NON-CONFIDENTIAL

FY2023 Financial Results
12-month period ended December 31, 2023
13 February 2024 | Sosei Group Corporation (TSE: 4565)

Disclaimer
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© Sosei Group Corporation. Sosei Heptares is the corporate brand and trade mark of Sosei Group Corporation. Sosei, Heptares, the logo and StaR® are trade marks of Sosei Group companies.

2

Agenda3

1

Financial Results

2

Operational Highlights

3

Sales in Japan and APAC

4

R&D Progress

5

Objectives for FY2024 and Beyond 2030 Vision

1. Financial

2. Operation

1
FY2023 Financial Results
Hironoshin Nomura, CFO

4

3. JP/APAC

4. R&D

5. Strategy

Appendix1. Financial

2. Operation

3. JP/APAC

4. R&D

5. Strategy

Financial summary for FY2023
2023 results incorporate transformational acquisition of Idorsia’s Japan/APAC business.

1

Revenue of ¥12,766m ($91m) vs. ¥15,569m ($119m) in the prior year.
Revenue lower due to lack of new business development out-licensing upfront payments.
This reduction partially offset by the inclusion of ¥ 6,109m ($43m) of PIVLAZ® sales in Japan.

2Core Operating Loss of ¥3,075m ($22m) vs. Core Operating Profit ¥5,856m ($45m) in the prior year.
Decrease in profits due to decline in revenue and an increase in costs, including the planned increase ininvestment in Core R&D and the inclusion of additional core costs totaling ¥4,474m ($32m) from the
newly acquired Idorsia business.

3

Net Loss of ¥7,150m ($51m) vs. Net Profit of ¥383m ($3m) in the prior year.
Non-cash costs (incl. PIVLAZ® amortization) and non-recurring transaction related expenditures(professional fees). These were offset by a ¥3,486m / $25m tax credit and the absence of equity
accounting costs in 2023.

4¥49bn ($348m) cash balance as at December 31, 2023.
Strong cash balance maintained from the issuance of new shares (JPY2bn), a third-party allotment(JPY8bn) and partially funding the CHF399m / JPY 65bn Idorsia acquisition with a low interest rate bankloan with a 7-year term.

Note - USD:JPY FX rates used: Average rate YTD 2023 = 140.53; Average rate YTD 2022: 131.30; Spot rate Dec 31, 2023: 141.03

5

Appendix1. Financial

2. Operation

3. JP/APAC

4. R&D

5. Strategy

Key financial indicators
Product sales of PIVLAZ® made a significant contribution to total Revenue
Explanation

FY23 actual(JPY million)
20,000Upfront1

17,712

Revenue

11,408

8,842

10,000

1,948

3,259

3,489

3,017

3,426

FY20

FY21

FY22

0

12,766
3,839

7,397

3,405
5,000

4,666

◼

Royalty / Other◼

Product Sales◼

PIVLAZ® sales from 20 July 2023 (approx. 5.4 months)

Cost of Sales◼
◼

Inclusion of PIVLAZ® product supply costs
Additional CoS accounting charge only for current PIVLAZ®
stock

R&D

◼
◼

Planned increase in investment in discovery activities
Inclusion of Idorsia related R&D costs◼

Inclusion of Idorsia related SG&A costs
Amortization of intangible assets (PIVLAZ® and Daridorexant)
Inclusion of one-time cost relating to M&A

2,754
6,173

FY23

8,904

9,000

Operating
Profit /
Loss

6,000
3,000

928

2,904

3,775

5,856
3,436

0
(3,000)(6,000)OP(9,000)Core OP(3,076)(9,526)(12,000)
FY20

FY21

1 Upfront fee revenue recognised at deal inception
2 Milestone revenue recognised at milestone event + deferred revenue releases

6◼

Milestone2(JPY million)
12,000No new out-licensing transactions signed in FY2023 vs. two
new deals / upfront fees in the prior year (AbbVie & Eli Lilly)
Four milestone events in 2023 (2 milestone events relate to
IPJ business) vs. 5 milestone events in 2022
Partially offset by increased deferred revenue releases (which
relate to the active collaborations) as there were more active
collaborations
Royalty from product sales decreased

15,56915,000

◼

FY22

FY23

SG&A

◼
◼

Appendix1. Financial

2. Operation

3. JP/APAC

4. R&D

5. Strategy

Breakdown of FY2023 result
Impact of Non-cash/Non-recurring costs on full-year result is more significant in 2023 due to M&A(JPY million)

