INTERIM REPORT JANUARY SEPTEMBER 2017

Transcription

1 INTERIM REPORT JANUARY SEPTEMBER 2017 TELEPHONE CONFERENCE NO ONE SHOULD HAVE TO DIE WAITING FOR A NEW ORGAN Octber 27, 2017 MAGNUS NILSSON, CEO CHRISTOFFER ROSENBLAD, CFO NASDAQ OMX Stckhlm (mid cap): XVIVO

2 HIGHLIGHTS 2017-Q3 First patient Heart transplanted using the new machine and slutin Inclusin f all patients in NOVEL study cmpleted Basis fr PMA applicatin Inclusin f all patients in PrimECC study cmpleted 20 patients included in Liver study with STEEN Slutin n DBD livers Clean rm in Lund increased prductin and R&D capability January September 2017 Interim reprt presentatin 2

3 SALES HIGHLIGHTS 2017 JAN - SEP DOUBLE DIGIT GROWTH FOR NON-DURABLE SALES Sales: - Nn-durable gds +15%* r 102 MSEK Net sales in SEK millins (Rlling 12 mnths) Warm perfusin Cld preservatin Freight and ther EU & Aus: 2 new cuntries with XPS - Australia & the Netherlands - Cntinued high interest frm custmers fr the XPS & LS USA - XPS cntract signed with clinic in Kentucky and cntinued high interest frm new clinics * Lcal currency grwth fr nn-durable gds +13% YTD and +11% Q3 January September 2017 Interim reprt presentatin 3

4 PROFIT & LOSS Sales nn-durable +15% Cntinued strng grss margin Custmer supprt build up Jan Sep Jan Dec (SEK millins) Net sales Net sales nn-durable gds Grss prfit Grss Margin % 76% 74% 74% Grss Margin nn-durable gds % 79% 80% 80% Selling expenses excl. items aff. cmp% -31% -24% -24% Admin. expenses excl. items aff. cmp%* -13% -12% -12% R&D exp. excl. Amrt. & items aff. cmp%* -19% -18% -19% Items affecting cmparability* -2% -7% -8% R&D Amrtizatin %* -7% -8% -7% Other incme/expenses % -2% -2% -2% Operating Result % 2% 3% 2% Running business prfitable despite high investments in Marketing and R&D EBITDA excl. items eff. cmp.* EBITDA excl. items eff. cmp% 15% 20% 19% EBITDA EBITDA % % % % * Items affecting cmparability: 2017 Jan-Sep 2.3 (7.3) MSEK. R&D Amrtizatin : 2017 Jan-Sep 7.9 (7.7) MSEK. January September 2017 Interim reprt presentatin 4

5 PRODUCTS & MARKETS FOR FUTURE GROWTH

6 XVIVO - FUTURE GROWTH OPPORTUNITIES Expansin f Lung transplantatin indicatin, e.g. Infectin (e.g. Hep C) EVLP treatment, Increase f DCD lungs Heart Transplant prject, early clinical phase STEEN Slutin fr Liver Transplant, clinical phase ITT* - Drug administratin t islated rgans (e.g. Cancer) with STEEN Slutin, early clinical phase PrimECC imprve clinical prf, 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. January September 2017 Interim reprt presentatin 6

7 LUNG TRANSPLANTATION XPS & STEEN Slutin nly FDA (HDE) apprved device fr warm perfusin f lungs NOVEL study inclusin finalized: patients - Fllw-up 1 year - Frm basis fr PMA applicatin, study dcumentatin & mnitring and analysis nging - Dialgue with FDA nging PAS (Pst Apprval Study) - 5 patients until inclusin cmplete - Fllw-up 3 years Restrictins n patients and recipients will be remved when PAS inclusin finalized January September 2017 Interim reprt presentatin 7

8 LUNG TRANSPLANTATION Next steps fr lung warm perfusin (EVLP) XVIVO will cntinue t clinically develp EVLP: DCD transplantatin (Dnatin after Circulatry Death) cntrlled / uncntrlled Infectin therapy thrugh EVLP, e.g. Pneumnia therapy and virus reductin Hep C study: 2 patients included Investigate immunlgical respnse with EVLP targeting shrt- & lng-term survival New markers and parameters fr imprved evaluatin safer decisin making January September 2017 Interim reprt presentatin 8

9 XVIVO - HEART TRANSPLANTATION Heart perfusin and preservatin slutin and device develped by Prf. Steen First clinical trial started with new technlgy: First patient transplanted with the new device (new slutin and new machine) Prf f cncept study with 6 patients Pre-clinical prcine prf f cncept studies indicate: Avidance f ischemic time Better heart quality Lnger preservatin time (24h) pssible Mycardium tests cmparing perfused and nnperfused hearts. Heart Tx very gd fit with XVIVO XVIVO experience frm Lung device develpment Synergies in develpment, regulatry and M&S Many f the same clinics and KOLs make Heart and Lung Tx January September 2017 Interim reprt presentatin 9

10 PRIMECC Tailr made priming slutin aiming at imprving patients cnditin after having undergne pen-heart surgery with a heart-lung machine PRIMECC develped t avid side-effects when priming heart-lung machines. Schematic drawing f heart with heart-lung machine > pen heart surgeries every year in the USA alne. Estimated ~1 millin in the wrld / year. N FDA apprved prduct fr indicatin. Previus perfrmed clinical prf f cncept study shwed interesting results. Patent granted in EU, USA China and Japan. CE marked Class III Medical Device. January September 2017 Interim reprt presentatin 10

11 PRIMECC STUDY INCLUSION FINALIZED patients Sahlgrenska Univ. hsp. - randmized, cntrlled, blinded Aim t increase clinical dcumentatin fr PrimECC avidance f side-effects Results estimated t be analyzed & published during Q / Q EU & US multi-center studies planned t start after supprting clinical trial results are available January September 2017 Interim reprt presentatin 11

12 SUMMARY OTHER NEW INDICATIONS Liver transplantatin: Results n 20 patients in first clinical STEEN Slutin Liver study shw gd clinical results Marginal (DCD) Liver study planned t start in Canada n 2 centers Islated Tissue Therapy - Cancer Prf f cncept study perfusing lungs in viv fr treatment f cancer is nging 2nd patient successfully treated January September 2017 Interim reprt presentatin 12

13 OUTLOOK Q & 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 Heart - Accelerating Heart transplant clinical prgram PrimECC - Analysis f PrimECC clinical data and cntinued clinical prgram New indicatins Liver - STEEN Slutin clinical develpment fr DCD & marginal Livers ITT - Islated tissue therapy (STEEN Slutin IVLP: Cancer, Limb perfusin) Kidney cntinued pre-clinical studies with STEEN Slutin January September 2017 Interim reprt presentatin 13

14 Strategic gals Slidify psitin in Thracic surgery - Lungs + Heart Build new business using STEEN Slutin tech. in ther indicatins January September 2017 Interim reprt presentatin 14

15 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