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Bonesupport Holding Interim / Quarterly Report 2019
3016_10-k_2020-02-26_09170b33-d94e-42ba-9490-3ad1134144e4.pdf
Interim / Quarterly Report
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FULL YEAR REPORT JANUARY - DECEMBER 2019
PLATFORM FOR FURTHER GROWTH Q4
OCTOBER - DECEMBER 2019
- Net sales increased with 100 percent compared to previous year, and amounted to SEK 46.2 million (23.1). The EUROW segment continued to report stable growth of 21 percent compared to the same period last year. The NA segment reported an increase in sales with 454 percent, as an effect of the transition to the new distribution model and thereby low sales during previous year. For the US, a continued sequential increase of 26 percent was reported from the previous quarter.
- CERAMENT G and CERAMENT V grew by 23 percent compared to the same period previous year.
- Gross margin amounted to 88.9 percent (85.0).
- Operating profit amounted to SEK -38.6 million (-45.0).
- Earnings per share, before and after dilution, were both SEK -0.79 (-0.88).
SIGNIFICANT EVENTS
- BONESUPPORT announced in November that Fergus MacLeod joined the Company as General Manager & Executive Vice President Commercial Operations EUROW.
- BONESUPPORT announced in December that the CERTiFy study with CERAMENT BONE VOID FILLER has been published in Journal of Bone & Joint Surgery.
- BONESUPPORT announced in December that Kristina Ingvar will join the Company as Executive Vice President Quality Management & Regulatory Affairs in February 2020.
JANUARY – DECEMBER 2019
- Net sales increased with 61 percent compared to previous year, and amounted to SEK 155.5 million (96.6). The EUROW segment reported growth of 40 percent compared to last year. Sales in the US reported a 99 percent increase.
- CERAMENT G and CERAMENT V grew by 45 percent compared to 2018.
- Gross margin amounted to 87.4 percent (84.3).
- Operating profit amounted to SEK -158.1 million (-174.4).
- Earnings per share, before and after dilution, were both SEK -3.10 (-3.46).
SIGNIFICANT EVENTS AFTER PERIOD END
- BONESUPPORT announced at the end of January that the Company has signed an agreement with Skandinaviska Enskilda Banken (SEB) on a working capital facility of up to SEK 60 million.
- BONESUPPORT announced on February 12 that Patrick O'Donnell is leaving the Company and his role as GM & EVP Commercial Operations NA.
| Oct - Dec | Jan - Dec | 12 months | ||||
|---|---|---|---|---|---|---|
| KEY FIGURES | 2019 | 2018 | 2019 | 2018 | LTM | 2018 |
| Net sales, SEKm | 46.2 | 23.1 | 155.5 | 96.6 | 155.5 | 96.6 |
| Sales growth, %¹ | 99.9 | -14.5 | 60.9 | -25.3 | 60.9 | -25.3 |
| Gross profit, SEKm | 41.1 | 19.6 | 135.9 | 81.5 | 135.9 | 81.5 |
| Gross margin, %¹ | 88.9 | 85.0 | 87.4 | 84.3 | 87.4 | 84.3 |
| Operating loss, SEKm | -38.6 | -45.0 | -158.1 | -174.4 | -158.1 | -174.4 |
| Loss for the period, SEKm | -40.8 | -45.6 | -161.1 | -176.4 | -161.1 | -176.4 |
| Equity at period end, SEKm | 124.3 | 278.5 | 124.3 | 278.5 | 124.3 | 278.5 |
| Net debt, SEKm¹ | -81.7 | -261.5 | -81.7 | -261.5 | -81.7 | -261.5 |
| Operating cash flow, SEKm | -38.2 | -50.4 | -164.3 | -171.6 | -164.3 | -171.6 |
| Cash at period end, SEKm | 92.1 | 261.5 | 92.1 | 261.5 | 92.1 | 261.5 |
| Earnings per share, SEK | -0.79 | -0.88 | -3.10 | -3.46 | -3.11 | -3.46 |
1 APM: Alternative performance measures, see definitions on page 21.
CEO COMMENTS ON THE FOURTH QUARTER
CERTIFY PUBLISHED, US CONTINUES STRONGLY
Revenue in the fourth quarter of SEK 46 million were again a record high. Sales in the US were SEK 23 million, which is an increase of 26 percent compared to the third quarter. Sales in Europe and the rest of the world (EUROW) grew by 21 percent compared to the fourth quarter of 2018. The strong growth in the US is very satisfying. We transitioned to a new distribution structure in October 2018 and since then we have been approaching the US market significantly more efficiently, both in terms of width and depth.
The most important milestone of the quarter was the publication of the successful results of the CERTiFy study in the Journal of Bone & Joint Surgery, one of the most respected journals in the field of orthopedic surgery. The study showed that CERAMENT® BONE VOID FILLER (BVF) is as good as autograft, meaning as good as the patient's own bone tissue, when it comes to healing bone defects. These strong results, especially in bone remodeling, eliminate the need for transplantation of the patient's own bone tissue.
The study results also show an advantage for patients in regards of postoperative pain and blood loss. Given the ease of use and the other benefits of CERAMENT BVF, we expect the results to drive a change in the standard of care. No other bone graft substitute has such solid clinical evidence on bone regeneration as CERAMENT, and the results of the CERTiFy study play a key role in our growth strategy for both Europe and the US.
In the quarter, we had slightly lower sales growth in Europe, which is partly explained by an unusually strong fourth quarter of 2018 as well as the consumption variability of two large customers.
As our recently hired European sales representatives establish themselves, we enable sales activities in previously unpenetrated areas. Over time we will become less dependent on few large customers. The recruitment of sales representatives in Germany has taken longer than expected, but at the end of Q4 we were 25 people in sales functions in Europe, in line with the target we communicated in mid-2018.
