and new markets through market access and the offering of clinical and health economic evidence.
Sales for the period amounted to SEK 37.2 million (28.3), corresponding to a growth of 31 percent (26 percent in constant exchange rates).
Sales in key direct markets accounted for 85 percent (83) of the segment's sales during the quarter. Sales of the antibiotic-eluting products CERAMENT G and CERAMENT V corresponded to 93 percent (88). The increased share of sales in key direct markets and the high share of antibiotic-eluting products had a positive effect on the gross margin for the period.
The contribution from the segment amounted to SEK 9.3 million (7.3). Selling and marketing expenses increased compared to the corresponding quarter last year and amounted to SEK 22.0 million (16.4), as a result of filled vacancies and increase in sales representatives.
Net sales amounted to SEK 107.5 million (82.1), corresponding to a growth of 31 percent (26 percent in constant exchange rates).
The contribution amounted to SEK 24.3 million (20.1). The improved contribution is explained by the increase in sales.

| Full | |||||
|---|---|---|---|---|---|
| Jul - Sep | Jan - Sep | year | |||
| 2023 | 2022 | 2023 | 2022 | 2022 | |
| Net sales | 37.2 | 28.3 | 107.5 | 82.1 | 111.9 |
| Gross profit | 31.3 | 23.7 | 88.7 | 68.7 | 93.7 |
| Contribution | 9.3 | 7.3 | 24.3 | 20.1 | 23.1 |

A number of combinations with CERAMENT have been studied to add osteoinductive properties i.e., the capability to actively stimulate bone healing. Among other research activities, the Company has conducted research in the form of preclinical candidates which combined CERAMENT with bisphosphonates, bone morphogenic proteins (BMP), bone marrow aspirate (BMA) and demineralized bone matrix (DBM). Priority product candidates for own development are CERAMENT combined with bisphosphonate and CERAMENT combined with DBM, while CERAMENT combined with BMP is a candidate for potential partner development.
Bisphosphonate is a well-established substance in the treatment of osteoporosis and is used to inhibit the activity of osteoclasts, resulting in improved bone healing and bone density. Demineralized bone matrix is based on allograft which is reduced in minerals. The material has been shown to have wide usage in conditions and situations where natural bone regrowth is weak.
Preclinical research has shown that the addition of zoledronic acid to CERAMENT increases the bone volume at screw implants with osteoporotic bone. These findings have recently been supplemented by a published biomechanical study¹ showing that CERAMENT immediately improved anchor strength of hip screws.
Further preclinical research has shown that the combination of CERAMENT, zoledronic acid and bone morphogenic protein-2 (BMP-2) can also be used in the reconstruction of large segment defects instead of bone transplantation.
One of the three cornerstones of BONESUPPORT's 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 240 research publications and abstracts of preclinical and clinical studies with CERAMENT.
The September issue 2022 of The Bone & Joint Journal presented outstanding results from a long-term study2 of CERAMENT G. One hundred patients, treated at Nuffield Orthopaedic Centre, Oxford
| SOLARIO | CONVICTION | |
|---|---|---|
| Indication | Osteomyelitis | Osteomyelitis |
| Purpose | Evaluate whethersynthetic bone graft substitutes with antibiotics (CERAMENT G / V) can shorten treatment times with systemic antibiotics |
CERAMENT G |
| • Treatment time • Antibiotic resistance • • Cost |
• ICUR Reinfection • Complications • Amputations |
|
| Number of patients | 500 | 220 |
| Follow up time | 12 month | 24 month |
| Place | Europe | France, CRIOAc |
| Expected completion | During Q3 2024 | Q4 2026 |
816250 2. McNally, M, et. al., 'Mid- to Long-Term Results of Single-Stage Surgery for Patients with Chronic Osteomyelitis Using a Bioabsorbable Gentamicin-Loaded Ceramic Carrier', The Bone & Joint Journal, 104-B.9 (2022), 1095–1100
University Hospitals, were followed for an average of six years. At an average follow-up of six years, it was reported:
Previous this year, we also provided long-term data with CERAMENT G in severe open fractures in a study3 from Manchester University Hospital. The study was conducted in 81 patients who were managed in a one-step procedure with CERAMENT G. Patients were admitted to the hospital with significant tissue loss and exposed bone tissue. After an average follow-up of 55.8 months, after surgery, it was found that 96.3 percent of patients avoided amputation, achieved bone healing within 12 months and avoided deep infection.
The results from these two studies over a long follow-up period confirm that our protocol using CERAMENT G remains very effective over several years.
For several years, diabetes has been one of the fastest growing public diseases and more than every eleventh adult in the world has diabetes. The annual incidence of infected foot ulcers is 3.2 percent among diabetics. A condition that many times leads to severe complications. A clinical study published by Vasukutty et. al. means a powerful validation of our groundbreaking technology for the management of diabetic bone infection, a particularly challenging category of patients. The study, recently published in The Diabetic Foot Journal4 , shows that the use of CERAMENT G, along with a surgical debridement, resulted in avoidance of amputation in 94 percent of cases. In a recently published study in the Lancet, it is estimated that 1.3 billion people will have diabetes by 2050. With strong treatment results, BONESUPPORT has decided to support two recently started physician-initiated studies, one in the Netherlands and one in Spain, with the aim of further validating the benefits of CERAMENT G in various surgical techniques, for the treatment of diabetes-related bone infection.
CERTiFy5 was a randomized, controlled clinical trial conducted at 20 trauma centers in Germany with 135 patients. The study, which was done on tibial plateau fractures, shows that CERAMENT BVF can replace autograft as the 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 and 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.
BONESUPPORT supports the SOLARIO study (Short or Long Antibiotic Regimes in Orthopaedics), with the aim of investigating if synthetic bone graft substitutes containing antibiotics can lead to shorter treatment time compared to systemic antibiotics and thereby reduce risk of antibiotic resistance, side effects and additional costs. The study is led by the Oxford University Hospitals' 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 during Q3 2024. During August, the last patient was enrolled to the study, with a follow up time of twelve months. A positive result of the study may contribute to a paradigm shift in the protocol for treating bone infections.
The French CRIOAc6 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. A research grant from BONESUPPORT to partially finance the products used in the study, has been awarded.
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.
The recruitment of patients to the study has been slow and we are in dialogue with participating hospitals and CRIOAc about how we can increase the recruitment rate.
A positive outcome of the study would mean that a large commercial opportunity will arise in the French market and that improved reimbursement status is obtained.
3. Henry et. al., ´Long-Term Follow-Up of Open Gustilo-Anderson IIIB Fractures Treated With an Adjuvant Local Antibiotic Hydroxyapatite Bio-Composite´, Cureus 15(5): e39103.
6. 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 treatment is to ensure that healthcare systems around the world understand the value of the treatment and include it in the care offered to the patient. BONESUPPORT undertakes a variety of activities to ensure that the Company's products are included in the remuneration systems where our products are marketed.
