Onesource Specialty Pharma Limited · NSE:ONESOURCE
Onesource Specialty Pharma — Investor Presentation (September 2024)
34 slides from Onesource Specialty Pharma's investor presentation, Sep 26, 2024
Slide 1: Exchange filing cover letter: Corporate Deck of OneSource
September 26, 2024 The National Stock Exchange of India Limited The BSE Limited Exchange Plaza, Bandra-Kurla Complex, Bandra Phiroze Jeejeebhoy Towers, Dalal (E), Mumbai - 400 051 Street, Mumbai – 400 001 Scrip Code: STAR Stock Symbol: 532531 Dear Madam/ Sir, Sub: Corporate Deck of OneSource Please
Slide 2: OneSource Company Updates September 2024
OneSource Company Updates OneSource September 2024 Private and Confidential | OneSource Page 1
Slide 3: Disclaimer
Disclaimer OneSource OneSource Specialty Pharma Limited, formerly known as Stelis Biopharma Limited, is undergoing a significant transformation. As announced on September 23, 2023, OneSource will be acquiring and merging Strides' Oral Technologies (soft gelatin capsules) and SteriScience's Specialty
Slide 4: Combination of distinct entities and capabilities → OneSource
Corporate overview OneSource Combination of 3 distinct entities and capabilities → OneSource Customer want • One stop shops catering to wider outsourcing needs including development • Low complexity in managing fewer 3rd parties (reduce cost, time, resources, … ) Soft gelatin capsules division (Deme
Slide 5: OneSource is built on legacy of exemplary quality and compliance track record
Corporate overview OneSource OneSource is built on legacy of exemplary quality and compliance track record Incorporation of the Company as Successful commissioning and Rebranded Specialty Strides re-entered injectable Introduced OneSource, Strides Pharmaceuticals Private stabilization of Soft Gelati
Slide 6: OneSource is an end-to-end CDMO with one of the widest offerings
Corporate overview OneSource OneSource is an end-to-end CDMO with one of the widest offerings Common CDMO archetypes CDMOs (Non-exhaustive) ‘One Stop’ solution providers Drug Substance (DS) - Microbial Process & Analytical Biologics DS - Mammalian Development Drug Product (DP) - Fill finish Quality
Slide 7: Strong expertise in 'Development' with end-to-end capabilities, installed capacities and compliance track record
Corporate overview Strong expertise in ‘Development’ with end-to-end capabilities, installed capacities OneSource and compliance track record Competitive advantage Formulation capabilities – 35+ approved ANDAs for complex injectables and soft gelatin capsules Scale advantage – Installed capacities a
Slide 8: Globally accredited, state-of-the-art facilities with capacities for >100 million sterile dosages and ~2.4 billion capsules
Corporate overview Globally accredited, state-of-the-art facilities with capacities to produce >100 OneSource million sterile dosages and ~2.4 billion capsules per year Complex inj Drug-device combinations Multi-modal Biologics Soft gelatin capsules1,2 Complex injectables1 Penicillin fill finish1 In
Slide 9: Facilities are digitally enabled with industry-leading QMS
Corporate overview OneSource Facilities are digitally enabled with industry-leading QMS1 Company quality policy Select systems / applications installed at Unit 2 “To develop and deliver Enterprise Resource Planning & Material Management products of high and QMS Management consistent quality that wil
Slide 10: A diversified customer base with end sales primarily in regulated markets
Corporate overview OneSource A diversified customer base with end sales primarily in regulated markets Customer domicile End market sales End market sales 29 % 22 ROW % 5% - 10% 5% 33 90% - 95% % Developed Markets (USA, EU) 11 % Note: As of June 2024 Private and Confidential | OneSource Page 9
Slide 11: Strong management team with average ~23 years of experience
Corporate overview OneSource Strong management team with average ~23 years of experience Neeraj Sharma, CEO Prateek Gupta, Head of R&D and Scientific Services Neeraj has 28+ years of global experience in pharma. He has been an integral Prateek, a PhD from Cornell, has 16+ years of experience in biol
Slide 12: 3 disruptive changes provide tailwind for OneSource CDMO offerings
Corporate overview OneSource 3 disruptive changes provide tailwind for OneSource CDMO offerings CDMO acquisition GLP-1s rise BIOSECURE act Acquisition of a large CDMO Obesity and Diabetes are major societal Prohibit U.S. federal funding in connection with Acquisition of a large CDMO by a Pharmaceuti
Slide 13: OneSource is well positioned to capitalize on the emerging opportunities
Corporate overview OneSource is well positioned to capitalize on the emerging opportunities and OneSource capture a large part of the addressable market 1 Differentiated CDMO play with full-service capabilities and strong focus on ‘Development’ across multiple technology platforms Best in class manu
Slide 14: Drug-Device Combinations
OneSource Drug-Device Combinations Private and Confidential | OneSource
Slide 15: OneSource is a pioneer DDC solution provider with full-service offering
Business segment DDCs including GLP-1s OneSource OneSource is a pioneer DDC solution provider with full-service offering 2 9 9 NCE-1 GLP-1 Projects Molecules in portfolio incl. GLP-1s, Device platforms / formats being biologics & small molecules handled 55+ 17 20+ Years of cumulative Device and CMC
Slide 16: Bausch and Strobel filling line integrated with isolator for cartridge fill finish
Business segment DDCs including GLP-1s OneSource Bausch and Strobel filling line integrated with isolator for cartridge fill finish Page 15 Private and Confidential | OneSource
