Bronstein, Gewirtz & Grossman, LLC Is Investigating Johnson & Johnson (JNJ) And Encourages Investors to Connect ...

Core Viewpoint - Johnson & Johnson (JNJ) has initiated a rolling submission with the FDA for TAR-200, an investigational drug-device combination aimed at treating non-muscle invasive bladder cancer (NMIBC) in patients unresponsive to BCG therapy [1][4]. Group 1: FDA Submission and Review Process - The FDA will review the submission under its Real-Time Oncology Review (RTOR) program, which allows for the evaluation of parts of the application as they are ready, expediting the approval process for oncology drugs [2][3]. - The filing is supported by data from the phase IIb SunRISe-1 study, which demonstrated an 83.5% complete response (CR) rate without the need for reinduction, with 82% of responders maintaining CR at a median follow-up of nine months [5]. Group 2: Product Details and Competitive Landscape - TAR-200 represents an innovative method for sustained delivery of the chemotherapy drug gemcitabine directly into the bladder, potentially offering a less invasive alternative to radical cystectomy [4]. - If approved, TAR-200 may have a competitive edge over ImmunityBio's Anktiva and Merck's Keytruda, which are also approved for treating high-risk NMIBC but utilize different mechanisms of action [9]. Group 3: Market Context and Company Performance - JNJ's shares have declined nearly 10% over the past year, compared to a 4% decline in the industry [6]. - TAR-200 addresses a significant unmet medical need, particularly for older patients who are unable or unwilling to undergo radical cystectomy [8].

Industry Overview - The global pharmaceutical industry is valued at $1.4 trillion and is expected to grow at an annual rate of 6.1% through 2030 [1] - The industry is considered a cornerstone of healthcare, with strong staying power and long-term investment potential [1] Pfizer (PFE) - Pfizer has a rich history dating back to the mid-1800s and remains one of the leading pharmaceutical companies [3] - The company's COVID-19 vaccine (Comirnaty) and treatment (Paxlovid) generated $56.7 billion in sales at their peak in 2022 [3] - Pfizer is focusing on its oncology pipeline for future growth, following its $43 billion acquisition of Seagen in 2023 [4] - Analysts expect Pfizer to grow earnings by an average of 14% annually over the next three to five years [4] - The stock offers a dividend yield of 6.3% with a strong payout ratio of 57% of earnings [5] - Pfizer's stock is valued at less than 10 times forward earnings estimates, indicating potential for double-digit total investment returns [5] Johnson & Johnson (JNJ) - Johnson & Johnson is a diversified healthcare company with a strong pharmaceutical core and a MedTech segment [6] - The company spun off its consumer products business as Kenvue in August 2023 [6] - Johnson & Johnson is a Dividend King with 62 consecutive annual dividend increases [6] - The company's growth is driven by innovation, acquisitions, and share repurchases, resulting in slow but steady earnings growth [7] - Johnson & Johnson's stock trades at a forward P/E ratio of just over 13, with analysts expecting 5% to 6% annualized long-term earnings growth [8] - The stock offers a 3.5% dividend yield and is expected to produce 6% to 10% annualized returns, making it a reliable long-term investment [8]

