The Zacks Analyst Blog Highlights: Amgen, Sanofi, Regeneron, Alnylam and Coach

CHICAGO, March 28, 2012 /PRNewswire/ -- Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include Amgen (Nasdaq: AMGN), Sanofi (NYSE: SNY), Regeneron (Nasdaq: REGN), Alnylam (Nasdaq: ALNY) and Coach Inc. (NYSE: COH).

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Here are highlights from Tuesday's Analyst Blog:

Encouraging Data on Amgen Candidate

Amgen (Nasdaq: AMGN) recently presented positive data on its hypercholesterolemia candidate, AMG145. Results were presented at the American College of Cardiology Scientific Session from a phase Ib study that was conducted in high cholesterol patients taking statins.

Results in Detail

AMG 145, a fully human monoclonal antibody, is a PCSK9 inhibitor. The phase Ib study (n=51) was conducted to evaluate the safety, efficacy and tolerability of AMG145 compared to placebo. Results showed that patients on low to moderate doses of statin experienced a mean reduction in LDL-C (bad cholesterol) levels of up to 75% (at week 6) when administered AMG145 every two weeks.  

Patients on low-to-moderate doses of statin experienced a mean reduction in LDL-C (bad cholesterol) levels of up to 66% (at week 8) when administered AMG145 every four weeks. Meanwhile, patients on high doses of statin experienced a mean reduction in LDL-C (bad cholesterol) levels of up to 63% (at week 6) when administered AMG145 every two weeks.

Amgen said that the magnitude and duration of effect depended on the dose, with PCSK9 being undetectable at higher doses.

Phase II Studies Ongoing

AMG145 is currently in a phase II program consisting of six studies which will involve about 1,900 patients. The program will not only evaluate AMG145 plus statins in patients with or at risk for cardiovascular disease, it will also be studied in patients who cannot tolerate statins. Besides this, AMG145 will be evaluated as a stand-alone treatment in patients with low cardiovascular risk, and in patients with heterozygous familial hypercholesterolemia. Amgen said that results from these studies should be out later this year.

Intense Competition

Although statins (the current standard of treatment) are effective, many patients have problems achieving their cholesterol goals. Moreover, several patients are unable to tolerate statin therapy. In such a scenario, the successful development of PCSK9 inhibitors would be a major breakthrough in the area of cholesterol management. Besides Amgen, several other companies are working on developing PCSK9 inhibitors for cholesterol management.

Companies working on PCSK9 inhibitors include Sanofi (NYSE: SNY)/Regeneron (Nasdaq: REGN) and Alnylam (Nasdaq: ALNY).

Outperform on Amgen

We currently have an Outperform recommendation on Amgen, which carries a Zacks #2 Rank (short-term "Buy" rating). We are bullish on Prolia/Xgeva and we expect Amgen to utilize its cash towards share buybacks and acquisitions or deals that will help boost its pipeline and drive long-term growth.

Coach's Balancing Act

Being a leading American marketer of fine accessories and gifts, Coach Inc. (NYSE: COH) boasts of a proven strategy of investing in stores to enhance sales productivity through product innovation, compelling pricing strategy, new merchandise assortments and a cost-effective global sourcing model, which should drive comparable-store sales and operating margins in the long term.

Management remains confident of sustaining double-digit growth in both top and bottom lines in fiscal 2012. The company's long-term growth drivers include expansion of its global distribution model and entry into under-penetrated markets. The company lays more emphasis on globalization and accelerated international distribution growth.

After North America and Asia, Coach also extended its global footprint in Europe. It is also investing in rapidly growing emerging markets, such as China, Brazil, Vietnam and Kuwait to increase its brand awareness.

Management now expects to achieve at least $300 million in sales in fiscal 2012 in China, backed by the sustained growth momentum it is currently witnessing. As a part of its strategy to directly control certain Asian markets, Coach is now directly operating its retail business in Singapore and Taiwan. The company is also under discussion to acquire its Malaysian retail business in July.

Coach maintains a healthy balance sheet with significant cash balance and negligible debt load. The company also has been proactively managing its cash flows by making prudent capital investments and enhancing shareholder returns. The company's strong liquidity positions it well to drive future growth.

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