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Episurf Interim / Quarterly Report 2017

May 20, 2017

3157_10-q_2017-05-20_7d734e79-14d3-4180-ac7b-f32fb2b116b2.pdf

Interim / Quarterly Report

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Interim Report 1 January–31 March 2017

First quarter

  • » Group net sales amounted to SEK 462,979 (411,834).
  • » Income after financial Items for the Group amounted to SEK –19,036,869 (–11,696,747).
  • » Episurf Medical announced and conducted a rights issue and raised approximately SEK 109.5M prior to transaction costs.
  • » Episurf Medical is expanded its Clinical Advisory Board with Radiologist Adam Mitchell.
  • » Dennis D. Stripe to act as executive chairman.
  • » Episurf Medical obtained its first granted patents in China.
  • » Positive patent development in the US for Episurf Medical's 3D-based damage assessment tool.
  • » Episurf Medicals CEO Rosemary Cunningham Thomas stepped down – search for new CEO initiated.

First quarter compared to 2016, Group

  • » Group net sales increased by 12% to SEK 462,979 (411,834).
  • » Other operating income amounted to SEK 71,902 (–).
  • » Income after financial items amounted to SEK –19,036,869 (–11,696,747).
  • » Earnings per share (weighted average) amounted to SEK –0.66 (–0.89).

Significant events during the first quarter

  • » Episurf Medical announced and conducted a rights issue and raised approximately SEK 109.5 M prior to transaction costs.
  • » Episurf Medical is expanded its Clinical Advisory Board with Radiologist Adam Mitchell.
  • » Dennis D. Stripe to act as executive chairman.
  • » Episurf Medical obtained its first granted patents in China.
  • » Positive patent development in the US for Episurf Medical's 3D-based damage assessment tool.
  • » Episurf Medicals CEO Rosemary Cunningham Thomas stepped down search for new CEO initiated.

Significant events after the first quarter

  • » Episurf Medical announced that the 50th implantation in Germany of the Episealer® knee implant will take place in the coming days.
  • » Episurf Medical obtained further granted patent in Australia.
  • » Episurf Medical strengthened the company's management group.
  • » Episurf Medical obtained further granted patent in the US.
  • » Episurf Medical reached milestone of 200 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, Acting CEO and CFO

Message from the CEO

Progress across the business

During the first quarter, the Episurf Medical team continued to inform and educate surgeons across Europe about the benefits of Episealer technology, winning new converts and new patients. We also participated formally at an industry congress in the US for the first time, and reached a number of other important milestones.

As I write this, 193 patients have been treated with the Episealer® knee implant technology and, as we recently announced, we look forward to our 200th surgery in the coming days. Over 40 patients have now had their Episealer® implants for two years or longer, and 12 for three years or more. These numbers will continue to grow rapidly, supported by very strong clinical data.

In our 2016 annual report on April 20, 2017, we summarized Episurf Medical's participation at the AAOS 2017 (American Academy of Orthopaedic Surgeons annual meeting 2017), our first formal participation in a major US congress. We maintain our very strong focus towards the

surgeons interested in starting to use the Episealer® technology. With broadening knowledge about the Episealer® technology among surgeons in Germany, we can now also increase our informational activities and marketing towards patients.

In the first quarter, we also announced changes in our management group. The Episurf management team is becoming a close-knit group with a wide variety of relevant competences and backgrounds. I feel that the organization is now well-staffed and working efficiently, and we do not expect any significant changes to the workforce during 2017. I look forward to working with this leadership team and all our dedicated employees to develop Episurf Medical together.

The result for the first quarter 2017 was negatively impacted by expenses of some SEK 3 million related to the termination of the previous CEO. Further, we have developed our accounting methodology for intangible assets,

"As I write this, 195 patients have been treated with the Episealer® knee implant technology and, as we recently announced, we look forward to our 200th surgery in the coming days."

US, and the US market constitutes a significant opportunity for Episurf Medical. I refer to the annual report for a longer review of the AAOS meeting, but our main conclusions were regarding the growing demand in the industry for personalized treatment options and the confirmation that our strategy of consistent collection and production of clinical data is correct. We continue to develop our strategy for the US and we will maintain an open dialogue with our shareholders on this topic.

Just at the close of the first quarter, we announced to the market that we had performed our 50th implantation in Germany. I am proud to say that our sales force is now covering all 16 local German regions, with a population of well over 80 million people. We are working our way systematically through the regions, and our technology has gained real traction in the German market, with many leading to a negative effect or SEK 0.6 million during the first quarter.