Revenue

Sosei Heptares* ＋(12 months)

5,157

IPJ/IPK*=(7/20-12/31:c.5.4month)

Consolidated
Non-recurring
Consolidated
Non-cash cost ＋＋=
P&L (Core)
Costs
P&L (IFRS)

7,609

12,766

12,766A

Cost of Sales+
SG&A(1,812)Current PIVLAZ® stock(3,791)(3,697)(7,488)

B

(611)

C

Amortization - Product IPD(1,263)(13,067)

M&A-related fee(1,893)
Others

R&D(8,426)(778)(9,204)

Other income

844

6

850

OP/Core OP(6,216)

3,140Core OP(871)(3,076)(10,075)
850
OP(9,526)

M&A related
Adjustments

A Additional CoS charge only for current PIVLAZ® stock. This impact will continue until around mid 2024.

(total. JPY 3,686 mil.)

C One time M&A related fee covering the IPJ/IPK transaction and evaluation of other potential opportunities was fully charged in Q3 2023

OthersB Amortization of intangible assets (relating to PIVLAZ® and Daridorexant). Annual charge to increase to c. JPY 1,700m per year from 2025.

D Amortization of other intangible assets (e.g. IP), depreciation (e.g. laboratory equipment) and share-based payments* Sosei Group, Sosei Co. Ltd., Sosei K.K. and Heptares Therapeutics Ltd., IPJ: Idorsia Pharmaceuticals Japan, IPK: Idorsia Pharmaceuticals Korea

7

D

Appendix1. Financial

2. Operation

3. JP/APAC

4. R&D

5. Strategy

Full year product sales guidance
PIVLAZ® sales are projected to reach JPY 16+ billion* (c. 114+ million USD) in 2024
Actual Sales of PIVLAZ® (NHI base)c. JPY 7.5 Bn

Target Sales in FY2024

JPY 16.0 + Bn

c. JPY 13.4 Bn
4,537
3,477

3,326

2,365

3,071
2,322

1,846

Q2

Q3

FY2022* NHI base sales
The assumed USD:JPY FX rate in 2024 is 140

8

Q4

Q1

Q2

Q3

FY2023

Q4

Sales growth supported by higher level ofevidence (included in 2023 Guideline
Recommendation).

Appendix1. Financial

2. Operation

3. JP/APAC

4. R&D

5. Strategy

Full year cost guidance
Incremental investment designed to deliver greater returns over the medium to long term
R&D expenses (IFRS basis)

Latest Guidance(JPY million)¥12,000 to ¥14,000m
15,00014,000~12,00010,000

5,000

3,793

5,931

7,454

10,075

0
FY20

FY21

FY22

FY23

FY24

Inclusion of
IPJ/IPK cost
Strengthening
capability
Advancing priority
programs(JPY million)◼

Inclusion of IPJ/IPK R&D costs for a full year◼

Investment in discovery and translational medicine
capabilities◼

Maturity of several priority programs, incl. at least 1 clinical
trial initiation
Advancing priority programs further in the clinic will deliver
greater value through higher out-licensing revenues◼

S&M + G&A expenses (IFRS basis)¥18,000 to ¥20,000m

25,00020,000~18,00020,00015,00010,0009Inclusion of IPJ/IPK SG&A costs for a full year
Increase in amortization charge (c. JPY 700 mil.)Increase in support for PIVLAZ® to drive growth,commercialization of Daridorexant in Japan and preparation
for launch of PIVLAZ® in South Korea (c. JPY 2,000m)◼

Costs relating to the acquisition of IPJ/IPK (post-merger
integration) are expected in 2024 (c. JPY 1,000m)

9,965

5,000
0

Inclusion of
IPJ/IPK cost

◼
◼
◼

3,435

3,940

4,377

FY20

FY21

FY22

FY23

FY24

Post-merger
integration

Appendix1. Financial

2
Operational Highlights
Chris Cargill, CEO

10

2. Operation

3. JP/APAC

4. R&D

5. Strategy

Appendix1. Financial

2. Operation

3. JP/APAC

4. R&D

5. Strategy

AppendixSignificant progress in 2023 across in-house and partnered programs

IN-HOUSE

Pre-Discovery / Discovery

10+ PROGRAMS

15+ PROGRAMS

Preclinical

Phase 1EP4 ag.

GPR52 ag. HTL’149

Inflammatory Bowel Disease

Schizophrenia

M1 ag.

