Mad Hedge Biotech & Healthcare Letter
August 12, 2021
Fiat Lux
FEATURED TRADE:
(THE FUTURE OF REGENERATIVE MEDICINE)
(CRSP), (EDIT), (BLUE), (PFE), (AZN), (GSK), (TAK), (REGN)
As our bodies begin to show signs of aging and fatigue, exploring ways to regenerate our organs has become crucial in ensuring a hale and hearty lifespan.
This demand has given rise to a branch of biotechnology and healthcare, which could very well be on the brink of becoming the next big thing in the mainstream biopharmaceutical industry: regenerative medicine.
For example, experts at Gladstone Institutes is applying gene therapy to repair heart damage. Basically, their goal is to reprogram scar tissue and transform it into a new heart cell.
What they do is inject the genes into the damaged heart caused by a heart attack. Then, these “new” genes alter the scar cells, converting them into beating hearts.
This approach no longer demands any cloning to obtain an extra set of organs. The Gladstone Institutes’ use of gene therapy allows us to regrow our own set of organs right inside our bodies.
And in case you’re wondering whether this type of work actually has a future or just another trend that would quietly disappear in the future, I’m telling you that this industry has incredibly potential.
Just look at the $12 billion valuation of a biotechnology unicorn called Samumed in San Diego.
Founded in 2008, this company has spent most of its lifetime operating under the radar. It impressively came out of the shadows last 2016 and was quickly dubbed as an “anti-aging” company.
To them, though, they’re a “de-aging” company. That is, they believe that people should be brought back to their peak health conditions before they can even begin to restore youth.
This ideology is exhibited by the company’s lead program: a knee osteoarthritis cure called Lorecivivint.
As we know, osteoarthritis has no known treatment that works to reverse the damage to the joint.
That’s why the doctors focus on handling or managing the symptoms. They tell their patients to exercise and lose weight to boost muscle strength and decrease the burden on their joints.
They also prescribe various drugs like painkillers, some anti-inflammatory pills, and even cortisone shots. Other patients would eventually need to go through replacement surgery.
This is where Samumed comes in.
The company created Lorecivivint to repair the joint damage. That way, patients will no longer need to go through all the burden of managing the symptoms of knee osteoarthritis.
In their proof-of-concept report, Samumed shared that one year after getting injected with Lorecivivint, the X-rays of the knees of the patients showed that there was an increase in “medial compartment joint space width.”
In simpler terms, the knees grew cartilage after a single shot of Lorecivivint.
Other than working on a cure for knee osteoarthritis, Samumed is also looking into treating male pattern baldness.
Another impressive biotechnology company focused on regenerative medicine is Humacyte, which recently shifted from being a clinical-stage firm to a commercial one.
Humacyte’s core work is on Human Acellular Vessels (HAVs) or “implantable regenerative human tissue.”
A use case for this is when a patient has damaged blood vessels. Typically, there are three options to treat this: take a vessel from another part of the body, try to implant a donated vessel, or utilize a plastic tube.
The first one requires at least two surgeries and, of course, losing a vessel in another part of your body.
Meanwhile, the second and third options expose the patient to the possibility of an infection or the body rejecting the vessel or plastic tube.
Humacyte’s HAVs offer a fourth option.
Since the HAVs carry similar properties as the native tissues of the patient’s body, they significantly lower the risk of rejection.
Basically, they’re “growing” HAVs that won’t be rejected by the body.
More importantly, the company is creating engineered off-the-shelf replacement tissue that can be implanted to anyone without using immunosuppressive drugs.
This is impressive because immunosuppressants are staples in ensuring that the body does not reject the organs. However, the use of this can be dangerous because it increases the risk of infections.
So far, Humacyte has been working on coming up with safer and more effective treatments for hemodialysis patients since the current methods tend to expose them to higher risks of infections.
If everything goes according to plan, then the company will be able to file for FDA approval by 2022.
While the technologies offered in the regenerative medicine space have been discussed and even praised for years, it’s only recently that these became commercially viable.
For all the noise and hype surrounding these breakthrough and next-generation treatments, only a handful of patients have actually benefited from them.
However, 2021 might just mark the year that all these will change.
Other than the private firms and smaller biotechnology companies like CRISPR Therapeutics (CRSP), Editas Medicine (EDIT), and bluebird Bio (BLUE), bigger names in the biopharmaceutical space, including Pfizer (PFE), AstraZeneca (AZN), GlaxoSmithKline (GSK), Takeda Pharmaceuticals (TAK), and Regeneron (REGN), are also starting to invest more aggressively into it.
