Mad Hedge Biotech and Healthcare Letter
January 3, 2023
Fiat Lux
Featured Trade:
(A REPRIEVE IN THESE TURBULENT TIMES)
(VRTX), (CRSP)
Mad Hedge Biotech and Healthcare Letter
January 3, 2023
Fiat Lux
Featured Trade:
(A REPRIEVE IN THESE TURBULENT TIMES)
(VRTX), (CRSP)
Following a punishing 2022, it’s reasonable to expect that the situation won’t get any better, especially with a recession hanging over our heads this 2023. Hence, industries widely known to be “resilient,” “stable,” and “durable” will sustain their momentum and continue to gain more investors. Meanwhile, sectors typically associated with “buzzy” updates will struggle to keep their businesses afloat.
That means the best businesses to put your money in are those where people have no other recourse but to spend regardless of the economic situation. With this in mind, investors are projected to load up on healthcare stocks to help them weather the incoming financial storm.
Actually, this has been the trend since the pandemic started, with the Health Care Select Sector SPDR ETF (XLV) only falling by 4.2% in 2022. It’s still good news, especially in light of significant tailwinds, like wars, inflation rates, and political turmoil. Looking at the performance of this sector, it’s evident that people will still seek medical care no matter what. That makes the healthcare sector the ideal combo of a reasonable valuation and defense.
Among the names in this segment, finding a company that performed better than Vertex Pharmaceuticals (VRTX) would be difficult. This business has swum against the tide throughout 2022, with shares climbing amid the struggles of the S&P 500. While Vertex already presented solid fundamentals this year, it could perform even better in 2023.
Vertex’s shares have risen by 32% year to date. In contrast, the S&P 500 has shown a 19% decline. What makes Vertex different from its competitors? Here is the short answer. The company is equipped with the tools to continue delivering impressive financial results in both the short and long terms.
The next couple of years will see Vertex continue to lean on its high-performing lineup of treatments that target cystic fibrosis (CF). This rare genetic condition results in digestive issues and affects the internal organs of patients.
Vertex has a virtual monopoly of this highly lucrative market, being the sole game in town targeting not only CF but the underlying conditions of this rare disease.
Actually, Vertex has been aggressive in expanding its CF franchise. Before 2022 wrapped up, the company submitted its Investigational New Drug application for another CF treatment called VX-522. This is an mRNA-based therapy, which was already cleared by the US Food and Drug Administration.
The CF market has massive potential, which Vertex has yet to explore fully. By 2025, the CF market is estimated to hit a whopping $13.9 billion. Considering that Vertex is the only drugmaker making an impact on this condition, this could translate to an even bigger revenue stream for the company.
Vertex’s lineup of CF treatments has enabled the company to start creating and developing new programs that hold the potential to become blockbusters. Thus far, the company has developed a pipeline of candidates for gene-editing and acute pain treatments.
To date, Vertex and its co-developer, CRISPR Therapeutics (CRSP), are awaiting regulatory approval for their one-time gene-editing therapy called Exa-cel. This treatment has the potential to cure two rare genetic blood diseases, namely, sickle cell disease and transfusion-dependent beta-thalassemia. Apart from being able to possibly treat these conditions, the capability of Exa-cel to eliminate the necessity for transfusions makes it incredibly impressive.
Another potential top-selling treatment for Vertex is VX-548, which targets neuropathic and acute pain. This is a non-opioid alternative that the company hopes to offer in an effort to curb the debilitating opioid addiction in the US. VX-548 is slated to undergo Phase 3 trials in the first half of 2023.
Overall, Vertex is an excellent buy for investors looking for a safe and solid stock in the healthcare industry. It has proven itself to be an extremely profitable company over the past decade, and its pipeline of potential treatments queued for clinical trials are indicative of its ability to grow beyond its CF program. Given Vertex’s success over the years, the business potential, and the current price, this company can quickly become a crowd favorite in 2023.
Mad Hedge Biotech and Healthcare Letter
December 20, 2022
Fiat Lux
Featured Trade:
(PATIENCE IS KEY FOR THIS BIOTECH)
(VRTX), (MRNA), (CRSP)
This year has been challenging for the majority of the stocks, with even the strongest and most dominant names struggling to keep up. The three major indexes all slipped into bear territory while economic issues such as rising inflation brought turbulent earnings seasons across virtually every industry.
