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Medistim

Quarterly Report Oct 25, 2018

3662_rns_2018-10-25_ed2b0d3b-d095-4e3f-876b-baf6233d578f.pdf

Quarterly Report

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  • Sales ended at MNOK 77.6 for the quarter (MNOK 75.7), a 2.5 % growth. Sales as of September increased by 4.0 % and ended at MOK 228.0 (MNOK 219.2)
  • Revenue from own products showed a currency neutral decline of 0.4 % for the quarter and a currency neutral growth of 4.2 % YTD
  • Operating profit (EBIT) for the quarter ended at MNOK 14.5 (MNOK 19.4). Operating profit as of September ended at MNOK 46.2 (MNOK 49.1)
  • Solid growth in system sales that creates the basis for future probe revenue. Number units year to date increases with 25.0 %
  • The final results from the REQUEST study was presented during EACTS in Milano. The study confirms the value of the combined use of flow and imaging.

3rd quarter 2018

FINANCIAL DEVELOPMENT (Comparative numbers for 2017 in parenthesis)

Sales and geographic split

Sales in the 3rd quarter ended at MNOK 77.6 (MNOK 75.7), a 2.5 % increase. In the largest regions, Europe and USA, there where growth in sales in NOK with 2.0 % and 0.6 % respectively. In Asia sales decreased with 14.8 %, while "the rest of the world" increased with 65.5 %. Both Asia and "the rest of the world" are smaller regions for Medistim with larger variations per quarter.

Sales as of September increased with 4.0 % and ended at MNOK 228.0 (MNOK 219.2). There was a growth measured in NOK in all regions except in the USA. In USA there was a decline measured in NOK of 3.5 %. Currency neutral growth USA was 0.0 %. In Europe and Asia there was a growth of 5.2 % and 16.6 % respectively. In the rest of the world there was a decrease of 20.3 %, which in NOK amounted to MNOK 2.1.

The effect from currency

With the same rates as in 2017 sales would have amounted to MNOK 77.4 for the quarter, a currency neutral growth of 2.2 %. Similar as of September would have resulted in sales of MNOK 226.8, a currency neutral growth of 3.5 %.

Split of own products and 3.party products.

Sales of own products amounted to MNOK 59.2 (MNOK 59.4). Sales of 3.party products ended at MNOK 18.4 (MNOK 16.3). As of September sales of own products ended at MNOK 173.4 (MNOK 165.3) and sales of 3.party products ended at MNOK 54.5 (MNOK 53.9).

For sales of own products in the third quarter MNOK 52.1 was sales within the cardiac segment, while MNOK 7.1 was sales to the vascular segment, so the vascular segment represented 12.0 % of sales of own products. Similar percentage year to date was 14.6 % towards the vascular segment.

Cost of goods sold

Cost of goods sold ended at MNOK 21.5 for the quarter (MNOK 15.3) and cost of goods sold represent a percentage of 27.7 % of total sales (20.2 %). As of September cost of goods sold ended at MNOK 58.4 (MNOK 52.6), which represent a percentage of 25.6 % (23.8 %). The main reason for the higher level of cost of goods sold was related to higher level of sales of third party products. In addition there was a lower margin on the third party products compared to last year. Also, product mix of own products, sales through direct channel or through distributors and a new more expensive flow probe also affects the cost of goods sold.

Salary, social and other operating expenses

Salaries and social expenses ended at MNOK 26.9 (MNOK 27.0) for the quarter. Other operating expenses ended at MNOK 11.6 (MNOK 10.6) for the quarter. As of September salaries and social expenses ended at MNOK 74.5 (MNOK 71.6). Other operating expenses ended at MNOK 39.6 (MNOK 36.6). The increase in salary expenses was related to the increased production capacity throughout 2017. The increase in other expenses was in relation to recruitment, development expenses and increased IT expenses.

R & D expenses

For the quarter MNOK 2.6 (MNOK 2.1) was used within research and development (R&D). Result before R & D, depreciations and write offs was MNOK 19.6 (MNOK 25.0). This equals a margin of 25.2 % (33.0 %). During the quarter MNOK 0.7 of the R & D expense was activated in the balance sheet (MNOK 0.0).