The antibiotic eluting products in Europe now represent 85 percent of total EUROW sales. The clinical benefit of the unique local antibiotic elution from CERAMENT G and CERAMENT V has been demonstrated in several clinical studies and provides a significant contribution in the fight against antibiotic resistance. The work and preparation of bringing CERAMENT G to the US market is proceeding according to plan and we expect to submit the PMA1 application to the FDA at the end of 2021, after completion of the FORTIFY study.
We conclude another positive quarter where our strategic focus continues to generate results. During 2019, we made major changes both in our organization and in our commercial platform, which resulted in an expanded customer base and increased sales.
All in all, we have established a solid foundation and aim to grow by 40 percent annually in the years to come. I look forward to providing continuous updates during 2020.
Emil Billbäck, CEO Bonesupport
1 PMA (Pre Market Approval) is the FDA process to review class III medical devices.
NORTH AMERICA (NA)
The North American market is the world's largest for synthetic bone graft products and is the most important market for the Company. The focus of the North America segment is the continued development of the new distribution structure that was established in October 2018. At the end of the quarter, BONESUPPORT had its own commercial organization with 24 (21) employees and 50 (38) contracted distributors.
OCTOBER - DECEMBER
Sales
Sales for the period amounted to SEK 23.3 million (4.2). The low sales previous year are explained by the new distribution structure that was initiated during the fourth quarter of last year. As in the previous quarters of this year, the segment has shown stable sequential growth. The sequential increase from the previous quarter was 26 percent.
The quarterly sales growth has been a strong confirmation of our strategy to reach the US market more efficiently with a new distribution structure.
Contribution1
The contribution from the segment was SEK -9.3 million (-17.4). The reduced loss is attributable to increased sales. Sales and marketing expenses during the fourth quarter amounted to SEK 25.7 million (15.2), of which sales commissions to the distributors was SEK 8.0 million (1.1). The contribution was also burdened by R&D costs amounting to SEK 5.5 million (5.9).
JANUARY - DECEMBER
Net sales amounted to SEK 68.0 million (34.1), corresponding to an increase of 99 percent. The increase can be explained by the completed transition to a new distribution structure.
The contribution amounted to SEK -56.5 million (-45.0). The negative contribution is mainly due to increased sales and marketing efforts as well as the sales commissions resulting from the new distribution structure.
Net sales, gross profit and contribution, SEKm
| Oct - Dec | Jan - Dec | ||||
|---|---|---|---|---|---|
| 2019 | 2018 | 2019 | 2018 | ||
| Net sales | 23.3 | 4.2 | 68.0 | 34.1 | |
| Gross profit | 21.8 | 3.7 | 62.4 | 29.6 | |
| Contribution | -9.3 | -17.4 | -56.5 | -45.0 |
1 APM: Alternative performance measures, see definitions on page 21.
Solid growth for CERAMENT G and CERAMENT V
EUROPE & REST OF THE WORLD (EUROW)
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 organization. In 2019, BONESUPPORT's own sales organization was gradually expanded and at the end of the year there were 25 (25) employees. The focus is on utilizing the results of the CERTiFy study to increase the use of CERAMENT. In the other eight European markets and in other parts of the world (ROW), the Company cooperates with specialist distributors.
OCTOBER – DECEMBER
Sales
Sales for the segment increased by 21 percent compared to the previous year and amounted to SEK 22.9 million (18.9). Sales in key markets accounted for 84 percent of the segment's sales. Sales of the antibiotic eluting products CERAMENT G and CERAMENT V together increased by 23 percent compared with the fourth quarter last year.
Contribution1
The contribution from the segment was SEK -0.5 million (-3.9). The improved contribution is an effect of increased sales and gross profit. Sales and marketing expenses decreased by SEK 0.5 million compared to the corresponding period last year and amounted to SEK 19.3 million (19.9). The previous year was charged with large recruitment costs related to the expansion of the sales organization. The current period was affected by a couple of vacant positions that were open during part of the quarter.
JANUARY – DECEMBER
Net sales amounted to SEK 87.4 million (62.5), an increase of 40 percent compared with the previous year. Sales of the antibiotic eluting products CERAMENT G and CERAMENT V together increased by 45 percent.
The contribution amounted to SEK 8.0 million (-9.7). The positive contribution is attributed to increased sales and improved gross margin. During the year, sales and marketing costs for completed commercial investments increased.
Net sales, gross profit and contribution, SEKm
| Oct - Dec | Jan - Dec | ||||
|---|---|---|---|---|---|
| 2019 | 2018 | 2019 | 2018 | ||
| Net sales | 22.9 | 18.9 | 87.4 | 62.5 | |
| Gross profit | 19.3 | 15.9 | 73.5 | 51.8 | |
| Contribution | -0.5 | -3.9 | 8.0 | -9.7 |
Net sales per quarter, SEKm
1 APM: Alternative performance measures, see definitions on page 21.
RESEARCH AND DEVELOPMENT
BONESUPPORT's clinical development program focuses on further developing CERAMENT's properties, broadening clinical application areas and utilizing CERAMENT's unique drug eluting 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 made research in the form of preclinical candidates that has 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 be widely used in conditions and situations where there is weak natural bone remodeling.
CLINICAL EVIDENCE, A STRATEGIC CORNERSTONE
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, the CERTiFy study was published in the highly regarded JB&JS Journal of Bone & Joint Surgery. With regards to future clinical data, we have high expectations for the FORTIFY and the SOLARIO studies.
