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Tag Archive for: (RHHBY)

Mad Hedge Fund Trader

The Biggest News in Biotech Today

Biotech Letter

It’s not typical for stock market news to alter the lives of millions of people across the globe, but this is what Biogen (BIIB) managed to accomplish this week.

The company received accelerated approval from the US Food and Drug Administration (FDA) for its controversial Alzheimer’s disease treatment, Aducanumab.

The drug, which is now marketed as Aduhelm, marks a potential breakthrough medication for over 6 million Americans suffering from the debilitating illness and to possibly billions all worldwide.  

Basically, Aduhelm targets what Biogen calls “a defining pathology of the disease” by decreasing the amyloid beta plaque levels in the brains of patients suffering from Alzheimer’s disease.

Biogen shares spiked by roughly 60% following the Aduhelm news, with the pop in the biotechnology stock even more impressive than what was initially predicted.

This latest FDA approval also brings a ray of hope for the biotechnology industry.

Biotech shares have been in a slump this year, with the SPDR S&P Biotech ETF (XBI) falling by 9.2% thus far.

Potential second-order effects of the Biogen win can easily be seen in other developers of Alzheimer’s disease treatments.

Although the moves may not be as dramatic as Biogen’s, several biotech companies benefited from the good news.

Directly benefiting from it is Japanese drugmaker Eisai (ESALY), which has been working with Biogen on Alzheimer’s disease treatment. This company’s American depository receipts climbed by 48.2% after the news broke.

Eli Lilly (LLY), which is also working on its own Alzheimer’s therapy, saw its shares go up 9.3%.

Even Roche (RHHBY), which is still in the early stages of its development of a similar treatment, enjoyed a 1.6% increase, while an under-the-radar biotech company, Denali Therapeutics (DNLI), experienced a 7.8% increase.

Other smaller companies that benefited from Biogen’s news include Sarepta Therapeutics (SRPT), Ionis Pharmaceuticals (IONS), Intercept Pharmaceuticals (ICPT), Cassava Sciences (SAVA), and Annovis Bio (ANVS).

In terms of pricing, Aduhelm is estimated to cost $56,000 per year.

Although there is still no definite number in terms of how much Aduhelm could generate in sales for the company, there have been early estimates prior to this news.

Before this accelerated approval, Aduhelm was projected to add at least $16 billion in market capitalization to Biogen.

If successful, the drug can contribute a minimum of $10 billion in sales annually—a performance that would make Aduhelm one of the best-selling drugs of all time. 

At this price point as well, the drug could peak at $5.7 billion by 2027.

Understanding that the cost is too high for some, Biogen has been working on establishing partnerships with healthcare and insurance companies to help patients cover the expenses.

So far, Biogen has been negotiating with Cigna (CI) to come up with terms to make Aduhelm available to Alzheimer’s patients via a value-based contract.

That is, the pricing will be assessed based on how responsive the patient will be to the treatment.

Biogen has also been working on collaborating with CVS Health (CVS) to develop more efficient ways to implement cognitive screenings in urban markets.

The two companies have been looking into boosting testing within underserved communities to improve early diagnosis, with the project commencing by September.

Some cities included in this initiative are Washington, D.C., Los Angeles, Dallas, Chicago, South Carolina, Atlanta, New York, Detroit, and Philadelphia.

Biogen has finally regained its momentum thanks to this accelerated and unprecedented approval.

That means we can expect Biogen to leverage this massive revenue stream to round out the rest of its programs and boost its R&D, as well as possibly compensating its shareholders with share buybacks and even dividends in the second half of this decade.

 

aduhelm

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Mad Hedge Fund Trader

May 20, 2021

Biotech Letter

Mad Hedge Biotech & Healthcare Letter
May 20, 2021
Fiat Lux

FEATURED TRADE:

(REGENERATED REGENERON)
(REGN), (PFE), (JNJ), (AMGN), (BMY), (GILD), (MRK), (LLY), (SNY), (BAYRY), (NVS), (RHHBY)

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Mad Hedge Fund Trader

Regenerated Regeneron

Biotech Letter

The biotechnology and healthcare sectors have become attractive investment targets for investors who recognize the value and essence of these industries along with the possible risks associated with them.

While not all companies in these areas are great investments, some offer remarkable growth opportunities.

One company worth considering is Regeneron (REGN), with its strong and stable investment thesis and steady organic growth.

Regeneron joins the ranks of Pfizer (PFE) and Johnson & Johnson (JNJ) as one of the handful of biopharmaceutical companies to release solid first quarter results this 2021 compared to other big names in the industry, including Amgen (AMGN), Bristol Myers Squibb (BMY), Gilead Sciences (GILD), Merck (MRK), and Eli Lilly (LLY). 

