Biotech Letter Archives

More Players Enter the Race for a Corona Cure

Special issue on COVID-19 vaccines: Moderna Inc (MRNA), Arcturus (ARCT), Johnson & Johnson (JNJ), Sanofi (SNY), GeoVax (GOVX), Altimmune (ALT), Novavax (NVAX), GlaxoSmithKline (GSK), Generex (GNBT), Vaxil Bio (VXL.V), Inovio Pharmaceuticals (INO), Applied DNA Sciences (APDN), Zydus Cadila (CADILAHC)

The hunt is definitely underway for potential treatments to fight COVID-19 but coming up with vaccines will take a much longer time.

Since we already have the genetic code of the novel coronavirus (click here for the link), researchers can now use the complete blueprint to come up with ways to defeat this disease.

With code in hand, it takes a supercomputer just three hours to create model vaccines. Then it is just a question of how fast you can make them, if at all. Many proposed models are far beyond our existing technology.

To date, there are roughly 35 companies and academic organizations actively seeking ways to come up with a COVID-19 vaccine. While the process will still take time, there are several promising prospects.

Among the companies working on this, Moderna Inc (MRNA) has been recognized as the first biotechnology company to conduct human trials to test its COVID-19 vaccine in March. The trial includes 45 males and non-pregnant females aged 18 to 55.

Moderna’s vaccine utilizes the genetic sequence of the novel coronavirus. Basically, the goal is to build a vaccine out of messenger RNA.

Aside from Moderna, another biotech company called Curevac has been at the forefront of this cutting-edge technology.

In China, RNACure Biopharma has been working with Fudan University and Shanghai JiaoTong University on using the same technique to come up with a vaccine as well.

China’s CDC along with Tongji University and Stermina as well as Duke-NUS in partnership with Arcturus (ARCT) are also using a similar approach.

Although Moderna’s vaccine reached Phase 1 in record time, authorities cautioned that the development time frame is somewhere between 12 and 18 months — and this is even dubbed as an “overly optimistic” timeline.

Meanwhile, there are companies like Sanofi Pasteur (SNY) elected to use previously deployed vaccine platforms in earlier epidemics like SARS.

Johnson & Johnson (JNJ) also decided to employ the same strategy using its Ebola vaccine platform. In fact, JNJ shared that it’ll be ready to conduct human testing of its non-replicating viral vector by November.

Aside from JNJ, another biotechnology company in China called CanSino Biologics (HKG: 6185) in collaboration with the Academy of Military Medical Sciences is utilizing the same technology.

Just last week, Chinese authorities approved CanSino’s Phase 1 clinical trials.

Apart from JNJ and CanSino, other biotechnology companies are also working on a vaccine using the same non-replicating viral vector technology.

The list includes Wuhan’s BravoVax along with GeoVax (GOVX), Altimmune (ALT), Vaxart (VXRT), Greffex, and the University of Oxford.

Another strategy is employed by Novavax (NVAX), which is to construct a “recombinant” vaccine.

In a nutshell, this strategy entails extraction of the genetic code for the protein found on the Sars-CoV-2. This is a part of the virus that can trigger the immune system. This will then be pasted into the genome of a bacterium or yeast.

In effect, this vaccine will force the microorganisms to produce huge quantities of the protein to be able to fight off the virus.

Big biotechnology companies like Sanofi and GlaxoSmithKline (GSK) are following the same technique.

Smaller firms are also in on the action including Generex Biotechnology Corporation (GNBT), Vaxil Bio (VXL.V), EpiVax, and Clover Biopharmaceuticals.

The University of Georgia, Baylor College of Medicine, and the University of Miami are pursuing the same lead as well.

On top of these, several biotechnology companies use a DNA-based approach to come up with a vaccine.

Last March 12, the Bill & Melinda Gates Foundation provided a $5 million grant to Pennsylvania-based biotech firm Inovio Pharmaceuticals (INO) to help the company speed up the tests needed for its DNA vaccine called INO-4800.

This is on top of the roughly $9 million in funding it received from the Coalition for Epidemic Preparedness Innovations earlier.

At the moment, INO-4800 is in preclinical studies with plans to push it to Phase 1 clinical trials by April.

Aside from Inovio, Applied DNA Sciences (APDN), Zydus Cadila (CADILAHC), Takis, and Evivax are also pursuing the same strategy.

Despite implementing the most effective and even draconian measures to contain COVID-19, these tactics only managed to slow down the spread of the virus.