EP4 ant. HTL’732

Neurology

Advanced solid tumoursCXCR4 mAb KY1051

M1M4 ag. NBI’570

OX2 ag. ORX750
Narcolepsy

PARTNEREDP
Multiple

Multiple

Inflammatory/Neurology

GI

GPR35 ag.

MC4 ant. PF’669

IBD

Malnutrition

Lucerastat
Fabry diseaseP

M4 ag. NBI’568
Schizophrenia

M1 pref. ag. NBI’567 P CCR6 ant. PF’894

P

P
AI-drivenP
PAR2 peptide

P

Neurology

IBD

Cenerimod

Filed

PDaridorexant

APAC*

Systemic lupus erythematosus

P M4 pref. ag. NBI’569 P

Neurology

Phase 3
Insomnia

P

APAC*

Commercial

P PIVLAZ®

APAC*

APAC*

Cerebral vasospasm

Oravi®
Mouth candidiasis

Ultibro® Breezhaler®
COPD

Seebri® Breezhaler®
COPD

Enerzair® Breezhaler®
AsthmaGut-brain axis

GLP-1 ag. PF’522

P

Metabolic diseases

mGlu5 NAM TMP-301P
Substance abuse: Under regaining negotiation: Exclusive opt-in right

P : Updates of 2023
Note: Seebri®, Ultibro®, Enerzair® and Breezhaler® are registered trademarks of Novartis AG.
Pref. ag.: Preferring agonist

11

P

Diabetes/Metabolic

Ongoing technology collabs.
AI-drivenP

Neurology

Immuno-oncology

Previous and ongoing
discovery collabs.

Phase 2

1. Financial

2. Operation

3. JP/APAC

4. R&D

5. Strategy

2023 in review – a transformative year
CORPORATEMILESTONES

IN-HOUSE
PROGRAMS✓

Up-listed to Tokyo Stock
Exchange Prime Segment✓

PIVLAZ® receives Marketing
Approval in South Korea✓

Acquisition of Idorsia
Pharmaceuticals Japan &APAC (ex-China)✓

Japan NDA submission ofdaridorexant for insomnia✓

HTL’149 (GPR52 Ag) enteredPh.1 study for schizophrenia✓

HTL’732 (EP4 Ant) entered
Ph.1/2a study for advanced
solid tumors✓

Landmark investment fromJapan Govt JIC VGI fund

PARTNEREDPROGRAMS✓✓✓

Neurocrine initiated Ph.1
studies of muscarinic
compounds (M1/M4, M1, M4
agonists) in neuropsychiatry
Pfizer initiated new Ph.1 ofonce daily oral GLP-1 Ag (PF’522)
Tempero Bio received Ph.1 FDA
clearance of TMP-301 (mGlu5
NAM) for substance abuse

2023 A YEAR OF CORPORATE ACTION AND INVESTMENT FOR FUTURE GROWTH

12

Appendix1. Financial

2. Operation

3. JP/APAC

4. R&D

5. Strategy

Performance against FY2023 objectives
Majority achieved. New high value partnership discussions are ongoing
FY2023 OBJECTIVES

1

1

Invest to enhance GPCR SBDD platform
capability✓

MAJOR CASH
FLOW GENERATINGPARTNERSHIPS

2

Execute at least one new high value
collaboration, and progress existing
partnerships✗

Ongoing

EVOLVE
IN-HOUSE R&D

3Advance at least two new in-houseprograms into first-in-human clinical trials✓

GPR52 Ph1 start
EP4 Ant Ph1/2a startJAPAN
COMMERCIAL
PHARMA UNIT

4

Take clear steps to build a Japan
Commercial Pharma Unit✓WORLD-LEADINGDRUG DISCOVERY
2

3

4

13

FY2023 ACHIEVEMENT

Japan
Korea

Appendix1. Financial

2. Operation

3. JP/APAC

4. R&D

5. Strategy

Exposed to the fastest growing areas of medicine
Muscarinic agonism in neuropsychiatry, plus current and next-gen targets for metabolic diseases
Metabolic disease: latest news

Neuropsychiatry: latest news
• 22 December 2023: Bristol Myers Squibb to acquire Karuna
Therapeutics for c.US$14bn• 23 January 2024: Novo Nordisk partners with EraCal Therapeutics
for up to US$255m for novel obesity medicine• Novel medicine KarXT (M1/M4 receptor agonist) LINK

• Oral small molecule appetite suppressor for obesity LINK

• 6 December 2023: AbbVie to acquire Cerevel Therapeutics for
c.US$9bn• Novel medicine Emraclidine (M4 receptor PAM) LINK
M4 agonist; dual M1/M4 agonist

