Mad Hedge Biotech and Healthcare Letter
July 28, 2022
Fiat Lux
Featured Trade:
(IS THIS THE NEXT MODERNA?)
(BVNRY), (SIGA), (EBS), (INO), (MRNA), (BNTX)
Posts
The growing concern for a potential global outbreak of monkeypox has sent shares of the biotechnology company behind the only approved vaccine soaring.
From a market value of $1.2 billion in May, Bavarian Nordic (BVNRY) has now reached $3.4 billion.
More than that, this figure is expected to climb higher as the World Health Organization (WHO) recently declared monkeypox a “public health emergency of international concern.”
Bavarian Nordic wasn’t the only vaccine maker that benefitted from this announcement. Shares of other developers, notably Siga Technologies (SIGA), Emergent Biosolutions (EBS), and Inovio Pharmaceuticals (INO), were also buoyed.
To date, there are roughly more than 16,000 recorded cases of monkeypox worldwide and 5 deaths. Most regions are categorized as moderate risk, while Europe is placed at high risk due to the number of infections in the area.
Siga Technologies rose 26% following WHO’s announcement. This company develops an antiviral named TPOXX, which is approved by the EU to use against monkeypox. The US has also stockpiled this drug despite not yet being approved by the FDA.
Meanwhile, Emergent Biosolutions climbed 11% after the news came out. While it’s also not yet marketed commercially for this particular outbreak, this biotech has developed a smallpox vaccine that could be applied as a preventive measure for monkeypox.
As for Inovio Pharmaceuticals, which rose 6%, the company does not have a monkeypox-centered product in its pipeline or portfolio. However, the biotech worked on an experimental vaccine against smallpox in 2010. This candidate is reportedly able to provide protection against monkeypox.
Despite all these candidates, Bavarian Nordic’s monkeypox vaccine, called Jynneos, is expected to remain the dominant vaccine. Apart from the US, it was also approved as a monkeypox vaccine in the EU and Canada.
Jynneos, which is administered in two doses, works as a non-replication live virus vaccine. It uses a modified or altered version of a virus that came from the same family as the monkeypox. The goal is to train the immune system to fight off monkeypox and smallpox infections.
Essentially, Jynneos is an advanced version of Emergent Biosolutions’ smallpox vaccine.
Considering the potency and safety of Jynneos, experts believe that no other smallpox or monkeypox candidate could rival Bavarian Nordic’s vaccine in the next 10 to 20 years.
Aside from the difficulties of developing a new and better vaccine, gathering data to prove the efficacy of the candidates would be highly challenging. Large-scale clinical trials involving humans might not be possible, both from an ethical and practical point of view.
Since it’s the only vaccine authorized so far, Bavarian Nordic is arguably the best bet for investors looking to capitalize on this demand.
Moreover, the biotech company has a strong balance sheet and can produce at least 30 million doses of its product. It also has several candidates in its pipeline, making it a safe play in this space.
In terms of competitors, the closest would most likely be Siga Technologies, which has a market capitalization of $1.3 billion. This biotech has a similar profile to Bavarian Nordic.
Meanwhile, its vaccine, TPOXX, showed little to no side effects. More than these, Siga recently received approval from the EU. That means gaining FDA approval in the US could very well be on the way as well.
Overall, there’s an apparent demand for the monkeypox vaccine. Right now, it’s only offered to individuals suffering from monkeypox or with significant exposure to infected people.
While it may not reach the heights of Moderna (MRNA) and BioNTech (BNTX) in terms of skyrocketing share prices, Bavarian Nordic’s vaccine is a great stepping stone for the company.
After all, Jynneos is basically a cousin to the smallpox vaccine that practically saved humanity.
So, if someone gets it, they would probably get the vaccine, just like you would rush to the hospital for a tetanus shot if you stepped on a rusty nail. Without these vaccines, life and the economy as we know them today would not be possible.
