Mad Hedge Biotech and Healthcare Letter
August 24, 2023
Fiat Lux
Featured Trade:
(FUTUREPROOFING BIOTECH)
(REGN), (SNY), (BAYN), (RHHBY)
Mad Hedge Biotech and Healthcare Letter
August 24, 2023
Fiat Lux
Featured Trade:
(FUTUREPROOFING BIOTECH)
(REGN), (SNY), (BAYN), (RHHBY)
The financial landscape of 2023 offers a captivating tableau. While stock market giants, such as the S&P 500 and the Nasdaq Composite, have been garnering attention with their respective 18% and 34% gains, the biotechnology and healthcare domain unfolds a more nuanced story.
When I take a look at this sector, I notice certain ETFs, notably the iShares Biotechnology and the SPDR S&P Biotech, in a decellerative phase. However, the industry's canvas is dotted with companies that are scripting their distinct success stories.
Among these trailblazers is Regeneron Pharmaceuticals (REGN).
Contrary to the broader biotech trend, Regeneron has asserted itself with a commendable 7% growth this year. This is complemented by its sturdy revenue and an impressive EPS trajectory showcased in Q2.
For those not completely familiar with the annals of biotech, the name Regeneron is synonymous with pioneering achievements in therapeutic proteins. Their landmark collaboration with Bayer (BAYN) resulted in the creation of Eylea, a beacon in the anti-VEGF drug realm.
Their story doesn't end there.
Together with Sanofi (SNY), they've masterminded treatments that have potentially revolutionized the way we approach cancer, inflammation, and specific respiratory disorders. A testament to this partnership's prowess is Dupixent, which registered a remarkable $8.68 billion in sales during 2022.
Insider chatter hints at the possibility of these figures ascending to an ambitious $20 billion by the end of this decade.
A retrospective look at Regeneron's journey over the past decade reveals a remarkable story of resilience and growth. Their compound annual growth rate (CAGR) stood at an enviable 24.2% from 2012 to 2022.
When contrasted against the S&P 500's relatively modest 16.3% in the same window, it underscores the vast potential that biologic therapies hold. Moreover, it showcases Regeneron's ability to harness this potential effectively.
Yet, as we look ahead, the landscape is not devoid of challenges.
Enter Roche’s (RHHBY) Vabysmo — a new contender that has begun to question Eylea's unchallenged dominion since its 2022 introduction.
Recognizing this, Regeneron has strategically moved towards bolstering Eylea to ensure it maintains its market presence. These evolving dynamics serve as a reminder that the arena of retinal disease treatments is becoming increasingly competitive.
Anticipating the industry's fluid dynamics, Regeneron has exhibited strategic foresight. Their ventures into the realm of immuno-oncology, notably their stalwart, Libtayo, are significant.
They've not stopped there, however.
Their strategic diversification includes incursions into groundbreaking fields like gene therapy, RNA interference, and more. The company's research pipeline, promising an influx of innovative drugs in the near future, showcases its commitment to remaining at the industry's forefront.
A key partnership that's generating interest is Regeneron's association with Intellia Therapeutics (NTLA) in the sphere of gene editing.
This venture is pivotal. Such therapies have the potential to redefine medicine, offering transformative, perhaps even curative, treatments. Their adoption, however, comes with its fair share of challenges.
The industry's somewhat tentative approach towards gene editing, with a preference for licensing and equity stakes rather than outright acquisitions, underscores the nascent and experimental nature of this domain.
In conclusion, Regeneron Pharmaceuticals stands as an epitome of innovation and adaptability in the biotech sector. It amalgamates a rich history of achievements with an ambitious vision for the future.
As the company maneuvers through the intricate maze of opportunities and challenges that the 2020s present, investors ought to approach with both optimism and prudence. In a domain characterized by rapid advancements and uncertainties, Regeneron's journey offers valuable insights.
The upcoming years promise a blend of innovation, challenges, and milestones, and firms like Regeneron are poised to shape this narrative. I suggest you buy the dip.
Mad Hedge Biotech and Healthcare Letter
January 26, 2023
Fiat Lux
Featured Trade:
(SLOW AND STEADY WINS THE RACE)
(REGN), (SNY), (RHHBY), (BAYN)
If you are on the lookout for stocks that have the potential to deliver dramatic gains right away, you’d be hard-pressed to find a better place than the biotechnology industry.
Hardly a month passes without at least one or two biotech names skyrocketing or tumbling thanks to updates about clinical studies. And this year won’t be any different for this group.
