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Expert Financial Analysis and Reporting

Archive for May, 2016

Relypsa: FDA Issuance of a CRL for ZS-9 is a Significant Positive (RLYP, Buy, $18.50)

Investment Thesis The receipt of a CRL for ZS-9 delays its possible approval by perhaps one year or more which substantially enhances the first mover advantage of Veltassa. AZN comments on the CRL minimize the potential that the mechanism of action of ZS-9 (which exchanges sodium for potassium) is a safety concern, but I am […]

Relypsa: Comments on Possible Outcomes of ZS-9 PDUFA Date

I have previously written that the Veltassa launch sales figures are not likely to excite investors for some time. However, there is a major catalyst aside from this that could move the stock and that is the May 26th PDUFA date for ZS-9. Here is the issue. The mechanism of action of ZS-9 exchanges sodium […]

Updates on My Investment Opinion for 15 Stocks I Follow Closely

Report Overview This blog gives a quick update on my thinking on the 15 stocks which I cover. In most cases, it just offer my opinion with a few supporting thoughts and provides a link to more extensive articles. Also, the reports section of my website has other in-depth reports that you may want to […]

Caladrius Biosciences: The Business Model is Intriguing, But the Cash Position Is Weak (CLBS, $0.57, No Opinion at this time)

Investment Overview I am interested in Caladrius Biosciences primarily because of the potential for its PCT cell therapy manufacturing business. PCT has a rapidly growing sales base that had $13 million of sales in 2014 and $23 million in 2015. Management is projecting $30 million in 2016. These are all revenues from third parties and do […]

Relypsa: Analyzing April Results of the Veltassa Launch (RLYP, Buy, $14.00)

Investment Overview Investors are closely watching the launch progress of Veltassa following its December 2015 introduction. Medicare and managed care have set up barriers to prescribing that makes getting a prescription filled for a new drug laborious and time consuming and sometimes futile. With very few exceptions, most new product launches have disappointed investors to the […]

Relypsa: Update Following 1Q, 2016 Conference Call (RLYP, Buy, $14.15)

Investment Thesis for Relypsa The investment issues for Relypsa are complex. Its key drug Veltassa was launched in December of 2015 so that we are now about five months into the launch. Over the last several years it has become increasingly apparent that there is a new paradigm for drug introductions. Managed care has been […]

Windtree Therapeutics: Key Points from Conference Call on 1Q, 2016 Results (WINT, $2.04)

Investment Thesis The current market valuation of Windtree is only $16 million. This seems extremely low for a Company that is close to having phase 2b data for its key drug Aerosurf. With success in phase 2b, Aerosurf, which potentially has blockbuster commercial potential, will be ready for a phase 3 trial. This key asset […]

Chimerix: Thinking on the Stock in the Aftermath of Results from the AdVise Trial (CMRX, $4.95)

Overview In a report published on April 14th I recommended purchasing Chimerix at a price of $5.67. The catalyst for my recommendation was the pending release of data from the AdVise trial of brincidofovir in life threatening adenoviral infections in children and adults. I estimate that the US addressable market for this indication as perhaps $150 […]

Northwest Biotherapeutics: The Company Provides an Operations Update (NWBO, $1.23)

Report Overview I usually start my reports with a summary and investment thesis. However, in this report I am putting this section at the end of the report. Northwest issued a press release on May 3 that gave an important operational update on the Company. The press release makes six distinct comments and in this report […]

Antares: Presentation Highlights from Deutsche Bank Conference (ATRS, Buy, $0.97)

Overview I listened to CEO Bob Apple speak at the Deutsche Bank conference and wanted to pass along a few pieces of information that are incremental to my recent report. Antares: An Outstanding Product Pipeline Promises Dramatic Growth Through 2022 AB EpiPen In regard to AB EpiPen, he said that they are working with Teva […]