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Medistim

Earnings Release Oct 23, 2015

3662_rns_2015-10-23_291770c5-519c-4187-8db2-521b34517cbd.pdf

Earnings Release

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Medistim ASA Third Quarter 2015

Kari E. Krogstad, President and CEO Thomas Jakobsen, CFO October 23rd, 2015

Disclaimer

The information included in this Presentation contains certain forward-looking statements that address activities, events or developments that Medistim ASA ("the Company") expects, projects, believes or anticipates will or may occur in the future. These statements are based on various assumptions made by the Company, which are beyond its control and are subject to certain additional risks and uncertainties. The Company is subject to a large number of risk factors including but not limited to economic and market conditions in the geographic areas and markets where Medistim is or will be operating, IP risks, clinical development risks, regulatory risks, fluctuations in currency exchange rates, and changes in governmental regulations. For a further description of other relevant risk factors we refer to Medistim's Annual Report for 2014. As a result of these and other risk factors, actual events and our actual results may differ materially from those indicated in or implied by such forward-looking statements. The reservation is also made that inaccuracies or mistakes may occur in this information given above about current status of the Company or its business. Any reliance on the information above is at the risk of the reader, and Medistim disclaims any an all liability in this respect.

Table of contents

    1. Highlights third quarter
    1. Financial statements
    1. Business segments update
    1. Implementing the strategy

1. Highlights third quarter

Highlights third quarter 2015

Q3 2015 Q o Q

Double digit growth in the third quarter
Strong development in the USA continues, with
o
40.3 % revenue growth in NOK, 6.7 % in USD
Sale of 3.party products up 19.5 % to MNOK 17.1
o
Revenue
MNOK 61.6 (52.0)
18.5%

Strong EBIT growth to MNOK 12.7 for the quarter
YTD, EBIT is MNOK 34.4 (MNOK 28.9)
o
EBIT
MNOK 12.7 (10.0)
26.3 %

Profit per share increased with 32 % for the quarter to NOK
0.57 per share
Currency 11.4 %

Launch of MiraQ
Vascular, the new product for use in vascular
No of
units
sold:
surgery, at the European Society of Vascular Surgery meeting Systems 33 -5,7 %

Medistim enters into strategic partnership with em-tec
Flow
probes
1 403
-23.1 %
Imaging
probes
24
60.0 %
Procedures
(USA) 10 936
19.5 %

2. Financial statements

Profit and loss Q3 2015

Profit & loss Q3 2015 Q3 2014
All numbers in NOK 1000
Sales 61 646 51 999
Cost of goods sold 13 796 12 839
Salary and sosial expenses 21 347 17 930
Other operating expenses 11 175 9 156
Total operating expenses 46 318 39 925
Op. res. before depr. and write-offs (EBITDA) 15 328 12 074
EBITDA % 24,9 % 23,2 %
Depreciation 2 670 2 052
Write offs and accruals - -
Operating result (EBIT) 12 658 10 022
EBIT % 20,5 % 19,3 %
Financial income 2 517 1 751
Financial expenses 952 1 698
Net finance 1 565 53
Pre tax profit 14 224 10 075
Tax 3 906 2 248
Result 10 317 7 827

EBIT per Quarter (TNOK)

Profit and loss YTD September 2015

Profit & loss YTD Sep 2015 YTD Sep 2014
All numbers in NOK 1000
Sales 176 807 148 724
Cost of goods sold 44 562 38 143
Salary and sosial expenses 55 724 47 652
Other operating expenses 31 180 27 855
Total operating expenses 131 466 113 650
Op. res. before depr. and write-offs (EBITDA) 45 341 35 074
EBITDA % 25,6 % 23,6 %
Depreciation 7 872 6 161
Write offs and accruals 3 200 -
Operating result (EBIT) 34 269 28 913
EBIT % 19,4 % 19,4 %
Financial income 13 637 5 292
Financial expenses 9 439 4 967
Net finance 4 198 325
Pre tax profit 38 467 29 237
Tax 10 272 9 049
Result 28 195 20 188
Dividend 25 362 14 481

EBIT per Quarter (TNOK)

9

Balance sheet - Assets

Balance sheet 30.09.2015 31.12.2014
All numbers in NOK 1000
Assets
Intangible assets 53 394 53 257
Fixed assets 14 804 15 276
Total intangible and fixed assets 68 198 68 533
Inventory 48 250 36 874
Customers receivables 40 861 39 948
Other receivables 7 980 8 658
Cash 35 702 49 475
Total current assets 132 792 134 955
Total assets 200 990 203 488
  • Inventory build up related to MiraQ product line introduction
  • Cash reduced due to dividend payment of MNOK 25,4 in May 2015