Largest portfolio of oral small molecule
muscarinic agonists in development
globally. Broad M4; M1/M4 and M1
agonism for neuropsychiatric disorders✓

GPR52 agonist(in-house)

HTL’149 (Ph.1) novel
FIC oral small molecule
GPR52 agonist for
schizophrenia

✓

✓

✓

GLP-1 agonist

Beyond GLP-1
agonists

PF’522 (Ph.1) oral
small molecule GLP1 agonist for
metabolic disease

Multiple prediscovery/discovery
oral small molecules forobesity

Next-generation ✓targets (in-house)

Upstream of incretintargets, a novel oral
small molecule
appetite suppressor

PERFECTLY POSITIONED WITH THE RIGHT PARTNERS IN THE FASTEST GROWING AREAS OF MEDICINE

14

Appendix1. Financial

2. Operation

3. JP/APAC

3
Development and Sales
in Japan and APAC
Dr. Satoshi Tanaka, President of IPJ

15

4. R&D

5. Strategy

Appendix1. Financial

2. Operation

3. JP/APAC

4. R&D

5. Strategy

PIVLAZ® Our first commercially available
medicine protecting Japanese lives every day
JP GUIDELINES INCLUSION FOR MANAGEMENT OF STROKE1•

Aug '23: Authorized and recommended by theJapanese Stroke Society•

Demonstrated the true endpoints of Subarachnoid
Hemorrhage (SAH) with higher level of evidence•

Provides confidence to neurosurgeons to prescribe
PIVLAZ® as a new standard of care for SAH based onstrong evidence it can prevent delayed cerebral
ischemia and poor outcomes

10,377

Cum. patients to have received PIVLAZ®

Q1

Q2

Q3

Q4

Q5

Q6

Q7

FY2023
JPY 13.4 BN

NHI-based Sales

MARKETING APPROVAL FOR SOUTH KOREA•

Dec '23: Received Marketing Approval in South Korea•

Early 2025: Commercially available to patients

Q1

Q2

Q3

Q4

Q5

Q6

PIVLAZ® RAPIDLY BUILDING REAL WORLD EVIDENCE MITIGATING THE RISK OF CEREBRAL VASOSPASM
1 Japanese Stroke Society Guideline 2021 for the Management of Stroke (Revised Version 2023)

16

Q7

Appendix1. Financial

2. Operation

3. JP/APAC

4. R&D

5. Strategy

Daridorexant J-NDA filed; expected launch in late 2024
Daridorexant will contribute significantly to Japanese society
Impact of Insomnia on Japanese Society

15 TRILLION YEN (3% GDP)ECONOMIC LOSS
Due to decreased productivity
604,000
LOST WORKING DAYS / YEAR
Due to absences and sick leave
10%
HIGHER MORTALITY RISK

If average <6 hrs sleep per nightQ4 2024 POTENTIAL LAUNCH IN JAPAN•Oct-23: J-NDA submitted for the approval of
daridorexant, a dual orexin receptor antagonist, forthe treatment of adult patients with insomnia•

NDA includes robust Ph 3 trial data demonstrating
improved Total Sleep Time and Latency for Sleep
Onset, while maintaining a favorable safety profile•

Daridorexant is marketed in the U.S. and Europe as
QUVIVIQ™ by Idorsia Pharmaceuticals Ltd (Switzerland)•

In Japan, Idorsia Pharmaceuticals Japan and MochidaPharmaceutical Co., Ltd have co-developed and plan toco-market daridorexant pending Japan approval

THE IMPACT OF SLEEP DISORDERS ON JAPANESE SOCIETY IS SIGNIFICANT.
DARIDOREXANT IS A BEST-IN-CLASS SOLUTION FOR INSOMNIA
Source: “Why sleep matters – the economic costs of insufficient sleep” (2016) RAND Research Reports

17

Appendix1. Financial

2. Operation

3. JP/APAC

4
R&D Progress
Dr. Matt Barnes, President of Heptaresand Head of UK R&D

18

4. R&D

5. Strategy

Appendix1. Financial

2. Operation

3. JP/APAC

4. R&D

5. Strategy

Appendix

P Clinical milestone in 2023

Clinical partnered programs
Significant progress through 2023
Schizophrenia
NBI-1117568 M4 Ag

