Intercept: Amid The FDA Draft Guidance OCA Will Be Approved

Summary

Intercept is an excellent contrarian bet due to a stream of negative news flow amid the strong fundamental development. As such, there is definitely a silver lining in the dark.

The current pessimism against Intercept is the 2019 NASH draft guidance. Mr. Market believes that the draft will hamper the prospect of obeticholic acid's approval. This is certainly overblown.

As the light that shines in the darkness, the Phase 3 REGENERATE trial for obeticholic acid covers all bases. With strong data, OCA will gain approval for all NASH stages.

You only have to do very few things right in your life so long as you don't do too many things wrong. - Warren Buffett

In Benjamin Graham's book The Intelligent Investor, the Father of Value Investing epitomizes the fickle nature of the equity niche as "Mr. Market." Driven by emotion, Mr. Market usually makes impulsive decisions that are disconnected from the stock's fundamentals. His mood is reflective of a pendulum that swings to either extreme optimism or grave pessimism. As I'm cognizant of his behavior, I'm enthused by a good investment prospect disdained by Mr. Market. In my view, investors have a much better chance of uncovering undervalued equities during a stock's period of unpopularity. If all experts are opining positively on a stock, chances are that it's either optimally priced over overpriced. A prime example of this phenomenon is Intercept Pharmaceuticals (ICPT).

Figure 1: Intercept chart (Source: StockCharts)

The current market consensus believes that there are irreparable safety issues centering the lead medicine obeticholic acid (Ocaliva). Nonetheless, OCA is already approved for another liver disease for years. Therefore, it's acceptable safety profile is established. As I addressed those specific issues in prior articles, I'll defer from going over the same issues. That aside, it seems that Mr. Market is now having a fit regarding the latest FDA guidance for nonalcoholic steatohepatitis ("NASH"). Despite the grim outlook, the fundamental picture of Intercept is brighter than ever. In this article, I'll present a fundamental analysis of Intercept while focusing on the ramification of the FDA draft guidance.

About The Company

As usual, I'll deliver a brief corporate overview for new investors. If you are familiar with the firm, I suggest that you skip to the subsequent section. Headquartered in New York City, Intercept is focused on the innovation and commercialization of a semisynthetic bile acid known as OCA to treat serious liver conditions. In binding to the “holy grail” receptor farnesoid X, OCA activates many key regenerative responses. On May 2016, the FDA approvedOCA as Ocaliva for the treatment of a rare and chronic liver condition, primary biliary cholangitis ("PBC").

Figure 2: Therapeutics pipeline (Source: Intercept)

Currently in a Phase 3 trial, Intercept is most likely the first company to launch a medicine for managing the highly prevalent fatty liver disease, NASH. As the crown jewel of Intercept is its fatty liver disease franchise, I'll shift gears to cover the recent market concern regarding NASH.

IBI Top Picks For Summer 2019 Part II: Which Bioscience Stock Will Sit On The Iron Throne?

Summary

Last weekend, I featured Part I of the Top Picks for Summer 2019. I'll finish up this series by presenting four more growth companies.

As a leader in the non-alcoholic steatohepatitis space, Madrigal is most likely to deliver strong advance data and thereby takes its crown as the undisputed champion in the $25B market.

To honor of my Father, I'm giving out a 50% discount gift to new members this weekend in advance of next week's Father's Day.

One thing that could help would be to write down the reason you are buying a stock before your purchase. Force yourself to write this down. It clarifies your mind and discipline. - Warren Buffett

Author's note: In honor of my Father, I'm offering new subscribers a 50% discount gift in advance of next weekend's Father's Day. Send me a message if you wish to receive yours.

In Part I of my Top Picks For Summer 2019, I featured four powerful bioscience growth equities. To complete this summer expedition, I recently came out of the jungle of bioscience equities to deliver to you four more intriguing investment leads. In my view, they are low hanging fruits that can catapult your portfolio to the new high, provided that you hold them for the next several years. In my view, the most outsized returns arise from long-term investing.

