Nxera Pharma Co., Ltd. · TSE:4565
Nxera Pharma — H1 2021 Earnings Presentation
33 slides from Nxera Pharma's earnings presentation, Aug 12, 2021
Slide 1: H1 FY2021 Financial Results
NON-CONFIDENTIAL H1 FY2021 Financial Results Six-month period ended June 30, 2021 August 12, 2021 | Sosei Group Corporation (TSE:4565)
Slide 2: Disclaimer
Disclaimer The material that follows is a presentation of general background information about Sosei Group Corporation and its subsidiaries (collectively, the “Company”) as of the date of this presentation. This material has been prepared solely for informational purposes and is not to be construed
Slide 3: Agenda
Agenda 1 Overview of Financial Results 2 Operational Highlights 3 Muscarinic Agonist Programs 4 Q&A 5 Appendix Note: This material was created to explain the details of our company and is not intended to be used for investment decisions. In addition, the contents reflect the views of our company at
Slide 4: Overview of Financial Results
1 Overview of Financial Results Chris Cargill, COO and CFO 4
Slide 5: Continued to execute on objectives and targeted investments
Continued to execute on objectives and targeted investments Summary Financial Highlights for the 6 months ended 30 June 2021 Revenue of ¥3,123m ($28.9m) vs. ¥2,516m ($23.2m) in H1 2020, driven by achievement of several 1 progress-related milestone events and larger releases of deferred revenue from
Slide 6: Encouraging revenue growth offset by planned increase in R&D and non-cash costs
Encouraging revenue growth offset by planned increase in R&D (muscarinic and priority in-house programs) and non-cash costs Revenue (JPY million) Cash Operating Expenses1,2 (JPY million) Operating Loss (JPY million) 3,123 3,638 2,516 2,425 (1,136) (1,849) 6m to 30-Jun-20 6m to 30-Jun-21 6m to 30-Jun
Slide 7: Encouraging revenue growth offset by planned increase in R&D (cont'd)
Encouraging revenue growth offset by planned increase in R&D (muscarinic and priority in-house programs) and non-cash costs (cont’d) JPY million USD million Revenue by Type 6m ended 6m ended 6m ended 6m ended 30 Jun 2020 30 Jun 2021 30 Jun 2020 30 Jun 2021 Revenue 2,516 3,123 23.2 28.9 13% Cash Cost
Slide 8: Robust and well capitalized balance sheet
Sustainability of business model and corporate strategy is reflected in our robust and well capitalized balance sheet JPY million USD million Commentary As of As of As of As of 1 Small cash inflow when balances are aggregated in JPY, 31 Dec 30 Jun 31 Dec 30 Jun however weaker JPY in H1 2021 drove
Slide 9: Unchanged FY2021 financial guidance
Unchanged FY2021 financial guidance (12m to 31-Dec-21) Cash R&D expenses Cash G&A expenses ¥4,000 to 5,000m ¥1,800 to 2,300m Increased investment in HTL’878 Continued global implementation of Guidance selective M4R agonist program – Oracle Netsuite Enterprise (Dec-21) valuable opportunity to sec
Slide 10: Successful international offering and buyback of existing bonds
Successful international offering and buyback of existing bonds completed after the period ended Net proceeds of ¥29.8bn from Euro-Yen denominated convertible bonds due 2026 Use of proceeds: Largest mid-cap convertible bond raise in Asia Pacific • Approximately ¥18.9bn to be region since 2015 allo
Slide 11: Operational Highlights
2 Operational Highlights Shinichi Tamura, Chairman and CEO 11
Slide 12: Excellent progress expanding our drug discovery business
Excellent progress expanding our drug discovery business Summary Operational Highlights for the 6 months ended 30 June 2021 New strategic technology collaborations with PharmEnable and InveniAI* for AI-driven drug discovery, and Metrion Biosciences to explore SBDD approaches for ion channels Excel
Slide 13: 10 drug candidates from SBDD platform advanced into clinical trials
10 drug candidates generated from our SBDD platform have been successfully advanced into clinical trials LAST 12 YEARS (StaR® / SBDD GENERATED) TODAY MEDIUM TERM OUTLOOK DRUG DISCOVERY DEVELOPMENT LEAD OP TECHNOLOGY DRUG DISCOVERY New 5 compounds Generate on Identified Generated Produced Deliver at
Slide 14: Excellent progress across our deep pipeline and new technology collaborations
We saw excellent progress across our deep pipeline and added multiple new technology collaborations Pre-Disc. / Discovery Preclinical studies Phase 1 Phase 2 Marketed Multi-target GPR35 ag. GLP-1 ag. A2a ant. combo(s) Ultibro® Breezhaler® Multiple IBD T2DM/Obesity mCRPC COPD Multi-target CCR6 ant.
