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april@madhedgefundtrader.com

Eye Spy The Next Big Thing

Biotech Letter

Who knew that the path to restored vision would involve recycling?

Not the kind where you sort plastics from paper, but the fascinating world of cellular hand-me-downs, where scientists are taking stem cells - nature's ultimate blank slate - and transforming them into made-to-order eye parts.

While most medical breakthroughs involve pills, patches, or the occasional well-placed zap of electricity, doctors have managed something far more incredible: they've successfully restored vision in multiple patients by essentially giving their eyes a cellular renovation via stem cell transplants.

But before you picture entire eyeballs being swapped out like lightbulbs, let me explain: We're talking about precision repair work at the cellular level, particularly targeting the notorious troublemakers of the vision world - macular degeneration and corneal damage.

The numbers behind this story are enough to make your eyes pop (sorry, couldn't resist).

Nearly 20 million Americans over 40 are currently living with age-related macular degeneration (AMD). That's more people than the entire population of New York City, all dealing with various stages of vision loss.

Break it down further, and you've got 18.34 million people with early-stage AMD and 1.49 million with the late-stage version, according to those number-crunchers at JAMA Network.

And once you hit 75, your chances of having AMD jump to nearly 30% - not exactly the golden years surprise package anyone's hoping for.

Here's where things get interesting - and by interesting, I mean expensive.

The National Eye Institute estimates that vision loss costs the U.S. about $139 billion annually. That's not just medical bills. It's everything from lost productivity to the cost of assistance devices and support services.

To put this in context, $139 billion could buy every resident of California a lifetime supply of carrots - though that wouldn't help their eyesight nearly as much as stem cell therapy.

Speaking of which, the stem cell therapy market, currently valued at a modest $456 million (pocket change in pharmaceutical terms), is expected to bulk up considerably, growing at a clip of 25.23% annually from 2025 to 2030.

By 2032, we're looking at a market worth $56.15 billion. That's what financial types call a growth opportunity, and what I call a lot of zeros.

Now, let’s take a look at the companies betting big on this cellular vision quest.

Lineage Cell Therapeutics (LCTX) is developing something called OpRegen, which sounds ominous but is actually a therapy using retinal pigment epithelium cells.

They must be onto something because Roche’s (RHHBY) Genentech liked it enough to throw $670 million at them in a collaboration deal.

Then there's Astellas Pharma (ALPMY), working on their own vision-restoration treatment, and Adverum Biotechnologies (ADVM), which is taking a slightly different approach with gene therapy.

Editas Medicine (EDIT) is getting even fancier, using CRISPR technology - think molecular scissors for DNA - to snip out the bad bits causing blindness.

Regenxbio (RGNX) rounds out our vision-quest dream team with their work on something called RGX-314, which uses viral vectors to deliver therapy (think of it as FedEx for genes).

The whole field of regenerative medicine, currently a $13.3 billion industry, is expected to grow exponentially, with projections showing a 23.3% annual growth rate by 2030.

That's significant considering the vision restoration market alone is worth $30 billion globally, with plenty of room to expand. Of course, that’s assuming these treatments make it through the regulatory obstacle course.

For one, there's the FDA to convince, manufacturing challenges to solve (turns out, growing eye cells at scale is tricky), and the ever-present question of who's going to pay for it all.

But given the alternative - a future where millions more lose their vision to degenerative diseases - the motivation to solve these challenges is crystal clear.

For those watching this space, I advise adding these names to your watchlist. After all, the future of vision care isn't just about getting better glasses or contact lenses anymore - it's now about regrowing the parts of the eye that wear out.

And that's a vision worth keeping an eye on (last eye pun, I promise).

 

 

 

 

 

 

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april@madhedgefundtrader.com

November 26, 2024

Biotech Letter

Mad Hedge Biotech and Healthcare Letter
November 26, 2024
Fiat Lux

 

Featured Trade:

(NO MORE EATING AT YOU)

(PFE), (LLY), (NVO), (AMGN), (RYTM), (ALT)

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april@madhedgefundtrader.com

No More Eating At You

Biotech Letter

In 1903, the original “diet miracle” was invented—tapeworm pills. Yes, people willingly ingested parasites to lose weight.