If you take equity investment similar to buying a house, it'll make much more sense. One cannot expect to flip a house overnight for the most gargantuan profit. A house needs years to appreciate multiple folds. From the fundamental paradigm, equity investment works pretty much the same way. Time is simply a requisite for a growth business to unlock its full potential. Buffett said it best: "You can't produce a baby in one month by getting nine women pregnant."

My view is in line with the Oracle of Omaha, Buffett. Nevertheless, I believe that you can still bank short-term profits in bioscience. This occurs in situations known as "binary events" like an FDA approval or clinical data reporting. Nonetheless, one needs to have expert forecasting skills to have an edge over the market. Armed with all the arsenals, it's still quite risky. Moreover, the returns are not outsized as in ultra-long-term holding to make investing worthwhile.

CRISPR: Vertex Doubled Down On The Reigning Champion CRISPR/Cas9

Summary

Monitoring pharmaceutical-partnership is a prudent strategy to assess the underlying value of a platform technology.

Due to its stellar CRISPR/Cas9 platform, CRISPR Therapeutics is able to expand its collaborative relationship with the pharmaceutical elite, Vertex.

Leveraging CRISPR's expertise, Vertex is marching into the lands of gene-editing to galvanize medicines for Duchenne Muscular Dystrophy and Myotonic Dystrophy Type 1.

To honor of my Father, I'm giving out a 50% discount gift to new members this weekend in advance of next week's Father's Day.

All there is to investing is picking good stocks at good times and staying with them as long as they remain good companies. - Warren Buffett

Author's note: In honor of my Father, I'm offering new subscribers a 50% discount gift in advance of next weekend's Father's Day. Send me a message if you wish to receive yours.

If you look at a fruitful marriage, chances are that the house is filled with joy and laughter. In bioscience investment, the pursuit of happiness also comes from partnership and acquisition. And, there is an aplenty of partnership to drive the common goal of delivering hopes for patients while reaping profits for shareholders. That being said, the most transcending situation occurs when a partner doubled down its initial commitment. In my view, there has to be something like an invaluable technology platform that enticed the partner. Consequently, I believe that this situation usually leads to an outright acquisition.

The prime example of the aforesaid phenomenon is the union between Vertex Pharmaceuticals (VRTX) and CRISPR Therapeutics (CRSP). Due to the partnership expansion, CRISPR shares appreciated 15% today and thereby procured a 119% profits for my Core Portfolio Alpha. Nonetheless, the best is yet to come. In this research, I'll present a fundamental analysis of CRISPR while focusing on partnership expansion.

Figure 1: Crispr stock chart (Source: StockCharts)

About The Company

As usual, I'll deliver a brief corporate overview for new investors. If you are familiar with the firm, I suggest that you skip to the subsequent section. Based in Switzerland, CRISPR Therapeutics is focused on the development and commercialization of gene-based therapies to serve the unmet needs in blood disorders, immuno/oncology conditions, and regenerative medicines. On the shoulders of its stellar gene-editing platform dubbed CRISPR/Cas9, CRISPR set out to make history. In a two-pronged approach, the firm is nourishing a highly promising portfolio of gene-editing medicines and CAR-T therapeutics.

As it galvanizes the next-generation gene-editing medicines, CRISPR attracted the attention of Vertex. In unison, the partners are developing up to six CRISPR/Cas9-based molecules. Nevertheless, CTX-001 is simply the first prodigy child in this harmonious union. But there is much more to come, as shown in the deep pipeline below.

Figure 2: Therapeutic pipeline (Source: Crispr)

IBI Notable Community Discussion: The Best Is Yet To Come

Summary

Bioscience stocks commenced the week on a rally with the momentum building stronger toward the weekend. Nektar, Portola, Sesen, and especially Regenxbio are trading northbound.

Packing heavy punches, Sesen Bio is knocking market bears toward an approval. Due to the robust VISTA outcomes, Vicinium will ultimately replace Valstar as the standard of care.