Balance sheet - Equity and liability

Balance sheet 30.09.2015 31.12.2014
All numbers in NOK 1000
Share capital 4 585 4 585
Premium fund 41 852 41 852
Other equity 96 236 92 659
Total equity 142 673 139 096
Total long term debt 7 280 13 117
Total short term debt 51 036 51 275
Total equity and liability 200 990 203 488

• 12.8 MNOK in interest bearing debt

3. Business segments update

Flow probes and systems in units

Flow probes in units VeriQ and MiraQ systems in units

1 000 1 100 1 200 1 300 1 400 1 500 1 600 1 700 1 800 1 900 Q3 13 Q4 13 Q1 14 Q2 14 Q3 14 Q4 14 Q1 15 Q2 15 Q3 15

  • Slow probe sales for all regions in Q3
  • Lower number of probes sold in particular to Germany due to the switch from probes approved for 30 times use to 50 times use

0 5 10 15 20 25 30 35 Q2 13 Q3 13 Q4 13 Q1 14 Q2 14 Q3 14 Q4 14 Q1 15 Q2 15 Q3 15 Europe US ROW Asia

  • System sales at the same level as Q3 last year
  • Of the 21 flow systems sold, 9 were MiraQ systems, 6 were sold in Europe and 3 in ROW

Imaging probes and systems in units

Imaging probes in units

• 24 imaging probes sold when including sales to capital accounts in the USA, up 60 % compared to Q3 in 2014 VeriQ C & MiraQ systems in units

  • System sales back on track after a slow Q2
  • Of the 12 imaging systems sold, 3 were MiraQ systems, 1 was sold to Japan and 2 were sold in Europe

Q3 revenue performance by region

Mill NOK Q3 '15 Q3 '14 Q / Q YTD 15 YTD 15 H / H
Europe 34,2 29,5 16,0 % 99,2 88,9 11,6 %
USA 19,8 14,1 40,3 % 56,4 39,4 43,1 %
Asia & Jp 4,8 5,6 -14,4 % 13,6 13,3 1,7 %
ROW
(MEA, CAN, SA)
2,8 2,7 1,6 % 7,6 7,1 8,0 %
Total 61,6 52,0 18,5 % 176,8 148,7 18,9 %

• In Europe, the regional performance for Q3 was driven by strong 19.5% growth from 3. party products. YTD September, 3. party products increased with 9,6 MNOK or 21.2 % over last year. Sale of own products ended at 17.1 MNOK for the quarter, up 12.7 %. YTD September sales of own products ended at 44.1 MNOK, up 1.5 %.

  • In the USA, the strong growth continues, partly driven by favorable currency. Currency neutral growth was 6.7 % for Q3 and 10.7 % YTD September.
  • Both Asia/Japan and ROW are so far smaller sales territories for Medistim and quarterly performance varies significantly. Performance YTD is positive for both territories.

Positive currency effects for Q3 with 5.9 MNOK and accumulated YTD September with 16.7 MNOK. Average rate to USD was 7.90 in 2015 vs 6.11 in 2014. Average rate to EUR was 8.81 in 2015 vs 8.28 in 2014.

Q3 revenue performance by product

Mill NOK Q3 '15 Q3 '14 Q/Q YTD 15 YTD 14 YTD15/YTD14
Procedures (USA) 18,4 12,3 50,4 % 51,7 34,3 50,6 %
Flow probes 15,4 16,1 -4,1 % 44,2 44,4 -0,4 %
Flow systems (VeriQ & MiraQ) 3,1 3,5 -12,1 % 9,2 10,4 -11,6 %
Imaging systems (VeriQ C & MiraQ) 6,2 5,0 23,3 % 13,0 11,4 13,4 %
Imaging probes 0,9 0,5 82,9 % 2,1 1,4 50,6 %
3rd party 17,1 14,3 19,5 % 55,2 45,5 21,2 %
Other 0,4 0,3 38,3 % 1,5 1,2 17,2 %
Total revenues 61,6 52,0 18,5 % 176,8 148,7 18,9 %
  • Procedure sale in the USA: The number of flow procedures is up 16.2% and imaging procedures is up 50.5 % in Q3. YTD September flow procedures are up 12.2 % and imaging procedures is up by 45.0 %. Positive contribution from currency.
  • Flow probes revenue: Revenue slightly down from Q3 last year, due to reduced number of probes sold particularly in Germany, due to the switch from probes for 30x use to 50x use.
  • Flow systems: The number of systems sold in Q3 is par with LY. The reduction in NOK is related to the relative split between distributor and direct sales, and system configuration. The number of systems sold YTD September is down 11.7%.
  • Imaging systems and probes: Good development for the imaging portfolio, with system sales back on track after a slow Q2 and probe sales increasing due to an expanding installed base.
  • 3rd party products: Very strong quarter and sales YTD with 19.5 % and 21.2 % growth respectively.