Still, 2022 has revealed a handful of exceptions. Some businesses delivered good news and, against all odds, solid stock performance. Some investors lined up to buy shares of these companies. While some have soared to unreasonable prices, it’s not too late to invest in other players sold at modest prices.
A particularly promising stock that meets these criteria is Vertex (VRTX).
Vertex has risen notably this year, recording a 38% boost to date. However, it’s trading at roughly 20 times its forward earnings predictions. Hence, buying this stock could very well guarantee solid investment in the long run. After all, the following years are expected to be filled with significant turning points.
An excellent starting point in reviewing Vertex’s potential is its portfolio. Right now, the company has six drugs sold commercially, reporting $7.5 billion in revenue last year. All six focus on cystic fibrosis (CF).
Vertex has been hailed as the worldwide leader in the CF market for years. On an even more promising note, the company is projected to sustain this momentum until the late 2030s.
Specifically, Vertex’s most recent CF treatment, Trikafta, has presented plenty of room for revenue growth in the years to come, courtesy of anticipated additional approvals in more countries and younger age brackets.
Vertex is also reviewing another CF candidate, which is now in Phase 3 trials. Based on previously released data, this new product has the potential to become even better than Trikafta.
Another CF candidate queued for review is the drug Vertex has been working on in collaboration with Moderna (MRNA). If approved, this product will cover patients not eligible for the current CF roster of Vertex.
Surprisingly, however, the potential catalyst for Vertex’s share price in the coming years has absolutely nothing to do with its highly successful and established CF program.
Rather, it has something to do with the company’s new venture on blood disorders: Exa-cel. This is a one-time cure developed by Vertex and Crispr Therapeutics (CRSP), which targets two blood orders. To this day, there remain minimal options for patients with these diseases.
For two key reasons, gaining approval for Exa-cel could be a massive game changer for Vertex. One is that it can provide definitive proof that the company can expand beyond its CF programs.
The second is that it would provide an additional revenue stream for Vertex, and that’s always a desired outcome regardless of the billions of dollars the company is already generating.
CF sales have clearly powered Vertex’s net income, which increased by about 1,140% in the past five years. With exa-cel, though, it’s evident that the company has been working to diversify its market to cover other diseases.
Reviewing its pipeline, Vertex has 18 programs with excellent chances of getting commercialized in the next 10 years. These run the gamut of treatments and therapies, including promising results for sickle cell disease, type 1 diabetes, kidney disease, and acute pain relief.
While it’s impossible to accurately determine the amount of money these drugs could make by 2032, it’s not that hyperbolic to believe that they can at least contribute several billions to the company.
Overall, Vertex stock offers a bright and solid future. In the next 10 years, the business would evolve into a much bigger, more entrenched, and more diversified entity. That means it would be a less risky investment compared to today.
Vertex would be an excellent choice for patient investors seeking to start a position in some biotechnology and healthcare companies.
Mad Hedge Biotech and Healthcare Letter
November 3, 2022
Fiat Lux
Featured Trade:
(INVEST LIKE IT’S 2009)
(VRTX), (CRSP)
Some investors look at a glass of water as half-empty, while hardcore pessimists believe that the glass is drizzled with arsenic. I’m neither.
You can count me as one who constantly looks at the glass of water as half-full.
Admittedly, it has been challenging to continue being optimistic, given the current conditions of the stock market. Some stocks in my portfolio have suffered a beating, too. Nevertheless, I’m still optimistic about the next 10 or 15 years.
Why? Because this horrible bear market has presented us with one of the most exciting and promising investment opportunities in over a decade.
If you don’t believe me, think back to 2009. Unquestionably, that was an incredible year to buy stocks. The S&P 500 index skyrocketed over 320% from January 2009 to today. Meanwhile, the Nasdaq 100 index soared 830%.
However, there's a crucial detail: this realization comes in retrospect. Remember, around early 2009, the Great Recession was still well underway. It didn’t feel like any investment was a promising opportunity at that time.
