Second Quarter 2008 Investor Fact Sheet
Download PDF (243Kb)
This fact sheet is a summary of a more detailed disclosure that can be found in Amgen’s U.S. Securities and Exchange Commission (SEC) filings and press releases. This fact sheet contains forward-looking statements that involve significant risks and uncertainties, discussed on here. Unless otherwise indicated, the information in this fact sheet is given as of the date of the referenced documents, and Amgen does not undertake any obligation to update any information in these documents.
About Amgen
Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing novel medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives.
Selected Press Releases
A list of all recent press releases can be found on Amgen’s web site here.
Amgen’s Principal Products
See Form 10-K for the year ended December 31, 2007.
These descriptions are intended to provide only an overview of Amgen’s products; for more information, please refer to Amgen’s most recent annual report, Form 10-K, press releases and other public information.
Aranesp®
Introduced in 2001, Aranesp® (darbepoetin alfa) is approved in the United States, most countries in Europe, Canada , Australia, and New Zealand for the treatment of anemia associated with chronic renal failure in patients both on dialysis and not on dialysis. In 2002, Aranesp® was also approved in the United States and Europe for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy.
In the US, Aranesp® is indicated for the treatment of anemia due to the effect of concomitantly administered chemotherapy based on studies that have shown a reduction in the need for red blood cell transfusions in patients with metastatic, non-myeloid malignancies. Studies to determine whether Aranesp® increases mortality or decreases progression-free/recurrence-free survival are ongoing.
Aranesp® is a recombinant erythropoietic protein that stimulates production of oxygen-carrying red blood cells, with a longer half-life than Epoetin alfa.
|
WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR and THROMBOEMBOLIC EVENTS, and INCREASED RISK OF TUMOR PROGRESSION or RECURRENCE. Renal failure: Patients experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL. Cancer:
|
Aranesp® is contraindicated in patients with uncontrolled hypertension.
Enbrel®
Enbrel® (etanercept) is a fully human soluble anti-TNF receptor approved for use to reduce the signs and symptoms and inhibit the progression of structural damage in patients with moderately to severely active Rheumatoid Arthritis (RA). It is also approved to reduce the signs and symptoms of active arthritis in patients with psoriatic arthritis, moderately to severely active polyarticular-course juvenile idiopathic arthritis (JIA) in patients ages 2 and older, ankylosing spondylitis, and chronic moderate to severe plaque psoriasis. ENBREL® acts by binding TNF, a naturally occurring cytokine that is involved in normal inflammatory and immune responses.
|
WARNINGS: RISK OF INFECTIONS Infections, including serious infections leading to hospitalization or death, have been observed in patients treated with ENBREL® (see WARNINGS and ADVERSE REACTIONS). Infections have included bacterial sepsis and tuberculosis. Patients should be educated about the symptoms of infection and closely monitored for signs and symptoms of infection during and after treatment with ENBREL®. Patients who develop an infection should be evaluated for appropriate antimicrobial treatment and, in patients who develop a serious infection, ENBREL® should be discontinued. Tuberculosis (frequently disseminated or extrapulmonary at clinical presentation) has been observed in patients receiving TNF-blocking agents, including ENBREL®. Tuberculosis may be due to reactivation of latent tuberculosis infection or to new infection. Data from clinical trials and preclinical studies suggest that the risk of reactivation of latent tuberculosis infection is lower with ENBREL® than with TNF-blocking monoclonal antibodies. Nonetheless, postmarketing cases of tuberculosis reactivation have been reported for TNF blockers, including ENBREL®. Patients should be evaluated for tuberculosis risk factors and be tested for latent tuberculosis infection prior to initiating ENBREL® and during treatment. Treatment of latent tuberculosis infection should be initiated prior to therapy with ENBREL®. Treatment of latent tuberculosis in patients with a reactive tuberculin test reduces the risk of tuberculosis reactivation in patients receiving TNF blockers. Some patients who tested negative for latent tuberculosis prior to receiving ENBREL® have developed active tuberculosis. Physicians should monitor patients receiving ENBREL® for signs and symptoms of active tuberculosis, including patients who tested negative for latent tuberculosis infection. |
EPOGEN®
Amgen launched EPOGEN® (Epoetin alfa), one of the first biologically derived human therapeutics, into the
EPOGEN is contraindicated in patients with uncontrolled hypertension.
Neulasta®
Neulasta® (pegfilgrastim) received approval in 2002 in the United States and
Splenic rupture (including fatal cases), acute respiratory distress syndrome, and sickle cell crises have been reported. Allergic reactions, including anaphylaxis, have also been reported. The majority of these reactions occurred upon initial exposure. However, in rare cases, allergic reactions, including anaphylaxis, recurred within days after discontinuing anti-allergic treatment.
