Monday, September 30, 2019

IBI Market Insight: To Profit From Value Disconnect

Summary
In recent years, stellar breakthroughs such as CAR-T and gene therapies painted the bioscience landscape.
Previously limited by expertise, we're witnessing an increasing number of companies brewing gene-editing molecules.
Precision medicine therapeutics and companion diagnostics are powering the next wave of innovation.
Nonetheless, the China Trade War and drug pricing pressure lead bioscience stocks to exchange hands at a deep discount.
At the turn of the next market cycle, the long-term oriented investors will enjoy sizable profits.
I like the idea of using artificial intelligence because we're so short of the real thing. - Charlie Munger
I hope that you guys had a great weekend. Asides from doing light tasks like posting on my social media, I shifted away from work during the weekend. In my view, it's best to conduct investment research and news analysis during weekdays. As family and God are matters of the heart, they should at least have the weekend. I believe it's more healthy and balance for you to reserve the weekend to rejuvenate and improve other arenas of life. After all, there is more to life than investing. And, the investment process is not a sprint. It's a marathon so pace yourself accordingly.
Figure 1: Charlie Munger and Warren Buffett (Source: Robyn Twomey)
That being said, I'd like to kick off the week with another series coined Market Insight. This publication is similar to the Industry Trends analysis that I conducted from time to time. Despite the resemblance, there are significant differences. Specifically, Market Insight explores current affairs that are driving broader market behaviors. Aside from providing you with the intelligence affecting your investment value, Market Insights offers various strategies to help you capitalize gains and minimize losses.

Thursday, September 26, 2019

IBI Reports On Marinus: Robust Phase 2 Data For Ganoxolone

Summary
Marinus Pharmaceutical reported stellar data for its Phase 2 trial investigating the lead medicine (ganoxolone) for refractory status epilepticus.
All trial patients experienced strong efficacy with an overall good safety profile.
The shares exhibited a strong initial rally. As investors take profits, the initial optimism is fizzling out.
Marinus Pharmaceuticals (MRNS) made its way into IBI's daily commentary today. Due to the positive Phase 2 study of its lead medicine ganaxolone, the stock appreciated over 58% in the pre-market. Nonetheless, the rally is fizzling out toward mid-day trading. It seems that market optimism is fading, as Marinus is currently exchanging hands at 18% premium to yesterday's close.
Figure 1: Marinus chart (Source: StockCharts)
Accordingly, Marinus is focused on the innovation and commercialization of novel molecules to serve the unmet needs in epilepsy and psychiatric medicine. Instead of diversifying into a broad pipeline, Marinus is brewing one stellar molecule (ganaxolone) for various neurological indications, including refractory pediatric epilepsy, acute epilepsy, and postpartum depression.

Thursday, August 29, 2019

Amarin: Elucidating Bullish And Bearish Claims

Summary
The Vascepa recommendation as the standards of care by both the American Diabetes Association and American Heart Association are stellar developments that foretell robust growth ahead.
The upcoming supplemental new drug application decision for Vascepa is the ultimate catalyst that will catapult Vascepa sales by multiple folds.
Amid overwhelming odds of approval, the recent Prescription Drug User Fee Act delay still incites fear of a negative regulatory binary.
This idea was discussed in more depth with members of my private investing community, Integrated BioSci Investing. Get started today »
Calling someone who trades actively in the market an investor is like calling someone who repeatedly engages in one-night stands a romantic. - Warren Buffett
In bioscience investing, you are certain to encounter much volatility. Due to the notion that what went up must goes down, it seems to me that a rallied stock is more volatile than other equities. Facing the market's whim, it's important for shareholders to properly interpret the ongoing saga of your stocks. As such, you can avoid selling out prematurely on spectacular performers. Equally important, you can build shares in promising companies during opportunistic occasions.
The aforesaid phenomenon exemplifies the investment thesis on Amarin Corporation (AMRN). In light of a regulatory delay, the market sentiment now shifted out of favor for Amarin. Nonetheless, the development of the overall fundamentals is quite robust. By empowering yourself with market intelligence, you can make an informed decision rather than being victimized. In this research, I'll present a fundamental analysis of Amarin while dissecting bullish and bearish views.
Figure 1: Amarin chart (Source: StockCharts)

About The company

As usual, I'll provide a brief corporate overview for new investors. If you are familiar with the firm, I recommend that you skip to the subsequent section. Based in Bedminster New Jersey and Dublin Ireland, Amarin is focused on the innovation and commercialization of therapeutics to serve the strong unmet needs in cardiovascular health. Powered by its expertise in lipid science, Amarin successfully developed and commercialized icosapent ethyl (Vascepa) in the U.S. using an in-house sales force.
Figure 2: Therapeutic pipeline (Source: Amarin)

