Slide 1: Nubeqa (Darolutamide) – committed to change the treatment paradigm in prostate cancer
Nubeqa (Darolutamide) – committed to change the treatment paradigm in prostate cancer /////////// Investor Webinar February 18, 2022 Christian Rommel Head of R&D, Bayer Pharmaceuticals Robert LaCaze Head of Oncology, Bayer Pharmaceuticals Matthew Raymond Smith M. D., Ph.D., Director of the Genitouri
Slide 2: Agenda
Agenda Welcome 1 Oliver Maier Head of Investor Relations 2 Prepared Remarks Christian Rommel Robert LaCaze Matthew Raymond Smith, M.D, Ph.D. Head of R&D, Head of Oncology, Director of the Genitourinary Malignancies Program, Bayer Pharmaceuticals Bayer Pharmaceuticals Massachusetts General Hospital C
Slide 3: Cautionary statements regarding forward-looking information
Cautionary statements regarding forward-looking information This presentation may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the ac
Slide 4: Oncology is a key focus of our Pharma growth strategy
Oncology is a key focus of our Pharma growth strategy – our ambition is to be among top-10 players by 2030 Bayer Capital Markets Day March 2021: Oncology 4 /// Nubeqa Investor Webinar /// 18th February 2022
Slide 5: Nubeqa is a key cornerstone to grow our Oncology franchise short-to-mid term
Nubeqa is a key cornerstone to grow our Oncology franchise short-to-mid term Launch Brands Main Inline Brands Pipeline Precision molecular oncology Targeted alpha therapies Next generation IO e.g. cell therapy Drive short to mid-term growth Lay foundation for future sustainable growth 5 /// Nubeqa I
Slide 6: Despite significant advancements in prostate cancer treatment there are still high unmet medical needs
Despite significant advancements in the treatment of prostate cancer patients there are still high unmet medical needs Blocking androgen signaling Key Unmet Needs Pituitary gland 1. Extend overall survival (OS) and 1. Chemical castration (ADT*): Prolong Survival delaying the development of inhibitio
Slide 7: Darolutamide is an ARi with a structure associated with low blood-brain barrier penetration
Darolutamide is an ARi with a structure that is associated with low blood-brain barrier penetration Apalutamide3 Enzalutamide2 Qualitative [14C] brain distribution in rats1 Darolutamide Apalutamide Enzalutamide Darolutamide1 Nubeqa Darolutamide 8% Apalutamide 85% Enzalutamide 81% 0% 50% 100% Structu
Slide 8: Prostate cancer is #2 of the most common cancer types in men worldwide
Prostate cancer is at #2 of the most common cancer types in men worldwide with significant unmet medical need Estimated number of new cases in 2020, worldwide, males, all ages Characteristics of Prostate Cancer • Usual onset: age >50 years Lung 1,435,943 (14.3%) Other cancers • Diagnostic method: PS
Slide 9: Results of ARAMIS study demonstrated Nubeqa's strong clinical benefit for mid-stage prostate cancer patients
Results of ARAMIS study demonstrated already Nubeqa’s strong clinical benefit for mid-stage prostate cancer patients Patient progression in prostate cancer ~10+ years (Neo-)Adjuvant Nonmetastatic Metastatic early-stage mid-stage late-stage BCR4 nmCRPC3 mHSPC2 mCRPC1 G7 Drug treated epidemiology ~145
Slide 10: ARAMIS also revealed Darolutamide's positive tolerability profile
On top of strong efficacy, ARAMIS also revealed Darolutamide’s positive tolerability profile ARAMIS1,2 SPARTAN3,4 PROSPER5 Any Grade % Darolutamide (N=954) Placebo (N=554) Apalutamide (N=803) Placebo (N=398) Enzalutamide (N=930) Placebo (N=465) 13.2 % 32.6 % 37.4 % Fatigue 8.3 % 21.4 % 15.7 % 5.2 %
Slide 11: Nubeqa showed a successful market launch in nmCRPC
Based on its strong value proposition for patients and physicians, Nubeqa showed a successful market launch in nmCRPC Rapid progress of External validation of Strong launch performance global launches differentiated profile • 32 commercial market • Approval in China despite no Market launch launches
Slide 12: ARASENS Study Design
12 ARASENS Study Design Global, randomized, double-blind, placebo-controlled phase III study (NCT02799602) Endpoints Docetaxel × 6 Primary: OS Patients (N=1306) • mHSPC Secondary Primary analysis Darolutamide 600 mg twice daily + ADT • ECOG PS 0 or 1 • Time to CRPC • Candidates for ADT 1:1 • Time to
Slide 13: ARASENS Primary Endpoint: Overall Survival
13 ARASENS Primary Endpoint*: Overall Survival Darolutamide significantly reduced the risk of death by 32.5% *Primary analysis occurred after 533 deaths (darolutamide, 229; placebo, 304). CI, confidence interval; NE, not estimable. PRESENTED BY: Matthew R. Smith, MD, PhD