Slide 17: 20+ automatic and semi-automatic assembly stations to support multiple device formats
Business segment DDCs including GLP-1s OneSource 20+ automatic and semi-automatic assembly stations to support multiple device formats Page 16 Private and Confidential | OneSource 16
Slide 18: GLP commercial supplies to start from Q4 FY25 onwards
Segment overview DDCs including GLP-1s OneSource GLP commercial supplies to start from Q41 FY25 onwards MSA CSA Molecule Key Customers FY ‘24 FY ‘25 FY ‘26 FY ‘27 FY ‘28 FY ‘29 FY ‘30 GLP-1 3 of the top 5 global generics + Others Molecule A Started receiving Purchase Orders (Q4 FY25 launch1) Top 3 g
Slide 19: OneSource has significant DDC opportunity beyond GLP-1s
Segment overview DDCs including GLP-1s OneSource OneSource has significant DDC opportunity beyond GLP-1s DDCs are critical for self administration via subcutaneous route and are increasingly being Significant opportunities preferred for delivering biologics beyond GLP-1s E.g., delivery route for app
Slide 20: Biologics
OneSource Biologics Private and Confidential | OneSource
Slide 21: Widest offering amongst the peer group to benefit from multiple tailwinds including BIOSECURE act
Segment overview Biologics Widest offering amongst the peer group to benefit from multiple tailwinds OneSource including BIOSECURE act Mid sized CDMOs offerings and coverage in Biologics (Non exhaustive list) OneSource opportunity Microbial Mammalian Sterile fill finish Device assembly & Pkg ▪ End t
Slide 22: Our sites offer integrated Biologics development & manufacturing
Segment overview Biologics OneSource Our sites offer integrated Biologics development & manufacturing Unit 1 State-of-the-Art Facilities Unit 2 Process Development: DS Manufacturing: • Mammalian platform • 1000L for DS from • Microbial platform Microbial platform Analytical Method • 2000L x 2 suites
Slide 23: End-to-end capabilities enabling biologics asset development for regulatory approvals
Segment overview Biologics End-to-end capabilities enabling biologics asset development for regulatory OneSource approvals Clone Development Process development Process Characterization Clinical & Commercial & Selection & Formulation Lock & Validation Manufacturing • Robust clone/strain with good •
Slide 24: OneSource has leading capacities and capabilities in the Biologics space
Segment overview Biologics OneSource OneSource has leading capacities and capabilities in the Biologics space 1 1st 10+ of the few sites globally to offer Innovator molecule onboarded with Ongoing projects and RFPs integrated DS-DP mfg. from same site a top 3 animal health company 1,000 4,000 Liters
Slide 25: Sterile fill finish
OneSource Sterile fill finish Private and Confidential | OneSource
Slide 26: Focused on critical care injectables frequently in shortage; strong supply and compliance track record
Segment overview Sterile fill finish Focused on critical care injectables frequently in shortage; Strong supply and OneSource compliance track record enables industry leading margins OneSource focus ▪ Product shortages – Portfolio (ANDAs and dormant IPs) addressing market needs in shortage areas ▪ P
Slide 27: Significant installed capacities across multiple dose formats
Segment overview Sterile fill finish OneSource Significant installed capacities across multiple dose formats Aseptic liquid filling lines for all formats: Vials (Liquid and Lyo), PFS, Cartridge and Device. Vial line for TS products. Dosage format Capacity per annum Cold rooms for storage of Pre-fill
Slide 28: OneSource has stellar compliance and supply track record in sterile injectables
Segment overview Sterile fill finish OneSource OneSource has stellar compliance and supply track record in sterile injectables 20+ 1 30+ Years of development and Of the few FDA approved mfg. sites Formulations developed in-house manufacturing experience for Penicillin globally 70+ 15+ Million eaches
Slide 29: Oral Technologies
OneSource Oral Technologies Private and Confidential | OneSource
Slide 30: OneSource is one of the largest prescription focused softgel capsules manufacturers
Segment overview Oral technologies OneSource is one of the largest prescription focused softel capsules manufacturer OneSource 3 2.4 Global Decades Billion Presence of rich experience in Capsules manufactured Our products are sold in all soft gel R&D and manufacturing every year regulated markets So
Slide 31: Uniquely placed with full value chain coverage
Segment overview Oral technologies Uniquely placed with full value chain coverage OneSource Vendor network R&D Manufacturing • Design niche and novel patentable formulation • 4 highly sophisticated encapsulation lines ➔ 2.4 billion • Strong network of Gelatin and HPMC capsules annually suppliers wit
Slide 32: Legacy of ~3 decades of development and manufacturing softgel capsules
Business segment Oral technologies OneSource Legacy of ~3 decades of development and manufacturing softgel capsules 30 30+ ~20 Years of development and Products developed fully in-house Products commercialized in US manufacturing experience Top 4 40+ Manufacturer of prescription Customers in regulat
Slide 33: OneSource Mid term guidance
Financials OneSource 2x 350 – 400 M$ 160 - 180 M$ OneSource FY 2025E 3 – 4 years Mid term guidance EBITDA% ~34% >40% Private and Confidential | OneSource Page 32
Slide 34: OneSource
OneSource OneSource Private and Confidential | OneSource Page 33
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