Mad Hedge Biotech and Healthcare Letter
May 26, 2022
Fiat Lux
Featured Trade:
(WAITING FOR THIS BIOTECH TO STOP MONKEYING AROUND)
(INO), (BVNKF), (EBS), (JNJ), (PFE), (MRNA), (BNTX), (AZN), (NVAX), (REGN), (QGEN)
Almost immediately after US President Joe Biden advised that “everybody” should be concerned over the new worldwide outbreak of the monkeypox virus, the shares of biotechnology and healthcare companies working on monkeypox treatments and vaccines started to rise.
Shares of Danish company Bavarian Nordic (BVNKF), the only monkeypox vaccine developer approved in the US, were up 5.8% in premarket following the announcement.
Bavarian Nordic’s vaccine, called Jynneos, uses a live version of the smallpox virus, which has been altered so that it no longer can replicate in the recipient’s body or cause any infection.
Instead, it has been engineered to activate the immune system and prepare the body’s defenses to fight off smallpox and monkeypox viruses.
Based on data from Africa, two shots of Jynneos, administered 28 days apart, recorded up to 85% in terms of efficacy against monkeypox.
In 2019, Jynneos received regulatory approval from the US FDA for both smallpox and monkeypox.
Aside from Bavarian Nordic, shares of Emergent BioSolutions (EBS) also rose by 11.8% following Biden’s announcement.
While Emergent has no vaccine specifically for monkeypox, it has a smallpox vaccine that can be used to prevent monkeypox.
It can be recalled that Emergent BioSolutions has been an exiled ticker after the US Congress launched an investigation on the manufacturing issues in its Bayview Facility in 2021.
Although the company has managed to clean up that mess and is back to working with Johnson & Johnson (JNJ) to produce COVID-19 vaccines, EBS has yet to return to investors’ good graces.
While the scale of the threat has yet to be determined, the US has secured contracts for Jynneos and Emergent BioSolutions’ vaccine and is already stockpiling in case of an outbreak.
What’s curious, though, is that another company has benefited from this announcement despite not having any monkeypox or even smallpox vaccine candidates.
Inovio Pharmaceuticals (INO) shares rose by 12.2% following the announcement—a surge that couldn’t be adequately explained since the company has no relevant product and does not seem to have any program even remotely linked to this potential outbreak.
As far as I can tell, the last time Inovio even mentioned monkeypox was in 2010 when it discussed a potential experiment on a vaccine that could protect nonhuman primates against the virus. However, nothing came out of that plan either.
If Inovio sounds familiar to you, it’s probably because it was one of the frontrunners in the early days of the COVID-19 vaccine race.
However, it eventually lagged behind the likes of Moderna (MRNA), Pfizer (PFE), BioNTech (BNTX), and AstraZeneca (AZN).
One primary reason for this is the FDA’s decision to suspend Inovio’s Phase 3 trial in late 2020, with the study only resuming sometime in 2021.
As if that’s not enough, Inovio also faced some internal battles following the resignation of its CEO.
Now, the company has shifted gears and plans to offer its COVID-19 candidate as a booster shot instead of a primary vaccine.
The change of plans regarding the COVID-19 vaccine might be disappointing for some, but it’s essential to be realistic about expectations.
At the moment, the vaccine landscape has been dominated by Pfizer and Moderna, with AstraZeneca and Johnson & Johnson gaining ground as well.
Just recently, another challenger joined the fray: Novavax (NVAX).
Needless to say, the COVID-19 vaccine market is becoming crowded, and the competition is getting more intense.
Considering that Inovio has yet to catch up with the development of its candidate, it would be unwise to challenge the already established developers dominating the market today.
Hence, offering its COVID-19 candidate as a booster would provide it with higher marketability since health experts encourage people to mix and match their vaccines.
Outside these efforts, Inovio is a leader in developing DNA plasma-based vaccines. Before the pandemic, the company had been working on an extensive pipeline using this technology.