RESULTS FROM CERTIFY DRIVES CHANGED STANDARD OF CARE
CERTiFy is a prospective, 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. We expect that the results of the study will drive a change in the standard of care and that more and more clinics in consultation with the patient will choose CERAMENT over autograft.
THE FORTIFY STUDY
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 trial will include up to 230 patients in clinics in the US and Europe. Data from the FORTIFY study will be used to support a planned PMA (pre-market approval) application of CERAMENT G to the FDA at the end of 2021.
THE SOLARIO STUDY
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 including 500 patients. The first patient was recruited in February 2019 and the study is expected to be closed by the second half of 2022. A positive result of the study may mean a paradigm shift in the protocol for treating bone infections.
THE CONVICTION STUDY
The French CRIOAc1 Network initiates CONVICTION, a randomized controlled trial to evaluate the efficacy of CERAMENT G in the treatment of osteomyelitis (chronic bone infection). 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.
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.
HEALTH ECONOMICS
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 different 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 health care 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 England.
In September, 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 5 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 had, on average, 11 days fewer hospital stays 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. We await publication of the study for final and conclusive results.
FINANCIAL OVERVIEW
PROFIT AND LOSS
OCTOBER - DECEMBER 2019 Net sales
Net sales amounted to SEK 46.2 million (23.1), an increase of 100 percent compared to the previous year. The EUROW segment increased by 21 percent to SEK 22.9 million (18.9). Sales in the US increased from 4.2 previous year year to SEK 23.3 million as a result of the ongoing development of a new distribution structure. A more detailed description is given in the segment sections. The currency translation effect was positive with SEK 0.0 million (1.6).
Cost of goods sold
Cost of goods sold amounted to SEK 5.1 million (3.5), giving a gross margin of 88.9 percent (85.0). Increased sales in the US had a positive impact on gross profit.
Selling expenses
Selling expenses amounted to SEK 49.3 million (38.8), an increase of 27 percent. Personnel costs amounted to SEK 21.2 million (17.6) as an effect of implemented investments in the sales organization. Furthermore, costs for sales commissions in the US increased to SEK 8.0 million (1.1). Other sales costs amounted to SEK 20.1 million (20.1). The NA segment reported a cost increase of 69 percent to SEK 25.7 million (15.2), driven by increased costs for sales commissions. In EUROW, expenses amounted to SEK 19.3 million (19.9). Included in this are marketing activities that were delayed from the third quarter and thereby charged to the fourth quarter, with SEK 2.3 million. Unallocated costs decreased somewhat to SEK 4.3 million (4.8).
Research and development expenses
Research and development expenses amounted to SEK 18.5 million (17.6), an increase of 5 percent. Personnel costs corresponded to SEK 6.7 million (5.7) due to increased staff. Other expenses totaled SEK 11.8 million (11.9). The NA segment reported expenses amounting to SEK 5.5 million (5.9).
Administrative expenses
Administrative expenses amounted to SEK 11.6 million (9.3), an increase of 24 percent. Personnel costs amounted to SEK 6.5 million (4.2). The increase is mainly related to accruals for the active incentive programs. Other expenses amounted to SEK 5.1 million (5.1).
Other operating income and expenses
Other operating income and expenses consisted primarily of exchange rate gains and losses on operating assets and liabilities. Other operating income amounted to SEK 3.1 million (1.3) and other operating expenses amounted to SEK -3.4 million (-0.2) for the quarter.
Net Sales per quarter, SEKm
Operating result
Operating result amounted to SEK -38.6 million (-45.0), where the decreased loss is mainly explained by higher sales both in EUROW but above all in NA.
Net financial items
Net financial items amounted to SEK -0.1 million (0.0).
Loss for the period
For the reasons described above, the loss for the fourth quarter amounted to SEK -40.8 million (-45.6), which corresponds to earnings per share of SEK -0.79 (-0.88).
JANUARY - DECEMBER 2019
Net sales
Net sales amounted to SEK 155.5 million (96.6), an increase of 61 percent. The EUROW segment increased by 40 percent to SEK 87.4 million (62.5) and the NA segment increased by 99 percent to SEK 68.0 million (34.1).
Operating result
Operating result amounted to SEK -158.1 million (-174.4), where sales growth mainly contributed positively with improved gross profit, while operating expenses increased as a result of completed commercial investments.
Loss for the year
For the reasons reported above, the loss for the year amounted to SEK -161.1 million (-176.4), which corresponds to earnings per share of SEK -3.10 (-3.46).
FINANCIAL POSITION AND CASH FLOW
| SEKm | Dec 31 | |||
|---|---|---|---|---|
| Financial position | 2019 | 2018 | ||
| Cash and cash equivalents | 92.1 | 261.5 | ||
| Interest bearing debt¹ | 10.4 | 0.0 | ||
| Net debt¹ | -81.7 | -261.5 | ||
| Equity | 124.3 | 278.5 |
1 APM: Alternative performance measures, see definitions on page 21.
| SEKm | Oct - Dec | Jan - Dec | |||
|---|---|---|---|---|---|
| Cash flow | 2019 | 2018 | 2019 | 2018 | |
| Operations | -38.2 | -50.4 | -164.3 | -171.6 | |
| Investing activities | -1.5 | -1.7 | -4.2 | -2.7 | |
| Financing activities | 2.4 | 0.2 | -1.6 | -98.8 |
Cash and cash equivalents at the end of the period amounted to SEK 92.1 million (261.5), a decrease of SEK 169.4 million since the beginning of the year. The change mainly consisted of cash from operating activities amounting to SEK -164.3 million (-171.6), mainly attributable to operating loss of SEK -158.1 million (-174.4). This also explains the change in net debt. Interest bearing debt has increased with SEK 10.4 million which can be explained by the transition to IFRS 16 Leases. The effects of this transition are explained further in Note 1.
