Medistim ASA Fourth Quarter Kari E. Krogstad, President and CEO Thomas Jakobsen, CFO March 1st, 2016

Transcription

1 Medistim ASA Furth Quarter 20 Kari E. Krgstad, President and CEO Thmas Jakbsen, CFO March 1st, 2016

2 2 Disclaimer The infrmatin included in this Presentatin cntains certain frward-lking statements that address activities, events r develpments that Medistim ASA ( the Cmpany ) expects, prjects, believes r anticipates will r may ccur in the future. These statements are based n varius assumptins made by the Cmpany, which are beynd its cntrl and are subject t certain additinal risks and uncertainties. The Cmpany is subject t a large number f risk factrs including but nt limited t ecnmic and market cnditins in the gegraphic areas and markets where Medistim is r will be perating, IP risks, clinical develpment risks, regulatry risks, fluctuatins in currency exchange rates, and changes in gvernmental regulatins. Fr a further descriptin f ther relevant risk factrs we refer t Medistim s Annual Reprt fr As a result f these and ther risk factrs, actual events and ur actual results may differ materially frm thse indicated in r implied by such frward-lking statements. The reservatin is als made that inaccuracies r mistakes may ccur in this infrmatin given abve abut current status f the Cmpany r its business. Any reliance n the infrmatin abve is at the risk f the reader, and Medistim disclaims any an all liability in this respect.

3 3 Table f cntents 1. Highlights furth quarter 2. Financial statements 3. Business segments update 4. Implementing the strategy

4 1. Highlights furth quarter

5 5 Highlights frth quarter 20 All time high sales and strng grwth driven by currency in Q4 Strng develpment in sales f imaging prducts, up 29 % t MNOK 12.1 US sales up.7 % t MNOK 19.9 Full year sales grws 17% t MNOK (214.8) 10.7 % EBIT grwth t MNOK 16.0 fr the quarter Full year EBIT grwth is.9 % t MNOK 50.3 (43.4) Medistim enters int a strategic partnership with em-tec GmbH The REQUEST clinical study has enrlled >200 patients Prfit per share grws 28.9% t NOK 2.23 (1.73) The Bard will suggest a dividend f NOK 1.65 (1.40) per share t the sharehlders meeting Revenue MNOK 74.6 (66.1) EBIT MNOK 16.0 (14.4) Currency Q4 20 N f units sld: Systems 45 Flw prbes Imaging prbes 27 Prcedures (USA) Q Q 12.9% 10.7 % 9.9 % % 0.4 % 68.8 % 1.4 %

6 2. Financial statements

7 7 Prfit and lss Q4 20 Prfit & lss Q4 20 Q All numbers in NOK 1000 Sales Cst f gds sld Salary and ssial expenses Other perating expenses Ttal perating expenses Op. res. befre depr. and write-ffs (EBITDA) EBITDA% 24,5 % 25,0 % Depreciatin Write ffs (453) - Operating result (EBIT) EBIT% 21,4 % 21,9 % Financial incme Financial expenses Net finance Pre tax prfit Tax Result Sales per Quarter (TNOK) Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q Q2 12 EBIT per Quarter (TNOK) Q4 12 Q2 13 Q4 13 Q2 14 Q4 14 Q2 Q4 40,00 % 35,00 % 30,00 % 25,00 % 20,00 %,00 % 10,00 % 5,00 % 0,00 %

8 8 Prfit and lss 20 Prfit & lss All numbers in NOK 1000 Sales Cst f gds sld Salary and ssial expenses Other perating expenses Ttal perating expenses Op. res. befre depr. and write-ffs (EBITDA) EBITDA% 25,3 % 24,0 % Depreciatin Write ffs Operating result (EBIT) EBIT% 20,0 % 20,2 % Financial incme Financial expenses Net finance Pre tax prfit Sales per Year (TNOK) EBIT per year (TNOK) Tax Result

9 9 Balance sheet - Assets Balance sheet All numbers in NOK 1000 Assets Intangible assets Fixed assets Ttal intangible and fixed assets Inventry Custmers receivables Other receivables Cash Ttal current assets Ttal assets Q4 14 Q1 Q2 Q3 Q4 Intangible assets Fixed assets Inventry Accunts receivable Other assets Cash Inventry build up related t MiraQ prduct line intrductin Strng sales in Q4 and 43 % f sales landed in December increases receivables

10 10 Balance sheet - Equity and liability Balance sheet All numbers in NOK 1000 Share capital Premium fund Other equity Ttal equity Ttal lng term debt Ttal shrt term debt Ttal equity and liability Q4 14 Q1 Q2 Q3 Q4 Share capital Premium fund Other equity Lng term debt Shrt term debt 11.0 MNOK in interest bearing debt The bard suggests a dividend f NOK1.65 per share