As of September MNOK 7.0 (MNOK 6.2) was used within research and development (R&D). Result before R & D, depreciations and write offs was MNOK 60.0 (MNOK 64.6). This equals a margin of 26.3 % (29.5 %). As of September MNOK 2.4 (MNOK 1.0) of the R & D expense was activated in the balance sheet.

Earnings

Operating profit before depreciation (EBITDA) for the quarter ended at MNOK 17.6 (MNOK 22.8). Operating profit before depreciation (EBITDA) as of September ended at MNOK 55.5 (MNOK 58.8).

Result before tax and finance (EBIT) ended at MNOK 14.5 (MNOK 19.4) for the quarter. As of September result before tax and finance (EBIT) ended at MNOK 46.2 (MNOK 49.1).

Net finance ended negative with MNOK 0.3 for the quarter (negative MNOK 1.5).

As of September net finance ended negative with MNOK 2.1 (negative MNOK 0.8).

Net finance was related to realized and unrealized gains or losses related to currency, hedging contracts, cash in USD and EUR and customer receivables.

Result before tax was MNOK 14.2 (MNOK 17.9) for the quarter. Result after tax for the quarter was MNOK 11.0 (MNOK 13.4).

As of September result before tax was MNOK 44.1 (MNOK 48.3). Result after tax as of September was MNOK 33.2 (MNOK 35.1).

Result per share for the quarter was NOK 0.61 (NOK 0.74). Result per share as of September was NOK 1.82 (NOK 1.93).

Average number of shares outstanding was 18.178.836 (18. 161.336) by end of September 2017.

Balance sheet

Equity by the end of September was MNOK 180.3 (MNOK 169.2). This equals an equity ratio of 77.1 % (74.4 %).

Cash as of 30th of September was MNOK 35.7 (MNOK 27.7) and the company had MNOK 11.2 in interest bearing debt. A dividend of MNOK 36.4 was paid in May.

The balance sheet ended at MNOK 233.3, a reduction of MNOK 17.8 from MNOK 251.1 by the beginning of the year.

OPERATIONAL STATUS

Europe

In Europe there was an increase in sales of 2.0 % The growth was driven by a 13.1 % increase in 3.party products or MNOK 2.1. Own products ended down MNOK 1.4 or 9.0 %.

As of September sales of 3.party products increased with MNOK 0.6, or 1.2 %. Sales of own products ended at MNOK 61.5, which represent an 8.3 % increase or MNOK 5.1.

USA

Medistim has a business model in the US that is mainly based upon a leasing model and sale of procedures, but also offer capital sale as in other markets.

The US ended the third quarter with an increase in sales in NOK of 0.6 % compared to last year. Currency neutral sales declined 1.8 %. For the quarter there was sold 13.222 procedures compared to last year 13.351. During the quarter 1.847 (1.608) procedures was sold to customers using the imaging system. Further, 11.375 flow procedures were sold (11.743) during the quarter.

Sales in NOK decreased with 3.5 % as of September 2018. Currency neutral sales was at the same level as last year. As of September there were sold 38.215 procedures (36.845) of which 5.110 were imaging procedures (4.658) and 33.105 flow procedures (32.178).

In the US about 80 % of the bypass surgeries are performed with no other quality assurance of blood flow other than the surgeons experience by feeling pulse on the vessels using the finger. It is clinically proven that this method is not reliable. It is therefore a large potential and need for Medistims products in the US. Medistim has large ambitions in the US market. So far Medistim has achieved a market penetration of more than 18.0 % of the total market of approximately 240.000 bypass surgery procedures performed annually. Medistim has a market penetration of about 70-80 % in Germany, Scandinavia and Japan. Medistim expect that the market penetration in the US will develop in the same manner over time.

