Dr. Jörg Möller, Head of Global Clinical Development at Bayer HealthCare Pharmaceuticals

Transcription

1 Credit Suisse 2012 Healthcare Conference Innovations at Bayer Pharma Dr. Jörg Möller, Head of Global Clinical Development at Bayer HealthCare Pharmaceuticals November 14, 2012

2 Science For A Better Life This presentation may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer s public reports which are available on the Bayer website at The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. Disclaimer

3 Leading Positions in Key Healthcare Markets Sales Split by Segment 2011 Pharma 9,949m Leading positions in key therapeutic categories 25% 58% 20% Consumer Care 3,534m Global #2 in OTC-pharmaceuticals 7% 14% Medical Care 2,500m #1 in fluid injection systems, #1 in contrast media, #4 in blood glucose meters HealthCare 17,169m Animal Health 1,186m Global #5 Page 1 Credit Suisse 2012 Healthcare Conference Nov At The Verge of a Business-Transforming New Product Cycle in Pharma Xarelto Eylea (VEGF Trap-Eye) Radium-223 Dichloride (Alpharadin) Stivarga (Regorafenib) Riociguat > 2bn* 1bn* 1bn* 1bn* > 0.5bn* HealthCare s top priority remains to successfully commercialize the new pharmaceutical products Page 2 Credit Suisse 2012 Healthcare Conference Nov *peak sales estimates CTEPH: Chrionic thrmoboemblic pulmonary hypertension

4 Xarelto Effective Anticoagulation For More Patients 1) Clinical 1 Breadth of indications: met or exceeded primary efficacy endpoint in 11/11 phase III studies 2) Regulatory EU: CHMP recommendation for approval for the treatment of PE and prevention of recurrent DVT and PE US: Approved for treatment of DVT, PE and to reduce the risk of recurrent DVT and PE Filed for secondary prevention of ACS in Europe and US 3) Marketing Launched in 120 countries for VTE prevention following total knee/hip replacement surgery* Launched in > 50 countries in SPAF* and DVT treatment* Peak sales potential > 2bn Euro Page 3 Credit Suisse 2012 Healthcare Conference Nov * as of October, 2012 SPAF: prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, DVT: deep vein thrombosis; VTE: Venous thromboembolism; ACS: Acute coronary syndrome Xarelto Expect to Exceed Sales Target for 2012 of m Germany with outstanding launch performance; market share 1 ~23% vs. dabigatran ~9% US 2 : became #1 preferred brand among Cardiologists for AF and among Orthopedic Surgeons for Orthopedic use 3 Brazil: strong launch, ~22% market share 1 ; starting to break warfarin loyalty France: roll-out for SPAF started in September 2012, market share 1 6-7% Spain: roll-out for SPAF started in September 2012 Japan: market share still low around 4%; two week Rx restriction UK: Acceptance for novel OACs generally low; market share ~2-3%, growth in SPAF Canada: obtained reimbursement; market share 1 ~ 7% Page 4 Credit Suisse 2012 Healthcare Conference Nov Status as of October, 2012 SPAF: prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, 1: retail anticoagulants; ex manufacturer prices; 2: marketed by J&J 3: September 2012 proprietary ATU survey