OTHER DISCLOSURES
PARENT COMPANY
The Parent Company BONESUPPORT HOLDING AB (publ) is a holding company. The Parent Company generated SEK 17.4 million (15.3) in sales of internal services to subsidiaries during the quarter. The result for the quarter was SEK -6.1 million (0.5). No investments were made during the quarter.
EMPLOYEES
On average, the Group had 86 (72) employees (full-time equivalent) during the quarter, of whom 23 (20) worked within Research and Development.
SIGNIFICANT EVENTS DURING THE QUARTER
For significant events, see page 1.
SIGNIFICANT EVENTS AFTER PERIOD END
For significant events, see page 1.
SHARES AND RELATED PROGRAMMES
The Company has ordinary shares and C shares, see Note 4. The quotient value of the shares is SEK 0.625 per share. During the year, the number of shares has increased as a result of converted employee stock options. As of December 31, 2019, the total number of common shares amounted to 52,016,342, distributed among 2,555 shareholders. The major shareholders are shown below.
BONESUPPORT has three employee stock option programs, three performance share programs and three warrant programs. These are described in Note 8.
Shareholders December 31, 2019
| HealthCap VLP | 12.7% |
|---|---|
| Stiftelsen Industrifonden | 9.2% |
| Swedbank Robur Fonder | 7.9% |
| Tredje AP-fonden | 7.7% |
| Tellacq AB | 5.7% |
| Fjärde AP-Fonden | 4.8% |
| Lundbeckfonden Invest A/S | 4.4% |
| Other shareholders | 47.6% |
FINANCIAL CALENDAR
- April 2020 Annual report 2019
- May 8, 2020 Interim report Q1 2020
- May 19, 2020 Annual general meeting
- July 17, 2020 Interim report Q2 2020
- November 5, 2020 Interim report Q3 2020
NOMINATION COMMITTEE
The nomination committee is elected based on the principles decided at the AGM held on May 14, 2019. These principles are described on BONESUPPORT's website. The task of the committee is to present a proposal to the AGM, which is planned in May 19, 2020 in Lund. The members of the committee are:
- Jacob Gunterberg, Chairman of the Committee, representing HealthCap VLP
- Lennart Johansson, Chairman of the Board
- Bo Lundgren, representing Swedbank Robur fonder
- Jonas Jendi, representing Stiftelsen Industrifonden
THIS REPORT
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.
DECLARATION OF THE CEO
The CEO assures that this full year 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 full year report has been reviewed by the company's auditors.
Lund February 26, 2020
Emil Billbäck CEO
CONDENSED CONSOLIDATED INCOME STATEMENT
| Oct - Dec | Jan - Dec | ||||
|---|---|---|---|---|---|
| SEKt | Note | 2019 | 2018 | 2019 | 2018 |
| Net sales | 7 | 46,199 | 23,108 | 155,462 | 96,623 |
| Cost of sales | 7 | -5,114 | -3,460 | -19,587 | -15,157 |
| Gross profit | 7 | 41,085 | 19,648 | 135,875 | 81,466 |
| Selling expenses | -49,292 | -38,760 | -182,323 | -133,311 | |
| Research and development expenses | -18,527 | -17,607 | -68,878 | -66,064 | |
| Administrative expenses | -11,566 | -9,343 | -43,280 | -58,345 | |
| Other operating income | 3,080 | 1,251 | 10,667 | 8,530 | |
| Other operating expenses | -3,379 | -226 | -10,163 | -6,680 | |
| Operating loss | 7 | -38,599 | -45,037 | -158,102 | -174,404 |
| Net financial items | 7 | -64 | 41 | -177 | -465 |
| Loss before income tax | 7 | -38,663 | -44,996 | -158,279 | -174,869 |
| Income tax | -2,186 | -629 | -2,781 | -1,536 | |
| Loss for the period | -40,849 | -45,625 | -161,060 | -176,405 | |
| Earnings per share before dilution, SEK | -0.79 | -0.88 | -3.10 | -3.46 | |
| Earnings per share after dilution, SEK | -0.79 | -0.88 | -3.10 | -3.46 | |
| Average number of shares, thousands | 51,982 | 51,664 | 51,889 | 50,971 |
Loss for the period is attributable to equity holders of the Parent.
CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
| Oct - Dec | Jan - Dec | |||
|---|---|---|---|---|
| SEKt | 2019 | 2018 | 2019 | 2018 |
| Loss for the period | -40,849 | -45,625 | -161,060 | -176,405 |
| Other comprehensive income: | ||||
| Items to be reclassified to profit or loss in subsequent periods | ||||
| Exchange differences on translation of foreign operations | -153 | -114 | 115 | 129 |
| Total comprehensive income for the period | -41,002 | -45,739 | -160,945 | -176,276 |
Total comprehensive income for the period is in its entirety attributable to equity holders of the Parent.