Thankfully, modern weight-loss drugs have evolved to become a bit more... palatable. Enter Pfizer (PFE), taking the pharmaceutical stage in Q3 2024 with a performance that’s anything but parasitic.

Pfizer just reported a stunning $17.7 billion in Q3 2024 revenue—a 31% year-over-year increase that has nothing to do with parasites and everything to do with strategic positioning.

But here's where it gets interesting. Even if you strip away Pfizer's COVID-19 products (which, let's face it, had their moment like platform shoes in the '70s), they're still sitting pretty with $13.6 billion in revenue.

That's a 14% operational increase that has nothing to do with our old friend coronavirus.

Meanwhile, in the weight-loss corner of the ring, Eli Lilly (LLY) and Novo Nordisk (NVO) are experiencing what we might delicately call "growing pains."

Eli Lilly reported $11.44 billion in Q3 revenue—impressive until you consider analysts expected $12.18 billion.

Novo Nordisk's story is even more peculiar. Their weight-loss wonder drug Wegovy is selling like hotcakes (irony noted) at 17.3 billion Danish krone (about $2.75 billion USD).

But here's the catch: Novo Nordisk can't make enough of it. It's the pharmaceutical equivalent of having a hit restaurant where half the menu items are perpetually "sold out."

This shortage highlights just how insatiable the market's appetite for these drugs has become.

In 2023 alone, the US market for prescription weight-loss drugs more than doubled from $5.1 billion to $11.9 billion.

Gone are the days of dubious diet pills and miracle cures. We're witnessing the dawn of scientifically backed weight management solutions.

As for Pfizer, they’re not content to watch from the sidelines. They're developing something called danuglipron (a name that sounds like it was conceived during a particularly intense game of Scrabble). It's an oral weight-loss drug currently in Phase 2B trials.

Danuglipron’s key selling point? It's an oral medication—no needles required.

As someone who once spent three months investigating the science of injection phobia for a story, I can confirm this detail matters more than you might think.

Pfizer’s plans go beyond just one drug. In the first 9 months of 2024, they invested $7.8 billion in R&D.

Their recent acquisition of Seagen has already contributed $854 million in Q3 2024 revenue, proving that their strategy of buying innovation is paying off.

In fact, they're so confident about their trajectory that they've raised their full-year 2024 revenue guidance to between $61 billion and $64 billion.

But let's talk about the elephant in the pharmacy – regulatory approval. The FDA, bless their bureaucratic hearts, has been keeping everyone on their toes with their evolving stance on weight-loss drugs and other treatments.

Still, Pfizer managed to snag approvals for two new drugs in October 2024: Abrysvo (for RSV in adults) and Hympavzi (for hemophilia).

Both approvals came through in October 2024, showing off Pfizer’s ability to navigate modern pharmaceutical regulations.

Looking globally, the weight loss and obesity management market is projected to grow from $14.51 billion in 2024 to $48.39 billion by 2034.

Of course, no good pharma story is complete without a plot twist. Pfizer's oncology drug Ibrance saw a 12% operational decrease in Q3 2024 revenue, reminding us that even pharmaceutical juggernauts can stub their toes.

And those patents? They're like time bombs ticking away in the legal department's filing cabinet.

The obesity field is attracting new players, too. Amgen (AMGN) is developing MariTide, while Rhythm Pharmaceuticals (RYTM) focuses on genetic obesity disorders.

Altimmune's (ALT) pemvidutide is showing promising Phase 2 results, adding to the increasingly crowded field of weight-loss treatments.

So, where should you park your money? Here’s a quick guide to the stocks worth scooping up when the market takes a breather.

Novo Nordisk remains the heavyweight champion of weight-loss drugs, with Wegovy and Ozempic bringing in the big bucks. Yes, they're wrestling with production issues, but their first-mover advantage and global reach make them a solid buy for the long haul.

Eli Lilly, with Mounjaro and the freshly minted Zepbound, deserves a spot in your portfolio too. Their supply chain headaches are likely temporary, and their pipeline is bursting with potential.

