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Episurf — Interim / Quarterly Report 2017
Aug 18, 2017
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Interim / Quarterly Report
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Interim Report 1 April–30 June 2017
Second quarter
- » Group net sales amounted to SEK 622,897
- » Loss before tax for the Group amounted to SEK –12,990,707
- » Episurf Medical announced that the 50th implantation in Germany of the Episealer® knee implant was performed
- » Episurf Medical obtained further granted patents in Australia, US and Europe
- » Episurf Medical strengthened the company's management group
- » Episurf Medical reached milestone of 200 implants
- » Episurf Medical continued Its communication with the US Food and Drug Administration (FDA)
- » Episurf Medical's Board named Pål Ryfors new CEO and appointed Veronica Wallin as new CFO
- » Episurf Medical appointed Dr Michael Manley Special Advisor for the US strategy
The period in brief Q2
Second quarter 2017, compared to 2016, Group
- » Group net sales increased by 33% to SEK 622,897 (469,380)
- » Other operating income including capitalized development expenditure amounted to SEK 607,140 (381,298)
- » Loss before tax amounted to SEK –12,990,707 (–16,473,988)
- » Earnings per share (weighted average) amounted to SEK –0.45 (–1.03)
Significant events during the second quarter
- » Episurf Medical announced that the 50th implantation in Germany of the Episealer® knee implant was performed
- » Episurf Medical obtained further granted patents in Australia, US and Europe
- » Episurf Medical strengthened the company's management group
- » Episurf Medical reached milestone of 200 implants
- » Episurf Medical continued its communication with the US Food and Drug Administration (FDA)
- » Episurf Medical's Board named Pål Ryfors new CEO and appointed Veronica Wallin as new CFO
- » Episurf Medical appointed Dr Michael Manley Special Advisor for the US strategy
First six months 2017, compared to first six months 2016, Group
- » Group net sales increased by 23% to SEK 1,085,876 (881,214)
- » Other operating income including capitalized development expenditure amounted to SEK 1,151,883 (946,584)
- » Loss before tax amounted to SEK –31,947,724 (–28,170,735)
- » Earnings per share (weighted average) amounted to SEK –1.12 (–1.00)
- » Equity per share amounted to SEK 3.99 (5.16)
- » Equity ratio amounted to 93.0% (94.1)
Significant events after the second quarter
- » Dennis D. Stripe re-assumed the position as non-executive chairman of the board
- » Case-report with clinical data of Episealer® patient was published
- » Another preclinical paper on the Episealer® Implant published
- » Episurf Medical became an approved supplier to Spire Healthcare, one of the UK's largest Independent hospital providers
- » Episurf Medical reported a brief clinical update
- » Management group changes in Episurf Medical were announced
- » Episurf Medical reached milestone of 250 implants
Our priorities for 2017 will be focused around the following four cornerstones
- » Continued commercialization in our European key markets together with production of clinical evidence
- » Next step on our US strategy with the aim of submitting a FDA approval application
- » Continued product development with focus on our 3D based damage marking tool (Epioscopy®) as well as
- » Continued strengthening within the areas of reimbursement, health economic studies and IP
Pål Ryfors, CEO
Message from the CEO Significant improvement of the financial results
During the second quarter of 2017, we continued our important work of acquainting orthopeadic surgeons across Europe with the Episealer® technology. This work brings us closer to our goal of standardising patient-specific treatment alternatives for the treatment of focal cartilage and bone defects of the knee joint. During the quarter, we have continued to focus on our key markets in Germany, the UK, the Nordic region and Benelux. We have also continued our preparatory work for the US market. We are reporting on a significant improvement in the financial results, primarily driven by lower costs.
As I write this, we have just communicated that the 250th surgery with our Episealer® knee implant is scheduled for the coming weeks. More than 100 of our patients have now had their implants for over one year since surgery and almost 50 of those have had their implants for two years, 12 patients have had their implants more than three years and four patients have had their implants more than three years since the Episealer® surgery, the patient continues to demonstrate significant improvements in pain and outcome scores that have also enabled a return to sporting activities. This patient has, after many years of severe pain and inability to work, returned to an active life. The patient's life quality increased significantly during the follow-up period and the good results did not deteriorate during these three years. In addition to the encouraging clinical results, we are also intrigued by the fact that this case report mentions the wider welfare savings that can potentially be offered by our technology, enabling patients to get back to work. Orthopaedic surgeons see this kind of patient daily, and when the Episealer® technology constitutes a natural part of the treatment algorithm, we will have achieved our goal.
Moreover, we recently communicated that we have been appointed as approved supplier to Spire Healthcare, one of the largest hospital groups in the UK. This is of great
"I can conclude that the result improved significantly compared to the previous quarter and compared to the corresponding quarter the previous year."
than four years since surgery. These numbers will continue to increase rapidly, supported by very strong clinical data.
I would like to continue by briefly summarising a recently published case study with clinical data of an Episealer® patient. I choose to focus on this report as it in many ways is representative for situations we encounter daily. The peer-reviewed case study, written by the Danish orthopaedic surgeon Jens Ole Laursen, was recently published in the Journal of Exercise, Sports and Orthopedics. The patient in focus had sustained a sporting injury that severely damaged a zone of knee cartilage. The damage led to several failed surgeries and two years of unemployment. At the age of 31, the patient underwent an Episealer® surgery, recovered quickly from the procedure and returned to work as a carpenter within three months. Now, more
importance to us, not only because of future business volumes, but also because it is a recognition of the quality of our technology and a signal about the fact that there is a need for more efficient treatment methods for this previously difficult-to-treat patient group.