CONDENSED CONSOLIDATED BALANCE SHEET
| Dec 31 | |||
|---|---|---|---|
| SEKt | Note | 2019 | 2018 |
| ASSETS | |||
| Non-current assets | |||
| Intangible assets | 7,679 | 5,511 | |
| Tangible assets | 1 | 14,585 | 3,885 |
| Other non-current assets | 951 | 375 | |
| Total non-current assets | 23,215 | 9,771 | |
| Current assets | |||
| Inventories | 39,331 | 23,681 | |
| Trade receivables | 6 | 29,848 | 18,683 |
| Other operating receivables | 6 | 11,873 | 12,538 |
| Cash and cash equivalents | 6 | 92,065 | 261,468 |
| Total current assets | 173,117 | 316,370 | |
| TOTAL ASSETS | 196,332 | 326,141 | |
| EQUITY AND LIABILITIES | |||
| Equity attributable to equity holders of the Parent | 4 | 124,309 | 278,531 |
| Non-current liabilities | |||
| Leasing debt | 1 | 5,703 | 0 |
| Provisions | 305 | 289 | |
| Total non-current liabilities | 6,008 | 289 | |
| Current liabilities | |||
| Leasing debt | 1, 6 | 4,682 | 0 |
| Trade payables | 6 | 13,649 | 12,472 |
| Other operating liabilities | 6 | 47,684 | 34,849 |
| Total current liabilities | 66,015 | 47,321 | |
| TOTAL EQUITY AND LIABILITIES | 196,332 | 326,141 |
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
| Accumulated losses |
|||||||
|---|---|---|---|---|---|---|---|
| SEKt | Share capital | Paid but not registered share issue |
Other paid in capital |
Reserves | Fund for development expenses |
including loss for the period |
Total equity |
| As at January 1, 2018 | 31,424 | 0 | 1,189,015 | -304 | 1,592 | -770,941 | 450,786 |
| Loss January - December 2018 | 129 | -176,405 | -176,276 | ||||
| Change in fund for development | |||||||
| expenses | 209 | -209 | 0 | ||||
| New share issue | 949 | 949 | |||||
| Allotted warrants | 740 | 740 | |||||
| Transaction costs, new share issue | -1,860 | -1,860 | |||||
| Share-based payment transactions | 4,192 | 4,192 | |||||
| As at January 1, 2019 | 32,373 | 0 | 1,187,895 | -175 | 1,801 | -943,363 | 278,531 |
| Loss January - December 2019 | 115 | -161,060 | -160,945 | ||||
| Change in fund for development | |||||||
| expenses | 1,751 | -1,751 | 0 | ||||
| New share issue | 137 | 137 | |||||
| New share issue under process | 100 | 3,880 | 3,980 | ||||
| Own shares | 316 | -316 | 0 | ||||
| Share-based payment transactions | 2,606 | 2,606 | |||||
| As at December 31, 2019 | 32,826 | 100 | 1,191,775 | -60 | 3,552 | -1,103,884 | 124,309 |
Reserves comprise exchange differences on translation of foreign operations.
CONSOLIDATED STATEMENT OF CASH FLOWS
| Oct - Dec | Jan - Dec | |||||
|---|---|---|---|---|---|---|
| SEKt | 2019 | 2018 | 2019 | 2018 | ||
| Operating loss | -38,599 | -45,037 | -158,102 | -174,404 | ||
| Non-cash adjustments: | ||||||
| -Share-based payments | 870 | 396 | 2,606 | 4,192 | ||
| -Item affecting comparability | 0 | 0 | 11,000 | 0 | ||
| -Other | 3,576 | -1,742 | 3,758 | -962 | ||
| Interests received | 35 | 46 | 98 | 46 | ||
| Interests paid | -99 | -5 | -275 | -868 | ||
| Other paid financial costs | 0 | 0 | 0 | 558 | ||
| Income tax paid | -4,188 | -1,135 | -5,210 | -2,151 | ||
| Net cash flows from operating activities before changes in working | ||||||
| capital | -38,405 | -47,477 | -146,125 | -173,589 | ||
| Changes in working capital | 186 | -2,878 | -18,134 | 1,964 | ||
| Net cash flows from operating activities | -38,219 | -50,355 | -164,259 | -171,625 | ||
| Investments in intangible assets | -1,012 | -664 | -2,915 | -997 | ||
| Investments in tangible assets | -523 | -1,019 | -1,319 | -1,609 | ||
| Investments in financial assets | 0 | -8 | 0 | -113 | ||
| Net cash flows from investing activities | -1,535 | -1,691 | -4,234 | -2,719 | ||
| New share issue | 4,024 | 150 | 4,118 | 949 | ||
| Transaction costs, new share issue | 0 | 0 | 0 | -1,860 | ||
| Allotted warrants | 0 | 0 | 0 | 740 | ||
| Repayments of borrowings | -1,621 | 0 | -5,694 | -98,620 | ||
| Net cash flows from financing activities | 2,403 | 150 | -1,576 | -98,791 | ||
| Net cash flows | -37,351 | -51,896 | -170,069 | -273,135 | ||
| Cash and cash equivalents as at beginning of period | 129,892 | 313,168 | 261,468 | 533,367 | ||
| Net exchange difference | -476 | 196 | 666 | 1,236 | ||
| Cash and cash equivalents as at end of period | 92,065 | 261,468 | 92,065 | 261,468 |
CONDENSED PARENT COMPANY INCOME STATEMENT
| Oct - Dec | Jan - Dec | |||||
|---|---|---|---|---|---|---|
| SEKt | 2019 | 2018 | 2019 | 2018 | ||
| Net sales | 17,353 | 15,337 | 48,290 | 51,578 | ||
| Administrative expenses | -25,030 | -15,478 | -65,568 | -66,756 | ||
| Other operating income | 504 | 400 | 961 | 528 | ||
| Other operating expenses | -25 | -407 | -1,357 | -1,033 | ||
| Operating loss | -7,198 | -148 | -17,674 | -15,683 | ||
| Net financial items | 1,069 | 666 | 1,767 | 2,105 | ||
| Result after financial items | -6,129 | 518 | -15,907 | -13,578 | ||
| Income tax | 0 | 0 | 0 | 0 | ||
| Result for the period | -6,129 | 518 | -15,907 | -13,578 |
Parent Company loss for the period equals comprehensive income.