One of the obvious health economic benefits that comes from the clinical benefits CERAMENT offers is a reduced utilization of healthcare resources. A reduced number of re-infections and reduced amputation frequency as a result of treatment with CERAMENT G and CERAMENT V in a one-step procedure naturally leads to fewer return visits and fewer surgeries and, as a consequence, fewer hospital stays. The significance of health benefits and the calculation models for evaluating the cost-effectiveness of health benefits differ between different healthcare systems. A common way to evaluate whether a product should be covered by a reimbursement system is by performing an HTA - Health Technology Assessment. An HTA is the scientific work that evaluates the relative effect and safety of a treatment, i.e. what is the benefit of the product in comparison with what is already used in healthcare. The model we have now established has increased our opportunities to more quickly include the CERAMENT platform in replacement systems in new markets.
One of the major projects recently carried out is a cost-benefit analysis of what a change of treatment regime to a one-step procedure with CERAMENT G could mean for the US healthcare system. The modelling, which is based on available clinical data as well as cost data from CMS, Centers for Medicare & Medicaid Services, was done in collaboration with national expertise in health economics and clinical orthopedics. The results were presented at the end of 2022, partly at the leading health economic conference ISPOR and partly at the SOMOS conference aimed at orthopedic surgeons. The analysis shows that a one-step procedure with CERAMENT G is a cost-effective strategy for treating bone infection compared to current US healthcare standards. When using CERAMENT G, instead of PMMA beads with antibiotics, the cost reduction is estimated on average to be about SEK 300 thousand (USD 27,943) per patient, over a period of two years, due to fewer surgeries and fewer surgical complications during and after procedures¹. The analysis also shows improved quality of life for patients. It will be an important tool for communicating the value of CERAMENT G to, among others, private insurance companies.
The Nuffield Orthopaedic Centre (NOC) has shown that they have been able to reduce the degree of re-infection in osteomyelitis patients by 56 percent compared to their previous standard of treatment. In an analysis involving approximately 25,000 patients who underwent surgical treatment for osteomyelitis in 2013-2017, the patient group treated at NOC after the introduction of CERAMENT G or CERAMENT V in a one-step procedure was compared with patients cared for at other hospitals in England. The results presented in The Journal of Bone and Joint Infection2 showed that CERAMENT G or CERAMENT V in a one-step procedure contributed to significantly improved patient outcomes. The hospital stay, in connection with osteomyelitis surgery and the following two years, were on average 16 days shorter for the group that received CERAMENT G and CERAMENT V at NOC. In addition, patients at NOC had a significantly lower risk of amputation (6.47 percent) compared to the Rest of England control group (12.71 percent). With the addition of CERAMENT G or CERAMENT V in the treatment of osteomyelitis, the total saving in the number of days of care associated with surgery and subsequent care, could amount to approximately GBP 44 million annually, calculated on 6,250 treated patients per year.
Another area where CERAMENT G and CERAMENT V could help reduce healthcare costs is in the treatment of open tibial fractures. Open tibial fractures represent about 15 percent² of all tibial fractures and have a high incidence of infection, with no bone healing as a result. Bone infections often lead to great suffering for the patient and very high healthcare costs. In a Belgian study by Hoekstra et. al.³ of 358 patients, the cost of tibial fractures was studied. The study showed that healthcare costs for patients affected by a deep infection were on average five times higher than for those who did not get an infection, resulting in the cost of treatment increasing from EUR 9,500 to EUR 48,700. There are a number of studies that show that CERAMENT contributes to cost-effective care by reducing the number of deep infections. One of these is a study by Henry et. al.4 on 81 patients with severe open tibial fractures treated with CERAMENT G in a one-step procedure. In the study, with a mean follow up time of 55.5 months, three patient (3.7 percent) suffered from a deep infection compared with historical references of up to 52 percent incidence of infection. This shows that onestep treatment with antibiotic-eluting CERAMENT for open tibial fractures can effectively reduce the incidence of cost-driving infections.
2. Ferguson, J et. al. A retrospective cohort study comparing clinical outcomes and healthcare resource utilisation in patients undergoing surgery for osteomyelitis in England: a case for reorganising orthopaedic infection services, J. Bone Joint Infect., 6, 151–163.
3. Hoekstra et. al. Economics of open tibial fractures: the pivotal role of length-of-stay and infection. Health Econ Rev 2017; 7:32. 4. Henry, Joshua A et al. "Long-Term Follow-Up of Open Gustilo-Anderson IIIB Fractures Treated With an Adjuvant Local Antibiotic Hydroxyapatite Bio-Composite." Cureus vol. 15,5 e39103. 16 May. 2023, doi:10.7759/cureus.39103
Net sales amounted to SEK 158.2 million (84.6), an increase of 87 percent compared to the previous year (76 percent at constant exchange rates).
In the North America segment, net sales amounted to SEK 121.0 million (56.3), which corresponds to growth of 115 percent (102 percent at constant exchange rate). The strong growth in the quarter comes from an expanded customer base, extended use of CERAMENT among existing customers and sales of CERAMENT G. Sales of CERAMENT G in the quarter amounted to SEK 62.6 million (0.0).
Net sales for the EUROW segment amounted to SEK 37.2 million (28.3), which corresponds to an increase of 31 percent (26 percent at constant exchange rates).
The currency translation effect in the period amounted to SEK +2.9 million (+3,2).
Selling expenses, including sales commissions and fees, amounted to SEK 96.1 million (59.9), an increase of 61 percent. This is explained in the table below:
| Jul - Sep | Jul - Sep | Jul - Sep | ||
|---|---|---|---|---|
| SEKm | 2023 | 2023 (CER) | 2022 | |
| Sales commissions and fees | 42.7 | 40.1 | 21.1 | |
| Personnel expenses | 33.7 | 32.7 | 26.2 | |
| Other selling expenses | 19.7 | 19.2 | 12.6 | |
| Total selling expenses | 96.1 | 92.0 | 59.9 |
As a result of the growth in sales, the NA segment reported a cost increase to SEK 67.6 million (37.7) of which sales commissions and fees increased from SEK 21.1 million to SEK 42.2 million. In EUROW, expenses amounted to SEK 22.0 million (16.4). Non-allocated costs increased to SEK 6.6 million (5.9). The non-allocated costs include one off expenses of SEK 2.5 million regarding a self-correction of EC VAT for earlier years. The background to the self-correction is complicated prerequisites relating to the production process. The self-correction has been initiated by the Company. The self-correction led to interest expenses of SEK 1.9 million and exchange rate losses of SEK 0.6 million in the period.
Research and development expenses amounted to SEK 12.5 million (12.6). Personnel costs amounted to SEK 7.0 million (6.6). Other expenses totaled SEK 5.5 million (6.0).
Administrative expenses amounted to SEK 21.6 million (20.8).
Administrative expenses before effects from the Group's incentive programs amounted to SEK 11.9 million (11.3), of which personnel costs amounted to SEK 5.3 million (5.5).
Effects regarding incentive programs amounted to an expense of SEK 9.7 million (9.5). Of the total cost, only SEK 0.2 million is cash flow related. The remainder regards technical accounting measures.
Other operating income and expenses consisted primarily of exchange rate gains and losses on operating assets and liabilities. Reported currency effects were clearly affected by the large exchange rate changes that occurred during the period, mainly in USD.

