### **Overview** **OneSource Specialty Pharma Ltd. (BSE: 544292, NSE: ONESOURCE)** is India’s first pure-play, multi-modality contract development and manufacturing organization (CDMO), focused on complex specialty pharmaceuticals. The company was formerly known as **Stelis Biopharma Limited** and rebranded to consolidate the group’s capabilities in **biologics, drug-device combinations (DDC), sterile injectables, and oral technologies**, especially **soft gelatin capsules**. Listed in January 2025, OneSource has rapidly emerged as a trusted, end-to-end CDMO partner for global pharmaceutical innovators, generics players, and biotech firms. With **five globally compliant manufacturing facilities** across **India and Poland**, a strong regulatory track record (including approvals from USFDA, EU-GMP, MHRA, ANVISA), and over **1,300 employees**, OneSource is strategically positioned to benefit from the rising demand for outsourced drug development and manufacturing—especially in high-growth areas such as **GLP-1 therapies, biologics, and self-administered injectables**. --- ### **Core Business Segments & Capabilities** OneSource operates across four primary platforms: #### 1. **Biologics** - **Integrated DS-DP (Drug Substance–Drug Product) platform**, one of the few in the world, enabling seamless scale-up from development to commercial manufacturing. - **Mammalian cell culture**: 4,000L (4KL) installed, with 20KL ready for installation. - **Microbial fermentation**: 1,000L (1KL) operational, planned expansion to **6KL**. - **High-concentration, low-viscosity formulation tech**: Enables subcutaneous delivery of biologics up to **300 mg/mL (viscosity <20 cps)**. - **Platform capabilities** include CHO cell-based monoclonal antibodies, Fc-fusion proteins, and glycoproteins with titers of **8–10 g/L**. - Achieved a major milestone in FY25 with its **first Novel Biologic Entity (NBE)** program. - **Rapidly expanding pipeline**: Biologics development funnel is nearly **four times larger in FY26 vs FY25**. #### 2. **Drug-Device Combinations (DDC)** - **Industry-leading installed capacity**: 40 million cartridges and 38 million pre-filled syringes (PFS) in FY25, scaling to **220 million cartridges by FY28**. - Offers end-to-end services: device conceptualization, tech transfer, automated assembly, and packaging for **pen injectors, autoinjectors, safety syringes, and cartridges**. - **11 device platforms** in use; managing **45+ DDC projects**, with nine in **NCE-1** stage. - Currently **sold out** due to strong demand; accelerating capacity expansion to **over 200 million units by end-2026**, a full year ahead of schedule. - **Take-or-pay agreements** and **capacity reservation fees** from customers provide de-risked revenue visibility. #### 3. **Sterile Fill-Finish & Injectables** - **Key facilities**: - **Vadodara, India** (Brooks Steriscience): Vertically integrated anti-infective site (carbapenems, penicillins), USFDA-approved, low COGS, supplies US GPOs. - **Warsaw, Poland** (EU facility): USFDA- and EU-approved; manufactures **Europe’s largest anesthetic brand** under a long-term CDMO contract. - Capabilities include: - Lyophilization (freeze-drying), suspension-based products, emulsions, liposomes, and implants. - **Niche expertise** in critical care injectables and **505(b)(2)** products. - One of **fewer than 10 dedicated USFDA-approved penicillin sites** globally. - Focus on **essential medicines** and **shortage-prone injectables** ensures high-margin, steady demand. #### 4. **Oral Technologies (Soft Gelatin Capsules)** - Among the **top five global producers**, with **2.4 billion capsules annual capacity**. - Offers **innovative formats**: enteric-coated, chewable, vegan (carrageenan-based), mini softgels, nano-encapsulation, and twist-off precision dosing. - Proprietary tech to **prevent capsule leakage** and ensure high bioavailability (e.g., SMEDDS with <50-micron droplets). - Strategic