AbbVie (ABBV) announced that the European Commission has granted marketing approval to its blockbuster drug Rinvoq for treating giant cell arteritis (“GCA”), an autoimmune disease that causes inflammation of the medium to large arteries. GCA marks the eighth approved indication for Rinvoq.Rinvoq (15 mg, once daily) is the first JAK inhibitor to be approved in the EU for the GCA indication and is also the first oral advanced therapy for treating the condition. The approval for GCA was based on data from the ...

Core Insights - AbbVie announced that the European Commission granted marketing authorization for RINVOQ® (upadacitinib) for the treatment of giant cell arteritis (GCA) in adult patients, making it the first and only oral JAK inhibitor approved in the EU for this condition [1][4]. Group 1: Product Approval and Significance - The approval of RINVOQ provides a new treatment option for patients with GCA, a condition that primarily affects older adults and can lead to severe complications such as vision loss [2][4]. - RINVOQ's approval is based on the results from the Phase 3 SELECT-GCA trial, which demonstrated significant efficacy in achieving sustained remission and reducing steroid exposure compared to placebo [4][8]. Group 2: Clinical Trial Results - In the SELECT-GCA trial, 46.4% of patients receiving RINVOQ achieved sustained remission at week 52, compared to 29.0% in the placebo group (p=0.002) [5][8]. - Key secondary endpoints showed that 34.3% of patients on RINVOQ experienced at least one disease flare, compared to 55.6% in the placebo group (p=0.001), and cumulative steroid exposure was significantly lower in the RINVOQ group (median exposure of 1615 mg vs. 2882 mg, p<0.001) [5][6]. Group 3: Safety Profile - The safety profile of RINVOQ in the trial was consistent with other approved indications, with serious infections occurring in 5.7% of the RINVOQ group compared to 10.7% in the placebo group [3][40]. - No major adverse cardiac events were reported in the RINVOQ group, while two events occurred in the placebo group [6][40]. Group 4: Broader Context of RINVOQ - RINVOQ is already approved for multiple indications in the EU, including rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis, marking the eighth approved indication for the drug [4][10]. - The drug is a selective and reversible JAK inhibitor, which is being studied for various immune-mediated inflammatory diseases [9][10].

Stocks of several large-cap pharmaceutical companies plummeted on Friday after China hit back with retaliatory tariffs of 34% on all U.S. imports, escalating fears of a global recession. This move comes just two days after Trump announced his ‘Liberation Day’ speech.Though Trump is yet to impose tariffs on imports of medicines and active pharmaceutical ingredients (API), China decided to impose an additional 34% tariff on all U.S.-originated goods, effective April 10. Investors were concerned that China’s r ...

Group 1: AbbVie - AbbVie's share price has increased by a double-digit percentage in 2025, indicating strong demand for its products regardless of economic conditions [2] - The company has effectively managed the patent expiration of its top-selling drug, Humira, with successors Rinvoq and Skyrizi expected to generate more sales combined than Humira at its peak [3] - AbbVie has made significant acquisitions, adding growth drivers like Elahere, Botox, and Vraylar, and has over 90 programs in clinical development, including promising late-stage candidates [4] - AbbVie boasts a forward dividend yield of 3.25% and has a history of 53 consecutive years of dividend increases, qualifying it as a Dividend King [5] Group 2: Amgen - Amgen has faced challenges in organic revenue growth and a clinical setback with its weight management drug, MariTide, but its long-term prospects remain strong [6] - The company has strengthened its lineup through acquisitions, with growth drivers like Tepezza and Tezspire, and has over 30 candidates in phase 3 studies to ensure steady revenue and earnings growth [7][8] - Amgen has consistently raised its dividends, with a 201% increase over the past decade, and a forward yield of 3.1%, surpassing the S&P 500 average of 1.3% [8][9] Group 3: Eli Lilly - Eli Lilly's current dividend yield is less than 1%, but the company has significantly increased its dividend over the years, currently paying $1.50 per quarter, more than double the amount from five years ago [10][11] - The stock has appreciated by 480% over the past five years, with total returns including dividends reaching approximately 533%, compared to the S&P 500's 135% [12] - Eli Lilly is recognized for its growth potential with assets like Zepbound and Mounjaro, and despite a high valuation, it is considered a strong long-term investment due to its fast-growing business and robust dividend growth [13]

