Expert Financial Analysis and Reporting

SmithOnStocks Research Approach is Changing I am altering the way I do research and then publish articles on SmithOnStocks. My prior approach was to try to identify small, biopharma companies that are not well covered by Wall Street analysts and as a result might be (usually were) inefficiently priced. I then tried to do intensive […]

Investment Overview There are Good Reasons to Believe that Phase 3 Trial of DCVax-L in Newly Diagnosed Glioblastoma Multiforme Will Be Successful and Lead to Approval The phase 3 trial of DCVax-L is nearing unblinding as discussed in my November 21, 2019 report. and investors are awaiting anxiously to see if the trial will be […]

Fourth Quarter Biopharma Results Come Up Short Cryoport pre-announced 4Q, 2019 results on Friday January 10, 2020; audited full year results will be released on March 5, 2020. Management stated that it expects to report 2019 revenues of about $33.9 million (an increase of 73%) and 4Q, 2019 revenues of around $9.2 million (up 61% […]

Full Year Sales of Andexxa were Impressive but there was a Troubling Drop in Sequential Sales in US in 4Q, 2019 Portola held a conference call on January 9, 2020 to pre-announce disappointing 4Q sales for Andexxa in the US. Following its launch in May of 2019, Andexxa recorded US sales of $24 million in […]

Investment Overview My reason for first looking at Novocure in depth was that it provided important comparative information versus Northwest Biotherapeutics’ DCVax-L. Those of you who have followed my research know that I believe that there are very good reasons to believe that DCVax-L will be approved in 2020 or 2021 for newly diagnosed glioblastoma. […]

Investment Overview ASH is a Key Annual Event The annual meeting of the American Society of Hematology (ASH) is a closely watched showcase for new clinical data on drugs. Each year, there are literally thousands of papers presented. One of the really hot areas this year (as has been the case for the last two […]

Objective of This Report Antares is an extremely difficult company to model on a sales and earnings basis. Its core technology is based on the use of sophisticated, subcutaneous injector devices to deliver injectable drugs, both patented and generic. This has resulted in two business models. One is based on its proprietary products, Xyosted and […]

Investment Perspective The main revenue driver for Cryoport from 2015 to 2019 came from providing cryogenic shipping services to companies conducting clinical trials preparatory to seeking regulatory approval. However, this began to change in 1Q, 2018 as regulatory approvals were gained for two commercial products, the CAR-T drugs Kymriah and Yescarta. These were supported by […]

Purpose of Report I just listened to the presentation by Antares at the Jefferies conference in London on Wednesday, November 20 and this report is a summary of key points that I heard on the call. I am in the process of coming up with my sales and earnings model for 2020 and beyond. There […]

Key Points In the third quarter 10-Q regulatory filing, it was disclosed that the draft form of the trial’s Statistical Analysis Plan (SAP) has been finalized for the phase 3 trial of DCVax-L in glioblastoma multiforme (GBM). This followed lengthy and extensive work on the part of independent statisticians and the distinguished Scientific Advisory Board. […]