Stocks only showed signs of bottoming out at the very end of the first quarter of that year, and no one could confidently say when the bear market would end.
Fast forward to 2022. While there’s still no official word on whether we are in a recession, analysts have insisted that we’re well on our way to another one soon.
Although the present situation is obviously distinct from what happened in 2009 because of the COVID-induced recession and the continuation of the 2020 bear market, I fully believe that investors will look back to this period and realize that it’s the prime time to buy stocks.
So, how can investors make the most of this buying opportunity?
First, don’t focus on waiting for the market to bottom. A better way to deal with the situation is to determine the stocks of companies with solid core businesses that currently trade reasonably priced (or if you can find them, bargain) valuations.
Second, choose stocks that you can buy incrementally. It’s definitely possible that the market will fall even more. If that happens, investing gradually or in stages rather than dropping all your money into stocks at a single time could be a failsafe strategy.
Third, be patient. This tip cannot be highlighted enough. It’s critical to provide stocks with sufficient time to run. Investors who bought stocks early in 2009 and sold them by 2010 or 2011 missed out on most of the best and longest bull run in history.
The good news is that many excellent stocks meet the criteria mentioned above.
A particular name stands out in the biotechnology and healthcare industry: Vertex Pharmaceuticals (VRTX).
Unlike other businesses, Vertex has been trouncing the broader market this year, climbing by over 35% year to date. More importantly, the company’s pipeline of candidates looks even brighter.
One of the reasons this biotechnology giant is performing well is its monopoly of the cystic fibrosis (CF) market. In the third quarter of 2022, Vertex’s CF programs generated $2.33 billion in sales and $931 million in profits.
It doesn’t end there, as Vertex has plans to maximize its monopoly of the CF market.
More therapies are under development to target more patients in this sector, which means Vertex would eventually become its own biggest rival. Needless to say, this will make its hold in the CF market much stronger.
In terms of adding more monopoly money to its portfolio, Vertex has been working on a treatment for APOL1-mediated kidney disorder. To date, there remains no therapy for this condition.
On top of these, Vertex has been collaborating with CRISPR Therapeutics (CRSP) to develop treatments for two rare blood disorders. Given the timeline released by both companies, these candidates should be ready for regulatory approval by December 2022 or early 2023.
Another promising candidate in its pipeline is the non-opioid pain treatment VX-548 for moderate to severe acute pain. Ultimately, Vertex’s goal is to offer this alternative to end the opioid epidemic.
Meanwhile, its acquisition of Viacyte has catapulted Vertex into one of the Type 1 diabetes market leaders.
Overall, Vertex’s forward earnings multiple of 20 may not look all that attractive, but the biotech’s growth prospects are up-and-coming. Hence, I view this stock as a bargain at the moment.
Again, Vertex is only one of the examples of companies that could be an excellent investment in this bear market. The healthcare and biotechnology sector has more great stocks to buy in this crisis. Indeed, the glass of water is most definitely half-full.
Mad Hedge Biotech and Healthcare Letter
October 4, 2022
Fiat Lux
Featured Trade:
(A POWERHOUSE BIOTECH GOING HIGHER)
(VRTX), (BIIB), (CRSP)
There is no single recipe for building wealth over the years. There are several ways to achieve this goal. However, a particularly effective one is recognizing solid businesses that deliver revenue and profit over time.
You can easily find many excellent candidates in the biotechnology and healthcare world. Actually, a lot of biotech stocks have managed to outperform the struggling market this 2022.
One name that emerged virtually unscathed from the onslaught of economic, political, and financial crises is Vertex Pharmaceuticals (VRTX).
Admittedly, the market downturn has yet to end. That means the company could still experience the effects of macro headwinds and tensions in the near future.
With that said, Vertex is one of the few companies equipped with the right tools to deliver excellent returns in the long run.
One of the reasons Vertex is at the top of the list in the biotech world is its history. The company has been generating solid returns for investors for quite a while now.
In fact, it has impressively surpassed the S&P 500 Index in the past 10 years.
Apart from that, Vertex continues to boost its revenue and profits courtesy of its monopoly in the market for treatments that target the underlying reasons or causes behind cystic fibrosis (CF).
Vertex is the market leader in the CF space worldwide. The company sells four therapies targeting this condition.