One of the most promising DNA-based vaccines from Inovio is VGX-3100, which targets an HPV-triggered disease called cervical dysplasia. Simply, this is a pre-cancer condition.
Inovio’s candidate is the first-ever DNA-based treatment that reached Phase 3 trials and reaped positive results.
This is an exciting development, especially in light of Inovio’s partnership with Qiagen (QGEN), as the two can leverage their work to determine which patients are at risk.
Basically, Inovio and Qiagen might just be on the verge of coming out with a preventive vaccine for cancer.
If things go according to plan, the data should be released by the second half of 2022. In terms of price, VGX-3100 is expected to cost roughly $10,000.
Aside from these, Inovio is also collaborating with Regeneron (REGN) to develop a cure for glioblastoma, an incredibly aggressive type of brain cancer. So far, Phase 2 trial results look promising, and the partners are on their way to progressing to Phase 3.
Inovio’s pipeline covers many DNA vaccines targeting infectious diseases and cancers. Most are still in the early phases of development.
While the programs in Phase 2 and 3 trials are promising, I think it’s still too early to predict whether Inovio is truly capable of delivering on its promises.
I know that Inovio shares look like such a bargain these days, especially if the company ends up receiving regulatory approvals in the coming months, but I’m not yet fully convinced.
Overall, Inovio is worth considering right now. It’s definitely on my list.
But before I commit, I’d like to see at least whether the company’s COVID-19 and HPV pipelines can move past the latest headwinds and advance to the next levels.
Mad Hedge Biotech and Healthcare Letter
May 24, 2022
Fiat Lux
Featured Trade:
(FROM A BORING BIOTECH TO A TRAILBLAZING PIONEER)
(VRTX), (ABBV), (MRNA), (CRSP), (EDIT), (BEAM), (NTLA)
When will the turmoil in the stock market come to an end? Unfortunately, nobody can offer a definitive answer.
At this point, there’s still no end in sight to high inflation, climbing interest rates, and the continuing war in Ukraine.
Needless to say, all these issues are affecting the stock market. However, not all stocks are getting negatively affected by the turmoil.
There are still relatively safe bets to buy, with some crushing the market these days.
One of them is Vertex (VRTX).
Vertex stock soared by over 30% year-to-date by mid-April.
While it has given up some of that gain in the past weeks, this biotechnology and healthcare stock is comfortably outperforming the rest of the market, with its shares still up by around 15%.
One reason for Vertex’s good performance is its undisputed monopoly in the cystic fibrosis (CF) market. In fact, its closest potential competitor is AbbVie (ABBV), which recently announced disappointing results for its Phase 2 trials for a CF combo.
This means Vertex’s dominance in the CF space is set to go on for quite some time.
Here’s a bit of background. Vertex has 4 CF treatments.
Among these, the latest treatment, Trikafta, generates the lion’s share of the profits. It raked in $1.7 billion in the first quarter of 2022 alone, with the total revenue for the entire CF pipeline recording $2 billion.
Considering its approved indications and potential approvals, Trikafta is anticipated to treat 90% of the entire CF patient population.
Looking at its current performance and how strong its hold is in the CF market, it appears that Vertex’s prediction that it can sustain its dominance in this segment until at least the late 2030s will be proven right.
Moreover, it’s evident that Trikafta has yet to reach its peak revenue. However, Vertex isn’t depending on this particular treatment alone.
Rather, the company is working on developing a worthy competitor to this top-selling treatment.
That is, Vertex is working on a CF candidate that may potentially be even more effective than Trikafta.
So far, this new drug candidate not only has the capacity to beat Trikafta in terms of efficacy but also offers a more convenient option.
Trikafta is a twice-a-day oral drug that comes in the form of 3 tablets. Meanwhile, this potential competitor is a once-a-day alternative.
If everything goes according to plan, the Phase 3 trial for this Trikafta challenger could start by the end of 2022 or early 2023.
This means that the closest potential rival for the company’s top-selling treatment is its own candidate.