Core Viewpoint - The healthcare sector is often avoided by investors due to a lack of reliable dividend payers, but notable exceptions exist in companies like Amgen and AbbVie, which have attractive dividend policies [1][2]. Group 1: Amgen - Amgen is recognized for its strong performance in the obesity drug market and has a robust lineup of blockbuster drugs and a promising pipeline [3]. - In the previous year, Amgen's overall revenue increased by 19% to over $33.4 billion, with net income at nearly $4.1 billion, despite higher costs in research and development [5]. - Amgen raised its quarterly dividend by 6% to $2.38 per share, resulting in a yield of approximately 3%, which is nearly double the average yield of S&P 500 companies [6]. Group 2: AbbVie - AbbVie emphasizes its quarterly dividend, currently yielding over 3%, and has a history of regular dividend increases, with a recent 6% hike to $1.64 per share [8]. - Over the past decade, AbbVie has more than tripled its per-share payout, demonstrating a strong commitment to returning value to shareholders [9]. - AbbVie reported a nearly 4% increase in total net revenue to $56.3 billion, with net income slightly down to just under $4.3 billion due to rising costs [11]. - The company is well-positioned for future growth, with a projected compound annual growth rate (CAGR) in revenue in the high single-digit percentages through 2029, and an increased sales forecast for its drugs Rinvoq and Skyrizi to $31 billion by 2027 [12].

Financial Guidance - Full-year 2025 adjusted diluted EPS guidance is projected to be between $11.99 and $12.19, including the impact of Q1 2025 expenses[6] - Q1 2025 adjusted diluted EPS guidance is estimated to be between $2.34 and $2.38, factoring in the acquired IPR&D and milestones expense[6] Expenses and Impact - AbbVie expects acquired IPR&D and milestones expense of $248 million for Q1 2025, impacting GAAP and adjusted non-GAAP diluted EPS by $0.13[5] - The licensing agreement with Gubra for GUB014295 closed after Q1 2025 and is not included in the current guidance[6] Risks and Uncertainties - AbbVie cautions that forward-looking statements are subject to risks and uncertainties that may materially affect actual results[9]

Core Viewpoint - AbbVie has successfully managed the loss of exclusivity for its blockbuster drug Humira by launching new immunology drugs, Skyrizi and Rinvoq, which are expected to drive revenue growth in the coming years [5][6][24]. Financial Performance - AbbVie stock has increased by 16.1% this year, outperforming the industry average of 4.0% and also surpassing the sector and S&P 500 index [1][3]. - The company anticipates a return to robust revenue growth in 2025, following the decline due to Humira's loss of exclusivity [6][24]. - AbbVie’s ex-Humira drugs saw a reported growth of approximately 19% in 2024, exceeding internal expectations [23]. Product Performance - Skyrizi and Rinvoq generated combined sales of $17.7 billion in 2024, with expectations to exceed $31 billion by 2027 due to strong market growth and new indications [8][9]. - The drugs are particularly strong in the inflammatory bowel disease market, including ulcerative colitis and Crohn's disease, and have shown competitive advantages in clinical studies [8][9]. Pipeline and Acquisitions - AbbVie has a diverse pipeline with several early/mid-stage candidates that have blockbuster potential, with multiple regulatory submissions and approvals expected in the next 12 months [11][12]. - The company has been actively acquiring new technologies and candidates, signing over 20 early-stage deals since the beginning of 2024, including a recent entry into the obesity treatment space [13]. Challenges and Market Conditions - AbbVie faces challenges such as the erosion of Humira's sales due to biosimilars and declining sales of Juvederm fillers, which fell by 14.6% in 2024 [14][15]. - The aesthetics portfolio's global sales declined by 0.6% in 2024, with a lowered long-term growth guidance for this segment [16]. Valuation and Estimates - AbbVie shares currently trade at a price/earnings ratio of 16.21, slightly lower than the industry average of 16.28, but higher than its five-year mean of 11.88 [17]. - The Zacks Consensus Estimate for 2025 earnings has increased from $12.18 to $12.30 per share over the past 60 days, indicating positive sentiment [19].

If tariffs are put in place, it will be a big change for the industry. A 1994 World Trade Organization agreement eliminated levies on a whole swath of pharmaceutical products and the substances used to make them. This gave rise to companies pursuing a host of business strategies aimed at lowering tax rates. "This is largely due to low tax rates in these countries," Wells Fargo analyst Mohit Bansal said. "These companies pay lower overall taxes due to these manufacturing operations and oftentimes [intellectu ...

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