Number of procedures sold per quarter in the US

Asia

In Asia there was an decrease in sales for the quarter with 14.8 %, while as of September sales increased with 16.6 %. The number of flow- and the combined flow and ultrasound imaging systems sold in Asia in 2018 has had a solid growth with 58 % and 38 % respectively. The systems sales creates the basis for future sale of consumables like flow probes and imaging probes.

Other markets (Middle-East, Africa, South America and Canada)

In other markets sales for the third quarter increased with 65.5 %. Year to date sales increased with 20 %. In total this is marginal markets that have little effect on the total sales, and where quarterly sales vary.

In general for all markets

In general, there has for all markets been a positive development in system sales. For the quarter number of systems increased with 36.7 %, while so far this year the increase was 25.0 %. The system sales form the basis for future probe revenue of both flow probes and imaging probes. Of Medistims own products probe sales represent 55 % og annual revenue.

Clinical studies

The REQUEST study:

the final results from the REQUEST registry study was presented at the European Association of Cardiothoracic Surgery (EACTS) annual conference in Milan, Italy, on the 20th of October. The final results confirm earlier indications from the study.

The objective for the REQUEST study is to document how often the combination of high-frequency ultrasound imaging (HFUS) and transit time flow measurement (TTFM) performed with Medistim's VeriQ C or MiraQ devices will change the surgical procedure. The REQUEST surgical coronary artery bypass grafting (CABG) protocol includes ultrasound scanning of the aorta, conduits, target coronary

vessels and anastomoses, as well as TTFM graft assessment.

The final results, after more than 1000 patients where included, showed that 25 % of the patient population had one or more surgical changes made to the surgical strategy based on imaging and flow data. Of the sub-populations that went through aorta scanning and coronary target scanning, 10 % and 20 % of the patients had changes in the surgical strategy, respectively. Graft assessment with TTFM was performed in 99 % of the patients, with a result of 3 % anastomotic revision rate in 7 % of the patients. These results may be compared with previously published data showing about 4-5 % anastomotic revision rate in about 10 % of the patients.

Furthermore, the in-hospital outcomes showed a remarkably low mortality rate of 0.6 % and stroke/TIArate of 1 %.

Medistim's interest in this study has been to investigate and document the clinical value of the combined use of TTFM and HFUS. With these final results, the REQUEST study has provided new insights that may positively impact clinical outcomes and change clinical practice going forward. The data will support initiatives for further guideline recommendations as well as reimbursement.

The CIDAC study:

During the quarter Medistim followed up its vascular opportunity and participated at the ESVS (European Society of Vascular Surgery). During this exhibition, a vascular study from the University hospital in Munich was presented. The study were performed and presented by C Knappic, A. Zimmernann and HH Eckstein. The purpose of the study was to compare the use of angiogram and Medistims ultrasound imaging capability when performing carotid endarterectomy. This is a type of procedure where a stenosis inside the carotid artery is removed surgically.150 patients was included in the study and it concluded that Medistims ultrasound imaging capabilities improved reliability and images. This resulted in improved outcome for the patients. The published study is yet to come. The global vascular market represents a significant opportunity for Medistim and is estimated to represent approximately 600,000 procedures annually. In comparison, cardiac bypass surgery, a segment where Medistim has its strongest position with a global market penetration of about 25 %, represent 700,000 procedures annually.

PROSPECTS AND TRENDS

Goals and vision

The company aims to develop products to meet surgeons' growing need for quality control of heart-bypass surgery, peripheral vascular surgery and transplant surgery. Our vision is that Medistim's solutions should represent the «standard of care» for clinical practice and that blood flow

Strategy

Medistim's focus is to strengthen the company's ability to effectively commercialize existing product portfolio on a global basis. One of the key tasks to achieve this is closer contact with customers through a strengthened sales and marketing organization. Another important task is to produce enhanced clinical documentation and focus on putting blood flow measurements, ultrasound imaging, surgical guidance and quality assurance on the agenda in relevant forums and channels.

Continious technology and product development will secure Medistims products and leading position within cardiac surgery also in the future. The company also has ambitions to launch new products adapted to specialities within vascular- and transplant surgery.

