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Episurf — Interim / Quarterly Report 2016
Feb 20, 2017
3157_10-k_2017-02-20_d24811d0-b49c-4618-849f-d91ff55ef8b5.pdf
Interim / Quarterly Report
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Year-end report 1 October–31 December 2016
Fourth quarter
- » Group net sales amounted to SEK 1,007,759.
- » Income after financial Items for the Group amounted to SEK –18,454,211.
- » Episurf Medical achieves milestone of 150th Implant.
- » Episurf Medical's 50th Episealer® Femoral Twin Implant demonstrates rapid clinical adoption.
- » Touch surgery released Episealer® surgical knee training simulations in collaboration with Episurf Medical.
Fourth quarter compared to 2015, Group
- » Group net sales increased by 168% to SEK 1,007,759 (375,368).
- » Other operating income amounted to SEK 821,447 (1,849,848).
- » Income after financial items amounted to SEK –18,454,211 (–14,148,843).
- » Earnings per share (weighted average) amounted to SEK –1,16 (–0,89).
Twelve months 2016, compared to 2015, Group
- » Group net sales increased by 137% to SEK 2,405,614 (1,016,462).
- » Other operating income amounted to SEK 1,859,976 (5,628,598).
- » Income after financial items amounted to SEK –61,667,464 (–43,974,662).
- » Earnings per share (weighted average) amounted to SEK –3,87 (–3,52).
- » Equity per share amounted to SEK 3,05 (6,89).
- » Equity ratio amounted to 80,8% (93,0).
Significant events during the fourth quarter
- » Episurf Medical achieves milestone of 150th Implant.
- » Episurf Medical's 50th Episealer® Femoral Twin Implant demonstrates rapid clinical adoption.
- » Touch surgery released Episealer surgical knee training simulations in collaboration with Episurf Medical.
Significant events after year end
- » Episurf Medical's CEO Rosemary Cunningham Thomas steps down search for new CEO Initiated.
- » Episurf Medical is expanding Its Clinical Advisory Board.
- » Episurf Medical announces an up to approx. SEK 120 million rights issue subject to EGM approval and brings forward date of year-end report; Dennis Stripe to act as executive chairman.
- » Episurf Medical obtains its first granted patents in China.
- » Episurf Medical's 3D-based image assessment tool: positive development in US patenting.
Pål Ryfors, Acting CEO and CFO
Message from the CEO
The fourth quarter represented a strong conclusion of 2016
Dear Shareholder,
The fourth quarter represented a strong conclusion of 2016 for Episurf Medical as 34 surgeries were performed with the Episealer® implant which represents a doubling of the number of surgeries performed in the third quarter. Revenues for the quarter amounted to SEK 1,008k and by that, Episurf Medical generated revenues in excess of SEK 1 million during a single quarter for the first time. Germany represented our highest performing market during the fourth quarter with 16 surgeries performed. In total, we ended 2016 with 86 surgeries performed and SEK 2.4 million of revenues. The number of approved orders amounted to 103 for the full year of which 26 came in the fourth quarter.
2016 in review
When summarizing 2016, I can conclude that there were a number of strong achievements during the year, however,
The first congress presentation with compiled Episealer® clinical data was held in May 2016, when 12 months' data was presented at the SFAIM-meeting in Sweden. This was followed by presentations of clinical data at the SOF-meeting in Sweden as well as at ICRS World Congress. The results show statistically significant clinical improvements from preoperatively to 12 and 24 months' follow-up of the patients. Continued production of clinical evidence is of utmost importance for us and we are very satisfied with the progress we made in 2016. However, we realize that we are in the beginning of the process of building our clinical track record and we look forward to increase the patient population.
Another priority for 2016 was our regulatory preparatory work for our goal of obtaining FDA approval in the US, the world's largest orthopedic market. In order for us to obtain FDA approval we have to go through one of three possible regulatory pathways. In July 2016, we
"2016 was an important year for Episurf Medical as we took several important steps on our development curve "
in some parts of our business, the speed of execution did not fully meet the expectations. That said, when taking the long-term view on the company, our positive view remains and clearly outweighs the challenges we met during 2016. Let me explain why.
