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3 Biotech Stocks Set To Revolutionize Medicine

Today, many diseases still lack effective treatments, mainly because developing new drugs can take years and cost a fortune. But that's changing fast, thanks to the integration of artificial intelligence (AI) and other cutting-edge technologies into biotech research. Experts believe that when properly integrated into research, AI could drastically speed up drug discovery, leading to faster and more effective patient treatments.

Given the industry's positive prospects, it could be ideal to invest in quality biotech stocks such as Gilead Sciences, Inc. (GILD), Regeneron Pharmaceuticals, Inc. (REGN), and Biogen Inc. (BIIB), which are set to revolutionize medicine.

The biotechnology sector is buzzing with activity as several biotech firms have gained attention for their groundbreaking research and strong market performance. Moreover, the rising demand for personalized medicine drives the development of tailored treatments based on individual genetic profiles, creating an environment ripe for innovation and expansion.

So far this year, the U.S. Food and Drug Administration (FDA) has approved 35 new drugs for conditions such as breast cancer, pulmonary disease, Alzheimer's disease, hypertension, and more. And with more approvals expected before year-end, the sector is poised for even more growth.

The global biotechnology market is projected to hit around $4.61 trillion by 2034, exhibiting a CAGR of 11.5%. Meanwhile, the U.S. Market is expected to reach $830.31 billion by the same year. This growth is propelled by increasing funding, supportive government initiatives, growing industry partnerships, and M&A activities.

In addition, the potential impact of biotech and AI on healthcare is profound. AI can revolutionize drug discovery and development by enhancing medical personalization and streamlining complex healthcare data analysis. Generative AI, in particular, is transforming the field by using algorithms to design novel molecules and proteins. The generative AI market in biotech is expected to expand at a CAGR of 24.9%, reaching $472 million by 2032.

With that in mind, let's delve into the fundamentals of the three Biotech stock picks, starting with the third choice.

Stock #3: Regeneron Pharmaceuticals, Inc. (REGN)

REGN discovers, invents, develops, manufactures, and commercializes medicines for treating various diseases. Its product portfolio includes EYLEA, Dupixent, Libtayo, Praluent, REGEN-COV, Kevzara solution, and ARCALYST, among other injections.

On September 27, the U.S. Food and Drug Administration (FDA) approved Dupixent® (dupilumab) as the first-ever biologic medicine to treat adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.

In the same month, the FDA also approved Dupixent as an add-on maintenance treatment for adolescent patients aged 12 to 17 with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). This approval expands the initial June 2019 FDA approval for CRSwNP for patients aged 18 years and older.

REGN's net revenues for the second quarter (ended June 2024) increased 12% year-over-year to $3.55 billion. Its non-GAAP net income grew 14.3% from the year-ago value to $1.35 billion, while its income from operations stood at $1.07 billion, up 5.2% year-over-year. The company's non-GAAP net income per share came in at $11.56, representing a 12.9% year-over-year growth.

The consensus revenue estimate of $3.66 billion for the fiscal third quarter (ended September 2024) represents an 8.8% improvement year-over-year. The consensus EPS estimate of $11.75 for the to-be-reported quarter represents a 1.4% increase from the same period last year. The company has a promising earnings surprise history, as it surpassed the consensus EPS estimates in three of the trailing four quarters.

Shares of REGN have gained 20.8% over the past year and 15.5% year-to-date.

REGN's POWR Ratings reflect this robust outlook. The stock has an overall rating of B, equating to a Buy in our proprietary rating system. The POWR Ratings assess stocks by 118 different factors, each with its own weighting.

It has a B grade for Value and Quality. REGN is ranked #10 among 331 stocks in the Biotech industry. Click here to access additional REGN ratings (Growth, Momentum, Stability, and Sentiment).

Stock #2: Biogen Inc. (BIIB)

BIIB is a global biopharmaceutical company focused on discovering, developing, and delivering advanced therapies worldwide for people with serious and complex diseases. The company has a portfolio of medicines to treat multiple sclerosis (MS), spinal muscular atrophy (SMA), Alzheimer's disease, and amyotrophic lateral sclerosis (ALS).

On August 22, BIIB and Eisai Co., Ltd. Announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) in Great Britain granted marketing authorization to its Leqembi®, the humanized amyloid-beta (Aβ) monoclonal antibody.

In July, BIIB, Beckman Coulter, Inc., and Fujirebio announced a collaboration to potentially identify and develop accessible, minimally invasive blood-based biomarkers specific for tau-pathology in the brain. These tools have the potential to stratify patients or monitor treatment response for a new generation of future therapies impacting tau pathology in Alzheimer's disease.