With the World Health Organization tagging this situation as a pandemic, everyone has become more desperate in the search for a vaccine because only a vaccine can stop people from getting sick.

However, even the unprecedented speeds afforded, the biotechnology companies couldn’t change the fact that developing a vaccine requires at least a year. It’s crucial to not make mistakes along the way especially since the product could potentially be injected into most of the world’s population.

After all, there’s only a single thing that can be considered worse than a bad virus — and that is a bad vaccine.

March 26, 2020

Biotech Letter

Mad Hedge Biotech & Healthcare Letter
March 26, 2020
Fiat Lux

Featured Trade:

(PFIZER PUSHES AHEAD WITH A CORONA CURE),
(PFE), (BNTX), (MYL)

Pfizer Pushes Ahead with a Corona Cure

Biotech Letter

Pfizer (PFE) has been widely recognized as one of the leading and largest vaccine makers in the industry.

Now, one of America’s biggest biotechnology companies will throw its weight behind German firm BioNTech (BNTX) in its quest to develop a COVID-19 vaccine.

Prior to this announcement, BioNTech has already been working inside China in collaboration with Chinese biopharmaceutical company Fosun Pharma (SHA: 600196).

Its partnership with Pfizer will entail efforts outside China and will be in collaboration with the University of Pennsylvania and the Bill and Melinda Gates Foundation. Specifically, the work will be done at sites in the US and Germany.

What we know so far about this experimental COVID vaccine is that it’s called BNT162.

Like the experimental vaccine from Moderna (MRNA), BioNTech’s version is also based on messenger RNA. Clinical trials will start by April.

BioNTech shares were up 55% following the announcement of this collaboration with Pfizer. Meanwhile, the giant biotechnology company’s shares jumped by 3.8%.

Before this coronavirus vaccine collaboration, BioNTech and Pfizer were already partners.

In 2018, the two companies agreed to work together in developing flu vaccines based on mRNA.

However, this recent expansion of their partnership gained more attention because of the intense focus on the efforts to combat the novel coronavirus.

The output of this partnership won’t be kept within the confines of the companies though.

According to Pfizer, any information or tool it comes up with will be shared with the entire scientific community.

The company also pledged its assistance to small biotechnology companies working on COVID-19 treatments and vaccines, going as far as offering its manufacturing power to help speed up the process.

Aside from its coronavirus efforts, the giant biotech has been working on plans to bolster its revenue streams.

Addressing the loss of exclusivity for seizure disorder drug Lyrica, an issue that weighed on the company’s top and bottom lines last year, Pfizer has been gearing up to merge the Upjohn unit with Mylan (MYL).

The merged companies will be called Viatris.

This is a good strategy. Since Upjohn is home to Lyrica and several older drugs nearing the end of their patent exclusivity, separating this unit will allow Pfizer to streamline its portfolio.

Instead of holding on to Lyrica as an anchor, the “new” Pfizer will focus on its new line of blockbuster drugs like breast cancer medication Ibrance and blood clot treatment Eliquis.

Apart from these, Pfizer is investing more on marketing its rising stars like Vyndaquel. The company’s pipeline is also filled with potential blockbusters particularly its 20-valent pneumococcal vaccine.

Although the Upjohn-Mylan merger will inevitably lower Pfizer’s dividend, shareholders of the giant biotech will still own part of Viatris. That means they would have a share in the dividend of the merged companies as well.

The combination of the dividends from both Pfizer and Viatris would total to roughly the same amount as the “old” Pfizer, which currently yields 5%.

What we’re experiencing right now is definitely unprecedented. COVID-19 has mutated from a respiratory disease affecting a single province in China into a global threat endangering everyone’s physical and financial well-being.

However, there’s always good news.

From an objective perspective, this coronavirus crisis has provided a rare opportunity for investors. After all, stock market corrections are actually quite common occurrences.

Looking at each correction in equities in the past, you can see that these were eventually triggered by a bull-market rally.

Remember, the ongoing vaccine research conducted by companies worldwide will yield results sooner or later. So even if COVID-19 is here to stay, it will no longer be a deadly threat in the long run.

In times like these, I think it’s more prudent to consider major biotechnology stocks when looking to invest.

This is because they have a higher capacity to keep trucking through this health crisis and to deal with its aftermath.

Despite the growing fear that this pandemic will lead us to a recession, Pfizer can still be easily categorized as a profitable company.

Considering that it’s trading at merely 13 times its expected earnings, this stock is quite a bargain.

Pfizer has a strong cash flow. Its long history shows that it has also weathered economic storms.

