Q Conference Call 8 May 2014 Presenting team

Transcription

1 Q Cnference Call 8 May 2014 Presenting team Maris Hartmanis, President and CEO Charltte Edenius, EVP Develpment Richard Bethell, EVP Discvery Research Rein Piir, EVP Crprate Affairs & IR

2 Reflectins n first quarter 2014 Maris Hartmanis, CEO 2

3 First quarter 2014 things are n track and mving Our pharmaceuticals Our pharmaceutical prtfli cmprises 16 prescriptin pharmaceuticals that are marketed in the Nrdic regin, where we in the future will have a strng fcus n specialty pharmaceuticals in the grwth phase. During the first quarter, ur pharmaceutical sales experienced a slight dwnturn, primarily due t fewer unit sales fr Mllipect as a result f a mild influenza and cmmn cld seasn. In April, we re-launched Suscard, an established pharmaceutical fr the treatment f angina pectris. The pharmaceutical prtfli generated a turnver f SEK 46.4 millin. During the first quarter Medivir received SEK 161 millin in ryalty frm ur partner J&J. Adasuve was launched in April, a new specialist pharmaceutical fr the treatment f agitatin assciated with biplar disrder and schizphrenia. The rganisatin is well prepared fr the launch f simeprevir in the Nrdic regin, which we expect t happen at the end f the secnd quarter. 3

4 Cnslidated incme statement CONSOLIDATED INCOME STATEMENT SUMMARY Q1 Q1 FY Cntinuing peratins (MSEK) Net turnver Grss prfit EBITDA EBIT Prfit/lss befre tax Prfit/lss after tax

5 Net turnver breakdwn Net turnver breakdwn Q1 Q1 FY (MSEK) Outlicensing and partnership agreements: Nn-recurrent payments Pharmaceutical sales Ryalties Other services Ttal

6 Net turnver cntinuing peratins per quarter, MSEK Q4-13 Q1-14 Ryalty Milestnes, Up frnt & Outlicensing revenues Pharmaceuticals sales revenues 6

7 Net turnver cntinuing peratins per quarter, MSEK Q2-12 Q3-12 Q4-12 Q1-13 Q2-13 Q3-13 Q4-13 Q1-14 Pharmaseutical sales revenues Milestnes, Up frnt & Outlicensing revenues Ryalty 7

8 2014 ur mmentum is strng Mving twards sustainable prfitability, simeprevir being a imprtant cmpnent. Simeprevir is selling well part f the nly IFN-free regimen currently in use based n recent guidelines frm January During the first quarter simeprevir had a ~50% market share in Japan, a ~20% market share in the US and cntinues t develp psitively. Our Nrdic cmmercial rganizatin will sell simeprevir and enable additinal pprtunities such as Adasuve. Our R&D pipeline has three internally driven prjects, which all are advancing and will enable new partnerships r jint ventures. This will enable us t fcus n value creatin and risk diversificatin. 8

9 Simeprevir After the launch in December, simeprevir sales have grwn rapidly: ~20% market share in the US currently. The glbal first quarter net sales f simeprevir were 354 MUSD, f which 291 MUSD were sales in the US. Medivir s ryalties based n these sales were 161 MSEK (18 MEUR) fr the first quarter. Simeprevir received a psitive recmmendatin frm EMA s advisry cmmittee, the Cmmittee fr Medicinal Prducts in Human Use (CHMP), fr the treatment f adults with chrnic hepatitis C and was apprved in Russia. Interim results (SVR4) presented frm a phase II all-ral cmbinatin study f simeprevir and samatasvir (IDX719). Final results (SVR12) presented frm a phase IIa study evaluating simeprevir and daclatasvir in hepatitis C patients f gentype 1. Final results presented frm the phase III ATTAIN study (treatment with simeprevir and telaprevir). Final results (SVR12) were reprted frm the COSMOS study f simeprevir and sfsbuvir in cirrhtic and nncirrhtic patients. Tw phase III studies evaluating treatment f hepatitis C-infected patients with simeprevir and sfsbuvir have recently been initiated. A supplemental New Drug Applicatin has been submitted t the FDA in the US fr nce-daily use f simeprevir in cmbinatin with sfsbuvir. 9

10 Develpment Highlights Q Charltte Edenius, EVP Develpment 10

11 MIV a cathepsin K inhibitr in clinical develpment fr stearthritis (OA) Ostearthritis A chrnic prgressive disease characterized by excessive bne resrptin and cartilage degradatin leading t pain and disability Medical need The mst cmmn jint disease, affecting 10-15% f the US ppulatin and with mre than 80M sufferers in the US, Eurpe and Japan* MIV-711 mechanism f actin Inhibits cathepsin K, which degrades bth bne and cartilage cllagen Reduces bimarkers reflecting these prcesses Prtects frm structural changes in OA mdels Tw abstracts with MIV-711 data presented at the OA cnference, Paris (April 24-29): Nn-clinical: nvel results demnstrate that nce daily MIV-711 reverse subchndral bne lss in an experimental mdel f OA Clinical: 28 days treatment f pst menpausal wmen (100 mg, OD) reduced urinary bimarkers fr bne resrptin and cartilage degradatin with up t 98% and 55%, respectively MIV preparing fr clinical phase II and partnership *Datamnitr,