In early 2016 we set up a number of strategic priorities for the year, namely (i) production of scientifical clinical evidence (ii) commercial execution, (ii) regulatory and reimbursement work with respect to our geographical expansion, including a specific focus towards the US market, as well as (iv) continued innovation of products and services. We made significant progress on all of our strategic priorities, and I will continue by focusing on some of the highlights and challenges within each area.
participated in a pre-submission meeting with the FDA in Washington. Following this meeting, we submitted a 513(g) Request for information for obtaining FDA's views about the classification and the regulatory requirements that may be applicable to the Episealer® device. We await FDA's response to our 513(g) Request. We are confident that we did an excellent job with our pre-submission work during 2016 and we are well prepared for taking the next steps on our US strategy. In parallel, we are continuing to work towards securing reimbursement levels in our European key markets.
When it comes to product development, we have continued to develop our Episealer® technology during 2016. This work has been underpinned by our close
co-operation with our surgeons as well as with our clinical advisory board. The highlight during the year was the CE mark of our Epioscopy® Damage assessment tool. We have received very satisfactory feedback from our surgeons on the 3D-based damage assessment tool and its role in the clinical decision making process. We see great potential in Epioscopy® and will continue to develop the product during 2017.
We shall also acknowledge that the speed of execution of our commercialization did not fully meet our expectations and our conclusion is that we underestimated the lead times in our sales cycle. Commercialisation of a novel technology in a previously difficult to treat patient group, with a new sales team in the traditionally conservative sector of orthopedic implants, does come with challenges. It is a top priority in our daily work to remove the bottlenecks and challenges we have faced in our early days and shorten the time from product introduction to actual order and surgery. Efforts to convince surgeons about Episealer's benefits has been a relatively straight-forward sales communication. However, the other selling steps are more challenging, such as re-imbursement, MRI compatibility and clinical data. The surgeon acceptance is clearly a strength. And, we will continue to build off that base. All our sales representatives have intense activity in their respective regions and we look forward to seeing that their persistent work bears fruit.
Establishing ourselves in the industry
I would also like to mention that during 2016, it was very important for Episurf Medical to establish our brand within the knee industry and for our technology to gain recognition as an accepted treatment option through our marketing activities. In May 2016, we attended the ESSKA (European Society of Sports, Traumatology, Knee Surgery and Arthroscopy) congress in Barcelona, attended predominantly by leading European knee surgeons but with a strong international visiting faculty. Later in the
year, we attend the ICRS (International Cartilage Repair Society) World Congress in Sorrento. Here we delivered an educational symposium with well-known surgeons from around the world coming to find out how our technology works. These activities are important in our work towards becoming accepted as a valid treatment option for patients with articular cartilage damages in their knee joints.
In summary, 2016 was a good year for Episurf Medical as we took several important steps on our development curve. We now need to continue our persistent work, which is the only way to introduce a new technology into our targeted market. Every day, we are seeing evidence of the fact that we are becoming a part of the surgeons' treatment algorithm for focal cartilage lesions.
Looking forward
Our priorities for 2017 will build on the momentum from 2016 and our speed of execution shall improve across our business. Continued commercialization in our key European markets together with production of clinical evidence is a top priority for us. The next step of the US strategy, namely the submission of an application for FDA approval, is a second priority. A third priority is continued product development with a focus on our unique digital 3D-based damage assessment tool (Epioscopy®). The fourth key priority is continued strengthening of our positions in the fields of reimbursement, health economic studies and IP. In January 2017, we announced a rights issue of SEK 120 million for the purpose of funding this strategy. All in all, continued progress on this strategy indicates a very interesting future for Episurf Medical.
Stockholm, February 2017
Pål Ryfors Acting CEO and CFO
Business update and forward-looking statements
As of the reporting date on February 20 2017, Episurf Medical's implants had been used in 171 surgeries. The first quarter 2017 started with 12 surgeries performed in the first weeks. As illustrated by the clinical scores (KOOS and VAS, shown on page 6), 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 171 implants, we now have 2 patients who have had their implants for more than 4 years and 24 patients have now had their implants for more than 2 years since the surgery date.
During the fourth quarter, 34 surgeries were performed with Episealer® and Germany was the strongest region with 16 surgeries performed. Germany now represents 25% of our total implant portfolio. 26 orders were approved for surgery during the fourth quarter.