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
August 5, 2021
Fiat Lux
FEATURED TRADE:
(LET THE BIOTECH BUYOUTS BEGIN)
(TBIO), (SNY), (MRNA), (PFE), (BNTX), (ARCT), (GSK), (JNJ), (MRK), (BLUE), (CVAC)
One of my predictions for this year just came true: the biotechnology buyouts have begun.
In my letter last January, I forecasted that the growing popularity of the mRNA technology courtesy of the COVID-19 vaccines from Moderna (MRNA) and Pfizer (PFE / BioNTech (BNTX) would trigger acquisitions of smaller biotechnology companies this year.
I predicted that bigger players in the healthcare industry would scoop up smaller players to stake a claim in this quickly growing space.
Topping our list of buyout candidates is Translate Bio (TBIO)—the very same company hogging headlines in the past days following its $3.2 billion acquisition by Sanofi (SNY).
The all-cash deal values each TBIO share at $38, representing a premium of over 30% above the stock’s price. If all goes well, the deal should be completed by the third quarter of 2021.
This is one of the first major moves by Sanofi following the healthcare giant’s recent pivot into vaccines.
However, this isn’t the first time Sanofi and TBIO worked together.
The two companies have actually started collaborating back in 2018, working on a potential mRNA-based flu vaccine—a project that has Sanofi and TBIO ahead of the pack, with BioNTech and Arcturus Therapeutics Inc. (ARCT) trailing behind.
Sanofi and TBIO’s mRNA seasonal flu vaccine candidate is expected to commence with Phase 1 results expected to be out by the fourth quarter of this year.
Considering that Sanofi is one of the leading vaccine makers in the world with roughly $3 billion in sales in flu vaccines alone in 2020, it won’t come as a surprise if their candidate breezes through the trials.
Even prior to this acquisition, Translate Bio has been working on using its mRNA platform to develop vaccines and treatments for a broad range of diseases like liver and pulmonary ailments.
So far, its novel pipeline has 2 clinical-stage programs along with 7 pre-clinical work covering direct therapeutics and vaccines.
One of its lead candidates is MRT5005, which is an mRNA-based therapy for cystic fibrosis (CF).
This is a groundbreaking treatment because it takes advantage of mRNA’s capability to deliver proteins to lung cells. It’s also extremely non-invasive, as patients can simply inhale the mRNA drug into their bodies.
Other than helping with the treatment of CF, this inhalation delivery system can also open avenues for other pulmonary targets.
Most importantly, TBIO’s MRT5005 doesn’t only offer treatments. It actually is a cure for CF.
TBIO’s work on CF treatment is extremely important. This disease is terrible, recording a median age of death among patients in the US as 30.6 years old. In this country alone, over 30,000 people suffer from the condition, and more than 70,000 are recorded worldwide—and the numbers continue to climb each year.
In terms of the CF market, the global demand for treatments for this disease is expected to reach $16.3 billion by 2026, hitting roughly 16.8% in CAGR over the years.
With the acquisition of Translate Bio, Sanofi plows ahead of its competitors in the space, including Pfizer, GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), and Merck (MRK), as the sole Big Pharma company with a wholly-owned in-house mRNA platform.
This is on top of Sanofi’s recent $470 buyout of another mRNA company, Tidal Therapeutics, to bolster its immuno-oncology and inflammatory diseases segments.
Apart from its aggressive buyout strategy, Sanofi also announced its plan to allocate roughly $476 million annually to a “vaccines mRNA Center of Excellence” with the goal of queuing at least six mRNA-based candidates in clinical trials by 2025.
Allotting $476 million to this plan is a telling move on the company’s future direction, as it comprises a substantial fraction of Sanofi’s $6.5 billion overall R&D budget.
These moves strongly signal that Sanofi’s going all-in on the mRNA platform, which could obviously pose a challenge to the likes of Moderna and, of course, BioNTech.
With smaller cap companies like bluebird Bio (BLUE) and CureVac (CVAC) still up for grabs, it’s only a matter of time before another big company decides to follow suit.
Mad Hedge Biotech & Healthcare Letter
August 3, 2021
Fiat Lux
FEATURED TRADE:
(SHAKING UP THE BIOTECHNOLOGY AND HEALTHCARE INDUSTRY)
(PSTX), (PFE), (NVS), (GILD), (GSK), (BLUE), (CRSP), (EDIT)
With the advancement of biotechnology and healthcare, it’s not hard to imagine a future where drugs and therapies will be tailored to every person’s unique genetic profile.
