SSR Health New Product Approval Portfolios & Supporting Data


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Drug, biotech, and research-based spec pharma stocks tend to outperform their peers in the year or so before and after regulatory actions (‘PDUFA’ dates) on major new products, with a large portion of total risks being concentrated in the days immediately preceding and following the PDUFA date

Since November of 2011 we’ve run 3 ‘pre-PDUFA’ and 3 ‘post-PDUFA’ portfolios consisting solely of names with pending or recent major product regulatory actions, respectively. The 3 sub-portfolios within the broader ‘pre-‘ and ‘post-PDUFA’ portfolios differ only in terms of how large the new product is as a percentage of the company’s total sales forecast. E.g. the ‘1% pre-PDUFA’ portfolio consists of all names with pending regulatory decisions on products that account for at least 1% of the company’s total sales forecast, and so on for the ‘5%’ and ‘20%’ pre- and post-PDUFA portfolios. To moderate risks, all portfolios follow rules to limit long positions in the days immediately before and after regulatory actions

Since inception, the 1% pre-PDUFA portfolio has produced greater returns (53% v. 38%) at a lower standard deviation of returns (12% v. 15%) than an ‘innovator index’ of all companies eligible for inclusion in these portfolios. The 5% pre-PDUFA portfolio has outperformed by an even greater margin as compared to the innovator index (64% v. 38%), though at a higher s.d. of returns than the innovator index (24% v. 15%)

We expect US real pricing power for pharmaceuticals to fade, which will further amplify the importance of new product flow to relative performance. Thus screening for names with attractively priced new product flow is an appropriate first step to stock selection across the drug, biotech, and spec pharma sub-sectors. We offer two related tools, the first being these portfolios of names with major pending or recent regulatory actions (which we will publish monthly); the second being our Hidden Pipeline series of reports that identify undervalued phase 2 and earlier pipelines (published quarterly)

Please note: regularly included in this series of reports are detailed tables of all (major or not) pending new molecular entity (NME) or new biological entity (NBE) regulatory approvals for all US-listed drug, biotech, and research-based spec pharma companies; and, detailed tables of all phase 3 products under active development by these companies 

For our full research notes, please visit our published research site

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