During the fourth quarter, the two first revisions of Episealer® implants were made, one in Sweden and one in Belgium. In one of these cases, our damage marking report indicated damages in several areas of the knee prior to surgery, and the surgeon were left with few treatment options. The surgeon took the decision that an Episealer® was the most appropriate treatment in this difficult case, and the surgery outcome was satisfactory. However, 16 months after the Episealer implantation, the patient went on to do a partial knee replacement given that the damages in the knee were extensive. In the other case, the patient suffered from an infection and our analysis showed that there were no problems with the implant as such and that the surrounding cartilage was well preserved. Both revisions went well.
Clinical follow-up data
The graphs below present clinical data obtained for 48 Episealer® patients that have passed 12 months' follow-up, expressed as the clinical scores KOOS and VAS.
Financial information
Group
Net sales and operating profit/loss
Group net sales amounted to SEK 1,007,759 SEK (375,368) in the quarter and to SEK 2,405,614 (1,016,462) for the financial year 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 December, eight for Sales and Market three in England, three in Germany and two in Sweden. Three new employees have also been hired for Operation, Management and Administration and three have left the company.
Financial position
Group cash and cash equivalents at end of period amounted to SEK 42,300,018 (103,960,776). The equity ratio was 80.8% (93.0). Group investments in intangible assets amounted to SEK 1,718,275 (2,902,558) for the quarter of which SEK 545,053 (1,781,175) are related to capitalized development costs and the financial year investments in intangible assets amounted to SEK 5,405,142 (7,247,777) of which SEK 1,605,049 (4,643,111) are related to capitalized development costs, remaining investments relates to patents. Investments in tangible assets amounted to SEK 29,191 (128,610) for the quarter and SEK 135,721 (128,610) for the financial year.
Human resources
Number of employees in the Group at end of the period was 27 (18). The increase is primarily a result of recruitment in marketing and sales.
Parent Company
Net sales and operating profit/loss
Total income amounted to SEK 565,594 (2,605,164) for the quarter and for the financial year to SEK 1,605,019 (6,382,257) Income after financial items amounted to
SEK –13,966,603 (–6,464,129) for the quarter and SEK –34,127,522(–21,709,809) for the financial year.
Financial position
Cash and cash equivalents at the end of period for the Parent Company amounted to SEK 40,109,215 (101,963,730). The equity ratio was 90,2% (97,0). Investments in intangible assets, capitalized development costs, amounted to SEK 545,053 (1,781,175) for the quarter and SEK 1,605,049 (4,643,111) for the financial year. Investments in tangible assets amounted to SEK 62,499 (–) for the quarter and for the financial year.
Human resources
Number of employees in the Parent Company at end of the period was 14 (12).
Transactions with closely related parties
Shareholder and Board member Leif Ryd has received consulting fees of SEK 540,000 (540,000).
Serendipity Professionals AB has received consulting fees of SEK 0 (1,629,951) of which SEK 0 (662,875) was recharged costs, Serendipity Communications AB has received a consultancy fee of SEK 850,073 (613,265), Serendipity Legal AB has received consulting fees of SEK 50,000 SEK (–) and Sprof AB has received consulting fees of SEK 21,375 (–). Serendipity Professionals AB, Serendipity Communications AB, Serendipity Legal AB and Sprof AB are related parties to Episurf Medicals largest shareholder Serendipity Ixora AB. The Chairman and Members of the boards fees were agreed by the AGM and is shown below.
The Chairman receive SEK 400,000. Wil Boren and Wilder Fulford receive remuneration of SEK 200,000. Saeid Esmaeilzadeh, Leif Ryd and Christian Krüeger receive remuneration of SEK 100,000 respectively. In total, the board fees amount to SEK 1,100 000 (500,000). 8/12 of the Directors fees are accrued during 2016.