Market size and trends

On a global basis it is performed more than 700,000 heart bypass surgeries per year. The US represents the largest market for Medistims products with 1/3 of the world market. The global number of procedures has in the past been constant. The decrease in number of procedures perfomed in the western countries has been compensated by an increase in the BRIC countries (Brazil, Russia, India and China). It is therefore expected to have a stabil growing trend in the years to come.

Adding intraoperative ultrasound imaging to flow measurements more than doubles Medistims market potential, because of new applications and relevance and higher pricing compared to traditional flowmeasurement technollogy. Total market size within cardiac surgery is estimated to be 2 billion NOK annualy. The imagingfunctionallity makes MiraQTM and VeriQC relevant in other cardiac surgeries and not just by pass surgery. Medistim estimates this potential to be 1 billion NOK.

In addition, the company has a significant potential within the global vascular market, which is estimated to be about 600,000 vascular procedures annually. Total market size within vascular surgery is estimated to be over 1 billion NOK.

The trend in surgery moves towards less intervention and keyhole surgery, which gives the surgeon less workspace and the ability to control in a traditional way. It is therefore an increased need to verify the desired result in the future.

Global demographic trends are an important driving force for the many cost-efficiency measures around the world. Focus on quality is growing, driven by the need to reduce costs, particularly related to correction of errors, the need for repeated treatments and repeated hospital admissions. Medistim therefore has a good opportunity to position their

products as an important contributor to achieving these goals.

Position and Competition

Medistim's flow meters have been in use in more than 2.0 million patients worldwide since it came on the market, and the company is the clear leader in its niche. In total Medistim has installed 2500 systems in more than 60 countries. The equipment is used today in more than 32 % of the total number of by-pass surgeries performed worldwide. Medistims penetration and market share is expected to increase gradually as quality assurance in surgery is getting more attention and acceptance.

There are competitors that use the transit time measurement principle. Equipment from competitors is estimated to be in use in about 5 % of the procedures performed. This means that in about 65 % of the cases where by pass surgery is performed there is no equipment in use to verify blood flow. This market represent Medistim's largest opportunity.

With Medistim's Ultrasound imaging technollogy and MiraQTM platform, the company has acquired a new edge compared to competitors, with unique and differentiated products that is currently alone in its segment.

Exposure towards currency

The company is exposed to EUR and USD. Exposure can vary depending on how large share of revenues and costs USD and EUR account for of total income and expenses. For 2018 a 10 % change in the exchange rate against USD and EUR would result in a 7.6 % change in sales and a 17.9 % change in operating result. The company partly secures its positions with hedging contracts.

SHARHOLDER AFFAIRS

The company had 158.500 Medistim shares by the end of September 2018. The shares were purchased at a price per share of NOK 14.67. The share price was NOK 79.40 per share at the end of the quarter. The number of shares traded as of September 2018 was 4.399.864. The five largest shareholders by the end of September 2018 were Intertrade Shipping AS with 4.003.500 shares, Salvesen & Thams Invest with 1.862.500 shares, Swedbank Robur with 1.376.596 shares, Skandinaviska Enskilda med 1.034.379 shares and Follum Capital with 1.000.000 shares.

Accumulated sales per quarter

Accumulated operating profit per quarter

Oslo 24th of October 2018, Board of Directors and managing director in Medistim ASA