In a placebo-controlled trial, bone pain occurred at a higher incidence in Neulasta®-treated patients as compared to placebo-treated patients (31% vs 26%). The most common adverse events reported in either placebo- or active-controlled trials were consistent with the underlying cancer diagnosis and its treatment with chemotherapy, with the exception of bone pain.
NEUPOGEN®
NEUPOGEN® (Filgrastim), launched in 1991 in the U.S. and
Splenic rupture and sickle cell crises have been reported in patients receiving NEUPOGEN®; some cases have been fatal. Acute respiratory distress syndrome and allergic reactions have also been reported. Allergic reactions occurred with initial or subsequent treatment. Alveolar hemorrhage manifesting as pulmonary infiltrates and hemoptysis requiring hospitalization has been reported in healthy donors undergoing peripheral blood progenitor cell mobilization, an unapproved use of NEUPOGEN®. Hemoptysis resolved with discontinuation of NEUPOGEN®. In clinical trials of patients with cancer who received myelosuppressive chemotherapy, the most common adverse event was bone pain, reported in approximately 24% of patients.
Nplate™
On August 22, 2008, we announced that the Food and Drug Administration (FDA) approved Nplate™ (romiplostim), the first and only platelet producer for the treatment of thrombocytopenia in splenectomized (spleen removed) and non-splenectomized adults with chronic immune thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Nplate™, the first FDA-approved Peptibody protein, works by raising and sustaining platelet counts, representing a novel approach for the treatment of this chronic disease.
Serious adverse reactions associated with Nplate™ in clinical studies were bone marrow reticulin deposition and worsening thrombocytopenia after Nplate™ discontinuation. Additional risks include Bone Marrow Fibrosis, Thrombotic/Thromboembolic Complications, Lack or Loss of Response to Nplate™, and Hematological Malignancies and Progression of Malignancy in Patients with a Pre-existing Hematological Malignancy or Myelodysplastic Syndrome (MDS).
Nplate™ is not indicated for the treatment of thrombocytopenia due to MDS or any cause of thrombocytopenia other than chronic ITP
Nplate™ is available only through a restricted distribution program called Nplate™ NEXUS (Network of Experts Understanding and Supporting Nplate™ and Patients) Program.
In the placebo-controlled studies, headache was the most commonly reported adverse drug reaction.
Sensipar®
Approved by the FDA in March 2004, Sensipar® (cinacalcet) is an oral medication for the treatment of secondary hyperparathyroidism (HPT) in patients with chronic kidney disease (CKD) on dialysis and for the treatment of elevated levels of calcium in patients with parathyroid carcinoma. To regulate parathyroid hormone (PTH), Sensipar® acts directly on the parathyroid gland calcium-sensing receptor.
Sensipar® lowers serum calcium; therefore, it is important that patients have a serum calcium > 8.4 mg/dL when initiating therapy. Significant reductions in calcium may lower the threshold for seizures. Secondary HPT patients, particularly those with a history of seizure disorder, should be carefully monitored for the occurrence of low serum calcium or symptoms of hypocalcemia.
In Sensipar® postmarketing use, isolated, idiosyncratic cases of hypotension and/or worsening heart failure were reported in patients with impaired cardiac function. The causal relationship to Sensipar® therapy could not be completely excluded and may be mediated by reductions in serum calcium levels.
The most commonly reported side effects were nausea, vomiting, and diarrhea.
Vectibix®
Approved by the FDA in September 2006, Vectibix® (panitumumab) is indicated as a single agent for the treatment of EGFR-expressing, metastatic colorectal carcinoma (mCRC) with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
The effectiveness of Vectibix® as a single agent for the treatment of EGFR-expressing, metastatic colorectal carcinoma is based on progression-free survival. Currently no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Vectibix®.
|
WARNINGS: DERMATOLOGIC TOXICITY and INFUSION REACTIONS Dermatologic Toxicity: Dermatologic toxicities occurred in 89% of patients and were severe (NCI-CTC grade 3 and higher) in 12% of patients receiving Vectibix® monotherapy. Withhold Vectibix® for dermatologic toxicities that are grade 3 or higher or are considered intolerable. If toxicity does not improve to < grade 2 within 1 month, permanently discontinue Vectibix®. The clinical manifestations included, but were not limited to, dermatitis acneiform, pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and skin fissures. Subsequent to the development of severe dermatologic toxicities, infectious complications, including sepsis, septic death, and abscesses requiring incisions and drainage were reported. Infusion Reactions: Severe infusion reactions occurred in approximately 1% of patients. Severe infusion reactions included anaphylactic reactions, bronchospasm, and hypotension. Although not reported with Vectibix®, fatal infusion reactions have occurred with other monoclonal antibody products. Stop infusion if a severe infusion reaction occurs. Depending on the severity and/or persistence of the reaction, permanently discontinue Vectibix®. |
Product and Product Candidate Update (as of August 22, 2008)
The Company provides the following updates on selected late-stage clinical programs (Aranesp, denosumab, and Nplate).