M&A Activity Overview - The JP Morgan Healthcare Conference in San Francisco has seen increased activity compared to last year, with significant M&A announcements from J&J, Eli Lilly, and GSK [1] J&J Acquisition of Intra-Cellular Therapies - J&J has entered into a definitive agreement to acquire Intra-Cellular Therapies for approximately $14.6 billion, offering $132.00 per share, which is a nearly 40% premium over ITCI's closing price [2] - The acquisition will enhance J&J's neuroscience pipeline by adding ITCI's approved drug, Caplyta, which is used for treating bipolar I and II depression and schizophrenia [3] - ITCI is also pursuing additional approvals for Caplyta as an adjunctive treatment for major depressive disorder, with ongoing phase III studies for other mental health disorders [3] - The deal will include other CNS candidates from ITCI, such as ITI-1284, which is in phase II development for generalized anxiety disorder and Alzheimer's disease-related psychosis and agitation [4] Eli Lilly's Acquisition of Scorpion Therapeutics - Eli Lilly announced the acquisition of Scorpion Therapeutics' PI3Kα inhibitor, STX-478, for approximately $2.5 billion, aimed at strengthening Lilly's oncology pipeline [5] - The STX-478 program will be spun off into a new independent company, with Scorpion's current shareholders retaining ownership and Lilly holding a minority stake [6] GSK's Acquisition of IDRx - GSK has agreed to acquire IDRx, a biotech focused on precision therapeutics for gastrointestinal cancers, with an upfront payment of $1 billion and a potential regulatory milestone payment of $150 million [7] - IDRx's key candidate, IDRX-42, is a selective KIT tyrosine kinase inhibitor that targets mutations driving tumor growth in gastrointestinal stromal tumors [7] Future M&A Trends - The recent acquisition announcements suggest a potential rebound in M&A activity in the healthcare sector in 2025, following a quieter 2024 [8] - The focus areas for future M&A are expected to include rare diseases, next-generation oncology treatments, obesity, immunology, and neuroscience [8] - Major drugmakers are looking to fill their R&D pipelines as they face upcoming loss of exclusivity for blockbuster products, leading to more frequent smaller deals, although large multibillion-dollar deals may be less likely [9]

Johnson & Johnson (NYSE:JNJ) 43rd Annual J.P. Morgan Healthcare Conference January 13, 2024 12:00 PM ET Company Participants Joaquin Duato - Chairman & CEO Conference Call Participants Chris Schott - JPMorgan Chris Schott Good morning, everybody. I'm Chris Schott at JPMorgan, and it's my pleasure to be hosting this fireside discussion with Joaquin Duato, Chairman and CEO of JNJ. Joaquin, Happy New Year. Thanks for joining us. A lot to go through, and some – particularly, big M&A news today. So, I thought ma ...

Johnson & Johnson (NYSE:JNJ) 43rd Annual J.P. Morgan Healthcare Conference January 13, 2024 12:00 PM ET Company Participants Joaquin Duato - Chairman & CEO Conference Call Participants Chris Schott - JPMorgan Chris Schott Good morning, everybody. I'm Chris Schott at JPMorgan, and it's my pleasure to be hosting this fireside discussion with Joaquin Duato, Chairman and CEO of JNJ. Joaquin, Happy New Year. Thanks for joining us. A lot to go through, and some – particularly, big M&A news today. So, I thought ma ...

Dividend stocks are great for various reasons, and it's even better to invest in them while they are going through a rough patch, provided there are good reasons to believe they will recover. This description fits several dividend stocks on the market, among which are CVS Health (CVS 4.35%) and Johnson & Johnson (JNJ -0.15%). Although these two healthcare leaders have had their share of headwinds that have led to market-lagging performances, they have plenty of qualities dividend investors will like. Let's ...

Analyst Background and Focus - The analyst specializes in high-quality companies with competitive advantages (economic moat) and high defensibility, focusing on long-term market outperformance [1] - The analyst's coverage includes European and North American companies across all market capitalizations, from large-cap to small-cap [1] - The analyst holds a Master's Degree in Sociology with a focus on organizational and economic sociology, and a Bachelor's Degree in Sociology and History [1] Previous Analysis and Outlook - The analyst published a previous article on Johnson & Johnson (JNJ) in July 2024, rating the stock as a "Buy" due to optimism about the company's business [1] Disclosure and Position - The analyst holds a beneficial long position in Gilead Sciences (GILD) through stock ownership, options, or other derivatives [2] - The article represents the analyst's personal opinions and is not influenced by compensation or business relationships with the mentioned companies [2]