The New York-based company reported a 38% boost in its revenue compared to the same period in 2020, reaching $2.5 billion for the first quarter of 2021 alone.

Virtually all of Regeneron’s products generated solid growth during this period, with the company’s COVID-19 antibody cocktail REGEN-COV delivering the highest sales at $262 million.

To underscore just how significant REGEN-COV is to Regeneron this quarter, its absence from the roster would take away 18% from the company’s overall revenue growth.

Riding the momentum of its COVID-19 program, Regeneron has developed Inmazeb, which is a treatment for Ebola virus infection.

Aside from its COVID-19 antibody cocktail, Regeneron also saw an impressive boost in the performance of its atopic dermatitis drug Dupixent.

Dupixent, which Regeneron sells in partnership with Sanofi (SNY), generated $1.26 billion in sales in the first quarter, showing off a notable 48% increase from its 2020 report.

Although Dupixent is a shared product with Sanofi, this dermatitis drug holds incredible promise for Regeneron.

To date, only 6% of eligible patients are being treated with Dupixent. This indicates a massive space that is yet to be explored by both companies.

Taking into consideration the pace at which Dupixent has been growing so far, this drug is projected to peak at roughly $12.5 billion in sales in the coming years.

Another high-selling drug for Regeneron is wet age-related macular degeneration (AMD) treatment Eylea.

Sales for this drug, which was developed in collaboration with Bayer (BAYRY), went up from $1.2 billion in the first quarter of 2020 to $1.3 billion this year.

The increase in sales for Eylea is a welcome surprise for both Regeneron and Bayer, especially since more and more competitors are attempting to topple the drug as the top product in the niche.

Cornering the AMD segment is an attractive venture for any biopharmaceutical company.

After all, Eylea generated $4.9 billion in sales in 2020 from the US market alone.

Thus far, two main competitors have come forward as the strongest.

One is Novartis (NVS), which released Beovu in 2019.

The second, and possibly the stronger competitor between the two, is Roche (RHHBY) with Faricimab.

To ensure its dominance in the AMD market, Regeneron has been expanding the use of Eylea.

The latest development is the drug’s enrollment in the Phase 3 program, which would allow extended periods in between treatments but still deliver the same level of efficacy and safety.

Aside from these, Regeneron is looking into additional revenue streams ahead.

One growth segment is its oncology program, particularly its cancer drug Libtayo, which may soon be marketed to cover a fourth type of cancer.

Regeneron aims to submit Libtayo for review as a treatment for advanced cervical cancer.

On top of this, the drug is also a strong contender in the development of several antibody treatments.

Thus far, the company has 12 oncology antibodies under clinical development.

Overall, Regeneron’s strong results for the first quarter of 2021 highlighted its continuous evolution into a company carrying multiple and diverse portfolios of products and pipeline programs that address an extensive range of serious diseases, from COVID-19 and rare diseases to cancer.

regeneron

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Mad Hedge Fund Trader

April 27, 2021

Biotech Letter

Mad Hedge Biotech & Healthcare Letter
April 27, 2021
Fiat Lux

FEATURED TRADE:

(THE FUTURE OF MEDICINE)
(CRSP), (VRTX), (EDIT), (NTLA), (PFE), (NVS), (GILD), (RHHBY),
(BMRN), (QURE), (SGMO), (CLLS), (ALLO), (BEAM)

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Mad Hedge Fund Trader

The Future of Medicine

Biotech Letter

Winning the Nobel Prize in 2020 provided biotechnology companies more traction on Wall Street.

The victory led to commercializing the 2012 discovery, Crispr-Cas9, at breakneck speed, with gene editing companies like CRISPR Therapeutics (CRSP), Editas Medicine (EDIT), and Intellia Therapeutics (NTLA) gaining considerable boost in their values.

Since then, the total market value for the products of these three has more than doubled in recent months to reach $23 billion.

Basically, Crispr-Cas9 functions like molecular scissors.

What makes this technology incredible is that Crispr-Cas9 can classify a single address out of 3 billion letters within the genome by using only a particular sequence. With this, we can repair thousands of genetic conditions and even offer more potent ways to battle cancer.

The market favorite among the gene editing companies so far is CRISPR Therapeutics, with $8.72 billion in market capitalization.

In comparison, Editas has $2.76 billion while Intellia Therapeutics has $4.15 billion.

CRISPR Therapeutics is currently working on a treatment that would implant tumor-targeting immune cells in cancer patients. The company is also prioritizing therapies that could edit cells to treat diabetes.