11 3. Business segments update

12 12 Flw prbes and systems in units Flw prbes in units VeriQ and MiraQ systems in units Q4 13 Q1 14 Q2 14 Q3 14 Q4 14 Q1 Q2 Q3 Q Q3 13 Q4 13 Q1 14 Q2 14 Q3 14 Q4 14 Q1 Q2 Q3 Q4 Eurpe US ROW Asia Strng quarter fr Asia with 11% grwth in units Eurpe delivers 5% grwth despite the lwer number f prbes sld in Germany due t the switch frm prbes apprved fr 30 times use t 50 times use. This resulted in 800 fewer units sld in 20 cmpared t Lack f grwth in flw systems is cmpensated by strng sales f cmbined flw-and-imaging systems Of the 17 flw systems sld, 7 were MiraQ systems sld in regins with regulatry apprval, 6 in Eurpe and 1 in Asia

13 13 Imaging prbes and systems in units Imaging prbes in units VeriQ C & MiraQ systems in units Q4 13 Q1 14 Q2 14 Q3 14 Q4 14 Q1 Q2 Q3 Q4 0 Q4 13 Q1 14 Q2 14 Q3 14 Q4 14 Q1 Q2 Q3 Q4 Imaging prbes US imaging prbes VeriQC ex US VeriQC US MiraQ imaging Psitive trend with 27 imaging prbes sld in Q4, up 35 % cmpared t LY Shift in system sales frm flw-nly t cmbined flwand-imaging systems Of the 28 imaging systems sld, 20 were MiraQ systems, 11 were sld in Eurpe, 5 in ROW and 4 in Asia

14 Average rate t USD was 8.07 in 20 vs 6.30 in Average rate t EUR was 8.95 in 20 vs 8.35 in Q4 revenue perfrmance by regin Mill NOK Q4 ' Q4 '14 Q / Q Y/Y Eurpe 42,5 39,8 6,6 % 141,7 128,8 10,1 % USA 19,9 17,2,7 % 76,2 56,5 34,8 % Asia & Jp 8,1 5,4 50,9 % 21,7 18,7,9 % ROW (MEA, CAN, SA) 4,2 3,7 12,1 % 11,8 10,8 9,4 % Ttal 74,6 66,1 12,9 % 251,4 214,8 17,0 % In Eurpe, the quarterly perfrmance was driven bth by 3. party prducts and wn prducts, with 6.4% and 6.8% grwth respectively. Fr the year, 3. party prduct grwth was very strng with 10.9 MNOK r 16.7 %. Sale f wn prducts was up a mderate 3.2 % due t the change frm 30x use prbes t 50x use. In the USA, the strng grwth in NOK in Q4 is driven by favrable currency, as currency neutral sales fr the quarter shws a 8.8 % decline, driven by lack f capital sales cmpared t Q4 LY. This weak quarter slws dwn the annual grwth, which ends up at 4.6 % fr the full year (currency neutral). Bth Asia/Japan and ROW are s far smaller sales territries fr Medistim and quarterly perfrmance varies significantly. Perfrmance YTD is psitive fr bth territries. Psitive currency effects fr Q4 with 6.5 MNOK and accumulated YTD December with 21.3 MNOK.

15 Q4 revenue perfrmance by prduct Mill NOK Q4 ' Q4 '14 Q/Q Y/Y Prcedures (USA) 18,0 14,0 28,8 % 69,7 48,3 44,3 % Flw prbes 19,9 17,2 16,0 % 64,1 61,6 4,2 % Flw systems (VeriQ & MiraQ) 3,6 6,6-44,7 % 12,9 17,0-24,4 % Imaging systems (VeriQ C & MiraQ) 10,3 8,4 22,9 % 23,3 19,8 17,4 % Imaging prbes 1,8 1,0 80,3 % 3,9 2,4 62,9 % 3rd party 20,9 19,7 6,4 % 76,1 65,2 16,7 % Other 0,0-0,7-100,0 % 1,5 0,5 176,9 % Ttal revenues 74,6 66,1 12,9 % 251,4 214,8 17,0 % Prcedure sale in the USA: The lwer number f capital rders in Q4 gives a lwer number f prcedures as well. Flw prcedures are up 1.4% and imaging prcedures are dwn 21.7 % in Q4. Hwever, fr the full year, flw prcedures are up 10.1 % and imaging prcedures are up 23.2 %. The high grwth in NOK is due t favrable currency. Flw prbes revenue: Abut half f the revenue grwth in Q4 is currency driven. The mderate annual grwth is due t the switch frm prbes fr 30x use t 50x use. Flw systems: Flw system sales is lw cmpared t LY bth fr the quarter and year, explained by increasing interest fr imaging systems. Imaging systems and prbes: Gd develpment fr the imaging prtfli fr the quarter and fr the full year rd party prducts: Very strng in year with a 16.7 % grwth in sales.