Pfizer, our surprising comeback kid, rounds out the list. They might be fashionably late to the weight-loss party, but their diversification strategy and that promising GLP-1 pill in development make them worth your investment dollars. Plus, their global reach could give them an edge against their competitors.

On the hold list, we’ve got Amgen and Rhythm Pharmaceuticals—stocks you might want to keep an eye on but not necessarily dive into headfirst just yet.

Amgen's MariTide shows promise, but they're playing in a very crowded pool. Rhythm's focus on genetic obesity disorders is fascinating, but they're like a promising indie band - they might hit it big, or they might not.

As for Altimmune and Viking Therapeutics? Sometimes you need to know when to fold 'em. Despite promising early results, they're up against giants with deeper pockets and better-established supply chains.

Unless you enjoy roller coasters without safety bars, consider redirecting those investment dollars elsewhere.

Looking back, we've come an astonishingly long way from those desperate days of tapeworm pills—turns out the real money wasn't in selling parasites, but in pioneering their prescription-strength replacements.

And that's the kind of progress that would make those 1903 tapeworm salesmen drop their jaws (and hopefully nothing else).

 

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april@madhedgefundtrader.com

November 21, 2024

Biotech Letter

Mad Hedge Biotech and Healthcare Letter
November 21, 2024
Fiat Lux

 

Featured Trade:

(TRACE ELEMENTS)

(SNY), (MTZPY), (BIIB), (IONS), (AMLX)

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april@madhedgefundtrader.com

Trace Elements

Biotech Letter

In a corner office somewhere in Cambridge, Massachusetts, a team of scientists is attempting something that sounds like it belongs in a sci-fi novel: they're trying to reprogram the genetic instructions that tell our neurons how to behave.

If they succeed, they might help 97% of people with ALS keep their neurons from self-destructing.

Welcome to Trace Neuroscience, where $101 million in venture capital is betting on what amounts to a molecular spell-check for your nervous system.

You might be wondering, as I did, how one starts a company with the audacious goal of tackling one of medicine's most notorious puzzle boxes.

The answer, it turns out, involves three scientists, working in three different labs, who all stumbled upon the same cellular culprit – a protein called UNC13A - the sort of name that makes you wonder if scientists moonlight as license plate generators.

But to understand why UNC13A has everyone buzzing, we need to talk about ALS itself.

ALS, if you're not familiar with it, is the kind of disease that keeps neurologists up at night. Every year, it claims about 5,000 new victims in the US alone, and we still don't know what causes 90% of cases.

Here's a simple way to envision it – think of your nervous system as a complex metropolitan subway system.

ALS is like having someone systematically shut down every station, one by one, until the entire network grinds to a halt. Despite decades of research and millions in funding, we're still mostly watching helplessly as stations go dark.

Sure, the global market for ALS treatments reached $667.3 million in 2023, but that impressive-sounding number masks an uncomfortable truth: we're still barely keeping the lights on, let alone fixing the underlying problem.

The current FDA-approved medications, Sanofi’s (SNY) Riluzole and Mitsubishi Tanabe Pharma’s (MTZPY) Edaravone (marketed as Radicava), are like trying to stop a flood with a handful of sandbags. They might slow things down a bit, but they're not exactly what you'd call a solution.

So how do you tackle a troublemaker like UNC13A? Enter Trace Neuroscience's bold approach: antisense oligonucleotides, or ASOs for those who don't enjoy tongue twisters.

Think of ASOs as tiny molecular scissors that can edit the body's protein-making instructions with surprising precision - in this case, they're specifically designed to fix how UNC13A behaves when it goes rogue.

The science behind this approach comes from a rather serendipitous confluence of research.

Aaron Gitler at Stanford, Pietro Fratta at University College London, and Michael Ward at the NIH – three scientists who probably should have just gotten a group chat going – independently discovered how certain RNA-processing molecules go haywire in ALS patients.

It's like they each found a different piece of the same puzzle, and when they put them together, the picture suddenly made sense.

And where there's breakthrough science in biotech, money usually follows.