So far, it has made significant progress in developing treatments for a genetic disorder called sickle cell.

In the US alone, at least 100,000 people suffer from sickle cell disease, with 4,000 more born every year. Conservatively, we can estimate at least 3,000 patients availing of this one-time treatment at over $1.6 million a pop. 

To date, CRISPR Therapeutics has five candidates under clinical trials for diseases like B-thalassemia, sickle cell disease, and other regenerative conditions.

It has four more queued, which target diabetes, cystic fibrosis, and Duchenne muscular dystrophy.

Compared to its rivals in the space, it’s clear that CRISPR Therapeutics is ahead when it comes to product development and trials.

Two of its candidates, transfusion-dependent beta thalassemia treatment CTX001 and sickle cell disease therapy CTX110, have already been submitted for clinical tests for safety and efficacy.

Recently, Vertex (VRTX) boosted its 2015 agreement with CRISPR Therapeutics by 10%, with the deal reaching $900 million upfront to push for quicker results in developing CTX001.

This is a crucial move for Vertex, but more so for CRISPR Therapeutics as CTX001 holds a highly lucrative addressable market.

The additional funding significantly widened the gap between the Vertex-CRISPR team and bluebird bio (BLUE) in the race to launch a new gene editing therapy targeting sickle cell disease and beta thalassemia.

To sustain its growth, CRISPR Therapeutics’ strategy is to develop drugs that only require mid-level complexity but can rake in generous financial rewards.

This is a similar tactic used by bigger and more established biotechnology companies like Pfizer (PFE), Novartis (NVS), and Gilead Sciences (GILD).

Evidently, this strategy is a great way to ensure cash flow.

Aside from its earning from the commercialization of these products, CRISPR Therapeutics can also attract larger companies to buy the intellectual property of their breakthrough treatments.

After all, startups generally get 100% premiums in contracts with Big Pharma.

Good examples of this are Novartis that bought AveXis and Roche’s (RHHBY) purchase of Spark Therapeutics.

The Roche-Spark agreement led to the first-ever FDA-approved treatment since gene therapy trials started in the 1990s. It was for the genetic blindness therapy Luxturna, which received the green light in 2017.

The second approved treatment was a muscle-wasting disease therapy Zolgensma, which was the fruit of the Novartis-Avexis acquisition.

Both conditions are rare, but the financial rewards are impressive.

At $2 million for each treatment, Zolgensma sales reached $1.2 billion annually. At the rate the therapy is selling, Novartis estimates that Zolgensma will surpass the $2 billion mark in 2021.

Novartis and Roche aren’t the only ones partnering with smaller gene editing companies.

Pfizer has been working with biotechnology companies BioMarin Pharmaceutics (BMRN) and UniQure (QURE) to develop a treatment for blood-clotting disorder hemophilia.

The COVID-19 frontrunner is also collaborating with Sarepta Therapeutics (SRPT) to come up with a treatment for Duchenne muscular dystrophy.

Gene editing has also served as the foundation for several biotechnology companies out there today like Sangamo Therapeutics (SGMO), Cellectis (CLLS), and Allogene Therapeutics (ALLO).

The market size for gene editing treatments is estimated to be worth $11.2 billion by 2025, with the number rising between $15.79 billion to $18.1 billion by 2027.

This puts the compounded annual growth rate of this sector to be at least roughly 17%.

While this is already groundbreaking with only a handful of companies knowing how to utilize the technology, the gene editing world has come up with a more advanced technique than Crispr-Cas9.

The technology is founded on the “base editing” or “prime editing” technique, which is the simplest type of gene editing that alters only one DNA letter.

So far, one company holds exclusive rights to this technology: Beam Therapeutics (BEAM).

When the technology became public, Beam stock has increased sixfold since its IPO in February 2020.

This latest development can resolve thousands of genetic diseases. However, it still requires further trials since “base editing” can also trigger damaging responses from the body.

Overall, I think CRISPR Therapeutics is the safest among these high-risk stocks.

The data from two of its candidates, CTX001 and CTX110, are incredibly promising. Plus, the added funding from Vertex boosts the confidence of investors that regulatory approval is well on its way.

The company is also capitalizing on the surging price of its stock and investing aggressively across different rare disease programs.

While the company has yet to be considered a major force in the biotechnology world, the potential multiple successes of its products could generate a company worth hundreds of billions.

This potential alone offers an investing opportunity with a substantial asymmetric advantage for its current share price.

