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Amgen Provides Update on Status of Puerto Rico Operations - October 25, 2017

In the five weeks since Hurricane Maria hit Puerto Rico, Amgen has been providing support to our staff members and the local community while implementing our robust business continuity plans and restoring manufacturing operations at our site in Juncos. The Company continues to provide an uninterrupted supply of medicines for patients around the world.

Staff and Community

  • We are thankful to have now accounted for all of our staff and external workers. Nearly all (97 percent) of our staff have returned to work at our manufacturing site and commercial affiliate.
  • Amgen’s on-site child care center has reopened. Chiqui Amgen was the first corporate on-site child care center on the island when it was established in 2005.
  • Cafeteria services have resumed full operations at the site as has the BioPharma Co-op Credit Union branch.
  • Amgen continues to mobilize a comprehensive set of resources to support our staff in Puerto Rico. Recent additions include offering laundry services on-site and providing bags of ice for staff to take home. Gasoline pumps for personal vehicles have been discontinued since fuel is now more readily available in the community.

Site

  • The critical manufacturing areas of our facility were not significantly impacted by the storm. The company continues to provide an uninterrupted supply of medicines for patients around the world. Our drug substance manufacturing and packaging plants are fully operational and we expect to resume formulation/filling and small molecule commercial production by the end of October 2017.
  • Amgen has a network of back-up generators powering the site and regular deliveries of diesel fuel are being supplied under pre-arranged contracts.
  • Water service has been restored with sporadic interruptions and is being supplemented by on-site wells and Amgen’s water storage tanks.
  • The site has telecommunications connectivity via local carriers and continues to maintain back-up microwave and satellite connections.
  • Supplies of medical-grade oxygen and nitrogen on the island are limited. Amgen has arranged deliveries of both types of gas from the U.S. mainland and other countries, and is establishing alternate supply chains until reliable service on the island is restored.

Supply of Medicines for Patients

The Company continues to provide an uninterrupted supply of medicines for patients around the world. Our long-standing risk mitigation strategy includes:

  • Maintaining inventory levels to address unplanned situations
    • Our warehouse in Puerto Rico has resumed shipments of medicines.
    • The majority of our finished goods inventory is maintained on the U.S. mainland.
  • Investing in capacity and redundant facilities
    • Amgen’s global manufacturing network includes a redundant fill/finish facility in Ireland and we have relationships with established contract manufacturers in the U.S. and Europe for additional capacity.
    • We are in the process of activating manufacturing and packaging lines at our own sites in Ireland and the Netherlands and at contract manufacturers in the U.S. and Europe to absorb some production volume and serve as a relief valve while our Puerto Rico site resumes full operations.
  • Exercising our business continuity plans on a regular basis
    • Following its established plans, the Puerto Rico site was prepared and responded before, during and after the hurricane.
    • A cross-functional team from across the company is supporting the site recovery efforts with materials/supplies, logistics and engineering support, and resources for staff and the local community.

Puerto Rico Infrastructure

  • Amgen performs a substantial majority of our commercial manufacturing activities at our facility in Puerto Rico. The global supply of our products is significantly dependent on the uninterrupted and efficient operations of this facility.
  • We are in regular contact with the U.S. Food and Drug Administration (FDA) to keep the agency informed of our progress in resuming operations and have confirmed that we do not anticipate an impact on patient supply.
  • To return our site to routine operations and ensure supply over the long-term, we are actively engaging with Puerto Rico and Federal government officials to coordinate recovery activities and highlight the importance of restoring power, water, telecommunications and other critical infrastructure to the island.
    • Amgen has signed a letter to Members of Congress – from a cross-section of companies across a wide range of industries – urging them to address the evolving humanitarian crisis in Puerto Rico by helping to restore the basic services of government and public utilities.
  • The Amgen Foundation has pledged $3 million to support urgent Hurricane Maria relief efforts in Puerto Rico. The Foundation also has committed up to an additional $2 million for longer-term rebuilding efforts. The first grants from this pledge are:
    • $1 million to Direct Relief
    • $1 million to International Medical Corps
    • $500,000 to Americares