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Medistim

Earnings Release Oct 23, 2015

3662_rns_2015-10-23_a7ca3fbd-f903-4c34-a48b-4b2d1ccebdcd.pdf

Earnings Release

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  • Sales ended at MNOK 61.6 for the quarter (MNOK 52.0), an 18.5 % growth. Sales as of September increased by 18.9 % and ended at MOK 176.8 (MNOK 148.7).
  • Operating profit (EBIT) for the quarter ended at MNOK 12.7 (MNOK 10.0). Operating profit as of September ended at MNOK 34.3 (MNOK 28.9) after an accrual of MNOK 3.2 related to termination of the Medtronic agreement.
  • Profit per share increased with 32 % for the quarter and ended at NOK 0.57 (NOK 0.43). Accumulated profit per share was NOK 1.56 (NOK 1.12).
  • The positive development in USA continues with a currency neutral growth of 6.7 % for the quarter. Currency neutral growth as of September was 10.7 %.
  • Medistim introduced its new product within vascular surgery in the 3rd quarter.

3rd quarter 2015

FINANCIAL DEVELOPMENT

(Comparative numbers for 2014 in parenthesis)

Sales and geographic split

Sales in the 3rd quarter ended at MNOK 61.6 (MNOK 52.0), an 18.5 % increase. USA had a strong quarter with a 40.3 % growth in sales, while sales in Europe increased with 16.0 %. In Asia sales decreased with 14.4 % while in the rest of the world sales ended at the same level as last year. Asia and the Rest of the world are smaller regions and sales vary more per quarter.

Sales as of September increased with 18.9 % and ended at MNOK 176.8 (MNOK 148.7). There was a growth measured in NOK in all regions. In the US there was a 43.1 % growth. In Europe and Asia there was a growth of 11.6 % and 1.7 % respectively. In the Rest of the world there was an 8.0 % growth.

The effect from currency

With the same rates as in 2014 sales would have amounted to MNOK 55.7 for the quarter, a currency neutral growth of 7.1 %. Similar as of September would have resulted in sales of MNOK 160.1, a currency neutral growth of 7.6 %.

Split of own products and 3.party products.

Sales of own products amounted to MNOK 44.5 (MNOK 37.7). Sales of 3.party products ended at MNOK 17.1 (MNOK 14.3). As of September sales of own products ended at MNOK 121.6 (MNOK 103.2) and sales of 3.party products ended at MNOK 55.1 (MNOK 45.5)

Cost of goods sold

Cost of goods sold ended at MNOK 13.8 for the quarter (MNOK 12.8) and cost of goods sold represent a percentage of 22.4 % of total sales (24.7 %). As of September cost of goods sold ended at MNOK 44.5 (MNOK 38.1), which represent a percentage of 25.2 % ( 25.6 %).

Salary, social and other operating expenses

Salaries and social expenses ended at MNOK 21.3 (MNOK 17.9) for the quarter. Other operating expenses ended at MNOK 11.2 (MNOK 9.2) for the quarter.

As of September salaries and social expenses ended at MNOK 55.7 (MNOK 47.7). Other operating expenses ended at MNOK 31.2 (MNOK 27.9). The increase in expenses was mainly related to the increase of 5 sales representatives in the US and the enrolment of patients in the REQUEST study. The remaining increase in expenses was related to a weaker NOK against USD and EUR. MNOK 3.8 of the increase in salary expenses was related to a weaker NOK against USD and EUR. Equally for other operating expenses was MNOK 2.4.

R & D expenses

For the quarter MNOK 2.5 (MNOK 2.3) was used within research and development (R&D). Result before R & D, depreciations and write offs was MNOK 16.4 (MNOK 12.4). This equals a margin of 26.6 % (23.8 %). During the quarter MNOK 1.3 of the R & D expense was activated in the balance sheet (MNOK 2.0).

As of September MNOK 7.8 (MNOK 9.5) was used within research and development (R&D). Result before R & D, depreciations and write offs was MNOK 48.6 (MNOK 37.0). This equals a margin of 27.5 % (24.9 %). As of september MNOK 4.5 (MNOK 7.6) of the R & D expense was activated in the balance sheet.