Friday, August 23, 2019

Amarin: A Competitive Intelligence Analysis On Vascepa


Summary
Hindsight is 20/20 yet higher-level intelligence drives future profits. As such, I focus on forecasting the upcoming regulatory binary for Vascepa's label expansion and other corporate developments.
Despite Vascepa's dominant position, there are competing molecules such as Lovaza and over-the-counter Omega-3 supplement (OOS) that investors should assess.
In the spirit of sharing, I'll present part of what I discussed today inside my private investment community earlier than usual.
The best thing that happens to us is when a great company gets into temporary trouble ... We want to buy them when they're on the operating table. - Warren Buffett
As the weekend is winding down, I'll conduct competitive intelligence analysis on Amarin Corporation (AMRN). The inspiration from a ScienceDirect article that an Integrated BioSci Investing ("IBI") member shared catalyzed this analysis. As such, I'd like to express my gratitude to all IBI members for your continuous intellectual generosity. Equally important, I appreciate the counter-viewpoint. And, I encourage you to continue sharing your inputs.
In my view, IBI is a community where we learn from one another to become better investors. Therefore, all respectful debates are welcoming. By dissecting opposing arguments, we can learn about an investing thesis on a deeper level where most value resides. Without further ado, I'll take a deep-dive into this commentary.
Figure 1: Amarin chart (Source: StockCharts)
Accordingly, I found the recent article on Vascepa's competitor intriguing for various reasons. Notwithstanding, they all underlies the "impurity" and "subpar quality" of over-the-counter supplements (i.e. OOS), which I attributed to their regulatory laxity. The author remarked,
Elucida Research in Beverly, MA, found that Omega-3 fatty acid (3FA) levels fluctuated greatly from product to product, from as low as 33% to as high as 79%. However, it also determined that high levels of saturated fat and oxidized 3FA found in the supplements may actually undermine their possible health benefits.
As Elucida elucidated, one can best hope for a 79% Omega-3 from OOS. Adding further injury to insult, I believe that the aforementioned 79% is not pure eicosapentaenoic acid (EPA) like Vascepa. Asides from "fillers and oxidized Omega-3," OOS harbors the silent cardiovascular-disease inciter (i.e. docosahexaenoic acid or DHA).
Specifically, research proved that DHA raises the level of low-density lipoprotein (i.e. bad cholesterol or LDL-C), the culprit of heart diseases. As such, when you consume OOS or other Omega-3 products (Lovaza), they contain both DHA and EPA. Consequently, the health benefits - triglyceride ("TG") and cardiovascular risk reduction from EPA - are neutralized by DHA's LDL-C elevating effect.
As proof in the pudding of Vascepa dominance, there is a "fundamental shift" in the medical guideline. In the August Advisory, the American Heart Association (AHA) shined the light into DHA by explicating its negative health consequences.
Figure 2: AHA recommendation (Source: AHA)
As the truth is revealed, the AHA switched stance to endorse pure EPA. The endorsement comes on top of the Vascepa recommendation as Standards of Care by the American Diabetes Association (ADA) in March.

Wednesday, August 21, 2019

Aimmune: Contextualizing The ICER Statement

Summary
Aimmune published highly robust Phase 3 (RAMSES, ARTEMIS, and PALISADE) data for AR101. Therefore, the drug is positioned to gain FDA approval for treating peanut allergy by January 2020.
Nonetheless, ICER recently issued a report that questioned the utility of desensitization therapies for peanut allergy.
As opinions rather than facts, the ICER statement is a theory that is used to generate discussion. As such, they do not have any material impact on AR101's approval.
This idea was discussed in more depth with members of my private investing community, Integrated BioSci Investing. Get started today »
The stock market is designed to transfer money from the active to the patient. - Warren Buffet
In bioscience investment, it's crucial to filter out opinions from facts. Despite that you hold a fundamentally sound company, you will face streams of negative market opinions. To stay grounded, it's imperative for you to conduct research due diligence to know when the news is simply a "head fake." This phenomenon is best epitomized by the investment thesis on a food allergy innovator dubbed Aimmune Therapeutics (AIMT).
Though Aimmune delivered extremely robust clinical outcomes for the Phase 3 (RAMSES, ARTEMIS, and PALISADE) trials, its desensitization therapy has been the subject of market negativity. The latest discussion originated from the Institute for Clinical and Economic Review. Notwithstanding, the intelligent Aimmune shareholders are undeterred because such news is simply opinion rather than fact. In this research, I'll present a fundamental analysis of Aimmune while dissecting the negative arguments.
Figure 1: Aimmune 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. Headquartered in Brisbane California, Aimmune Therapeutics is focused on the innovation and commercialization of medicines to serve the food allergy market. As the crown jewel of the pipeline, AR101 is an oral biologic for peanut allergy. Designed by the characterized oral desensitization immunotherapy (i.e. CODIT) platform, AR-101 is a powerful preventative (i.e. prophylactic) therapy. Asides from AR101, Aimmune is expanding its development to serve the unmet needs in other food allergies such as egg and walnut.
Figure 2: Therapeutic pipeline (Source: Aimmune)