Recently, we communicated that we have hired Dr. Michael Manley to the company as special strategic advisor for our US strategy. Dr. Manley has held leading positions in the orthopaedic industry in research and development for more than 30 years. Since 1987, Dr. Manley has been with Stryker Orthopaedics, one of the leading companies of the orthopaedic industry. At Stryker, Dr. Manley was Chief Scientific Adviser up to December 2016. Dr. Manley will play an important role for us in our preparatory work for a launch in the US market.
I would like to continue by addressing the financial results for the second quarter, and I can conclude that the result improved significantly compared to the previous quarter and compared to the corresponding quarter the previous year. The result is approximately SEK 3.5 million better than during the second quarter 2016 and approximately SEK 6 million better than during the first quarter 2017. During Q1 2017, the result was negatively impacted by extraordinary expenses of some SEK 3 million related to the previous CEO, however, also adjusted for these expenses, there is an evident result improvement. The sales are increasing, however, as this development is yet to fully impact the financial statements, the improvements to date are primarily generated from lower expenses. We are continuously focusing on cost control and we are looking forward to seeing continued result improvements driven by future increases in sales, both on the short- as well as long-term. Our view is that the costs for the US efforts will increase from current levels although our ambition is that we will partly off-set this increase by increased efficiency in the European operations.
On a final note, I would like to highlight a couple of organisational changes that have taken place since our last report. In June, the Board appointed me as Chief Executive Officer of Episurf Medical, and I am both very happy and proud of this expression of confidence. I am convinced about the potential that this company has and I am determined to contribute to ensuring that this company and its technology achieve their full potential and reach the position they deserve. Following my appointment as CEO, Veronica Wallin was appointed Chief Financial Officer of Episurf Medical. Previously, Wallin held the position as Head of Finance, but she now assumes the full responsibility for our financial operations. Just after the CEO appointment, Dennis Stripe re-assumed his position as Chairman of the Board, having held the position of Executive Chairman since January 5.
We have a full team in place, the clinical results are excellent, the financial results are clearly developing in the right direction, more and more patients become aware of the opportunity of a treatment with the Episealer® implant, and the acceptance of our technology is increasing rapidly. Our full team is very enthusiastic about the future for Episurf Medical.
Stockholm, August 2017
Pål Ryfors CEO
Business update and forward-looking statements
By the reporting date on August 18 2017, Episurf Medical's implants had been used in 212 surgeries. Episurf Medical has seen an increase in the business volumes in recent weeks, and another 38 orders are approved for surgery in the coming weeks. Episurf Medical's patients are experiencing significant improvements in pain and mobility. Furthermore, they are also experiencing a short recovery time. Out of the total implant portfolio of 212 implants, we now have 4 patients who have had their implants for more than 4 years and 47 patients have now had their implants for more than 2 years since the surgery date. During the
second quarter, 24 surgeries were performed with the Episealer® knee implant and we continued to make progress in all of our key markets. 28 orders were approved for surgery during the first quarter. We continue to note a demand for the Episealer® Femoral Twin implant as 67% of the surgeries performed in the second quarter were of this product. This clearly shows that there is a demand for treating the more elongated lesions and the Episurf technology and the Episealer® Femoral Twin implant meets this demand in a very good way
Financial information
Group
Net sales and loss before tax
Group net sales amounted to SEK 622,897 (469,380) in the quarter and to SEK 1,085,876 (881,214) for the first six months as a result from increased sales activities in prioritized markets. Loss before tax amounted to SEK –12,990,707 (–16,473,988) for the quarter and SEK –32,027,576 (–28,170,735) for the first six months.
Financial position
Group cash and cash equivalents at end of period amounted to SEK 103,137,924 (71,586,135). The equity ratio was 93.0% (94.1). Group investments in intangible assets amounted to SEK 1,578,442 (738,983) for the quarter of which SEK 710,376 (343,756) are related to capitalized development costs and for the first six months investments in intangible assets amounted to SEK 3,954,336 (2,057,933) of which SEK 1,712,130 (897,056) are related to capitalized development costs, remaining investments relates to patents. Investments in tangible assets amounted to SEK 0 (45,574) for the quarter and SEK 32,690 (62,498) for the first half year.
Human resources
Number of employees in the Group at end of the period was 28 (29).
Parent Company
Net sales and profit before tax
Other operating income including capitalized development expenditure amounted to SEK 533,168 (327,485) for the quarter and for the first six months to SEK 1,005,995 (880,784). Loss before tax amounted to SEK –6,124,456 (–7,267,449) for the quarter and SEK –16,998,702 –13,082,298) for the first six months.
Financial position
Cash and cash equivalents at the end of period for the Parent Company amounted to SEK 93,175,156 (67,977,072). The equity ratio was 98% (97.6). Investments in intangible assets, capitalized development costs, amounted to SEK 710,376 (343,758) for the quarter and SEK 1,712,130 (897,057) for the first six months. Investments in tangible assets amounted to SEK – (–) for the quarter and for the first six months.
