Hikma Pharmaceuticals (HIK) investor relations material

R&D strategy and operating model

• Four growth pillars: balance simple and complex portfolios, invest in differentiated dosage forms, use manufacturing capabilities to unlock challenging products, and accelerate development and regulatory execution.

• R&D is organized around three technology platforms—injectables, solid orals, and respiratory, nasal, semi-solids and liquids—with shared operations and regulatory teams.

• Quarterly product selection incorporates commercial input from the US, Canada, EU and MENA; cross-functional reviews, NPV and ROI analysis, executive oversight and recurring stage gates guide investment and can stop programs if value deteriorates.

• R&D investment is increasing across platforms, with solid oral development emphasizing first-to-file and first-to-market opportunities; specialized teams, shared labs and regulatory support are intended to deepen expertise and create synergies.

• Capabilities are expanding into complex injectables, ready-to-use formulations, inhalation, nasal, devices, long-acting injectables, peptides and oligonucleotides.

Pipeline and execution

• Pipeline exceeds 330 products with an addressable market above $100bn; 16% are approved or tentatively approved, 28% filed and 52% in development.

• Launch profile comprises 72% near-term opportunities before 2030 and 28% long-term opportunities from 2030 onward; more than 30 products were added in 1H 2026.

• YTD through September 2026, pipeline activity included 60 submissions, 56 approvals and 59 launches.

• Late-phase assets are complemented by new project starts to replenish the pipeline; product selection follows a quarterly cycle, with business-unit committees prioritizing programs and a global committee reviewing high-investment opportunities.

• Investments are staged to manage risk in long-duration programs, with regular reviews of business cases, NPV and technical and regulatory success.

Respiratory, nasal, semi-solids and liquids platform

• The platform covers DPI, pMDI, soft-mist and nebulised products; multi- and single-dose nasal sprays; MENA creams and ointments; and oral solutions and suspensions, including controlled substances developed in Columbus.

• The respiratory pipeline covers ~66% of the US respiratory market and targets large markets with high barriers to entry; integrated expertise spans analytical science, formulation, process and clinical development, devices, human factors and regulatory affairs.

• Existing capabilities include generic Advair and fluticasone propionate multi-dose nasal spray; complex combination products require integrated drug, device, analytical, formulation and clinical expertise.

• Nasal products use ANDA and 505(b)(2) pathways, with additional 505(b)(2) programs and complex nasal ANDAs in development; semi-solids focus on creams, ointments and gels using existing plant.