12 MIV-247 a cathepsin S inhibitr fr neurpathic pain Neurpathic pain Assciated with a lesin r disease affecting the smatsensry system Includes e.g. diabetic neurpathic pain, pstherpetic neuralgia, neurpathic lwer back pain, cancer and HIV related pain, Mechanism f actin Cathepsin S is a validated target in a brad range f preclinical mdels f pain Inhibitin f Cathepsin S prevents inflammatry damage t the sensry nervus system Medical need Current treatments incl. anticnvulsants and antidepressants - Pain persists in 75% patients with at best a 50% reductin in verall pain - Significant side effects e.g. dizziness, smnlence MIV-247 Nn-clinical in viv studies supprt the develpment f MIV-247: - as mntherapy (fast and sustained efficacy seen in mdels f neurpathic pain) - as cmbinatin therapy (imprved efficacy shwn when cmbined with e.g. gabapentin) MIV IND phase twards clinical trials 12

13 Simeprevir n the market Japan (SOVRIAD ) Canada (GALEXOS ) USA (OLYSIO )* Russia (SOVRIAD ) EU: Psitive recmmendatin frm CHMP, apprval expected in May * 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 13

14 Simeprevir - nging and recently presented studies with PegIFN/ribavirin cmbinatin APASL (Brisbane, Feb) ATTAIN study (simeprevir vs telaprevir, prir null r partial respnder patients (N=744)) Simeprevir demnstrated nn-inferirity while having a superir safety prfile (lwer adverse event frequency, fewer serius adverse events, and a lwer incidence f anaemia GT1b patient subgrup analyses f phase III data (f imprtance fr the Asian markets) 85% and 86% cure rates in treatment naïve and prir relapsed HCV GT1b infected patients EASL (Lndn, April) Eurpean patient subgrup analyses f phase III data 87% and 88% cure rates in treatment naïve and prir relapsed HCV GT1 patients RESTORE (HCV GT4 treatment naïve and experienced including cirrhtics) high SVR12 rates (83% in treatment-naïve; 86% in prir relapsers; 60% in partial respnders and 40% in null respnders) 95% f patients with 24 weeks ttal treatment duratin achieved SVR12 On-ging studies: 12 weeks full stp single-arm study in treatment naïve GT1 and GT4 patients China - efficacy, safety & tlerability and pharmackinetics in treatment naive GT1 HCV patients (results available by year end) 14

15 COSMOS study an IFN-free cmbinatin study f simeprevir and sfsbuvir in hard-t-cure patients Arm 1 SMV + SOF + RBV Pst-treatment fllw-up Arm 2 SMV + SOF Pst-treatment fllw-up Arm 3 SMV+SOF+RBV Pst-treatment fllw-up Arm 4 SMV + SOF Pst-treatment fllw-up Weeks SMV 150 mg QD + SOF 400 mg QD Primary endpint SVR12 Chrt 1: METAVIR F0-F2, prir null respnders t PR therapy (n=80) Chrt 2: METAVIR F3-F4, prir null respnders r treatment-naïve (n=87) 15

16 SMV: simeprevir; SOF: sfsbuvir; RBV: ribavirin 16 EASL: COSMOS final data Chrt 1: Prir null respnders (METAVIR F0-F2) Chrt 2: naïves and nulls (METAVIR F3/4) N benefit demnstrated by additin f ribavirin High SVR12 rates regardless f baseline characteristics (HCV GT 1 subtype, Q80K plymrphism, METAVIR scre, IL28B GT r prir treatment histry) SMV/SOF QD +/- RBV was safe and well tlerated High SVR12 rates, 93-96%, with 12 weeks nce daily treatment with SMV + SOF in hard t cure patients

17 EASL: COSMOS Chrt 2 final data SVR12 amng patient subgrups with advanced liver disease (METAVIR scres F3-F4) 12 weeks treatment SVR12 SMV/SOF % (n/n) SMV/SOF + Rbv % (n/n) All patients 93 (13/14) 93 (25/27) HCV GT1a withut the Q80K plymrphism HCV GT1a with the Q80K plymrphism 88 (7/8) 93 (13/14) 100 (3/3) 88 (7/8) HCV gentype 1b 100 (3/3) 100 (5/5) Patients with METAVIR F4 scres 86 (6/7) 91 (10/11) SMV: simeprevir; SOF: sfsbuvir; RBV: ribavirin 17

18 Onging IFN-free studies with simeprevir - data driven apprach t explring different interfern-free cmbinatins Class Cmpund Partner Status PI Nuc Simeprevir Sfsbuvir Janssen OPTIMIST 1: null + naives (F0-3), 8 r 12 weeks (n=300) OPTIMIST 2: null + naïve s (F4), 12 weeks duratin (n=100) - n ribavirin in either study PI NS5A Simeprevir IDX719 Janssen Idenix Simeprevir JNJ Janssen Phase II n its way HELIX-1: Phase II, Gt1b and 4 (150 mg SMV + 50 mg SAM + RBV-> 85% SVR4) PI NS5A NNI Simeprevir IDX719 TMC055 Simeprevir JNJ TMC055 Janssen Idenix Janssen Janssen HELIX-2: Phase II started Dec-13 (Gt1) Phase II started Dec-13 IFN: interfern; Nuc: nucletide plymerase inhibitr; NNI: nn-nucleside plymerase inhibitr; NS5A: NS5A replicatin cmplex inhibitr; PI: prtease inhibitr 18

19 Q / A 19

20 Ticker: MVIR Exchange: OMX / NASDAQ Fr mre infrmatin please cntact Rein Piir, EVP Crprate Affairs & IR (rein.piir@medivir.cm) 20