Amgen Update Regarding COVID-19 For Media
April 30, 2020
As the COVID-19 pandemic continues to evolve, Amgen has mobilized around four priorities:
- Ensuring the safety and well-being of our 23,000 Amgen employees around the world;
- Continuing to serve patients – those currently on Amgen medicines and those that stand to benefit from potential new medicines in our pipeline;
- Contributing our therapeutic antibody and immunology expertise to the fight against COVID-19;
- And lending a helping hand in the communities where we live and work.
IMPACT TO OUR BUSINESS
- Early in March we activated our business continuity plans in the United States to avoid or minimize business disruption and ensure the well-being of our staff. Such plans were established in other regions earlier in the quarter as the pandemic progressed from Asia and then on to Europe.
- We continue to provide an uninterrupted clinical and commercial supply of our medicines for patients around the world, and we do not currently anticipate a shortage of our medicines due to COVID-19.
- Like others in our sector, we are seeing varying degrees of impact from COVID-19 across our portfolio as physician-patient interactions are interrupted. These reduced interactions have led to some delays in diagnosis and treatment, which in turn reduces patients starting new treatments.
- Our teams are working to address continuity of care issues and exploring novel solutions such as alternate sites of care, mobile nurse administered injections and prescription fills at specialty and retail pharmacies. We are also working with policy makers and advocacy organizations to address treatment challenges in this environment.
- Amgen continues to expect data read-outs from the fully enrolled potentially pivotal AMG 510 (sotorasib) Phase 2 non-small cell lung cancer study, the tezepelumab Phase 3 asthma study in collaboration with AstraZeneca, and the omecamtiv mecarbil Phase 3 heart failure study in collaboration with Cytokinetics in 2020. Data from the Otezla® (apremilast) Phase 3 study in patients with mild-to-moderate psoriasis are expected in Q2 2020.
- Study start-up activities are continuing where possible to allow rapid site activation and enrollment when that becomes feasible.
- Study procedures are being implemented consistent with recent guidance from regulators to maintain patient safety and study data integrity.
- Enrollment is paused in clinical trials where there is uncertainty around the ability of sites to ensure subject safety or data integrity.
- Research activities are increasing in various geographies as the situation safely permits.
- Medical conferences and journals are being engaged to ensure continued dissemination of important data in a timely manner.
- At this stage of the COVID-19 pandemic we cannot rule out future impact on our business.
CONTRIBUTING OUR THERAPEUTIC ANTIBODY AND IMMUNOLOGY EXPERTISE
Amgen is working collaboratively with other biotechnology companies, academic institutions, the Administration and other government research entities to identify effective treatments for COVID-19 as quickly as possible:
- Amgen is participating in the The National Institutes of Health (NIH) and the Foundation for the NIH’s (FNIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership. The ACTIV partnership aims to develop a collaborative framework for prioritizing vaccine and drug candidates, streamlining clinical trials, coordinating regulatory processes, and/or leveraging assets among all partners to rapidly respond to the COVID-19 and future pandemics.
- Otezla® (apremilast), an oral treatment approved in more than 50 countries for inflammatory diseases such as psoriasis and psoriatic arthritis, will be investigated as a potential immunomodulatory treatment in adult patients with COVID-19 in upcoming platform trials. Otezla inhibits the activity of phosphodiesterase 4 (PDE4), an enzyme found in inflammatory cells in the human body. By inhibiting PDE4, Otezla is thought to modulate the production of inflammatory cytokines and other mediators.
- Amgen has partnered with Adaptive Biotechnologies to discover and develop fully-human neutralizing antibodies to potentially prevent or treat COVID-19. The mutually exclusive collaboration brings together Adaptive’s proprietary immune medicine platform for the identification of virus-neutralizing antibodies with Amgen’s expertise in immunology and novel antibody therapy development. Adaptive will extend its high throughput platform to rapidly screen the massive genetic diversity of the B cell receptors from individuals that have recovered from COVID-19. This enables the identification of tens of thousands of naturally occurring antibodies from survivors of COVID-19 to select those that neutralize SARS-CoV-2. Amgen will then leverage its world-class antibody engineering and drug development capabilities to select, develop and manufacture antibodies designed to bind and neutralize SARS-CoV-2.