However, bear in mind that the stock is still a risk and should be played as a long-term investment. Hence, you should buy on dips.

crispr

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Mad Hedge Fund Trader

April 15, 2021

Biotech Letter

Mad Hedge Biotech & Healthcare Letter
April 15, 2021
Fiat Lux

FEATURED TRADE:

(BET ON THIS BIOTECH STALWART)
(BIIB), (LLY), (RHHBY), (SAGE)

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Mad Hedge Fund Trader

Bet On This Biotech Stalwart

Biotech Letter

Biogen’s (BIIB) move to develop the first approved treatment for Alzheimer’s disease remains the biggest story in the biotechnology industry.

Now, we’re down to the waiting part of the process as the US Food and Drug Administration reviews the drug, Aducanumab.

If successful, then Aducanumab could generate a whopping $12 billion in peak sales.

The approval could also push Biogen stock up to $400. Meanwhile, a failure could let it spiral to $200.

Aside from the United States, Biogen has also applied for approval in Europe and Japan.

Apart from Aducanumab, Biogen has another Alzheimer’s disease treatment candidate, Gosuranemab.

For comparison, Aducanumab targets the amyloid plaque in the brain while Gosuranemab targets another kind of brain protein, called tau. This candidate is currently undergoing a Phase 2 trial, with results expected to be released by June this year.

While there’s still not much to go on in terms of the efficacy of Gosuranemab, positive data from its study is estimated to push Biogen stock to reach into the $350 ballpark if we base it on previous movements involving Aducanumab.

Although Biogen is definitely the face of the race to find an approved treatment for Alzheimer’s disease, it’s not alone.

To date, its strongest competitors are Eli Lilly (LLY) with Donanemab and Roche (RHHBY) with Gantenerumab.

Outside its Alzheimer’s disease programs, Biogen has been working with Sage Therapeutics (SAGE) on another potential blockbuster.

The two companies have been developing a depression drug, Zuranolone, and the data so far have offered promising results.

Like Gosuranemab, Biogen expects data on the study in the first half of 2021 as well.

If the study on Zuranolone turns out positive results, then Biogen shares are projected to jump by as much as $72.

While all these are promising, less aggressive investors may not find Biogen a suitable investment at this point. Evidently, the stock brings with it a lot of risks.

Aside from the uncertainty of its Alzheimer’s programs, there’s also the ongoing patent battle involving one of its top-selling drugs, multiple sclerosis treatment Tecfidera.

When the company lost its patent exclusivity, the FDA started to approve generic versions of Tecfidera.

This is a major concern for Biogen since Tecfidera is a substantial revenue source.

For context, this drug generated $4.4 billion in sales in the US in 2019 alone. By 2020, sales dropped to $2.6 billion.

Now, sales for this drug are estimated to reach only $1.6 billion in 2021.

While Biogen appealed its loss of patent exclusivity, the company has already taken steps to continue benefiting from Tecfidera’s success.

An obvious effort is the launch of a newer and more potent multiple sclerosis drug, Vumerity.

To attract patients and retain its customers, Biogen has been marketing Vumerity as a more powerful and effective version of Tecfidera.

In terms of the uncertainty brought by Aducanumab, it’s true that gaining FDA approval would have the Biogen stock skyrocketing.

However, rejection won’t be as devastating to the stock. While shares are expected to fall if that happens, the suffering would be short-term.

In the long run, Vumerity will gradually gain traction and eventually reach the level of success of Tecfidera, while the rest of Biogen’s pipeline programs hold the potential to add to the company’s revenue stream.

After all, Biogen is one of the first names that comes to mind when you hear the word “biotech.”

Founded in 1978, this biotechnology company has amassed a market capitalization of more than $40 billion and multiplied its annual profit to over 200%.

While its gamble on finding a treatment for Alzheimer’s disease is a risk that not a lot of investors would be willing to take, Biogen still holds one of the most promising pipeline programs in the industry and a portfolio of existing drugs with notable potential.

Going forward, approval for Aducanumab would mean a massive year for shareholders of Biogen.

If not, then this is still a respectable company with strong rewards and worth investing in, especially if you buy the dips.

https://madhedgefundtrader.com/wp-content/uploads/2019/05/cropped-mad-hedge-logo-transparent-192x192_f9578834168ba24df3eb53916a12c882.png 0 0 Mad Hedge Fund Trader https://madhedgefundtrader.com/wp-content/uploads/2019/05/cropped-mad-hedge-logo-transparent-192x192_f9578834168ba24df3eb53916a12c882.png Mad Hedge Fund Trader2021-04-15 16:00:192021-04-20 00:27:54Bet On This Biotech Stalwart
Mad Hedge Fund Trader

April 13, 2021

Biotech Letter

Mad Hedge Biotech & Healthcare Letter
April 13, 2021
Fiat Lux

FEATURED TRADE:

(MEGA CAP PHARMA UP FOR GRABS)
(MRK), (ABMD), (ILMN), (ALGN), (JNJ), (GILD), (PAND), (ALKS), (IMV)

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Mad Hedge Fund Trader

Mega Cap Pharma Up for Grabs

Biotech Letter

Since the great 2007 financial crisis, many companies have been coping to recapture their former glory. The healthcare industry is not spared of this struggle.