4. Implementing the strategy

17

Growth opportunities – underdeveloped markets

  • 1. Strengthen our position as market leader by establishing combined TTFM & Imaging as the new standard of care through
  • o Early adopter KOL support
  • o Easier conversion to imaging with MiraQ
  • 2. Fight ignorance and indifference to QA by increasing the level of evidence and awareness through
  • o Clinical marketing
  • o Educational programs
  • o Increase sales capacity
  • 3. Product innovation and positioning to target new segments in vascular and open heart surgery
  • o MiraQ Vascular

High performance US sales organization

RESULTS YTD 2015

  • Revenues up by 43 % in NOK, 10.7 % in USD
  • Number of procedures up by 14.9%
  • o 12.2 % growth in flow procedures
  • o 45.0 % growth in imaging procedures
  • 20 new accounts
  • 6 TTFM accounts converted to Imaging

# of Procedures per Consecutive Quarter

Growth opportunities – all CABG markets

  • 1. Strengthen our position as market leader by establishing combined TTFM & Imaging as the new standard of care through
  • o Early adopter KOL support
  • o Easier conversion to imaging with MiraQ
  • 2. Fight ignorance and indifference to QA by increasing the level of evidence and awareness through
  • o Clinical marketing
  • o Educational programs
  • o Increase sales capacity
  • 3. Product innovation and positioning to target new segments in vascular and open heart surgery
  • o MiraQ Vascular

