(BIIB) Archives - Page 3 of 13 - Mad Hedge Fund Trader

From Memory Lapses To Market Leaps

In the intricate maze of Alzheimer's disease (AD) research, many pharmaceutical pioneers have found themselves at dead ends. Over the past decades, the quest for groundbreaking AD treatments has seen numerous experimental drugs falter. Yet, against this backdrop, Biogen (BIIB) stands out, having secured approvals for two AD drugs within a span of just a few years.

Given this remarkable achievement, one might expect Biogen's shares to be soaring. Surprisingly, the company's stock performance has been underwhelming.

Biogen's first AD therapy, Aduhelm, received approval in mid-2021. Yet, its introduction to the market was not without challenges. The approval of Aduhelm was mired in controversy due to inconclusive data regarding its effectiveness, leading to hesitancy among many physicians. This raised eyebrows among investors, questioning the drug's potential return on investment.

However, the real game-changer lies in Biogen's second AD drug, Leqembi, which entered the market this year. Developed in partnership with Japan-based Eisai (ESAIY), the two companies will equally share the profits and losses.

For investors, this partnership signifies a shared risk and potential for significant returns. Analysts have varying estimates regarding Leqembi's sales potential, with some projecting revenues of $3 billion by 2028. Such projections can translate to substantial earnings per share, making it a focal point for stock market enthusiasts.

Forecasts suggest that the Alzheimer’s disease (AD) sector will witness a significant expansion, with an anticipated compound annual growth rate of 20.0%, escalating from $2.2 billion in 2020 to a staggering $13.7 billion by 2030 in the primary eight markets, namely, eight major markets the United States, France, Germany, Italy, Spain, the United Kingdom, Japan, and urban China.

Considering the cautious approach after the Aduhelm situation, the market might be hesitant about making bold predictions for Leqembi. However, from an investment standpoint, Leqembi's financial trajectory appears promising. With a set annual list price and a growing patient base, the drug's revenue stream is poised for growth. For investors, this means a potential uptick in stock value and dividends in the coming years.

Diving deeper into Biogen's portfolio, the company's pipeline includes specific assets like BIIB080, an antisense oligonucleotide therapy targeting tau, a protein buildup in Alzheimer's patients' brains. There's also BIIB121 for Parkinson's Disease and BIIB124 for Essential Tremor. These assets, if approved, could open up new revenue streams, making Biogen's stock even more attractive.

Beyond its neuro portfolio, Biogen is diversifying its offerings. In August, the U.S. Food and Drug Administration (FDA) approved Zurzuvae, a medicine developed with Sage Therapeutics (SAGE) for postpartum depression (PPD). However, the FDA declined its use for major depressive disorder (MDD), a much larger market. Needless to say, this decision impacts the company’s potential revenue.

Further solidifying its position in the biotech market, Biogen is in the process of acquiring Reata Pharmaceuticals for $7.3 billion.

This acquisition brings Skyclarys, a treatment for Friedreich's ataxia, under Biogen's umbrella. Reports suggest that the market for drugs treating Friedreich's ataxia could surpass $2 billion annually by 2030.

So, what's the bottom line?

Biogen is proactively addressing its challenges, diversifying its portfolio, and showing potential for growth. While there are uncertainties, the company's strategic moves in the biotech space make it a contender for portfolio inclusion. For those with a keen eye on biotech stocks, the company offers both risks and rewards. Its recent approvals and acquisitions signal potential growth, but as with all investments, due diligence is crucial.

In the ever-evolving world of biotech investments, Biogen evidently stands as a company with potential. Its endeavors in Alzheimer's treatments, strategic partnerships, and acquisitions position it as a stock to watch. While challenges remain, the company's trajectory suggests a promising future, making it a consideration for investors seeking growth in the biotech sector. I suggest you buy the dip.

July 13, 2023

Biotech Letter

Mad Hedge Biotech and Healthcare Letter
July 13, 2023
Fiat Lux

Featured Trade:

(A ROCKY ROAD TO REDEMPTION)
(BIIB), (ESALY)

A Rocky Road to Redemption

Biotech Letter

In an era marked by dynamic biotech developments, Biogen (BIIB) had once emerged as an industry powerhouse, the fruitful labor of its innovative multiple sclerosis drugs catapulting revenues into the stratosphere.