For the second quarter of 2024, which ended on June 30, BIIB's total revenues increased marginally year-over-year to $2.46 billion. Its non-GAAP total net income attributable for the quarter amounted to $770.90 million or $5.28 per share, representing increases of 31.9% and 31.3%, respectively, from the same period last year.

Per the updated financial guidance for the fiscal year 2024, BIIB now forecasts a non-GAAP EPS between $15.75 and $16.25, up from the previous estimate of $15 and $16.

Street expects BIIB's revenue for the fiscal fourth quarter (ending December 2024) to increase 2.6% year-over-year to $2.45 billion. Its EPS for the same period is expected to register a 16.2% growth from the prior year, settling at $3.43. In addition, it surpassed the EPS estimates in three of the trailing four quarters, which is promising.

However, the stock has declined 2.1% over the past month to close the last trading session at $191.56.

BIIB's bright prospects are reflected in its POWR Ratings. The stock has an overall rating of A, which translates to a Strong Buy in our proprietary rating system.

It also has an A grade for Value and a B for Growth and Sentiment. Within the Biotech industry, it is ranked #6. Click here to see BIIB's ratings for Momentum, Stability, and Quality.

Stock #1: Gilead Sciences, Inc. (GILD)

GILD is a biopharmaceutical company dedicated to advancing treatments for life-threatening diseases such as human immunodeficiency virus (HIV), viral hepatitis, COVID-19, and cancer. Its portfolio of marketed products includes Biktarvy, Genvoya, Odefsey, Truvada, Harvoni, Vemlidy, and Veklury, among others.

On October 02, the company announced that it had signed non-exclusive, royalty-free voluntary licensing agreements with six pharmaceutical manufacturers to produce and sell generic lenacapavir (pending regulatory approval) in 120 countries (mainly low- and lower-middle-income) with high HIV incidence.

These agreements aim to expedite access to lenacapavir for HIV prevention once approved and align with GILD's goal of making HIV prevention accessible globally as part of its mission to end the epidemic.

On September 10, GILD and Genesis Therapeutics announced a strategic partnership to discover and develop new small molecule therapies targeting multiple areas. The collaboration will utilize Genesis' advanced AI platform, GEMS, to design and optimize molecules for targets chosen by Gilead. Both companies will work together on preclinical research, with GILD holding exclusive rights for the clinical development and commercialization of any resulting compounds.

For the fiscal second quarter, which ended on June 30, 2024, GILD's total revenues increased 5.4% year-over-year to $6.95 billion. Its operating income grew 58.8% from the prior year to $2.64 billion, while its non-GAAP net income stood at $2.52 billion, up 49.2% year-over-year. In addition, non-GAAP earnings per share attributable to the company rose 50% from the year-ago value to $2.01.

According to the full-year guidance, GILD forecasts product sales to range from $27.10 billion to $27.50 billion. The company also expects non-GAAP EPS to be between $3.60 and $3.90, an increase from the previous guidance of $3.45 to $3.85.

Analysts expect GILD's revenue for the fiscal years 2024 and 2025 to increase marginally from the prior year, reaching $27.72 billion and $28.02 billion, respectively. Its EPS for the current year is expected to be $3.80 and register a robust year-over-year of 88.6% next year.

Over the past six months, the stock has gained 24.9%, closing the last trading session at $85.05.

It's no surprise that GILD has an overall A rating, equating to a Strong Buy in our POWR Ratings system. It has an A grade for Value and a B for Sentiment and Quality. Of the 331 stocks in the same industry, it is ranked #5.

Beyond what is stated above, we've also rated GILD for Growth, Momentum, and Stability. Get all GILD ratings here.

What To Do Next?

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GILD shares were trading at $85.84 per share on Tuesday morning, up $0.79 (+0.93%). Year-to-date, GILD has gained 9.37%, versus a 24.10% rise in the benchmark S&P 500 index during the same period.

About the Author: Shweta Kumari image

Shweta's profound interest in financial research and quantitative analysis led her to pursue a career as an investment analyst. She uses her knowledge to help retail investors make educated investment decisions. More...

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How AZ's Respiratory Wins Are Ramping Up For A Bigger Prize In COPD

This story was originally published on PharmaVoice. To receive daily news and insights, subscribe to our free daily PharmaVoice newsletter.

Drugs for patients with respiratory diseases like asthma have come a long way in the last few decades. Once treated symptomatically with therapies like oral steroids that come with long-term side effects, drugmakers have narrowed the field to more specific targets.

In Dr. Donna Carstens' career as a pulmonologist, now senior medical director for the biologic respiratory drug Fasenra at AstraZeneca, she's seen the field take a full-on paradigm shift from "treat-to-fail" to "treat-to-target."