5 Xarelto - Exploring Potential for More Complete Protection in CAD and PAD Coronary Artery Disease (CAD) The most common cause of cardiovascular disease 7.3 million deaths worldwide every year One-third to one-half of all middle-aged men and women in high income countries are expected to develop CAD during their lifetime Peripheral Artery Disease (PAD) Often undiagnosed Affects over 27 million people in EU and North America A powerful risk marker of cardiovascular disease Globally, approximately 20% of adults older than 55 years have evidence of PAD Antiplatelet agents such as aspirin are current standard of care Despite providing significant protection, patients with CAD or PAD remain at risk of cardiac events Antiplatelets and anticoagulants have complementary mechanisms of action and when combined have been shown to improve outcomes in ACS patients We now have the opportunity to investigate the potential for more complete long- term protection with combined antiplatelet and anticoagulant therapy in patients with CAD and PAD: Page 5 Credit Suisse 2012 Healthcare Conference Nov Study Design Randomized, controlled global phase III study at least 19,500 patients Rivaroxaban 2.5 mg BID + Aspirin 100 mg OD Rivaroxaban 5 mg BID Aspirin 100 mg OD Study is event driven expected duration 3-4 years involving four periods (screening, run-in, follow-up and washout ) Primary Efficacy Endpoint: CV Death, MI, Stroke Primary Safety Endpoint: Major Bleeding Study is event driven expected duration 3-4 years involving four periods (screening, run-in, follow-up and washout) First patient expected to be enrolled Q Page 6 Credit Suisse 2012 Healthcare Conference Nov

6 Eylea A New Treatment Option For Various Retinal Diseases Expect first launches in wet AMD in Australia, Germany, Japan and UK end Launch team in place, staffing in various countries ongoing Co-promotion agreement with Santen, a leading ophthalmic pharmaceutical company in Japan established Regeneron reported encouraging uptake in the first year after launch in the US 2 Positive phase III data in CRVO - filing targeted for Q in Europe Late-stage clinical program underway addressing different back-of-the eye diseases including mcnv and DME Peak sales potential 1bn Euro ex-us AMD: age-related macular degeneration, CRVO: central retinal vein occlusion Page 7 Credit Suisse 2012 Healthcare Conference Nov mcnv: Myopic choroidal neovascularization; DME: Diabetic macular edema 1:subject to regulatory approval in EU 2 :Marketed by Regeneron; Regeneron has exclusive rights in the US Eylea Positive Clinical Data in CRVO Phase III program with two studies (COPERNICUS, GALILEO) in central retinal vein occlusion (CRVO) VEGF Trap-Eye vs. sham control injection Both studies met primary endpoint: Visual acuity change vs. baseline after 6 months of treatment Positive one-year results confirm primary endpoint results seen after 24 weeks Percentage of patients with improvement of vision of at least 15 letters after 6 months 22.1% 12.3% Sham injections GALILEO: p< % 56.1% VEGF Trap-Eye 2 mg monthly COPERNICUS: p< Filing in CRVO targeted for Q in Europe Page 8 Credit Suisse 2012 Healthcare Conference Nov CRVO: Central Retinal Vein Occlusion

7 Stivarga (Regorafenib) A Novel Multi-Kinase Inhibitor with 3-Dimensional Mode of Action Inhibition of proliferation of certain tumor cells Inhibition of tumor microenvironment signals Inhibition of neoangiogenesis Regorafenib is an oral tumor deactivation agent that potently blocks multiple protein kinases, including kinases involved in: Tumor angiogenesis (VEGFR1, -2, -3, TIE2) Oncogenesis (KIT, RET, RAF-1, BRAF, BRAFV600E) Tumor microenvironment (PDGFR, FGFR) Page 9 Credit Suisse 2012 Healthcare Conference Nov VEGFR: Vascular endothelial growth factor receptor; TIE2: Tyrosine kinase with immunoglobulin-like and EGF-like domains ; PDGFR: Platelet derived growth factor receptor; FGFR: Fibroblast growth factor receptor; Stivarga has Potential in Different Forms of Cancer Phase III in mcrc (CORRECT trial) showed a 29% improvement in Overall Survival vs. placebo US: launched Europe: filed - preparing for launch 1 for early 2013 Japan: filed - priority review granted Phase III in mgist (GRID trial) showed improvement in Progression-free Survival versus placebo (73% reduction in the risk of progression or death) US: Filed for metastatic/unresectable GIST in the US priority review granted; orphan drug status for GIST obtained Europe: filing 1H 2013e Clinical studies to explore efficacy in liver cancer (2 nd line) as well as colorectal cancer (adjuvant therapy after resection of liver metastases) under initiation Peak sales potential 1bn Euro Page 10 Credit Suisse 2012 Healthcare Conference Nov mcrc: Metastatic colorectal cancer; mgist: Metastatic gastrointestinal cancer *subject to regulatory approval