Unfortunately, time revealed a looming issue as the company's marquee products confronted diminishing exclusivity: stagnation.

Confronted by the precipice of change, Biogen made a strategic pivot toward the complex world of Alzheimer's disease. In partnership with the Japanese pharmaceutical giant Eisai (ESALY), they trailblazed the development of Leqembi, a game-changer that recently bagged the much-coveted traditional approval from the U.S. Food and Drug Administration (FDA).

The stamp of approval from federal authorities signifies a significant advancement towards broadening the drug's reach. Earlier in the year, the Centers for Medicare and Medicaid Services pledged to shoulder a considerable portion of the cost of Leqembi, contingent on the FDA's full authorization.

This commitment brings relief to aging American beneficiaries of Medicare, lightening the load of the drug's yearly $26,500 bill.

Armed with the FDA's endorsement and CMS agreeing to shoulder most of the expenses, there is anticipation that thousands, if not tens of thousands, of Alzheimer's patients across the US will be prescribed either lecanamab or donanemab in the imminent years.

But a question remains: Will this approval be sufficient to invigorate BIIB, a stock that has languished in the doldrums for the past decade?

Leqembi has been projected to become a blockbuster in a few years, with its total sales expected to exceed $12 billion from 2023 to 2028. Although Biogen and Eisai will be splitting the profits, Leqembi's potential as a significant asset for Biogen cannot be overlooked.

The imperative to treat Alzheimer's disease is grave, considering the current 6 million Americans living with the condition, a figure which could potentially burgeon to 13 million by 2050.

Disturbingly, this affliction claims more elderly lives than breast and prostate cancer combined.

In relation to this, the worldwide Alzheimer's therapeutics market is estimated to record a compound annual growth rate of 16.2% stretching into 2030, when it is anticipated to hit a worth of around $15.6 billion.

Eisai had earlier projected that Leqembi's peak sales could rake in a lucrative $7.3 billion by 2030. Meanwhile, experts believe the figure would be closer to $13 billion.

So, why didn't Biogen's shares experience a bounce on the back of this news?

They actually dipped by 3.5% in the trading session, and overall, the stock has remained relatively stable this 2023.

The answer lies in what happened last autumn when Biogen saw a nearly 40% surge in a single day when it announced Leqembi's successful achievement of clinical trial objectives. Given the positive data, investors largely anticipated an approval, suggesting that this recent positive update was already baked into the stock price.

What then about the future revenues?

Considering that Biogen isn’t exactly launching an “everyday pill,” there might be issues to resolve first.

Before commencing the treatment, patients would require PET scans or lumbar punctures for a confirmed diagnosis. Following this, Leqembi is to be administered at infusion centers -- a process that could potentially face capacity issues. These factors imply that rolling out Leqembi and getting all potential patients on the treatment might be a gradual process.

Biogen also anticipates that this year, the costs associated with bringing Leqembi to the market will eclipse the revenue it generates. As such, this novel product poses a short-term challenge and will likely dampen growth in 2023.

Should you then put money in Biogen stocks?

Answering this query isn't straightforward as it hinges on your risk appetite. It's possible that hurdles such as infusion center inadequacies can be overcome -- Biogen's vast experience places them in a strong position to address these.

However, the crux of the matter revolves around whether the medical community and patients will embrace the treatment, a point of uncertainty and risk.

For the thrill-seeking investor who embraces unpredictability, Biogen could offer an appealing opportunity at the moment.

If their new drug, Leqembi, attains success, the long-term potential for the stock's rise is significant.

For the more reserved investor, though, waiting for clearer signs of acceptance from doctors and patients might be a safer play. As for me, I suggest waiting and buying the dip.

May 4, 2023

Biotech Letter

Mad Hedge Biotech and Healthcare Letter
May 4, 2023
Fiat Lux

Featured Trade:

(A BIOPHARMA THAT KEEPS BEATING THE ODDS)
(LLY), (BIIB), (ESALY)

The Biopharma That Keeps Beating the Odds

Biotech Letter

If you're on the hunt for a stock that has a history of outperforming the market, then Eli Lilly (LLY) may have caught your attention.

Unlike many dividend and pharma stocks, Eli Lilly has a knack for beating the market. Just take a look at the company's shares, which have skyrocketed by 153% since the end of April 2020. That's three times more than the market's return of only 50% during the same period.