Cost of sales amounted to SEK 12.4 million (7.8), giving a gross margin of 92.1 percent (90.8). The improved gross margin is due to the strong growth for CERAMENT G in North America, but also to a favorable product mix in EUROW, with a high share of the antibiotic-eluting products.
Quarter 12 months
Operating result amounted to SEK +14.9 million (-13.9), including effects from the Group's incentive programs. Operating result before effects from the Group's incentive programs amounted to SEK +24.6 million (-4.4), an underlying improvement of SEK 29.0 million.
During the quarter, a self-correction of EC VAT was reported. The self-correction has led to an interest expense of SEK 1.9 million.
During the quarter, the Company has for the first time assigned a value to the tax losses carried forward in the balance sheet. The deferred tax income amounts to SEK 217.1 million (0.0).
For the reasons described above, the result for the quarter amounted to SEK +228.8 million (-15.0). This corresponds to earnings per share before dilution of SEK +3.52 (-0.23) and after dilution of SEK +3.47 (-0.23). Adjusted for deferred tax receivables, which have been reported for the first time this period, the earnings per share before and after dilution were SEK +0.18.
Net sales amounted to SEK 418.3 million (225.6), an increase of 85 percent (75 percent at constant exchange rates). The NA segment increased by 117 percent to SEK 310.8 million (143.5) and the EUROW segment increased by 31 percent to SEK 107.5 million (82.1).
Operating result amounted to SEK +21.6 million (-45.3). The sales increase contributed to improved gross profit at the same time as operating expenses increased compared with previous year, as a result of high activity level and the launch of CERAMENT G in the US. The operating result also included costs for incentive programs amounting to SEK 21.5 million, compared to SEK 19.2 million previous year. The underlying improvement in result before costs for incentive programs amounted to SEK 68.9 million.
During the quarter, a self-correction of EC VAT was reported. The self-correction has led to an interest expense of SEK 1.9 million.
During the quarter, the Company has for the first time assigned a value to the tax losses carried forward in the balance sheet. The deferred tax income amounts to SEK 217.1 million (0.0).
For the reasons described above, the result for the period amounted to SEK +234.3 million (-47.6). This corresponds to earnings per share before dilution of SEK +3.61 (-0.74) and after dilution of SEK +3.56 (-0.74). Adjusted for deferred tax receivables, which have been reported for the first time this period, the earnings per share before and after dilution were SEK +0.26.
| SEKm | Sep 30 | Dec 31 | |
|---|---|---|---|
| Financial position | 2023 | 2022 | 2022 |
| Cash and cash equivalents | 164.1 | 212.6 | 201.3 |
| Interest bearing debt¹ | 13.0 | 18.4 | 17.5 |
| Net debt¹ | -151.0 | -194.1 | -183.8 |
| Equity | 529.7 | 283.4 | 268.9 |
| SEKm | Jul - Sep | Jan - Sep | Full year | ||
|---|---|---|---|---|---|
| Cash flow | 2023 | 2022 | 2023 | 2022 | 2022 |
| Operating activities | 16.4 | -9.8 | -31.1 | -41.3 | -47.0 |
| Investing activities | -0.6 | -0.7 | -2.0 | -1.9 | -3.3 |
| Financing activities | -2.0 | 49.9 | -5.3 | 46.2 | 42.8 |
| Total | 13.8 | 39.4 | -38.4 | 3.0 | -7.5 |
Cash and cash equivalents at the end of the period amounted to SEK 164.1 million (212.6), a decrease of SEK 37.2 million since the beginning of the year. The change is mainly explained by cash flow from operating activities amounting to SEK -31.1 million (-41.3). The cash flow was affected during the year by the strong growth which has led to an increase in trade receivables of SEK 49.4 million and in inventories of SEK 10.3 million. The cash flow has also been affected by the self-correction of EC VAT, with an amount of SEK -7.1 million.
This also explains the change in net debt since the beginning of the year.
The Parent Company, BONESUPPORT HOLDING AB (publ), is a holding company. The Parent Company generated SEK 14.3 million (11.5) in sales of internal services to subsidiaries during the quarter.
During the quarter, the Company recognized deferred tax receivables on its tax losses carried forward. The reported deferred tax income amounted to SEK 17.9 million.
The result for the quarter was SEK +16.1 million (-17.2). Apart from the deferred tax income described above, the change was also due to the result during the comparison period being burdened by financial costs of SEK 11.3 million, when terminating a share swap.
No investments were made during the quarter.
On average, the Group had 105 (92) employees (full-time equivalent) during the quarter, of whom 25 (22) worked within Research and development.
For significant events, see page 1.
For significant events after the period, see page 1.
The Company has ordinary shares and C-shares, for more information about this 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 September 30, 2023, the total number of ordinary shares amounted to 65,055,575, distributed among 7,862 shareholders. The major shareholders are shown in the table on this page. No changes have been made to the number of shares during the quarter.
As of September 30, 2023, the total number of C-shares amounted to 1,142,060. No changes have been made during the quarter. BONESUPPORT HOLDING AB holds all C-shares.
BONESUPPORT has two employee stock option programs and three performance share programs. These are described in Note 8.
| Name | % of shares | % of votes |
|---|---|---|
| HealthCap V LP | 10.0% | 10.1% |
| Swedbank Robur Fonder | 9.1% | 9.3% |
| Capital Group | 7.9% | 8.0% |
| Avanza Pension | 6.9% | 7.0% |
| Fjärde AP-Fonden | 4.5% | 4.6% |
| Tredje AP-Fonden | 3.2% | 3.3% |
| Norges Bank | 2.7% | 2.8% |
| Other shareholders | 55.7% | 54.9% |
The nomination committee is elected based on the principles decided at the AGM May 17, 2023. These principles are described on BONESUPPORT's website. The task of the committee is to present a proposal to the AGM, which is planned to be held on May 16, 2024 in Lund, Sweden. The members of the committee are:
In addition, the chairman of the Board of BONESUPPORT, Lennart Johansson, is co-opted to the nomination committee except when the nomination committee shall address the matter of chair of the Board and remuneration to the chair of the Board. The nomination committee will appoint one if its members as committee chair.
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 CEO assures 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. This interim report has been reviewed by the Company's auditors.
Lund October 26, 2023
Emil Billbäck CEO
Board of Directors BONESUPPORT HOLDING AB (publ)
We have reviewed the condensed interim report for BONESUPPORT HOLDING AB (publ) as at September 30, 2023 and for the nine months period then ended. The Board of Directors and the Managing Director are responsible for the preparation and presentation of this interim report in accordance with IAS 34 and the Swedish Annual Accounts Act. Our responsibility is to express a conclusion on this interim report based on our review.
We conducted our review in accordance with the International Standard on Review Engagements, ISRE 2410 Review of Interim Financial Statements Performed by the Independent Auditor of the Entity. A review consists of making inquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with
International Standards on Auditing and other generally accepted auditing standards in Sweden. The procedures performed in a review do not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion.