Human resources
Number of employees in the Parent Company at end of the period was 13 (15).
Transactions with closely related parties
Shareholder and Board member Leif Ryd has received consulting fees during the first six months of SEK 330,000 (270,000). Serendipity Communications AB has received consulting fees of SEK 92,700 (175,000) and Serendipity Legal AB of SEK 11,250 (50,000).
Share information
There are two types of shares in the Company. Each Class A-share carries three votes, and entitles the holder to three votes at the General Meeting and each class B-share carries one vote and entitles the holder to one vote at the General Meeting. Class B shares have traded on Nasdaq Stockholm's Small Cap segment since 11 June 2014 with the ticker EPIS B.
30 June 2017
| A-shares | 6,386,468 |
|---|---|
| B-shares | 24,163,027 |
| Total number of shares | 30,549,495 |
| Total number of votes | 43,322,431 |
The ten largest shareholders in Episurf Medical AB at 30 June 2017
| No. of A-shares |
No. of B-shares |
Share capital in % |
Voting rights, % |
|
|---|---|---|---|---|
| Serendipity Ixora AB | 5,645,126 | 0 | 18.5 | 39.1 |
| JP Morgan Bank, Luxemburg | 112,066 | 2,163,630 | 7.5 | 5.8 |
| SEB London- Luxemburg, (SICAV Fond) | 0 | 1,324,693 | 4.3 | 3.1 |
| Försäkringsaktiebolaget, Avanza Pension | 0 | 1,309,477 | 4.3 | 3.0 |
| AMF Aktiefond småbolag | 0 | 1,240,448 | 4.1 | 2.9 |
| LMK Forward AB | 0 | 1,200,000 | 3.9 | 2.8 |
| Gile Medicinkonsult AB | 279,945 | 142,954 | 1.4 | 2.3 |
| Swedbank Försäkring | 0 | 788,602 | 2.6 | 1.8 |
| Person, Rutger | 0 | 627,074 | 2.1 | 1.5 |
| Lönn, Mikael | 106,179 | 280,000 | 1.3 | 1.4 |
| Total, 10 largets shareholders | 6,143,316 | 9,076,878 | 49.8 | 63.5 |
| Summary, other | 243,152 | 15,086,149 | 50.2 | 36.5 |
| Total | 6,386,468 | 24,163,027 | 100.0 | 100.0 |
Other information
Significant risks and uncertainty factors
Episurf Medical's material business risks, for the Group as well as for the Parent Company, are to obtain regulatory approval and market acceptance, the outcome of clinical studies, the ability to protect intellectual property rights and dependence on key personnel and partners. The Company does not see any new material risks for the upcoming three months. For a more detailed description of significant risks and uncertainties, refer to Episurf Medical's annual report.
The Board of Directors and the CEO hereby give their assurance that the Interim Report gives a true and fair view of the business activities, financial position and results of operations for the Group and Parent Company, and describes significant risks and uncertainty factors to which the Parent Company and the companies included in the Group are exposed.
Stockholm, 17 August 2017
Dennis D. Stripe Laura Shunk Board chairman Board member
Saeid Esmaeilzadeh Wilder Fulford Board member Board member
Board member Board member
Leif Ryd Christian Krüeger
Pål Ryfors CEO
The information in this interim report has not been reviewed by the company's auditors.
Condensed consolidated income statement
| SEK | Apr–Jun 2017 | Apr–Jun 2016 | Jan–Jun 2017 | Jan–Jun 2016 | Jan–Dec 2016 |
|---|---|---|---|---|---|
| Operating income | |||||
| Net sales | 622,897 | 469,380 | 1,085,876 | 881,214 | 2,405,614 |
| Capitalized development expenditure | 533,180 | 381,298 | 1,006,021 | 946,584 | 1,605,049 |
| Other operating income | 73,960 | – | 145,862 | – | 254,927 |
| Total income | 1,230,037 | 850,678 | 2,237,759 | 1,827,798 | 4,265,590 |
| Operation expenses | |||||
| Other expenses | –6,272,634 | –9,678,272 | –14,588,902 | –14,774,676 | –32,759,994 |
| Personnel costs | –6,932,407 | –6,766,926 | –17,655,364 | –13,532,019 | –29,157,850 |
| Depreciation | –1,021,083 | –888,494 | –2,030,410 | –1,719,656 | –4,056,494 |
| Total operating expenses | –14,226,124 | –17,333,692 | –34,274,676 | –30,026,351 | –65,974,338 |
| Operating loss | –12,996,087 | –16,483,014 | –32,036,917 | –28,198,553 | –61,708,748 |
| Financial items | |||||
| Financial income, other | 7,739 | 204,539 | 11,700 | 223,409 | 44,224 |
| Financial expenses, other | –2,359 | –195,513 | –2,359 | –195,591 | –2,940 |
| Results from financial items | 5,380 | 9,026 | 9,341 | 27,818 | 41,284 |
| Loss before tax | –12,990,707 | –16,473,988 | –32,027,576 | –28,170,735 | –61,667,464 |
| Tax on income for the period | – | – | – | – | – |