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 Dec 2016
| A-shares | 3,400,871 |
|---|---|
| B-shares | 12,548,933 |
| Total number of shares | 15,949 804 |
| Total number of votes | 22,813 418 |
The ten largest shareholders in Episurf Medical AB at December 31, 2016
| No. of A-shares |
No. of B-shares |
Share capital in % |
Voting rights, % |
|
|---|---|---|---|---|
| Serendipity Ixora AB | 2,822,563 | 0 | 17.7 | 37.22 |
| Nordea Investment Funds | 56,033 | 1,081,815 | 7.1 | 5.49 |
| Gile Medicinkonsult AB | 254,945 | 128,454 | 2.4 | 3.93 |
| Försäkringsaktiebolaget, Avanza Pension | 0 | 698,119 | 4.4 | 3.07 |
| Rhenman Healthcare L/S Fund | 0 | 688,178 | 4.3 | 3.02 |
| AMF - Försäkring och Fonder | 0 | 620,224 | 3.9 | 2.73 |
| LMK Forward AB | 0 | 600,000 | 3.8 | 2.64 |
| Lönn, Mikael | 106,179 | 280,000 | 2.4 | 2.63 |
| Kaupthing HF. | 0 | 501,334 | 3.1 | 2.2 |
| Swedbank försäkring | 0 | 399,518 | 2.5 | 1.76 |
| Total, 10 largest shareholders | 3,239,720 | 4,997,642 | 51.6 | 64.7 |
| Summary, others | 161,151 | 7,551,291 | 48.4 | 35.3 |
| Total | 3,400,871 | 12,548,933 | 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 Year-end 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, 19 February 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
Consolidated income statement
| SEK | Oct–Dec 2016 | Oct–Dec 2015 | Jan–Dec 2016 | Jan–Dec 2015 |
|---|---|---|---|---|
| Operating income | ||||
| Net sales | 1,007,759 | 375,368 | 2,405,614 | 1,016,462 |
| Other operating income | 821,447 | 1,849,848 | 1,859,976 | 5,628,598 |
| Total income | 1,829,206 | 2,225,216 | 4,265,590 | 6,645,060 |
| Operating expenses | ||||
| Other expenses | –10,417,842 | –5,619,686 | –32,759,994 | –21,584,339 |
| Personnel costs | –8,728,449 | –10,100,802 | –29,157,850 | –26,834,214 |
| Depreciation | –968,316 | –677,894 | –4,056,494 | –2,235,026 |
| Total operating expenses | –20,114,607 | –16,398,382 | –65,974,338 | –50,653,579 |
| Operating loss | –18,285,401 | –14,173,166 | –61,708,748 | –44,008,519 |
| Financial items | ||||
| Financial income, other | –168,790 | 24,606 | 44,224 | 34,544 |
| Financial expenses, other | –20 | –283 | –2,940 | –687 |
| Results from financial items | –168,810 | 24,323 | 41,284 | 33,857 |
| Loss before tax | –18,454,211 | –14,148,843 | –61,667,464 | –43,974,662 |
| Tax on income for the period | – | – | – | – |
| Loss for the period | –18,454,211 | –14,148,843 | –61,667,464 | –43,974,662 |
| Net loss attributable to: | ||||
| Parent company shareholders | –18,454,211 | –14,148,843 | –61,667,464 | –43,974,662 |
| Earnings per share before and after dilution are consistent | ||||
| with the rules in IAS 33 | –1,16 | –0,89 | –3,87 | –3.52 |
| Average number of shares | 15,949,804 | 15,953,620 | 15,949,804 | 12,504,417 |
Consolidated statement of comprehensive income
| SEK | Oct–Dec 2016 | Oct–Dec 2015 | Jan–Dec 2016 | Jan–Dec 2015 |
|---|---|---|---|---|
| Net profit | –18,454,211 | –14,148,843 | –61,667,464 | –43,974,662 |
| Other comprehensive income for the period: Other comprehensive income that may be reclassified subsequently to profit or loss for the period, net of tax |
–170,939 | 173,229 | 412 960 | 173,229 |
| Total comprehensive income for the period | –18,625,150 | –13,975,614 | –61 254 504 | –43,801,433 |
Consolidated balance sheet
| SEK | 31 Dec 2016 | 31 Dec 2015 |
|---|---|---|
| ASSETS | ||
| Non-current assets | ||
| Intangible assets | ||
| Capitalized development costs | 4,302,265 | 4,660,637 |
| Patent | 8,271,484 | 6,385,717 |
| Total intangible assets | 12,573,749 | 11,046,354 |
| Property, plant and equipment | ||
| Equipment | 382,054 | 423,838 |
| Total property, plant and equipment | 382,054 | 423,838 |
