Mad Hedge Biotech and Healthcare Letter
November 26, 2024
Fiat Lux
Featured Trade:
(NO MORE EATING AT YOU)
(PFE), (LLY), (NVO), (AMGN), (RYTM), (ALT)
Mad Hedge Biotech and Healthcare Letter
November 26, 2024
Fiat Lux
Featured Trade:
(NO MORE EATING AT YOU)
(PFE), (LLY), (NVO), (AMGN), (RYTM), (ALT)
Mad Hedge Biotech and Healthcare Letter
December 12, 2023
Fiat Lux
Featured Trade:
(A REBOUNDING BLUE CHIP)
(PFE), (LLY), (NVO), (RHHBY), (AZN), (SGEN), (VKTX), (TERN), (GPCR), (ALT)
In the maelstrom of 2023, Pfizer (PFE) found itself navigating through a tempest, much to the dismay of shareholders. The aftermath? A harrowing -40% total return loss, leaving shareholders reeling.
This downturn followed Pfizer's COVID-19 vaccine triumph, a success story that lost its sheen as global government demand for the vaccine and Paxlovid antiviral dwindled.
Looking back, Pfizer's narrative in 2023 could rival a Shakespearean tragedy. The demand dip for its COVID arsenal was just the beginning; a cascade of other factors compounded the company's misfortunes.
Take, for instance, the controversial $43 billion acquisition of Seagen (SGEN) in March. While this move aimed for cancer treatment breakthroughs, it was widely seen as a Hail Mary, signaling gaps in Pfizer's drug pipeline.
I estimate this strategy might have slashed shareholder value by at least 10%, given the immediate financial aftermath of the merger.
Then, adding to the woes, Pfizer's Nash County production facility in North Carolina faced devastation by a tornado in July.
It seemed as though, for Pfizer in 2023, trouble came not just in droves but in torrents.
The final blow? The discontinuation of the twice-daily dose development for Danuglipron, Pfizer's weight-loss drug candidate.
This decision casts a shadow over the prospects of its once-a-day dosage, still in trials, and simultaneously cracks open the door for other biotech players in the oral weight-loss drug arena.
Meanwhile, the company also aimed to join the race for obesity treatment innovation. In this arena, injectable weight-loss drugs from Eli Lilly (LLY) and Novo Nordisk (NVO) have set the stage, and now, the demand for oral solutions is burgeoning.
Pfizer once pegged this market's potential at an eye-watering $90 billion a year — a target that has not gone unnoticed by keen biotechs.
Yet, with Pfizer stepping back from its Danuglipron project due to adverse side effects, it finds itself trailing in this race. In comparison, Lilly and Novo are forging ahead with their products, turning Pfizer's stumble into a potential windfall for other biotech firms.
Notably, the biotech sector is witnessing a flurry of activity in response to Pfizer’s failed attempt.
Firms like Viking Therapeutics (VKTX), Terns Pharmaceuticals (TERN), Structure Therapeutics (GPCR), and Altimmune (ALT) have seen their share prices soar following their own positive trial results or strategic announcements.
The diverse approaches these biotechs are employing in their anti-obesity drug development have piqued investors’ interest.
In effect, speculation is rife about which one might emerge as a desirable acquisition target for Pfizer — and this speculation isn't without basis.
I previously shared that Roche Holding (RHHBY) recently acquired Carmot Therapeutics for $2.7 billion, and AstraZeneca (AZN) entered a licensing agreement with Eccogene.
With a history of significant acquisitions, Pfizer might well consider a similar path to address its challenges in the weight-loss pill sector.
Pfizer's journey through 2023 was a series of unfortunate events, to say the least. As we look to the future, questions about potential challenges in 2024 loom.
While major acquisitions seem unlikely in the wake of the Seagen deal, shareholder sentiment is fragile. The immediate risks for Pfizer include the possibility of a 2024 recession impacting sales and a generally bearish stock market, potentially keeping share prices around the $30 mark.
Historically, however, Pfizer has stood as a bastion of strength during recessions and bear markets.
Looking longer term, the specter of Medicare drug price negotiations looms large, threatening to dampen growth investor sentiment.
This challenge isn't unique to Pfizer; it's a cloud hovering over all of Big Pharma.
Yet, despite these formidable challenges, there's a sense that Pfizer's tumultuous 2023 journey might be approaching a pivotal turning point. Investor sentiment is at a nadir, marred by negative press and shareholder dissatisfaction, painting Pfizer as a stock currently out of favor.
As we look ahead into 2024, a cautious optimism emerges. Should Pfizer return to operational normalcy and continue to reduce its reliance on COVID-related sales — now a smaller part of its business — the company could reassert itself as a prime value and dividend player in the Big Pharma space.
For the resilient investor willing to delve into a bruised yet potentially rebounding blue-chip, Pfizer merits a closer examination. After a year where Murphy's Law seemed the only law, Pfizer stands as a beacon of resilience and a potential phoenix in the biotech and healthcare sector.
Mad Hedge Biotech and Healthcare Letter
May 9, 2023
Fiat Lux
Featured Trade:
(WEIGHT LOSS DRUGS: THE NEXT BIG THING OR JUST HYPE?)
(LLY), (NVO), (PFE), (JNJ), (AMGN), (ALT)
Selling hot products and crushing the competition is where the real money's at. However, the challenge is to avoid falling for the hype. You need to assess a company's growth to know if it's worth investing in for the long haul.