Now, I know what you're thinking - is this performance sustainable? After all, with a tumultuous economic and market environment causing investors everywhere to hit the brakes, it's possible that Eli Lilly's past success might not be repeated. Some may question whether this stock is still worth buying now or if they've missed the boat altogether.

Investors are always on the lookout for a good deal, so it's natural to question whether Eli Lilly is still a worthwhile investment following a less-than-stellar first-quarter earnings report.

Like many companies in the healthcare industry, Eli Lilly felt the pandemic's impact on its bottom line. Its coronavirus therapeutics segment contracted, leading to an 11% drop in sales to approximately $7 billion and a 38% decrease in EPS to $1.49.

But don't let the numbers scare you off just yet.

The decline in coronavirus sales was expected, and the company's other medicines saw a 10% YoY increase in revenue. Besides, it's essential to remember that a single quarter's results don't necessarily reflect a company's long-term value for dividend investors.

While Eli Lilly may have taken a hit, it's still a company with plenty of potential for the future.

That is, Eli Lilly’s expansion journey isn't about to stop anytime soon. For one, the pharmaceutical giant is waiting for regulators to approve four programs, including donanemab, a treatment for Alzheimer's disease, and tirzepatide, which could help combat diabetes and obesity.

If approved, Eli Lilly's latest offerings will enter contested markets, but there's still a substantial opportunity for them to outperform their competitors and gain market share, particularly with tirzepatide. Although the company may not see rapid revenue growth as a behemoth drug company, with 21 programs in phase 3 clinical trials, moderate-paced growth is still on the horizon.

Going back to its Alzheimer’s treatment candidate, it looks like the company has finally found a working formula to combat this lifelong disease.

Recently, Eli Lilly released positive results from the latest phase 3 study of its donanemab treatment for early Alzheimer's disease. The news pushed the stock to soar over 6% today, tacking over $20 billion to the company's market value.

Dubbed the Trailblazer-ALZ 2 study, the trial aimed to determine whether donanemab could help slow the debilitating effects of Alzheimer's by reducing the decline in a key rating scale of Alzheimer's-induced impairment. And the results? They were nothing short of promising.

Patients taking donanemab experienced a 35% reduction in the rate of decline, and a 40% smaller decline in their ability to perform daily activities, even 18 months into the study.

And that's not all: nearly half of the participants, a whopping 47%, showed no decline on a scale measuring clinical dementia after a year of treatment - compared to just 29% taking a placebo.

This is fantastic news for Eli Lilly and for the millions of people suffering from Alzheimer's worldwide. With such promising results, the company's donanemab treatment could be a game-changer in the fight against this devastating disease.

In comparison, Biogen (BIIB) and Eisai's (ESALY) Leqembi slowed cognitive decline by 27% compared to placebo in a similar patient group.

Notably, the trials for these two drugs had vital differences, so direct comparisons are difficult to make at this stage. Nevertheless, Lilly is determined to move forward with donanemab, despite the risks associated with the drug.

If approved, donanemab could help patients maintain their cognitive function for longer, allowing them to continue their daily activities such as managing finances, driving, and engaging in hobbies.

Thus far, Eli Lilly's donanemab has shown a potential best-in-class clinical profile, leading to the company planning to file for FDA approval later this quarter.

The estimated peak sales for the drug have yet to reach a consensus due to shifting clinical profiles and changing market dynamics over the past year. However, the market's initial estimate suggests it could reach $5 billion-plus per year, as evidenced by Lilly's $20 billion increase in market capitalization following the announcement.

While this estimate may seem reasonable, it's important to note that there is a safety signal in the latest clinical data - brain swelling - that could potentially hinder the drug's commercial uptake. Full trial results will be crucial for investors to consider once they become available.

Nonetheless, the dire need for new Alzheimer's therapeutics and the significant untapped market make the drug's potential highly compelling.

Overall, Eli Lilly is an excellent long-term investment. It has a long history of success, and its strong position in the pharmaceutical industry speaks volumes. While there are no guarantees when it comes to the stock market, this biopharma has a proven track record of delivering impressive returns to its shareholders.

Despite its current high price tag, this leading pharmaceutical company has some exciting growth prospects that could make it the top dog in healthcare before the decade is out. With drugs like donanemab, a potential game-changer for Alzheimer's treatment, and Mounjaro, a type 2 diabetes medication with promising results, Eli Lilly's stock may indeed be worth considering for investors looking for growth potential.