This approach led to last month's approval of Fasenra for the rare respiratory disease eosinophilic granulomatosis with polyangiitis (EGPA) after beating out GSK's Nucala in a head-to-head study. And while the disease affects a small population, many of whom also have severe asthma, the approval demonstrates Fasenra is a powerful tool more broadly against eosinophils, a type of white blood cell that at high levels causes inflammation leading to other respiratory conditions, Carstens said.

For Carstens, that speaks to Fasenra's dexterity in the respiratory arena, including the difficult-to-treat chronic obstructive pulmonary disorder. While Fasenra was first approved in 2017 for patients with severe eosinophilic asthma and has since expanded to more indications, the drug stumbled in 2018 in two late-stage trials for COPD.

But AstraZeneca is stepping up to the plate again with an ongoing phase 3 Fasenra trial in COPD — and this time, patients are more selectively chosen for their eosinophil count, powering the trial to play to Fasenra's strengths, Carstens said. The company, along with partner Amgen, is also seeking a COPD approval for the biologic Tezspire, providing another shot on target.

"This is science, and this is what happens. And that comes down to the eosinophils."

Dr. Donna Carstens

Senior medical director, Fasenra, AstraZeneca

Here, we spoke to Carstens about how the respiratory space has become more geared toward precision medicine, how evolving guidelines have allowed for better patient identification and how those earlier COPD trials paved the way for a more comprehensive understanding of the disease.

This interview has been edited for brevity and style.

DR. DONNA CARSTENS: As a pulmonologist since the mid-90s, over that timeframe there has been a tremendous explosion in opportunities to take care of patients with respiratory diseases. And that has really accelerated in the last 10 to 15 years. What was once an approach of adding inhalers or molecules when people fail — what we call treat-to-fail — has now become a treat-to-target approach. Now, we can identify patients who have certain treatable traits and focus our attention and treatment on that particular entity, we can make a better and more impactful difference for patients.

Story Continues

The use of biologics has really changed the outlook for many of these patients with severe diseases, but it's also been helped by the evolution of guidelines changing and staying in step with innovations. Having GOLD guidelines [for COPD], for example, and the GINA report [for asthma] every year … keeps a finger on the pulse of what needs to be done for patients. To me, it's a combination of advancing science in conjunction with guidelines that help clinicians know what's right to do — not just listening to a pharma talk saying 'ours is the best,' but taking an unbiased approach to the management of disease. That helps tremendously with the adoption of these therapies.

The biggest challenge is, even within severe asthma, the majority of late-onset patients are actually eosinophilic. And with the majority of patients with asthma being managed in primary care, there's a big, big issue with the recognition of the value of these agents when many of those patients aren't being referred to a specialist. So one of our goals is to educate around that, helping to understand beyond the brand what those guidelines are. It's a heavy lift from primary care to understand the different types and severities. And that's where the majority are being treated with oral steroids, which are very bad — they cause a lot of problems, and when used excessively over years, they can significantly impact a patient's outcome. We have great data in steroid sparing and hope to change the practice paradigm.

Since the first study was done by GSK against placebo, the FDA advised that this should be head to head [for non-inferiority]. And yes, there was risk, but we had a lot of confidence in this drug in terms of eosinophil directed therapy. The mechanism of action is much more specific in terms of eradication of eosinophils. And so at the core, the belief was that if you get rid of them as opposed to getting rid of 80% of them, then you likely would have a better outcome. And that's what happened [with the secondary endpoint for patients who tapered off of oral corticosteroids]. So when you look at endpoints where 41% of patients [receiving Fasenra] were able to completely come off steroids, versus 26% [with Nucala], to me that speaks to the mechanism of action and reinforces what we believe.

This is science, and this is what happens. And that comes down to the eosinophils. With our asthma studies, we did not have an eosinophil requirement, but at least 70% of patients with severe asthma are eosinophilic. That's not the same in COPD. What we learned in those phase 3 studies was that we had to identify the population that would benefit better. Now what you have with [Dupixent from Sanofi and Regeneron] as a biologic approved in COPD with an eosinophilic phenotype is a higher confidence level for Fasenra. In our ongoing study, which has completed enrollment and reads out next year, ideally for a 2026 approval, we have enriched for that population of 300 and greater eosinophils, a severe population where this is add-on therapy. And this is how we learn — we learn from science with resilience and belief in a product.

The truth is medicine has evolved. Now that we have a drug like Fasenra that targets eosinophils, we are finding that a lot of COPD patients have eosinophilia. We didn't realize back in the day how much that had an impact. Because we have a tool now, we've started looking. If you have a hammer, you look for nails. If you don't have a hammer — and we didn't back then — then what's the point in finding nails? We've come a long way in advancing the science and following it to make a difference.






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