CONDENSED PARENT COMPANY BALANCE SHEET
| Dec 31 | ||||
|---|---|---|---|---|
| SEKt | Note | 2019 | 2018 | |
| ASSETS | ||||
| Non-current financial assets | 726,652 | 704,652 | ||
| Other receivables | 6 | 125,245 | 153 | |
| Prepaid expenses | 6 | 651 | 728 | |
| Cash | 6 | 73,549 | 243,247 | |
| TOTAL ASSETS | 926,097 | 948,780 | ||
| EQUITY AND LIABILITIES | ||||
| Equity | ||||
| Restricted equity | 4 | 32,926 | 32,372 | |
| Unrestricted equity | 862,277 | 874,620 | ||
| Total equity | 895,203 | 906,992 | ||
| Non-current liabilities | 19,203 | 0 | ||
| Current liabilities | 6 | 11,691 | 41,788 | |
| TOTAL EQUITY AND LIABILITIES | 926,097 | 948,780 |
CONDENSED CONSOLIDATED INCOME STATEMENT PER QUARTER
| 2019 | 2018 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| SEKt | Q4 | Q3 | Q2¹ | Q1 | Q4 | Q3 | Q2 | Q1 | |
| Net sales | 46,199 | 39,115 | 37,320 | 32,828 | 23,108 | 14,246 | 28,184 | 31,085 | |
| Cost of sales | -5,114 | -4,795 | -5,047 | -4,631 | -3,460 | -2,587 | -3,548 | -5,562 | |
| Gross profit | 41,085 | 34,320 | 32,273 | 28,197 | 19,648 | 11,659 | 24,636 | 25,523 | |
| Gross margin, % | 88.9% | 87.7% | 86.5% | 85.9% | 85.0% | 81.8% | 87.4% | 82.1% | |
| Selling expenses | -49,292 | -39,509 | -52,689 | -40,833 | -38,760 | -35,086 | -31,820 | -27,645 | |
| Research and development expenses | -18,527 | -17,449 | -15,987 | -16,915 | -17,607 | -16,426 | -17,193 | -14,838 | |
| Administrative expenses | -11,566 | -10,874 | -10,482 | -10,358 | -9,343 | -17,531 | -14,940 | -16,531 | |
| Other operating income | 3,080 | 2,977 | 2,434 | 2,176 | 1,251 | 1,818 | 2,530 | 2,931 | |
| Other operating expenses | -3,379 | -2,153 | -3,369 | -1,262 | -226 | -2,851 | -1,033 | -2,570 | |
| Operating loss | -38,599 | -32,688 | -47,820 | -38,995 | -45,037 | -58,417 | -37,820 | -33,130 | |
| Net financial items | -64 | -16 | -53 | -44 | 41 | -4 | -5 | -497 | |
| Loss before income tax | -38,663 | -32,704 | -47,873 | -39,039 | -44,996 | -58,421 | -37,825 | -33,627 | |
| Income tax | -2,186 | -486 | -67 | -42 | -629 | -377 | -379 | -151 | |
| Loss for the period | -40,849 | -33,190 | -47,940 | -39,081 | -45,625 | -58,798 | -38,204 | -33,778 |
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.
NOTE 1 GENERAL INFORMATION, ACCOUNTING PRINCIPLES
This year end 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 2018 have also been applied in this year end report. New or amended standards or interpretations of standards effective as of January 1, 2019 have not had any significant impact on BONESUPPORT's financial statements, except for IFRS 16 Leases described below.
IFRS 16 Leases
IFRS 16 Leases is applied from January 1, 2019 and replaces IAS 17. The effect is described in the annual report for 2018. IFRS 16 implies that, in principle, all leases are recognized in the balance sheet; the right to use the leasing objects as tangible assets and the remaining lease payments as current and noncurrent debt. In the income statement, the leasing cost has been replaced by depreciation of the assets and interest expense on the lease liabilities. Key ratios such as equity ratio and debt/equity ratio have changed as liabilities in the balance sheet have increased. The leasing agreements that are reported in the balance sheet relate primarily to the leasing of premises. BONESUPPORT applies IFRS 16 according to a simplified method. This implies a calculation period based on the remaining payments, and that the comparison year is not recalculated. The right to use assets is valued at an amount equal to the leasing debt. Contracts shorter than 12 months have not been taken into account.
As of January 1, 2019, the effect of transition to accounting in accordance with IFRS 16 is an increased balance sheet total of 14,145 SEKt, of which Tangible assets 14,145 SEKt, Non-current leasing debt 7,370 SEKt and current leasing debt 6,775 SEKt. Ie without impact on Equity. The equity ratio was reduced from 85.4 percent to 81.9 percent as of January 1, 2019.
At the end of the period, the Group has the following values regarding leased assets: Tangible assets 10,385 SEKt, Leasing debt 10,385 SEKt of which 5,703 SEKt is non-current and 4,682 SEKt is current. The effect of IFRS 16 in the consolidated income statement for January - December 2019 is that depreciation of 5,694 SEKt and an interest expense of 239 SEKt have replaced an operational leasing expense of 5,933 SEKt. The new standard has therefor not had any effect on the net loss for the period. When calculating the liability of remaining payments, an interest rate of 6 percent has been applied as discount rate. There is no marginal borrowing rate since the Group has no loans. After discussing with external lenders, a reaonable borrowing rate for a real estate loan has been evaluated. A development company carries a high risk premium why 6 percent is considered reasonable.
Correction of error 2018
Correction of comparison figures have been made regarding the Parent Company's Income statement for Q4. The comparison figures for the full year 2018 are unchanged.
