Slide 1: Acquisition of Idorsia's Pharmaceuticals Business in Japan and APAC (ex-China)
NON-CONFIDENTIAL Acquisition of Idorsia’s Pharmaceuticals Business in Japan and APAC (ex-China) Combining a synergistic clinical development capability and profitable commercial operation with a world-class GPCR-targeted drug discovery business July 2023 | 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: Accelerating Our Mission
Accelerating Our Mission Now delivering life-changing medicines to patients Japan Korea INVESTING IN WORLD-LEADING SCIENCE… …TO DELIVER LIFE-CHANGING MEDICINES GPCR-Targeted Research & Experienced Clinical Development & Drug Discovery Platforms MISSION Profitable Commercial Operations + APAC (ex-Chi
Slide 4: Transaction Overview
Transaction Overview Fully funded by existing cash and a new long-term, low-rate corporate loan TRANSACTION FUNDING ACQUIRED LEGAL ENTITIES2 PORTFOLIO OF CATALYST RICH PRODUCTS Idorsia Pharmaceuticals Japan (IPJ) | Cerebral vasospasm associated with aSAH3 Established: 26 March 2018 • Commercially av
Slide 5: Transaction Rationale
1 Transaction Rationale Chris Cargill, CEO 5
Slide 6: Investment Highlights
Investment Highlights World-class drug development capability with profitable commercial operations Accelerating our mission by adding experienced clinical development capability and profitable commercial P operations in Japan, with a lean model for sales and marketing, and the ability to scale and
Slide 7: Profitable and Fast-Growing Commercial Operations
Profitable and Fast-Growing Commercial Operations Lean sales and marketing model with leverage from digital engagement and contract sales force CURRENT COMMERCIAL ACTIVITIES IN JAPAN1 PEER PROFITABILITY RATIOS (EBIT/SALES %)2 FY 2022 FY 2023 (E) % Growth JPY million ACTUAL FORECAST YOY IPJ 22% Repor
Slide 8: Securing and Expanding Our Future In-House Pipeline
Securing and Expanding Our Future In-House Pipeline Adds two major life-changing medicines; plus, rights for up to seven additional programs Discovery Preclinical Phase 1 Phase 2 Phase 3 Commercial P P P HTL’732 HTL’149 ACT-1004-1239** Daridorexant APAC* PIVLAZ® APAC* EP4 antagonist GPR52 agonist AC
Slide 9: Securing and Expanding Our Future In-House Pipeline (cont'd)
Securing and Expanding Our Future In-House Pipeline (cont’d) Now with three sources of innovation to deliver life-changing medicines to patients Sources of innovation Early Development Late Development Commercial 1 Out-Licensing GLOBAL P Global Partners Specialty care/Orphan indication P JAPAN & APA
Slide 10: Highly Skilled Team With Proven Track Record Of Excellence
Highly Skilled Team With Proven Track Record Of Excellence Dr. Satoshi Tanaka to lead new Japan/APAC Pharma Business and become an Executive Officer of Sosei Group J-NDA APPROVAL & COMMERCIAL TRACK RECORD1 (JPY billion) Expansion to Digital Ulcers and Pediatric PAH CAREER BIOGRAPHY 34.0 30 28.1 Nov.
Slide 11: Leveraging Japan's Quality Clinical Environment
Leveraging Japan’s Quality Clinical Environment Japan will serve as our base to expand across APAC markets and to extend product launches Established market with strong volumes Second largest pharma Universal health care system market (excl. China) Relatively weak incumbents JAPAN 580 2021, Billion
Slide 12: Product portfolio
2 Product portfolio Satoshi Tanaka, President of IPJ/IPK 12
Slide 13: Strong And Attractive Fundamentals
Strong And Attractive Fundamentals Robust product portfolio with innovative clinical development and commercial capabilities 1 Top-Tier Portfolio of Medicines and Programs with Excellent Potential Robust Product/ 1 Cenerimod + 5 ROFR/ROFN Pipeline Lucerastat programs 2 Highly Skilled Team with a Pro
Slide 14: PIVLAZ – Commercially Available (Launched Japan in 2022)
PIVLAZ® – Commercially Available (Launched Japan in 2022) Strong uptake since launch and growing number of patients treated Cumulative Patients Treated Since Launch PIVLAZ® (clazosentan) is a fast-acting, selective endothelin A (ETA) receptor antagonist for the ~300% (2Q YoY ) prevention of cerebral
Slide 15: PIVLAZ – Japan Specific Registration Program
PIVLAZ® – Japan Specific Registration Program Positive top-line results RESULTS OF TWO PIVOTAL PHASE 3 STUDIES IN JAPAN1 COILING STUDY CLIPPING STUDY • PIVLAZ® (clazosentan) demonstrated significant reduction of Event rate (%) vasospasm-related morbidity and all-cause mortality in p=0.0001 patients