Earnings

Operating profit before depreciation (EBITDA) for the quarter ended at MNOK 15.3 (MNOK 12.1). Operating profit before depreciation (EBITDA) as of September ended at MNOK 45.3 (MNOK 35.1).

Result before tax and finance (EBIT) ended at MNOK 12.7 (MNOK 10.0) for the quarter. As of September result before tax and finance (EBIT) ended at MNOK 34.3 (MNOK 28.9). During 2015 profit was charged with a provision of NOK 3.2 million. The provision was related to the termination of the distribution agreement Medistim Norway has with Medtronic. The accrual covers inventory write-downs and restructuring costs due to the lost agency.

Net finance ended positive with MNOK 1.6 for the quarter (MNOK 0.1).

As of September net finance ended positive with MNOK 4.2 (MNOK 0.3).

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 10.1) for the quarter. Result after tax for the quarter was MNOK 10.3 (MNOK 7.8).

As of September result before tax was MNOK 38.5 (MNOK 29.2). Result after tax as of September was MNOK 28.2 (MNOK 20.2).

Result per share for the quarter was NOK 0.57 (NOK 0.43). Result per share as of September was NOK 1.56 (NOK 1.12).

Average number of shares outstanding was 18.113.336 (18. 101.336) by end of September 2015.

Balance sheet

Equity by the end of September was MNOK 142.7 (MNOK 127.0). This equals an equity ratio of 71.0 % (69.9 %). A dividend of MNOK 25.4 was paid in May.

Cash as of 30th Compared to last year working capital has increased with MNOK 10.0. The reason for the increase in working capital is related to build up of component to the new productline MiraQ, while the VeriQ productline still needs to be maintained. Increased sales and securing critical components has also contributed to increased working capital. of September was MNOK 35.7 (MNOK 33.6) and the company had MNOK 12.8 in interest bearing debt.

In 2014 the company paid a dividend of MNOK 14.5 and increased its loan with MNOK 15. In 2015 the company paid a dividend of MNOK 25.3 and reduced long term debt with MNOK 5.3.

The balance sheet ended at MNOK 201.1 from MNOK 203.5 by the beginning of the year.

OPERATIONAL STATUS

Europe

In Europe there was a growth in both sales of own products and sales of 3.party products. 3. Party products increased with MNOK 2.8 or 19.5 %, while sales of own products ended at MNOK 17.1, a 12.7 % increase. As of September sales of 3.party products increased with MNOK 9.6, a 21.2 % increase. Sales of own products ended at MNOK 44.1, which represent a 1.5 % increase. Adjusted for currency sales decreased with 4.6 % as of September. The decrease is related to probe sales in Germany where probe usage was increased from 30 times to 50 times with effect from the 1st of January 2015.

In total for the first half there was sold 24 flow systems and 7 flow- and imaging systems. 12 of the flow systems sold were on the new platform MiraQ, and equally 5 of the flow- and imaging systems were on the new platform.

Introduction of new specialized product for vascular surgery

Medistim introduced in the quarter its new solution for vascular surgery during ESVS (European Society of Vascular Surgery). The congress gathers vascular surgeons from across Europe. At this congress Medistim presented its new system MiraQ Vascular together with new custom made flow probes that are specifically designed to meet the needs of intraoperative ultrasound guidance and quality assurance within vascular surgery. The system represents a new product line that is originated from the MiraQ platform. The first product line on this platform was MiraQ Cardiac, launched in October 2014. In addition to general improvements, the MiraQ Vascular product comes with specialized control panel, an application that is customized with a user interface adapted to the vascular surgeons needs, and new probes tailored for the vascular application areas.

The launch of the new vascular solution is in line with Medistims strategy, as stated earlier by the company. The

www.Medistim.com

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 20-25%, represent 700,000 procedures annually. Medistim estimate that the vascular market has an annual potential of NOK 1 billion. The company is well positioned in the vascular market in the Nordic countries and in Germany, but has so far only a modest coverage in the vascular segment in other countries.