| Loss for the period | –12,990,707 | –16,473,988 | –32,027,576 | –28,170,735 | –61,667,464 |
| Net loss attributable to: | |||||
| Parent company shareholders | –12,990,430 | –15,909,156 | –31,947,724 | –28,170,735 | –61,254,504 |
| Earnings per share before and after dilution | |||||
| are consistent with the rules in IAS 33 | –0.45 | –1.03 | –1.12 | –1.77 | –3.87 |
| Average number of shares | 28,704,479 | 15,949,804 | 28,704,479 | 15,949,804 | 15,949,804 |
Condensed consolidated statement of comprehensive income
| SEK | Apr–Jun 2017 | Apr–Jun 2016 | Jan–Jun 2017 | Jan–Jun 2016 | Jan–Dec 2016 |
|---|---|---|---|---|---|
| Net profit | –12,990,707 | –16,473,988 | –32,027,576 | –28,170,735 | –61,667,464 |
| Other comprehensive income for the period: Other comprehensive income that may be reclassified subsequently to profit or loss for |
|||||
| the period, net of tax | 277 | 564,832 | 79,852 | 616,380 | 412,960 |
| Total comprehensive income for the period |
–12,990,430 | –15,909,156 | –31,947,724 | –27,544,355 | –61,254,504 |
Condensed consolidated balance sheet
| SEK | 30 Jun 2017 | 30 Jun 2016 | 31 Dec 2016 |
|---|---|---|---|
| ASSETS | |||
| Non-current assets | |||
| Intangible assets | |||
| Capitalized development costs | 5,436,742 | 4,981,827 | 4,302,265 |
| Patent | 9,150,376 | 7,073,375 | 8,271,484 |
| Total intangible assets | 14,587,118 | 12,055,202 | 12,573,749 |
| Property, plant and equipment | |||
| Equipment | 325,421 | 432,359 | 382,054 |
| Total property, plant and equipment | 325,421 | 432,359 | 382,054 |
| Total non-current assets | 14,912,539 | 12,487,561 | 12,955,803 |
| Current assets | |||
| Inventories, finished goods and goods for resale | 1,136,261 | 1,190,558 | 1,106,057 |
| Trade receivables | 592,201 | 536,370 | 581,336 |
| Other receivables | 1,678,179 | 760,729 | 1,570,475 |
| Prepaid expenses and accrued income | 1,642,152 | 953,849 | 1,791,272 |
| Cash and bank balances | 103,137,924 | 71,586,135 | 42,300,018 |
| Total current assets | 108,186,717 | 75,027,641 | 47,349,158 |
| TOTAL ASSETS | 123,099,256 | 87,515,202 | 60,304,961 |
| EQUITY AND LIABILITIES | |||
| Equity | 114,439,534 | 82,380,183 | 48,698,610 |
| Liabilities | |||
| Non-current liabilities | |||
| Non-current liabilities | 7,022 | – | 10,320 |
| Total long-term liabilities | 7,022 | – | 10,320 |
| Current liabilities | |||
| Trade payables | 1,744,073 | 2,214,274 | 6,234,498 |
| Other liabilities | 2,121,534 | 1,034,947 | 1,584,129 |
| Accrued liabilities and deferred income | 4,787,093 | 1,885,798 | 3,777,404 |
| Total current liabilities | 8,652,700 | 5,135,019 | 11,596,031 |
| Total liabilities | 8,659,722 | 5,135,019 | 11,606,351 |
| TOTAL EQUITY AND LIABILITIES | 123,099,256 | 87,515,202 | 60,304,961 |
| Equity ratio | 93.0% | 94.1% | 80.8% |
| Equity per share, SEK | 3.99 | 5.16 | 4.88 |
Condensed consolidated statement of changes in equity
| Attributable to equity holders of the parent | ||||||
|---|---|---|---|---|---|---|
| SEK | Share capital | Other contributed capital |
Reserves | Accumulated deficit incl. loss for the year |
Total equity | |
| Opening equity 1 Jan 2016 | 4,788,991 | 237,044,614 | 173,229 | –132,072,295 | 109,934,539 | |
| Total comprehensive income | ||||||
| Loss for the year | 412,960 | –61,667,464 | –61,254,504 | |||
| Total comprehensive income | 412,960 | –61,667,464 | –61,254,504 | |||
| Transactions with shareholders | ||||||
| Options issued to staff | –18,575 | –18,575 | ||||
| Total transactions with shareholders | –18,575 | –18,575 | ||||
| Closing equity 31 Dec 2016 | 4,788,991 | 237,044,614 | 586,189 | –193,739,759 | 48,698,610 | |
| Opening equity 1 Jan 2017 | 4,788,991 | 237,044,614 | 586,189 | –193,739,759 | 48,698,610 | |
| Total comprehensive income | ||||||
| Loss for the period | 79,852 | –32,027,575 | –31,947,723 | |||
| Total comprehensive income | 79,852 | –32,027,575 | –31,947,723 | |||
| Transactions with shareholders | ||||||
| New share issue, net after issue expenses* | 4,383,615 | 93,344,336 | 97,727,951 | |||
| Options issued to staff | – | – | – | –20,729 | –20,729 | |
| Total transactions with shareholders | 4,383,615 | 93,344,336 | – | –20,729 | –20,729 | |
| Closing equity 30 June 2017 | 9,172,606 | 330,388,950 | 666,041 | –225,788,063 | 114,439,534 |
* Issue expenses amounts to SEK 11,775,738 according to IAS 32.39.