In readying for an upcoming approval of NKTR-181, Nektar formed the new subsidiary Inheris. It'll ensure a robust launch for NKTR-181, the silver bullet for the prescription opioid abuse epidemic.

Special thanks of all Integrated BioSci Investing members who participated in our daily discussion. I'm grateful for your intellectual generosity.

In honoring our troops who sacrificed their lives for our freedom, I'm offering a time-limited 50% discounts to new members. Message me if you wish to get your Memorial Day weekend gift.

You only have to do very few things right in your life so long as you don't do too many things wrong. - Warren Buffett

For the Memorial Day weekend, I'll feature another Integrated BioSci Investing Notable Community Discussion ("NCD"). This series is born out of my quest to continually improve the service for our community. As follow, an NCD fills in the gap for members who are unable to join the daily chat due to work and other obligations. As such, present pertinent highlights that we discussed during the week.

On Tuesday, May 21st, Flamman initiated an excellent discussion. As the market traded lower, the opportunistic investor Flamman - at least that's how I viewed him - prudently picked up shares in some key companies. Some of his purchases included the red hot Sesen Bio (SESN), Nektar Therapeutics(NKTR), and Omeros Corporation (OMER). Of note, I recently published updates on both Sesen and Nektar. You should definitely check out those research if you haven't done so. My trading analytics suggest that the momentum is building in Sesen, Nektar, Omer, and Regenxbio. These stocks have been trading on an uptrend earlier in the week.

Figure 1: Notable IBI stocks (Source: Yahoo Finance)

IBI Industry Trends: Important Ramifications From The Amazon Acquisition Of PillPack

Summary

Due to the PillPack acquisition, Amazon will reduce the service demand for traditional brick-and-mortal retail pharmacy.

There is an industry shift favoring mail-order prescription and online pharmacy. Ultimately, it's changing the landscapes for traditional operators like Walgreens and CVS Health.

Under Amazon's gargantuan infrastructure and improved logistics, PillPack will enjoy aggressive business growth. Moreover, it'll launch Amazon's online pharmacy as the initial step for more market domination.

In conveniently offering various medicines in a package, PillPack reduces the complexity of taking drug combination and thereby improves patient convenience.

The theme of investing in logistics providers to capitalize on the growth of another related industry is quite intriguing. This strategy leads to highly profitable returns.

The business schools reward difficult complex behavior more than simple behavior, but simple behavior is more effective. - Warren Buffett

In supplementing my daily research, I periodically feature other articles in various series for members of Integrated BioSci Investing. My goal is to provide members with additional coverage to synergize my usual in-depth research. In the past, I experimented with the excessive emphasis on series articles. And, I learned that it reduced the quality of Integrated BioSci Investing's usual research. With more wisdom, I'll ensure that these brief analysis solely serve to "enhance" rather than "replace" my core value to our private investment community. Through my work, I seek to empower you in making prudent investment decisions and becoming better investors.

Figure 1: Amazon chart (Source: StockCharts)

Though I focus on therapeutic innovation, it's also important for me to assess related business (i.e. retail pharmacy). After all, how innovated drugs are utilized down the vertical chain influences the profitability of bioscience stocks. That being said, I'm intrigued by the recent Amazon (AMZN) acquisition of PillPack. The aforementioned merger and acquisition (M&A) came to my awareness through IBI community discussion.

A notable IBI member shared with the community an article from Christina Farr of CNBC. In my opinion, Farr did a fine coverage of the inside story regarding the Amazon acquisition of PillPack. Instead of solely reading the news, I believe that it's important for you to analyze the information and place them within their appropriate context. In my learning process, I created a "mental framework of data" to make more accurate investment decisions.

My biological analysis machinery is upgraded every time I read up on news and trial results. Consequently, it continually fine-tunes my analytical forecast of clinical trial results and regulatory approvals. And, I want to teach you how to conduct your own analysis rather than simply listening to my recommendation. It's much rewarding to instruct a man how to fish rather than providing him the fish alone.