Mad Hedge Biotech and Healthcare Letter
January 13, 2022
Fiat Lux
Featured Trade:
(NO REST FOR THIS PANDEMIC SUPERSTAR)
(PFE), (MRK), (RHHBY), (DNAY), (JNJ), (LLY), (BNTX), (EDIT)
Mad Hedge Biotech and Healthcare Letter
January 13, 2022
Fiat Lux
Featured Trade:
(NO REST FOR THIS PANDEMIC SUPERSTAR)
(PFE), (MRK), (RHHBY), (DNAY), (JNJ), (LLY), (BNTX), (EDIT)
Amid the pandemic fatigue hounding everyone these days, one name continues to attack the situation with consistent vigor: Pfizer (PFE).
It’s not a stretch to say that its COVID franchise is the most popular line in Pfizer’s portfolio today.
Needless to say, this is highly lucrative from a shareholder’s point of view. The company’s vaccination business has recorded over 3 billion doses to generate roughly $36 billion in sales from Comirnaty alone in 2021.
Riding the momentum of its successful 2021, the company anticipates an even more successful 2022.
So far, Pfizer is targeting an increase in its Comirnaty production to hit at least 4 billion doses this year.
Aside from being one of the first companies to develop a vaccine, the company has also created a highly effective antiviral COVID treatment that can be taken orally: Paxlovid.
While Merck (MRK) has earlier announced its move to come up with a similar oral treatment, Pfizer’s pill proved to be more effective.
Actually, customers are starting to take note of the difference and are switching brands. France already canceled their agreement with Merck and decided to order Pfizer’s Paxlovid instead.
This once again underscored the dominance of Pfizer’s brilliant R&D segment and the company’s capacity to rapidly come up with highly effective solutions for issues involving COVID.
The way Pfizer has been handling the COVID situation can be compared to Roche’s (RHHBY) approach and eventual blockbuster success with Tamiflu over 20 years ago.
Although the flu is obviously not as deadly as the coronavirus, it still caused widespread economic breakdown and health problems.
When Tamiflu eventually entered the market, the world was finally granted a simple medical answer for what was initially thought to be an unsolvable health problem.
Pfizer’s Paxlovid could very well be the Tamiflu for COVID.
Looking at Paxlovid’s effect in terms of revenue, it’s safe to say that this oral treatment can drive medium-term growth for Pfizer.
To date, Pfizer disclosed that Paxlovid would be sold for roughly $700 for each treatment course.
Let’s use the US numbers as an example to help put things in perspective. So far, the country has recorded approximately 170,000 cases per day.
If we assume that this will be the average for 2022, then there will be about 62 million COVID patients this year.
Let’s say that only 40% of these patients qualify for Pfizer’s treatment; then this would reach 24 million people at $700 each to rake in roughly $17 billion in total revenue in the US alone.
The number would definitely be significantly higher considering that Paxlovid will be offered as a global COVID treatment.
It’s evident that Pfizer’s efforts are paying off, as the sheer earnings power of the company’s COVID-19 pandemic franchise could provide a medium-term boon for its investors.
In 2021, Pfizer recorded a 130% growth in its revenue, with the numbers still climbing.
While its pandemic response has become its primary growth driver, Pfizer’s other key segments also posted promising revenues.
To sustain its climb, the company has continued to invest in R&D heavily.
A notable investment it made recently is an $8 million upfront payment to Codex DNA (DNAY) for the smaller biotechnology company to “produce certain materials of interest to Pfizer.”
According to the deal involving the exclusive product, Codex expects $10 million in technical milestone payments, up to $60 million in clinical development milestones, and $180 million in sales milestones.
Codex DNA is a small biotechnology company with a market capitalization of $267 million. It’s a spinoff from a California company called Synthetic Genomics.
While Pfizer and Codex have yet to share their plans publicly, we can hypothesize that it has something to do with the large biopharma using the small biotech’s technology to accelerate its mRNA vaccine development process.
After all, Codex’s distinct value proposition lies in its rare ability to automate various elements of the entire process. Its push-button, end-to-end solutions promise to build functional grade synthetic mRNA and DNA.
In effect, this will save cost and time for its clients.
Aside from Pfizer, this small biotech has been collaborating with other organizations like Duke University and MIT.
It has also been working with large biopharmas, including Johnson & Johnson (JNJ), Eli Lilly (LLY), BioNTech (BNTX), Merck, and even gene therapy expert Editas (EDIT).
For 2022, Pfizer is anticipated to generate at least $96 billion in sales, showing off a jaw-dropping 17.2% jump from its 2021 revenue and a 229% increase from 2020.
