Analyst Conference Summary |
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Amgen
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Q4 revenues in $ millions |
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Drug |
2007 |
2006 |
Aranesp |
$827 |
$1106 |
Epogen |
638 |
661 |
Neulasta |
784 |
711 |
Neupogen |
334 |
313 |
Enbrel |
856 |
792 |
Sensipar |
128 |
98 |
Vectibix |
33 |
39 |
Other |
18 |
17 |
Cost of sales was $606 million, R&D $822 million, selling, general and administrative $1.00 billion, amortization $74 million, other operating items $185 million. Leaving operating income of $1.06 billion. Interest income was $1 million. Income tax provision was $223 million.
Operating expenses have been reduced, in particular R&D expense, driven by licensing deals. Capital expenditures were $234 million, down from $384 million year-earlier. 22.6% tax rate.
Aranesp labeling revision discussions with regulatory agencies are ongoing. Enbrel may have some new issues too, but so far maintains market leadership despite increasing competition. Sensipar is growing revenues quickly.
Denosumab head-to-head study versus alendronate results were discussed, with good results (safety and effectiveness), so we are optimistic about Denosumab prospects. Phase 3 breast SRE study, prostate cancer study, and post-menopausal fracture studies underway.
A regulatory decision on Nplate for thrombocytopenia is expected in the first half of 2008 following a review in March by the Oncologic Drugs Advisory Committee. Filings have also been mae in Europe, Canada, and Australia.
Vectibix Phase III study for colorectal cancer completed enrollment. In 2007 it received conditional approval in Europe using the KRAS biomarker.
Wholesale inventories ended at the high end of usual range.
$6 billion of stock repurchases have been authorized but not used.
First 2 quarters of 2008 will have difficult year-to-year comparisons because Aranesp issues had not been so bad then. Aranesp competition so far has had little international effect except for some price erosion. Completed enrollment in Aranesp TREAT study.
Epogen revenues increased sequentially in Q4 from Q3. But will be affected by January 1 EMP implementation.
Q&A:
Aranesp non-oncology US segment revenue decline? Doctors are using a lower hemoglobin level and so decreased dosing.
Patient use of ESAs are down about 50% from 2006, more in Medicare than in Commercial. This reflects the new reimbursement environment and the new label.
ODAC decision base for guidance? Don't want to talk about that before FDA makes its decision.
Denosumab fracture and infection rates? Very similar to alendronate, which you would expect with this many patients and compared to a known active agent.
Box warning effect on Enbrel sales? Forecast for guidance contemplated a box warning, because we will still have differentiation even with a warning.
How will you select from pipeline? We believe diversification will develop naturally with the pipeline. Other issues are size of market. We do want to be in more therapeutic areas. We would like to be stronger in the bone area. We also would like more geographic diversity.
Don't interpret our willingness to license out part of our pipeline as indicating a lack of intention to commit to R&D expense.
For ESAs is it just a matter of a management program or do you need more clinical studies? We are already agreed to a robust vigilance program, and we know more trials should be done, but we have not agreed on the design for the studies. You need large studies with homogeneous tumor types.
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Disclaimer: Our analyst summaries may include both our condensations of statements made by company representatives and our own analysis. They are not covered by any warranty. We cannot guarantee anything said by company representatives is true. We try not to make errors, but it is possible. Before making or terminating an investment you should always verify any factual basis of your decision.
Copyright 2007 William P. Meyers