This makes the continuous growth of Merck (MRK) all the more impressive, with the company reaching $195 billion in market capitalization and sustaining its rise for over 130 years.

Curiously, Merck’s share price is still in the mid-$70s.

Meanwhile, other large-cap biopharmaceutical companies that offer similar products and services are trading higher.

For instance, the share price for Abiomed (ABMD) is over $330 while Illumina (ILMN) is nearly $400, and Align Technology (ALGN) is at a whopping $600.

Like Merck, investors gravitate towards Abiomed, Illumina, and Align because of their capacity to generate long-term sustainable revenues and boost earnings.

Notably, though, none of them hold the same depth or even breadth of products and services that Merck offers.

Recently, Merck disclosed some of its initiatives to boost the company’s earnings in the near- and long term.

One of the most visible efforts is its collaboration with Johnson & Johnson (JNJ) to help with the manufacturing of JNJ-78436735, in which Merck received federal funding. 

While JNJ is one of the biggest healthcare companies across the globe, with a market capitalization of roughly $425 billion, joining forces with Merck will substantially boost its vaccine manufacturing capacity.

For context, JNJ’s goal prior to Merck’s help is to deliver 100 million doses by the end of the second quarter of 2021.

With Merck’s assistance, JNJ can now realistically manufacture up to 3 billion doses in 2022 alone.

This means that JNJ can implement a massive vaccination drive in the next two years since its manufacturing capacity ensures that it can deliver shots to over one-third of the population.

This is obviously good news for everyone as it means that the virus will be contained, but the enhanced manufacturing capacity also means profit accretion for both JNJ and Merck.

This partnership with JNJ is possibly a key factor in Merck’s move to invest heavily in the vaccine business.

Merck recently announced its plans to allocate $20 billion to expand its global vaccine manufacturing network from 2021 to 2024. This would mean an annual investment of $5 billion.

Part of this global vaccine plan is Merck’s acquisition of Pandion Therapeutics (PAND) in 2020.

Another recent initiative of the company is its joint effort with Gilead Sciences (GILD) to develop long-lasting HIV treatments.

Gilead will be in charge of the US market, while Merck will handle the EU and the rest of the international markets.

For starters, the companies will focus on a combination of Merck’s Islatravir and Gilead’s Lenacapavir to create a long-lasting and well-tolerate HIV treatment.

Outside these partnerships, Merck has been working on strengthening its oncology segment.

In fact, its top-selling drug, Keytruda, can be used to medicate an extensive range of indications, which include colorectal, esophageal, and even lung cancers.

At this point, Keytruda is generating north of $16 billion in sales every year and exhibiting roughly 30% growth annually.

Since the drug continues to gain approvals for additional indications, it looks like its growth runway is definitely far from over.

Keytruda is poised to reach $24 billion in annual sales in a few years’ time, which puts it on track to become the best-selling drug in the world by 2023.

Although Keytruda will be under patent protection until 2028, Merck remains active in expanding its oncology pipeline.

By then, Merck is projected to have multiple immunotherapy staples in its portfolio not only derived from its own R&D but also via partnerships like its 2020 collaboration with Alkermes (ALKS) to work on an ovarian cancer study and Immunovaccine (IMV) to cooperate on a blood cancer study.

The total oncology market is estimated to be $200 billion annually, with over 30 million cases projected to be added by 2040.

Overall, Merck is a well-oiled company that continues to deliver good results thanks to strategic acquisitions and partnerships neatly tied up together in a particular domain.

While its rival biotechnology and pharmaceutical companies become hot properties in the market and pose higher price tags, Merck silently moves forward in the shadows of sustainability and familiarity.

merck company

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Mad Hedge Fund Trader

April 8, 2021

Biotech Letter

Mad Hedge Biotech & Healthcare Letter
April 8, 2021
Fiat Lux

FEATURED TRADE:

(A LOW-KEY POST-COVID-19 RECOVERY STOCK)
(REGN), (MRNA), (NVAX), (BNTX) (PFE), (VIR), (LLY), (RHHBY), (NVS)

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