There are many types of applications within vascular surgery. Key target segments for Medistim will be peripheral bypass surgery and carotid endarterectomy, where the global number of procedures performed per year is 200,000 and 225,000 respectively. Peripheral bypass surgery is performed primarily on the major arteries in the legs. Carotid endarterectomy is a procedure where blockages in the neck arteries surgically are removed to ensure fresh blood flow to the brain. The new MiraQ Vascular product support both type of interventions using ultrasound imaging and blood flow measurements to guide the surgeon during the procedure and to quality assure clinical outcome.

USA

Medistim has a business model in the US that is mainly based upon sales of procedures and not capital sale as in other markets.

The US had a strong third quarter and sale increased with 40.3 % compared to last year. Currency neutral growth was 6.7 %. For the quarter there was sold 10.936 procedures compared to last year 9.153. During the quarter 1.297 (862) procedures was sold to customers using the imaging system VeriQ C. Further, 9.639 flow procedures were sold (8.291) which represent an increase of respectively 50.5 % and 16.3 %. Sales increased with 43 % as of September 2015. The currency neutral growth was 10.7 %. As of September there were sold 30.258 procedures (26.327) of which 3.160 were imaging procedures (2.180) and 27.098 flow procedures (24.147).

Number of procedures sold per quarter in the US

This is the sixth quarter in a row with solid growth in the US market. The targeted initiatives to increase usage by existing customers and the capture of new customers have given the expected positive effect. The development is positive and according to the company's ambition in the US market.

Based on the positive trend, the company announced during the quarter that it has decided to expand its US operations. The company has hired 5 new sales representatives and is thereby increasing its capacity from 13 to 18 sales reps. The company consider 2015 as a training period for new sales resources and expect to see positive results on sales performance in 2016.

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 14.0 % of the total market of approximately 230.000 bypass surgery procedures performed annually.

Asia

In Asia there was a decrease in sales for the quarter with 14.4 %, while as of September the sales was at the same level as last year. The reduction for the quarter was related to lower sales of flowsystems. Sales of flow and imaging systems were at the same level as last year.

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

In other markets sales for the quarter was at the same level as last year. As of September sales increased with 8.0 %. Of the total of 13 systems sold in as of September, 8 of the systems was on the new platform MiraQ.

Compare to the total these are marginal markets that have little effect on the total sales.

CLINICAL TRIALS

REQUEST, a multicenter registry study

As previously annonced, Medistim is sponsoring the REQUEST1) register study with 1 million EUR. This prospective, multicenter, registry study of about 1,000 patients will provide new data on how the use of Medistim's devices for flow measurement and intraoperative imaging can be employed to optimize decision making during coronary artery bypass grafting (CABG) and become routine clinical practice. Such data have so far never been recorded and analyzed. The study could be groundbreaking for an increased acceptance and use of the combined blood flow measurement and ultrasound imaging during cardiac bypass surgery.

The objective with the study is to establish a consensus for a recommended workflow to optimize decision making during CABG, and hopefully, gain guideline endorsements for such use of flow measurement and imaging data, in the USA as well as other countries.

As of September the study is progressing according to plan and data from 100 patient was registered. The expenses related to the study by the end of September was MNOK 1,5. This includes start up expenses for the project.

1) Registery for Quality assESmenT with Ultrasound Imaging and TTFM in cardiac bypass surgery

R & D

Products within vascular surgery

Medistim has in 2015 focused its development efforts towards vascular surgery based upon the new MiraQ™ platform. The new product was introduced in the 3rd quarter and is already decribed under operational status.

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 measurements and intraoperative ultrasound imaging are performed on all patients.

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 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 33 % 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. 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, with America's health care reform as very important. 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 1.5 million patients worldwide since it came on the market, and the company is the clear leader in its niche. The equipment is used today in more than 25 % of the total number of by-pass surgeries performed worldwide.

Accumulated sales per quarter

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 7 % of the procedures performed. This means that in about 70 % 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 2015 a 10 % change in the exchange rate against USD and EUR would result in a 6.9 % change in sales and a 21.5 % change in operating result. The company partly secures its positions with hedging contracts.

SHARHOLDER AFFAIRS

The company had 221.000 Medistim shares by the end of September 2015. The shares were purchased at a price per share of NOK 15.02. The share price was NOK 46.00 per share at the end of the quarter. By year end 2014 the share price was NOK 27.50 per share.