Condensed cash flow statement
| SEK | Apr–Jun 2017 | Apr–Jun 2016 | Jan–Jun 2017 | Jan–Jun 2016 | Jan–Dec 2016 |
|---|---|---|---|---|---|
| Operating activities | |||||
| Operating loss | –12,996,087 | –16,483,014 | –32,036,917 | –28,198,553 | –61,708,748 |
| Adjustments for items not included in cash flow | |||||
| Depreciation | 1,021,083 | 888,494 | 2,030,410 | 1,719,656 | 4,056,494 |
| Employee stock option expenses | 8,437 | 204,539 | 20,729 | 223,409 | 18,575 |
| Interest received | 7,739 | –195,513 | 11,700 | –195,591 | 43,438 |
| Interest paid | –2,359 | – | –2,359 | –2,940 | |
| Cash flow from operating activities before change in working capital |
–11,961,187 | –15,585,494 | –29,976,437 | –26,451,079 | –57,593,181 |
| Change in working capital | |||||
| Decrease/increase in inventory | 92,426 | 23,149 | –30,204 | –35,980 | 48,520 |
| Decrease/increase in trade receivables | –224,622 | 283,165 | –10,865 | –26,671 | –381,472 |
| Decrease/increase in current receivables | 75,697 | –96,839 | 41,416 | –609,823 | –1,946,942 |
| Decrease/increase in current liabilities | –9,771,679 | –1,043,776 | –2,926,929 | –3,130,667 | 3,777,031 |
| Change in working capital | –9,828,178 | –834,301 | –2,926,582 | –3,803,141 | 1,497,137 |
| Cash flow from operating activities | –21,789,365 | –16,419,795 | –32,903,019 | –30,254,220 | –56,096,044 |
| Investing activities | |||||
| Purchase of intangible fixed assets | –1,578,442 | –738,983 | –3,954,336 | –2,057,933 | –5,405,142 |
| Purchase of property, plant and equipment | – | –45,574 | –32,690 | –62,498 | –159,572 |
| Cash flow from investing activities | –1,578,442 | –784,557 | –3,987,026 | –2,120,431 | –5,564,714 |
| Financing activities | |||||
| New share issue | –815,505 | – | 97,727,951 | – | – |
| Cash flow from financing activities | –815,505 | – | 97,727,951 | – | – |
| Cash flow for the period Cash and cash equivalents at beginning of |
–24,183,312 | –17,204,352 | 60,837,906 | –32,374,651 | –61,660,758 |
| period | 127,321,236 | 88,790,487 | 42,300,018 | 103,960,776 | 103,960,776 |
| Cash and cash equivalents at end of period |
103,137,924 | 71,586,135 | 103,137,924 | 71,586,125 | 42,300,018 |
Income statement, Parent Company
| SEK | Apr–Jun 2017 | Apr–Jun 2016 | Jan–Jun 2017 | Jan–Jun 2016 | Jan–Dec 2016 |
|---|---|---|---|---|---|
| Operating income | |||||
| Net sales | – | – | – | – | – |
| Capitalized development expenditure | 533,180 | 327,485 | 1,006,021 | 880,784 | 1,605,049 |
| Other operating income | –12 | – | –26 | – | –30 |
| Total income | 533,168 | 327,485 | 1,005,995 | 880,784 | 1,605,019 |
| Operating expenses | |||||
| Other expenses | –3,024,295 | –4,765,469 | –10,695,981 | –7,214,302 | –21,327,889 |
| Personnel costs | –3,319,333 | –2,782,551 | –6,683,046 | –6,597,962 | –13,596,551 |
| Depreciation | –320,709 | –321,426 | –636,119 | –637,050 | –1,697,907 |
| Total operating expenses | –6,664,337 | –7,869,446 | –18,015,146 | –14,449,314 | –36,622,347 |
| Operating loss | –6,131,169 | –7,541,961 | –17,009,151 | –13,568,530 | –35,017,328 |
| Financial items | |||||
| Financial income, other | 7,740 | 276,464 | 11,476 | 488,262 | 891,836 |
| Financial expenses, other | –1,027 | –1,952 | –1,027 | –2,030 | –2,030 |
| Loss from net financial items | 6,713 | 274,512 | 10,449 | 486,232 | 889,806 |
| Loss before tax | –6,124,456 | –7,267,449 | –16,998,702 | –13,082,298 | –34,127,522 |
| Tax on income for the period | – | – | – | – | – |
| Loss for the period | –6,124,456 | –7,267,449 | –16,998,702 | –13,082,298 | –34,127,522 |
Parent Company statement of comprehensive income
| SEK | Apr–Jun 2017 | Apr–Jun 2016 | Jan–Jun 2017 | Jan–Jun 2016 | Jan–Dec 2016 |
|---|---|---|---|---|---|
| Net profit | –6,124,456 | –7,267,449 | –16,998,702 | –13,082,298 | –34,127,522 |
| Other comprehensive income for the period: |