In November 2024, Trace managed to convince some of the biggest names in venture capital – Third Rock Ventures, Atlas Venture, GV (formerly Google Ventures), and RA Capital Management – to part with $101 million.

That's quite a vote of confidence for a company whose main product is still theoretical.

The timing couldn't be more interesting. The ALS treatment market is expected to grow at a rather specific 5.8% per year until 2030, reaching about $1.1 billion.

But in this field, even the success stories come with asterisks.

Take Biogen's (BIIB) Qalsody, which got FDA-approved in May 2024 despite not actually meeting its main trial goals.

It's a rare win in a field where the scoreboard has been mostly zeros, as the rest of the ALS treatment landscape makes painfully clear.

Ionis Pharmaceuticals (IONS) had to shut down their ALS program with Biogen in May 2024, and Amylyx Pharmaceuticals (AMLX) faced the bitter task of pulling their drug Relyvrio from the market in April 2024, laying off 70% of their staff in the process.

These setbacks illuminate an uncomfortable truth about ALS drug development: the path from lab bench to pharmacy shelf is paved with perfectly logical theories that simply didn't work in real bodies.

The math is brutal - only 6.2% of neurological drugs survive the journey from Phase I to approval. Trace's response to these odds? Assemble a team that's seen enough clinical trial failures to know how to (hopefully) avoid them.

Their CEO, Eric Green, M.D., Ph.D., leads a squad that includes Chief Medical Officer Irina Antonijevic and Chief Operating Officer Megan Baierlein.

They're aiming to start clinical trials by early 2026, which in drug development terms is practically tomorrow.

For investors, timing like this transforms Trace from a scientific curiosity into a near-term catalyst.

Their approach - anchored in genetic evidence and measurable biomarkers - stands out in a field where most companies are still shooting in the dark with better bullets.

The story of Trace Neuroscience reads like molecular medicine's version of going from medieval star-gazing to GPS navigation.

While traditional ALS treatments chase symptoms, Trace is tracking proteins with the precision of an atomic clock.

They've transformed one of medicine's most frustrating puzzles into something remarkably concrete: either their molecular markers will move, or they won't.

In the biotech world, that kind of clarity is worth watching.

 

 

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april@madhedgefundtrader.com

November 19, 2024

Biotech Letter

Mad Hedge Biotech and Healthcare Letter
November 19, 2024
Fiat Lux

 

Featured Trade:

(HONEY, I SHRUNK THE MARKET CAP)

(ABBV), (BMY), (AVNX)

https://madhedgefundtrader.com/wp-content/uploads/2019/05/cropped-mad-hedge-logo-transparent-192x192_f9578834168ba24df3eb53916a12c882.png 0 0 april@madhedgefundtrader.com https://madhedgefundtrader.com/wp-content/uploads/2019/05/cropped-mad-hedge-logo-transparent-192x192_f9578834168ba24df3eb53916a12c882.png april@madhedgefundtrader.com2024-11-19 12:02:072024-11-19 12:22:39November 19, 2024
april@madhedgefundtrader.com

Honey, I Shrunk The Market Cap

Biotech Letter

If you've ever wondered what $9 billion in disappointment looks like, ask the folks at AbbVie (ABBV). They've just learned the hard way that even the most promising psychiatric drugs can pull a vanishing act worthy of Houdini when it comes to clinical trials.

Their great hope, emraclidine – a name that sounds like it could either cure schizophrenia or clean your bathtub – recently face-planted in not one, but two Phase 2 trials.

Dr. Roopal Thakkar, AbbVie's Chief Scientific Officer, probably wishes this particular day came with a reset button, as the company's experimental once-daily pill performed with all the therapeutic punch of a sugar tablet in treating schizophrenia.

Somewhere, in a parallel universe, there's probably a version of Dr. Thakkar who didn't just watch $40 billion in market value evaporate faster than a teenager's allowance at a gaming convention.

Unfortunately, in our universe, AbbVie's stock took a 12.6% nosedive to $174.43.

But here's where it gets interesting, in that peculiar way that only Wall Street can manage. While AbbVie was having its very bad, no-good day, Bristol Myers Squibb (BMY) was practically dancing in the streets.