Neuropsychiatry
Phase 2

P NBI-1117569 M4 Ag

MetabolicPhase 1

P PF-06954522 GLP-1 Ag

Dec. ’23• Oral M4 agonist for the potential
treatment of adults withschizophrenia• Anticipating Phase 2 top-line
data in 2H 2024

Neuropsychiatry

P NBI-1117570 M1M4 Ag• Oral M4-preferring agonist
studied for the treatment ofneurological andneuropsychiatric conditions• Phase 1 study started

Neuropsychiatry
Phase 1

NBI-1117567 M1 Ag

Inflammatory bowel disease
Phase 1

• Oral small molecule GLP-1
receptor agonist• Phase 1 clinical trials started

PF-07258669 MC4 Ant

Phase 1P TMP-301 mGlu5 NAM

Phase 1
Q1 ’23• Oral M1-preferring agonist
studied for the treatment ofneurological andneuropsychiatric conditions• Phase 1 study planned to be
initiated in 2024

• The MAD study is listed ascompleted on clinicaltrials.gov• The molecule was generally safe
and well tolerated.

FOUR CLINICAL MILESTONES IN 2023
MC4 Ant Link: https://clinicaltrials.gov/study/NCT05113940#study-plan

19• Ongoing Phase 1b study is
progressing as planned• Expected to be completed within
2024

Substance use disorder

Sep. ’23• Oral selective M1/M4 dual
agonist progressed into Phase 1
clinical trials for potential
treatment of neurological andneuropsychiatric conditions

Phase 1

Aug. ’23

Malnutrition
Phase 1

PF-070548942 CCR6 Ant• Phase 1 trials ongoing for thetreatment of substance use
disorders1. Financial

2. Operation

3. JP/APAC

P EP4 Ant

Schizophrenia
and psychosis

Phase 1/2a

HTL00039732

P GPR52 Ag

Inflammatory bowel
diseasePhase 1EP4 AgAppendix

Inflammatory bowel
diseasePhase 1 ready

GPR35 Ag

Phase 1 ready

HTL0048149• Once daily oral small molecule• Combination with checkpoint
inhibitors• Collaboration with Cancer
Research UK• Participants: 150 patients• Estimated duration: 8/2023 9/2026• Novel FIC oral small molecule• Once daily• 24hr target engagement• Participant: 104 healthy
volunteers• Estimated duration: 6/2023 11/2024• Oral GI restricted• Good potency and selectivity• Minimal GI systemic exposure• Preclinical work is now
completed and submitted forregulatory approval• Targeting Phase 1 start 1H 2024

• Potent selective oral small
molecule• Supportive preclinical and safety
data• GSK received prior UK MHRA
regulatory approval• Discontinued by GSK due tochanges in immunology strategy
and leadership• Good progress to date forreversion

TWO CLINICAL STARTS IN 2023. TWO ASSETS WELL PLACED FOR 2024.
EP4 Ant study link: https://clinicaltrials.gov/study/NCT05944237?term=Heptares&viewType=Table&page=2&rank=15
GPR52 Ag study link: https://www.isrctn.com/ISRCTN17231793?q=&filters=&sort=&offset=58&totalResults=23608&page=6&pageSize=10
Note: 1 Sosei Heptares to regain full ownership of GSK4381406 from GSK (announced 24-Nov-2023)

20

5. Strategy

P Clinical milestone in 2023

Rapidly advancing in-house programs into the clinic
Immunosuppression
In solid tumors

4. R&D1. Financial

2. Operation

3. JP/APAC

4. R&D

5. Strategy

GPR52 Agonist – A Novel Approach to Treat Schizophrenia
First-in Class mechanism
Disease Rationale

Results so far• GPR52 is expressed on D2 dopamine neurons in striatum
where activation could lead to D2 antagonist-like effect totreat positive symptoms, e.g. hallucinations• In June 2023 we were the first company to initiate a Phase1 study against thisnovel GPR52 target.