Profit & loss 3. quarter 18 3. quarter 17 As of 30.09.18 As of 30.09.17 2017
All numbers in NOK 1000
Sales 77 613 75 694 227 967 219 231 301 461
Cost of goods sold 21 521 15 321 58 382 52 206 72 782
Salary and sosial expenses 26 907 26 998 74 523 71 561 98 281
Other operating expenses 11 605 10 588 39 599 36 633 51 705
Total operating expenses 38 512 37 586 114 121 108 195 149 986
Opr. res.before. depr. and write offs 17 579 22 788 55 464 58 831 78 693
EBITDA % 22,7 % 30,1 % 24,3 % 26,8 % 26,1 %
Depreciation 3 070 3 358 9 240 9 729 13 223
Operating result 14 510 19 430 46 223 49 102 65 470
EBIT % 18,7 % 25,7 % 20,3 % 22,4 % 21,7 %
Financial income 1 425 1 494 4 179 5 327 8 838
Financial expenses 1 758 2 993 6 265 6 161 7 696
Net finance (333) (1 499) (2 085) (834) 1 142
Pre tax profit 14 177 17 931 44 138 48 269 66 612
Tax 3 151 4 514 10 974 13 171 19 038
Result 11 026 13 417 33 164 35 097 47 574
Dividend - - 31 782 29 950 29 950
Comprehensive income
Result after tax 11 026 13 417 33 164 35 097 47 574
Exchange differences arising - - - - -
on translation of foreign operations 188 (548) - (824) (223)
Total comprehensive income 11 214 12 869 33 164 34 273 47 351
Key figures 3. quarter 18 3. quarter 17 As of 30.09.18 As of 30.09.17 2017
Equity share 77,1 % 74,4 % 77,1 % 74,4 % 72,9 %
Earnings per share 0,61 0,74 1,82 1,93 2,62
Earnings per share diluted kr 0,61 kr 0,74 kr 1,82 kr 1,93 kr 2,62
Average shares outstanding in 1000 18 179 18 161 18 178 18 161 18 161
Average shares outstanding in 1000 diluted 18 179 18 161 18 178 18 161 18 161
Split of operating profit
per segment 3. quarter 18 3. quarter 17 As of 30.09.18 As of 30.09.17 2017
All numbers in NOK 1000
Res from Medistim products 13 627 17 938 40 650 41 948 56 293
Margin Medistim products 23,0 % 30,2 % 23,4 % 25,4 % 24,5 %
Res from 3rd party products 883 1 492 5 573 7 154 9 177
Margin 3rd party products 4,8 % 9,2 % 10,2 % 13,3 % 12,8 %
Totalt result 14 510 19 430 46 223 49 102 65 470
Margin 18,7 % 25,7 % 20,3 % 22,4 % 21,7 %
Balance sheet 30.09.2018 30.09.2017 31.12.2017
All numbers in NOK 1000
Assets
Intangible assets 42 609 46 335 45 090
Fixed assets 29 205 23 033 25 744
Total tangible and fixed assets 71 814 69 368 70 834
Inventory 58 786 62 136 62 722
Customers receivables 57 968 59 199 57 307
Other receivables 9 588 8 847 5 825
Cash 35 658 27 718 54 411
Total current assets 162 000 157 900 180 265
Total assets 233 814 227 268 251 099
Equity and liability
Share capital 4 585 4 585 4 585
Share premium reserve 41 852 41 852 44 172
Other equity 133 849 122 758 134 226
Total equity 180 286 169 195 182 984
Deferred income 0 153 0
Other long term debt 8 250 11 250 10 500
Total long term debt 8 250 11 403 10 500
Total short term debt 45 278 46 670 57 616
Total equity and liability 233 814 227 268 251 099
Net interest bearing debt (24 408) (10 656) (39 036)
Change in equity 30.09.2018 30.09.2017 31.12.2017
All numbers in NOK 1000
Equity start of period 182 984 166 703 166 703
Result for the period 33 164 35 097 47 574
Dividend (36 358) (31 782) (31 782)
Medistim shares - - 711
Changes in exchangerates 497 (824) (223)
Equity end of period 180 286 169 195 182 984
Cash flow analysis 30.09.2018 30.09.2017 31.12.2017
All numbers in NOK 1000
Result for the period 33 164 35 097 47 574
Cash flow from operation (2 839) (10 228) 12 339
Cash flow from operation 30 325 24 869 59 913