A particular biotech to keep on an eye on is Regeneron Pharmaceuticals (REGN).
This 2023, Regeneron has several upcoming trial readouts that could potentially push its stock price to an all-time high. The earliest update to watch out for involves its anti-inflammatory drug Dupixent, which is already a leading treatment for asthma and eczema.
Gaining its first approval back in 2017, Dupixent has been generating over $7 billion in sales every year for both Regeneron and its co-developer, Sanofi (SNY).
Riding this momentum, Regeneron stock could climb higher courtesy of the upcoming results of experimental studies with Dupixent and patients suffering from chronic obstructive pulmonary disease or COPD.
Based on data from the World Health Organization, COPD is the third leading cause of death across the globe. Despite this, there remains a shortage of effective and accessible treatment options for patients. Needless to say, this represents an untapped potential market and a promising fresh revenue stream for Regeneron.
Meanwhile, another product in Regeneron’s portfolio could soon get a shot in the arm. After struggling with unimpressive results in the earlier months of 2022, the company’s shares soared around September. As expected when it comes to biotechs, this type of double-digit percentage is triggered by positive clinical updates.
For Regeneron, the trigger was Eylea.
Aside from its blockbuster drug Dupixent, Eylea is another top-selling product of Regeneron. It is a rare eye disorder treatment that it developed with Bayer (BAYN). Recently, Regeneron disclosed that Eylea proved to be effective in a Phase 3 clinical study that justified a higher dosage of the treatment.
For years, Eylea has been a generous cash cow for the companies. Now, it could become an even more lucrative source. However, this development is even more critical for Regeneron because Eylea’s patent exclusivity is set to expire in 2024.
With the recent development, the company could easily apply for an extension of patent protection, which is obviously excellent news for Regeneron and its shareholders.
This news could not have come at a more timely period since Regeneron stock started tumbling following the biotech’s report of lower sales for Eylea in the fourth quarter of 2022.
In a preliminary report on its fourth-quarter earnings, Regeneron shared that the sales for Eylea during this period only reached $1.5 billion, which fell short of the $1.64 billion expectation from analysts.
The disappointing update scared off some shareholders and caused interested investors to think twice before putting their money in this company. However, these results were justifiable since they coincided with the launch of a rival drug treatment, Vabysmo from Roche (RHHBY).
Nonetheless, Regeneron remains a good investment in these turbulent times. Despite the challenges, its products, especially Eylea and Dupixent, continue to deliver solid financial results.
More importantly, the company has several promising pipeline candidates. To date, Regeneron has roughly 40 clinical trials ongoing, with a quarter of these queued for Phase 3 studies. This indicates the company’s capacity and plans to extend its lineup to launch brand-new treatments.
Meanwhile, it has also been working on label extensions for its already successful products, as seen in its efforts with Dupixent and Eylea.
With these solid products in its portfolio and other promising candidates for regulatory approval this 2023 and early 2024, Regeneron looks ready to deliver solid results in 2023 and beyond. Even if it doesn’t, the company is equipped with the tools to keep churning out strong returns in the long run. I suggest you buy the dip.
Mad Hedge Biotech & Healthcare Letter
September 7, 2021
Fiat Lux
FEATURED TRADE:
(A LONG-TERM STOCK FOR PATIENT INVESTORS)
(REGN), (RHHBY), (BAYN), (SNY), (MRK), (BMY), (NTLA)
While August ushered in the end of the “dog days of summer,” with temperatures generally at their highest throughout the US, some stocks might be just starting to get warmed up this September.
This is particularly true in the biotechnology industry.
Considering that the broad market indices are reaching historic highs, the biotechnology sector, caused by its relatively low valuation, is deemed one of the appealing targets for investors who truly understand the essence of the industry and can manage the potential risks associated with it.
While not all biotechnology companies are attractive opportunities, some are great long-term investments.
One of them is Regeneron (REGN).
In fact, Regeneron is the manufacturer of a treatment projected to become the top-selling drug globally by 2030.
Annual sales of the moneymaking drug, autoimmune diseases’ medication Dupixent, could hit $21 billion by the start of the next decade—an almost fourfold jump from its current sales estimate of $5.6 billion per annum.
The projection came following Regeneron’s announcement that Dupixent can also be used to treat atopic dermatitis among children aged 6 months to 5 years old.
This makes Dupixent the first-ever biologic treatment to release positive results for that population.