As we slowly accept that COVID will become a staple in our lives in the coming years, I think investors would be wise to add proven “experts” in their portfolio to take advantage of the ever-present and increasing demand.
Mad Hedge Biotech and Healthcare Letter
January 4, 2022
Fiat Lux
Featured Trade:
(A BIOTECH DIAMOND IN THE ROUGH)
(BDSI), (TEVA)
Small-cap names tend to have a terrible reputation. However, the possibility of discovering a diamond in the rough pulls traders back in the game over and over.
Fortunately, applying a bit of critical thinking in sifting through the seemingly endless lists of small-cap companies can yield a handful of names worth consideration.
In the biotechnology and healthcare sector, one name that holds the potential is BioDelivery Sciences International (BDSI).
While it’s understandable if you’ve never even heard of BDSI, this company has actually been making waves in the field of severe pain management.
To date, it has three drugs out in the market and holds the patent for a slow-release biofilm technology used to administer these medications. Simply, BDSI is proving to be a profitable and fast-growing company.
The company’s main product is Belbuca, an opioid medication targeting chronic severe pain.
The competitive edge of Belbuca against other drugs is that it’s not an oral pill. Instead, it’s a tiny film that patients keep in their cheeks. This film then slowly dissolves, offering more potent pain relief over time.
Moreover, Belbuca is more difficult to abuse, making it a more attractive option for physicians to prescribe.
At the moment, Belbuca has a 4.7% market share of the long-acting opioid treatment segment.
While that sounds like an unimpressive number, this achievement becomes more pronounced when you find out that Belbuca only held 0.5% of the market when it launched in the fourth quarter of 2017.
By the first quarter of 2021, its market share expanded by 25% year over year, indicating that segment penetration is moving forward swimmingly despite the pandemic.
In fact, Belbuca’s revenues increased by over 95% in the last 3 years.
It also reported that its trailing-12-month earnings since the first quarter of 2020 have skyrocketed to a jaw-dropping 233%.
More excitingly, BDSI successfully defended its patent exclusivity against competitors.
Recently, it managed to ward off attempts from more prominent names like Teva Pharmaceuticals (TEVA), which hoped to gain access to BDSI’s slow-release biofilm technology.
Bolstering its hold on the pain management market, BDSI has also been successful in marketing Symproic.
This prescription medication, which targets opioid-induced constipation therapies, has seen a steady rise in market share over the past 2 years.
By the first quarter of 2021, Symproic has managed to take hold of 12.6% market share, making it a promising partner to the company’s major growth driver, Belbuca.
Highly aware of the growing competition in the opioid market, BDSI has decided to venture into other segments as well.
In September 2021, the company acquired the rights to acute migraine pain medication Elyxyb for $15 million.
Elyxyb is the first-ever FDA-approved, ready-to-use oral drug aimed to treat acute migraine. In terms of peak sales, BDSI is projected to rake in $350 million to $400 million from this acquisition.
BDSI plans to launch its own take on Elyxyb by the first quarter of 2022, with the goal of adding another catalyst in its growth story and a new revenue stream.
Looking at its history and trajectory, it’s evident that things are heading towards a bright future with BDSI.
This small-cap company managed to sustain the expansion of its market share and boost its sales growth despite the pandemic and the patent challenges from bigger rivals.
Moreover, its balance sheet looks solid. Its margins and cash flow have been exhibiting notable improvements as well.
Simply, there remains no identifiable business concern that might cause it to tumble in the future.
Overall, BDSI’s long-term risk-reward outlook still appears to be attractive regardless of the market’s less-than-stellar reaction to the stock in 2021.
Needless to say, BDSI’s remarkable performance hasn’t been convincing enough for investors to believe that the stock is worth their money.
That turns this promising $315.16 million market cap biotechnology company into an exciting opportunity for deep-value investors searching for diamonds in the rough and an astoundingly cheap growth play.
Mad Hedge Biotech and Healthcare Letter
December 30, 2021
Fiat Lux
Featured Trade:
(“WHOLE-PERSON CARE” IS THE FUTURE OF HEALTHCARE)
(TDOC), (PFE), (BNTX), (MRNA)
Alongside the likes of Pfizer (PFE), BioNTech (BNTX), and Moderna (MRNA), another name stood out during the pandemic: Teladoc (TDOC).
This telehealth company was one of the biggest breakout stars amid the worst periods of the COVID-19 pandemic, with its shares skyrocketing 138%—a feat sustained throughout 2020.
However, Teladoc’s narrative faltered in 2021.
The change wasn’t in terms of the company’s financial future. If anything, the company had been consistent in recording increasing revenues and visits. Teladoc actually even boosted its earnings guidance this year.