|||||
| Other comprehensive income for the period, net of tax |
– | – | – | – | – |
| Total comprehensive income for the period |
–6,124,456 | –7,267,449 | –16,998,702 | –13,082,298 | –34,127,522 |
Balance sheet, Parent Company
| SEK | 30 Jun 2017 | 30 Jun 2016 | 31 Dec 2016 |
|---|---|---|---|
| ASSETS | |||
| Non-current assets | |||
| Intangible assets | |||
| Capitalized development costs | 5,827,355 | 4,981,827 | 4,692,878 |
| Patent | – | – | – |
| Total intangible assets | 5,827,355 | 4,981,827 | 4,692,878 |
| Tangible fixed assets | |||
| Machinery and equipment | 160,480 | 282,862 | 218,946 |
| Total tangible fixed assets | 160,480 | 282,862 | 218,946 |
| Financial assets | |||
| Shares in group companies | 61,083,375 | 19,753,375 | 46,183,375 |
| Long-term receivables from group companies | 19,400,722 | 27,238,238 | 15,142,260 |
| Total financial assets | 80,484,097 | 46,991,613 | 61,325,635 |
| Total fixed assets | 86,471,932 | 52,256,302 | 66,237,459 |
| Current assets | |||
| Short term receivables | |||
| Other receivables | 1,074,009 | 349,059 | 603,742 |
| Prepaid expenses and accrued income | 838,578 | 560,422 | 797,070 |
| Total short term receivables | 1,912,587 | 909,481 | 1,400,812 |
| Cash and bank balances | 93,175,156 | 67,977,072 | 40,109,215 |
| Total current assets | 95,087,743 | 68,886,553 | 41,510,027 |
| TOTAL ASSETS | 181,559,675 | 121,142,855 | 107,747,486 |
| EQUITY AND LIABILITIES | |||
| Equity | 177,924,836 | 118,240,811 | 97,195,587 |
| Liabilities | |||
| Long-term liabilities | 3,079 | – | 4,795 |
| Total long-term liabilities | 3,079 | – | 4,795 |
| Current liabilities | |||
| Trade payables | 563,544 | 1,264,185 | 4,154,482 |
| Non-current liabilities to group companies | – | – | 2,914,675 |
| Other liabilities | 1,220,992 | 650,214 | 530,461 |
| Accrued liabilities and deferred income | 1,847,224 | 987,645 | 2,947,486 |
| Total current liabilities | 3,631,760 | 2,902,044 | 10,547,104 |
| TOTAL EQUITY AND LIABILITIES | 181,559,675 | 121,142,855 | 107,747,486 |
Statement of changes in equity, Parent Company
| SEK | Share capital |
Develop ment fund |
Other contribut ed capital |
Loss brought forward |
Loss for the period |
Total equity |
|---|---|---|---|---|---|---|
| Opening equity 1 Jan 2016 | 4,788,991 | – | 235,844,614 | –80,546,687 | –28,763,809 | 131,323,109 |
| Comprehensive loss for the period | – | |||||
| Loss for the year | –34,127,522 | –34,127,522 | ||||
| Disposition according to AGM | ||||||
| Loss brought forward | –28,763,809 | 28,763,809 | – | |||
| Development fund | 1,057,775 | –1,057,775 | – | |||
| Other | – | – | – | – | ||
| Total comprehensive loss for the period |
1,057,775 | –110,368,271 | –34,127,522 | 97,195,587 | ||
| Transactions with shareholders | ||||||
| Total transactions with shareholders | – | – | – | – | – | – |
| Closing equity 31 Dec 2016 | 4,788,991 | 1,057,775 | 235,844,614 | –110,368,271 | –34,127,522 | 97,195,587 |
| Opening equity 1 Jan 2017 | 4,788,991 | 1,057,775 | 235,844,614 | –110,368,271 | –34,127,522 | 97,195,587 |
| Comprehensive loss for the period | ||||||
| Loss for the period | –16,998,702 | –16,998,702 | ||||
| Disposition according to AGM | ||||||
| Loss brought forward | –34,127,522 | 34,127,522 | – | |||
| Development fund | 1,647,159 | –1,647,159 | – | |||
| Other | – | – | – | – | ||
| Total comprehensive loss for the period |
2,704,934 | –146,142,952 | –16,998,702 | 80,196,885 | ||
| Transactions with shareholders | ||||||
| New share issue net after issue expenses* |
4,383,615 | 93,344,336 | 97,727,951 | |||
| Total transactions with shareholders | 4,383,615 | 93,344,336 | 97,727,951 | |||
| Closing equity 30 Jun 2017 | 9,172,606 | 2,704,934 | 329,188,950 | –146,142,952 | –16,998,702 | 177,924,836 |
* Issue expenses amounts to SEK 11,775,738 according to IAS 32.39.