More importantly, it has a product pipeline that we find essential regardless of pandemics and strict quarantines. It doesn’t hurt that they’re priced attractively as well.

March 24, 2020

Biotech Letter

Mad Hedge Biotech & Healthcare Letter
March 24, 2020
Fiat Lux

Featured Trade:

(THE BIG CORONA PLAY WITH TELEDOC HEALTH),
(TDOC) (HUM), (AET), (CI)

The Big Corona Play with Teladoc Health

Biotech Letter

The coronavirus disease (COVID-19) outbreak continues to inspire terror across the globe.

To date, there are roughly 398,107 confirmed cases and over 17,454 documented deaths, pushing communities to take proactive measures to stem the tide of this global pandemic.

In its wake, an increasing number of government officials and health professionals like the US Centers for Disease Control (CDC) have advised patients to take advantage of telemedicine and virtual health systems as much as possible. This is particularly helpful for those with respiratory symptoms since using these platforms could minimize contact with others along with the spread of the virus.

One of the no-brainer beneficiaries of this advice is virtual healthcare services provider Teladoc Health (TDOC).

Basically, companies like Teladoc offer personalized care without the need for patients to leave their houses. Although the kinks have yet to be worked out, the telemedicine sector should be expected to skyrocket in the weeks and even months ahead.

In fact, Teladoc shares gained 9% since February 19 -- a good sign for the company especially since the broader market went down by roughly 20% over the same period.

Earlier this month, Teladoc disclosed that the number of patient visits registered in its system showed a 50% increase week over week.

Ever since COVID-19 hit the country, the company has been fielding at least 15,000 visits on a daily basis, reaching over 100,000 weekly. Teladoc shared that it has been experiencing "visit demand consistent with peak flu volumes."

The convenience that companies like Teladoc provide can ease the burden on the broader healthcare system, which has been overworked with COVID-19 cases.

Another factor that could have contributed to Teladoc’s increasing patient load is the decision of some major health insurers to waive the patient costs for telemedicine visits.

So far, Humana (HUM), Aetna (AET), and Cigna (CI) confirmed that this policy will be relaxed throughout the national health emergency.

Needless to say, this announcement was highly appreciated by their clients, with Teladoc reporting that over half its patient visits in the past weeks are from first-time users.

However, this isn’t exactly Teladoc’s first big break.

Even prior to the pandemic and the recommendations from health experts, Teladoc has been quite impressive on its own.

Throughout the years, Teladoc has been consistent in reporting strong growth metrics. Since it went public in 2015, the stock has skyrocketed to 330% compared to the 30% gain for the S&P 500.

Reviewing its fourth-quarter earnings report for 2019, it’s clear that this is a stock for long-term investors. Based on the management’s commentary and how the story is playing out in the past months, there’s a good possibility that investors will be richly rewarded as well.

In 2019 alone, Teladoc added a total of 14 million new members to record an impressive growth rate of 61%. The company closed the year with 36.7 million patients registered in its system.

In terms of revenue, Teladoc delivered $156.5 million, showing off a 27% jump year over year.

This is particularly impressive as it eclipsed the high end of its guidance, which fell somewhere between $149 million and $153 million. It also beat the consensus estimates of analysts at $152.95 million.

This increase in revenue was bolstered by strong growths both in the US and the international markets. Its subscription-access fees reached $127 million, which was a 24% increase year over year.

Fees collected from visits showed quicker growth to contribute $29.5 million, demonstrating a 47% jump compared to the same period in 2018.

Total office visits increased by 44%, climbing to 1.24 million and surpassing the company’s guidance range of 1 million and 1.2 million as more and more patients opt for the subscription-based plans.

Meanwhile, its paid memberships in the US climbed 61% year over year to reach 36.7 million while its fee-only access soared by 104% to jump to 19.3 million members.

While 2019 was definitely a good year for the company, it’s difficult to downplay the reality that its impressive adoption curve recently could make 2020 an even better year for Teladoc.

Looking at how the company has been thriving, two things could happen for Teladoc.

One possibility is for it to develop into one of the most disruptive companies in the industry. The second possibility is that it will get acquired by a bigger player.

No matter what happens, the outcome will be a win-win for its investors.

The Race to Find a Corona Cure

Biotech Letter

Naturally, many people are wondering about which stocks to own in light of the coronavirus. The latest development on the race to find a coronavirus cure is a joint effort involving two giant names from the biotechnology industry: Regeneron Pharmaceuticals (REGN) and Sanofi (SNY).