Slide 16: Daridorexant – Best-In-Class Drug With 2H 2023 J-NDA Filing
Daridorexant – Best-In-Class Drug With 2H 2023 J-NDA Filing Expected to launch 2H 2024 Daridorexant is a dual orexin receptor antagonist DORA class sales in Japan (NHI basis) (JPY BN) 19% (DORA) that selectively blocks the binding of 80 17% the wake-promoting neuropeptides for the DORA market share
Slide 17: QUVIVIQ – Global And Japan-Specific Program
QUVIVIQ® – Global And Japan-Specific Program Positive Japanese Phase 3 study; in-line with US study as published in The Lancet1 RESULTS OF GLOBAL AND JAPANESE PIVOTAL TRIALS1 TWO PRIMARY ENDPOINTS FULLY MET IN GLOBAL PHASE 3 TRIAL • A Japanese Phase 3 trial1 in 490 adult and elderly patients met WAK
Slide 18: Cenerimod and Lucerastat
Cenerimod and Lucerastat Exclusive opt-in rights for two potentially exciting product opportunities Cenerimod Lucerastat Indication Systemic Lupus Erythematosus (SLE) Indication Fabry Disease MoA Selective S1P1 receptor modulator MoA Glucosylceramide synthase inhibitor Stage Global Ph3 studies ongoi
Slide 19: Japan Is A Leading Market for Clinical Innovation And Quality
Japan Is A Leading Market for Clinical Innovation And Quality APAC countries respect Japan for its high data quality Quality Clinical Development Quality Regulatory Environment Deep High quality High Reasonable NHI Prolongation of Regional understanding data from penetration in Quality excellent acc
Slide 20: Fully integrated biopharma
3 Fully integrated biopharma Chris Cargill, CEO 20
Slide 21: Sosei Group's Structure Post-Acquisition
Sosei Group’s Structure Post-Acquisition Now accelerating our mission and vision with 370 total employees Sosei Group TSE Prime Segment listed (4565-JP) Group Operations | 46 people Heptares Therapeutics Sosei Co. IPJ IPK Cambridge | 177 staff Tokyo | 12 staff Tokyo | 130 staff Seoul | 5 staff Resea
Slide 22: Broad, Diversified and Balanced Pipeline
Broad, Diversified and Balanced Pipeline Pioneering novel and differentiated therapies across multiple therapeutic areas Pre-Discovery / Discovery Preclinical Phase 1 Phase 2 Phase 3 Commercial EP4 ant. HTL’732 GPR52 ag. APAC* P PIVLAZ® APAC* P Daridorexant Advanced solid tumors Schizophrenia Insomn
Slide 23: Expected News Flow
Expected News Flow Several catalysts on-track to be achieved over the next 18 months 2H 2023 1H 2024 2H 2024 1H 2025 Japan ✓ Included in treatment guidelines (July) Sth Korea Approval Launch 1 Japan Filing Approval Launch Sth Korea Phase 3 start Cenerimod Opt-in decision Lucerastat Opt-in decision E
Slide 24: Investment Highlights
Investment Highlights World-class drug development capability with profitable commercial operations Accelerating our mission by adding experienced clinical development capability and profitable commercial P operations in Japan, with a lean model for sales and marketing, and the ability to scale and
Slide 25: On Track To Achieve Our 2030 Vision
On Track To Achieve Our 2030 Vision Novel medicines on the market globally, through our collaborations with partners Commercial business in Japan, based on in-licensed and own products Broad, deep and sustainable pipeline of programs with significant potential Rapidly growing sales, cash flow and pr
Slide 26: Appendix
Appendix 26
Slide 27: Exclusive Opt-in Rights And ROFN/ROFR
Exclusive Opt-in Rights And ROFN/ROFR1 Option to develop up to seven clinical programs for Japan and APAC (ex-China) from Idorsia Program Mechanism of Action Indication Stage Region Cenerimod S1P1 receptor modulator Systemic lupus erythematosus Phase 3 Exclusive Opt-in Right Lucerastat Glucosylceram
Slide 28: Financial Impact
Financial Impact Transaction expected to be cash flow positive in the first full calendar year Long-term corporate loan: From existing Transaction Purchase Price ~JPY65 Bn1 (CHF400 Mn) ⚫ JPY40 Bn cash: Funding ⚫ 7 year, low-rate loan from Mizuho Bank ⚫ JPY25 Bn Closing Date Purchase Price Payment Da
Slide 29: Locations
Locations SOSEI GROUP PMO Hanzomon 11F Midtown East, F17, 410 Teheran-Ro Steinmetz Building North West House 2-1 Kojimachi, Chiyoda-ku 9-7-2 Akasaka Minato-ku GangHam-Gu Granta Park, 119 Marylebone Road Tokyo 102-0083 Tokyo 107-0052 Seoul 06192 Cambridge CB21 6DG London NW1 5PU Japan Japan South Kor