| Total non-current assets | 12,955,803 | 11,470,192 |
| Current assets | ||
| Inventories, finished goods and goods for resale | 1,106,057 | 1,154,578 |
| Trade receivables | 581,336 | 199,864 |
| Other receivables | 1,570,475 | 869,741 |
| Prepaid expenses and accrued income | 1,791,272 | 545,064 |
| Cash and bank balances | 42,300,018 | 103,960,776 |
| Total current assets | 47,349,158 | 106,730,023 |
| TOTAL ASSETS | 60,304,961 | 118,200,215 |
| EQUITY AND LIABILITIES | ||
| Equity | ||
| Equity attributable to owners of the parent | ||
| Share capital | 4,788,992 | 4,788,991 |
| Other capital | 104,990,893 | 237,044,614 |
| Reserves | 586,189 | 173,229 |
| Earned income including net result | –61,667,464 | –132,072,295 |
| Total equity | 48,698,610 | 109,934,539 |
| Liabilities | ||
| Non-current liabilities | ||
| Non-current liabilities | 10,320 | – |
| Total long-term liabilities | 10,320 | – |
| Current liabilities | ||
| Trade payables | 6,234,498 | 1,787,912 |
| Other liabilities | 1,584,129 | 1,745,361 |
| Accrued liabilities and deferred income | 3,777,404 | 4,732,403 |
| Total current liabilities | 11,596,031 | 8,265,676 |
| Total liabilities | 11,606,351 | 8,265,676 |
| TOTAL EQUITY AND LIABILITIES | 60,304,961 | 118,200,215 |
| Equity ratio | 80.8% | 93.0% |
| Equity per share, SEK | 3.05 | 6.89 |
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 2015 | 2,386,974 | 124,560,235 | – | –88,097,632 | 38,849,577 |
| Total | – | ||||
| Total comprehensive income for the period | 173,229 | –43,974,663 | –43,801,434 | ||
| Total comprehensive income | – | – | 173,229 | –43,974,663 | –43,801,434 |
| Transactions with shareholders | |||||
| New share issue, net after issue expenses | 2,402,017 | 112,484,379 | 114,886,396 | ||
| Total transactions with shareholders | 2,402,017 | 112,484,379 | 114,886,396 | ||
| Closing equity 31 Dec 2015 | 4,788,991 | 237,044,614 | 173,229 | –132,072,295 | 109,934,539 |
| Opening equity 1 Jan 2016 | 4,788,991 | 237,044,614 | 173,229 | –132,072,295 | 109,934,539 |
| Total | |||||
| Total comprehensive income 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 December 2016 | 4,788,991 | 237,044,614 | 586,189 | –193,721,184 | 48,698,610 |
Condensed cash flow statement
| SEK | Oct–Dec 2016 | Oct–Dec 2015 | Jan–Dec 2016 | Jan–Dec 2015 |
|---|---|---|---|---|
| Operating activities | ||||
| Operating loss | –18,285,401 | –14,173,166 | –61,708,748 | –44,008,519 |
| Adjustments for items not included in cash flow | ||||
| Depreciation | 968,316 | 677,894 | 4,056,494 | 2,235,026 |
| Employee stock option expenses | 9,536 | – | 18,575 | – |
| Interest received | 5,765 | 24,606 | 43,438 | 34,544 |
| Interest paid | –20 | –283 | –2,940 | –687 |
| Paid taxes | – | – | – | – |
| Cash flow from operating activities before change in working capital |
–17,301,804 | –13,470,949 | –57,593,181 | –41,739,636 |
| Change in working capital | ||||
| Decrease/increase in inventory | –26,643 | 97,271 | 48,520 | 319,086 |
| Decrease/increase in trade receivables | 277,705 | –25,439 | –381,472 | –175,520 |
| Decrease/increase in current receivables | –559,035 | 647,628 | –1,946,942 | –493,057 |
| Decrease/increase in current liabilities | 5,523,335 | 2,136,296 | 3,777,031 | 4,050,095 |
| Change in working capital | 5,215,362 | 2,855,756 | 1,497,137 | 3,700,604 |
| Cash flow from operating activities | –12,086,442 | –10,615,193 | –56,096,044 | –38,039,032 |
| Investing activities | ||||
| Purchase of intangible fixed assets | –1,718,275 | –2,902,558 | –5,405,142 | –7,247,777 |
| Purchase of property, plant and equipment | –29,191 | –128,610 | –159,572 | –128,610 |
| Cash flow from investing activities | –1,747,466 | –3,031,168 | –5,564,714 | –7,376,387 |