NOTE 2 SIGNIFICANT RISKS AND UNCERTAINTIES
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 2018.
NOTE 3 TRANSACTIONS WITH RELATED PARTIES
The financial reports include costs related to the following transactions between BONESUPPORT and related parties.
| SEKt | Oct - Dec | Jan - Dec | |||
|---|---|---|---|---|---|
| Related party | Service | 2019 | 2018 | 2019 | 2018 |
| Route 2 Advisors Ltd (Simon Cartmell, Board member) | Consultancy | 113 | 0 | 615 | 81 |
| Seagles AB (Lars Lidgren, Board member) | Purchase of patent | 0 | 600 | 900 | 600 |
NOTE 4 NUMBER OF SHARES AND POTENTIAL SHARES
| Ordinary shares | Number of shares | Potential shares |
|---|---|---|
| December 31, 2018 | 51,795,917 | 2,446,248 |
| Converted employee stock options | 220,425 | -220,425 |
| Returned employee stock options | 0 | -20,209 |
| December 31, 2019 | 52,016,342 | 2,205,614 |
| Series C shares | ||
| December 31, 2018 | 0 | 505,000 |
| Issued shares | 505,000 | -505,000 |
| Potential performance shares | 0 | 720,000 |
| December 31, 2019 | 505,000 | 720,000 |
In addition to the above, 157,201 shares are in the process of being issued. Payment has been received in December 2019 but registration is done in January 2020.
NOTE 5 PLEDGED SECURITIES AND CONTINGENT LIABILITIES
The US subsidiary BONESUPPORT Inc. has provided a guarantee of 56 USDt (56), corresponding to 523 SEKt (502) 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 979 SEKt (979).
NOTE 6 FINANCIAL ASSETS AND LIABILITIES
Fair values of current financial assets and liabilities are assessed to agree with values accounted for.
NOT 7 SEGMENT INFORMATION
The Group manages and monitors operations in the North America (NA) and Europe & Rest of the World (EUROW) segments. Other comprises eliminations and 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 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 1.8 million (1.3) in the quarter. US, Germany and UK were the only markets that delivered more than 10 percent of consolidated net sales.
| SEKt | Oct - Dec 2019 | Oct - Dec 2018 | ||||||
|---|---|---|---|---|---|---|---|---|
| Profit and loss items | NA | EUROW | Other | Totalt | NA | EUROW | Other | Total |
| Net sales | 23,256 | 22,942 | 0 | 46,199 | 4,201 | 18,907 | 0 | 23,108 |
| of which CERAMENT BVF | 23,256 | 3,218 | 0 | 26,474 | 4,201 | 2,871 | 0 | 7,072 |
| of which CERAMENT drug eluting¹ | 0 | 19,724 | 0 | 19,724 | 0 | 16,036 | 0 | 16,036 |
| Cost of sales | -1,483 | -3,631 | 0 | -5,114 | -489 | -2,971 | 0 | -3,460 |
| Gross profit | 21,774 | 19,311 | 0 | 41,085 | 3,712 | 15,936 | 0 | 19,648 |
| Operative costs | -31,082 | -19,801 | 0 | -50,883 | -21,110 | -19,883 | 0 | -40,993 |
| Contribution | -9,308 | -489 | 0 | -9,798 | -17,398 | -3,947 | 0 | -21,345 |
| Other operating items | 0 | 0 | -28,802 | -28,802 | 0 | 0 | -23,692 | -23,692 |
| Operating result | -9,308 | -489 | -28,802 | -38,599 | -17,398 | -3,947 | -23,692 | -45,037 |
| Net financial items | 0 | 0 | -64 | -64 | 0 | 0 | 41 | 41 |
| Result before income tax | -9,308 | -489 | -28,866 | -38,663 | -17,398 | -3,947 | -23,651 | -44,996 |
| SEKt | Jan - Dec 2019 | Jan - Dec 2018 | ||||||
|---|---|---|---|---|---|---|---|---|
| Profit and loss items | NA | EUROW | Other | Totalt | NA | EUROW | Other | Total |
| Net sales | 68,013 | 87,448 | 0 | 155,462 | 34,126 | 62,497 | 0 | 96,623 |
| of which CERAMENT BVF | 68,013 | 13,512 | 0 | 81,525 | 34,126 | 10,993 | 0 | 45,119 |
| of which CERAMENT drug eluting¹ | 0 | 73,936 | 0 | 73,936 | 0 | 51,504 | 0 | 51,504 |
| Cost of sales | -5,654 | -13,933 | 0 | -19,587 | -4,497 | -10,660 | 0 | -15,157 |
| Gross profit | 62,360 | 73,515 | 0 | 135,875 | 29,629 | 51,837 | 0 | 81,466 |
| Operative costs | -118,889 | -65,535 | 0 | -184,424 | -74,587 | -61,564 | 0 | -136,151 |
| Contribution | -56,529 | 7,981 | 0 | -48,549 | -44,958 | -9,727 | 0 | -54,685 |
| Other operating items | 0 | 0 | -109,553 | -109,553 | 0 | 0 | -119,719 | -119,719 |
| Operating result | -56,529 | 7,981 | -109,553 | -158,102 | -44,958 | -9,727 | -119,719 | -174,404 |
| Net financial items | 0 | 0 | -177 | -177 | 0 | 0 | -465 | -465 |
| Result before income tax | -56,529 | 7,981 | -109,730 | -158,279 | -44,958 | -9,727 | -120,184 | -174,869 |
1 CERAMENT drug eluting includes CERAMENT G and CERAMENT V.
NOTE 8 OPTION PROGRAMS AND PERFORMANCE SHARE PROGRAMS
At the period end, there are three different employee stock option programs, three performance share programs and three warrant programs.