Cash flow from investments (8 596) (7 121) (14 291)
Cash flow from financial activities (40 482) (21 095) (22 276)
- - -
Change in cash for the period (18 753) (3 347) 23 346
- - -
Cash at start of period 54 411 31 065 31 065
Cash by the end of period 35 658 27 718 54 411
Geographic split of sales 3. quarter 18 3. quarter 17 As of 30.09.18 As of 30.09.17 2017
All numbers in NOK 1000
USA 27 482 27 319 74 358 77 072 104 590
Asia 6 974 8 182 24 801 21 271 26 954
Europe 37 542 36 801 116 061 110 292 150 317
Rest of the world 5 615 3 392 12 747 10 596 19 600
Total sales 77 613 75 694 227 967 219 231 301 461
Geographic split
of sales in number of units 3. quarter 18 3. quarter 17 As of 30.09.18 As of 30.09.17 2017
USA
Procedures flow measurement 11 375 11 743 33 105 32 187 43 957
Procedures imaging and flow 1 847 1 608 5 110 4 658 6 843
Capital sales MiraQ and VeriQ flowmeasurement instrumen 6 4 10 6 17
Capital sales MiraQ and VeriQC imaging and flowmeasurem 2 3 5 9 11
Lease flow instrument 2 5 9 7 8
Lease imaging and flow instrument 1 - 2 3 5
Asia
MiraQ and VeriQ flowmeasurement instrument 9 2 30 19 23
MiraQ and VeriQC imaging and flowmeasurement instrume 4 6 18 13 16
Imaging probes 5 7 15 12 16
Flowmeasurement probes 325 502 1 042 1 299 1 666
Europe
MiraQ and VeriQ flowmeasurement instrument 10 5 28 23 41
MiraQ and VeriQC imaging and flowmeasurement instrume 2 7 9 13 17
Imaging probes 7 7 15 23 36
Flowmeasurement probes 933 1 078 3 160 2 944 4 057
Rest of the world
MiraQ and VeriQ flowmeasurement instrument 3 1 11 9 14
MiraQ and VeriQC imaging and flowmeasurement instrume 5 2 9 4 12
Imaging probes 4 3 9 6 12
Flowmeasurement probes 260 148 522 470 915
Total sales outside the US in units
Number of MiraQ and VeriQ flow instruments outside USA 22 8 69 51 78
MiraQ and VeriQC imaging and flowmeasurement instrum 11 15 36 30 45
Total number of imaging probes 16 17 39 41 64
Total number of flowmeasurement probes outside USA 1 518 1 728 4 724 4 713 6 638
Split of sales per segment 3. quarter 18 3. quarter 17 As of 30.09.18 As of 30.09.17 2017
All numbers in NOK 1000
USA
Procedural revenue flow 16 603 17 728 51 309 54 842 73 609
Procedural revenue Imaging and flow 4 127 3 577 10 608 9 534 12 412
Capital sales MiraQ and VeriQ flowmeasurement instrumen 4 700 2 722 7 420 3 651 7 564
Capital sales MiraQ and VeriQC imaging and flowmeasure 2 051 3 292 5 022 9 046 11 006
Outside USA
MiraQ and VeriQ flowmeasurement instrument 6 296 1 757 17 326 10 253 15 770
MiraQ and VeriQC imaging and flowmeasurement instrume 4 899 6 517 15 732 14 253 20 976
Imaging probes 853 919 2 368 2 716 4 177
Flowmeasurement probes 18 890 21 101 60 710 55 923 78 850
Other 800 1 823 2 920 5 117 5 407
Total sale of Medistim products 59 220 59 437 173 414 165 334 229 771
Sale of 3 party products 18 393 16 256 54 553 53 897 71 690
Total sales 77 613 75 693 227 967 219 231 301 461
Split of sales between coronary
and vascular surgery and 3 party products 3. quarter 18 3. quarter 17 As of 30.09.18 As of 30.09.17 2017
All numbers in NOK 1000
Sales within coronary surgery 52 102 51 195 148 012 139 779 196 138
Sales within vascular surgery 7 118 8 242 25 402 25 555 33 633
Sales of 3. party products 18 393 16 256 54 553 53 897 71 690
Total sales 77 613 75 693 227 967 219 231 301 461

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