LENDING A HELPING HAND IN OUR COMMUNITIES
Amgen and the Amgen Foundation have made an initial commitment of up to $12.5 million in COVID-19 relief funds to support emergency response efforts. The Amgen Foundation is also matching donations made by our employees worldwide who wish to contribute their own funds to the relief efforts. These funds are being deployed as quickly as possible and include:
- COVID-19 relief funds in those U.S. states where Amgen has a significant presence, including California, Rhode Island, Massachusetts, New Jersey, Florida and Kentucky. A few examples:
- Senior Concerns, an adult day care center located in Amgen’s headquarter location of Thousand Oaks, California, received a $100,000 grant to ensure that their critical meals delivery programs to affected seniors could continue despite the collapse of their income generating programs.
- In Tampa, Amgen made donations focused on ensuring that children from low-income families can bridge the technology challenges being faced as they work hard to learn from home.
- Two long-time Amgen Foundation partners, Direct Relief and International Medical Corps.
- Patient-focused organizations, such as the Leukemia & Lymphoma Society, which is providing eligible blood cancer patients with a $250 stipend to help with non-medical expenses
Amgen has also expanded their Staff Volunteer program to allow medically trained staff the opportunity to take voluntary leaves to support COVID related work in their communities.
Additionally, the Amgen Foundation is a proud sponsor of two on-line learning platforms – Khan Academy and LabXchange – that are providing free world-class educational content to millions of students around the world at a time when many are no longer going to school.
- In January, the Amgen Foundation and Harvard’s Faculty of Arts and Sciences launched LabXchange, a free online science education platform that provides users access to personalized instruction, virtual lab experiences and networking opportunities across the global scientific community. As the founding sponsor, the Amgen Foundation awarded $11.5 million in grant funding to Harvard to deepen the impact of this new online learning platform across the globe.
- The Amgen Foundation is the founding biology partner of the Khan Academy, a leading innovative and effective educational technology platform with over 70 million registered users across the globe.
- Free online learning programs supported through both of these deep relationships are available to help students continue their science education during school closures, and can be accessed via the LabXchange and Khan Academy’s online learning websites.
ENSURING THE SAFETY AND WELL-BEING OF OUR EMPLOYEES
- We have committed to pay continuity for employees and will assess the duration of that commitment as the situation evolves.
- We are providing staff working from home in the U.S. and Puerto Rico a monthly stipend for home broadband Internet access along with an allowance to purchase any necessary home office equipment of their choice.
Working from Home Assistance
- We have set up an internal website dedicated to COVID-19 for employees to review updates, video messages from leadership, podcasts, access to training, and frequently asked questions.
- We have launched an additional teleconferencing platform globally with dedicated technical support.
- Ongoing online training and development is being used by thousands of employees.
Employee Wellness Resources
- We have launched a virtual health and wellness program for all Amgen team members with an emphasis on work-at-home strategies.
- We have implemented a virtual workout, nutrition, and yoga app offering all of our Amgen team members around the world hundreds of regionally appropriate online programs free of charge.
- We are offering mental health resources, including virtual coaching, therapy sessions, meditation and mindfulness programs.
- We are providing manager resources, such as resilience training, to help our leaders assist their teams through this period of dynamic change.
- Our largest medical plan is offering telemedicine visits for all illnesses with no deductibles or co-insurance for 90 days to encourage the safety of our team members, their families and healthcare providers.
Guidance to Staff on Work Locations, Meetings, and Travel
- Since Monday, March 16, all employees who were able to work from home have been doing so until further notice. This includes staff at our corporate headquarters in Thousand Oaks, CA. Our teams in Europe and Asia have been proactively modeling this behavior for many weeks and in some cases are now returning to work based on local conditions and guidance from local health officials.
- In addition, we have made the decision to suspend all in-person meetings and interactions with the healthcare community and professionals in the U.S. As of March 16, all U.S. field staff have been working from home and have moved to a virtual interaction model.
- Amgen has suspended international business travel and limited domestic travel in the U.S.
- We have suspended attendance at medical congresses, conferences and other large events.
- Enhanced cleaning procedures and visitor screenings were implemented at all Amgen locations.
This communication contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company, including Adaptive Biotechnologies (including statements regarding such collaboration’s ability to discover and develop fully-human neutralizing antibodies targeting SARS-CoV-2 to potentially prevent or treat COVID-19), BeiGene, Ltd., or the Otezla® (apremilast) acquisition, including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion, as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on our business, outcomes, progress, or effects relating to studies of Otezla as a potential treatment for COVID-19, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this communication and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.
Megan Fox, 805-447-1423 (media)
Trish Rowland, 805-447-5631 (media)
Arvind Sood, 805-447-1060 (investors)