investor presentation - sosei heptares · references to "fy" in this presentation for...
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The material that follows is a presentation of general background information about Sosei Group Corporation and i ts 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 as a solicitation or an offer to buy or sell any securities and should not be treated as giving investment advice to recipients. It is not targeted to the specific investment objectives, financial situation or particular needs of any recipient. It is not intended to provide the basis for any third party evaluation of any securities or any offering of them and should not be considered as a recommendation that any recipient should subscribe for or purchase any securities.
The information contained herein is in summary form and does not purport to be complete. Certain information has been obtained from public sources. No representation or warranty, either express or implied, by the Company is made as to the accuracy, fairness, or completeness of the information presented herein and no reliance should be placed on the accuracy, fairness, or completeness of such information. The Company takes no responsibility or liability to update the contents of this presentation in the light of new information and/or future events. In addition, the Company may alter, modify or otherwise change in any manner the contents of this presentation, in its own discretion without the obligation to notify any person of such revision or changes.
This presentation contains “forward-looking statements,” as that term is defined in Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. The words “believe”, “expect”, “anticipate”, “intend”, “plan”, “seeks”, “estimates”, “will” and “may” and similar expressions identify forward looking statements. All statements other than s tatements of his torical facts included in this presentation, including, without limitation, those regarding our financial position, business strategy, plans and objectives of management for future operations (including development plans and objectives relating to our products), are forward looking statements. Such forward looking s tatements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward looking s tatements. Such forward looking s tatements are based on numerous assumptions regarding our present and future business strategies and the environment in which we will operate in the future. The important factors that could cause our actual results, performance or achievements to differ materially from those in the forward looking statements include, among others, risks associated with product discovery and development, uncertainties related to the outcome of clinical trials, slower than expected rates of patient recruitment, unforeseen safety i ssues resulting from the administration of our products in patients, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. These factors include, without limitation, those discussed in our public reports filed with the Tokyo Stock Exchange and the Financial Services Agency of Japan. Although the Company believes that the expectations and assumptions reflected in the forward-looking statements are reasonably based on information currently available to the Company's management, certain forward looking s tatements are based upon assumptions of future events which may not prove to be accurate. The forward looking statements in this document speak only as at the date of this presentation and the company does not assume any obligations to update or revise any of these forward statements, even if new information becomes available in the future.
This presentation does not constitute an offer, or invitation, or solicitation of an offer, to subscribe for or purchase any securities. Neither this presentation nor anything contained herein shall form the basis of any contract or commitment whatsoever. Recipients of this presentation are not to construe the contents of this summary as legal, tax or investment advice and recipients should consult their own advisors in this regard.
This presentation and its contents are proprietary confidential information and may not be reproduced, published or otherwise disseminated in whole or in part without the Company’s prior written consent. These materials are not intended for distribution to, or use by, any person or entity in any jurisdiction or country where such distribution or use would be contrary to local law or regulation.
This presentation contains non-GAAP financial measures. The non-GAAP financial measures contained in this presentation are not measures of financial performance calculated in accordance with IFRS and should not be considered as replacements or alternatives profit, or operating profit, as an indicator of operating performance or as replacements or alternatives to cash flow provided by operating activities or as a measure of liquidity (in each case, as determined in accordance with IFRS). Non-GAAP financial measures should be viewed in addition to, and not as a substitute for, analysis of the Company's results reported in accordance with IFRS.
References to "FY" in this presentation for periods prior to 1 January 2018 are to the 12-month periods commencing in each case on April 1 of the year indicated and ending on March 31 of the following year, and the 9 month period from April 1 2017 to December 31 2017. From January 1 2018 the Company changed its fiscal year to the 12-month period commencing in each case on January 1. References to "FY" in this presentation should be construed accordingly.