Despite all these, the stock fell by roughly 50%.
Looking at the reasons for this baffling fall, it became evident that investors started to fret over the gradual reopening of the economy and the return of people to offices.
They believed that these would result in patients abandoning virtual health consultations and opting to go back to their doctor’s clinics.
As far as we can see, though, that has not happened yet.
Moreover, the recent events and predictions about the future all but guarantee that these fears are baseless. Now, this raises the question of whether or not Teladoc is set to rebound in 2022.
It’s sort of obvious that the company has been moving alongside the COVID-19 headlines, but this doesn’t necessarily mean that Teladoc’s long-term plans depend heavily on the pandemic.
The vital thing we need to understand is that telehealth is here to stay. The pandemic merely accelerated the adoption of this groundbreaking technology.
There’s actually a widespread misunderstanding of Teladoc’s goal over the long term. Some investors seem to assume that the company aims to replace physical healthcare services.
This is extremely far from the truth.
What Teladoc wants to do is simply provide a complementary platform for the physical system.
That is, the company aims to virtualize all the things that can be virtualized and serve as the front door to the actual physical care.
Doing so will offer a more convenient option for patients and for the entire healthcare industry because this new and improved system can generate savings and better allocate resources in one of the most woefully managed and inefficient sectors across the globe.
Our current traditional healthcare system is extremely fragmented. Patients visit an average of 19 doctors in their lifetime, and every new doctor typically necessitates a new practice, a new professional relationship, and another set of medical records.
To get rid of the stress, prevent “wasting time” in waiting rooms, and sometimes receive unsatisfying experiences, which can even lead to unresolved or undetected health issues, Teladoc has come up with a comprehensive system.
It built Primary360, which it dubbed as the “whole-person care” platform.
The idea behind “whole-person care” is to bring all the services, including mental health, primary healthcare, and even treatments for chronic conditions, in one virtual package. This can then be easily accessed via the patient’s phone.
Teladoc integrates data and analytics to develop personalized healthcare experiences for its users, which became even more accurate and comprehensive thanks to its $18.5 billion acquisition of Livongo.
Another advantage in acquiring Livongo is its ability to work with AI.
Virtual care has the ability to offer more proactive solutions as opposed to reactive treatments.
Having a massive set of data, Teladoc can provide proactive measures to manage or prevent symptoms instead of mitigating them when they manifest.
After all, what would patients want more?
Their doctors informing them that they have a high risk of a heart attack in the following month if they fail to receive treatment or wait until it actually happens?
Wearables, such as smartwatches and Oura rings, can send data to Teladoc, which can then be used to prevent these kinds of health crises from arising.
Aside from Livongo, Teladoc has also acquired BetterHelp in 2015 for $4.5 million to form part of its “whole-person care” platform.
This acquisition, which has been on track to rake in $100 million in revenue in 2021, is geared towards mental health services.
Teladoc’s earnings reports in 2021 have been reassuring. In the third quarter, for instance, the company’s revenue skyrocketed 81% while patient visits rose 37% to reach over 3.9 million.
Meanwhile, the company estimates the “whole-person care” to be worth roughly $75 billion within its current client base.
Moreover, the National Labor Alliance of Health Care Coalitions, the largest organization of labor groups, announced that it will make Teladoc’s complete set of services available to all its members.
For context, these members pay for the health services of over 6 million individuals.
Going back to the question of whether Teladoc shares will bounce back in 2022, I think it’s clear that it can easily recover given its current trajectory.
In 2020, the telehealth industry was valued at $62.45 billion. By 2030, the telemedicine segment worldwide is projected to reach more than $431 billion.
Meanwhile, the compound annual growth rate (CAGR) from 2021 until 2030 is estimated to be at 26%.
Given Teladoc’s pioneering status, the company may even surpass the expectations from the industry. At a target 2022 revenue of $2.6 billion and $4 billion by 2024, the company’s projected CAGR is at 25% to 30% in the next three years.
Undeniably, Teladoc has fallen out of favor this year. However, the company is far from underperforming.
In fact, it has been doing an excellent job at sticking to its long-term objectives.
Looking at its low valuation at the moment, Teladoc holds the potential to become a highly rewarding venture for long-term investors who are capable of focusing on the fundamentals instead of the short-term noise.
Mad Hedge Biotech and Healthcare Letter
December 28, 2021
Fiat Lux
Featured Trade:
(ANOTHER VICTIM OF OVERBLOWN FEARS)
(BMY), (PFE), (BNTX), (MRNA), (MRK)
Inflation is one of the primary concerns of investors these days, and rightly so.