Employee stock option 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 share in BONESUPPORT when exercising the option. This at a price of 0.125 SEK per option, equivalent to 0.625 SEK per share, in the first two programs and 5.30 SEK per option, equivalent to 26.50 SEK per share, in the third program. 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, 21.2 million (20.4) options were fully vested before the end of the period.
Performance share programs
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 2, 3 or 4 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 0.625 SEK per share. The program that runs until 2022 has been implemented during the year.
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.
Warrant programs
There are three warrant programs where the latest program was executed in 2018. Warrants in the first two programs give the holder the right to acquire 0.2 ordinary shares and the third program 1 share.
Further information on these programs is presented in Notes 12, 23 and 25 in the Annual Report 2018.
| Employee stock option programs | No of options¹ | Equal to no of shares | WAEP² |
|---|---|---|---|
| Balance January 1, 2019 | 6,180,190 | 1,236,038 | 9.92 |
| Exercised | -1,102,125 | -220,425 | 0.63 |
| Returned | -101,045 | -20,209 | 0.63 |
| Balance December 31, 2019 | 4,977,020 | 995,404 | 12.12 |
| Performance share programs | Right to no of shares |
|---|---|
| Balance January 1, 2019 | 505,000 |
| Granted | 730,000 |
| Returned | -10,000 |
| Balance December 31, 2019 | 1,225,000 |
| Warrant programs | No of options | Equal to no of shares | WAEP² |
|---|---|---|---|
| Balance January 1, 2019 | 4,606,664 | 1,210,210 | 20.87 |
| Balance December 31, 2019 | 4,606,664 | 1,210,210 | 20.87 |
1 Not allocated options amounted to 3,925,380.
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 2,605 SEKt (4,192). Accrued social security contributions amounts to 3,515 SEKt (2,277).
DEFINITIONS
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
CF. Cash Flow.
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.
DR. Doctor.
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.
Histology. The study of the microscopic anatomy (microanatomy) of cells and tissues of plants and animals.
IDE. Investigational Device Emption. Exemption from regulatory approval to conduct clinical studies on a medical device.
Iliac crest. The upper wing of the hip bone (ilium).
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.
12M. 12 Months (shows economic turn out during the latest 12 months before period end).
DEFINITIONS - ALTERNATIVE PERFORMANCE MEASURES
BONESUPPORT uses Alternative Performance Measures (APM) to enhance understandability of the information in the financial reports, both for external analysis, comparison and internal performance assessment.
Alternative Performance Measures are key figures not defined in financial reports prepared according to IFRS. The following key figures are used:
Sales growth
The difference in net sales between two periods in relation to net sales for the earlier period. Shows the operations sales performance.
Gross profit
Net sales minus cost of sales. Shows the profit to cover other costs and profit margin.
Gross margin
Net sales minus cost of sales, in relation to net sales. Shows the margin to cover costs and profit.
Contribution
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.
Interest bearing debt
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.
Net debt
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.
| Oct - Dec | Jan - Dec | |||
|---|---|---|---|---|
| 2019 | 2018 | 2019 | 2018 | |
| Net sales, SEKm | 46.2 | 23.1 | 155.5 | 96.6 |
| Sales growth, % | 99.9 | -14.4 | 60.9 | -25.3 |
| Cost of sales, SEKm | -5.1 | -3.5 | -19.6 | -15.2 |
| Gross profit, SEKm | 41.1 | 19.6 | 135.9 | 81.5 |
| Gross margin, % | 88.9 | 85.0 | 87.4 | 84.3 |
| Directly attributable selling expenses, SEKm | -45.3 | -34.6 | -159.6 | -112.6 |
| Selling expenses, not directly attributable, SEKm | -4.0 | -4.2 | -22.7 | -20.7 |
| Selling expenses, SEKm | -49.3 | -38.8 | -182.3 | -133.3 |
| Directly attributable research & development expenses, SEKm | -5.5 | -5.9 | -24.8 | -23.6 |
| Research & development expenses, not directly attributable, SEKm | -13.0 | -11.7 | -44.0 | -42.5 |
| Research & development expenses, SEKm | -18.5 | -17.6 | -68.9 | -66.1 |
| Contribution, SEKm | -9.8 | -20.8 | -48.6 | -54.7 |
| Dec 31 | |||
|---|---|---|---|
| SEKm | 2019 | 2018 | |
| Non-current borrowings | 5.7 | 0.0 | |
| Current borrowings | 4.7 | 0.0 | |
| Interest bearing debt | 10.4 | 0.0 | |
| Cash and cash equivalents | 92.1 | 261.5 | |
| Net debt | -81.7 | -261.5 |
ABOUT BONESUPPORT
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 was founded in 1999 and 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 40,000 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 and extend it to further indications by the release of other drugs.
CERAMENT BVF is currently commercially available in several markets in Europe, the US, India, Malaysia, Oman and Singapore. CERAMENT G and CERAMENT V are available in the same European markets, as well as in Malaysia and Oman. CERAMENT G is also available in India.
BONESUPPORT was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT's mission is to bring people with bone and joint diseases back to an active life. The company is based in Lund, Sweden.
PRESENTATION OF FULL YEAR REPORT JANUARY - DECEMBER 2019
legislation.
The Company invites investors, analysts and media to a web conference (in English) on February 26 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 February 26, 2020. For further details regarding participation, see the investor pages at 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
FORWARD LOOKING STATEMENTS
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
CONTACT INFORMATION
Emil Billbäck, CEO T: +46 46 286 53 70
Håkan Johansson, CFO T: +46 46 286 53 70
E: [email protected] www.bonesupport.com