Condensed cash flow statement, Parent Company
| SEK | Apr–Jun 2017 | Apr–Jun 2016 | Jan–Jun 2017 | Jan–Jun 2016 | Jan–Dec 2016 |
|---|---|---|---|---|---|
| Operating activities | |||||
| Operating loss | –6,131,169 | –7,541,961 | –17,009,151 | –13,568,530 | –35,017,328 |
| Adjustments for items not included in cash flow | |||||
| Depreciation | 320,709 | 321,426 | 636,119 | 637,050 | 1,697,907 |
| Interest received | 7,740 | 276,464 | 11,476 | 488,262 | 891,837 |
| Interest paid | –1,027 | –1,952 | –1,027 | –2,030 | –2,030 |
| Change in non-current liabilities | 2,645 | – | –1,716 | 4,795 | |
| Cash flow from operating activities before change in working capital |
–5,801,102 | –6,946,023 | –16,364,299 | –12,445,248 | –32,424,819 |
| Change in working capital | |||||
| Decrease/increase in current receivables | –121,692 | –65,270 | –511,775 | –275,628 | –766,960 |
| Decrease/increase in current liabilities | –8,541,100 | –596,902 | –6,915,344 | –1,213,757 | 6,461,563 |
| Change in working capital | –8,662,792 | –662,172 | –7,427,119 | –1,489,385 | 5,694,603 |
| Cash flow from operating activities | –14,463,894 | –7,608,195 | –23,791,418 | –13,934,633 | –26,730,216 |
| Investing activities | |||||
| Acquisition of intangible assets | –710,376 | –343,758 | –1,712,130 | –897,057 | –1,605,049 |
| Acquisition of property, | |||||
| plant and equipment Changes in financial assets |
– –15,656,260 |
–62,499 –9,742,307 |
– –19,158,462 |
–62,499 –19,092,469 |
–62,499 –33,456,751 |
| Cash flow from investing activities | –16,366,636 | –10,148,564 | –20,870,592 | –20,052,025 | –35,124,299 |
| Financing activities | |||||
| New share issue | –815,505 | – | 97,727,951 | – | – |
| Cash flow from financing activities | –815,505 | – | 97,727,951 | – | – |
| Cash flow for the period | –31,646,035 | –17,756,759 | 53,065,941 | –33,986,658 | –61,854,515 |
| Cash and cash equivalents at beginning of period |
124,821,191 | 85,733,831 | 40,109,215 | 101,963,730 | 101,963,730 |
| Cash and cash equivalents | |||||
| at end of period | 93,175,156 | 67,977,072 | 93,175,156 | 67,977,072 | 40,109,215 |
Notes
Note 1 Accounting policies
The interim report for the Group has been prepared in accordance with IAS 34 Interim Reports and the Annual Accounts Act. The interim report for the Parent Company has been prepared in accordance with the Annual Accounts Act.
The Group's accounting policies are unchanged from the previous year.
Capitalized expenditures for development of products
Expenditure for development, where research results or other knowledge are applied to achieve new or improved products or processes, is recognized as an asset in the Statement of Financial Position only if the following conditions are satisfied:
- 1) It is technically possible to complete the intangible asset and use or sell it,
- 2) The Company intends to complete the intangible asset and use or sell it,
- 3) The conditions to use or sell the intangible asset are in place,
- 4) The Company demonstrates how the intangible asset will generate likely future economic benefits,
- 5) There are adequate technological, economic and other resources to complete development and to use or sell the intangible asset, and
- 6) The expenditure relating to the intangible asset during its development can be measured reliably
Directly related expenditure that is capitalized mainly consists of expenditure from subcontractors and expenses for employees.
Other development expenditure that does not satisfy these criteria is expensed when it arises. Development expenditure previously expensed is not recognized as an asset in subsequent periods. The group has assessed all the above criteria to be fulfilled during the period, the costs for development that has been incurred is therefor activated.
Shareholder and Board member Leif Ryd has received consulting fees of SEK 330,000 (270,000).
Serendipity Communications AB has received consulting fees of SEK 92,700 SEK (175,000) and Serendipity Legal AB of SEK 11,250 SEK (50,000)
Glossary
Approved orders: Orders which have been approved for surgery, are in production and will be invoiced.
Arthritis: see Osteoarthritis.
Arthroscopy: Inspection of the inside of a joint with the help of an arthroscope. An instrument is introduced through a small cut to investigate the inside of the joint and possibly correct any problems (a type of keyhole surgery).
Cartilage: The smooth, rubbery layer of shiny, white connective tissue that covers the end of bones at the joints. This tissue allows movement with low friction.
Cartilage defect of grade III (ICRS scale): Lesion through the cartilage, exposing the bone.
Cartilage defect of grade IV (ICRS scale): Lesion through the cartilage and in the underlying bone.
CE marking: CE marking is a manufacturer's or importer's declaration that a product meets the EU's fundamental health, environmental and safety requirements. The product in question undergoes a conformity assessment by a Notified Body, which decides whether the product fulfils the applicable product requirements in the EU. A CE mark means that the manufacturer or importer has the formal approvals necessary to market and sell the product in the European Economic Area.
Cobalt: A chemical element commonly occurring in metal alloys used in knee prostheses.
Cobalt chrome: A metal alloy mainly consisting of cobalt and chromium, commonly occurring in metal alloys used in knee prostheses.
CT scan: X-ray computed tomography scan, a medical imaging technique where a series of x-ray images allows the user to get three-dimensional image data of the patient.
Debridement: Removal of damaged tissue.
Degenerative origin: Conditions in which the cells, tissues or organs deteriorate and lose function. In degenerative joint disease, the deterioration is due to wear, tear or breakdown of cartilage.
FDA: US Food and Drug Administration.
Focal cartilage defect: A cartilage defect in a well defined area.
Hyaline cartilage: Natural articular cartilage.
Hydroxyapatite: A mineral that is the major component of human bone tissue and the main mineral of dental enamel and dentin.
Invasive treatment alternative: Treatments that require a surgical procedure.
KOL: Key Opinion Leader, prominent and opinion-leading surgeon.
KOOS: Knee injury and Osteoarthritis Outcome Score, a questionnaire used to assess the patient's opinion about their knee and associated problems.
Microfracture: A surgical technique that can be used in treatment of focal cartilage defects (not extensive osteoarthritis) in an attempt to stimulate the growth of new cartilage.
Mosaicplasty: A surgical technique for treatment of cartilage and underlying bone defects where cylindrical bone and cartilage plugs are harvested from less weight-bearing surfaces of the knee joint and inserted into the damaged area.
MRI: Magnetic resonance imaging, a medical imaging technique where images acquired using a strong magnetic field allows the user to get three-dimensional image data of the patient.
Orthopaedics: The medical specialty that focuses on injuries and diseases of the body's musculoskeletal system. This complex system includes bones, joints, ligaments, tendons, muscles and nerves.
Osteoarthritis: Osteoarthritis is type of joint disease that is characterised by loss of joint function with varying destruction of joint cartilage and the underlying bone.
Osteochondral autograft procedure: See Mosaicplasty.
Osteochondral defect: Cartilage and underlying bone defect.
Prosthesis: An artificial device that replaces a missing or injured body part, such as artificial arm or leg. The term prosthesis is also used for certain of the implants that are used to repair joints, such as hip and knee prostheses.
Traumatic damage: Damage caused by an outside force, such as fall injuries.
VAS: Visual Analogue Scale, a psychometric response scale which is used as a pain scale in questionnaires.
Episurf Medical
– a unique solution for every patient
EPISURF MEDICAL WAS FOUNDED IN 2009 on a commitment to offering people with painful joint injuries a more active and healthy life through customised treatment alternatives. We put the patient in the centre of the design of implants and surgical instruments. By combining advanced 3D imaging technology with the latest manufacturing technologies, we are able to adapt not only each implant to the patient's injury and anatomy, but also the surgical instruments used. In this way, we can ensure that each patient receives treatment that is perfectly suited to his or her anatomy and, thus, ensure a faster, more secure, and better patient-specific treatment for a more active and healthy life.
A proprietary web-based IT platform for patient-specific design and surgical pre-planning
Episurf Medical's scalable μiFidelity® system has been developed for damage assessment, surgical pre-planning and cost-effective patient customisation of implants and associated surgical instruments. In a first step, the company's main focus is on early stage arthritic changes in the knee joint.
Three different knee implants with a focus on early stages of arthritis
Episurf Medical currently has three types of patient-specific implants on the market.
- » Episealer® Condyle Solo for the treatment of localised cartilage and underlying bone defects on the femoral condyles of the knee joint.
- » Episealer® Trochlea Solo for the treatment of localised cartilage and underlying bone defects in the area behind the patella (the trochlea area).
- » Episealer® Femoral Twin for the treatment of elongated localised cartilage and underlying bone defects both on the femoral condyles and in the trochlea area of the knee joint.
Episealer® Condyle Solo
Trochlea Solo Episealer® Femoral Twin
Patient-specific surgical instruments
Every product is delivered with our surgical drill guide Epiguide®. We also offer a surgical drill guide, Epiguide® MOS, that is designed for use in mosaicplasty surgery for treatment of cartilage and deep underlying bone defects in the knee joint.
Patents and patent applications
The generation of new intellectual property and the ongoing maintenance of current IP is of paramount importance for Episurf Medical to ensure that Episurf Medical's proprietary, existing technologies and future innovations are well protected. In total Episurf Medical has approximately 100 patents and patent applications worldwide, distributed over more than 20 patent families.
» Episurf Medical's head office is located in Stockholm and the company has an in-house sales organisation in Europe.
» The share (EPIS B) has been listed on Nasdaq Stockholm since June 2014.
Financial calendar
| Interim report July–September 2017 | 10 November 2017 |
|---|---|
| Year-End Report 2017 | 23 February 2018 |
This is a translation of the original Swedish interim report. In the event of a discrepancy between this translation and the Swedish original, the Swedish interim report takes precedence.
This information is information that Episurf Medical AB (publ) is obliged to make public, pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out below, on 18 August 2017 at 08.30 (CET).
The following analysts follow Episurf Medical's development: Erik Penser Bank Analyst: Johan Lochen
Jarl Securities Analyst: Markus Augustsson
IR contact
Pål Ryfors CEO Phone: +46 709 62 36 69 e-mail: [email protected]
On Monday May 22nd 2017, the 2017 Annual General Meeting of Episurf Medical was held in Stockholm. Approximately 100 guests including shareholders and employees of Episurf Medical had gathered for this year's Annual General Meeting.
During the evening, presentations where given for example by Professor Leif Ryd who presented his view on Episurf's development from a 10-years perspective and Chairman Dennis Stripe spoke about the historical development of the orthopaedic industry and why Episurf Medical's technology is a logical continuation of this historical development.
Episurf Medical AB (publ) Corp. ID no. 556767-0541 Karlavägen 60, 114 49 Stockholm, Sweden www.episurf.com