Slide 15: Next wave of COVID-19 therapies: SARS-CoV-2 protease inhibitors
Next wave of COVID-19 therapies – SARS-CoV-2 protease inhibitors – are starting to show promise PF-07321332 – small molecule oral S-217622 – small molecule oral SH-879 – small molecule oral antiviral antiviral treatment; twice a day antiviral treatment; once a day treatment; once or twice daily dosi
Slide 16: MPro inhibitor SH-879 opportunity for oral COVID-19 treatment
Our MPro inhibitor SH-879 represents an excellent opportunity for further development as an oral drug for the treatment of COVID-19 NEXT STEPS M Pro enzyme inhibition TARGET PRODUCT PROFILE 120 IC50: 14 nM 100 IC50: 18 nM SH-879 80 IC50: 4.9 μM PF-07321332 % Inhibition 60 boceprevir Once or twice da
Slide 17: Organic growth plan driving GPCR drug discovery
Organic growth plan driving our world-leading GPCR drug discovery OBJECTIVE ORGANIC GROWTH PLAN OBJECTIVE At least 2 new Continue to expand Preclinical Candidates expertise in GPCRs on average, Extend technology / Generate high quality every year platform leadership novel candidates OBJECTIVE OBJECT
Slide 18: Strategic growth plan driving corporate value expansion
Strategic growth plan driving corporate value expansion OBJECTIVE STRATEGIC GROWTH PLAN OBJECTIVE Add new technology Capital raise capabilities to our completed to pursue SBDD platform revenue focused deals in 2021 Seek out revenue- Invest / collaborate in generating opportunities novel technolo
Slide 19: Muscarinic Agonist Programs
3 Muscarinic Agonist Programs – A neuroscience pipeline with a multi-blockbuster profile Dr. Tim Tasker, CMO 19
Slide 20: Recapping status and progress of Muscarinic programs
Recapping the status and progress of our Muscarinic programs Patented StaR® technology enabled SBDD approach to identify novel highly selective muscarinic M4R, M1R and dual M1R/M4R orthosteric agonists Muscarinic M4R and M1R represent clinically validated targets for the treatment of psychosis and
Slide 21: Muscarinic programs: a ready-made neuroscience pipeline
Our Muscarinic programs represent a ready-made neuroscience pipeline with multiple blockbuster opportunities Next Milestone Program Compound Indication Discovery Preclinical Phase 1 Phase 2 12-18 months HTL’878 Schizophrenia Phase 2 ready M4R ortho agonist Completion of ortho orthoagonist agonist No
Slide 22: 4th-gen candidates aim to treat SZ with fewer side effects
4th-gen candidates aim to be effective treatments for SZ with HTL’878 fewer side effects Efficacy Safety Positive Negative Cognitive Extrapyramidal Weight gain symptoms symptom impairment symptoms** Peak sales Number of patients Number of patients Number of patients MoA Typical medicine Generation 2
Slide 23: Modulation of muscarinic M4R increasingly de-risked and validated target
Modulation of the muscarinic M4R now an increasingly HTL’878 de-risked and validated target for treating multiple types of SZ Lead Program KarXT CVL-231 HTL’878 M1R/M4R Agonist, MoA M4R PAM1 M4R Direct Agonist M2R/M3R Antagonist Current Phase Phase 2 ready (most Phase 3 Phase 1b (near term) advanced
Slide 24: HTL'878 is differentiated, highly selective orthosteric M4 agonist
HTL’878 is differentiated and is the only highly selective HTL’878 orthosteric agonist of the muscarinic M4 receptor in development Direct agonism of • Direct agonism of the muscarinic M4 mechanism is a clinically validated target for the treatment of psychoses M4R is a clinically (Xanomeline, KarXT
Slide 25: Q&A
4 Q&A Shinichi Tamura, Chairman and CEO 25
Slide 26: Thank you for your attention
Thank you for your attention Summary Financial and Operational Highlights for the 6 months ended 30 June 2021 Revenue of ¥3,123m New strategic technology collaborations Excellent progress across partnered programs Robust cash balance of ¥40.6bn with multiple Phase 1 starts Potential clinical
Slide 27: Appendix
5 Appendix 27
Slide 28: Progression of Partnered Pipeline
Progression of Partnered Pipeline FY2020 stage FY2021-Now progress Compound Target / Mechanism of Action Modality Indication Partner Disc. PCC Ph1 Ph2 Ph3 App Mkt Traditional Out-licensing Collaborations Seebri® Breezhaler® LAMA SME COPD Ultibro® Breezhaler® LAMA+LABA SME COPD Enerzair® Breezhaler®
Slide 29: Progression of In-house Pipeline
Progression of In-house Pipeline FY2020 stage FY2021-Now progress Compound Target / Mechanism of Action Modality Indication Originator Dis PCC Ph1 Ph2 Ph3 App Mkt. In-house Programs (Not yet partnered) HTL’878 Muscarinic M4 agonist SME Neurology diseases HTL’318 1 Muscarinic M1 agonist SME Neurology
Slide 30: M4R PAM less likely to be successful in DRP than an M4R Agonist
M4R PAM less likely to be successful in DRP than an M4R Agonist - CVL-231 probability of success in dementia remain uncertain as cholinergic system significantly altered - Xanomeline did show efficacy in psychotic symptoms in Alzheimer’s Disease, providing validation for an agonist • Is there suffic
Slide 31: M4R Receptor Orthosteric Partial Agonist HTL'878
Sosei Heptares M4R Receptor Orthosteric Partial Agonist HTL’878 - Potentially superior clinical profile compared to a PAM such as CVL-231 - Superior selectivity profile to KarXT HTL’878 binds to a partial agonist receptor conformation acting as a replacement for Ach PAM binding to allosteric ‘ 878 d
Slide 32: Potential Market of M1 Ag
Potential Market of M1 Ag Adding on to Donepezil (standard therapy, peak sales was $3,9BN+), potential to be best in class Alzheimer's disease DLB Mild Moderate Severe Number of patients (2030 forecast) Number of patients (2030 forecast) Number of patients (2030 forecast) Number of patients (2030 fo
Slide 33: Locations
Locations SOSEI HEPTARES PMO Hanzomon 11F Steinmetz Building North West House 2-1 Kojimachi, Chiyoda-ku Granta Park, Cambridge 119 Marylebone Road Tokyo 102-0083 CB21 6DG London NW1 5PU Japan United Kingdom United Kingdom