Disclaimer
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What we have achieved in 2019…
Multiple programs advancing well
• Next-generation immuno-oncology program (A2a antagonist AZD4635) partnered with AstraZeneca moves towards Phase 2, triggering a $15 million progress-related milestone
• Two candidates nominated by Pfizer to advance into clinical development under the multi-target collaboration, triggering a total $6 million in progress-related milestones
• Valid Marketing Authorisation Application submitted to the EMA for QVM149, a new inhaled therapy for asthma partnered with Novartis, triggering a $2.5 million progress-related milestone
• SSTR selective somatostatin agonist candidate successfully dosed in subject
Creation of two asset-centric companies
• Orexia Ltd and Inexia Ltd created to develop novel therapies based on positive modulators of orexin OX1 and OX2 for neurological diseases
• Medicxi will be investing in both companies with an aggregate amount of up to €40 million
New multi-target collaboration deals
• New multi-target research collaboration and license agreement with Genentech targeting a range of diseases; $26m upfront and near-term payments, $1bn+ potential milestone payments
• New multi-target R&D and commercialization partnership with Takeda targeting high priority GI targets; $26m upfront and near-term payments, $1.2bn+ potential milestone payments
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Japan-listed biotech with state-of-the-art R&D center in the UK
1 Stabilized receptor technology2 Structure-based drug design
R&D CENTERCAMBRIDGE, UK
Proprietary StaR®1 GPCR technology underpin
Research, Drug Discovery and SBDD2 Platform
Translational and Early-Stage Clinical Development Expertise
Business Development
HEADQUARTERSTOKYO, JAPAN
Late-Stage Japanese Development Expertise
Access to Capital and also Royalty Income from Novartis
Japan-anchored, with a fully integrated global discovery and development business in Cambridge, UK, driving enhanced science, productivity, and collaboration and partnership opportunities
~120 EMPLOYEES ~30 EMPLOYEES
Sosei Group CorporationTSE: 4565
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We are the world leader in GPCR drug discovery and development
WE ARE RECOGNIZED GLOBALLY FOR WORLD-CLASS, PIONEERING SCIENCE
Solved
260+Molecular structures
From
25+Different GPCRs
Solved
>30%Structures of GPCR targets
OUR TECHNOLOGY HAS ATTRACTED WORLD LEADING PHARMA AND
BIOTECHS AS KEY PARTNERS
COLLABORATIONS WITH LEADING ACADEMIC GROUPS KEEP US AT THE
CUTTING EDGE OF SCIENTIFIC RESEARCHOUR CO-FOUNDER
RICHARD HENDERSON WAS AWARDED THE
NOBEL PRIZE IN CHEMISTRY
FORMED 2 SPIN-OUT COMPANIES
4PRODUCTS ON MARKET
GLOBALLY
29R&D PROGRAMSDISCLOSED WITH
BROAD AND DEEP PIPELINE BEHIND
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Highly productive GPCR-focused drug discovery engine
1 Phase 2 trial of HTL0018318 for DLB in Japan remains under voluntary suspension. The Group plans to resubmit a new clinical trial notification for HTL0018318 (or another novel M1 agonist) to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in the future
Discovery Preclinical development Phase 1 Phase 2 Phase 3
DRUG DISCOVERY DEVELOPMENT PROGRAMS (IN-HOUSE AND PARTNERED)
Marketed
COMMERCIALIZED
15+ 7 5 2 1 4
QVM149M1Ph 1b
M4
A2A
mGlu5
SSTR
M1M4
Undisc.
Undisc.
CXCR4
GLP-1 ant
CGRP
GLP-2
Ultibro®
Seebri®
Oravi®
Norlevo®
Neurology
Immuno-oncology
Gastrointestinal
Rare/specialty
A2A
M1DLB1
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Significant opportunity to create new or improved GPCR drugs
Drugged 27%
In trials17%
Currentlyundrugged
56%
Of the ~400 GPCR targets active in diseases, 56% have yet to be drugged
EXPANDS CAPACITY TO EXPLORE MORE GPCRs
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Our platform technology has revolutionized GPCR drug discovery
SaBRE
CHESS
SMARTER DRUG DESIGN
ACCELERATES AND IMPROVES
DRUG DISCOVERY
ALTERNATIVE MODES OF ACTION
NEW TECHNIQUE TO IMAGE BIOMOLECULES
Cryo-EM
DNA EncodedLibraries
STAR® TECHNOLOGY
AI / MACHINE LEARNING
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Our powerful StaR® technology enables better and smarter drug design
Improved physiochemical properties(more polar, more selective, lower dosage)
Better safety and efficacy
Reduced clinical attrition
Small molecule, peptide or antibody discovery
Our StaR®/SBDD platform capabilities allow us to develop better, differentiated drug candidates against emerging novel GPCR target mechanisms
Clinical Precedence,
33%
Clinical Validation,
45%
Pre-clinical Validation
22%
CURRENTLY IN DEVELOPMENT
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Our team is recognized for challenging the frontiers of science
From
>25different receptors
Solved
>260X-ray
structures
Solved
>30%Structures of GPCR targets
Over
180+Journal
publications
World leaderin GPCR
drug discovery and
development
CRF1mGlu5 CCR9 GLP1R
GCGR PAR2 C5aR
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Our core strengths differentiate us from our peers
NEW GPCR TARGET STRUCTURE AND FUNCTION
HIGH QUALITY COMPOUNDS
GLOBAL DEVELOPMENT CAPABILITY
FLEXIBLE PARTNERING STRATEGY
37%
36%
18%
9%
50%
10%
20%
20%
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Evolving with a specialist therapeutic focus
We are building significant expertise in Immunology/GI in addition to our existing expertise in Neurology