Just last month, the consumer price index (CPI) climbed at an astonishing 6.8% year over year — the highest increase ever recorded in almost four decades.
In response, many investors have decided to focus their attention on stocks that protect their portfolios from inflationary pressures.
While some are looking at cryptocurrencies and, of course, gold as their preferred hedges against inflation, I don’t think it’s wise to ignore dividend stocks.
History dictates that stocks that offer above-average dividend yields have been known to surpass expectations during the difficult periods of high inflation.
An excellent example of this is Bristol Myers Squibb (BMY).
BMY is one of the biggest names in the healthcare sector, with a market capitalization of over $125 billion.
Unfortunately, BMY’s shares have experienced a 9% fall in 2021 to date.
The company has also been underperforming compared to the broad market, which went up by more than 20% during the same period.
While this is unfavorable for investors who bought BMY in 2020, the current situation offers an attractive entry point for those looking to inject new money here.
Looking at the reasons for BMY’s relatively weak performance, one key point to consider is that the company is a major player in an industry that is not particularly sought after at the moment.
This year, most investors poured money on stocks that would benefit firsthand from the reopening efforts of the economy.
Consequently, the dependable, non-cyclical healthcare and biotechnology sectors have been generally disregarded—barring the COVID-19 vaccine stocks like Pfizer (PFE), BioNTech (BNTX), and Moderna (MRNA).
Apart from that, some company-specific issues plagued BMY as it faces impending patent expirations on a few key products in the following years.
Oral cancer drug Revlimid, which generated $12.1 billion in 2020, is expected to face patent loss by 2025.
Meanwhile, blood clot treatment Eliquis, which raked in $9.2 billion last year, will be dealing with the same issue by 2027.
This will be followed by lung cancer medication Opdivo, which recorded $7 billion in sales, in 2028.
Taken together, these key drugs generate roughly $28 billion in annual revenue, which comprises more than half of the company’s $46 billion revenue per year.
While this can be a cause of concern, it doesn’t necessarily mean that these products will generate zero revenues for the company when their patents expire.
In fact, a previous study revealed that top-selling drugs typically lose about 50% of their sales in the 5 years after their patent expiration.
That means that BMY can still expect well above $10 billion each year from these three key drugs through the 2020s.
Moreover, worries over the patent expirations appear to be overblown, considering that these will happen several years from now. Considering that BMY has an extensive list of growth assets and a robust pipeline, I think this situation has been more than accounted for.
The fear of patent expirations is well-founded, though. If companies fail to navigate a patent cliff, it can have serious ramifications for a company
However, a company that’s well-diversified and wisely invests in lucrative growth assets in advance of these impending patent expirations—even the losses of exclusivity of top-selling drugs—can handle the situation easily.
So far, BMY has shown three clear ways in terms of handling patent losses. One is expanding the indications of their newer drugs. Another is launching new products to the market. The third is acquiring new assets through beneficial deals.
The first cluster of drugs that BMY has brought to market and is growing rapidly includes anemia medication Reblozyl, which recorded an impressive 67% increase in its revenue in the third quarter of 2021
This translated to $160 million, or over $600 million in annual sales.
Recently, the FDA has accepted BMY’s collaboration with Merck (MRK) to use Reblozyl as part of the treatment for beta-thalassemia. The approval for this work is anticipated to be released by the second quarter of 2022.
Following this growth rate, it wouldn’t be a surprise to discover in the future that Reblozyl has transformed into a blockbuster drug with yearly sales reaching over $1 billion.
Another potential blockbuster is multiple sclerosis treatment Zeposia, which has boosted its sales 20x since 2020.
While it started from a low base of $2 million, this drug has the ability to reach peak sales of $5 billion annually.
Aside from these, BMY has a deep pipeline filled with drugs holding blockbuster potential in the coming years.
Meanwhile, BMY just hiked its dividend by 10%, pushing its dividend yield to 3.5%—easily doubling what investors can receive from the broad market, with the S&P yielding 1.3%.
In terms of its acquisitions, BMY has been on a buying spree lately. The most massive deal following its $75 billion acquisition of Cologne is its $13 billion deal with MyoKardia.
Simply put, BMY is cheap. At current prices, this healthcare company is trading at only 7.5x this year’s earnings, while the estimates for 2022 look to be even lower.
However, BMY is an impressive company with a remarkable portfolio of assets.
Moreover, the impending patent losses of its top-performing drugs have already been dealt with thanks to the company's solid revenue replacement strategy.
Hence, this issue should no longer sound any alarm bells.
Overall, BMY is an attractive option for the long-term and buy-and-hold type of investors, particularly those aiming for a sizable and steadily growing dividend stream.