Apart from this, Vertex is working with Moderna (MRNA) to come up with an mRNA therapy for CF patients.
The goal is to offer an alternative option to patients who are not eligible for the current CF therapies.
Although this continued dominance in the CF sector is already a good enough reason to buy Vertex shares, they may be an even better one.
To date, Vertex has at least 6 programs queued in mid to late-stage clinical studies, all of which are projected to become multi-billion dollar revenue streams.
Outside its CF segment, Vertex could have another big winner in the form of gene-editing treatment CTX001.
This is a treatment for sickle cell disease and transfusion-dependent beta-thalassemia that the company has been working on with CRISPR Therapeutics (CRSP).
While CTX001 is promising, it won’t be entering the gene therapy market without any competition. It has to battle the likes of Editas (EDIT), Beam Therapeutics (BEAM), and Intellia (NTLA).
Nonetheless, CTX001, if approved, is a game-changer because it is developed as a one-time cure for genetic blood disorders.
So far, trial results have been positive, and the collaborating duo is expected to file for regulatory approval by the end of 2022 and possibly launch the product by the first half of 2023.
This gene-editing therapy is a significant milestone for Vertex, with CTX001 expected to become another blockbuster, raking in roughly $1 billion in annual sales for the company even after giving CRISPR its share of the profits.
Recently, Vertex added another $900 million to its collaboration with CRISPR to boost its share from 50% to 60%, indicating that it values CTX001 at roughly $10 billion.
Other critical treatments outside the CF space are VX548, an opioid alternative targeting acute pain, and VX800, a stem cell-derived therapy developed to treat Type 1 diabetes.
Vertex has been accused as a company scared of getting out of its comfort zone for quite some time.
With these new ventures, Vertex has become something of a pioneer—a strategy that is projected to open long-term and lucrative revenue streams for the company.
Overall, all these efforts paint an obvious picture. That is, Vertex is a well-balanced company with a main business that capably and reliably generates billions and is complemented by an exciting pipeline that holds the potential to replicate the success of its already established portfolio.
Mad Hedge Biotech and Healthcare Letter
May 4, 2022
Fiat Lux
Featured Trade:
(A PICK AND SHOVELS BUSINESS POISED TO EXPLODE)
(TMO), (CRSP), (MRNA), (BNTX), (A), (DHR), (ILMN)
There’s never a wrong time to begin investing. In 2021, the markets generated positive buzz when things started to heat up again.
That same optimism has recently transformed into bearishness following the decline in share prices.
Nevertheless, there’s still good news.
Given the lower valuations, investors can now get more bang for their buck.
In the past two years, we’ve experienced so many unprecedented events. Among the most heavily affected by the pandemic is the life sciences sector.
One of the biggest names in this field is Thermo Fisher Scientific (TMO).
With a market capitalization of roughly $200 billion, it’s no longer accurate to describe this as an under-the-radar company. TMO has received minimal fanfare among investors despite its massive size for decades.
A key reason for this is its lowkey steady execution of a well-established or tried-and-tested strategy.
Although it lacks the pizzazz of more exciting companies these days like CRISPR Therapeutics (CRSP), Moderna (MRNA), and BioNTech (BNTX), TMO has rewarded its investors with substantial returns.
Over the last 40 years, TMO has recorded an annual growth rate of 16.5%, hitting a 27,000% return in total by 2021.
In fact, TMO came off a strong 2021.
Its sales grew by 22% from 2020 to report $39.2 billion. While acquisitions played significant roles in the company’s growth, the 17% organic revenue growth of TMO served as its primary growth driver behind its solid numbers in 2021.
Even its COVID-19-related sales, particularly its testing products, contributed to reach $9.2 billion.
Looking at TMO’s business model, it’s evident that the company offers investors great exposure to the entire healthcare field via a single investment only.
That is, TMO is a broad business. It covers practically all life sciences solutions, analytical tools, specialty diagnostics, lab items, and even clinical, biotechnology, and pharmaceutical services.