8 Alpharadin Addressing Unmet Need for Treating Cancer Bone Metastases Alpharadin (Radium-223 Dichloride) is an alpha-pharmaceutical delivering highly energetic, short ranging radiation; in-licensed from Algeta Radium as natural bone seeker targeting bone metastases ALSYMPCA (phase III) trial in symptomatic CRPC patients with bone metastases stopped early Alpharadin (Radium-223 Dichloride) demonstrated 44% improvement in overall survival First submissions targeted before end of 2012 Broader clinical development program in preparation Tumor cells Newly formed bone Bone metastases Peak sales potential 1bn Euro Radium-223 deposition highly localized tumor cell killing Page 11 Credit Suisse 2012 Healthcare Conference Nov CRPC: Castration-resistant prostate cancer Riociguat: Forms and Epidemiology of Pulmonary Hypertension (PH) PH encompasses multiple disease subtypes but approved treatments are only indicated for pulmonary arterial hypertension (PAH) ~ 700,000 patients diagnosed 1 with diseases related to / including PH with ~ 300,000 patients thereof being potentially eligible for PH treatment ~30,000 PAH ~20,000 CTEPH ~410,000 2 PH owing to lung disease ~240,000 PH-LVD Page 12 Credit Suisse 2012 Healthcare Conference Nov Diagnoses estimated in 2009 in US, EU5, J; 2 Thereof ~ <20% could be treated for PH CTEPH: Chronic thromboembolic pulmonary hypertension LVD: Left ventricular disease

9 Riociguat A New Mode of Action Pulmonary hypertension (PH) is associated with endothelial dysfunction, impaired synthesis of nitric oxide (NO) and insufficient stimulation of the NO-sGC-cGMP pathway Riociguat targets sgc to increase production of cgmp Stimulates native form of sgc directly (independently of NO) Activity unaffected by depleted NO levels Makes sgc more sensitive to the body s own residual / existing NO Riociguat sgc cgmp Nitric Oxide (NO) Vasodilatation Page 13 Credit Suisse 2012 Healthcare Conference Nov sgc: Soluble guanylate cyclase; cgmp: Cyclic guanosine monophosphate Successful Phase III Trial in PAH (PATENT-1) Riociguat demonstrated highly significant efficacy and robust results The statistically significant effect was consistently demonstrated Primary endpoint met: significant improvement in 6MWD from baseline after 12 weeks compared with placebo (36m; p<0.0001) Significant improvement observed in relevant secondary endpoints, including PVR, NT-pro BNP, WHO FC, TTCW, Borg dyspnea score Efficacy observed In both treatment-naïve and pre-treated PAH patients Riociguat was generally well tolerated with a good safety profile in patients with PAH The efficacy benefits were improved and sustained in an exploratory analysis in the long-term extension study (PATENT-2) 6MWD: Six minute walking distance; PVR: Pulmonary vascular resistance; NT-pro BNP: N-terminal pro brain natriuretic peptide WHO FC: World health organization functional class; TTCW: Time to clinical worsening; PAH: Pulmonary arterial hypertension Page 14 Credit Suisse 2012 Healthcare Conference Nov