April 25, 2023

Biotech Letter

Mad Hedge Biotech and Healthcare Letter
April 25, 2023
Fiat Lux

Featured Trade:

(SMALL BIOTECHS, BIG OPPORTUNITIES)
(PFE), (SGEN), (MRK), (RXDX), (BMY), (BIIB), (ETNB), (KRTX), (MORF), (IDYA)

Small Biotechs, Big Opportunities

Biotech Letter

The biopharma sector has seen a flurry of merger and acquisition activity recently, and the trend seems to continue. This is good news for smaller biotech stocks looking to capitalize on the trend.

In the first quarter of 2023, the total healthcare and life sciences M&A in the United States reached roughly $71 billion, more than double the $28 billion seen in the same quarter in 2022. Notably, this figure includes Pfizer's (PFE) acquisition of Seagen (SGEN) for $43 billion.

Still, the situation isn't as dire as it may seem especially considering that in 2022, the total M&A spending in the U.S. dropped to about $300 million year over year from the $400 billion recorded in 2021.

The main culprit behind this trend appears to be higher interest rates, which have made financing a deal less appealing for buyers, particularly when there is the potential for a less optimistic profit outlook due to a slowing economy.

Even with these concerns, pharmaceutical deals have been far from stagnant since the end of the first quarter.

Merck (MRK), a biopharmaceutical company with a market capitalization of $288 billion, announced that it would purchase Prometheus Biosciences (RXDX) for roughly $11 billion, representing a premium of about 75% over the pre-announcement price. The announcement had a considerable impact on Prometheus stock, which saw a surge in value.

Shareholders of Prometheus enjoyed significant gains as Merck seeks to replace its revenue stream from cancer treatment Keytruda, which generates just over $20 billion annually.

Keytruda's patent is set to expire in 2028, leaving room for competitors to gain market share and making Merck's acquisition of Prometheus a critical move. For context, Prometheus's ulcerative colitis product alone has a total available market worth roughly $30 billion.

This deal could be just the beginning of a wave of new mergers and acquisitions in the biotechnology and healthcare industry. Experts note that we are entering a "smart optimism" period in the sector.

It makes sense for larger pharma companies to explore mergers and acquisitions in the current market for several reasons.

For one, many larger companies are seeking to revamp their drug pipelines. Take Bristol Myers Squibb (BMY), for example, which has a market capitalization of $146 billion. Sales of its myeloma treatment, Revlimid, likely peaked at just over $12 billion in 2021. As the patent for Revlimid expires, the company is expected to lose market share, causing sales to plummet to the low hundreds of millions.

While the company has several new drugs in development, it may still seek to acquire smaller firms to safeguard its future. However, given that Bristol has just over $9 billion in cash, any significant acquisitions it pursues could require taking on debt. Such a move would not be unprecedented, as Pfizer financed roughly 70% of its Seagen purchase with long-term debt.

Another big name that could be on the lookout for an attractive deal is Biogen (BIIB), a company with a market capitalization of $42 billion. Biogen is reportedly interested in the neuropsychiatric and inflammatory sectors and could strike a deal as early as the latter half of 2023.

Looking at things from a seller's point of view, many of these companies are now much less valuable than they once were on the public market and, therefore are easier targets for acquisition.

The SPDR S&P Biotech ETF (XBI) has taken a 50% hit from its all-time high set in February 2021. This is mainly due to higher interest rates, which have diminished the perceived value of future profits. Since many small biotechs are valued based on their projected earnings well into the future, this has significantly affected their stock prices.

Some biotech companies have been eyed as potential takeover targets due to their reduced market value.

One is 89bio (ETNB), with a market cap of $1.2 billion and a stock price falling by more than 50% from its all-time high, could be a potential target.

Similarly, Karuna Therapeutics (KRTX), which has a market cap of $7.4 billion and has seen a decline of almost 30% from its all-time high, is also considered an acquisition candidate.

Morphic Holding (MORF), with a market cap of $1.8 billion and a drop of more than 35% from its all-time high, and Ideaya Biosciences (IDYA), which has a market cap of $706 million and has lost almost half its value from its all-time high, could also be targeted for acquisition.

