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Globe and Mail
5 days ago
- Business
- Globe and Mail
Gilead Sciences Stock Gains 21% YTD: Buy, Sell or Hold?
Biotech giant Gilead Sciences, Inc. GILD has put up a strong performance amid a volatile market. Shares of this biotech giant have gained 21.1% year to date against the industry 's decline of 4.7%. The stock has outperformed the sector and the S&P 500 Index in this timeframe. Gilead Outperforms Industry, Sector & S&P 500 Index Gilead Sciences is a dominant player in the HIV market with market-leading treatments. Its diverse portfolio also includes drugs for liver, hematology/oncology and inflammation/respiratory diseases. Approval of new drugs, encouraging pipeline progress and positive data readouts have boosted investors' sentiment in the past six months. However, the oncology business is under pressure. Let's delve into GILD's strengths and weaknesses to analyze how to play the stock at present. GILD's Leading HIV Franchise Will Continue Its Momentum Gilead's flagship drug, Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg, BIC/FTC/TAF), for HIV-1 infection has become the number-one prescribed regimen for both treatment-naïve and switch patients. Biktarvy accounts for over 51% share of the treatment market in the United States and should maintain momentum for GILD in the upcoming quarters. Descovy (FTC 200 mg/TAF 25 mg) for pre-exposure prophylaxis (PrEP) is also witnessing good uptake. It maintains over 40% market share in the PrEP market in the United States. Gilead's efforts to innovate its HIV portfolio are impressive. Late-stage studies, PURPOSE 1 and PURPOSE 2, validated lenacapavir's potential to prevent HIV. The FDA accepted new drug application submissions for twice-yearly lenacapavir for HIV prevention under priority review, with a target action date of June 19, 2025. The European Medicines Agency validated the Marketing Authorization Application and EU-Medicines for All application for twice-yearly lenacapavir for HIV prevention. The successful development and potential approval of lenacapavir for the prevention of the disease should solidify Gilead's HIV franchise. Per GILD, lenacapavir, with its twice-yearly dosing, could set a new bar for HIV prevention and allow PrEP to reach a larger number of people who could benefit from a prevention regimen. Livdelzi Approval Strengthens GILD's Liver Disease Portfolio The FDA approval of seladelpar for the treatment of primary biliary cholangitis (PBC) has strengthened GILD's liver disease portfolio and validated its CymaBay acquisition. The drug's initial uptake is encouraging. The candidate was approved under the brand name Livdelzi. Gilead also recently received conditional marketing authorization from the European Commission for seladelpar for the treatment of PBC. Challenges for GILD's Oncology Business Gilead's oncology portfolio, comprising the Cell Therapy franchise and breast cancer drug Trodelvy, has diversified its overall business. However, the Cell Therapy franchise, comprising Yescarta and Tecartus, is currently under pressure due to competitive headwinds in the United States and Europe that are expected to continue in 2025. Breast cancer drug Trodelvy's sales were lower than expected in the first quarter due to inventory dynamics. Gilead announced positive top-line results from the phase III ASCENT-03 study on Trodelvy, which showed highly statistically significant and clinically meaningful improvement in progression-free survival in patients with first-line metastatic triple-negative breast cancer (mTNBC) who are not candidates for checkpoint inhibitors. The potential launch of anito-cel in multiple myeloma and Trodelvy in first-line mTNBC in 2026 will strengthen the company's oncology business. GILD's Valuation and Estimate Revision From a valuation standpoint, GILD is expensive. According to the price/earnings ratio, GILD's shares currently trade at 13.70x forward earnings, lower than the large-cap pharma industry's average of 14.62X but higher than its mean of 10.53X. Earnings estimates for GILD have moved north in the past 60 days. The bottom-line estimate for 2025 has increased to $7.91 from $7.87, while that for 2026 has improved to $8.39 from $8.31. Stay Invested in GILD Large biotech companies are generally considered safe havens for investors interested in this sector as they are well equipped to weather the uncertain macroenvironment. GILD is one of the dominant players in the HIV market. Gilead's efforts to constantly innovate its HIV portfolio should enable it to maintain growth amid competition from GSK plc GSK. GILD has also collaborated with Merck MRK to evaluate the investigational combination of islatravir and lenacapavir for the treatment of HIV. The potential launch of lenacapavir for PrEP in 2025 will be a significant boost for the company. Gilead's strategic deals and acquisitions to diversify its business are encouraging. However, Biktarvy sales are expected to be under pressure due to Medicare Part D redesign, which, in turn, should impact overall HIV growth. Hence, we advise prospective investors to wait and watch how well Biktarvy and the oncology business combat the existing headwinds before making a positive investment decision. In addition, we believe investors should also wait for better entry levels. For investors already owning the stock, it's important to note that Gilead has been consistently increasing and paying out dividends. The company declared a quarterly dividend of $0.79 per share of common stock for the second quarter of 2025. Its strong cash position (as of March 31, 2025, GILD had $7.9 billion of cash, cash equivalents and marketable debt securities) indicates that the current yield of 2.91% is sustainable. Gilead presently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. 