Evidently, the breadth of Dupixent’s indications, complemented by the long-established safety profile of the drug, contribute to its long-term success—an achievement that’s expected to multiply and be carried over to the next decade.
While the next decade is clearly exciting for Regeneron, the company is actually performing well these days.
So far, Regeneron shares are up by roughly 40% year to date—a record-breaking rise not only for the company but also in the biotech sector.
Regeneron’s revenue skyrocketed by 163% year-over-year in the second quarter, pushing its earnings per share to leap 260% higher.
Apart from Dupixent, another catalyst for Regeneron’s impressive gains is its COVID-19 cocktail: REGEN-COV.
This treatment, albeit controversial, is anticipated to make Regeneron and its partner, Roche (RHHBY), a lot of money in the following months, especially with the delta variant wreaking havoc in the world.
Moreover, sales for all six of Regeneron’s highest-selling products, such as its eye disease drug Eylea, which it developed with Bayer (BAYN), immunology drug Kevzara, which is a product of its collaboration with Sanofi (SNY), lung cancer treatment Libtayo, and cholesterol drug Praluent, have been consistently growing by double-digit percentages.
Apart from these current treatments displaying solid sales momentum, the company also has a loaded pipeline that can easily boost Regeneron’s revenue streams in the future.
In terms of the new products under development, Regeneron has partnered with Intellia Therapeutics (NTLA), one of the leaders in the CRISPR-Cas9 gene-editing sector, to come up with next-generation treatments.
Aside from developing new products, Regeneron is expanding the indications of its top-selling drugs. Just like its efforts with Dupixent, the company is also working on expanding Libtayo’s indications.
So far, Regeneron has been working to turn Libtayo into a go-to treatment for skin cancer.
This effort could open up new avenues for Regeneron, as at least 9,000 cases of skin cancer are recorded in the US annually.
Of these, approximately 3,200 fall under the category that the company is targeting for Libtayo’s expansion.
This is a strategic move if Regeneron has any hope to dethrone the most dominant players in this competitive immunology market: Merck’s (MRK) Keytruda and Bristol-Myers Squibb’s (BMY) Opdivo.
Looking at the average net price of Libtayo, which is at $130,000 per year, the expected sales for this drug could grow to $400 million by 2026 in the US alone and roughly $700 million worldwide—and these are only for the approved indications of the drug.
In addition to its current applications, Regeneron is also working to gain approval for Libtayo to be used for cervical cancer.
Overall, Regeneron is an excellent investment for patient buy-and-hold investors. Its current portfolio of products is performing well, while its pipeline programs and partnerships offer promising growth potential.
Mad Hedge Biotech & Healthcare Letter
August 10, 2021
Fiat Lux
FEATURED TRADE:
(CLEARING THE SMOKE)
(PM), (GSK), (NVS), (BAYN)
Philip Morris (PM) has long been synonymous with tobacco products, with the company dating all the way back in 1847.
Over 170 years later, though, this $154.6 billion company has gathered and read the tea leaves—and it looks like it finally realized that the future is “smoke-free.”
In a complete about-face, the Marlboro maker is now telling people that it wants to find a cure for heart and lung problems—the very same health conditions people get from tobacco.
Turning from poacher to gamekeeper, Philip Morris has decided to use its widely known expertise in inhalation to improve the health of the people.
One of its major moves towards this decision is to gatecrash the bidding for Vectura, a UK-based contract development and manufacturing company (CDMO) for the healthcare and pharmaceutical industry.
Vectura is known for its expertise and device technology in inhaled products, and the company has been working with numerous companies in the healthcare field, including GlaxoSmithKline (GSK), Novartis (NVS), and Bayer (BAYN).
Basically, Vectura develops treatments and medicines that help manage and cure smoking-related diseases.
So far, Vectura has 13 inhaled medicines along with 11 non-inhaled treatments in the market today.
To date, Philip Morris has raised its offer price to beat out the other contenders bidding for Vectura.
It’s now offering $2.30 per share, with the total reaching roughly $1.4 billion. That puts an almost 45% premium over Vectura’s shares—an offer that experts believe wouldn’t be matched elsewhere.
Considering that Vectura only generated $245 million last year, this is a massive gamble for Philip Morris.
This move comes after Philip Morris acquired Fertin Pharma for $820 million in July.
Fertin is known for developing nicotine chewing gum, lozenges, chewable tablets, and “pouch powders” that quickly dissolve in the user’s mouth.