• GPR52 also co-located with D1 dopamine receptor in
prefrontal cortex where activation could lead to D1 agonistlike effect to improve cognition, e.g. attention• Phase 1 on track, SAD now completed. Interim PK data is in line with preclinicalpredictions, linear across current dose range with low variability and consistent
with once daily dosing

DLPFC

Striatum
GPR52 & D2

• HTL’149 developed using SBDD for once-daily profile• Phase 1 MAD study now ongoing

vmPFC
Frontal Cortex
GPR52 & D1

PCP: phencyclidine
Poulter et al. ACS Med Chem Lett. 2023;14(4):499-505; MacSweeney et al. SOBP 2020 (poster); MacSweeney et al. SIRS 2022 (poster)

21

Appendix1. Financial

2. Operation

3. JP/APAC

4. R&D

5. Strategy

P Strategic milestone in 2023

Platform & Discovery Growth2023 Highlights
Platform GrowthTarget Identification/Validation

Discovery

P

P

P

Non-GPCR Drug Targets Jun. ’23• Membrane protein, ion channel & transporter
projects initiated• Drug targets with strong validation selected
where SBDD approach offers differentiation• Opportunity to demonstrate technical feasibility& generate BIC medicinesP

Laboratory Expansion

Oct. ’23

FIC GPCR progression• Collaboration expanded to a 2nd
neurological target

P

Target ID / Validation• $3.75M payment• Progression of a FIC projecttargeting an undisclosed GPCR

P
Oral OX2R agonist

Oct. ’23P
Gut-brain axis platform Nov. ’23• Nomination & validation of 1st GPCR in
GI Diseases• BIC potential for treatment of
narcolepsy and other sleep-wakedisorders presented at the World
Sleep Congress

CONTINUED INVESTMENT/ADVANCEMENT IN PLATFORM GROWTH & DISCOVERY PIPELINE
22 FIC = First in Class; BIC = Best in Class

Oct. ’23

Oct. ’23• Nomination & validation of 1st GPCR in
immunological diseases

Dec. ’23• New Phage Display lab created to utilize naïve
nanobody libraries to screen against purified
GPCR StaR® targets – identify Protein Binders to
support cryo-EM and SBDD platform• New Mass Spectrometry (MS) facility created &state-of-the-art mass spectrometer purchased
to drive advanced GPCR MS methodologies.

AI Drug Design

Appendix1. Financial

2. Operation

5
Objectives for FY2024 andBeyond 2030 Vision
Chris Cargill, CEO

23

3. JP/APAC

4. R&D

5. Strategy

Appendix1. Financial

2. Operation

3. JP/APAC

4. R&D

5. Strategy

Objectives for FY2024
Positioning for long-term growth potential
1

JPY 16 billion + NHI sales for PIVLAZ®

2JNDA approval for daridorexant in Japan

3

Acquire/in-license at least one late-stage medicine for the Japan/APAC (ex-China) region

4

Execute at least one new major partnership, and initiate at least one new in-house Ph.1 study

5

PMI investment in new brand concept, plus systems and applications for efficiency and scalability
BUILDING JAPAN’S NEXT GENERATION, TOP 15 PHARMA COMPANY

24

Appendix1. Financial

2. Operation

3. JP/APAC

4. R&D

5. Strategy

Several potential catalysts over the next 12 months(excluding new business development transactions)
PROGRAM

TIMING

EVENT

Cenerimod

1H 2024

Exclusive opt-in decision

Lucerastat

1H 2024

Exclusive opt-in decision

EP4 Ag

1H 2024

Ph.1 start

Daridorexant (Sth Korea)

2H 2024

New Partnership & Ph.3 start

2H 2024

Potential NDA Approval

PIVLAZ® (Sth Korea)

1H 2025

New Partnership & Launch

GPR35 Ag2H 2024

Program reversion

NBI-568 (M4 Ag)

2H 2024

Ph.2 completion

NBI-567 (M1 Ag)

2024

Ph.1 start

TMP-301 (mGlu5 NAM)

2024

Ph.2 start

ORX750 (Ox2 Ag)

2024

Ph.1 start

Daridorexant (Japan)

1 Co-development and co-promotion agreement with Mochida

25

PARTNER

1

Appendix1. Financial

2. Operation

3. JP/APAC

4. R&D

5. Strategy

Beyond 2030 vision

Next-generation pharma company and top 15 in Japan by market capitalization
Focused on innovative specialty medicines

Tech-powered systems for decision-making speed and scalability
Development and commercialization partner of choice for Japan and APAC
AI and Machine Learning-enabled platforms for accelerated drug discovery

WORLD LEADING SCIENCE, LIFE CHANGING MEDICINES

26

Appendix1. Financial

Appendix27

2. Operation

3. JP/APAC

4. R&D

5. Strategy

Appendix1. Financial

2. Operation

3. JP/APAC

4. R&D

5. Strategy~¥8bn ($54m) investment from new OPF1 fund of JIC VGIJIC Venture Growth Investments is an affiliate of govt-backed Japan Investment Corporation (JIC)JIC VGI OPPORTUNITY
FUND NO.1 (OPF1)