5 Stocks Set to Double Each was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2024. While not all picks can be winners, previous recommendations have soared +143.0%, +175.9%, +498.3% and +673.0%. Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor. Today, See These 5 Potential Home Runs >> Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report GSK PLC Sponsored ADR (GSK): Free Stock Analysis Report Merck & Co., Inc. (MRK): Free Stock Analysis Report Gilead Sciences, Inc. (GILD): Free Stock Analysis Report
UPI
5 days ago
- Health
- UPI
Eight times more young adults now take HIV prevention meds
More young Americans are taking antiretroviral meds to protect them from HIV infection than a decade ago. File Photo by John Angelillo/UPI | License Photo Eight times more young Americans are taking antiretroviral meds to protect them from HIV infection than a decade ago, a new study says. About 208 of every 100,000 U.S. young adults were using pre-exposure prophylaxis, or PrEP, to prevent becoming infected with HIV in 2023, researchers reported recently in the Journal of General Internal Medicine. That's up from 26 of 100,000 who filled a prescription for PrEP pills in 2016, researchers found in their analysis of data for 18- to 25-year-olds. "This is a patient population we often neglect in health care, because we don't think about them belonging to pediatric care or adult care, and their stage of cognitive development means they underestimate their STI [sexually transmitted infection] risk in general - yet they're one of the highest risk groups for a new diagnosis of HIV," said lead researcher Dr. Nina Hill, a general internist and pediatrician at the University of Michigan Medical School. "We're encouraged to see more prescribing over time, but the question remains: are we getting it to the highest-risk patients?" Hill added in a news release. For the study, researchers analyzed records on more than 1.4 million PrEP prescriptions dispensed to nearly 240,000 young adults between 2016 and 2023. The first PrEP medication, Truvada, was introduced in 2012 and became available as a generic drug in 2020, researchers said in background notes. A second oral option, Descovy, became available in 2019. The drugs reduce the chances of acquiring HIV through sex by 99%, when taken consistently as prescribed, researchers said. Nearly 9 of 10 (87%) of the prescriptions went to men, but Hill noted that some women also are at risk for HIV and could be eligible for PrEP. Unfortunately, results also showed that the length of time a person remained on PrEP declined by more than two weeks. This might indicate inconsistent use of PrEP, or show that young adults have trouble keeping up with the appointments and tests needed to continue the medication, researchers said. Nurse practitioners accounted for 39% of the prescriptions, while family doctors handed out 22% of the scrips, results show. Internists and physician assistants accounted for 14% and 11%, respectively. PrEP has been recommended since 2019 by the U.S. Preventive Services Task Force for teens and adults with an increased risk of acquiring HIV, researchers said. Under the Affordable Care Act, most insurance programs are required to make PrEP and HIV screening available to patients at no cost. However, the ACA's preventive care provisions are now under review at the U.S. Supreme Court, and a ruling is expected soon. More information The U.S. Department of Health & Human Services has more on pre-exposure prophylaxis. Copyright © 2025 HealthDay. All rights reserved.
Medscape
23-05-2025
- Health
- Medscape
Generic Version of HIV Drug Recommended for EU
The European Medicines Agency (EMA) has given a positive opinion to a generic medicine, emtricitabine/tenofovir alafenamide, for the treatment of adults and adolescents infected with HIV type 1 (HIV-1). The EMA's Committee for Medicinal Products for Human Use (CHMP) said that the combination is a generic of the branded medicine Descovy, which has been authorized in the EU since April 21, 2016. The two active substances are antivirals that exert their effects by inhibiting HIV reverse transcriptase through incorporation into the viral DNA, resulting in chain termination. Studies have demonstrated the satisfactory quality of emtricitabine/tenofovir alafenamide, CHMP said, and its bioequivalence to the reference product Descovy. Like Descovy, emtricitabine/tenofovir alafenamide is indicated in combination with other antiretroviral agents for the treatment of adults and adolescents aged 12 years or older with body weight at least 35 kg, who are infected with HIV-1. The drug is an oral medication available as 200 mg/25 mg and 200 mg/10 mg film-coated tablets to be taken once daily. The most common side effects include nausea, diarrhea, headache, dizziness, depression, fatigue, insomnia, strange dreams, stomach pain, weight loss, and rash. Therapy should be initiated by a physician experienced in the management of HIV infection. Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorization has been granted by the European Commission.
