REGN

PCSK9 Woes Weigh on Amgen and Regeneron

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Image shown: Amgen and Regeneron have both meaningfully trailed the market since October of 2017.  The robustness of the clinical pipeline offers an important clue regarding the health and vitality of a biotech/pharma company, as the clinical pipeline is critical towards maintaining and growing the top line. One of the most promising, and dare-we-say, overhyped new treatments to enter the market is the PCSK9 cholesterol-lowering agents, with Amgen and Regeneron leading the pack. Let’s discuss the results of Regeneron’s treatment along with a discussion of the path forward for the treatment. By Alexander J. Poulos Amgen’s Repatha The PCSK9 class is delineating into two competing treatments with little to differentiate between the two products. The key to perhaps gaining a … Read more

Our Reports on Stocks in the Biotech Industry

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Image Source: Celgene This listing has been discontinued. Please view the following links for our work on pharmaceutical stocks: Pharmaceuticals – Big: ABBV, ABT, AMGN, AZN, BMY, GSK, LLY, MRK, NVO, NVS, PFE, SNY Pharmaceuticals – Biotech/Generic: ALXN, AGN, BIIB, BMRN, CELG, GILD, MYL, REGN, TEVA, VRX, VRTX, ZTS Structure of the Biotechnology Industry Firms in the biotechnology industry face no certain future. Drug development is complex, difficult, and risky, and failure rates are high. Product development cycles are extended—approximately 10 to 15 years from discovery to market. A potential new medicine must undergo years of testing to establish safety/efficacy. Sales depend on reimbursement from third-party payers. Competition can be fierce when biosimilar products exist, though patents are material competitive advantages. We like the group on the … Read more

The “Luck” and “Randomness” of Index Funds

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Please select the image below to download the document. Image shown, page 1 of 14. Tickerized for Valuentum’s coverage universe.

Video: Quants! You’re NOT Measuring VALUE and Nelson’s Theory of Universal Value

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President of Investment Research Brian Nelson defines the concept of universal value and shows how quantitative statistical methods are inextricably linked to those of fundamental, financial, business-model related analysis. Value does not exist in respective process vacuums! Value is universal. Find out why. Running time: ~10 minutes.  Tickerized for Valuentum’s stock and ETF coverage universe. Transcript Hi this is Brian Nelson from Valuentum Securities, and this is the tenth edition of a series that I call “Off the Cuff,” where I get in front of the camera and I talk for ten minutes. This is what we have to talk about today. We have to talk about this concept: The Theory of Universal Value. Value does not exist in vacuums … Read more

Novartis Gearing Up for Growth

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Dividend Growth Newsletter portfolio idea Novartis continues to grow its free cash flow stream while producing a string of products still in the infancy of their respective growth curves. The pharma/biotech realm remains bedeviled with patent issues that can disrupt cash flow generation once protection is lost, causing us to look for companies positioned for a fresh leg of growth. To that end, let’s take a look at Novartis’ pipeline, near-term potential, and how it relates to its dividend health. By Alexander J Poulos Alcon Division In Novartis’ (NVS) third quarter of 2017, results released October 24, its Alcon division posted an impressive constant-currency revenue jump of 7% from the year-ago period and a 23% year-over-year increase in core operating … Read more

Key Oncology Assets Powering Johnson & Johnson Higher

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Image Source: JNJ third quarter earnings presentation Shares of newsletter portfolio holding Johnson & Johnson continue their stellar run, posting new all-time highs on the heels of an impressive third quarter earnings report. Let’s take an in-depth review of key pharma product franchises as they relate to the performance of the stock. By Alexander J. Poulos and Kris Rosemann Immunology Johnson & Johnson’s (JNJ) largest pharmaceutical division remains Immunology–an area where the company continues to be a pioneer–but the division has begun to feel the strain of the coming biosimilar onslaught as its legacy molecule Remicade continues to cede ground to biosimilar competition. The drug posted a 7.6% year-over-year revenue decline in the third quarter of 2017 to ~$1.65 billion … Read more

Restasis Patent Protection Weighing on Shares of Allergan

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We have witnessed numerous examples over the years of biotech/pharma companies selling-off over fears of the length of patent protection on an essential product. The concern is well-founded–if the company relies on the product for a significant portion of sales, it may be challenging to replace, especially if the clinical pipeline is relatively bereft of viable next-generation products. We believe the recent sell-off in the shares of Allergan may now be wholly factoring in the loss of patent protection of one of its core assets in Restasis, and the equity may not be getting enough credit for its highly diversified revenue stream. By Alexander J. Poulos and Kris Rosemann Overview Allergan (AGN) in its current configuration is an amalgamation of … Read more

An Overview on Valuing Junior Biotech Companies — Does Clovis Fit the Bill?

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The biotech industry remains one of the most fascinating yet perplexing industries for investors. Anecdotes of the entry-stage biotech with a home-run new therapy are often romanticized, but the reality is the vast majority of molecules fail in various stages of clinical testing.  Due to the boom-bust nature of the industry, many are wary of investing in the space, and traditional valuation metrics are not as useful due to a large number of such speculative entities being in the pre-revenue stage. With this in mind, let’s take a glimpse into our thought process when evaluating upstart biotech companies. By Alexander J. Poulos Before we dig in, we feel a word of caution is warranted. Entry-stage biotechs (IBB) inherently come with … Read more

The Legal Battle Between Regeneron and Amgen Heats Up

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Image Source: Regeneron The legal battle between two of the titans of the biotech world heated up further with a recent ruling overturning the injunction of a critical asset. We are updating our thesis in light of current events. By Alexander J. Poulos Legal Battle Amgen (AMGN) is locked in a protracted battle with Regeneron Pharmaceuticals (REGN) and its partner Sanofi (SNY) over a potential patent infringement. The asset in question is Praluent which belongs to the PCSK9 inhibitor, which is approved for the patient class afflicted with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, which require additional lowering of LDL-C. The nexus of Amgen’s complaint is Praluent infringes on some of the intellectual property (IP) that backs its … Read more

Best in Biotech? Global Blood Therapeutics’ Promising Treatment for Sickle Cell Anemia

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We remain impressed with the depth of research conducted over a wide host of disease states. Though a molecule may appear to hold significant promise in the pre-clinical phase, we have often witnessed the unique ability of the human body to react to various treatments. Often an unwanted side effect can torpedo a treatment, thus relegating millions of dollars of research obsolete. However, if a promising molecule is brought to market, the payoff is often well worth the effort. Our goal is to sift through the various clinical data to unearth the most promising treatments with the understanding that nothing is assured until the FDA authorizes the product for marketing in the US. We believe we have identified a promising … Read more