Based on our review, nothing has come to our attention that causes us to believe that the interim report is not prepared, in all material respects, in accordance with IAS 34 and the Swedish Annual Accounts Act regarding the Group, and in accordance with the Swedish Annual Accounts Act regarding the Parent Company.
Malmo, October 26, 2023
Ernst & Young AB
Authorized Public Accountant
| Jul - Sep | Jan - Sep | Full year | ||||
|---|---|---|---|---|---|---|
| SEKt | Note | 2023 | 2022 | 2023 | 2022 | 2022 |
| Net sales | 7 | 158,204 | 84,623 | 418,334 | 225,597 | 328,818 |
| Cost of sales | 7 | -12,423 | -7,797 | -36,014 | -22,297 | -31,111 |
| Gross profit | 7 | 145,781 | 76,826 | 382,320 | 203,300 | 297,707 |
| Selling expenses | -53,470 | -38,751 | -157,533 | -111,311 | -158,073 | |
| Sales commissions and fees | 7 | -42,663 | -21,103 | -109,742 | -52,235 | -80,375 |
| Research and development expenses | -12,490 | -12,557 | -39,558 | -38,278 | -53,088 | |
| Administrative expenses | 3, 8 | -21,626 | -20,798 | -57,011 | -52,054 | -73,305 |
| Other operating income | 9,414 | 19,903 | 29,751 | 38,761 | 43,206 | |
| Other operating expenses | -10,078 | -17,460 | -26,639 | -33,435 | -40,607 | |
| Operating result | 7 | 14,868 | -13,941 | 21,588 | -45,252 | -64,535 |
| Net financial items | 7 | -2,126 | -462 | -2,481 | -747 | -159 |
| Result before income tax | 7 | 12,742 | -14,403 | 19,107 | -45,999 | -64,694 |
| Income tax | 216,029 | -552 | 215,180 | -1,632 | -3,473 | |
| Result for the period | 9 | 228,771 | -14,955 | 234,287 | -47,631 | -68,167 |
| Earnings per share before dilution, SEK | 3.52 | -0.23 | 3.61 | -0.74 | -1.07 | |
| Earnings per share after dilution, SEK | 3.52 | -0.23 | 3.56 | -0.74 | -1.07 | |
| Average number of shares, thousands | 65,056 | 64,518 | 64,925 | 64,425 | 63,999 | |
| Average number of shares after dilution, thousands | 65,878 | - | 65,747 | - | - |
Result for the period is attributable to equity holders of the Parent.
Number of shares after dilution not calculated for the periods with a negative result, as the dilution does not affect earnings per share.
| Jul - Sep | Jan - Sep | Full year | |||
|---|---|---|---|---|---|
| SEKt | 2023 | 2022 | 2023 | 2022 | 2022 |
| Result for the period | 228,771 | -14,955 | 234,287 | -47,631 | -68,167 |
| Other comprehensive income: | |||||
| Items to be reclassified to profit or loss in subsequent periods: | |||||
| Exchange differences on translation of foreign operations | -763 | 1,584 | 1,502 | 2,702 | 1,831 |
| Total comprehensive income for the period | 228,008 | -13,371 | 235,789 | -44,929 | -66,336 |
Total comprehensive income for the period is in its entirety attributable to equity holders of the Parent.
| Sep 30 | Dec 31 | |||
|---|---|---|---|---|
| SEKt | Note | 2023 | 2022 | 2022 |
| ASSETS | ||||
| Non-current assets | ||||
| Intangible assets | 8,664 | 8,408 | 8,384 | |
| Tangible assets and right-of-use assets | 19,855 | 24,120 | 24,625 | |
| Deferred tax asset | 9 | 229,600 | 0 | 0 |
| Financial assets | 1 | 0 | 1 | |
| Total non-current assets | 258,120 | 32,528 | 33,010 | |
| Current assets | ||||
| Inventories | 66,637 | 56,480 | 56,310 | |
| Trade receivables | 6 | 112,017 | 53,901 | 62,624 |
| Other current assets | 6 | 30,131 | 14,212 | 18,593 |
| Cash and cash equivalents | 6 | 164,051 | 212,581 | 201,281 |
| Total current assets | 372,836 | 337,174 | 338,808 | |
| TOTAL ASSETS | 630,956 | 369,702 | 371,818 | |
| EQUITY AND LIABILITIES | ||||
| Equity attributable to equity holders of the Parent | 4, 9 | 529,650 | 283,397 | 268,928 |
| Non-current liabilities | ||||
| Leasing debt | 6 | 8,507 | 13,283 | 12,350 |
| Provisions | 344 | 363 | 344 | |
| Total non-current liabilities | 8,851 | 13,646 | 12,694 | |
| Current liabilities | ||||
| Leasing debt | 6 | 4,517 | 5,158 | 5,101 |
| Trade payables | 6 | 12,345 | 15,251 | 23,571 |
| Other operating liabilities | 6 | 75,593 | 52,250 | 61,524 |
| Total current liabilities | 92,455 | 72,659 | 90,196 | |
| TOTAL EQUITY AND LIABILITIES | 630,956 | 369,702 | 371,818 |
| Balanced result |
|||||||
|---|---|---|---|---|---|---|---|
| Paid but not | Fund for | including | |||||
| SEKt | Share capital | registered share issue |
Other paid in capital |
Translation reserve |
development expenses |
result for the | period Total equity |
| As at January 1, 2022 | 40,909 | 0 | 1,563,670 | 129 | 5,490 | -1,344,494 | 265,704 |
| Loss January - September 2022 | 2,702 | -47,631 | -44,929 | ||||
| Share swap¹ | 51,039 | 51,039 | |||||
| Change in fund for development | |||||||
| expenses | 444 | -444 | 0 | ||||
| New share issue, employee stock options | 44 | 166 | 210 | ||||
| Share-based payment transactions | 11,373 | 11,373 | |||||
| As at September 30, 2022 | 40,953 | 166 | 1,563,670 | 2,831 | 5,934 | -1,330,157 | 283,397 |
| Loss October - December 2022 | -871 | -20,536 | -21,407 | ||||
| Change in fund for development | |||||||
| expenses | 101 | -101 | 0 | ||||
| New share issue, employee stock options | 406 | -152 | 166 | 420 | |||
| Share-based payment transactions | 6,518 | 6,518 | |||||
| As at January 1, 2023 | 41,359 | 14 | 1,563,836 | 1,960 | 6,035 | -1,344,276 | 268,928 |
| Result January - September 2023 | 1,502 | 234,287 | 235,789 | ||||
| Change in fund for development | |||||||
| expenses | 645 | -645 | 0 | ||||
| New share issue, employee stock options | 15 | -14 | 26 | 27 | |||
| Transaction costs, share issue | -58 | -58 | |||||
| Deferred tax on earlier transaction costs | 12,500 | 12,500 | |||||
| Share-based payment transactions | 12,464 | 12,464 | |||||
| As at September 30, 2023 | 41,374 | 0 | 1,563,862 | 3,462 | 6,680 | -1,085,728 | 529,650 |
1 During 2021, BONESUPPORT entered into a share swap agreement to secure the commitments in the Group's performance share program LTI 2021. A total of 786,000 shares were hedged at an average value of SEK 79.30 per share, a total value of SEK 62,333 thousand. At the Annual General Meeting in May 2022, the Company received the mandate to issue C-shares to cover its commitment within the performance share programs LTI 2021, including coverage for social security charges. The mandate to issue C-shares enabled the close of the share swap that was entered into during 2021. The close led to an inflow of cash amounting to SEK 51,039 thousand. The expenses for the termination amounted to SEK 355 thousand. The cash flow for 2022 was thereby affected positively with SEK 50,684 thousand.