Mad Hedge Biotech and Healthcare Letter
December 21, 2021
Fiat Lux
Featured Trade:
(A BREAKOUT BIOTECH WITH A STRONG STAYING POWER)
(MRNA), (PFE), (BNTX), (MRK), (AZN), (VRTX), (CRSP), (GILD)
The biotechnology and healthcare sector has been ruthlessly hammered in 2021.
In fact, the largest exchange-traded funds that keep track of the biotechnology industry have been in the negative in the past months.
However, the string of bad news doesn’t automatically mean that none of the biotechs can deliver strong returns in the coming days.
An excellent example of a biotech that’s an exception to the general theme of the sector these days is none other than the famous Moderna (MRNA).
Moderna stock has already delivered a 434% gain in 2020. Meanwhile, it has so far recorded a 160% rise this year—a number that’s expected to go higher before 2021 ends.
These gains came after the biotech became one of the market leaders in the COVID-19 vaccine race, alongside Pfizer (PFE) and BioNTech (BNTX).
Considering how COVID-19 catapulted the stock to dizzying heights, some investors fear that Moderna’s performance will decline in a post-pandemic setting.
That’s not necessarily the case.
Viruses present complex problems. Right now, we’re dealing with yet another coronavirus variant, Omicron.
This latest strain appears to be more contagious than the previously discovered Delta variant, which was then reported to be more virulent than the original.
What’s the takeaway here?
COVID-19 isn’t going to disappear anytime soon. Since the vaccines and boosters seem to wane gradually, these are expected to become staples moving forward.
This means everyone will need ongoing protection, which translates to ongoing sales for vaccines and boosters for companies like Moderna.
Moreover, the continuous demand for new and more potent vaccines makes it a no-brainer that Moderna will once again deliver market-crushing performances in the next few years.
For context, the company estimates that Spikevax, its COVID-19 vaccine, will rake in roughly $15 billion to $18 billion in sales in 2021.
Orders for 2022 have been secured as well, with Moderna already locked in for over $22 billion worth of Spikevax doses through advance purchase deals.
This is still expected to rise, considering the vaccines under development for the new variants getting discovered.
But even when the panic and anxiety over the viruses subside, we can still reasonably expect roughly $15 billion in annual sales from Spikevax
After all, the vaccine and boosters are expected to become the norm eventually.
Believe it or not, though, the best reason to buy Moderna isn’t its coronavirus vaccine.
Outside Spikevax, Moderna has a long list of promising pipeline candidates under development—the majority of which are based on the mRNA technology that’s behind its potent COVID vaccine.
While that does not guarantee that all the candidates will gain approval, the fact that the technology has been proven to work on humans presents a bright future for these candidates.
The company has been actively advancing its programs using its cash on hand, with over half a dozen queued in Phase 2 trials.
A potential blockbuster is its cytomegalovirus (CMV) vaccine candidate.
CMV, a virus that can be deadly to unborn babies and individuals with compromised immune systems, currently has no vaccine.
This represents an untapped market with high demand. Conservatively speaking, Moderna can generate roughly $2 billion to $5 billion in peak sales for this vaccine if it gains regulatory approval.
Other impressive programs in the biotech’s pipeline are its HIV vaccine candidate and a personalized cancer vaccine, which Moderna has been developing with Merck (MRK).
Needless to say, both hold the potential to become game-changers not only for Moderna but also for the entire industry.
Aside from its personalized cancer vaccine, another relatively advanced program in its pipeline is its work with AstraZeneca (AZN) on the AZD8601 program.
The AZD8601 program aims to use mRNA therapies to encode for vascular endothelial growth factor-A in people who are supposed to go through a coronary artery bypass grafting.
In layman’s terms, AstraZeneca and Moderna want to develop a treatment that induces the heart blood vessels of heart bypass surgery patients to repair themselves.
However, the most exciting collaboration is Moderna’s work with Vertex (VRTX) to develop a cystic fibrosis (CF) treatment.
Considering that Vertex is practically a monopoly in the CF space, this can turn out to be a lucrative direction for Moderna as well.
In terms of competition, the biotech might go head-to-head against Vertex’s other partner, CRISPR Therapeutics (CRSP).
Until two years ago, Moderna was an obscure biotechnology company with no product out on the market.
Today, it is hailed as one of the biggest biotechs worldwide thanks to its market capitalization of roughly $120 billion, surpassing long-established names in the sectors like Gilead Sciences (GILD) and even Vertex.
Some investors point out that Moderna’s breakneck rise to the top might also mean a steady descent.
While I agree that its climb was faster than the usual biotech, I still believe that Moderna possesses the right tools to sustain its momentum for the years to come.
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