BoA Global Healthcare Conference 2014 Rein Piir, EVP Corporate Affairs & IR

Transcription

1 BA Glbal Healthcare Cnference 2014 Rein Piir, EVP Crprate Affairs & IR

2 2 Medivir Nrdic base with glbal R&D Headquartered and listed in Stckhlm, Sweden ~ 140 emplyees, f which 90 are in R&D Wrld leading expertise in plymerase and prtease drug targets R&D pipeline: 4 majr internally driven prjects Nrdic cmmercial rganizatin marketing 16 Rx pharmaceuticals Tw innvative specialty care prducts, Olysi and Adasuve recently launched in the Nrdics Tw pharmaceuticals taken frm idea t market: - Olysi (simeprevir) fr treatment f chrnic hepatitis C, licensed t J&J glbally excluding the Nrdics - Xerclear fr treatment f labial herpes, licensed t GSK in Eurpe

3 Financial facts Listed n NASDAQ OMX Stckhlm since 1996 Brad institutinal sharehlder base, >25% EU & US sharehlders Slid financial psitin (430 MSEK end Q2, 14*), n the way t sustainable prfitability Sales in 2013 were 176 MSEK (~25MUSD) CONSOLIDATED INCOME STATEMENT SUMMARY Q2 Q2 FY Cntinuing peratins (MSEK) Net turnver Grss prfit EBITDA EBIT Prfit/lss befre tax Prfit/lss after tax Market Capitalizatin: 4,100 MSEK 590MUSD Cash (June 30)*: 430 MSEK 61 MUSD Debt (June 30): 42MSEK 6 MUSD Revenues Q2, 14: 564 MSEK 81 MUSD Shares Outstanding: Class B: 30,600,027 Class A: 660,000 Optins: 404,374 Fully Diluted: 31,664,401 Net turnver breakdwn Q2 Q2 FY (MSEK) Outlicensing and partnership agreements: Nn-recurrent payments Pharmaceutical sales Ryalties Other services Ttal *Q2 simeprevir ryalties f 500 MSEK nt accunted fr in cash psitin. Including the ryalties, the end Q2 cash psitin was 930 MSEK (133 MUSD) 3

4 Secnd quarter 2014 gd perfrmance fr ur Rx prtfli Our pharmaceuticals Perfrmance Medivir s pharmaceutical prtfli cmprises 16 prescriptin pharmaceuticals marketed in the Nrdic regin. Ging frward we will cntinue t fcus n specialty pharmaceuticals in a grwth phase. In the secnd quarter, ur pharmaceutical sales shwed an increase f 22,2 MSEK, r ~55% cmpared t the same quarter in The increase was primarily due t ur market intrductin f simeprevir (Olysi). New prduct launches Simeprevir (Olysi) was launched in Sweden already in late May and by the end f the perid it was available in all Nrdic cuntries. Adasuve, a new specialty pharmaceutical fr the treatment f agitatin assciated with biplar disrder and schizphrenia was launched in April, alng with the re-launch f Suscard, an established pharmaceutical fr the treatment f angina pectris. Sales and revenues The pharmaceutical prtfli generated sales f 62,9 MSEK, f which simeprevir made up 21,7 MSEK. Fr the secnd quarter we received 500,7 MSEK in ryalties frm ur partner J&J. 4

5 Medivir Cmmercial: A Nrdic cre plus cuntry teams t maximize synergies & catch the full ptential in each cuntry NORDIC TEAM Generating strategy and leading/supprting the cuntry teams t maximize the utput f custmer activities Marketing & Sales Medical Affairs Market Access & Public Affairs Supprt functins COUNTRY TEAMS Fr the daily custmer activities Market Leads Key Accunt Managers Medical Affairs Managers 5

6 OLYSIO launch update -Quick uptake and psitive perceptin acrss the Nrdics Cuntry teams peratinal in NO, SE, DK and FI frm Q1 t prepare successful launches The COSMOS data perceived as being very psitive by custmers Cmpassinate use experience befre launch in all cuntries Quick natinal apprval prcesses SE launch late May fllwed by DK, FI and NO in June Psitive media expsure related t Medivir, Olysi and the new HCV cure pprtunity Supprting treatment guidelines already available in SE and DK Nrdic OLYSIO Sales, MSEK May 2,3 June 19,

7 Simeprevir n the glbal market Japan (SOVRIAD ) Canada (GALEXOS ) USA (OLYSIO )* Russia (SOVRIAD ) EU (OLYSIO ) Mexic (OLYSIO ) Australia (OLYSIO ) * A supplemental New Drug Applicatin has been submitted t the U.S. FDA fr simeprevir in cmbinatin with sfsbuvir based n the data frm the COSMOS trial 7

8 8 Simeprevir Simeprevir sales have grwn rapidly. Simeprevir is part f the nly IFN-free regimen currently in use, based n recent guidelines frm January 2014 and has ~30% market share in the US. J&J`s glbal secnd quarter net sales f simeprevir were 831,8 MUSD, f which 725,4 MUSD were in the US. Medivir s ryalties based n these sales were 500,7 MSEK (54,4 MEUR) fr the secnd quarter. In May, Simeprevir was apprved in the EU fr the treatment f adults with hepatitis C gentype 1 and 4 infectin and is nw als apprved in Mexic and Australia. Phase II COSMOS study results were published in The Lancet n the Wrld Hepatitis Day in July. FDA granted Pririty Review fr a supplementary New Drug Applicatin fr simeprevir (OLYSIO ) in cmbinatin with sfsbuvir, filed by Janssen in May. Tw phase III studies, OPTIMIST 1 and 2, evaluating treatment f hepatitis C-infected patients with simeprevir and sfsbuvir, are well under way. Cntinued strng cmmitment frm J&J in the HCV area

9 Many interesting pprtunities in ur pipeline 9

10 Present fcus in ur fur internally driven R&D prgrams The pipeline was strengthened during the quarter Phase I data have previusly been reprted fr MIV-711, a cathepsin K inhibitr in clinical develpment fr stearthritis (OA). Cmpletin f new preclinical studies prvide supprt f efficacy data fr an OA indicatin. T facilitate new partnerships r jint ventures, a decisin was made t initiate lng term txiclgy studies (6 mnth), which will be cmpleted by mid MIV-247 a cathepsin S inhibitr fr neurpathic pain is currently in preclinical develpment, mving twards clinical phase I studies, expected t cmmence during H Our nucletide HCV inhibitr is presently being evaluated in extensive preclinical safety studies. A preclinical RSV Fusin Inhibitr Prject was recently in-licensed frm Behringer Ingelheim. It cnstitutes a lgical step t strengthen ur presence in infectius diseases and t braden ur pipeline. 10

11 11 Our business mdel Partnerships R&D Market demand Cmmercial Different revenue streams: Out-licensing f prjects Pharmaceuticals In-licensing and acquisitins f pharmaceuticals Sales revenues Ryalty incme Milestne payments In-licensing and acquisitins f prjects

12 Ticker: MVIR Exchange: OMX / NASDAQ Fr mre infrmatin please cntact Rein Piir, EVP Crprate Affairs & IR (rein.piir@medivir.cm) 12