| Jul - Sep | Jan - Sep | Full year | |||
|---|---|---|---|---|---|
| SEKt | 2023 | 2022 | 2023 | 2022 | 2022 |
| Operating result | 14,868 | -13,941 | 21,588 | -45,252 | -64,535 |
| Non-cash adjustments: | |||||
| -Share-based payments | 6,807 | 5,256 | 12,464 | 11,373 | 17,891 |
| -Depreciation regarding right of use assets | 1,912 | 1,642 | 5,492 | 5,071 | 7,109 |
| -Unrealized exchange rate differences | -1,821 | -11,264 | -6,587 | -21,268 | -14,474 |
| -Other | 2,424 | 864 | 3,811 | 3,274 | 4,459 |
| Interests received | -44 | 6 | 0 | 6 | 811 |
| Interests paid | -2,083 | -466 | -2,481 | -750 | -716 |
| Income tax paid | -785 | 97 | -1,230 | -1,130 | -2,686 |
| Net cash flows from operating activities before | |||||
| changes in working capital | 21,278 | -17,806 | 33,057 | -48,676 | -52,141 |
| Changes in working capital | -4,910 | 8,042 | -64,126 | 7,399 | 5,156 |
| Net cash flows from operating activities | 16,368 | -9,764 | -31,069 | -41,277 | -46,985 |
| Investments in intangible assets | -396 | -325 | -1,320 | -1,012 | -1,321 |
| Investments in equipment and tools | -176 | -388 | -713 | -892 | -1,958 |
| Net cash flows from investing activities | -572 | -713 | -2,033 | -1,904 | -3,279 |
| Share swap¹ | 0 | 51,039 | 0 | 51,039 | 50,684 |
| New share issue, employee stock options | 0 | 157 | 27 | 210 | 230 |
| Transaction costs, share issue | 0 | 0 | -58 | 0 | 0 |
| Repayments of leasing debt | -1,997 | -1,274 | -5,314 | -5,071 | -8,132 |
| Net cash flows from financing activities | -1,997 | 49,922 | -5,345 | 46,178 | 42,782 |
| Net cash flows | 13,799 | 39,445 | -38,447 | 2,997 | -7,482 |
| Cash and cash equivalents as at beginning of period | 149,756 | 171,828 | 201,281 | 206,464 | 206,464 |
| Net exchange difference | 496 | 1,308 | 1,217 | 3,120 | 2,299 |
| Cash and cash equivalents as at end of period | 164,051 | 212,581 | 164,051 | 212,581 | 201,281 |
1 During 2021, BONESUPPORT entered into a share swap agreement to secure the commitments in the Group's performance share program LTI 2021. A total of 786,000 shares were hedged at an average value of SEK 79.30 per share, a total value of SEK 62,333 thousand. At the Annual General Meeting in May 2022, the Company received the mandate to issue C-shares to cover its commitment within the performance share programs LTI 2021, including coverage for social security charges. The mandate to issue C-shares enabled the close of the share swap that was entered into during 2021. The close led to an inflow of cash amounting to SEK 51,039 thousand. The expenses for the termination amounted to SEK 355 thousand. The cash flow for 2022 was thereby affected positively with SEK 50,684 thousand.
| 2023 | 2022 | 2021 | ||||||
|---|---|---|---|---|---|---|---|---|
| SEKt | Q3 | Q2 | Q1 | Q4 | Q3 | Q2 | Q1 | Q4 |
| Net sales | 158,204 | 140,388 | 119,742 | 103,221 | 84,623 | 74,632 | 66,342 | 61,402 |
| North America | 121,008 | 103,863 | 85,947 | 73,390 | 56,286 | 46,012 | 41,188 | 34,798 |
| EUROW | 37,196 | 36,525 | 33,795 | 29,831 | 28,337 | 28,620 | 25,154 | 26,604 |
| Cost of sales | -12,423 | -12,185 | -11,406 | -8,814 | -7,797 | -8,195 | -6,305 | -6,582 |
| Gross profit | 145,781 | 128,203 | 108,336 | 94,407 | 76,826 | 66,437 | 60,037 | 48,826 |
| Gross margin, % | 92.1% | 91.3% | 90.5% | 91.5% | 90.8% | 89.0% | 90.5% | 79.5% |
| Selling expenses | -53,470 | -55,033 | -49,030 | -46,762 | -38,751 | -37,370 | -35,189 | -35,389 |
| Sales commissions and fees | -42,663 | -37,183 | -29,896 | -28,140 | -21,103 | -16,800 | -14,332 | -13,890 |
| Research and development expenses | -12,490 | -14,613 | -12,455 | -14,810 | -12,557 | -13,586 | -12,135 | -14,395 |
| Administrative expenses | -21,626 | -19,849 | -15,536 | -21,251 | -20,798 | -16,716 | -14,540 | -14,827 |
| Other operating income | 9,414 | 17,263 | 3,074 | 4,445 | 19,903 | 11,859 | 6,999 | 5,175 |
| Other operating expenses | -10,078 | -12,836 | -3,725 | -7,172 | -17,460 | -8,679 | -7,296 | -3,267 |
| Operating result | 14,868 | 5,952 | 768 | -19,283 | -13,941 | -14,855 | -16,456 | -21,773 |
| Net financial items | -2,126 | -180 | -175 | 588 | -462 | -68 | -217 | -279 |
| Result before income tax | 12,742 | 5,772 | 593 | -18,695 | -14,403 | -14,923 | -16,673 | -22,052 |
| Income tax | 216,029 | -564 | -285 | -1,841 | -552 | -1,380 | 300 | -2,151 |
| Result for the period | 228,771 | 5,208 | 308 | -20,536 | -14,955 | -16,303 | -16,373 | -24,203 |
Result for the period is attributable to equity holders of the Parent.
| Jul - Sep | Jan - Sep | Full year | |||
|---|---|---|---|---|---|
| SEKt | 2023 | 2022 | 2023 | 2022 | 2022 |
| Net sales | 14,304 | 11,473 | 42,913 | 34,419 | 47,783 |
| Administrative expenses | -18,715 | -17,445 | -56,309 | -47,293 | -61,831 |
| Other operating income | 12 | 0 | 147 | 24 | 119 |
| Other operating expenses | 715 | -1,269 | -2,469 | -2,725 | -2,791 |
| Operating loss | -3,684 | -7,241 | -15,718 | -15,575 | -16,720 |
| Net financial items | 1,925 | -9,998 | 5,927 | -6,823 | -4,756 |
| Result after financial items | -1,759 | -17,239 | -9,791 | -22,398 | -21,476 |
| Income tax 9 |
17,859 | 0 | 17,859 | 0 | 0 |
| Result for the period | 16,100 | -17,239 | 8,068 | -22,398 | -21,476 |
Parent Company result for the period equals comprehensive income.