The number of shares traded as of September 2015 was 1.973.461. The five largest shareholders by the end of September were Intertrade Shipping AS with 3.850.000 shares, Salvesen & Thams Invest with 1.862.500 shares, Stenshagen Invest AS with 1.526.123 shares, Skagen Vekst with 1.265.625 shares and Follum Capital with 1.000.000 Shares.

Accumulated operating profit per quarter

A MNOK 3.2 accrual related to Medtronic was booked in the Q2 results.

Oslo 22end Board of Directors and managing director in Medistim ASA of October 2015,

Profit & loss 3. quarter 15 3. quarter 14 As of 30.09.15 As of 30.09.14 2014
All numbers in NOK 1000
Sales 61 646 51 999 176 807 148 724 214 817
Cost of goods sold 13 796 12 839 44 562 38 143 55 571
Salary and sosial expenses 21 347 17 930 55 724 47 652 69 175
Other operating expenses 11 175 9 156 31 180 27 855 38 449
Total operating expenses 46 318 39 925 131 466 113 650 163 195
Opr. res.before. depr. and write offs 15 328 12 074 45 341 35 074 51 622
EBITDA % 24,9 % 23,2 % 25,6 % 23,6 % 24,0 %
Depreciation 2 670 2 052 7 872 6 161 8 260
Write offs and accruals - - 3 200 - -
Operating result 12 658 10 022 34 269 28 913 43 362
EBIT % 20,5 % 19,3 % 19,4 % 19,4 % 20,2 %
Financial income 2 517 1 751 13 637 5 292 9 495
Financial expenses 952 1 698 9 439 4 967 7 964
Net finance 1 565 53 4 198 325 1 531
Pre tax profit 14 224 10 075 38 467 29 237 44 892
Tax 3 906 2 248 10 272 9 049 13 647
Result 10 317 7 827 28 195 20 188 31 245
Dividend - - 25 362 14 481 14 481
Comprehensive income
Result after tax 10 317 7 827 28 195 20 188 31 245
Exchange differences arising
on translation of foreign operations (113) (163) 444 (316) 697
Total comprehensive income 10 204 7 664 28 639 19 872 31 942
Key figures 3. quarter 15 3. quarter 14 As of 30.09.15 As of 30.09.14 2014
Equity share 71,0 % 69,9 % 71,0 % 69,9 % 68,4 %
Earnings per share 0,57 0,43 1,56 1,12 1,73
Earnings per share diluted kr 0,57 kr 0,43 kr 1,56 kr 1,12 kr 1,73
Average shares outstanding in 1000 18 116 18 101 18 113 18 101 18 101
Average shares outstanding in 1000 diluted 18 116 18 101 18 113 18 101 18 101
Split of operating profit
per segment 3. quarter 15 3. quarter 14 As of 30.09.15 As of 30.09.14 2014
All numbers in NOK 1000
Res from Medistim products 10 128 9 469 28 229 23 672 35 590
Margin Medistim products 22,8 % 25,1 % 23,2 % 22,9 % 23,8 %
Res from 3rd party products 2 530 553 6 040 5 241 7 772
Margin 3rd party products 14,8 % 3,9 % 10,9 % 11,5 % 11,9 %
Totalt result 12 658 10 022 34 269 28 913 43 362
Margin 20,5 % 19,3 % 19,4 % 19,4 % 20,2 %
Balance sheet 30.09.2015 30.09.2014 31.12.2014
All numbers in NOK 1000
Assets
Intangible assets 53 394 52 303 53 257
Fixed assets 14 804 13 204 15 276
Total tangible and fixed assets 68 198 65 507 68 533
Inventory 48 250 37 850 36 874
Customers receivables 40 861 37 055 39 948
Other receivables 7 980 7 709 8 658
Cash 35 702 33 646 49 475
Total current assets 132 792 116 261 134 955
Total assets 200 990 181 768 203 488
Equity and liability
Share capital 4 585 4 585 4 585
Share premium reserve 41 852 41 852 41 852
Other equity 96 236 80 593 92 659
Total equity 142 673 127 030 139 097
Pension liability - - -
Deferred income 1 550 2 248 2 074
Other long term debt 5 731 12 794 11 043
Total long term debt 7 280 15 042 13 117