20

New, dedicated congress for coronary surgery

  • Medistim highly profiled in the meeting
  • Well attended "Lunch box" training session
  • Prime time exposure in the main program
$11:27 - 11:35$ How I Choose OPCAB vs ONCAB in 2015
Sheng-Shou Hu, Fuwai Hospital, China
22. Exclusive Relian
1999: Late Clinical
$11:35 - 11:43$ Teaching On Pump & Off Pump CABG to Surgical
Residents & Practicing Surgeons
Paul T. Sergeant, Gasthuisberg University Hopsital, Belgium
Alistair Royse, The
Australia, The Royal
Victoria, Australia
$11:43 - 11:53$ Expert Opinion: Why Hasn't OPCAB Lived Up
To Expectations?
Bruce D. Lytle, Baylor Healthcare, USA
Anthony Brennan, T
Australia
Colin Royse, The Ro
$11:53 - 12:15$ Panel Discussion: Best Practices for OPCAB in 2015
Federico Benetti, Harold L. Lazar, David P. Taggart,
John D. Puskas, Joseph F. Sabik, III, Sheng-Shou Hu,
Victoria, Australia
23. Coronary Artery
A.V. Pavlov, MD, II, (
$12:15 - 1:30$ Paul T. Sergeant, Bruce D. Lytle
LUNCH BOX SESSION - Industry Symposia
Cardiosurgery Cent
Panel Discussion: A
Session 14A Off Pump CABG via Median Sternotomy: Harold L. Lazar, Kir
Part 2 (Simultaneous Session)
Moderators: Enio Buffolo & Paul T. Sergeant
Session 15 Graft Assessment v
Frequency Ultrasou
$1:30 - 1:38$ The Evolution of OPCAB
Enio Buffolo, Federal University of Sao Paulo School
of Medicine. Brazil
$2:20 - 2:26$ Moderation Turbist
onould Intraoperati
Standard of Care?
$1:38 - 1:46$ Tips & Tricks for OPCAB
John D. Puskas, Mount Sinai Beth Israel, USA
$8 - 2:36$ David P. Taggart, Un
How Does TTFM Act
$1:46 - 1:54$ Coronary Shunting & Other Adjuncts to OPCABG
Paul T. Sergeant, University of Leuven, Belgium
$2:36 - 2:44$ Gabriele Di Giamman
Graft Flow Measure
Mean & When to Re
$1:54 - 2:02$ Common Pitfalls of OPCAB
Claudio Muneretto, University of Brescia Medical School, Italy
$2:44 - 2:52$ Gabriele Di Giamman
High Frequency Ultras
$2:02 - 2:08$ Off-Pump Plication of Post MI Left Ventricular
Aneurysm: Improve Cardiac Function & Mitral Regurgi
Ajeet Bana, Fortis Escorts Hospital, Delhi, India
$2:52 - 3:00$ Hirokuni Arai, Tokyo
Graft Flow Measure
$2:08 - 2:20$ Panel Discussions: My Tips & Tricks for
State-of-the-Art OPCAB
$3:00 - 3:15$ Teresa M. Kieser, Lil
Alberta, University of
Discussion: Best Pra
Session 14B Enio Buffolo, Paul T. Sergeant, John D. Puskas, Claudic
Muneretto, Ajeet Bana
Abstracts/Videos (Simultaneous Session)
in CABG
Hirokuni Arai, James
Moderators: Harold L. Lazar & Kim Ki-Bong $3:15 - 3:35$ Di Giammarco, Teres
$2:20-3:15$ ABSTRACTS Session 16A COFFEE BREAK - Ex
MIDCAB, Hybrid Rev
17. MICS CABG: The Learning Curve: Lessons Learned
Mahesh Ramchandani, Odeaa Al Jabbari, Walid K Abu
Saleh, Basel Ramlawi, Houston Methodist DeBakey Heart &
$3:35 - 3:43$ via Thoracotomy (Sir
Moderators: Francis
Outcomes with MIDO
Vascular Center, Houston, TX
18. Coronary Microsurgery
David Glineur, Univer:
George E Green, MD,*Retired, Columbia-Presbyterian
Hospital, Professor of Clinical Surgery, Columbia U. Coll.
2.55
3:43
Tips & Tricks for MID
Marc Ruel, University
Physicians & Surgeons, New York, NY
Daniel G Swistel, MD, NYU Medical Center, New York, NY
19. Application of Cabrol Technique in Coronary Artery
$3:55 - 4:03$ Vessel CABG v
How I Do it
Marc Ruel, University
Bypass Grafting
Chab-Young Na, MD, Ph.D, Department of Cardiothoracic
Surgery, Keimyung Univerisity, Daegu, South Korea
$4:03 - 4:11$ Angiographic Outcon
from Around the Wor
Naresh K. Trehan, Mr
20. Research Angiography more than 10 years Postoperative
in Patients with Each of Internal Mammary Artery, Radial
Artery & Saphenous Vein Graft
$4:11 - 4:19$ Is there Any Real Ad
Median Sternotomy 1
Michael E. Halkos, Er
Alistair Royse, The University of Melbourne, Melbourne,
Australia, The Royal Melbourne Hospital, Melbourne, Australia
Jared Ou-Young, Zulfayandi Pawanis, The University of
Melbourne, Melbourne, Australia
$4:19 - 4:27$ Current Role of Hybr
Chinese Perspective
Sheng–Shou Hu, Fuw
Colin Royse, The University of Melbourne, Melbourne, Australia,
The Royal Melbourne Hospital, Melbourne, Australia
$4:27 - 4:35$ Current Role of Hybr
North American Pers
Francis P. Sutter, Lan
21. Very Long-Term (20 Years) Consequences of Radial
Artery Removal on Forearm Circulation
Mario Gaudino, MD, Department of Cardiac Surgery,
Catholic Univeristy, Rome, Department of Cardio-thoracic
Surgery, Weill-Cornell Medical College, New York
Roberto Flore, MD, Department of Angiology, Catholic
$4:35 - 4:50$ Panel Discussion: W
MIDCAB via Thoracot
State-of-the-Art MII
Francis P. Sutter, Nar
Michael E. Halkos, Sh
University, Rome
Valentina Milazzo, MD. Department of Cardiac Sumany
Session 16B Abstracts/Videos (Sin
Moderators: James T:

Growth opportunities – vascular market

  • 1. Strengthen our position as market leader by establishing combined TTFM & Imaging as the new standard of care through
  • o Early adopter KOL support
  • o Easier conversion to imaging with MiraQ
  • 2. Fight ignorance and indifference to QA by increasing the level of evidence and awareness through
  • o Clinical marketing
  • o Educational programs
  • o Increase sales capacity
  • 3. Product innovation and positioning to target new segments in vascular and open heart surgery

o MiraQ Vascular

MiraQ Vascular Launch MiraQ Vascular launched in Q3

  • Launched at the European Society of Vascular Surgery in Porto, Portugal 23-25. September
  • A specialized and complete product offering for vascular surgery:
  • o MiraQ Vascular system
    • Application adjusted front panel
    • Adapted vascular software features
  • o Vascular flow probes for use on delicate blood vessels completed with small sizes