Aranesp®
The Trial to Reduce Cardiovascular Events with Aranesp® Therapy (“TREAT”) phase 3 study, initiated in 2004, is a large (4,000 patient), multi-center, randomized, double-blind, controlled trial designed to determine the impact of anemia therapy with darbepoetin alfa on mortality and non-fatal cardiovascular events in patients with CKD, anemia and type 2 diabetes. In December 2007, the TREAT study completed enrollment.
The Reduction of Events with darbepoetin alfa in Heart Failure (“RED-HF™”) Trial phase 3 study, initiated in 2006, is a large (3,400 patient), global, randomized, double-blind, placebo- controlled study to evaluate the effect of treatment of anemia with darbepoetin alfa on morbidity and mortality in patients with symptomatic left ventricular heart failure. The RED- HF™ Trial continues to enroll patients.
Denosumab
We are conducting a number of phase 3 studies of denosumab in the treatment of postmenopausal osteoporosis (PMO). In 2007, we disclosed that the phase 3 PMO prevention study met its primary and all secondary endpoints. In January 2008, we disclosed that the head-to-head study comparing the effects of twice-yearly subcutaneous injections of denosumab versus weekly oral doses of alendronate (FOSAMAX®) on bone mineral density (“BMD”) in postmenopausal women with low BMD met its primary and all secondary endpoints. On July 25, 2008, we announced that the 7800-patient pivotal fracture trial evaluating denosumab in the treatment of postmenopausal osteoporosis met its primary and all secondary endpoints. Additional data from this study will be presented at the upcoming meeting of the American Society of Bone and Mineral Research in September 2008.
Denosumab is also being studied in patients with breast cancer, prostate cancer, other solid tumors or multiple myeloma for treatment to prevent skeletal related events (“SRE”). All of the phase 3 SRE clinical studies are ongoing. The phase 3 study evaluating denosumab in patients with non-metastatic prostate cancer to prevent bone metastases is also ongoing. Denosumab is also being evaluated in bone loss induced by hormone ablation therapy (“HALT”) for breast cancer and prostate cancer. In 2007, we disclosed that the phase 3 HALT breast cancer study met primary and all secondary endpoints. On July 14, 2008, we announced that the phase 3 HALT prostate cancer study met its primary and secondary endpoints.
Selected Medical Meetings
This is a list of selected medical meetings in areas in which Amgen conducts research and clinical development activities. Amgen is providing this information as of August 22, 2008, and does not undertake any obligation to update any of this information as a result of new information, future events or otherwise.
Sept 12-16 American Society of Bone & Mineral Research (Montreal, Quebec)
Oct 24-29 American College of Rheumatology (San Francisco, CA)
Nov 4-9 American Society of Nephrology (Philadelphia, PA)
Dec 6-9 American Society of Hematology (San Francisco, CA)
Dec 11-14 San Antonio Breast Cancer Symposium (San Antonio, TX)
Q2 2008 Financial Update
Amgen July 28, 2008 Press Release
| $ in millions except EPS |
Q2 Sales | YOY% Growth |
| Aranesp® |
$825 |
(13)% |
| EPOGEN® |
$622 |
(0)% |
| Neulasta® / NEUPOGEN® |
$1,201 |
15% |
| ENBREL® |
$841 |
2% |
| Sensipar® |
$150 |
39% |
| Vectibix® |
$32 |
(29)% |
| Total Product Sales |
$3,692 |
2% |
| Adjusted EPS* |
$1.14 |
2% |
* Non-GAAP financial measure. See reconciliations of non-GAAP financial measures to Generally Accepted Accounting Principles (GAAP)
Historical Financials
2008 Selected Guidance†
Product Sales
($ billions)Revenues
($ billions)Adjusted R&D Expenses†
($ millions)Adjusted Net Income†
($ millions)Adjusted EPS†
(in dollars)† Non-GAAP financial measure.
See reconciliations.
| Total Revenue | $14.6 - $14.9 Billion |
| Adjusted EPS* | $4.25 – $4.45 |
†Guidance is as of July 28, 2008 and is not being updated at this time.
* Non-GAAP Financial measure. See reconciliations.