Taking a page off Gilead Sciences’ (GILD) move to recycle HIV drug Remdisivir and Roche Holding’s (ROG) decision to utilize rheumatoid arthritis Actemra, Sanofi and Regeneron are looking into an existing drug’s ability to offer refuge for patients suffering from COVID-19.

According to a recent announcement, the two companies are looking to test rheumatoid arthritis medication Kevzara on COVID-19 patients.

This drug was initially approved in 2017 and while it failed to reach blockbuster status at the time, Sanofi and Regeneron are preparing to transform it into the next leader in this pandemic race.

It should be noted though that Kevzara is not a coronavirus cure. Rather, the companies are hoping to use this drug to combat the symptoms related to COVID-19.

This is why it’s promising.

When a person gets infected by the novel coronavirus, the immune system is activated and starts attacking the virus to protect the body. As time passes, the immune system goes into overdrive and ends up overreacting, causing additional damage.

Gradually, the immune system starts attacking even the healthy tissue and organs as with the case for some COVID-19 patients.

This means that the coronavirus is causing an accelerated response from the immune system resulting in the patients’ damaged organs starting with the lungs.

This is where Kevzara comes in.

The drug functions as an inhibitor of the protein that triggers the patient’s immune and inflammatory response.

That is, Kevzara can stop the body from attacking itself despite the triggers caused by the coronavirus.

In terms of the specifics of this joint effort, Regeneron will take the lead for the US trials while Sanofi will be in charge of international efforts.

Aside from Kevzara, both Regeneron and Sanofi have been pursuing separate leads on how to deal with the pandemic.

Sanofi has been working in tandem with the US Department of Health and Human Services (HHS), specifically with the Biomedical Advanced Research and Development Authority (BARDA), to come up with a coronavirus vaccine.

However, it’s the coronavirus efforts of Regeneron that gained much attention in the past weeks.

In February, Regeneron and the HHS expanded their partnership to come up with potential COVID-19 treatments. So far, the biotechnology giant has decided to work on monoclonal antibodies via its VelocImmune platform.

This avenue is particularly promising since Regeneron has already come up with an antiviral drug to combat Ebola. Its collaboration with HHS has also already resulted in plans to develop a MERS treatment, which is also a type of coronavirus.

According to Regeneron executives, the company will have a coronavirus treatment ready for human testing by August. If all goes well, then it aims to produce 200K prophylactic doses.

Although its innovative coronavirus proposals are exciting, Regeneron remains focused on its older and more dependable money makers particularly the eye drug Eylea.

This strength is in display in Regeneron’s fourth quarter results, which showed better than expected numbers.

For Eylea alone, the company generated an 11% year-over-year growth in sales.

Despite the emergence of new competitors like Novartis’ (NOVN) Beovu, Regeneron’s eye drug remains the leading product in this sector. In fact, Eylea managed to cross $2 billion in global sales just for the year 2019.

As for inflammation-reducer Dupixent, the treatment’s global sales climbed 136% in 2019.

Meanwhile, revenue from its cancer immunotherapy Libtayo soared to over quintuple from the previous period.

Building from the strength of Eylea, Regeneron also announced its successful late-stage clinical study that aimed to expand the indication of the drug to moderately severe to severe non-proliferative diabetic retinopathy (NPDR).

If this Eylea expansion pushes through, then Regeneron has yet another blockbuster drug in its hands.

In the past five years, Regeneron has demonstrated a strong EPS growth, growing by 23.74% annually. Given its recent performance and based on forward-looking statements, the company can be expected to report an average of 17.4% growth on its EPS in the next two years.

Amid the panic and confusion caused by the coronavirus pandemic, it’s crucial to remain objective, especially with the stock market.

Before making a decision, ask yourself this question: “Will this current situation change the 10-year or even the 20-year outlook for the financial sector?”

Despite the paranoia proliferating in the market in the past months, I believe the answer to this question is still a resounding “no.”

For now, it would be wise to treat owning stocks like how to own businesses. It's important to think about which stocks to own during the coronavirus, but don’t do it just to make a quick buck. Rather, take a look at lasting and stable companies with the capacity to not only grow over the years but also to compound their returns.

March 17, 2020

Biotech Letter

Mad Hedge Biotech & Healthcare Letter
March 17, 2020
Fiat Lux

Featured Trade:

(THERMO FISHER SCIENTIFIC BECOMES A MAJOR CORONA PLAYER),
(TMO), (QGEN)

Thermo Fisher Scientific Becomes a Major Corona Player

Biotech Letter

Thermo Fisher Scientific (TMO) recently executed a strategic move that effectively transformed itself into a major coronavirus disease (COVID-19) player overnight.

