Bradway highlighted the company’s core strategy that continues to focus on innovation, discovery and development of breakthrough molecules to address unmet medical needs, and manufacturing of high-quality biologics. He spoke of pivotal data from eight late-stage programs anticipated between 2013 and 2016 and progress with growth drivers such as international expansion and upcoming plans to launch six biosimilar therapies beginning in 2017. Bradway also touched upon the company’s continued commitment to serve patients and return value to shareholders.
“Amgen is in a unique position to capitalize on major advances in drug discovery and biologics manufacturing. We are making strategic investments to drive long-term growth and deliver for both patients and shareholders.”
– Robert Bradway, Chairman and Chief Executive Officer, Amgen
Members of Amgen’s senior leadership team also touched upon evolving elements of the strategy within its R&D, commercial, and manufacturing organizations.
Sean Harper, M.D., Amgen’s executive vice president, Research and Development, told investors the company’s R&D approach will continue to focus on innovations that address unmet needs for patients with serious illnesses, but will follow four strategic priorities:
“Amgen is uniquely positioned to shape the future of biotechnology,” noted Harper. “Our new R&D strategy embraces a ‘pick the winners’ approach, which takes advantage of the knowledge we’ve gained from decades of experience and our industry-leading position in human genetics that has resulted from our acquisition of deCODE.”
Tony Hooper, executive vice president, Global Commercial Operations, spoke of Amgen’s commercial strategy to reach new patients. This includes expanding Amgen’s geographic footprint in new and emerging markets, including Japan and China; and improving the patient experience with new delivery devices. He also noted plans to begin launching a portfolio of six new biosimilar medicines starting in 2017; four cancer medicines and two for inflammatory diseases. “Biosimilars represent a meaningful growth opportunity for the company,” he said.
Jonathan Peacock, executive vice president and chief financial officer at Amgen, reviewed Amgen's results over the past 12 months, and the strategic priorities that will allow the company to successfully execute plans for broad-based growth in 2013 and into the future. Peacock highlighted strong commercial execution, continued pipeline progress, increased focus on operational excellence and return on investment, recent acquisitions, and capital allocation strategy. Peacock detailed that Amgen has continued to execute on its capital allocation strategy focused on returning, on average, more than 60 percent of adjusted net income to shareholders through dividend growth and share repurchases.
Bradway, Hooper, and Peacock also said that Amgen is focused on developing new manufacturing processes and technologies, driving expanded throughput and flexibility and lower capital needs.
Related Links and Documents:
Forward Looking Statements
This article contains forward-looking statements that are based on management's current expectations and beliefs. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements regarding: the Company's commercial, operational, capital allocation, biosimilars, geographic expansion, planned research and product development or other strategies; estimates of revenues, operating margins, capital expenditures, cash, dividend distributions, stock repurchases, tax rates, earnings per share or other financial metrics; expected legal, arbitration, political, regulatory or clinical results or practices; customer and prescriber patterns or practices; reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those described, including those risks discussed below and more fully described in our Form 10-K for the year ended Dec. 31, 2011, and in our periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of the date of this article and does not undertake any obligation to update any forward-looking statements contained in this article 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. 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, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and products liability claims. 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. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.
In addition, sales of our products are affected by the reimbursement policies imposed by third-party payors, 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 as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, 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 and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, 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 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.
The scientific information discussed in this article related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Only the FDA can determine whether the product candidates are safe and effective for the use(s) being investigated. Further, the scientific information discussed in this article relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration (FDA) for the products. The products are not approved for the investigational use(s) discussed in this article, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this article.