Overall, this is a promising period for the sector. So, take a moment to consider some of the smaller biotech firms in the market. Suppose these companies have a hard time finding interested buyers. In that case, there is still hope for shareholders as there's a chance that a larger corporation may step in and make an acquisition, leading to a substantial payout.

March 21, 2023

Biotech Letter

Mad Hedge Biotech and Healthcare Letter
March 21, 2023
Fiat Lux

Featured Trade:

(A BUMP IN THE ROAD)
(SRPT), (BIIB), (VRTEX), (RHHBY)

A Bump In The Road

Biotech Letter

Little Orphan Annie had already predicted it: “The sun will come out tomorrow.” While it is disheartening that we’re still in a bear market, stocks will bounce back eventually.

It looks like Wall Street overreacted once again following the change in leadership in the Food and Drug Administration earlier this month. Dr. Billy Dunn, the public face of the highly controversial accelerated approval granted to Biogen’s (BIIB) Alzheimer’s disease drug and the standard bearer of the organization’s push for more flexibility on drug approvals, retired.

Biotech investors have expressed anxiety over the possibility of facing more stringent rules in the drug approval process. The fear is that Dunn’s departure would signify a step toward a more conservative handling of applications.

While the FDA assured the public that the approval process would likely remain the same, some notable decisions are proving otherwise.

One of them involves Sarepta Therapeutics (SRPT).

Sarepta Therapeutics is a biopharmaceutical company that focuses on developing and commercializing RNA-targeted therapies for rare neuromuscular diseases. Founded in 1980, this Cambridge-based company’s most notable drug is Exondys 51 (eteplirsen), used to treat Duchenne muscular dystrophy (DMD), a rare genetic disorder affecting muscle function.

Exondys 51 is designed to skip over a faulty section of the dystrophin gene, which helps to produce a functional protein that can slow the progression of the disease. Sarepta is also developing RNA-targeted therapies for rare diseases, such as limb-girdle muscular dystrophy and myotonic dystrophy. Since then, the company has earned additional approvals for Vyondys 53 and Amondys 45.

Basically, Sarepta is to DMD as Vertex Pharmaceuticals (VRTX) is to cystic fibrosis—both have virtual monopolies in their target markets.

Recently, though, Sarepta stock has started to fall. This came after the FDA announced its plan to seek additional input from a panel of independent experts regarding the company’s new DMD gene-therapy candidate: SRP-9001.

The move came as a surprise since Sarepta disclosed only a week or so ago that the FDA had no intention to convene an advisory board to evaluate the candidate. However, since SRP-9001 is one of the first-ever gene therapies biologics license applications built on a surrogate perspective, meaning it’s an alternative to clinical results, the FDA felt the need to add a layer of review.

Still, the fall in Sarepta’s share prices appeared to be yet another overreaction. Besides, the move was not triggered by any issue with the candidate or data from the trials. It was simply a precautionary measure. Despite the slight detour, Sarepta remains optimistic that it will receive the go signal for SRP-9001 by May 2023.

Prior to this, Sarepta shares have been beating the market since 2023 started and have recorded more than double increases in the last five years. Although the company does not enjoy the same name recall as several of its peers, Sarepta’s platform of promising and innovative treatments has delivered critical wins in the past, especially in the DMD market.

On top of its DMD-centered products, Sarepta has over 40 clinical programs. That’s impressive for a biotech with an $11 billion market capitalization.

More importantly, the latest catalyst for Sarepta, SRP-9001, is projected to become another blockbuster. This Roche-partnered (RHHBY) treatment is estimated to generate more than $4 billion in peak sales.

Notably, this particular DMD indication has been shown to exhibit an extremely high barrier to entry, with practically all experimental treatments falling apart in clinical trials. Needless to say, SRP-9001 would have an exceedingly high commercial ceiling plus a built-in competitive moat.

Investors can expect remarkable progress from Sarepta as a company and its programs in the next five years. Given the company’s track record and history, it won’t be farfetched for it to come up with more blockbusters soon.

February 23, 2023

Biotech Letter

Mad Hedge Biotech and Healthcare Letter
February 23, 2023
Fiat Lux

Featured Trade:

(BATTLE FOR GENE THERAPY SUPREMACY)
(CRSP), (NVS), (BIIB), (BLUE), (VYGR), (GBIO), (SIOX), (NTLA), (EDIT), (VRTX), (PRIME), (BEAM)

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