Spanning the entire industry, such portfolio of products and services allow TMO to confidently go toe-to-toe against industry heavyweights like Agilent Technologies (A), Danaher (DHR), and Illumina (ILMN).
Actually, all of its segments grew last year, with TMO showing off quicker revenue increases than its competitors in the previous five years.
Hence, it is no surprise that TMO expects its numbers to climb in 2022. For this year, the company’s projected revenue is estimated to rise by at least 7% to reach $42 billion.
TMO strategically leveraged more significant acquisitions to build its diverse and deep portfolio today.
In 2011, the company spent $3.5 billion to buy Sweden’s blood-testing firm Phadia and cleverly maneuvered a relatively cheap deal to also grab chromatography company Dionex for only $2.1 billion.
In 2013, TMO bought a fast-growing genetic testing company called Life Tech for $13.6 billion.
At that time, Life Tech was the leader in this field and already possessed the technology to become a front-runner in the personalized medicine space.
In 2016, it shelled out $4.2 billion for electron microscopy company FEI and dropped another $7.2 billion in 2017 to buy pharmaceutical contract manufacturer Patheon.
To date, TMO’s most substantial deal is its $17.4 billion acquisition of contract research business Wilmington’s PPD.
This particular deal created a gateway between the biopharma giant and other drug developers, with TMO boosting its services segment focused on its biotechnology and pharmaceutical clients.
Between 2019 and 2021, the pharmaceutical and biotechnology market has experienced a promising over 20% growth.
This field is expected to grow to an additional $20 billion in 2022, following the growing interest in the industry in this post-pandemic era.
There is another emerging sector within the pharmaceutical and biotechnology market: the precision medicine and gene sequencing field.
Taking into consideration the growing demand for the products and services from this space, this market is estimated to reach roughly $1.6 trillion by 2030.
This makes TMO’s PPD acquisition timely, as it would allow the company to gain a bigger market share and expand its reach across the globe.
Furthermore, the previous acquisitions would bolster the company’s hold on the current market and ensure its position as a first-mover in potential groundbreaking innovations in the biotech and pharma sector.
Considering its expansion strategies and growth history, TMO doesn’t seem to be stopping anytime soon.
While the environment for mergers and acquisitions did become a bit more restrictive these days, there are still several potential buyout targets that could deliver favorable returns. So, we might hear about another TMO-linked acquisition sometime soon.
Overall, TMO is a healthcare stock offering robust and stable growth and a promising future regardless of economic downturns.
Moreover, its pick-and-shovels play makes it an excellent stock that looks poised to sustain its momentum and is well-positioned for global expansion. Hence, it would be wise to buy the dip.
Mad Hedge Biotech and Healthcare Letter
April 21, 2022
Fiat Lux
Featured Trade:
LET’S GET READY TO RUMBLE)
(MRNA), (PFE), (BNTX), (AZN), (ABBV), (MRK), (BMY), (TAK), (GILD),
(SNY), (ALNY), (NVS), (REGN), (IONS), (GSK), (BIIB), (CRSP)
As we gradually reach the pinnacle of biotechnology formation, a war is brewing in the life sciences world.
This can be one of the most exciting times for medical innovations for patients. Meanwhile, investors can be picky when picking where to put their money.
Even up-and-coming scientists can seize the opportunities to lay the groundwork for their own dream organizations.
At the same time, those aspiring to climb the corporate ladder have better chances at becoming CEO without the need to slog through the biopharma sector and scramble for whatever opening is available.
However, as more and more companies launch practically every day, claiming to offer groundbreaking and revolutionary breakthroughs, it’s critical to keep in mind that not all biotechs will succeed.
Actually, the number of biotech companies has been steadily rising since 2015.
In that year, 177 firms were formed, with biotech birth rates breaching the 200-per-annum mark by 2017 and 2018.