| Sep 30 | Dec 31 | |||
|---|---|---|---|---|
| Note | 2023 | 2022 | 2022 | |
| 9 | 30,359 | 0 | 0 | |
| 6 | 1,253,097 | 1,130,626 | 1,160,841 | |
| 1,283,456 | 1,130,626 | 1,160,841 | ||
| 75 | ||||
| 6 | 2,225 | 1,092 | 1,066 | |
| 6 | 45,779 | 169,002 | 143,402 | |
| 48,004 | 170,094 | 144,543 | ||
| 1,331,460 | 1,300,720 | 1,305,384 | ||
| 4 | 41,374 | 40,953 | 41,359 | |
| 9 | 1,226,139 | 1,205,187 | 1,205,723 | |
| 1,267,513 | 1,246,140 | 1,247,082 | ||
| 52,842 | 42,597 | 43,882 | ||
| 6 | 11,105 | 11,983 | 14,420 | |
| 1,305,384 | ||||
| 0 1,331,460 |
0 1,300,720 |
This interim 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 2022 have also been applied in this interim report. New or amended standards or interpretations of standards effective as of January 1, 2023 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 which 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.
Regarding deferred tax assets, see Note 9.
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 2022.
The war in Ukraine has created unrest and insecurity in the world. The business impact is difficult to predict, but higher shipping costs and higher prices for input goods are likely effects under prevailing market conditions.
The financial reports include costs related to the following transactions between BONESUPPORT and related parties.
| SEKt | Jul - Sep | Jan - Sep | Full year | |||
|---|---|---|---|---|---|---|
| Related party | Service | 2023 | 2022 | 2023 | 2022 | 2022 |
| Mary I O'Connor (Board member) | Consultancy | 286 | 267 | 839 | 356 | 624 |
| Mary I O'Connor (Board member) | Reimbursement of expenses | 0 | 0 | 27 | 0 | 57 |
| Ordinary shares | Number of shares | Potential shares |
|---|---|---|
| December 31, 2022 | 64,532,197 | 106,044 |
| Exercised employee stock options paid 2022 | 22,000 | -22,000 |
| Other exercised employee stock options | 1,000 | -1,000 |
| Conversion of class C-shares to ordinary shares | 500,378 | 0 |
| September 30, 2023 | 65,055,575 | 83,044 |
| Series C-shares | ||
| December 31, 2022 | 1,642,438 | 0 |
| Conversion of class C-shares to ordinary shares | -500,378 | 0 |
The US subsidiary BONESUPPORT Inc. has provided a guarantee of USD 42 thousand (56), corresponding to SEK 445 thousand (627) for rented premises. The Parent Company, BONESUPPORT HOLDING AB, guarantees a corresponding amount. During 2022, the Parent Company also provided a general guarantee of USD 500 thousand (500), corresponding to SEK 5,294 thousand (5,602).
September 30, 2023 1,142,060 0
The Group has pledged collateral for capital-invested direct pensions amounting to SEK 979 thousand (979).
Fair values of the consolidated financial assets and liabilities are assessed to agree with values accounted for.
Participations in subsidiaries are accounted for in the Parent Company in accordance with the cost method.
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 fees, and research and development expenses. Assets and liabilities are not reported by segment, these are managed and monitored on Group level by management and the Board of directors.
Net sales in Sweden (part of EUROW) was SEK 2.5 million (1.8) in the quarter. For the year to date, the corresponding amount was SEK 8.6 million (6,5). The US and UK were the only markets that delivered more than ten percent of the consolidated net sales.
| SEKt | Jul - Sep 2023 | Jul - Sep 2022 | ||||||
|---|---|---|---|---|---|---|---|---|
| Profit and loss items | NA | EUROW | Other | Total | NA | EUROW | Other | Total |
| Net sales | 121,008 | 37,196 | 0 | 158,204 | 56,286 | 28,337 | 0 | 84,623 |
| of which CERAMENT BVF | 55,771 | 2,682 | 0 | 58,453 | 54,828 | 3,326 | 0 | 58,154 |
| of which CERAMENT drug eluting¹ | 62,639 | 34,474 | 0 | 97,113 | 0 | 25,011 | 0 | 25,011 |
| of which other | 2,599 | 41 | 0 | 2,639 | 1,458 | 0 | 0 | 1,458 |
| Cost of sales | -6,562 | -5,861 | 0 | -12,423 | -3,172 | -4,625 | 0 | -7,797 |
| Gross profit | 114,446 | 31,335 | 0 | 145,781 | 53,114 | 23,712 | 0 | 76,826 |
| Sales commissions and fees | -42,151 | -512 | 0 | -42,663 | -21,076 | -27 | 0 | -21,103 |
| Other operative costs | -25,769 | -21,483 | 0 | -47,252 | -20,810 | -16,345 | 0 | -37,155 |
| Contribution | 46,526 | 9,340 | 0 | 55,866 | 11,228 | 7,340 | 0 | 18,568 |
| Other operating items | 0 | 0 | -40,998 | -40,998 | 0 | 0 | -32,509 | -32,509 |
| Operating result | 46,526 | 9,340 | -40,998 | 14,868 | 11,228 | 7,340 | -32,509 | -13,941 |
| Net financial items | 0 | 0 | -2,126 | -2,126 | 0 | 0 | -462 | -462 |
| Result before income tax | 46,526 | 9,340 | -43,124 | 12,742 | 11,228 | 7,340 | -32,971 | -14,403 |
| SEKt | Jan - Sep 2023 | Jan - Sep 2022 | ||||||
|---|---|---|---|---|---|---|---|---|
| Profit and loss items | NA | EUROW | Other | Total | NA | EUROW | Other | Total |
| Net sales | 310,818 | 107,516 | 0 | 418,334 | 143,486 | 82,111 | 0 | 225,597 |
| of which CERAMENT BVF | 155,361 | 10,647 | 0 | 166,009 | 139,267 | 10,763 | 0 | 150,030 |
| of which CERAMENT drug eluting¹ | 148,796 | 96,828 | 0 | 245,624 | 0 | 71,348 | 0 | 71,348 |
| of which other | 6,660 | 41 | 0 | 6,701 | 4,219 | 0 | 0 | 4,219 |
| Cost of sales | -16,614 | -18,838 | -562 | -36,014 | -8,839 | -13,458 | 0 | -22,297 |
| Gross profit | 294,204 | 88,678 | -562 | 382,320 | 134,647 | 68,653 | 0 | 203,300 |
| Sales commissions and fees | -108,444 | -1,298 | 0 | -109,742 | -44,916 | 0 | 0 | -44,916 |
| Other operative costs | -82,627 | -63,074 | 0 | -145,701 | -64,804 | -48,588 | 0 | -113,392 |
| Contribution | 103,133 | 24,306 | -562 | 126,877 | 24,927 | 20,065 | 0 | 44,992 |
| Other operating items | 0 | 0 | -105,289 | -105,289 | 0 | 0 | -90,244 | -90,244 |
| Operating result | 103,133 | 24,306 | -105,851 | 21,588 | 24,927 | 20,065 | -90,244 | -45,252 |
| Net financial items | 0 | 0 | -2,481 | -2,481 | 0 | 0 | -747 | -747 |
| Result before income tax | 103,133 | 24,306 | -108,332 | 19,107 | 24,927 | 20,065 | -90,991 | -45,999 |
At the period end, there are two employee stock option programs and three performance share programs.