10 Successful Phase III Trial in CTEPH (CHEST-1) CHEST-1 study shows Riociguat to be the first ever drug to consistently demonstrate clinical efficacy in a placebo-controlled trial in CTEPH Primary endpoint met: significant improvement in 6MWD from baseline after 16 weeks compared with placebo (46m; p<0.0001) Significant improvement observed in relevant secondary endpoints PVR, NT-pro BNP and WHO FC Efficacy was shown in patients inoperable CTEPH or persistent/recurrent PH after PEA Riociguat was generally well tolerated with a good safety profile in patients with CTEPH The efficacy benefits were improved and sustained in an exploratory analysis in the long-term extension study (CHEST-2) CTEPH: Chronic thromboembolic pulmonary hypertension; 6MWD: Six minute walking distance; PVR: Pulmonary vascular resistance NT-pro BNP: N-terminal pro brain natriuretic peptide; WHO FC: World health organization functional class; PEA: Pulmonary endarterectomy Page 15 Credit Suisse 2012 Healthcare Conference Nov Exploratory Phase II Study in PH-sLVD (LEPHT) Data presented at AHA Key findings (exploratory Phase IIb study) in patients with PH-sLVD and HF: Change from baseline in mpap with Riociguat not stat. significantly different vs. placebo after 16 weeks primary efficacy endpoint not met (study not powered for efficacy) Significant effects in Riociguat 2 mg titration target arm vs. placebo at 16 weeks: Significantly increased cardiac index without changing HR or systemic BP Significantly decreased SVR and PVR Significantly improved QoL (MLHF total score) Riociguat was well tolerated and had a good safety profile in this Phase IIb study These findings indicate that restoration of sgc cgmp signaling with an oral sgc stimulator can safely improve hemodynamics even in severe HF with PH-sLVD PH-sLVD: PH owing to systolic left ventricular dysfunction Page 16 Credit Suisse 2012 Healthcare Conference Nov HF: Heart failure; HR: Heart rate; BP: Blood pressure; mpap: Mean pu,monary arterial pressure SVR: systemic vascular resistance; PVR: Pulmonary vascular resistance; QoL: Quality of life

11 Riociguat Next Milestones Filing in PAH and CTEPH targeted for 1H 2013 Update on potential next steps in the development program for Riociguat 1H 2013 Page 17 Credit Suisse 2012 Healthcare Conference Nov CTEPH: Chronic thromboembolic pulmonary hypertension PAH: Pulmonary arterial hypertension PH-LVD: PH owing to left ventricular dysfunction Expanding the Hemophilia Franchise With a Long-Acting Recombinant Factor VIII B-domain deleted recombinant FVIII (BDD-rFVIII) that has undergone site-specific PEGylation (BAY ) Attachment of PEG extends halflife without reducing FVIII activity Phase I data showed significantly prolonged half-life vs. Kogenate FS BAY was well tolerated A combined Phase II/III study started summer 2012 Page 18 Credit Suisse 2012 Healthcare Conference Nov

12 Expected Major Pipeline Newsflow 2012 / 2013 Page 19 Credit Suisse 2012 Healthcare Conference Nov Note: primary completion estimates according to postings at clinicaltrials.gov

13 Science For A Better Life Date Event Publication Wednesday, November 21, 2012 Thursday, February 28, 2013 Thursday, April 25, 2013 Friday, April 26, 2013 Wednesday, July 31, 2013 Thursday, October 31, 2013 Meet Management in Tokyo Investor Conference Call Investor Conference Call Annual General Meeting Investor Conference Call Investor Conference Call Investor Conference 2012 Annual Report First Quarter 2013 Results Stockholders Newsletter Second Quarter 2013 Results Stockholders Newsletter Third Quarter 2013 Results Stockholders Newsletter Reporting Events and AGM

14 Science For A Better Life Dr. Alexander Rosar Head of Investor Relations Phone: alexander.rosar@bayer.com Dr. Jürgen Beunink Phone: juergen.beunink@bayer.com Judith Nestmann Phone: judith.nestmann@bayer.com Peter Dahlhoff Phone: peter.dahlhoff@bayer.com Dr. Olaf Weber Phone: olaf.weber@bayer.com Fabian Klingen Phone: fabian.klingen@bayer.com Investor Relations Contacts