Slide 14: Subsequent Life-Prolonging Therapies
14 Subsequent Life-Prolonging Therapies Darolutamide + ADT + docetaxel Placebo + ADT + docetaxel Subsequent life-prolonging therapy (n=315*) (n=495*) No. (%) of patients with subsequent life-prolonging 179 (56.8) 374 (75.6)† therapy Abiraterone acetate 112 (35.6) 232 (46.9) Enzalutamide 48 (15.2) 13
Slide 15: Overall Survival By Metastatic Stage at Initial Diagnosis
15 Overall Survival By Metastatic Stage at Initial Diagnosis De novo metastatic disease Recurrent metastatic disease PRESENTED BY: Matthew R. Smith, MD, PhD
Slide 16: Key Secondary Endpoints
16 Key Secondary Endpoints Time to CRPC Time to pain progression* *Pain progression was defined by change in the Brief Pain Inventory–Short Form questionnaire worst pain score or initiation of opioid therapy for ≥7 days. PRESENTED BY: Matthew R. Smith, MD, PhD
Slide 17: Key Secondary Endpoints
17 Key Secondary Endpoints Time to first SSE Time to first subsequent antineoplastic therapy PRESENTED BY: Matthew R. Smith, MD, PhD
Slide 18: ARASENS: Treatment-Emergent Adverse Events
18 ARASENS: Treatment-Emergent Adverse Events TEAE, n (%) Darolutamide + ADT + docetaxel Placebo + ADT + docetaxel (n=652*) (n=650*) Any 649 (99.5) 643 (98.9) Worst grade Grade 1 28 (4.3) 35 (5.4) Grade 2 162 (24.8) 169 (26.0) Grade 3 248 (38.0) 232 (35.7) Grade 4 183 (28.1) 181 (27.8) Grade 5 27 (4
Slide 19: Grade 3–4 Adverse Events
19 Grade 3–4 Adverse Events Grade 3–4 AEs in ≥2% of darolutamide- Darolutamide + ADT + docetaxel Placebo + ADT + docetaxel treated patients, n (%) (n=652) (n=650) Any AE 431 (66.1) 413 (63.5) Neutropenia* 220 (33.7) 222 (34.2) Febrile neutropenia 51 (7.8) 48 (7.4) Hypertension 42 (6.4) 21 (3.2) Anem
Slide 20: Adverse Events of Special Interest for AR Pathway Inhibitors
20 Adverse Events of Special Interest for AR Pathway Inhibitors AEs associated with AR pathway Darolutamide + ADT + docetaxel Placebo + ADT + docetaxel inhibitor therapy (n=652) (n=650) Patients, n (%) EAIR/100 PY* Patients, n (%) EAIR/100 PY* Fatigue 216 (33.1) 12.5 214 (32.9) 17.8 Bone fracture 49
Slide 21: ARASENS Conclusions
21 ARASENS Conclusions • Darolutamide in combination with ADT and docetaxel significantly improved OS compared with ADT and docetaxel in patients with mHSPC. Darolutamide reduced the risk of death by 32.5% • Darolutamide improved OS despite a high rate of subsequent life-prolonging systemic therapy
Slide 22: ARASENS strengthens Darolutamide's clinical profile
ARASENS strengthens Darolutamide’s clinical profile – strong survival benefit with favourable tolerability Efficacy Tolerability Primary endpoint Selected secondary endpoints ARAMIS Metastasis free survival Overall survival nmCRPC prolongation by 22.0 months, 31% risk reduction (HR=0.69, p=0.003) 59
Slide 23: We are committed to make Darolutamide available to a broad spectrum of prostate cancer patients
We are committed to make Darolutamide available to a broad spectrum of prostate cancer patients Patient progression in prostate cancer ~10-15 years (Neo-)Adjuvant Nonmetastatic Metastatic early-stage mid-stage late-stage BCR4 nmCRPC3 mHSPC2 mCRPC1 G7 Drug treated epidemiology ~145k ~85k ~46k ~75k ~1
Slide 24: Darolutamide with the chance to become a foundational drug in prostate cancer – peak sales potential lifted to >€3bn
Darolutamide with the chance to become a foundational drug in prostate cancer – peak sales potential lifted to >€3bn Planned submissions for mHSPC label extension • Highly efficacious ARi • First to show more than 30% risk Efficacy ARASENS primary reduction of death in nmCRPC and endpoint met mHSPC
Slide 25: We have significantly advanced Bayer's Oncology franchise over the last 5 years
We have significantly advanced Bayer’s Oncology franchise over the last 5 years Oncology planned to be a key growth pillar for Bayer Pharma • Doubled number of marketed products from 3 to 6 Growth in product • >75 commercialization approvals across multiple indications portfolio • Broader tumor focu
Slide 26: Questions & Answers
Questions & Answers Christian Rommel Robert LaCaze Matthew Raymond Smith, M.D, Ph.D. Head of R&D, Head of Oncology, Director of the Genitourinary Malignancies Program, Bayer Pharmaceuticals Bayer Pharmaceuticals Massachusetts General Hospital Cancer Center 26 /// Nubeqa Investor Webinar /// 18th Feb