INVESTMENT IN SOSEI GROUP CORPORATION• One of the JIC initiatives included in theJapan Government's “Startup
Development Five-year Plan”• JIC VGI has invested in many growth companies in thehealthcare and life sciences sector and has intrinsic
knowledge of biotech companies• Launched in Sept-23 to support the growthand sustainable development ofinnovative companies listed on the Tokyo
Stock Exchange• Investment due diligence process conducted over several
months, including site visits in the UK and Japan• Engages in next-generation industries ofsignificant economic and social benefit toJapan, such as healthcare and life sciences• As a government-supported fund, OPF1 serves as along-term investor, typically holding investments for 3-5
years on average• Sosei Group Corporation was the first investment projectfrom JIC VGI OPF1, accounting for 20% of its total fund size

OPF1’S INVESTMENT IN SOSEI RECOGNIZES OUR POTENTIAL TO BE AN EMERGING CHAMPION OF THE
GROWING PHARMA SECTOR IN JAPANSource: Japan Investment Corporation

28

Appendix1. Financial

2. Operation

3. JP/APAC

4. R&D

5. Strategy

Exclusive Opt-in Rights And ROFN/ROFR1

Option to develop up to seven clinical programs for Japan and APAC (ex-China) from Idorsia

Exclusive
Opt-in Right

ROFR/ROFN1

ProgramMechanism of Action

Indication**

Stage

Cenerimod

S1P1 receptor modulator

Systemic lupus erythematosus

Phase 3

Lucerastat

Glucosylceramide synthase inhibitor

Fabry disease

Phase 3Selatogrel

P2Y12 antagonist

Suspected acute myocardial infarction

Phase 3*

ACT-1004-1239

ACKR3 / CXCR7 antagonist

Multiple sclerosis and other demyelinating diseases

Phase 2*

ACT-1014-6470

C5aR1 antagonist

Immune-mediated disorders

Phase 1*IDOR-1117-2520

Undisclosed

Immune-mediated disorders

Phase 1*

ACT-777991

CXCR3 antagonist

Recent-onset Type 1 diabetes

Phase 1*

1 ROFN/ROFR - Right of first negotiation / Right of first refusal
2 Territories include Japan, South Korea, Australia, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, New Zealand, Philippines, Singapore, Taiwan, Thailand and Vietnam

29* Global Phase** This is an indication currently under development, but does not necessarily mean that Sosei will develop for this indication

RegionAPAC(ex-China)2

Appendix1. Financial

2. Operation

3. JP/APAC

4. R&D

5. Strategy

Introduction of ‘Core Operating Profit’Core Operating Profit – the financial indicator closer to the reality of our business
Operating Profit

Operating Profit“Core”“IFRS”

Core Operating Profit is a new key
financial indicator that highlights theunderlying recurring cash generating
capability of the business.
◼ Core Operating Profit is defined as IFRS
Operating Profit + material Non-cash costs+ material non-recurring costs◼ Material Non-cash Costs include
depreciation, amortization, share based
payments and impairment.
◼ Material Non-recurring Costs include
restructuring costs and other material
one-off items.
◼ Core Operating Profit = Cash Earnings +material Non-recurring Costs◼

+ Material Non-cash Costs(Depreciation, Amortization, Share based payments, Impairment...etc.)+ Material Non-recurring Costs(Restructuring costs and Other material one-off items...etc.)

Cash
Recurring

Non-recurring(Material)

30

Non-cash(Material)

Costs under“Core”

Costs under “IFRS”◼

Financial results recorded and prepared inaccordance with International Financial
Reporting Standards (IFRS)Appendix1. Financial

2. Operation

3. JP/APAC

4. R&D

5. Strategy

Partnered pipeline
CompoundTarget / Mechanism of Action

Modality

Indication

Seebri® Breezhaler®

LAMA

SME

COPD

Ultibro® Breezhaler®

LAMA+LABA

SME

COPD

Enerzair® Breezhaler®

LAMA+LABA+ICS

SME

AsthmaORAVI®

Antifungal agent miconazole

SME

Oropharyngeal candidiasis

Imaradenant1

Adenosine A2a ant. combo

SME

mCRPC

NBI-1117568

Muscarinic M4 agonist

SME

Schizophrenia

NBI-1117569

Muscarinic M4 preferring agonist SME

Neurology diseases

NBI-1117570

Muscarinic M1/M4 agonist

SME

Neurology diseases

NBI-1117567

Muscarinic M1 preferring agonist SME

Neurology diseases

PF-07081532

GLP-1 agonist

SME

T2DM/ObesityPF-07054894

CCR6 antagonist

SME

Inflammatory bowel disease

PF-07258669

MC4 antagonist

SME

Malnutrition

PF-06954522

GLP-1 agonist

SME

Metabolic diseases(Not disclosed)

