Amgen 2007 Annual Report Download - page 4

new reality, kept focused on our mission to serve patients,
and demonstrated that we are resilient and can take a punch.
We met the needs of patients and providers for our currently
approved medicines, advanced the pipeline, successfully
defended our intellectual property, and positioned ourselves
to deliver strong financial results in the future.
Before detailing our 2007 accomplishments, I want to share
my thinking about the environment we face and how we are
meeting the challenges and demands of this new world.
Physicians, patients and regulators have always understood
that no medicine is perfect and that benefit must always be
balanced against risk. There has also been a recognition
that while pre-approval clinical trials may be well designed
and conducted, we often learn more about medicines as
they are more broadly used over the years in larger patient
populations. Recently, a combination of factors has increased
the focus on the risk dimensions of medicines, and the FDA
and other regulators have responded. There is more focus
on safety and greater urgency around ensuring that safety
concerns are quickly and fully disclosed, thoroughly explored
and considered, and aggressively recognized in setting
payment and usage policy.
The implication for Amgen and our industry colleagues is that
we must focus even more intently on safety risk management.
In 2007, Dennis Fenton announced his decision to retire—a
declaration that profoundly affected the thousands of Amgen
staff who know firsthand Dennis’ energy and passion for our
mission to serve patients. Over the years, Dennis worked in
nearly every function at Amgen. After starting as a research
scientist, he helped to create Amgen’s Process Development
and Manufacturing organizations. At various times he led
Sales and Marketing, Research, Information Systems, Human
Resources, and most recently Operations. Dennis helped build
the world’s most reliable, efficient and skilled biotechnology
manufacturing organization to ensure that Amgen delivers vital
medicines to “every patient, every time.” Dennis, we’ll miss you,
and we wish you and your family many happy times ahead.
Dennis Fenton, Ph.D.,
Retires After 25 Years
2 Amgen 2007 Annual Report
Amgen has always been committed to meeting the very
highest standards with regard to patient safety, and we are
reinforcing those standards in every area of our organization.
In practical terms that means continued full disclosure of
safety-related concerns; early, robust, and ongoing discussions
with regulators; aggressive and extensive clinical trial-based
safety exploration and post-approval safety surveillance; and
effective two-way dialogues with providers and patient groups.
Our mission is to serve patients; our commitment to patient
safety is unwavering.
I am very proud of our accomplishments in the face of our
recent challenges. It is in tough times that companies find out
what they are made of, and 2007 brought out exceptional
efforts by Amgen staff worldwide.
• We demonstrated that we take very seriously our
responsibility and obligation to disclose safety information
quickly and transparently to regulatory authorities,
physicians and patients.
• We listened carefully to regulatory authorities, physicians
and patient groups regarding our anemia medicines and
worked with them to seek the best answers for patients.
• We restructured the company. We cut operating expenses,
dramatically reduced planned capital expenditures, and took
other swift and decisive actions to protect EPS and fund and
advance the pipeline. Despite the unexpected reduction in
operating income, we delivered 2007 adjusted EPS* of
$4.29, very close to the low end of our original guidance.
• We successfully defended our intellectual property rights
against Roche. Following a jury trial in the U.S. Federal
District Court in Boston, Roche’s peg-EPO product was
found to infringe 10 of Amgen’s U.S. patent claims for
erythropoietin alfa.
• Product sales outside of our ESA franchise grew 14 percent.
Enbrel®, Neulasta® and NEUPOGEN® grew, Sensipar® thrived,
and our international business delivered great results.
• Even in the midst of a challenging restructuring, our
manufacturing operations group turned in a stellar performance,
with an outstanding safety record and highly successful
compliance-related inspections. Most importantly, we
delivered reliable supply for patients.
*See reconciliation on page 6.