| Financing activities | ||||
| New share issue | – | –188,601 | – | 114,886,396 |
| Cash flow from financing activities | – | –188,601 | – | 114,886,396 |
| Cash flow for the period | –13,833,908 | –13,834,962 | –61,660,758 | 69,470,977 |
| Cash and cash equivalents at beginning of period | 56,133,926 | 117,795,738 | 103,960,776 | 34,489,799 |
| Cash and cash equivalents at end of period |
42,300,018 | 103,960,776 | 42,300,018 | 103,960,776 |
Income statement, Parent Company
| SEK | Oct–Dec 2016 | Oct–Dec 2015 | Jan–Dec 2016 | Jan–Dec 2015 |
|---|---|---|---|---|
| Operating income | ||||
| Net sales | – | 754,609 | – | 754,609 |
| Other operating income | 565,594 | 1,850,555 | 1,605,019 | 5,627,648 |
| Total income | 565,594 | 2,605,164 | 1,605,019 | 6,382,257 |
| Operating expenses | ||||
| Other expenses | –9,296,290 | –3,181,188 | –21,327,889 | –12,949,289 |
| Personnel costs | –4,935,958 | –5,513,251 | –13,596,551 | –14,968,281 |
| Depreciation | –300,996 | –496,498 | –1,697,907 | –589,997 |
| Total operating expenses | –14,533,244 | –9,190,937 | –36,622,347 | –28,507,567 |
| Operating loss | –13,967,650 | –6,585,773 | –35,017,328 | –22,125,310 |
| Financial items | ||||
| Financial income, other | 1,047 | 121,925 | 891,836 | 415,906 |
| Financial expenses, other | 0 | –281 | –2,030 | –405 |
| Loss from net financial items | 1,047 | 121,644 | 889,806 | 415,501 |
| Loss before contribution and tax | –13,966,603 | –6,464,129 | –34,127,522 | –21,709,809 |
| Contribution | ||||
| Group contributions | – | –7,054,000 | – | –7,054,000 |
| Loss before tax | –13,966,603 | –13,518,129 | –34,127,522 | –28,763,809 |
| Tax on income for the period | – | – | – | – |
| Loss for the period | –13,966,603 | –13,518,129 | –34,127,522 | –28,763,809 |
Parent Company statement of comprehensive income
| SEK | Oct–Dec 2016 | Oct–Dec 2015 | Jan–Dec 2016 | Jan–Dec 2015 |
|---|---|---|---|---|
| Net profit | –13,966,603 | –13,518,129 | –34,127,522 | –28,763,809 |
| Other comprehensive income for the period: | ||||
| Other comprehensive income for the period, net of tax | – | – | – | – |
| Total comprehensive income for the period | –13,966,603 | –13,518,129 | –34,127,522 | –28,763,809 |
Balance sheet, Parent Company
| 31 Dec 2016 31 Dec 2015 SEK ASSETS Non-current assets Intangible assets Capitalized development costs 4,692,878 4,660,637 Patent – – Total intangible assets 4,692,878 4,660,637 Property, plant and equipment Machinery 218,946 281,547 Total property, plant and equipment 218,946 281,547 Financial assets Shares in group companies 46,183,375 16,128,375 Non-current receivables from group companies 15,142,260 11,740,509 Total financial assets 61,325,635 27,868,884 Total non-current assets 66,237,459 32,811,068 Current assets Current receivables Other receivables 603,742 356,533 Prepaid expenses and accrued income 797,070 277,319 Total current receivables 1,400,812 633,852 Cash and bank balances 40,109,215 101,963,730 Total current assets 41,510,027 102,597,582 TOTAL ASSETS 107,747,486 135,408,650 EQUITY AND LIABILITIES Equity Restricted equity Share capital 4,788,992 4,788,991 Total restricted equity 4,788,992 4,788,991 Unrestricted equity Share premium reserve 235,844,613 235,844,614 Loss brought forward –109,310,495 –80,546,687 Loss for the period –34,127,523 –28,763,809 Total unrestricted equity 92,406,595 126,534,118 Total equity 97,195,587 131,323,109 Liabilities Non-current liabilities Non-current liabilities 4,795 0 Total non-current liabilities 4,795 0 Current liabilities Trade payables 4,154,482 640,962 Kortfristiga skulder till koncernbolag 2,914,675 0 Other liabilities 530,461 556,315 Accrued liabilities and deferred income 2,947,486 2,888,264 Total current liabilities 10,547,104 4,085,541 TOTAL EQUITY AND LIABILITIES 107,747,486 135,408,650 Pledged assets None None |