If you have heard of tirzepatide, then you know that this drug has taken the pharma world by storm, making Eli Lilly (LLY) the talk of the town. In fact, this popular treatment helps patients drop more than 20% of their weight. No wonder it's got everyone hyped up.
But it's not just Eli Lilly that's causing a stir. Novo Nordisk (NVO) has a similar drug that's making waves, too.
In the world of pharmaceuticals, few drugs have generated as much buzz as Lilly's tirzepatide and Novo's semaglutide. These medications are projected to be among the top sellers of the decade.
These game-changing treatments have joined the ranks of iconic meds like the birth control pill, Prozac, and Pfizer’s (PFE) Viagra.
As expected, the share prices of both Eli Lilly and Novo Nordish have gone through the roof. They're already valued at around $400 billion each, placing them right behind industry leader Johnson & Johnson (JNJ).
Still, drug development is unpredictable.
A recent reminder of this was the biotech company Altimmune's (ALT) disclosure in March that a significant number of patients in a closely watched trial of its new weight-loss drug dropped out due to gastrointestinal issues.
That’s why it's essential to distinguish between opportunity and hype. More importantly, it’s critical to determine what exactly makes Lilly's tirzepatide and Novo's semaglutide so game-changing.
First, it's crucial to know that these two drugs come in various forms and are marketed for different conditions.
Novo's semaglutide is sold under the names Ozempic and Wegovy for Type 2 diabetes and obesity treatment, respectively, as well as Rybelsus, a pill for Type 2 diabetes. Lilly's tirzepatide, on the other hand, is currently only available as Mounjaro, an injection for Type 2 diabetes, but may soon have a new name added to the roster.
The real revolutionary aspect of these drugs is their effectiveness in lowering blood sugar and promoting weight loss. They mimic natural hormones that stimulate insulin production and slow digestion, making people feel fuller for longer.
Weight loss has long been a tricky area for drug development, with previous attempts being either ineffective or dangerous, resulting in many weight loss drugs being removed from the market.
But these drugs from Novo and Lilly are proving to be safe, albeit with significant side effects, and their efficacy is impressive.
In one trial, patients using Lilly's tirzepatide lost an average of 22.5% of their body weight, while patients on Novo's semaglutide lost 14.9% of their body weight in a separate trial. By comparison, a previous Novo drug called Saxenda only cut patients' body weights by 7.4%.
Another pressing question is about the availability of these drugs.
Mounjaro and Novo's Ozempic, Wegovy, and Rybelsus are already available on the market but have been in high demand and short supply.
To address this issue, both companies have announced plans to increase production. In April, Novo revealed that it had secured a new contract manufacturer, while Lilly has stated that it plans to double its production capacity for Mounjaro and similar drugs by the end of 2023.
Considering the market size and potential for these treatments, it comes as no surprise that competitors are already emerging.
Pfizer is currently developing a similar pill to tirzepatide and semaglutide, while Amgen (AMGN) is testing a weight-loss drug that uses a different mechanism.
Lilly has other weight-loss drugs in its pipeline, including a pill called orforglipron, which could launch in 2027. This is projected to generate $9.9 billion in sales in 2030.
Despite the emergence of competition, the weight-loss market is substantial enough to accommodate several drugs. Sales of obesity drugs are estimated to reach $30 billion by 2030, not including the Type 2 diabetes indication.
It's no secret that obesity and Type 2 diabetes are among the most prevalent health issues affecting millions worldwide. But did you know that the combined market for drugs targeting these conditions is expected to skyrocket to $90 billion globally by 2030?
Given the alarming statistics provided by the Centers for Disease Control and Prevention, such a staggering figure is not hard to fathom.
Almost 42% of American adults are obese, and about one in ten have diabetes. No wonder drug companies are racing to develop effective treatments to cater to this massive patient pool.
But what's interesting is that these drugs, which are not curative, could be a cash cow for pharmaceutical companies, as patients will likely need to take them for a long time.
This is why it’s easy to be bullish on the earnings potential of drugs like Mounjaro, with estimates for peak sales ranging from a heady $100 billion a year to a still impressive $40 billion.
In the pharmaceutical industry, buzz-worthy drugs are a dime a dozen, but game-changing medications that can revolutionize an entire market are few and far between.
Lilly's tirzepatide and Novo's semaglutide are just that.
These drugs have demonstrated significant weight loss in patients and are projected to be top sellers for the next decade. Despite the risks, Lilly and Novo's drugs are impressive, as they mimic natural hormones in the body, stimulate insulin production, and slow digestion to promote weight loss.
With the weight-loss market projected to reach staggering amounts by 2030, the potential is significant, but drug development is unpredictable, and competitors will inevitably emerge. Needless to say, investors must determine if these drugs' sky-high expectations are already factored into current share prices or if there's still room for growth.
While the weight-loss drug race is far from over, it’s clear that Lilly and Novo are off to a good start.
Global Market Comments
March 31, 2020
Fiat Lux
Featured Trade:
(MORE PLAYERS ENTER THE RACE FOR A CORONA CURE)
(MRNA), (ARCT), (JNJ), (SNY), (GOVX), (ALT), (NVAX), (GSK), (GNBT), (VXL.V), (INO), (APDN), (CADILAHC)
Mad Hedge Biotech & Healthcare Letter
March 31, 2020
Fiat Lux
Featured Trade:
(MORE PLAYERS ENTER THE RACE FOR A CORONA CURE)
(MRNA), (ARCT), (JNJ), (SNY), (GOVX), (ALT), (NVAX), (GSK), (GNBT), (VXL.V), (INO), (APDN), (CADILAHC)
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.
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