Bayer Pharmaceuticals
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39th Annual J.P. Morgan Healthcare Conference
Stefan Oelrich,
President Pharmaceuticals
January 13, 2021
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 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 http://www.bayer.com/.
The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Guidance at constant currencies, not including portfolio divestitures if not mentioned differently.
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Driving Performance and Delivering New Growth Opportunities
Maximize the value of the existing portfolio
Exploit full potential of Xarelto and Eylea
Deliver on key pipeline assets
Three new potential blockbusters in Oncology, Cardiovascular and Women's Healthcare
Take advantage of breakthrough technologies
Expand into Cell & Gene Therapy
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After a Challenging Q2, V-shaped Recovery in Q3
Sales Growth vs Prior Year (cpa) by Quarter
5.3% | 3.9% | 5.9% | 7.2% |
-1.8% 3.9%
-8.8%
Q1 | Q2 | Q3 | Q4 |
2019 2020
EBITDA margin before special items
34.1% | 35.1% | 33.3% | 34.3% | 33.3% | 35.8% |
29.9% | |||||
Q1 | Q2 | Q3 | Q4 |
2019 2020
* Sales related growth rates are reported as currency and portfolio adjusted, and compared to the previous year
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- Pharma business recovering in Q3 from Covid-19 impact
- Xarelto´s growth trajectory intact (+13% YTD)
- Stringent cost management to protect the bottom-line
- Outlook for FY2020 confirmed on November 3, 2020:
- Expected Sales growth: -1%
- Expected underlying EBITDA margin: 34-35%
Increased Momentum to Deliver Innovation for Patients
Major achievements 2019/2020
Phase Transitions;
New Trials1
• Finerenone HFmr/pEF
• Aflibercept high dose nAMD & DME
• Aflibercept retinopathy of prematurity
• Regorafenib IO combi
• Regorafenib glioblastoma
• Factor XI portfolio
• P2X3 inhibitor
• PEG ADM inhale
• Runaciguat
1 Key Phase II and III trials only
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Positive Phase III
Trial Results
- Finerenone (FIDELIO-DKD)
- Vericiguat (VICTORIA)
- Copanlisib (CHRONOS-3)
- Darolutamide (ARAMIS OS-data)
- Rivaroxaban (PRONOMOS,
VOYAGER PAD, EINSTEIN-Jr.)
Filings & | External | ||||
Approvals | Innovation | ||||
• | Darolutamide | • | BlueRock | ||
• | Larotrectinib | • | AskBio | ||
• | Vericiguat | • | KaNDy | ||
• | Finerenone | • | Atara | ||
• | Eylea PFS | • | Daré Bioscience | ||
• | Rivaroxaban | • | investments | ||
pediatric |
A Successfully Matured Late-stage Pipeline that May Deliver Three New Potential Blockbusters
Nubeqa1 ̶AR-Antagonist
- Launched in nmCRPC - global roll-out underway
• Differentiated clinical profile - 31% OS benefit & favourable safety profile (ARAMIS)
• Prim. completion of phase III trial in mHSPC mid-2021e (ARASENS)
- Peak sales potential ≥€1bn
KaNDy NT-814 ̶Dual NK 1,3 Receptor-Antagonist
- First-in-classoral, non-hormonal,once-dailyneurokinin-1,3 receptor antagonist
- Positive phase IIb data for the treatment of frequent menopausal symptoms
- Phase III to be initiated in 2021
- Peak sales potential >€1bn
Finerenone ̶MR-Antagonist
- Significant reduction of renal and cardiovascular outcomes in patients with CKD and T2D
- Filed in key markets for CKD in T2D
- Phase III trials in CKD/T2D (FIGARO) and in HFm/pEF (FINEARTS-HF) ongoing
- Peak sales potential ≥€1bn
1In collaboration with Orion Corporation; 2In collaboration with Merck & Co. Inc., Kenilworth, NJ, USA
Vericiguat2 ̶sGC-Stimulator
- Significant reduction of the combined risk of CV- death or HF-hospitalization in HFrEF-patients (VICTORIA)
- Dosed on top of existing HF-therapies
- Filed - FDA action date January 20, 2021
- Peak sales potential ~€500m
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We Provide the Resources Needed for a Successful Commercialization of our Late-stage Pipeline Assets
Asset
Nubeqa1
Finerenone
KaNDy NT-814
Vericiguat2
Short- to mid-term Investment Areas
- Continued global rollout in additional markets
- Preparation for ARASENS readout
- Continue to leverage positive OS data and differentiated safety profile
- Preparation for potential first launches in 2021
- Investing to re-enter the US-market in CV diseases
- Preparation for FIGARO readout
- Continuation of the HFm/pEF development program
- Initiation of pivotal Phase III trial in 2021
- Potential launches in first markets in 2021
1In collaboration with Orion Corporation; 2In collaboration with Merck & Co. Inc., Kenilworth, NJ, USA