|||
|---|---|---|---|
| Contingent liabilities | None | None |
Statement of changes in equity, Parent Company
| Share | Other contributed |
Loss brought | Loss for | ||
|---|---|---|---|---|---|
| SEK | capital | capital | forward | the period | Total equity |
| Opening equity 1 Jan 2015 | 2,386,974 | 123,360,235 | –53,969,350 | –26,577,337 | 45,200,522 |
| Comprehensive loss for the period | – | ||||
| Loss for the period | –28,763,809 | –28,763,809 | |||
| Disposition according to AGM | |||||
| Loss brought forward | –26,577,337 | 26,577,337 | – | ||
| Other | – | – | – | ||
| Total comprehensive loss for the period | –80,546,687 | –28,763,809 | 16,436,713 | ||
| Transactions with shareholders | |||||
| New share issue, net after issue expenses | 2,402,017 | 112,484,379 | 114,886,396 | ||
| Total transactions with shareholders | 2,402,017 | 112,484,379 | 114,886,396 | ||
| Closing equity 31 Dec 2015 | 4,788,991 | 235,844,614 | –80,546,687 | –28,763,809 | 131,323,109 |
| 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 | – | ||
| Other | – | – | – | ||
| Total comprehensive loss for the period | –109,310,496 | –34,127,522 | 97,195,587 | ||
| Transactions with shareholders | – | – | – | – | – |
| Total transactions with shareholders | – | – | – | – | – |
| Closing equity 31 December 2016 | 4,788,991 | 235,844,614 | –109,310,496 | –34,127,522 | 97,195,587 |
Condensed cash flow statement, Parent Company
| SEK | Oct–Dec 2016 | Oct–Dec 2015 | Jan–Dec 2016 | Jan–Dec 2015 |
|---|---|---|---|---|
| Operating activities | ||||
| Operating loss | –13,967,650 | –6,585,773 | –35,017,328 | –22,125,310 |
| Adjustments for items not included in cash flow | ||||
| Depreciation | 300,996 | –6,557,502 | 1,697,907 | –6,464,003 |
| Interest received | 1,047 | 121,925 | 891,837 | 415,906 |
| Interest paid | – | –281 | –2,030 | –405 |
| Change in non-current liabilities | 3,536 | – | 4,795 | – |
| Cash flow from operating activities | ||||
| before change in working capital | –13,662,071 | –13,021,631 | –32,424,819 | –28,173,812 |
| Change in working capital | ||||
| Decrease/increase in current receivables | –31,640 | 995,855 | –766,960 | –5,779 |
| Decrease/increase in current liabilities | 8,564,460 | –758,097 | 6,461,563 | 1,040,414 |
| Change in working capital | 8,532,820 | 237,758 | 5,694,603 | 1,034,635 |
| Cash flow from operating activities | –5,129,251 | –12,783,873 | –26,730,216 | –27,139,177 |
| Investing activities | ||||
| Acquisition of intangible assets | –545,053 | –1,781,174 | –1,605,049 | –4,643,111 |
| Acquisition of property, | ||||
| plant and equipment | – | 3,378 | –62,499 | 3,378 |
| Changes in financial assets | –8,325,678 | 1,559,941 | –33,456,751 | –9,747,455 |
| Cash flow from investing activities | –8,870,731 | –217,855 | –35,124,299 | –14,387,188 |
| Financing activities | ||||
| New share issue | – | –188,601 | – | 114,886,396 |
| Cash flow from financing activities | – | –188,601 | – | 114,886,396 |
| Cash flow for the period | –13,999,982 | –13,190,329 | –61,854,515 | 73,360,031 |
| Cash and cash equivalents | ||||
| at beginning of period | 54,109,197 | 115,154,059 | 101,963,730 | 28,603,699 |
| Cash and cash equivalents at end of period | 40,109,215 | 101,963,730 | 40,109,215 | 101,963,730 |
Notes
Note 1 Accounting policies
The Year-end report for the Group has been prepared in accordance with IAS 34 Interim Reports and the Annual Accounts Act. The Year-end 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 of the above criteria to be fulfilled during the period, and the development costs that have been incurred have therefore been capitalized.