MiraQ Vascular Launch

Why perform surgical guidance & quality assessment in vascular surgery

MiraQ Vascular Launch

Surgical guidance & quality assessment in vascular surgery

• Guide carotid endarterectomy (CEA) and assess for technical imperfections

• Assess graft patency in peripheral bypass and evaluate anastomosis

• Quantify flow for guidance during AV access surgery

Immediate feedback to revise on the spot

MiraQ Vascular Launch

Combining surgical guidance & quality assessment in CEA

Improve surgical outcome, demonstrate quality and increase cost efficiency

MiraQ Vascular Launch Vascular market potential

  • Global vascular market is about 600 000 procedures annually
  • > 1 Billion NOK of market opportunity for Medistim
  • Key vascular applications:
  • Carotid endarterectomy (CEA)
  • Peripheral bypass surgery
  • Vascular access for hemodialysis (AV fistulae)
  • Niche application:
  • Liver transplant
Applications Size of key markets
# of procedures
(USA, Germany, Nordic)
Clinical needs
CEA
surgery
>135
000
Reduce risk of death and
stroke
Improve cost-effectiveness
Peripheral
bypass
surgery
>200
000
Improve long-term graft
patency
Improve quality of life
AV access
surgery
>80
000
Secure maturation of
shunt/fistula
Reduce risk of cardiac
failure & hand ischemia
Liver transplant
Surgery
20
000
(globally)
Increase success rate for a
costly
procedure

The MiraQ family completed with MiraQ Ultimate

Growth opportunities – emerging markets

  • 1. Strengthen our position as market leader by establishing combined TTFM & Imaging as the new standard of care through
  • o Early adopter KOL support
  • o Easier conversion to imaging with MiraQ
  • 2. Fight ignorance and indifference to QA by increasing the level of evidence and awareness through
  • o Clinical marketing
  • o Educational programs
  • o Increase sales capacity
  • 3. Product innovation and positioning to target new segments in vascular and open heart surgery
  • o MiraQ Vascular
  • o Entry-level flowmeter for price sensitive segments

29

Breaking news…. agreement signed October 22nd: Medistim enters into a strategic partnership with em-tec

Under the License and OEM agreement:

  • Medistim obtains exclusive, eternal, world-wide rights to market and sell em-tec's transit time flow measurement (TTFM) technology for use on human blood vessels within cardiac-, vascular- and transplant surgery
  • Medistim gets time- and cost efficient access to a basic, entry-level customer solution that meets lower price-point market segments and fills a gap within Medistim's product portfolio
  • Medistim gets access to a highly competent flow technology development partner for future technology and product developement

  • Upfront fee approx. €300,000

  • Minimum purchase commitments
  • First product to be launched 2016

Current em-tec product

Press release October 23rd 2015

  • Medistim ASA enters into a strategic partnership with em-tec GmbH
  • (Oslo, October 22nd 2015), Medistim ASA (OSE: MEDI), a medtech company that develops and distributes surgical guidance and quality assessment devices, has entered into a long-term agreement with em-tec GmbH.
  • Under the License and OEM agreement, Medistim obtains exclusive, eternal, world-wide rights to market and sell emtec's transit time flow measurement (TTFM) technology for use on human blood vessels within cardiac-, vascular- and transplant surgery. em-tec's flow measurement device is designed as a basic, entry-level customer solution that meets lower price-point market segments and fills a gap within Medistim's product portfolio. The first Medistim labeled device will be launched in 2016.
  • The financial terms of the agreement consist of an upfront payment of approx. EUR 300,000 and minimum purchase commitments.
  • In addition to the License and OEM agreement, the companies intend to collaborate on new technology and product development, thereby strategically combining the strengths of both companies.
  • "While Medistim is the market leader with our own high-end products for surgical guidance and blood flow measurement in cardiac-, vascular and transplant surgery, we have been lacking an entry-level device to reach some emerging market product segments," says Medistim President and CEO, Kari E. Krogstad. "This agreement gives us a time- and cost effective path to serve these segments, while at the same time, it opens up for very exciting opportunities from the two companies joining forces to further technological progress and engage in new product and technology development".

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