Considering that Fertin only generated roughly $160 million in sales in 2020, Philip Morris’ move to buy it at that price point also speaks volumes of its plans moving forward.
Although it has yet to wrap up its Vectura acquisition, Philip Morris is not one to wait around.
While waiting for a decision on the British company, it snapped up another respiratory drug development company: OtiTopic.
Founded in 2012, OtiTopic’s main work is focused on Aspirhale, which is a late-stage inhalable acetylsalicylic acid for intermediate to high-risk acute myocardial infarction.
In simpler terms, OtiTopic is working on an inhaled aspirin for heart attacks.
Specifically, Aspirhale works as a dry powder inhalation via a self-administered aerosol.
This is promising since early research indicates that inhaled systems can alleviate the condition in two minutes compared to the 20 minutes needed for chewable aspirin.
With Philip Morris behind it, OtiTopic expects to complete testing soon and file for FDA approval by early 2022.
Considering the massive and expanding market for inhaled therapeutics science, the work of OtiTopic and Philip Morris is estimated to generate at least $1 billion in net revenues by 2025.
Moreover, the tobacco company anticipates the market for inhaled therapeutics will rapidly grow in the next few years and reach as much as $41 billion globally by 2026—a reasonable justification for its decision to splurge on Vectura as well.
When Philip Morris announced that it’ll stop selling cigarettes in the United Kingdom in 10 years, a lot of people thought it’ll be folding up shop.
Truth be told, the company’s about-face to healthcare wasn’t the strongest possibility entertained by the market.
Most believed that it would join forces again with its spinoff, Altria Group (MO), to form a stronger company in the industry and become a powerhouse of smoke-free alternatives.
However, its recent acquisitions indicate that Philip Morris plans to use Fertin, OtiTopic, and Vectura as the core of its legacy business in the healthcare and pharmaceutical industry.
According to Philip Morris, these decisions are part of its "natural evolution into a broader healthcare and wellness company."
While it does feel a bit like an arsonist marketing fire damage insurance, Philip Morris appears to be putting money where its mouth is in terms of transforming itself into a serious life sciences company.
Mad Hedge Biotech & Healthcare Letter
January 26, 2021
Fiat Lux
FEATURED TRADE:
(EMERGING COVID-19 ALLIANCES)
(CVAC), (PFE), (MRNA), (TSLA), (NVAX), (JNJ), (SNY), (GSK), (BAYN)
Tesla (TSLA) has been sizzling hot for months now, and it looks like its Midas touch has reached the biotechnology world.
It seems that almost everything linked to Tesla achieves success. That could indicate terrific news for a particular biotech: CureVac (CVAC).
CureVac, an under-the-radar biotech stock, is closing in on the leading COVID-19 vaccine developers today.
A differentiating factor it has from the likes of Pfizer (PFE), BioNTech (BNTX), and Moderna (MRNA) is its bonafide tie-in with Tesla. Although it sounds like quite a stretch for an electric car company to have any involvement with a biotech stock, the connection actually makes sense.
Like Moderna and BioNTech, CureVac has also been working on utilizing messenger RNA (mRNA) technology to develop various vaccines and other treatments. If all goes well, this could even lead to finding a way to immunize people against cancer.
Where does Tesla come in?
It all started in 2019 when CureVac was awarded $34 million in funding by the Coalition for Epidemic Prepared Innovations (CEPI).
The goal was to create and eventually build a prototype of an mRNA “printer.” This high-tech tool would be used to produce mRNA doses in areas that suffer from viral outbreaks. It could be used by hospitals to create personalized medicines.
Having an mRNA printer would be groundbreaking in fighting off viral diseases, particularly in remote regions. As expected, this project faced many technology obstacles along the way.
Here’s where Tesla can offer a solution since one of the companies it acquired in the past years is Grohmann Engineering, which specializes in automated manufacturing.
This makes Tesla Grohmann Automation the logical partner for CureVac to turn for help in building its mRNA printer prototype.
What we know so far is that the two companies have been working closely on the project.
It’s only a matter of time before we find out if Tesla’s magic would once again blow our expectations out of the water and we are presented with yet another breakthrough.
Other than its alliance with Tesla in the mRNA race, CureVac has forged another partnership to transform itself into a stronger candidate in the COVID-19 vaccine competition.
CureVac has tapped into the global reach of Bayer (BAYN) to help it distribute its vaccine once it gains approval.
In terms of its own COVID-19 vaccine candidate, CureVac is anticipated to release positive results.