Their shares shot up 11% faster than you can say "competitive advantage." Why? Because their own schizophrenia drug, Cobenfy (another name that sounds like it came from the same random pharmaceutical name generator), just got the FDA's blessing.

Talk about impeccable timing.

Let's put this in perspective: We're talking about a global market worth $7.90 billion in 2023, projected to balloon to $11.35 billion by 2030. And it's not just about money.

The World Health Organization tells us there are 24 million people worldwide living with schizophrenia.

In the U.S. alone, it affects between 0.25% and 0.64% of adults, according to the National Institute of Mental Health. That's roughly the population of a small city, all waiting for better treatment options.

Meanwhile, other players in this high-stakes game are making moves that would impress a chess grandmaster.

Take Teva Pharmaceutical Industries (TEVA), busy cooking up a long-acting injectable version of olanzapine.

Or Alkermes plc (ALKS), sitting pretty with their $1.17 billion in revenue for 2022, thanks partly to their own injectable antipsychotic, Aristada.

Then there's H. Lundbeck A/S (HLBBF), the Danish company that spends 18% of its $2.7 billion revenue on R&D, like a scientist with an unlimited coffee budget.

And let's not forget the plucky underdog, Anavex Life Sciences Corp. (AVXL), burning through cash like a marathon runner through calories ($31.6 million in losses for 2022) while chasing their own psychiatric breakthrough.

Their compound, ANAVEX 3-71, sounds like a droid from Star Wars but might just be the next big thing in schizophrenia treatment. Or not.

That's the beauty and terror of biotech investing – you never quite know if you're backing the next breakthrough or the next spectacular failure.

AbbVie, thankfully, isn't exactly heading for the poorhouse. Their blockbuster drug Humira raked in $21 billion in 2022 alone – enough to buy everyone in New Zealand a really nice dinner.

The truth is, navigating the biotech market is less like following a recipe and more like trying to predict where lightning will strike while riding a unicycle.

So here's your biotech shopping list, served with a side of market reality.

AbbVie's spectacular face-plant has created a buying opportunity for the patient investor (that $21 billion Humira cushion makes for a soft landing).

Bristol Myers Squibb is strutting around with their fresh FDA approval like they own the place (and right now, they kind of do).

And if you're feeling particularly adventurous, Anavex Life Sciences offers a lottery ticket that might just pay off.

Whatever you choose, just remember to keep your antacids handy.

 

https://madhedgefundtrader.com/wp-content/uploads/2019/05/cropped-mad-hedge-logo-transparent-192x192_f9578834168ba24df3eb53916a12c882.png 0 0 april@madhedgefundtrader.com https://madhedgefundtrader.com/wp-content/uploads/2019/05/cropped-mad-hedge-logo-transparent-192x192_f9578834168ba24df3eb53916a12c882.png april@madhedgefundtrader.com2024-11-19 12:00:082024-11-19 12:22:25Honey, I Shrunk The Market Cap
april@madhedgefundtrader.com

November 14, 2024

Biotech Letter

Mad Hedge Biotech and Healthcare Letter
November 12, 2024
Fiat Lux

 

Featured Trade:

(BONE OF CONTENTION)

(AMGN), (NVO), (LLY), (PFE), (VKTX), (GPCR), (AZN)

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april@madhedgefundtrader.com

Bone Of Contention

Biotech Letter

Who knew the devil could lurk in an Excel spreadsheet? More specifically, in a hidden tab that, until recently, was minding its own business like a shy teenager at a school dance.

That is, until some eagle-eyed analyst at Cantor Fitzgerald decided to right-click their way into a $12 billion nightmare for Amgen.

(If you're wondering how to find these hidden tabs yourself, just right-click on any visible tab in Excel. Though after this debacle, pharmaceutical companies might start password-protecting their spreadsheets like they're nuclear launch codes.)

The data in question concerns MariTide, Amgen's hopeful contestant in the "help-America-lose-weight" sweepstakes.

The hidden tabs revealed what the published paper in Nature Metabolism conspicuously didn't mention: bone density scans that would make an osteoporologist reach for their stress ball.