Of the two employee stock option programs, one runs over ten years and expires 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 program of SEK 0.125 per option, equivalent to SEK 0.625 per share, and in the second 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 previously allocated 25.7 million options, 8.9 million options regard active programs. Of these 8.9 million options, 5.2 million (5.2) options were fully vested before the end of the period. Remaining 3.7 million (3.7) options were not allocated.
There are two programs for employees and one program for one Board member.
In the program for employees decided at the Annual General Meeting in 2020, each savings share gives the opportunity to be allotted to the employees a maximum of two or three 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.
In the program for employees decided at the Annual General Meeting in 2021, each savings share gives the opportunity to be allotted a maximum of six 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.
In the program for one Board member decided at the Annual General Meeting in 2021, each savings share gives the opportunity to be allotted a maximum of three performance shares without payment depending on share price development.
The Annual General Meeting in May 2022 authorized the Board to issue C-shares to cover social security charges for the latest programs. The mandate from the Annual General Meeting was fulfilled during 2022. The mandate to issue C-shares enabled the close of the share swap that was entered into during 2021.
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. At the end of the vesting period, a reduction in staff turnover is assumed, which entails an increased cost. 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 for the issued shares are credited to equity.
Further information on these programs is presented in Notes 12 and 23 in the Annual Report 2022.
CONT'D
| Employee stock option programs | No. of options¹ | Equal to no. of shares | WAEP² | |
|---|---|---|---|---|
| Balance January 1, 2023 | 420,208 | 84,044 | 26.50 | |
| Exercised | -5,000 | -1,000 | 26.50 | |
| Balance September 30, 2023 | 415,208 | 83,044 | 26.50 |
| Performance share programs | Right to no. of shares |
|---|---|
| Balance January 1, 2023 | 1,323,000 |
| Distributed regarding completed program | -500,378 |
| Cancelled during the year | -130,622 |
| Balance September 30, 2023 | 692,000 |
Not allocated options in active programs amounted to 3,699,047 (4,069,547).
Weighted Average Exercise Price per share (SEK).
During the year, the cost of performance share programs, excluding social security contributions, have been recognized as operating expenses amounting to SEK 12,465 thousand (11,373). The social security contributions amounted to an expense of SEK 8,768 thousand (7,819). Liability for social security contributions at the end of the period amounts to SEK 12,228 thousand (10,301).
The Group has tax losses carried forward based on historical losses. The Company makes ongoing assumptions about its future earnings. Based on a prudent but realistic assessment of the future utilization of these losses carried forward, the Company has during the period for the first time assigned a value in the balance sheet attributable to the tax losses carried forward, and also to other temporary differences. The tax losses carried forward are attributable to the research-focused period of the business, where the foundation and conditions for current and future sales and results were created. All tax losses carried forward are attributable to BONESUPPORT AB and BONESUPPORT HOLDING AB and the Swedish tax system, with full group contribution rights. The strong development in 2023 in terms of sales growth and with three consecutive quarters of positive and gradually increasing positive operating profit, together with a communicated sales target for 2023-2025, constitute a strong indication of the possibility to utilize these tax losses carried forward.
In the Group and in the Parent Company, the part of the deferred taxes that relate to transaction costs on share issue, has been posted directly over equity, as that is where the transaction costs were posted. The remaining part has been posted over the income statement.
| Group | Jul - Sep | Jan - Sep | Full year | |||
|---|---|---|---|---|---|---|
| SEKt | 2023 | 2022 | 2023 | 2022 | 2022 | |
| Tax losses carried forward and other temporary differences | 217,100 | 0 | 217,100 | 0 | 0 | |
| Tax losses carried forward, recognized directly over equity | 12,500 | 0 | 12,500 | 0 | 0 | |
| Total deferred tax asset | 229,600 | 0 | 229,600 | 0 | 0 | |
| Deferred tax income | 217,100 | 0 | 217,100 | 0 | 0 | |
| Current tax | -1,071 | -552 | -1,920 | -1,632 | -3,473 | |
| Total income tax | 216,029 | -552 | 215,180 | -1,632 | -3,473 |
| Parent Company | Jul - Sep | Jan - Sep | Full year | ||
|---|---|---|---|---|---|
| SEKt | 2023 | 2022 | 2023 | 2022 | 2022 |
| Tax losses carried forward | 17,859 | 0 | 17,859 | 0 | 0 |
| Tax losses carried forward, recognized directly over equity | 12,500 | 0 | 12,500 | 0 | 0 |
| Total deferred tax asset | 30,359 | 0 | 30,359 | 0 | 0 |
| Deferred tax income | 17,859 | 0 | 17,859 | 0 | 0 |
| Current tax | 0 | 0 | 0 | 0 | 0 |
| Total income tax | 17,859 | 0 | 17,859 | 0 | 0 |
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. BONESUPPORT's objective during 2023-2025 is to grow sales with 40 percent per year, measured as an average and normalized sales growth CAGR.
The difference in net sales between two periods in relation to net sales for the earlier period. The net sales for the current period is recalculated using the earlier period's exchange rates. Shows the operations' sales performance.
Net sales minus cost of sales. Shows the profit to cover other expenses and profit margin.
Net sales minus cost of sales, divided by net sales. Shows the gross profit in relation to net sales and the margin to cover other expenses and profit margin.
Net sales minus cost of sales, minus directly attributable selling expenses and research and development expenses. A measure of result showing the performance of segments and their contribution to cover other Group costs.
Operating result reduced with expenses for IFRS2 and reduced with the change in the liability for social security contributions for these incentive programs.
