Pending Completion of Phase 1 on the Expansion of the Almac Facility, 25 Fretz Road, Souderton, PA

May 22, 2025

In summer 2023 Almac announced the start of a major expansion of our North American Headquarters in Souderton, Pennsylvania. This expansion will not change the facility address and does not change the existing Almac service offering but will significantly increase storage and processing capacity. The expansion will be delivered in phases, concluding in 2026.

We are now pleased to inform you that the first phase of the expansion will complete in summer 2025.

This phase will deliver:

• New 7300-pallet 15-25°C Warehouse
• New Distribution Warehouse with expanded pick-face and additional processing workstations
• New Mobile Freezer Area with enablers to accommodate over 70 ultra-low temperature freezers
• New environmental monitoring system (EMS) providing continuous monitoring and alarm functionality for the new areas.

This letter provides formal notification of this change in accordance with the responsibilities defined in the Technical Agreement.

How the change is being managed:
The overall expansion program is governed by a Quality-approved change control. Linked to this are change controls governing the delivery of each GxP area and system. Impact assessment and regulatory review have informed the scope of the change plan for each area/system, and the associated change actions encompass a broad range of GxP and business readiness topics including commissioning, validation, notification to regulatory authorities and SOPs. Risk assessment has been used extensively to ensure change activities are appropriately controlled, maintaining focus on regulatory compliance, patient safety and business continuity. Almac has maintained service levels throughout the construction period, and this will continue during operational start-up in the new areas.

A more detailed view of the approach is provided in the Expansion of the Almac Facility document.

Expansion phase 1 milestones:
Validation of the new EMS is due to complete in Jul 2025. Validations of the 15-25°C Warehouse, Distribution Warehouse and Mobile Freezer Area are expected to complete in August 2025. Subsequent final Quality approval of the completed change controls for each area will authorize use of the new spaces. Almac will then commence the movement of existing material to the new areas. The second phase of the expansion – including construction of an additional 2-8°C store, 2-8°C production rooms and -15 to -25°C production rooms – will then commence within the vacated space.

Next steps:
Almac will provide an additional update when temperature mapping data is available and will share evidence of Validation completion and Quality approval of the change controls that are applicable to the phase 1 areas. Further notification will be provided in 2026 prior to completion of phase 2 of the expansion. There is no action required by you; however, we would be grateful if you share this notification of change to any parties within your organization who may be interested.

If you have any questions, please contact your Almac representative.

Senior Quality Management