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Increased Focus on External Innovation to Accelerate Replenishment of Pipeline and Broaden Modalities
Selected high-level overview
Momentum Significantly Increased
- More than 20 Transactions signed in 2020
- Deals covering the entire spectrum from equity investments (with LEAPS), over licensing agreements to acquisitions
- Active portfolio management taking internal assets outside (e.g. Vincera Pharma)
Strategic Focus
- Venturing into new modalities (Cell & Gene Therapy)
- Broadening the Oncology pipeline (e.g. Systems Oncology, Atara)
- Commercial partnerships in China (e.g. Hua Medicine)
- Deals in the Digital Space (e.g. R&D: Schroedinger, Exscientia, Recursion; Commercial: One Drop)
- Continued augmentation of core TAs: (WHC: KaNDy)
- Strengthening the Cardiovascular pipeline (PeptiDream, Broad Institute)
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Our Cell & Gene Therapy Strategy Builds on Four Integrated Platforms to Drive the Next Wave of Innovation at Pharma
Gene Augmentation | Stem Cells |
Allogeneic Cell Therapy
Collaboration with Atara
Biotherapeutics
- Industry-leadingAAV vector gene augmentation platform
- Monogenic & pathway diseases
- CDMO business (Viralgen) already generates revenues
- Creating induced pluripotent stem cells (iPSC) with broad differentiation
- Create an entirely new generation of cellular medicines
- IND for lead program in Parkinson's disease
- Next-generation,mesothelin-directedCAR-T cell therapies
- Focus on potential allogeneic, "off the shelf" tumor therapies
Gene Editing as cross-functional enabling technology
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Comprehensive Cell & Gene Therapy Pipeline that has Proven Ability to Yield Commercial Stage Assets
Project | Discovery | Preclinical | Phase I/II | |||
Pompe Disease - Gene Therapy
Parkinson's Disease - Gene Therapy
Congestive Heart Failure - Gene Therapy
Factor VIII - Gene Therapy1
MSLN CAR-T Therapy (ATA2271)2
Parkinson´s Disease - Cell Therapy
MSLN CAR-T Therapy (ATA3271)2
> 15 preclinical assets
- Comprehensive Cell & Gene Therapy pipeline established
- Pipeline already comprises 6 clinical assets and multiple IND generating opportunities
- AAV technology included in commercialized assets
1 In collaboration with Ultragenyx; | 2 In collaboration with Atara Biotherapeutics |
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Key Takeaways
1 | We continue to maximize the value of the existing portfolio |
2 | Increased momentum to deliver innovation - late-stage pipeline may deliver three new |
potential blockbuster products | |
3 | We provide the resources needed for a successful commercialization of our late-stage |
pipeline assets | |
4 | Cell & Gene Therapy platform in place to drive the next wave of breakthrough innovation |
5 | C>-Pipeline established - 6 clinical assets and multiple IND generating opportunities |
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Bayer Pharmaceuticals
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39th Annual J.P. Morgan Healthcare Conference
Stefan Oelrich,
President Pharmaceuticals
January 13, 2021
Abbreviations
AAV | Adeno-associated virus | IO | Immuno-oncology |
AR | Androgen receptor | iPSC | Induced pluripotent stem cells |
CAR-T | Chimeric antigen receptor modified T cells | mHSPC | Metastatic hormone sensitive prostate cancer |
CDMO | Contract development and manufacturing organization | MRA | Mineralocorticoid receptor antagonist |
CKD | Chronic kidney disease | nAMD | Neovascular age-related macular degeneration |
C> | Cell and gene therapy | NK | Neurokinin |
cpa | Currency and portfolio adjusted | nmCRPC | Non-metastatic castration resistant prostate cancer |
CV | Cardiovascular | OS | Overall survival |
DKD | Diabetic kidney disease | PAD | Peripheral artery disease |
DME | Diabetic macula edema | PFS | Pre-filled syringe |
EBITDA | Earnings before interest, tax, depreciation, and amortization | R&D | Research & Development |
FDA | U.S. Food and drug administration | sGC | Soluble guanylate cyclase |
HF | Heart failure | T2D | Type 2 diabetes mellitus |
HFmrEF | Heart failure with mid-range ejection fraction | YTD | Year to date |
HFpEF | Heart failure with preserved ejection fraction | ||
HFrEF | Heart failure with reduced ejection fraction | ||
IND | Investigational New Drug |
13J.P. Morgan Healthcare Conference, January 13, 2021
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Bayer AG published this content on 13 January 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 13 January 2021 13:11:02 UTC