Thanks to the continuous work on mass customization in the world of pharmaceuticals and even in whole genome sequencing, it’s only a matter of time before we can come up with a personalized pill for each popper.
Nowadays, robotics and automation have started to become tightly integrated with the medical arena. In fact, robotics in the field of pharmaceuticals is no longer anything novel.
The majority of drug manufacturers across the globe are already utilizing robots to address their needs, such as packaging and warehouse storage.
What interests me most, though, is how automation plays an active role in developing actual therapies. After all, doing this entails so much more than simply feeding codes to robots to teach them how to move test tubes around a lab.
One company that has been gaining traction in this space is Multiply Labs. Established in 2016 with roughly $22 million in funding thus far, this San Francisco company aims to be a force multiplier not only in creating personalized pills but also cell therapies.
Run by mostly MIT graduates, Multiply Labs started out by letting their robots take 24-hour shifts to quickly deliver biologic drugs needed for clinical trials.
That offers tremendously faster turnaround times and shorter waiting periods for researchers and pharmaceutical companies.
Since virtually perfecting that process, the company has decided to expand its focus to handle more challenging and complex work.
Now, it has set its sights on using its robotics platform to ease bottlenecks in the development of cell therapies.
As we know, cell therapies are regarded as powerful tools in the battle against cancer. However, the production process is extremely labor-intensive. This makes their development incredibly expensive.
Let’s take CAR-T cell therapy, which boosts the body’s immune system to help it fight off cancer, as an example.
In CAR-T cell therapy, scientists need to extract blood from the patient. Then they’d have to isolate the immune cells, which they would need to genetically engineer.
After that, they have to carefully grow the new cells. Finally, they’d inject these genetically engineered new cells back into the patient.
In most cases, every step needs to be repeated for individual patients.
What Multiply Labs is trying to do is automate several stages, such as genetically altering the harvested cells, which can only be performed by highly trained professionals.
Not only will they be able to cut down on the time needed to complete the procedures, they would also be able to reduce—if not completely eliminate—human error.
Aside from working with the University of California San Francisco, Multiply Labs has been collaborating with Cytiva, a subsidiary of Dannaher (DHR), to move their services closer to commercialization.
Apart from Multiply Labs, another San Francisco company has been working on improving the expensive, logistically complicated, and oftentimes error-filled cell therapy space: Cellares.
Unlike Multiply Labs, which aims to ease the bottleneck in the cell therapy creation process, Cellares’ goal is to handle the entire procedure on its own.
Dubbing its work as the “Cell Shuttle,” what Cellares offers is basically a “factory in a box” solution to the creators of cell therapies.
Basically, the “Cell Shuttle” is an end-to-end solution that comes in the form of a box designed to deliver an automated cell therapy platform. Cellares’ product handles everything from beginning to end, starting from taking in the cells of the patient to injecting the genetically engineered versions back into the individual.
Raking in roughly $100 million in funding so far, Cellares’ plan is to allow the pharmaceutical companies to scale and deploy the “Cell Shuttle” based on their needs.
To date, Cellares’ latest collaborator in this venture is Poseida Therapeutics (PSTX).
However, there are thousands of cell-based and cell therapy clinical studies conducted across the globe. The cell and gene therapy (CGT) sector is projected to be one of the fastest-growing markets in the healthcare sector, with the segment estimated to reach $14 billion by 2025.
Moreover, CGT offers promising treatments for severe and chronic conditions like obesity, diabetes, and, of course, cancer. It can also be the answer to rare genetic conditions and their related complications.
That’s why it comes as no surprise that Big Pharma names like Pfizer (PFE), Novartis (NVS), Gilead Sciences (GILD), and GlaxoSmithKline (GSK) are taking interest in this niche.
However, the progress of smaller companies, such as bluebird Bio (BLUE), CRISPR Therapeutics (CRSP), and Editas Medicine (EDIT), also offers incredible potential in this space.
And while Poseida Therapeutics may be the first to collaborate with the likes of Cellares and Multiply Labs, the rest would undoubtedly follow suit in integrating robotics and healthcare in the near future.