The company’s latest approval in this segment was for Trikafta, which received the green light in 2019. By 2021, Trikafta was already able to rake in over $5.6 billion in revenue.
Trikafta can be used as a treatment for up to 90% of CF patients. This number goes beyond any of those delivered by other Vertex products. More importantly, Trikafta will keep its patent exclusivity until the late 2030s.
That provides Vertex with plenty of time to make headway and expand the application of the product to cover previously untapped markets—a strategy that the company has been perfecting over the years.
Vertex has been busy winning approvals in new age groups and more reimbursements in several countries to ensure longer-lasting dominance in this segment.
Recently, the biotech has launched its Phase 3 trials for a candidate that may be an even better product than Trikafta.
While details have been kept under wraps, Vertex shared that the product would be a one-time curative treatment. Needless to say, this would translate to a massive payday for Vertex.
If everything goes according to plan, this new candidate might be launched by the first quarter of 2023.
At the same time, the biotech has been working on promising candidates for much-needed treatment areas, projected to generate billions of dollars in revenue.
This move is aligned with the strategy Vertex has been using over the years: target diseases with only a handful (if any) of safe and effective therapy options.
Among Vertex’s promising but ambitious programs is VX-880, a potential treatment for Type 1 diabetes.
While this could be a long shot, Vertex’s decision to buy ViaCyte for $320 million speaks volumes of the biotech’s seriousness about the endeavor. For context, ViaCyte is a private company focused on developing a functional cure for Type 1 diabetes.
This acquisition enables Vertex to add researchers who have been working on the same goal for years to contribute their expertise to the pipeline. Plus, ViaCyte can bolster Vertex’s manufacturing expertise for cell-based therapies targeting Type 1 diabetes.
Of course, there’s the work with CRISPR Therapeutics (CRSP) to develop gene therapies. Combining this collaboration with ViaCyte’s pipeline, which includes gene-edited cells created to evade the immune system, means Vertex could design a program eliminating the necessity for immunosuppressive therapy.
Meanwhile, there are other solid candidates in the biotech pipeline.
So far, Vertex has been having discussions with the FDA. The company has recently provided proof of concept data for its candidate for Exa-cel in sickle cell disease and transfusion-dependent thalassemia. Given the progress, the product should be slated for release by early 2023.
Another is VX-147, which is a kidney disease candidate that’s currently in crucial development. To date, the product is on track for accelerated approval and could start generating sales by late 2024.
On top of these, Vertex has been working on alternatives for opioids to avoid overdoses. Amid the growing concerns and data on the addictiveness of opioids, these continue to be prescribed as treatments.
This epidemic shows no signs of slowing down, with the CDC’s recent estimate increasing to 75,000 Americans dying from an overdose. According to the CDC, over 2 million Americans are addicted to opioids.
One explanation for this issue is that there is no effective alternative. While Vertex’s initial candidates failed to show an optimal profile, its latest candidate may very well be the answer.
The new candidate, VX-548, was created based on observations and research on families in Pakistan with the rare ability not to feel or experience any pain.
Due to this particular genetic abnormality, members of these families are able to walk on hot coals, get stabbed with knives, and jump from heights, and experience absolutely no pain at all.
The genetic mutation stops the peripheral nervous system from sending pain signals to the brain.
Vertex and other developers like Biogen (BIIB) are attempting to develop drugs that mimic the pain-blocking ability resulting from this genetic mutation.
If successful, VX-548’s greatest asset is its non-addictive potential, thereby making premium pricing more likely justified.
The current market for acute pain treatments annually is $4 billion, and that number is for generic pricing.
Considering that the pricing of a branded treatment would probably be at least double, then the commercial potential is massive.
Over the next 10 years, Vertex is expected to launch new biotech treatments which, combined with its current CF franchise, will propel its earnings, profit, and share price to even higher heights.
It’s currently facing the bear market without so much as breaking a sweat, with stock prices climbing by roughly 28% so far this 2022 compared to the market’s 19% decline. I suggest you don’t wait too long to buy into Vertex, as this is a top-tier biotech.