Patients receiving the 420-milligram dose saw their bone density drop by about 4% over 12 weeks - the kind of number that sends stock traders reaching for their sell buttons faster than you can say "osteoporosis."

Speaking of selling, this discovery sent Amgen's stock tumbling 7%, which in the biotech world is like watching $12 billion vanish faster than free cookies at a Weight Watchers meeting.

Amgen, doing what pharmaceutical companies do best when faced with uncomfortable data, assured everyone that their Phase 1 study doesn't suggest any bone safety concerns. (One imagines their PR team working overtime, possibly sustained by the same stress-eating habits their drug aims to curb.)

Now, let's talk about the increasingly crowded room of companies trying to help elephants become gazelles.

Novo Nordisk (NVO), the current crown prince of weight-loss drugs, is sitting pretty with Wegovy raking in 17.3 billion Danish kroner (about $2.5 billion) in just one quarter.

They're so confident they're throwing $11 billion at Catalent faster than you can say "production scale-up." That's enough kroner to buy every Danish pastry in Copenhagen, though that might defeat the purpose.

Not to be outdone, Eli Lilly's (LLY) Zepbound is showing off with weight loss results that would make Jenny Craig jealous - we're talking 21% body weight reduction.

Together with Novo Nordisk, they're expected to dominate 80% of the market, leaving other companies to fight over the crumbs like desperate dieters at a birthday party.

Still, the supporting cast is equally fascinating.

Pfizer's (PFE) danuglipron and Structure Therapeutics' (GPCR) GSBR-1290 are trying to turn these injectable drugs into pills, because apparently not everyone enjoys playing pin cushion.

Viking Therapeutics (VKTX) is getting creative with VK2735, a dual GLP-1 and glucagon receptor agonist, which is pharmaceutical speak for "two mechanisms of action are better than one."

Meanwhile, AstraZeneca's (AZN) AZD5004 is trying to join the party, though their early Phase I results are about as impressive as a rice cake at a dessert buffet.

Now, let’s take a look at the numbers. The global anti-obesity drugs market is expected to balloon from $6.15 billion in 2024 to an eye-watering $37.94 billion by 2032.

But, that seems to be just the conservative estimate. Some analysts are betting this market could hit $150 billion by the early 2030s.

So, what’s the smart move here?

For those watching this space (while probably patting their own midsections thoughtfully), the message is clear: This market is hotter than a freshman chemistry experiment gone wrong.

But as Amgen's Excel adventure shows, sometimes the devil really is in the details - or in this case, in Tab 9, hidden away like a chocolate bar in a dieter's sock drawer.

And like my old friend Deng Xiaoping used to say, sometimes you have to cross the river by feeling the stones.

Today, those stones are telling me this: hold off on buying Amgen - that bone density data isn't just a minor setback, it's a potential deal-breaker.

If you really want to take part in the action, opt for Novo Nordisk and Eli Lilly for their proven ability to execute and dominate.

And for those of you who, like me, enjoy a bit of calculated risk-taking, consider a speculative position in Structure Therapeutics and Viking Therapeutics.

Before you get too excited, though, I'd suggest limiting these speculative plays to no more than 5% of your portfolio each - promising early-stage biotechs can deliver spectacular returns, but they can also crash faster than a poorly maintained MIG-25.

 

https://madhedgefundtrader.com/wp-content/uploads/2019/05/cropped-mad-hedge-logo-transparent-192x192_f9578834168ba24df3eb53916a12c882.png 0 0 april@madhedgefundtrader.com https://madhedgefundtrader.com/wp-content/uploads/2019/05/cropped-mad-hedge-logo-transparent-192x192_f9578834168ba24df3eb53916a12c882.png april@madhedgefundtrader.com2024-11-14 12:00:442024-11-14 12:15:13Bone Of Contention
april@madhedgefundtrader.com

November 12, 2024

Biotech Letter

Mad Hedge Biotech and Healthcare Letter
November 12, 2024
Fiat Lux

 

Featured Trade:

(MEDTECH’S TRUMP CARD)

(RMD), (STE), (TNDM), (JNJ), (BDX), (MDT), (BSX), (SYK), (ZBH)

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