Mad Hedge Biotech & Healthcare Letter
July 29, 2021
Fiat Lux
FEATURED TRADE:
(A BIOTECH PREPARED FOR ANOTHER DOOMSDAY MARKET)
(BNTX), (PFE), (MRNA), (AZN), (JNJ), (GSK), (GILD)
If you’ve heard of Harry Dent Jr., then you know that he’s the economist who correctly and accurately forecasted the Japanese economic downturn back in 1989. He also hit the nail on the head when he predicted the collapse of the dot.com bubble in 2000.
Now, he’s saying that the stock market will crash in the next three months, describing it as “the biggest crash of our lifetime.”
There’s no precise method to determine if his pessimistic outlook is justified thus far.
Nonetheless, even if Dent turns out to be right, I don’t believe that all stocks will plummet. There are a handful of stocks that could soar if the stock market does crash this summer.
For instance, I think vaccine stocks would most likely take off if the new variants of COVID-19 triggered a market crash in the coming months.
After all, the best weapons we have in overcoming these issues are still vaccines.
I also think that one of the biggest—if not the biggest—winners in this segment is BioNTech (BNTX).
Let me share with you the reasons.
For one, BioNTech is actually the smallest of the biopharmaceutical companies in the vaccine market today.
Catalysts typically generate larger swings in stocks that hold smaller market capitalizations compared to those with bigger market caps.
It’s also telling that BioNTech and its co-vaccine developer, Pfizer (PFE), have started delving into tactics to handle the continuous rise of the Delta variant.
So far, what the partners have suggested includes adding a third dose to the COVID-19 vaccine to boost the immunity and protection of people against the new strain.
The two are also looking into beginning their clinical testing on a modified version of their vaccine, which would specifically target the Delta variant, by August.
BioNTech’s valuation also plays a key role. The company so far is the cheapest among the leading vaccine stocks, which include Moderna (MRNA) and AstraZeneca (AZN), based on its forward earnings multiples.
To date, BioNTech trades at roughly 6.3 times its expected earnings—a low valuation that wouldn’t last long, especially if fears about the new variants spark another massive downturn in the market.
Thus far, BioNTech and Pfizer have delivered roughly 392 million vaccine doses to the US alone.
However, the country is anticipating increasing demand for it, pushing it to sign up for an additional 200 million doses.
The duo plans to deliver 110 million doses to the US by the end of 2021 and the rest of the orders by April 2022.
In a separate agreement, the US also ordered 500 million doses as donations to developing countries across the globe.
In comparison, Moderna delivered 137.3 million, while Johnson and Johnson (JNJ) supplied 13.1 million.
On top of these, Pfizer and BioNTech are working to expand the reach of their vaccine.
The companies recently sealed an agreement with Biovac, a company in South Africa, to produce vaccine shots from a plant in Cape Town. Similar initiatives are under exploration in Latin America.
Riding the momentum of its COVID-19 vaccine, BioNTech is also working to develop a highly effective and widely tolerated malaria vaccine.
The malaria vaccine candidate is expected to build on two decades’ worth of mRNA research, which BioNTech used to co-develop the COVID-19 vaccine with Pfizer.
The clinical trial for this new project is planned to start by the end of 2022.
At this point, only one malaria vaccine is available on the market: GlaxoSmithKline’s (GSK) Mosquirix, which offers about 30% effectiveness in safeguarding kids from the mosquito-borne virus.
If successful, BioNTech will be easing a massive burden globally, as over 400,000 children die from malaria every year.
In addition to its malaria vaccine candidate, BioNTech is also looking into using its mRNA expertise to diversify its pipeline to include cancer treatments, including colorectal cancer, advanced melanoma, and other malignant solid tumors.
BioNTech’s move to attempt to conquer the oncology sector gained even more traction following its recent acquisition of Kite, a manufacturing plant under Gilead Sciences (GILD).
Kite primarily focuses on an experimental kind of cancer treatment relating to neoantigen T-cell receptor cell therapy.
In the first quarter of 2021, BioNTech was able to boost its sales by over 7,295%.
Its total revenues within that period reached $2.49 billion, which indicates a healthier revenue stream compared to its main competitor, Moderna, which raked in $1.9 billion.
In terms of sales outlook for the entire year, BioNTech also forges ahead with $26 billion, while Moderna anticipates $19.2 billion.
Needless to say, these numbers show how undervalued BioNTech has been lately.
Given the new developments concerning the new variants and the company’s expanded coverage of the market, it’s clear to see that the future looks bright for BioNTech regardless of Dent’s doomsday market predictions.