On a final note, we are humbled by and truly grateful for the confidence in our company demonstrated by both existing and new shareholders in our most recent capital raise of SEK 109.5 million. This capital raise was closed during the first quarter and it is the fuel we need to take Episurf Medical to the next level, and help even more patients back to life.

Stockholm, May 2017

Pål Ryfors Acting CEO and CFO

Business update and forward-looking statements

By the reporting date on May 15 2017, Episurf Medical's implants had been used in 193 surgeries. The second quarter 2017 started with 14 surgeries performed in the first 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 193 implants, we now have 4 patients who have had their implants for more than 4 years and 41 patients have now had their implants for more than 2 years since the surgery date.

During the first quarter, 20 surgeries were performed with the Episealer® knee implant. We continued to make progress in all of our key markets and we performed our first surgery in Israel. Israel is currently not a key market

for us, however, we were approached by a surgeon and a patient who had a strong desire to try the Episealer® technology, and we made arrangements to deliver on this request. This patient had undergone several biological procedures without any lasting results, and as in several other cases, the prospects were actually quite bad. 26 orders were approved for surgery during the first quarter.

We continue to note a demand for the Episealer® Femoral Twin implant as 70% of the surgeries performed in the first 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.

Cumulative implants

Number

Financial information

Group

Net sales and operating profit/loss

Group net sales amounted to SEK 462,979 (411,834) in the quarter as a result from increased sales activities in prioritized markets. The increase in personnel expenses compared with the previous year is a direct result of the Company's increased commercial focus. 11 new employees have been hired since last March, seven for Sales and Market two in England, three in Germany and two in Sweden. Four new employees have also been hired for Operation, Management and Administration and five have left the company.

The result for the first quarter was allso negatively impacted by expenses of some SEK 3 million related to the termination of the previous CEO. In addition we have conducted a bookkeeping measure relating to intangible assets that negatively impacts the operating profit of approximately SEK 0,6 million.

Financial position

Group cash and cash equivalents at end of period amounted to SEK 127,321,236 (88,790,487). The equity ratio was 87.4% (94.1). Group investments in intangible assets amounted to SEK 1,718,275 (1,318,950) for the quarter of which SEK 1,001,754 (553,299) are related to capitalized development costs, remaining investments relates to patents. Investments in tangible assets amounted to SEK 32,690 (16,924) for the quarter. A rights issue was performed during the third quarter and the Company raised SEK 109.5 million before issue related costs which amounted to SEK 11.0 million.

Human resources

Number of employees in the Group at end of the period was 29 (23). The increase is primarily a result of recruitment in marketing and sales.

Parent Company

Net sales and operating profit/loss

Other operating income amounted to SEK 71,902 (553,299) and capitalised development expenditure amounted to 472,841 (553,299) for the quarter. Income after financial items amounted to SEK –10,874,246 (–5,814,849) for the quarter.

Financial position

Cash and cash equivalents at the end of period for the Parent Company amounted to SEK 124,821,191 (85,733,831). The equity ratio was 93.8% (97.3). Investments in intangible assets, capitalized development costs, amounted to SEK 1,001,754 (553,299) for the quarter. Investments in tangible assets amounted to SEK – (–) for the quarter.

Human resources

Number of employees in the Parent Company at end of the period was 14 (14).

Transactions with closely related parties

Shareholder and Board member Leif Ryd has received consulting fees during the period of SEK 165,000 (135,000).

Right issue

Episurf Medical has during the first quarter completed a new share issue with preferential rights for the company's shareholders. The subscription price for the new shares of series A and B was SEK 7.50 per share and the subscription period took place from and including 27 February 2017 until and including 13 March 2017. The final outcome shows that 91.54 per cent of the new shares were subscribed by shareholders through primary and subsidiary pre-emptive rights. The total count shows that 13,477,883 shares (of which 2,983,597 were class A and 10,494,286 were class B shares), equal to 84.5 per cent of the offered shares, were subscribed through the exercise of subscription rights, while 1,121,808 shares, equal to 7.0 per cent of the offered shares, were subscribed without the support of subscription rights. The rights issue was subscribed to 91.5 per cent and the company raised approximately MSEK 109.5 before issue expenses (10,960,233). Through the new share issue, Episurf Medical's share capital increased by SEK 4,383,614.75. The number of class A shares increased by 2,985,597 and the number of class B shares increased by 11,614,094. The total number of shares thus increased by 14,599,691 and the total number of votes by 20,570,885.

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.

31 March 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 31 March 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 Luxembourg 112,066 2,163,630 7.5 5.8
SEB London- Luxemburg, (SICAV Fond) 0 1,324,693 4.3 3.1
AMF Aktiefond småbolag 0 1,240,448 4.1 2.9
Försäkringsaktiebolaget, Avanza Pension 0 1,215,821 4.0 2.8
LMK Forward AB 0 1,200,000 3.9 2.8
Gile Medicinkonsult AB 279,945 142,954 1.4 2.3
Swedbank Försäkring 0 766,602 2.5 1.8
Person, Rutger 0 634,074 2.1 1.5
Lönn, Mikael 106,179 280,000 1.3 1.4
Total, 10 largets shareholders 6,143,316 8,968,222 49.6 63.5
Summary, other 6,386,468 24,163,027 50.4 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.

Annual General Meeting 2017

Annual General Meeting in Episurf Medical AB (publ) will be held on Monday, May 22, 2017, at 6:oo pm at Odenplan 7A, Odengatan 65 in Stockholm, Sweden. Notice to the AGM is available on Episurf Medical's website, www.episurf.com.

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, 14 May 2017

Dennis D. Stripe Wil Boren Board chairman Board member

Saeid Esmaeilzadeh Wilder Fulford Board member Board member

Leif Ryd Christian Krüeger Board member Board member

Pål Ryfors Acting CEO and CFO

The information in this interim report has not been reviewed by the company's auditors.

Condensed consolidated income statement

SEK Jan–Mar 2017 Jan–Mar 2016 Jan–Dec 2016
Operating income
Net sales 462,979 411,834 2,405,614
Capitalised development expenditure 472,841 565,286 1,605,049
Other operating income 71,902 254,927
Total income 1,007,722 977,120 4,265,590
Operation expenses
Other expenses –8,316,268 –5,096,404 –32,759,994
Personnel costs –10,722,957 –6,765,093 –29,157,850
Depreciation –1,009,327 –831,162 –4,056,494
Total operating expenses –20,048,552 –12,692,659 –65,974,338
Operating loss –19,040,830 –11,715,539 –61,708,748
Financial items
Financial income, other 3,961 18,870 44,224
Financial expenses, other –78 –2,940
Results from financial items 3,961 18,792 41,284
Loss before tax –19,036,869 –11,696,747 –61,667,464
Tax on income for the period
Loss for the period –19,036,869 –11,696,747 –61,667,464
Net loss attributable to:
Parent company shareholders –19,036,869 –11,696,747 –61,667,464
Earnings per share before and after dilution are consistent with the rules in
IAS 33
–0.66 –0.73 –3.87
Average number of shares 28,704,479 15,949,804 15,949,804

Condensed consolidated statement of comprehensive income

SEK Jan–Mar 2017 Jan–Mar 2016 Jan–Dec 2016
Net profit –19,036,869 –11,696,747 –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 79,575 51,548 412,960
Total comprehensive income for the period –18,957,294 –11,645,199 –61,254,504

Condensed consolidated balance sheet

SEK 31 Mar 2017 31 Mar 2016 31 Dec 2016
ASSETS
Non-current assets
Intangible assets
Capitalized development costs 5,018,068 4,928,383 4,302,265
Patent 8,967,391 6,646,141 8,271,484
Total intangible assets 13,985,459 11,574,524 12,573,749
Property, plant and equipment
Equipment 369,313 404,846 382,054
Total property, plant and equipment 369,313 404,846 382,054
Total non-current assets 14,354,772 11,979,370 12,955,803
Current assets
Inventories, finished goods and goods for resale 1,228,687 1,213,707 1,106,057
Trade receivables 367,579 509,700 581,336
Other receivables 1,479,040 1,038,073 1,570,475
Prepaid expenses and accrued income 1,916,988 885,250 1,791,272
Cash and bank balances 127,321,236 88,790,487 42,300,018
Total current assets 132,313,530 92,437,217 47,349,158
TOTAL ASSETS 146,668,302 104,416,587 60,304,961
EQUITY AND LIABILITIES
Equity 128,253,328 98,289,340 48,698,610
Liabilities
Non-current liabilities
Non-current liabilities 934 10,320
Total long-term liabilities 934 10,320
Current liabilities
Trade payables 8,960,004 2,720,941 6,234,498
Other liabilities 2,304,087 1,028,923 1,584,129
Accrued liabilities and deferred income 7,149,949 2,377,383 3,777,404
Total current liabilities 18,414,040 6,127,247 11,596,031
Total liabilities 18,414,974 6,127,247 11,606,351
TOTAL EQUITY AND LIABILITIES 146,668,302 104,416,587 60,304,961
Equity ratio 87.4% 94.1% 80.8%
Equity per share, SEK 4.20 6.16 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 period 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 79,575 –19,036,869 –18,957,294
Total comprehensive income 79,575 –19,036,869 –18,957,294
Transactions with shareholders
New share issue, net after issue expenses* 4,383,615 94,159,841 98,543,456
Options issued to staff –12,869 –12,869
Total transactions with shareholders 4,383,615 94,159,841 –12,869 98,530,587
Closing equity 31 March 2017 9,172,606 331,204,455 665,764 –212,789,497 128,253,328

* Issue expenses amounts to SEK 10,960,233 according to IAS 32.39.

Condensed cash flow statement

SEK Jan–Mar 2017 Jan–Mar 2016 Jan–Dec 2016
Operating activities
Operating loss –19,040,830 –11,715,539 –61,708,748
Adjustments for items not included in cash flow
Depreciation 1,009,327 831,162 4,056,494
Employee stock option expenses 12,292 18,575
Interest received 3,961 18,870 43,438
Interest paid –78 –2,940
Cash flow from operating activities
before change in working capital
–18,015,250 –10,865,585 –57,593,181
Change in working capital
Decrease/increase in inventory –122,630 –59,129 48,520
Decrease/increase in trade receivables 213,757 –309,836 –381,472
Decrease/increase in current receivables –34,281 –512,984 –1,946,942
Decrease/increase in current liabilities 6,844,750 –2,086,881 3,777,031
Change in working capital 6,901,596 –2,968,830 1,497,137
Cash flow from operating activities –11,113,654 –13,834,415 –56,096,044
Investing activities
Purchase of intangible fixed assets –2,375,894 –1,318,950 –5,405,142
Purchase of property, plant and equipment –32,690 –16,924 –159,572
Cash flow from investing activities –2,408,584 –1,335,874 –5,564,714
Financing activities
New share issue 98,543,456
Cash flow from financing activities 98,543,456
Cash flow for the period 85,021,218 –15,170,289 –61,660,758
Cash and cash equivalents at beginning of period 42,300,018 103,960,776 103,960,776
Cash and cash equivalents at end of period 127,321,236 88,790,487 42,300,018

Income statement, Parent Company

SEK Jan–Mar 2017 Jan–Mar 2016 Jan–Dec 2016
Operating income
Net sales
Capitalised development expenditure 472,841 553,299 1,605,049
Other operating income –14 –30
Total income 472,827 553,299 1,605,019
Operating expenses
Other expenses –7,671,686 –2,448,833 –21,327,889
Personnel costs –3,363,713 –3,815,411 –13,596,551
Depreciation –315,410 –315,624 –1,697,907
Total operating expenses –11,350,809 –6,579,868 –36,622,347
Operating loss –10,877,982 –6,026,569 –35,017,328
Financial items
Financial income, other 3,736 211,798 891,836
Financial expenses, other –78 –2,030
Loss from net financial items 3,736 211,720 889,806
Loss before contribution and tax –10,874,246 –5,814,849 –34,127,522
Contribution
Group contributions
Loss before tax –10,874,246 –5,814,849 –34,127,522
Tax on income for the period
Loss for the period –10,874,246 –5,814,849 –34,127,522

Parent Company statement of comprehensive income

SEK Jan–Mar 2017 Jan–Mar 2016 Jan–Dec 2016
Net profit –10,874,246 –5,814,849 –34,127,522
Other comprehensive income for the period:
Other comprehensive income for the period, net of tax
Total comprehensive income for the period –10,874,246 –5,814,849 –34,127,522

Balance sheet, Parent Company

SEK 31 Mar 2017 31 Mar 2016 31 Dec 2016
ASSETS
Non-current assets
Intangible assets
Capitalized development costs 5,408,681 4,928,383 4,692,878
Total intangible assets 5,408,681 4,928,383 4,692,878
Tangible fixed assets
Machinery and equipment 189,487 251,475 218,946
Total tangible fixed assets 189,487 251,475 218,946
Financial assets
Shares in group companies 55,283,375 19,753,375 46,183,375
Long-term receivables from group companies 9,544,462 17,495,931 15,142,260
Total financial assets 64,827,837 37,249,306 61,325,635
Total fixed assets 70,426,005 42,429,164 66,237,459
Current assets
Short term receivables
Other receivables 847,686 307,050 603,742
Prepaid expenses and accrued income 943,208 537,161 797,070
Total short term receivables 1,790,894 844,211 1,400,812
Cash and bank balances 124,821,191 85,733,831 40,109,215
Total current assets 126,612,085 86,578,042 41,510,027
TOTAL ASSETS 197,038,090 129,007,206 107,747,486
EQUITY AND LIABILITIES
Equity
184,864,797 125,508,260 97,195,587
Liabilities
Long-term liabilities 434 4,795
Total long-term liabilities 434 4,795
Current liabilities
Trade payables 7,816,693 1,096,114 4,154,482
Non-current liabilities to group companies 2,914,675
Other liabilities 1,400,488 554,906 530,461
Accrued liabilities and deferred income 2,955,679 1,847,926 2,947,486
Total current liabilities 12,172,860 3,498,946 10,547,104
TOTAL EQUITY AND LIABILITIES 197,038,091 129,007,206 107,747,486

Statement of changes in equity, Parent Company

SEK Share
capital
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 period
–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 –10,874,246 –10,874,246
Disposition according to AGM
Loss brought forward –34,127,522 34,127,522
Development fund
Other
972,144
–972,144
0
Total comprehensive loss for the
period 2,029,919 –145,467,937 –10,874,246 86,321,341
Transactions with shareholders
New share issue,
net after issue expenses*
4,383,615 94,159,841 98,543,456
Total transactions with shareholders 4,383,615 94,159,841 98,543,456
Closing equity 1 Mar 2017 9,172,606 2,029,919 330,004,455 –145,467,937 –10,874,246 184,864,797

* Issue expenses amounts to SEK 10,960,233 according to IAS 32.39.

Condensed cash flow statement, Parent Company

SEK Jan–Mar 2017 Jan–Mar 2016 Jan–Dec 2016
Operating activities
Operating loss –10,877,982 –6,026,569 –35,017,328
Adjustments for items not included in cash flow
Depreciation 315,410 315,624 1,697,907
Interest received 3,736 211,798 891,837
Interest paid –78 –2,030
Change in non-current liabilities –4,361 4,795
Cash flow from operating activities
before change in working capital
–10,563,197 –5,499,225 –32,424,819
Change in working capital
Decrease/increase in current receivables –390,083 –210,358 –766,960
Decrease/increase in current liabilities 1,625,756 –616,855 6,461,563
Change in working capital 1,235,673 –827,213 5,694,603
Cash flow from operating activities –9,327,524 –6,326,438 –26,730,216
Investing activities
Acquisition of intangible assets –1,001,754 –553,299 –1,605,049
Acquisition of property,
plant and equipment –62,499
Changes in financial assets –3,502,202 –9,350,162 –33,456,751
Cash flow from investing activities –4,503,956 –9,903,461 –35,124,299
Financing activities
New share issue 98,543,456
Cash flow from financing activities 98,543,456
Cash flow for the period 84,711,976 –16,229,899 –61,854,515
Cash and cash equivalents
at beginning of period 40,109,215 101,963,730 101,963,730
Cash and cash equivalents at end of period 124,821,191 85,733,831 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 165,000 (135,000).

Serendipity Communications AB has received consulting fees of SEK 92,700 (–) and Serendipity Legal AB of SEK 11,250 (–)

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.

Trochlea Solo

Episealer® Condyle 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

AGM 22 May 2017
Interim report April–June 2017 18 August 2017
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 15 May 2017 at 08.30 (CET).

The following analysts monitor Episurf Medical's development: Erik Penser Bank Analyst: Johan Lochen

Jarl Securities Analyst: Markus Augustsson

IR contact

Pål Ryfors

Acting CEO and CFO Phone: +46 709 62 36 69 e-mail: [email protected]

Episurf Medical AB (publ) Corp. ID no. 556767-0541 Karlavägen 60, 114 49 Stockholm, Sweden www.episurf.com