This is because its technology closely mirrors that used by Moderna and BioNTech, which strongly indicates that the efficacy levels could be just as good.
However, CureVac’s vaccine candidate offers a competitive advantage over the others: it doesn’t require cold storage.
This means it would be easier and more convenient to distribute it compared to Moderna’s and Pfizer’s.
It also requires a much smaller dose compared to Moderna’s COVID-19 vaccine candidate. This translates to cheaper manufacturing costs.
CureVac has secured a deal with the EU to deliver an initial 405 million doses for half of the year plus 300 million doses more in 2021 alone. It also agreed to produce 600 million doses in 2022.
Meanwhile, its alliance deal with Bayer indicates that it has secured a powerful distribution partner.
Therefore, we could expect CureVac to leverage Bayer’s global supply network to deliver its vaccines worldwide.
However, CureVac and Bayer are thinking way ahead of 2022.
The alliance formed by the two companies sees to it that the CureVac vaccine candidate would become the strongest contender in the post-pandemic years.
As per Bayer’s projection, the companies estimate 12 billion to 14 billion vaccine doses just to bring this pandemic under control.
Considering that COVID is expected to become an endemic disease, annual or even bi-annual vaccination programs would become the norm.
While Pfizer, Moderna, and AstraZeneca have been well ahead of the vaccine race, the door is still firmly open for other developers like Novavax (NVAX), Johnson & Johnson (JNJ), GlaxoSmithKline (GSK), Sanofi (SNY), and, of course, CureVac to launch their own COVID-19 vaccines.
Only going public in August 2020, this German biotech company already has $18.2 billion in market capitalization.
Its public offering of 15.3 million shares sold at $16 each generated $245.3 million for the company back in August.
By early December 2020, CureVac shares were already being traded somewhere around $150 as investors quickly began to realize the value proposition.
If I am to look to invest in a COVID-19 vaccine developer at this point, CureVac would surely be one of my choices.
Legal Disclaimer
There is a very high degree of risk involved in trading. Past results are not indicative of future returns. MadHedgeFundTrader.com and all individuals affiliated with this site assume no responsibilities for your trading and investment results. The indicators, strategies, columns, articles and all other features are for educational purposes only and should not be construed as investment advice. Information for futures trading observations are obtained from sources believed to be reliable, but we do not warrant its completeness or accuracy, or warrant any results from the use of the information. Your use of the trading observations is entirely at your own risk and it is your sole responsibility to evaluate the accuracy, completeness and usefulness of the information. You must assess the risk of any trade with your broker and make your own independent decisions regarding any securities mentioned herein. Affiliates of MadHedgeFundTrader.com may have a position or effect transactions in the securities described herein (or options thereon) and/or otherwise employ trading strategies that may be consistent or inconsistent with the provided strategies.
This site uses cookies. By continuing to browse the site, you are agreeing to our use of cookies.
OKLearn moreWe may request cookies to be set on your device. We use cookies to let us know when you visit our websites, how you interact with us, to enrich your user experience, and to customize your relationship with our website.
Click on the different category headings to find out more. You can also change some of your preferences. Note that blocking some types of cookies may impact your experience on our websites and the services we are able to offer.
These cookies are strictly necessary to provide you with services available through our website and to use some of its features.
Because these cookies are strictly necessary to deliver the website, refuseing them will have impact how our site functions. You always can block or delete cookies by changing your browser settings and force blocking all cookies on this website. But this will always prompt you to accept/refuse cookies when revisiting our site.
We fully respect if you want to refuse cookies but to avoid asking you again and again kindly allow us to store a cookie for that. You are free to opt out any time or opt in for other cookies to get a better experience. If you refuse cookies we will remove all set cookies in our domain.
We provide you with a list of stored cookies on your computer in our domain so you can check what we stored. Due to security reasons we are not able to show or modify cookies from other domains. You can check these in your browser security settings.
These cookies collect information that is used either in aggregate form to help us understand how our website is being used or how effective our marketing campaigns are, or to help us customize our website and application for you in order to enhance your experience.
If you do not want that we track your visist to our site you can disable tracking in your browser here:
We also use different external services like Google Webfonts, Google Maps, and external Video providers. Since these providers may collect personal data like your IP address we allow you to block them here. Please be aware that this might heavily reduce the functionality and appearance of our site. Changes will take effect once you reload the page.
Google Webfont Settings:
Google Map Settings:
Vimeo and Youtube video embeds: