REPORT ON OPERATIONS 2017 TELEPHONE CONFERENCE

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1 REPORT ON OPERATIONS 2017 TELEPHONE CONFERENCE NO ONE SHOULD HAVE TO DIE WAITING FOR A NEW ORGAN February 12, 2018 MAGNUS NILSSON, CEO CHRISTOFFER ROSENBLAD, CFO NASDAQ OMX Stckhlm (mid cap): XVIVO

2 HIGHLIGHTS 2017-Q4 First XPS installed in China. Three XPS & LS delivered utside China. CPT Reimbursement cdes btained fr dctr s time during EVLP prcedure in US. Net Sales f nn-durable gds increased by 21% in lcal currency t 39.4 MSEK*. Warm perfusin sales frm nn-durable gds accunted fr 43% f ttal sales f nndurable gds. * Grwth +15% fr nn-durable gds in SEK. Reprt n Operatins 2017 presentatin 2

3 HIGHLIGHTS 2017 The first clinical heart transplant using the heart preservatin technlgy develped by XVIVO s partner Prfessr Stig Steen was perfrmed. All 220 patients included in the NOVEL study in the US which will frm the basis f the cmpany s PMA applicatin. PrimECC study n 80 patients at Sahlgrenska University Hspital cmpleted. A private placement f SEK 181 millin was carried ut t accelerate XVIVO's heart transplant prject t the market. Reprt n Operatins 2017 presentatin 3

4 SALES HIGHLIGHTS 2017 DOUBLE DIGIT GROWTH FOR NON-DURABLE SALES Sales: Nn-durable gds increased by 15%* t 141 MSEK. Net sales increased by 7% t 148 MSEK. Warm Perfusin Sales frm nndurable gds, in SEK millins (Rlling 12 mnths) 4 new cuntries with XPS r LS Australia China Prtugal the Netherlands EVLP reimbursement cdes (CPT) btained in the US. * Lcal currency grwth +15% fr nn-durable gds. Reprt n Operatins 2017 presentatin 4

5 SALES HIGHLIGHTS CPT cdes A CPT* cde is a way fr a hspital and surgical team t get reimbursed fr a specific prcedure. The three new cdes will simplify the reimbursement prcess fr EVLP. The three new cdes cver the full EVLP prcedure: Cde 1 - Related t preparatin f marginal dnr lungs. Cde 2 - Related t the EVLP prcess f a marginal lung. Cde 3 - Related t any additinal hur(s) needed fr an EVLP. * CPT = Current Prcedural Terminlgy Reprt n Operatins 2017 presentatin 5

6 PROFIT & LOSS Sales nn-durable +15% (SEK Millins) Net sales Net sales nn-durable gds Grss prfit Grss Margin % 76% 74% Grss Margin nn-durable gds % 78% 80% Mre resurces allcated t Custmer supprt Running business prfitable despite high investments in Marketing and R&D Selling expenses excl. items eff. cmp% -29% -24% Admin. expenses excl. items eff. cmp%* -13% -12% R&D exp. excl. Amrt. & items eff. cmp%* -18% -19% Items effecting cmparability* -2% -8% R&D Amrtizatin %* -7% -7% Other incme/expenses % -2% -2% Operating Result % 5% 2% EBITDA excl. items eff. cmp.* EBITDA excl. items eff. cmp% 17% 19% EBITDA EBITDA % 15% 12% * Items effecting cmparability: (10.4) MSEK. R&D Amrtizatin : (10.3) MSEK. Reprt n Operatins 2017 presentatin 6

7 CASH FLOW CH AP TE R TIT LE Psitive Cash flw frm lungs in 2017 Investments in heart amunted t 15 millin SEK New issue f shares amunted t 185 millin SEK Cash flw at the end f millin SEK

8 PRODUCTS & MARKETS FOR FUTURE GROWTH

9 XVIVO - FUTURE GROWTH OPPORTUNITIES Expansin f Lung transplantatin indicatin, EVLP imprvement prjects, increase f DCD Heart Transplant prject, early clinical phase STEEN Slutin fr Liver Transplant, early clinical phase ITT* - Drug administratin t islated rgans (e.g. Cancer) with STEEN Slutin, early clinical phase PrimECC imprve clinical prf, late clinical phase * ITT r Islated Tissue Therapy is a therapy where ne part f he bdy is islated fr treatment in rder t avid side effects. Reprt n Operatins 2017 presentatin 9

10 LUNG TRANSPLANTATION XPS & STEEN Slutin FDA has already HDE apprval -> preparing fr PMA applicatin NOVEL study inclusins cmpleted: patients - fllw-up 1 year (May 2018) Frm basis fr PMA applicatin - study data cllectin nging - submissin t the FDA planned q2/q3.. PAS (Pst apprval study) pat. inclusin cmpleted - fllw-up 3 years - Study prtcl induced restrictins n inclusins/exclusins f marginal dnrs/transplant recipients remved Reprt n Operatins 2017 presentatin 10

11 LUNG TRANSPLANTATION - Evlutin f lung warm perfusin (EVLP) Supprt t clinical develpment f EVLP: Using mre DCD dnrs (Dnatin after Circulatry Death) cntrlled / uncntrlled Anti-infectin therapy thrugh EVLP e.g. Pneumnia and anti-virus therapy Investigate immunlgical respnse with EVLP targeting lng term survival XPS evlutin, better decisin making tls during EVLP: New markers and parameters Reprt n Operatins 2017 presentatin 11

12 XVIVO - HEART TRANSPLANTATION Heart perfusin and preservatin slutin and device develped by Prf. Steen First clinical study started with new technlgy: First patient transplanted with the new technlgy (new slutin and new machine) Prf f cncept study with 6 patients Pre-clinical prf f cncept studies indicate: Better rgan quality (Mycardium tests perfrmance = hearts nt preserved) Lnger preservatin time pssible (24h in pig studies) Main fcus f next phase in heart transplant area: Adapt the heart perfusin technlgy fr internatinal clinical studies Prductin develpment f heart perfusin slutin Preparing fr next steps in clinical develpment Reprt n Operatins 2017 presentatin 12

13 PRIMECC study data analysis nging PRIMECC develped t avid side-effects when priming heart-lung machines: Patent granted in EU, USA, China & Japan. CE marked Class III Medical Device. Inclusin f patients cmpleted Next steps: Analysis f the patients nging - ready q1 Preparatins fr next steps in clinical develpment 1) Small studies fcusing n specific study bservatins 2) Brader multi-center studies n key markets Reprt n Operatins 2017 presentatin 13

14 SUMMARY OTHER NEW INDICATIONS Liver transplantatin Results n 20 patients in first clinical STEEN Slutin Liver study shws gd clinical results Marginal (DCD) Liver study planned (Canada in 2 centers) Islated Tissue Therapy Cancer Prf f cncept study perfusing lungs in viv fr treatment f cancer is nging Secnd patient successfully treated Reprt n Operatins 2017 presentatin 14

15 OUTLOOK FOCUS AREAS Thracic Surgery Lungs - Cntinue t increase ftprint and use f EVLP technlgy Lungs - PMA applicatin and submissin Lungs - Reinfrced clinical develpment f EVLP, especially in the US Lungs Implementatin f CTP cdes in US R&D - New indicatins Heart - Accelerating Heart transplant prject with aim f internatinal clinical study PrimECC - Analysis f PrimECC clinical data and fllw-up clinical studies t increase dcumentatin Liver - STEEN Slutin clinical develpment fr Liver Kidney pre-clinical studies with STEEN Slutin ITT - Islated tissue therapy (Cancer / STEEN Slutin IVLP) Lng-term gal is t slidify psitin in Thracic surgery and build new a new business in new indicatins using the STEEN Slutin technlgy. Reprt n Operatins 2017 presentatin 15

16 XVIVO PERFUSION Patients die waiting fr an rgan transplant XVIVO has a Patented, Apprved and Dcumented technlgy t make mre rgans available fr the benefit f patients XVIVO has the experience, capability, cmpetence and technlgy t expand int mre indicatins/markets