Total short term debt 51 036 39 696 51 275
Total equity and liability 200 990 181 768 203 488
Net interest bearing debt (13 770) (20 852) (11 533)
Change in equity 30.09.2015 30.09.2014 31.12.2014
All numbers in NOK 1000
Equity start of period 139 097 121 635 121 635
Result for the period 28 195 20 188 31 245
Dividend (25 362) (14 481) (14 481)
Medi-Stim shares 300 - -
Changes in exchangerates 444 (312) 697
Equity end of period 142 673 127 030 139 097
Cash flow analysis 30.09.2015 30.09.2014 31.12.2014
All numbers in NOK 1000
Result for the period 28 195 20 188 31 245
Cash flow from operation (3 930) 6 124 16 562
Cash flow from operation 24 265 26 313 47 808
Cash flow from investments (7 365) (9 594) (13 490)
Cash flow from financial activities (30 673) (2 918) (4 689)
Change in cash for the period (13 773) 13 801 29 629
Cash at start of period 49 475 19 846 19 846
Cash by the end of period 35 702 33 646 49 475
Geographic split of sales 3. quarter 15 3. quarter 14 As of 30.09.15 As of 30.09.14 2014
All numbers in NOK 1000
USA 19 806 14 119 56 351 39 368 56 539
Asia 4 833 5 646 13 569 13 339 18 730
Europe 34 234 29 506 99 247 88 942 128 768
Rest of the world 2 773 2 728 7 640 7 075 10 780
Total sales 61 646 51 999 176 807 148 724 214 817
Geographic split
of sales in number of units 3. quarter 15 3. quarter 14 As of 30.09.15 As of 30.09.14 2014
USA
Procedures flow measurement 9 639 8 291 27 098 24 147 32 734
Procedures imaging and flow 1 297 862 3 160 2 180 3 238
Capital sales VeriQ flowmeasurement instrument 1 1 3 4 5
Capital sales VeriQC imaging and flowmeasuremen 1 2 4 5 8
Asia
MiraQ and VeriQ flowmeasurement instrument 7 11 21 24 34
MiraQ and VeriQC imaging and flowmeasurement in 5 4 8 8 12
Imaging probes 4 5 16 12 16
Flowmeasurement probes 271 317 877 852 1 133
Europe
MiraQ and VeriQ flowmeasurement instrument 11 7 24 24 44
MiraQ and VeriQC imaging and flowmeasurement in 4 6 7 12 23
Imaging probes 5 6 13 14 24
Flowmeasurement probes 916 1 191 2 849 3 385 4 601
Rest of the world
MiraQ and VeriQ flowmeasurement instrument 2 3 5 8 8
MiraQ and VeriQC imaging and flowmeasurement in 2 - 13 3 8
Imaging probes 8 - 13 3 5
Flowmeasurement probes 216 317 501 627 801
Total sales outside the US in units
Number of MiraQ and VeriQ flow instruments ou 20 21 50 56 86
MiraQ and VeriQC imaging and flowmeasuremen 11 10 28 23 43
Total number of imaging probes 17 11 42 29 45
Total number of flowmeasurement probes outsi 1 403 1 825 4 227 4 864 6 535
Split of sales per segment 3. quarter 15 3. quarter 14 As of 30.09.15 As of 30.09.14 2014
All numbers in NOK 1000
USA
Procedural revenue 18 434 12 258 51 708 34 335 48 328
Capital sales VeriQ flowmeasurement instruments 297 303 1 171 1 584 1 788
Capital sales VeriQC imaging and flowmeasuremen 1 076 1 559 3 472 3 449 6 423
Outside USA
MiraQ and VeriQ flowmeasurement instrument 2 796 3 217 8 060 8 862 15 224
MiraQ and VeriQC imaging and flowmeasurement in 5 130 3 474 9 491 7 979 13 394
Imaging probes 942 515 2 102 1 396 2 385
Flowmeasurement probes 15 407 16 062 44 188 44 362 61 564
Other 430 274 1 450 1 237 527
Total sale of Medistim products 44 511 37 662 121 642 103 204 149 633
Sale of 3 party products 17 135 14 337 55 165 45 520 65 184
Total sales 61 646 51 999 176 807 148 724 214 817

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