The lab tools giant opened the month of March with a bang as it announced an $11.5 billion acquisition deal with Dutch company Qiagen (QGEN).

The transaction also includes Thermo Fisher’s assumption of Qiagen’s debts worth $1.4 billion, with the US biotechnology company paying roughly $43 per share. The deal is anticipated to be closed by the first half of 2021.

And just like that, Thermo Fisher has positioned itself at the forefront of the potential pandemic threatening to push the global economy to a recession.

What does this transaction mean to the race to solve the looming coronavirus pandemic?

Thermo Fisher and Qiagen make quite a good pair. The Massachusetts giant is a major manufacturer and developer of the CDC-approved scientific equipment used to detect Covid-19 in the US.

Meanwhile, Qiagen provided the equipment used during the SARS and swine flu outbreaks years ago.

In the past weeks since the Covid-19 outbreak, the company has been quietly working on tests for the Wuhan coronavirus as well. The latest update on this front is that Qiagen already shipped test kits for evaluation for the deadly epidemic to four hospitals in China.

Although it’s highly unlikely that Thermo Fisher splurged on an 11-figure deal for the sole purpose of getting ahead in finding the cure for the latest virus epidemic, Qiagen’s promising progress on that particular endeavor possibly nudged the big biotechnology company’s decision along.

Obviously, coronavirus test kits would eventually be huge sellers in the months and even years ahead. However, Thermo Fisher’s interest in this deal goes deeper than that.

Qiagen is a strategic addition to Thermo Fisher and could be a steady revenue source, and one of the key reasons for this collaboration is the complementary nature of both businesses.

Geographically speaking, Thermo Fisher and Qiagen can also conveniently cross-sell from each other’s existing lineups.

The Dutch company’s life sciences and molecular diagnostics solutions are expected to boost Thermo Fisher’s broader set of diagnostic offerings. Hence, this consolidation could potentially amount to approximately $200 million in savings every year in the next few years.

This isn’t the first time that Thermo Fisher wielded its huge cash flow to expand its growth segments.

In 2014, Thermo Fisher executed a $13.6 billion acquisition of genetic testing company Life Technologies. Working hand in hand, the two companies managed to contribute a 44% boost in revenue from $16.9 billion that year to $24.4 billion by 2018.

Just last year, Thermo Fisher snapped up one of the newest and most promising players in the gene therapy sector. Paying $1.7 billion to acquire Brammer Bio, the biotechnology giant secured the expansion of its cell and gene therapy pipeline.

With a free cash flow of roughly $3.9 billion in the past 12 months, the company still has room for additional acquisitions.

Amid all the major moves Thermo Fisher executed in the past five years though, the company has remained consistent in producing a strong bottom line.

Since the deal with Qiagen was announced, Thermo Fisher disclosed that it plans a 16% increase to its quarterly dividend to reach 22 cents per share compared to its current 19 cents. Moreover, the company expects a 14% growth in the next five years and projects to keep up its strong segmental performance.

Although the company’s growth level may not be as enticing for growth investors, its impressive diversification makes it an attractive investment.

Its broad mix of income from numerous segments combined with steady profits allows Thermo Fisher to provide investors the much-needed predictability and stability.

Special Pandemic Announcement

Biotech Letter, Diary, Newsletter, Tech Letter

To minimize risk to our staff while continuing to provide an excellent service to our customers, the Mad Hedge Fund Trader is going completely virtual. Of course, the fact that we are already a global virtual company makes this really easy.

All work will be done from home. Everyone has to lay in a two-month stockpile of food. If you have to leave the house, you must wear a 3M N-95 Respirator Mask (click here for the link). Make sure your Netflix account is paid up. Stay on good terms with your family. You are about to get to know them really well.

My bet is that most US companies will adopt the same policies in the coming weeks. The major Bay Area technology companies already have. The Internet was built to cope with a nuclear war. We got a biological one instead.

As long as the Internet and our key applications keep working, we should have no problem delivering our investment and trading advice several times a day as usual. Now, you have more time to read it. We have just suffered the most rapid bear market in market history with only modest trading losses. Making money from here should be like shooting fish in a barrel.

Again, thank you for supporting my research. Let’s make 2020 our best year ever!

Good Luck and Good Trading. And stay healthy.

John Thomas
CEO & Publisher
The Diary of a Mad Hedge Fund Trader