partnership with **Pharmagel (Italy)** to enhance gelatin process quality. --- ### **Strategic Growth Drivers (Nov 2025)** #### **Global Expansion & M&A** - **Acquired a USFDA-approved sterile fill-finish site in Poland**, bringing biologics, RTU (ready-to-use), and 505(b)(2) capabilities. - Adding a **vertically integrated anti-infective manufacturing site in Vadodara, India**, strengthening access to US GPOs and global anti-infective markets. - Targeting **M&A in the US and Europe** to deepen local presence, access talent, and diversify supply. #### **Integration with Xbrane Biopharma** - Strategic collaboration and equity investment in **Xbrane Biopharma AB (Nasdaq Stockholm)**, a leader in low-cost biosimilar platform tech. - Partnership focuses on co-developing biosimilars targeting **€23 billion in peak annual sales**, including **Ximluci® (ranibizumab biosimilar)** already launched in Europe. - Supports **FDA/EMA regulatory readiness** for OneSource’s biologics DS/DP facility; accelerates commercial scalability. #### **Capital Expenditure & Capacity Scaling** - **$100 million capex over 4 years** (accelerated by one year) to expand: - Cartridge capacity: **40M → 220M units by FY28** - Pre-filled syringes: **38M → 50M units** - Vials: **28M → 50M units** - Modular and fungible capacity design ensures **operational agility** and **ROCE-optimized growth**. - Funded via **equity proceeds, internal accruals, customer reservation fees, and borrowings**. #### **Commercial & Financial Outlook (FY28)** - **Revised revenue guidance**: Up to **$500–540 million (from $400M earlier)**, driven by: - Base business growth - Pending acquisition (adds **$100M incremental revenue**) - **EBITDA margin target**: **~40%** - **Revenue CAGR**: Targeting **25–30% from FY25 to FY28** - Currently **fully sold out** in DDC and biologics, with **contracted revenue of $100M+ expected in next 12 months**. --- ### **Customer Base & Market Access** - **70+ global customers**, including **four of the top five generic pharma companies** and major US GPOs. - Serves **20+ GLP-1 customers** globally; supports **semaglutide launches** in **Canada, Brazil, Saudi Arabia, India**, and **MENA**. - Anticipates **40–50% market share** in **semaglutide generics** across key emerging markets. - Strong demand post-patent expiry (FY26–FY28) in obesity/diabetes segment (**>$50B market**). - **9 new products** preparing to launch outside Canada; **multiple day-one launch capabilities** upon regulator approvals. - Customers engaged under **MSAs (Master Service Agreements)** transitioning to **CSAs (Commercial Supply Agreements)**, shifting revenue mix to **80% CSA by steady state**. --- ### **Regulatory & Operational Excellence** - Over **60+ successful regulatory and customer audits in FY25**, including **USFDA, ANVISA, Saudi FDA, Taiwan FDA**. - Flagship **Steriscience plant** (20 years old) undergoing major retrofit and expansion; completion expected in 12 months. - **54 regulatory/customer audits passed** in last 24 months. - Facilities approved by **FDA, EMA, MHRA, ANVISA, TGA, WHO**, ensuring **global compliance and market access**. --- ### **Key Strategic Advantages** 1. **Integrated Platform**: Rare capability to offer **end-to-end DS-DP for both microbial & mammalian biologics**, plus device integration. 2. **Geographic & Technological Diversification**: Dual presence in **India (cost advantage)** and **EU (advanced market access)**. 3. **De-risked Growth Model**: - **Take-or-pay agreements**, **advance capacity reservations**, **multi-customer dependencies**, and **diverse market launches**. - Not dependent on a single client or approval event. 4. **Biosimilar & GLP-1 Tailwinds**: Regulatory streamlining (e.g., **BIOSECURE Act**, 505(b)(2)) driving demand for trusted CDMOs outside China. 5. **Cross-Selling Success**: 12 customers now using **multiple service modalities**; 16+ new DDC projects won in FY25 from existing clients.