Stock Performance and Market Context - Johnson & Johnson (JNJ) stock lost about 7% in 2024, underperforming the S&P 500 index, which gained 23% for the year [1] - JNJ stock declined from $155 in early January 2024 to $144 by the end of the year [6] - Over the last four years, JNJ stock returns were 11% in 2021, 6% in 2022, -9% in 2023, and -5% in 2024 [6] Business Performance in 2024 - J&J saw an uptick in its medical devices business, driven by recent acquisitions, with electrophysiology and cardiovascular sales trending higher [3] - Market share increased for blockbuster drugs like Darzalex, Erleada, and Tremfya, with Darzalex generating around $3 billion in quarterly sales [3] - Biosimilar competition impacted key drugs like Imbruvica, which saw a 7% year-over-year decline in sales for the first nine months of 2024 [3] Acquisitions and Financial Impact - J&J acquired V-Wave for $1.7 billion, Shockwave Medical for $13.1 billion, Yellow Jersey for $1.25 billion, and Proteologix for $850 million to expand its MedTech and pharmaceutical businesses [4] - Cash position declined from $23 billion in 2023 to $20 billion as of September 2024, while overall debt increased from $29 billion to $36 billion [5] - The company increased its dividend by 4.2% to $4.96 in 2024 and spent $2 billion on share repurchases in the first three quarters [5] Outlook for 2025 - Stelara, a top-selling drug with $11 billion in annual sales in 2023, faces biosimilar competition in Europe and the U.S., potentially leading to a meaningful decline in sales [8][9] - J&J temporarily paused the use of its heart device Varipulse due to reports of neurovascular events, which was expected to generate over $1 billion in annual sales [9] - New drugs like Carvykti and Spravato are gaining market share, a trend expected to continue in 2025 [10] - Potential FDA approval for Nipocalimab and fast track designation for Posdinemab could provide growth opportunities [11] Valuation and Peer Comparison - JNJ stock is estimated to have a valuation of $172 per share, over 20% above its current levels of $142, based on a 17x forward P/E multiple [7] - The stock is trading at under 14x forward expected earnings, suggesting potential headwinds are largely priced in [12]

FDA Filing and Clinical Data - The FDA filing for nipocalimab is supported by data from the phase III Vivacity-MG3 study, which showed sustained disease control over 24 weeks in gMG patients receiving nipocalimab plus standard of care compared to placebo [1] - Vivacity-MG3 is the first and only study to achieve sustained disease control in gMG patients with anti-AChR, anti-MuSK, and anti-LRP4 positive antibodies, and it provides the longest dataset for an FcRn blocker in this indication [2] - Nipocalimab is designed to block FcRn, reduce autoantibody levels, and preserve immune function without causing broad immunosuppression [3] J&J Stock Performance - J&J's shares have lost 12% in the past year, compared to the industry's nearly 3% decline [4] Competitive Landscape in gMG - If approved, nipocalimab will compete with Argenx's Vyvgart/Vyvgart Hytrulo and UCB's Rystiggo, both of which are FcRn blockers approved for gMG [6] - Argenx's drug is approved for anti-AChR positive antibodies and chronic inflammatory demyelinating polyneuropathy (CIDP), while UCB's drug is approved for anti-AChR or anti-MuSK positive antibodies [7] Nipocalimab Development Pipeline - J&J is evaluating nipocalimab in multiple immunology and neuroscience indications, including late-stage studies for CIDP, hemolytic disease of the fetus and newborn (HDFN), and warm autoimmune hemolytic anemia (wAIHA) [9] - Mid-stage studies are ongoing for idiopathic inflammatory myopathy, Sjogren's disease, systemic lupus erythematosus, and rheumatoid arthritis [9] FDA Review Timeline - The FDA has granted priority review for nipocalimab, reducing the review period by four months, with a final decision expected in Q3 2025 [14] Other Biotech Stocks - Castle Biosciences (CSTL) has seen its 2024 bottom-line estimates improve from a loss of 8 cents per share to earnings of 34 cents per share, with shares surging 53% in the past year [12] - CytomX Therapeutics (CTMX) has narrowed its 2024 loss per share estimates from 18 cents to 5 cents, though its shares have lost 41% in the past year [13]