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Expert Financial Analysis and Reporting

Post archive for ‘Company Reports’

Trying to Define Path Forward for Lorcaserin with FDA (ARNA,$1.49)

Arena held a conference call on March 11, 2011 to update investors on the possible regulatory path forward for lorcaserin. It is trying to answer concerns raised by the FDA and addressed in the advisory committee last September on the finding that lorcaserin is associated with mammary tumors in rats and the relevance for women […]

Initial Buy Recommendation (JNJ, $62.69)

I believe that Johnson & Johnson will experience an acceleration in earnings based on an outstanding pipeline of new drugs. I am recommending purchase.   Perspective on Stock Performance Johnson & Johnson (JNJ) is coming off three poor years in which its unit volume and sales have been flat. It has suffered from a host […]

Preview of 1Q, 2011 (DNDN, $41.78)

Dendreon will be hosting its first quarter conference call on May 2, 2011 at 4:30 EST. I anticipate that Provenge sales in the 1Q, 2011 will be about $28 million, which is in line with Street expectations.   The key factors to listen for on the call will be: (1) whether the company reaffirms its […]

CMS May Issue Provenge Reimbursement Decision on March 31 (DNDN, $32.92)

CMS may issue on March 31, its draft guidance for the national coverage analysis of Provenge for use in asymptomatic or minimally symptomatic hormone resistant prostate cancer; Along with most investors, I expect that the guidance will recommend coverage of Provenge for patients as described in the label. It is my belief that the primary […]

Building a New Company on Zegerid’s Ashes (SNTS, $2.24)

Investors are evaluating the impact on the earnings of Santarus following the recent launch of a generic to its key product Zegerid. Of perhaps more importance they are also trying to gauge how much and when a pipeline of new in-licensed products can bolster sales and earnings.   Santarus: Building a New Company on a […]

Zegerid’s Patents Are Ruled Invalid (SNTS, $5.36)

On April 14th, Santarus announced that a Court has ruled that five patents covering Santarus’ ZEGERID® (omeprazole/sodium bicarbonate) prescription products are invalid due to obviousness. These patents were the subject of lawsuits brought by Santarus against Par Pharmaceutical, Inc. The case was heard in a five-day bench trial that concluded on July 17, 2009. Santarus […]

Par Launches Generic Zegerid At Risk (SNTS, $4.55)

Par Pharmaceutical’s launched at risk a its generic version of Zegerid capsules, Santarus responded by launching its own authorized generic, restructured its sales force and ceased promotion of Zegerid prescription products. The Zegerid patent litigation is still ongoing as SNTS filed an appeal to the US Court of Appeals for the Federal Circuit in late […]

Details on Par’s Challenge to Zegerid Parents (SNTS, $3.30)

Santarus has just anounced that Par has filed a paragraph IV challenge to Zegerid’s patents. Depending on the outcome there are two broadly divergent scenarios. The critical issue is whether Par will be found to infringe the Zegerid patents. If the patents are upheld, it will be a dramatic positive giving the company exclusivity until […]

Update on Santarus (SNTS, $1.78)

Overview I recently met with Debbie Crawford, Chief Financial Officer, and Martha Hough, Head of Investor Relations. I continue to feel that the chips are falling into place to make this an exciting investment opportunity. In this meeting we focused on the key components of the Santarus story.   Investment Overview Santarus is moving close […]

Initiation Report (MDVN, $17.09)

I am initiating coverage of Medivation based on my interest in their new drug for prostate cancer MDV 3100, which could be a major advance in therapy. I need to see more clinical data that substantiates the results seen in early stage studies before I recommend the stock.   Stock Opinion I am not inclined […]