Mad Hedge Biotech and Healthcare Letter
July 12, 2022
Fiat Lux
Featured Trade:
(THE LEADERSHIP BATON IS IN BIOTECH’S HANDS NOW)
(MRK), (SGEN), (CRSP), (VRTX), (BLUE), (BIIB), (LLY), (RHHBY)
Biotechnology companies have taken the reins and are expected to outperform the general market in the near future.
To date, the Nasdaq Biotech Index (NBI) has been up by 2.41% while the iShares Biotechnology (IBB) exchange-traded fund has climbed by 2.47%.
Numerous crucial factors place this industry in an advantageous position for growth. Alongside other segments of the pharmaceutical and healthcare industries, the biotechnology sector is essentially recession-proof.
With a roughly 40% fall in the biotech sector from 2021’s high, it’s highly likely for us to witness a boost in takeover activity in this space.
This is evident in recent reports of Merck (MRK) attempting to acquire cancer biotech Seagen (SGEN), as discussed in the June 30 issue of this biotech and healthcare letter.
The talks have progressed, and it appears that Merck is nearing the end of the process. The goal is to have the details worked out by the time the quarterly earnings report is released on July 28.
While no specifics have been made public, it is estimated that the larger healthcare company will pay a staggering $40 billion for this Seagen acquisition.
If this goes through, Merck will pay more than $200 per share for Seagen.
The news of this acquisition bolstered Seagen’s business as the stock rose by 4.6% at the time of the announcement.
This is welcome news given the perceived slowdown in biotech M&A activity since 2020. As a result, the idea fueled pessimism among investors who failed to see the big picture during this time period.
Analysis of 101 contracts signed by small, medium, and large biotechnology companies between January 2015 and June 2022 reveals that this year's contract volume and size are comparable to those of previous years.
In fact, there have been $17.7 billion in transactions so far in 2022. This translates to more than $13.9 billion in 2020 and $7.2 billion in 2021.
Some investors may be concerned about the quality of these acquisitions.
Even though the companies involved paid good premiums, the last 12 months' acquisitions were done at a big discount to the highest share prices of the businesses being bought.
To put it simply, there has been a problem with pricing in the sector as of late.
This is admittedly a "bittersweet" reality of recent biotech M&A transactions. As a result, market perceptions are clouded and investors are misled into believing that a much larger problem is brewing in the sector.
Executing megadeals is an obvious solution. This is why the Merck-Seagen merger is such good news for the industry.
The impact of this report suggests that large-scale M&A could be part of the path to the biotech sector's recovery.
The mere possibility of this transaction has already increased the SPDR S&P Biotech exchange-traded fund by approximately 20%.
In addition to Merck and Seagen, other biotechnology companies have been widely discussed as potential acquisition targets.
CRISPR Therapeutics (CRSP), which has a long-term partnership with Vertex Pharmaceuticals (VRTX), is a fan favorite. By the fourth quarter of 2022, the two intend to submit their sickle cell and beta-thalassemia treatment for approval.
Bluebird Bio (BLUE) is another company that has been on the radar whenever acquisition discussions begin.
This gene therapy and cancer biotech has been unnerving investors for months, even before the pandemic triggered an economic crisis, due to its lackluster performance. Despite this, its gene-editing program has enormous potential.
With a market capitalization of $368 million, it is an ideal candidate for Merck and even Moderna (MRNA). After all, both have been considering expanding its oncology program, and a dirt-cheap acquisition target appears to be an appealing option.
Biogen is another name associated with multiple interested parties (BIIB). Since its Alzheimer's treatment failed to materialize and deliver despite the biotechnology company exhausting virtually all available options to salvage the situation, the stock has yet to exhibit any signs of recovery.
After betting the farm on this candidate, Biogen has struggled to maintain its financial stability. In an effort to improve its cash flow and pay off its debts, the company has also been working overtime to advance the other programs in its pipeline.
Eli Lilly (LLY) and Roche (RHHBY), which have been working on their own Alzheimer's treatment, have recently been linked to Biogen.
With a market capitalization of $32 billion and a money-losing program, however, any transaction involving this biotech would require significantly more time.
Overall, it appears that biotechs are gradually regaining their footing. It is only a matter of time before all the pieces fall into place and the sector begins to move forward with full force.
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