Amgen Outlines Long-Term Strategy
02.07.2013
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- Research and Development (R&D): A more selective approach to R&D, embracing a "pick the winners" strategy with greater focus on human genetics to identify and validate targets, and a strong commitment to return on capital;
- Commercial: Transformation of the commercial model with an emphasis on expanded access and value to payers, increased presence in key new and emerging markets, investment in new growth opportunities, including biosimilars, and greater product differentiation through drug delivery devices; and
- Manufacturing: Emphasis on new manufacturing processes and technologies, driving expanded throughput and flexibility and lower capital needs.
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More Strategic Approach to R&D
The company's R&D approach will continue to focus on innovations that address significant unmet needs for patients with serious illnesses, but will follow four strategic priorities:
- Demonstrating the value of our medicines;
- Following a "biology first" approach;
- Identifying and validating targets through human genetics; and
- Driving improvements in operational efficiency.
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Harper said
- AMG 145: The AMG 145 Phase 3 program will enroll more than 26,000 patients across seven studies, including the treatment of hyperlipidemia with AMG 145 in:
- 1,700 patients at risk for cardiovascular disease who are on statin therapy;
- 300 patients who cannot tolerate statins;
- 600 patients as monotherapy; and
- 300 patients with heterozygous familial hypercholesterolemia.
Results from these four Phase 3 trials are expected in 2014. Additionally, a long-term Phase 3 outcomes trial is evaluating treatment with AMG 145 in combination with statins in 22,500 patients at high cardiovascular risk with results expected in 2018.
- Romosozumab (AMG 785): The romosozumab program will enroll approximately 10,000 postmenopausal osteoporosis patients in two pivotal Phase 3 studies:
- A pivotal placebo-controlled trial that will evaluate incidence of new vertebral fractures at 12 and 24 months in 6,000 patients; and
- An active-controlled trial versus alendronate that will evaluate the incidence of clinical fracture and new vertebral fracture at 12 and 24 months in 4,000 patients.
- Brodalumab (AMG 827): In Phase 3 for psoriasis. Results expected in 2014.
- AMG 416: In Phase 2 for secondary hyperparathyroidism. Results expected in 2014.
- Talimogene laherparepvec: In Phase 3 for melanoma. Results expected in 2013.
- Trebananib (AMG 386): In Phase 3 for ovarian cancer. Results expected beginning in 2013.
- Blinatumomab (AMG 103): In Phase 2 for acute lymphocytic leukemia. Results expected in 2014.
- Rilotumomab (AMG 102): In Phase 3 for gastric cancer. Results expected in 2016.
Harper also discussed AMG 334, a calcitonin gene-related peptide (CGRP) receptor antagonist monoclonal antibody, as an example of
Transforming the Commercial Model to Drive Revenue Growth
During the meeting,
- Growth and Differentiation of In-Market Products:
- Enbrel® (etanercept), the leading biologic in value terms within the fast-growing rheumatology and dermatology segments, continues to be the leading choice for new-to-biologic rheumatoid arthritis patients.
- Prolia® and XGEVA® (denosumab) combined delivered
$1.2 billion in sales in 2012. This franchise is expected to exceed$3 billion in revenues over time. - Growth-phase products Sensipar® (cinacalcet), Vectibix® (panitumumab), and Nplate® (romiplostim) have strong momentum and have opportunities for continued growth.
- New Product Launches:
Amgen reviewed the commercial opportunities for both AMG 145 and romosozumab. - Biosimilars:
Amgen outlined plans to launch a portfolio of six new biosimilars beginning in 2017, and noted that biosimilars represent a multi-billion dollar growth opportunity forAmgen . - New and Emerging Markets:
Amgen expects to deliver over$1 billion in sales in new and emerging markets by 2015 and plans to expand its operating footprint in key markets, includingJapan andChina . Currently, the company is exploring a partnership opportunity inJapan that will provide a stand-alone, fully-scaled subsidiary by 2020.Amgen also expects to launch its first products in the Japanese market by 2016. The company has a multi-pronged strategy forChina that includes establishing an R&D presence and local manufacturing when needed, and is exploring partnerships and acquisitions to accelerate its commercial presence.Amgen also expects to launch its first products in the Chinese market by 2015.
Strong Execution Supports Continued Financial Success
For 2013,
Peacock highlighted strong commercial execution, continued pipeline progress, increased focus on operational excellence and return on investment, recent acquisitions, and capital allocation strategy.
Peacock said
Peacock detailed that
A webcast of the Amgen Business Review meeting with presentation slides and video is available through www.amgen.com. The webcast will be archived and available for replay at least 30 days after the event.
About
Forward Looking Statements
This news release 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
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 news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the
Amgen Inc. |
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Reconciliation of GAAP EPS Guidance to "Adjusted" |
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EPS Guidance for the Year Ending December 31, 2013 |
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(Unaudited) |
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2013 |
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GAAP EPS (diluted) guidance |
$ 6.71 |
- |
$ 7.01 |
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Known adjustments to arrive at "Adjusted" earnings: |
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Amortization of acquired intangible assets |
(a) |
0.51 |
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Stock option expense |
(b) |
0.05 |
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Non-cash interest expense associated with our convertible notes |
(c) |
0.02 |
||||
Tax impact |
(d) |
(0.24) |
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"Adjusted" EPS (diluted) guidance |
$ 7.05 |
- |
$ 7.35 |
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(a) |
To exclude the non-cash amortization of intangible assets acquired in prior year business combinations. |
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(b) |
To exclude stock option expense. |
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(c) |
To exclude the non-cash interest expense associated with our convertible notes. |
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(d) |
To exclude tax impact of above items and tax impact of certain prior period items excluded from "Adjusted" earnings. |
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Reconciliation of GAAP Tax Rate Guidance to "Adjusted" |
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Tax Rate Guidance for the Year Ending December 31, 2013 |
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(Unaudited) |
||||||
2013 |
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GAAP tax rate guidance* |
9.7% |
- |
10.8% |
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Tax rate effect of known adjustments |
2.3% |
- |
2.2% |
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"Adjusted" tax rate guidance* |
12.0% |
- |
13.0% |
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* Includes Puerto Rico excise tax credit. |
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