CGRP antagonist

SME

Neurology diseases(Not disclosed)

GPR35 agonist

SME

Inflammatory bowel disease(Not disclosed)

Multi target

SME/LME

Multiple indications(Not disclosed)

Multi target

SME/LME

Gastrointestinal and other(Not disclosed)

Multi target

SME

Inflammatory/Neurology(Not disclosed)

Multi target

SME

Diabetes/MetabolicPartner

Disc.

PCC

Ph1

Ph2

Ph3

Partnered

Under regaining negotiation

Note: SME = small molecule. LME = large molecule. Seebri®, Ultibro®, Enerzair® and Breezhaler® are registered trademarks of Novartis AG. 1 AstraZenenca have removed the A2a program from their clinicalpipeline as at Q3 2021

31

App

Mkt

Appendix1. Financial

2. Operation

3. JP/APAC

4. R&D

5. Strategy

Partnered pipeline (cont’d)CompoundTarget / Mechanism of Action

Modality

Indication

KY1051CXCR4 mAb

mAb

Immuno-oncology(Not disclosed)

PAR-2

PeptideInflammatory diseases(Not disclosed)

AI-Augmented Drug Discovery

SME

Neurology diseases(Not disclosed)

Multi target AI-powered

SME/LME

Immune diseases(Not disclosed)

Gut-brain axis drug discovery

SME

Gastrointestinal disorders

TMP301mGlu5 NAM

SME

Substance use disorders

ORX750OX2 agonist (Oral)

SME

Narcolepsy

Co-development

Co-owned companies

Note: SME = small molecule. LME = large molecule

32

Partner

Disc.

PCC

Ph1

Ph2

Ph3

App

Mkt

Appendix1. Financial

2. Operation

3. JP/APAC

4. R&D

5. Strategy

In-house pipeline
CompoundTarget / Mechanism

Modality

Indication

PIVLAZ®

ETA antagonist

SME

Cerebral vasospasm

Daridorexant

Dual Orexin antagonist

SME

Insomnia

HTL’149

GPR52 agonist

SME

Neurology diseases

HTL’732

EP4 antagonist

SME

Immuno-oncology(Not disclosed)

EP4 agonist

SME

Inflammatory bowel disease(Not disclosed)

Muscarinic M1 agonist (JP)SME

Neurology diseases(Not disclosed)1

H4 antagonist

SME

Atopic Dermatitis(Not disclosed)

SARS CoV-2 Mpro

SME

Coronaviruses

Multiple programs

Not disclosed

SME/LME

Neurology diseases

Multiple programs

Not disclosed

SME/LMEGI and Inflammatory diseases

Multiple programs

Not disclosed

SME/LME

Immunology diseases

Originator

In-house Programs

In-house Programs (No longer internally funded. Targeting academic / industrial partnership)
HTL’310

SSTR5 agonist

PeptideHypoglycaemic disorders

HTL’097

GLP-1 antagonist

PeptideHypoglycaemic disorders

HTL’023

Dual GLP-2/GLP-1 agonist

PeptideIntestinal failure/NASH(Not disclosed)

Apelin agonist

PeptidePulmonary Arterial Hypertension

HTL’641

Dual orexin antagonist

SME

Insomnia and sleep disorders(Not disclosed)

PAR-2 mAb

mAb

Atopic Dermatitis/Pain

Note: SME = small molecule. LME = large molecule. 1 Due to changes of strategy, we deprioritized until we will find another indication opportunity

33

Disc.

PCC

Ph1

Ph2

Ph3

App

Mkt

AppendixLocations
SOSEI GROUPPMO Hanzomon 11F

Midtown East,

F17, 410 Teheran-Ro

Steinmetz Building

Burleigh on the Strand

2-1 Kojimachi,
Chiyoda-ku

9-7-2 Akasaka Minatoku

GangHam-Gu

Granta Park,355-359 Strand

Seoul 06192

Cambridge CB21 6DG

London WC2R 0HS

Tokyo 102-0083

Tokyo 107-0052

South Korea

United Kingdom

United Kingdom

Japan

Japan

Spaces Grosspeter
Tower
Grosspeteranlage 294052 Basel
Switzerland