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.
| Jul - Sep | Jan - Sep | ||||
|---|---|---|---|---|---|
| SEKm | 2023 | 2022 | 2023 | 2022 | 2022 |
| Net sales | 158.2 | 84.6 | 418.3 | 225.6 | 328.8 |
| Sales growth, % | 87.0 | 54.2 | 85.4 | 48.9 | 54.5 |
| Cost of sales | -12.4 | -7.8 | -36.0 | -22.3 | -31.1 |
| Gross profit | 145.8 | 76.8 | 382.3 | 203.3 | 297.7 |
| Gross margin, % | 92.1 | 90.8 | 91.4 | 90.1 | 90.5 |
| Directly attributable selling expenses | -89.6 | -55.5 | -253.0 | -152.2 | -159.8 |
| Selling expenses, not directly attributable | -6.6 | -4.4 | -14.3 | -11.3 | -18.1 |
| Selling expenses including commissions and fees | -96.1 | -59.9 | -267.3 | -163.5 | -238.4 |
| Directly attributable research and development expenses | -0.3 | -2.7 | -2.5 | -6.1 | -14.6 |
| Research and development expenses, not directly attributable | -12.2 | -9.9 | -37.1 | -32.2 | -38.4 |
| Research and development expenses | -12.5 | -12.6 | -39.6 | -38.3 | -53.1 |
| Contribution | 55.9 | 18.6 | 126.9 | 45.0 | 123.3 |
| Interest bearing debt and net debt | Sep 30 | Dec 31 | |
|---|---|---|---|
| SEKm | 2023 | 2022 | 2022 |
| Non-current borrowings | 8.5 | 13.3 | 12.4 |
| Current borrowings | 4.5 | 5.2 | 5.1 |
| Interest bearing debt | 13.0 | 18.4 | 17.5 |
| Cash and cash equivalents | 164.1 | 212.6 | 201.3 |
| Net debt | -151.0 | -194.1 | -183.8 |
| Operating result before effects from the Group's incentive programs | Jul - Sep | Jan - Sep | Full year | ||
|---|---|---|---|---|---|
| SEKm | 2023 | 2022 | 2023 | 2022 | 2022 |
| Operating result | 14.9 | -13.9 | 21.6 | -45.3 | -64.5 |
| Of which incentive costs | -9.7 | -9.5 | -21.2 | -19.2 | -28.4 |
| Operating result before effects from the Group's incentive programs | 24.6 | -4.4 | 42.8 | -26.1 | -36.2 |
| constant exchange rates | Jul - Sep Jan - Sep |
|||||
|---|---|---|---|---|---|---|
| SEKm | Net sales growth |
Net sales 2023 calculated with CER |
Net sales 2022 | Net sales growth |
Net sales 2023 calculated with CER |
Net sales 2022 |
| NA | 102% | 113.6 | 56.3 | 103% | 291.6 | 143.5 |
| EUROW | 26% | 35.6 | 28.3 | 26% | 103.1 | 82.1 |
| Total | 76% | 149.2 | 84.6 | 75% | 394.7 | 225.6 |
Allograft. The bone graft transplanted between genetically non-identical individuals of the same species. Allograft can be living related (harvested from femoral heads during hip arthroplasty) or cadaveric.
Autograft. A bone graft harvested from the patient's own skeleton, usually from the iliac crests.
Bisphosphonate. A group of medicines that inhibit bone breakdown.
BMA. Bone Marrow Aspirate.
BMP. Bone Morphogenic Protein.
Bone cement. Binders used to attach prostheses to bone or glue bone, often in the form of a hardening plastic, polymethyl acrylate (PMMA), or Calcium Phosphate.
Bone graft substitute. A synthetic material used as bone grafts instead of biological bone tissue.
CERAMENT BVF. CERAMENT BONE VOID FILLER.
CERAMENT G. CERAMENT with gentamicin.
CERAMENT V. CERAMENT with vancomycin.
CERTiFy. A prospective, randomized, controlled clinical trial with 135 patients in 20 leading trauma centers in Germany, aimed to compare treatment of CERAMENT BVF with autologous bone graft (autograft) transplantation.
Clinical study. A 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.
C-shares. Performance shares within performance share programs issued in the form of class C-shares.
DBM. Demineralized Bone Matrix. A processed form of allograft, an acid-extracted matrix from human bone sources.
FDA. US Food and Drug Administration. The federal medical authority in the US.
GPO. Group Purchasing Organization. An entity with the purpose to realize savings and efficiencies by aggregating purchasing volumes.
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.
HTA. Health Technology Assessment. Systematic evaluation of the relative safety, efficacy and cost-effectiveness of a treatment in comparison to current treatment alternatives.
ICUR. Incremental Cost-Utility Ratio. A quote that compares cost and utility between two alternative treatment alternatives.
LTM. Latest twelve months.
Micro-CT. Micro Tomography, uses X-ray scanning to recreate a 3D-model without destroying the object.
Osteoinduction. Osteoinduction at bone graft material (or a growth factor) can stimulate the differentiation of osteoblasts, forming new bone tissues.
Osteomyelitis. A bacterial infection affecting bones.
PMA. Pre-market approval. Market pre-approval from the FDA in the US for class III medical devices.
PMMA. Poly methyl methacrylate, often called "bone cement".
SOLARIO. 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.
Tibial plateau fracture. Fracture of the upper part of the tibia.
Toxicity. The degree to which substance (a toxin or poison) can harm humans or animals.

BONESUPPORT's unique product technology has properties with the potential to revolutionize the care of patients with bone disorders by enabling faster rehabilitation, limiting the number of surgical procedures and reducing the risk of severe infections. For patients, this means that they can return to a more normal life more quickly. Up to and including June 2023, BONESUPPORT's products have been used in approximately 100,000 surgical procedures in more than 20 countries. The most common procedures consist of bone disorders where the body is unable to perform natural healing and single-stage surgery in connection with bone infection.

BONESUPPORT's unique technology means that over time, the Company's injectable bio-ceramic bone graft substitutes remodel to natural bones and have the ability to release drugs. This enables new treatment standards in the treatment of bone diseases/skeletal injuries.
BONESUPPORT's objective during 2023-2025 is to grow sales with 40 percent per year.

Innovation – BONESUPPORT has the market's most innovative solution for the treatment of bone disorders.
Clinical and Health Economic Evidence – The clinical evidence for the CERAMENT platform continues to grow and now amounts to more than 240 publications and abstracts. An important milestone for BONESUPPORT is the CERTiFy study, which shows that CERAMENT is at least as good as autograft.
Effective commercial platform – BONESUPPORT's commercial and medical organization provides healthcare with products, information, service and training.
BONESUPPORT HOLDING AB (publ), org.nr. 556802-2171, based in Lund, is the Parent Company of BONESUPPORT AB. BONESUPPORT is a commercial orthobiology company primarily aimed at the orthopedic markets in the US and Europe. BONESUPPORT has its registered office in Lund and wholly owned subsidiaries in the US, the UK, Germany, Sweden, Denmark, Switzerland, Spain, the Netherlands and Italy.
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 has well-documented safety and efficacy experience and estimates, based on sales data, that up to and including June 2023 more than 100,000 treatments have been performed with its products worldwide. There is great market potential in trauma, chronic osteomyelitis, revision arthroplasty and oncology, as well as bone and foot infections due to diabetes.
The CERAMENT portfolio is currently commercially available in the largest European markets, as well as in a number of markets outside Europe. In addition, CERAMENT BVF and CERAMENT G are commercially available in the United States, CERAMENT G in Canada, and CERAMENT BVF and CERAMENT G in Australia.
The Company invites investors, analysts and media to a web conference (in English) on October 26, 2023 at 10.00 CET, 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 CET on the same day and the presentation from the webcast will be uploaded during the day on October 26, 2023. 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 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.
Emil Billbäck, CEO T: +46 46 286 53 70
Håkan Johansson, CFO T: +46 46 286 53 70
E: [email protected] www.bonesupport.com
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