Novartis’ Clinical Pipeline Continues to Innovate

We continue to be impressed with the depth of Novartis’ clinical pipeline, which should aid in the company’s acceleration from the revenue cliff experienced as a result of the patent loss of top-selling product Gleevec. We are adding Novartis to the portfolio of the Dividend Growth Newsletter. By Alexander J. Poulos Overview Novartis’ (NVS) primary strength, in our view, remains the company’s diverse revenue stream. Thus far, for example, Novartis has capably handled the revenue cliff from the loss of patent protection of its top-selling product Gleevec admirably, with only a 1% drop in sales during the first half of 2016. Though such a dynamic can change in coming periods, we have found the relative predictability of Novartis’ revenue stream … Read more

The Biosimilar Revolution Remains Stymied

Image Source: Express Scripts We remain intrigued by the potential of the upcoming wave of biosimilar versions of well-established specialty drugs. Even though we have been disappointed by recent FDA decisions, we feel it is inevitable biosimilars will enter the market. Let’s update readers on our thoughts. By Alexander J. Poulos Specialty Drug Spending The specialty drug space remains the fastest-growing portion of the overall drug spend in the US. In Medicare plans, however, the total dollars spent grew at a pace on par with inflation. The main reason for the subdued growth is the well-defined process of lower cost generic utilization. The average consumer is well-educated on the cost effectiveness of a generic alternative and shows little resistance to … Read more

Novartis Is Building a Significant Cardiovascular Franchise

Image shown: The performance of Novartis since the beginning of 2014. One of the more interest times to consider speculating in the biotech/pharmaceutical space is in advance of the identification of the full potential of the clinical pipeline. Once investors recognize the full “value” of an entity’s pipeline, they often bid the company’s equity price higher well in advance of what traditional near-term fundamental metrics might indicate. The results recently released by Novartis have significantly solidified its clinical pipeline, in our view. Let’s take a look. By Alexander J. Poulos Canakinumab The path a molecule follows moving from the realm of theory through the various phases of clinical trials is often fraught with peril. Often, as the molecule is tested … Read more

Pipeline Woes Continue to Plague Amgen

Image Source: kibbles_bits By Alexander J. Poulos Earnings Release We have written a few bearish pieces on biotech stalwart Amgen (AMGN) this year. In the first piece, “The Dreaded Patent Cliff: 3 Pharmaceutical Companies at Risk,” we presented a number of areas of concern, most notably the expected drop in revenue from Amgen’s two main products. In its first-quarter earnings release, issued April 26, Amgen posted earnings per share of $3.15 on a non-GAAP basis versus $2.90 for the same period last year. Upon first glance, the numbers would indicate solid growth, but upon further examination, a worrisome trend emerges. The “earnings beat” is a direct result of a decrease in expenses and a lower share count, as top line … Read more

Valuentum’s 3 Breakthroughs in the Field of Finance and More

Valuentum’s President Brian Nelson pauses for a picture before speaking at the CFA Society of Houston in March 2017. By Valuentum Editorial Staff Let’s cover Valuentum’s 3 major breakthroughs in the field of finance. The first one is big and may challenge you to rethink everything you think you know about investing. 1. On a logical framework, Valuentum has debunked John C. Bogle’s landmark syllogism that has paved the way for the concept of index investing. Index investing has been built on a logical shortcoming, whether supported by evidence or not. We think it is important that the investment community know of this. Read (pdf): The “Luck” and “Randomness” of Index Funds (2018), Brian Nelson, CFA See video documentation: /FALLACY_of_Index_Funds To … Read more

Three Notable Pending FDA Approvals

Image Source: Brandon Giesbrecht The final step of the drug approval process is the filing of a new drug application (NDA), when the FDA assesses trial results before deciding if the treatment warrants marketing approval. A delay or rejection can have a meaningful impact on the equity price, so let’s dig into a few notable upcoming decisions. By Alexander J. Poulos and Kris Rosemann Baricitinib Baricitinib is a Janus Kinase 1&2 inhibitor that is being studied for the treatment of a wide range of inflammatory diseases, and clinical trials for the indication of rheumatoid arthritis conclusively demonstrated superiority to placebo–and Humira. The superiority to Humira, in our view, is a key differentiator in the crowded inflammatory disease market, a direct result … Read more

Johnson & Johnson’s Oncology Division A Force to Be Reckoned With

Healthcare and consumer staples giant Johnson & Johnson is a core holding in both newsletter portfolios. Let’s take a deep dive into one of its key sources of growth, its ‘Pharmaceutical’ segment. By Alexander J. Poulos and Kris Rosemann Consistency of returns is one of the hardest goals to achieve in the investment world. Often, one of the key components when selecting equities to build a long-term portfolio is their respective durability through the ups and downs of the economic cycle (in portfolio theory their collective performance would matter). A company that is able to generate resilient returns under various conditions often has a business model with defensive characteristics and an attractive Economic Castle. Johnson & Johnson (JNJ), the consumer … Read more

Gilead Sciences Continues Its Meltdown

Valuentum has been out of Gilead in the newsletter portfolios for some time. As the Best Ideas Newsletter portfolio continues to make new highs, Gilead continues to set new 52-week lows. This is the power of “portfolio thinking,” something we’ve been preaching for a long time. By Alexander J. Poulos Gilead Sciences (GILD) burst into the mainstream in 2015 due to its aggressively priced treatment for hepatitis C (HCV). The company gained notoriety as it priced the treatment at $1,000 per tablet, garnering scorn from politicians on both sides of the political aisle. The original treatment (Sovaldi) was improved on with Harvoni, as Gilead ushered in a new age of cures for a dreaded infectious disease. The difficulty in modeling … Read more

Novartis’ Continuous Dividend Growth and Promising Pipeline

Image Shown: Novartis’ dividend history, source: Novartis. By Alexander J. Poulos and Brian Nelson, CFA Sometimes the most attractive opportunities manifest themselves in companies that are in the midst of a transition. In the case of entities in the pharmaceutical industry, the transition often occurs during the period of patent-protection loss of a top-selling treatment. Typically, the market will sour on the company’s prospects as revenue is expected to decline in the near term. However, the longer investment time horizon we have at Valuentum allows us to examine whether such opportunities still fit for inclusion in the newsletter portfolios. Said differently, we’re less interested in what the company will do in the next quarter or two than we are in … Read more

The Dreaded Patent Cliff: 3 Pharmaceutical Companies at Risk

Image Source: Global Panaroma Let’s have a look at 3 pharmaceutical giants that may encounter some troubles in coming years. By Alexander J. Poulos and Brian Nelson, CFA Established companies in the pharmaceuticals industry (XLV) generally offer an appealing blend of high profit margins, a relatively recession-resistant nature of commercialized products, and a flourishing drug pipeline. In many ways, companies in the industry can be viewed as largely defensive, with a resilient revenue profile and profit stream helping to power a steadily-growing dividend, which remains highly prized in the current income-starved environment. In addition to a focus on balance sheet health and the timing of future free cash flow generation, when it comes to pharmaceutical entities, we also analyze the … Read more