Note 2 Transactions with closely related parties
Shareholder and Board member Leif Ryd has received consulting fees of SEK 540,000 (540,000). Serendipity Communications AB has received consulting fees of SEK 850,073 SEK (613,265), Serendipity Legal AB of SEK 50,000 SEK (–) and Sprof AB SEK 21,375 (–). The Chairman and Members of the boards fees were agreed by the AGM and is shown below.
| Board members | 2016 | 2015 |
|---|---|---|
| Dennis Stripe, Chairman | 400,000 | – |
| Wil Boren, Member | 200,000 | – |
| Wilder Fulford, Member | 200,000 | – |
| Christian Krüeger, Member | 100,000 | – |
| Saied Esmaeilzadeh, Member | 100,000 | 100,000 |
| Leif Ryd, Ledamot, Member | 640,000 | 640,000 |
| Jeppe Magnusson, Member | – | 100,000 |
| Thomas Nortoft, Member | – | 100,000 |
| Robert Charpentier, Member | – | 100,000 |
| Total | 1,640,000 | 1,040,000 |
Note 3 Intangible fixed assets
| Patent, group | Dec 31 2016 | Dec 31 2015 |
|---|---|---|
| Opening cost | 16,725,678 | 9,477,901 |
| Purchases during the year | 3,800,093 | 2,604,666 |
| Capitalized development costs | ||
| Capitalisation during the year | 1,605,049 | 4,643,111 |
| Impairment development costs | –506,256 | – |
| Closing accumulated cost | 21,624,564 | 16,725,678 |
| Opening depreciation | –5,679,324 | –3,582,892 |
| Depreciation for the year | –2,304,939 | –1,630,256 |
| Capitalized development costs | ||
| Depreciation for the year | –1,066,552 | –466,176 |
| Closing accumulated depreciation | –9,050,815 | –5,679,324 |
| Total intangible fixed assets | 12,573,749 | 11,046,354 |
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 customized treatment alternatives. We put the patient in the center of the diagnosis and design of implants and surgical instruments. By combining advanced 3D imaging technology with the latest manufacturing technology, 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 system for patient-specific design and surgical pre-planning
The scalable μiFidelity® system has been developed for diagnostics, surgical pre-planning and cost-effective patient customization. In a first step, the company's main focus is on early stage arthritic changes in the knee joint.
Epioscopy®
Epioscopy® is an advanced clinical assessment tool intended to provide the physician with decision support information in the form of 3D-vizualizations of the segmented patient knee.
Three different knee implants with a focus on early stages of arthritis
Episurf Medical currently has three types of implants on the market.
- » Episealer® Condyle Solo for the treatment of localized cartilage and underlying bone defects in the knee joint.
- » Episealer® Trochlea Solo for the treatment of localized cartilage and underlying bone defects in the area behind the patella.
- » Episealer® Femoral Twin for the treatment of localized cartilage and underlying bone defects both in the knee joint and in the area behind the patella.
Episealer® Condyle Solo Episealer®
Trochlea Solo Episealer®
Femoral Twin
Drill guides
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 procedures.
Around 80 patents and patent applications
The technology that creates patient-specific implants and instruments is supported by a strong patent portfolio with approximately 80 patents and patent applications in the areas of image handling, patient-specific implant systems, patient-specific surgical techniques, patient-specific instrumentation and manufacturing for all of the body's joints.
Financial calendar
| Interim report January–March 2017 | 19 May 2017 |
|---|---|
| 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 20 February 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