NOW FUTURE
Neurology
Immunology/GI
Oncology
Rare
Currently in Development Currently in Discovery
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We are developing new therapies for areas of high unmet medical need
Sources: World Health Organization, EvaluatePharma, Management Estimates. Notes: Market sizes represent global sales of products targeted at any aspect of the market. Sosei Heptares may choose to only target a segment of the specific market. 1 Represents market size for Cushing’s syndrome, rather than Cushing’s disease
~300Kaffected globally
$1.1bn20241
Cushing’s
~50Maffected globally
$7.4bn2024
Dementia
~1.6Maffected in US (mod-sevuncontrolled)
$6.6bn2024
Atopic Dermatitis
~50Kaffected globally
$5.7bn2024
PAH
~450K affected globally
$1.2bn2024
ALS
~42Maffected globally
$220bn2024
Cancer
~3.1Maffected globally
$19.1bn2024
IBD
• SSTR agonist• M1 agonist• M4 agonist• M1/M4 agonist
• H4 antagonist• PAR2 mAb • Apelin agonist • mGlu5 NAM • A2a antagonist
• CXCR4 mAb • GPR35 agonist
~1.1Baffected globally
$8.3bn2024
Migraine
• CGRP antagonist
Product/Program Modality1 Indication Partner Discovery Preclinical Phase 1 Phase 2 Phase 3 MarketedJapan Marketed Products (Out-licensed to Marketing / Distribution / Commercialization Partners)
NorLevo® SME Emergency contraception
ORAVI® SME Oropharyngeal candidiasis
Partnered Pipeline - Respiratory Products (Traditional out-licensing)
Seebri®/Ultibro® SME COPD
QVM149 SME Asthma
Partnered GPCR Pipeline (Traditional out-licensing/collaboration projects)
A2a antagonist SME Multiple solid tumors
A2a antagonist SME EGFRm NSCLC
M1 agonist SME Alzheimer’s disease
M4 agonist SME Alzheimer’s disease
M1/M4 dual agonist SME Alzheimer’s disease
Single target SME Pain
Multiple targets SME Multiple indications
Multiple targets mAb Inflammation
Multiple targets SME/LME Multiple indications
Multiple targets SME/LME Multiple indications
Partnered GPCR Pipeline (Co-development/profit share)
CXCR4 mAb mAb Immuno-oncology
Single target mAb Immuno-oncology
Single target Peptide Inflammation
Asset-centric Companies
Orexin agonists SME Narcolepsy
Orexin agonists SME Narcolepsy
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Our partnered pipeline has multiple programs
1 Note: SME = small molecule; LME = large molecule; mAb = monoclonal antibody
: Next 12–18 months progress: Current stage
NEW
NEW
NEW
NEW
ADV
ADV
ADV
Product/Program Modality1 Indication Originator Discovery Preclinical Phase 1 Phase 2 Phase 3 Marketed
In-house (pre-partnered) GPCR pipeline
M1 agonist1 SME DLB (Japan)
mGlu5 NAM SME Neurology
SSTR agonist Peptide Endocrine disorders
CGRP antagonist SME Migraine
GLP-1 antagonist Peptide Metabolic diseases
GLP-2 agonist Peptide Intestinal failure
Orexin-1 antagonist SME Cocaine-use disorders
Apelin agonist Peptide PAH
GPR35 agonist SME Inflammatory bowel disorders
H4 antagonist SME Atopic dermatitis
PAR2 mAb mAb Atopic dermatitis
Multiple programs targeting a broad range of GPCRs
SME/LME/mAb/Peptide
Multiple indications across Neurology, GI / Inflammation, Immuno-oncology and rare / specialty diseases
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Our in-house (pre-partnered) pipeline is immensely broad and deep
1 Note: SME = small molecule; LME = large molecule; mAb = monoclonal antibody1 Phase 2 trial of HTL0018318 for DLB in Japan remains under voluntary suspension. The Group plans to resubmit a new clinical trial notification for HTL0018318 (or another novel M1 agonist) to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in the future
: Next 12–18 months progress: Current stageMultiple candidates entering clinical development and next wave of targets in advanced discussions
ADV
ADV
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Our growth strategy is driven by our pursuit of profitability
Platform Technology (StaR® - Structure)
Extend platform technology leadership
Drug Discovery
(SBDD)Development
Accelerating value creation by pursuing profitability
Business Development (New/Existing Partners)
Generate high quality novel candidates
Enhance focus on high value programs
Drive new and progress existing partnerships
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More sustainable balance of resources and capital going forward
Latest financials (H1 2019) FY19 financial guidance (12m to 31-Dec-19)
(JPY m)1 6m to 30-Jun-182 6m to 30-Jun-19
Revenue 1,512 5,056
Cash R&D (3,273) (1,862)
Cash G&A (1,381) (1,239)
Cash at hand 18,7603 16,915
(USD m) 6m to 30-Jun-182 6m to 30-Jun-19
Revenue 13.9 45.9
Cash R&D (30.2) (16.9)
Cash G&A (12.7) (11.3)
Cash at hand 169.13 157.0
1 Reporting currency in JPY; 2 Unaudited proforma information; 3 As at 31-Dec-18; 4 USD:JPY FX rate 108
Accelerating value creation by prioritizing the pursuit of profitability in 2019
Total R&D expenses Cash G&A expenses
¥4,320 to ¥4,860m
$40 to $45m4
¥1,620 to ¥2,160m
$15 to $20m4
Sustainable and focused R&D
Increase new partner activity
Tight management of cost base
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VISIONTo become a leading biotechnology company, anchored in Japan, with a global reach
MISSIONMaking a significant contribution to improving the quality of life and health of people around the world
VALUESIntegrity and Accountability, Passion, Courage and Resilience, Openness, Teamwork