16 4. Implementing the strategy

17 17 Grwth pprtunities in underdevelped markets Emerging, high-grwth markets (BRICs) 1. Strengthen ur psitin as market leader by establishing cmbined TTFM & Imaging as the new standard f care thrugh Early adpter KOL supprt Underdevelped markets (USA, UK, Fra) 2 Easier cnversin t imaging with MiraQ 2. Fight ignrance and indifference t QA by increasing the level f evidence and awareness thrugh Clinical marketing Mature markets (Jp, Nrdic, Germany) >50% share CABG surgery (2 BNOK) 1 3 Vascular surgery (>1 BNOK) Other pen heart surgery (1 BNOK) Educatinal prgrams Increased sales capacity 3. Prduct innvatin and psitining t target new segments in vascular and pen heart surgery MiraQ Vascular Entry-level flwmeter fr price sensitive segments

18 18 High perfrmance US sales rganizatin Number f prcedures per year RESULTS 20 # f Prcedures per Cnsecutive Quarter Revenues up by 34.8 % in NOK, a mderate 4.6 % in USD, driven by lw capital revenues in Q4 Number f prcedures up by 11.3% 10.1 % grwth in flw prcedures 23.2 % grwth in imaging prcedures 25 new accunts 6 TTFM accunts cnverted t Imaging Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q

19 19 Grwth pprtunities in emerging markets Emerging, high-grwth markets (BRICs) 1. Strengthen ur psitin as market leader by establishing cmbined TTFM & Imaging as the new standard f care thrugh Early adpter KOL supprt Underdevelped markets (USA, UK, Fra) 2 Easier cnversin t imaging with MiraQ 2. Fight ignrance and indifference t QA by increasing the level f evidence and awareness thrugh Clinical marketing Mature markets (Jp, Nrdic, Germany) >50% share CABG surgery (2 BNOK) 1 3 Vascular surgery (>1 BNOK) Other pen heart surgery (1 BNOK) Educatinal prgrams Increased sales capacity 3. Prduct innvatin and psitining t target new segments in vascular and pen heart surgery MiraQ Vascular Entry-level flwmeter fr price sensitive segments

20 20 Agreement signed Octber 22nd: Medistim enters int a strategic partnership with em-tec Under the License and OEM agreement: Medistim btains exclusive, eternal, wrld-wide rights t market and sell em-tec s transit time flw measurement (TTFM) technlgy fr use n human bld vessels within cardiac-, vascular- and transplant surgery Upfrnt fee apprx. 300,000 Minimum purchase cmmitments First prduct t be launched 2016 Medistim gets time- and cst efficient access t a basic, entry-level custmer slutin that meets lwer price-pint market segments and fills a gap within Medistim s prduct prtfli Medistim gets access t a highly cmpetent flw technlgy develpment partner fr future technlgy and prduct develpment Current em-tec prduct

21 21 Grwth pprtunities in mature markets Emerging, high-grwth markets (BRICs) 1. Strengthen ur psitin as market leader by establishing cmbined TTFM & Imaging as the new standard f care thrugh Early adpter KOL supprt Underdevelped markets (USA, UK, Fra) 2 Easier cnversin t imaging with MiraQ 2. Fight ignrance and indifference t QA by increasing the level f evidence and awareness thrugh Clinical marketing Mature markets (Jp, Nrdic, Germany) >50% share CABG surgery (2 BNOK) 1 3 Vascular surgery (>1 BNOK) Other pen heart surgery (1 BNOK) Educatinal prgrams Increased sales capacity 3. Prduct innvatin and psitining t target new segments in vascular and pen heart surgery MiraQ Vascular Entry-level flwmeter fr price sensitive segments

22 22 A study that is dcumenting the clinical findings frm rutine use f TTFM and HF-ECUS fr ultrasnic surgical guidance & quality assessment in CABG Reduce strkes Optimize graft strategy Verify graft functinality revise when needed Evaluate ascending arta prir t any manipulatin Evaluate mrphlgy f target crnaries & grafts Assess graft functinality PI<5, DF>50%, Q>ml/min Evaluate mrphlgy f anastmsis Imprve surgical utcme, demnstrate quality and increase cst efficiency

23 23 REQUEST a prspective, multicenter registry study: Perfrmed by leading heart prgrams in Eurpe, USA and Canada: Erasmus MC, Rtterdam, NL / Crdinating Investigatr Prf. A. P. Kappetein University f Oxfrd, UK / Principal Investigatr Prf. David Taggart University f Essen, GER / Principal Investigatr Dr. Daniel Wendt University G D Annunzi-Chieti, IT / Principal Investigatr Prf. Gabriele Di Giammarc Munt Sinai Beth Israel, New Yrk, USA / Principal Investigatr Prf. Jhn D. Puskas Medistim s rle Spnsring with EUR 1 millin Timelines: Study kicked ff in Q2 20 Status Plan t enrll 1,000 patients ver mnths Prgressing accrding t plan All 7 centers are actively enrlling patients >200 patients enrlled in ttal Gerge Wash. Univ., VA MC, Washingtn DC, USA / Principal Investigatr Dr. Gregry D. Trachitis University f Calgary, CAN / Principal Investigatr Dr. Teresa Kieser

24 24 WHAT S THE BIG DEAL? A grundbreaking study investigating the clinical value f implementing bth TTFM and HF-ECUS intraperatively Fight ignrance and indifference, build awareness and interest in surgical guidance and graft assessment as a means t imprve utcmes in CABG Gain supprt frm leading experts in the field based n clinical evidence Create cnsensus fr a recmmended wrkflw (prtcl) Obtain guideline endrsements fr this wrkflw

25 25 Seeing is believing