Seeing as many more have emerged even during the pandemic, it looks like the biotech world won’t be slowing down anytime soon.
Even funding hasn’t been deterred by economic downturns.
From 2015 to 2018, the total funding for biotech companies averaged between $68.6 million to roughly $90.2 million.
After a bustling, record-breaking 2020, the bar leading to 2021 was expectedly high.
Surprisingly, 2021 blew those figures out of the water as private investors opted to raise the bar even higher.
It’s the type of climb that’s truly hard to believe.
Biotechs raised over $22 billion in private funds in 2020 following a sluggish 2019. In 2021, that figure rose to $28.5 billion.
The top earner in these funding rounds last year was China’s Abogen, which took $1 billion in private investors’ money across two rounds.
Abogen is an mRNA-centered firm that’s currently working on a COVID-19 vaccine.
What makes its product different and possibly better than Moderna (MRNA), Pfizer (PFE), BioNTech (BNTX), and AstraZeneca (AZN) is that it would be thermostable. That is, it could be used in areas without access to refrigeration.
Another big winner in 2021 is Massachusetts-based biotech ElevateBio, which aims to be a one-stop shop for cell and gene therapies.
The idea is to develop a technology that fuses its gene-editing platform, cell engineering structure, and manufacturing warehouse into one system to ease and accelerate the drug development process.
Although not entirely the same, this plan has similarities with the strategies of Big Pharma names like AbbVie (ABBV) and Merck (MRK).
Amid the growing number of biotechs, a key challenge is how to stand out among companies that target the same disease areas. This kind of competition could hamper innovation.
The clearest indicator of success would be receiving approval and being able to launch the products commercially.
Ultimately, the goals are to offer safe and effective treatments and provide value to their shareholders.
Unfortunately, the reality is only a handful of startups do make it all the way to the top.
The more feasible scenario is that bigger businesses would acquire these companies—and that seems to be the case these days.
Alongside the booming biotech formation rate are the increasingly aggressive biotech buyout deals.
We’ve seen this before.
It started in 2019, with Bristol Myers Squibb (BMY) buying Celgene, followed by AbbVie splurging on Allergan and Takeda (TAK) merging with Shire.
In 2020, AstraZeneca bought biotech superstar Alexion Pharmaceuticals while Gilead Sciences (GILD) snapped up Immunomedics.
Meanwhile, Sanofi (SNY) stacked its deck with the $3.2 billion acquisition of Translate Bio. As for Merck, this biopharma sneaked in a massive win with an $11.5 billion buyout of Acceleron.
For this year, several names have already been eyed by Big Pharmas.
There’s Alynlam Pharmaceuticals (ALNY), an RNA-centered company, which seems to be the target of both Novartis (NVS) and Regeneron (REGN).
Another RNA-focused company, Ionis Pharmaceuticals (IONS), appears to be a key target as well, with the likes of GlaxoSmithKline (GSK), Bayer, and even Biogen (BIIB) waiting for an opportunity to pounce.
After all, acquisitions form an integral lifeline of the biotech world. Huge businesses with the resources swoop up promising buyout candidates to bolster their own pipelines.
However, M&A isn’t the only option for biotechs. There’s also the path where they can seek companies with similar focus and consolidate to become larger and more competitive entities.
This has been the expected plan for CRISPR Therapeutics (CRSP) for a long time. Hence, it is no surprise if other biotechs with their own groundbreaking technologies decide to follow the same route.
Overall, the biotech industry is booming amid its recent struggles with the market.
The faster growth rate of companies can be attributed to more investors seeing the industry's potential and, of course, better access to technology and scientific advancement.
Moreover, the world has become more interested in the biotech world and what the industry can offer due to the pandemic.
COVID-19 has shone a light on this sector following the quick and effective results of the vaccines and treatments.
That is, people have finally caught on to the idea that there is an incredible opportunity in biotech.
While a correction is to be expected at some point, the critical thing to bear in mind is that great ideas will always generate funding no matter what.
