INCY

Three Notable Pending FDA Approvals

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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

Can Vertex Pharmaceuticals Dominate the Race to Treat Cystic Fibrosis?

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Tickerized for holdings in the XLV and IBB. Cystic Fibrosis is a rare disease that afflicts an estimated seventy-five thousand patients worldwide. Vertex Pharmaceuticals is the first to market with a combination treatment to treat a portion of the overall patient population. Will Vertex win the race to bring forth a triple therapy to treat the vast majority of those afflicted? By Alexander J. Poulos Cystic fibrosis (CF) is a recessive genetic disorder. The patient that is afflicted will carry two copies of the cystic fibrosis conductance regulator protein (CFTR) gene. The CFTR gene allows the body to produce the CFTR protein, whose function is to remove chloride from the cells. Patients that have CF will suffer from a “thickening” … Read more

Pharma, Biotech and How to Consider Investing In It

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The Valuentum analyst team digs deep into recent trends in big pharma and biotech from the lofty pricing of drugs to political and competitive pressures to ETF considerations and beyond. ~10 mins. If you cannot view the podcast below, please view the transcript below or select the link here. Tickerized for holdings in the XLV and IBB. Brian Nelson, CFA Gilead’s (GILD) hepatitis C regimen, almost a hundred thousand dollars. Vertex’s (VRTX) cystic fibrosis drug — hundreds of thousands of dollars per year. Have the drug companies lost their mind? This is Brian Nelson from Valuentum Securities, and today joining me is Mr. Kris Rosemann and Mr. Chris Araos — and we are going to talk everything healthcare, biotech… Mr. … Read more

Our Thoughts on Big Pharma’s Calendar Fourth Quarter Earnings Reports

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Image Source: Merck & Company Inc – Fourth Quarter of 2021 IR Earnings Presentation By Callum Turcan In Alphabetical Order by Ticker: ABBV, GILD, LLY, MRK We include the Health Care Select Sector SPDR Fund ETF (XLV) in the Best Ideas Newsletter and Dividend Growth Newsletter portfolios to gain broad exposure to the health care sector. Instead of betting on one entity’s pipeline (which could be hit or miss), we like the exposure to lots and lots of “shots on goal” when it comes to the vast collective pipeline in the XLV ETF. We wrote up the calendar fourth-quarter results of the top two weightings in the XLV ETF, United Health (UNH) and Johnson & Johnson (JNJ) here and here, … Read more

Which Mid-Stage Biotech Can Grow Into the Next Large Cap Biotech Behemoth?

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Image Source: Steven Depolo The biotech field is on the cutting edge of scientific research. The production of new therapies often positively affects the share price of these innovative companies as long-term revenue and earnings expectations become embedded in the stock price. Let’s take a look at several mid-stage biotechs that may grow into dominant players. By Alexander J. Poulos The application of ETFs in investment strategies has gained widespread adoption during the past decade. Though the blind use of ETFs—buying a basket of stocks at any price—comes with myriad risks, there are certain advantages in that some ETFs offer desired exposure to certain themes or sectors. When it comes to biotech, the most liquid biotech ETF is the iShares Nasdaq … Read more

How the FDA’s Delay of Baricitinib Impacts Eli Lilly and Incyte

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Image Source: Paul Sableman The FDA dealt Eli Lilly and Incyte an unforeseen blow recently by rejecting their marketing application for Rheumatoid Arthritis candidate Baricitinib. Where does the duo go from here? By Alexander J. Poulos an Kris Rosemann The drug approval process is chock full of pitfalls, and until regulators give the final okay, anything can happen. The widely held consensus was Eli Lilly’s (LLY) and Incyte’s (INCY) marketing application for Rheumatoid Arthritis candidate Baricitinib would be approved, but the FDA shocked everyone by issuing a complete response letter requesting further data. Where does the duo of Eli Lilly and Incyte proceed from here? Baricitinib We were optimistic the FDA would approve Baricitinib for the indication of Rheumatoid Arthritis … Read more

Best Idea Vertex Pharma Is an Intriguing Biotech Play

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Image Shown: A snapshot of Vertex Pharmaceuticals Inc’s approved therapeutic offerings and its drug pipeline. Image Source: Vertex Pharmaceuticals Inc – January 2021 IR Presentation By Callum Turcan On January 12, we tweaked the Best Ideas Newsletter portfolio (link here) and added Vertex Pharmaceuticals Inc (VRTX) to the portfolio to gain exposure to a top tier biopharmaceutical company with powerful growth catalysts, a pristine balance sheet, a stellar cash flow profile, and exposure to next-generation treatments (gene therapies) through a strategic partnership that we will cover later on. The top end of our fair value estimate range for Vertex sits at $321 per share. Commercial Portfolio Overview Vertex’s commercialized therapeutics portfolio is heavily weighted towards treating cystic fibrosis (‘CF’) across … Read more

Valuentum: Now Bearish, We’ve Been Here Every Step of the Way

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Valuentum Has Been Here Every Step of the Way   From the COVID-19 top in February 2020 to the COVID-19 bottom to the massive bull run through the end of 2021, we’ve been here for you.    2022 started out to be a rough year, catching many by surprise.   But Valuentum stayed positive. When the markets headed south in June, Valuentum stood its ground. On June 14, Valuentum said that “we still believe stocks could make a “huge rebound” in the near term.   We reiterated our views a few days later and on June 19, we said that “investors shouldn’t panic during this bear market” and that “stocks remain an attractive proposition at the moment and a very attractive consideration … Read more

Stock Market Outlook for 2021

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By Valuentum Analysts February 8, 2021 2020 was one for the history books. We covered our thoughts and reflections on the past year in our “2020 Won’t Soon Be Forgotten” article (link here), and now we are looking towards the future. Global health authorities should be able to bring an end to the ongoing coronavirus (‘COVID-19’) pandemic sooner than many had expected as several vaccines have already been improved for emergency use and several others appear increasingly likely to get approved. Global vaccine distribution activities are currently underway, and this should allow the world to slowly return to pre-pandemic activities. Before then, immense stimulus measures launched primarily in developed nations should support global economic activities until the public health crisis … Read more