Yahoo
12-02-2025
- Business
- Yahoo
GILD Stock Up on Q4 Earnings and Sales Beat & Upbeat '25 Guidance
Gilead Sciences, Inc. GILD reported better-than-expected fourth-quarter results and provided an upbeat guidance for 2025. Adjusted earnings per share (EPS) of $1.90 beat the Zacks Consensus Estimate of $1.67. In the year-ago quarter, the company reported EPS of $1.72. The year-over-year increase in EPS was driven by higher product sales and lower acquired IPR&D expenses. Find the latest EPS estimates and surprises on Zacks Earnings Calendar. Total revenues of $7.6 billion comfortably beat the Zacks Consensus Estimate of $7.1 billion. Revenues also increased 6% year over year, primarily due to higher HIV, oncology and liver disease drug sales. The stock was up 4% in after-market trading on Feb. 11 in response to better-than-expected quarterly results and encouraging guidance for 2025. The stock is also up in pre-market trading today. Gilead's shares have surged 34.8% in the past year against the industry's decline of 11.7%. Image Source: Zacks Investment Research Total product sales rose 7% year over year to $7.5 billion. Excluding Veklury, product sales increased 13% to $7.2 billion. HIV product sales grew 16% year over year to $5.5 billion, primarily driven by higher demand, higher average realized price and favorable inventory dynamics. The figure beat both the Zacks Consensus Estimate and our model estimate of $5 billion. Flagship HIV therapy Biktarvy's sales increased 21% year over year to $3.8 billion, driven by higher demand, favorable inventory dynamics and higher average realized price. The reported number beat both the Zacks Consensus Estimate and our model estimate of $3.5 billion. Per GILD, Biktarvy accounts for over 50% share of the treatment market in the United States. Descovy (FTC 200 mg/TAF 25 mg) sales increased 21% year over year to $616 million, driven by higher demand and average realized price. The reported number beat the Zacks Consensus Estimate of $574 million and our model estimate of $558.5 million. Descovy maintained over 40% U.S. market share in pre-exposure prophylaxis (PrEP). The Liver Disease portfolio sales, which include chronic HCV, chronic hepatitis B virus (HBV) and chronic hepatitis delta virus (HDV), increased 4% to $719 million. The increase was driven by higher demand for HBV and HDV drugs, along with incremental sales of Livdelzi (seladelpar) in primary biliary cholangitis (PBC). Veklury sales plunged 53% to $337 million, primarily due to lower rates of COVID-19-related hospitalizations, particularly in the United States. Sales missed the Zacks Consensus Estimate of $338 million and our model estimate of $342 million. Cell Therapy product (comprising Yescarta and Tecartus) sales increased 5% to $488 million. The figure beat the Zacks Consensus Estimate of $480 million and our model estimate of $482 million. Yescarta sales increased 6% year over year to $390 million, primarily driven by higher average realized price and increased demand outside the United States, partially offset by lower demand in the country. Tecartus (adult acute lymphoblastic leukemia) sales were flat year over year at $98 million, as increased demand outside the United States was offset by lower demand in the country. Breast cancer drug Trodelvy's sales increased 19% year over year to $355 million, primarily driven by higher demand in all regions. Trodelvy's sales beat the Zacks Consensus Estimate of $282 million and our model estimate of $298.6 million. Adjusted product gross margin increased to 86.7% from 86.1% in the year-ago quarter due to product mix. Research and development expenses totaled $1.6 billion, up from $1.5 billion in the year-ago quarter due to incremental investments and clinical activities across its portfolio. SG&A expenses amounted to $1.9 billion, up 16%, driven by litigation accrual and higher sales and marketing spending. This can be attributed to launch preparation activities for lenacapavir for the investigational use of HIV PrEP and Livdelzi. Revenues in 2024 increased 6% to $28.8 billion due to higher sales in HIV, oncology and liver disease. The reported number surpassed the Zacks Consensus Estimate of $28.2 billion. EPS of $4.62 was down 31% from $6.72 in 2023 due to higher acquired IPR&D expenses related to the CymaBay acquisition and higher income tax expenses. The reported number, however, surpassed the Zacks Consensus Estimate of $4.36. Product sales are projected to be between $28.2 billion and $28.6 billion. The Zacks Consensus Estimate for the metric is pegged at $28.3 billion. Total product sales, excluding Veklury, are expected to be between $26.8 billion and $27.2 billion. Total Veklury sales are estimated to be $1.4 billion. Adjusted EPS is anticipated to be in the range of $7.70-$8.10. The Zacks Consensus Estimate for the same is pegged at $7.59. The FDA granted Breakthrough Therapy Designation to Trodelvy for the treatment of adult patients with extensive-stage small cell lung cancer whose disease has progressed on or after platinum-based chemotherapy. The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use recommended approval of seladelpar for the treatment of PBC in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone or as monotherapy in those unable to tolerate UDCA. Gilead submitted a new drug application to the FDA and marketing authorization application and an EU-Medicines for All application to the EMA for approval of twice-yearly lenacapavir for HIV prevention. Gilead announced that its board has declared an increase of 2.6% in its quarterly cash dividend, beginning the first quarter of 2025. The increase will result in a quarterly dividend of $0.79 per share of common stock. Gilead's fourth-quarter results were highly impressive as HIV growth driver Biktarvy maintained its dominant position across major markets. Descovy, too, put up a strong performance. Gilead Sciences, Inc. Price, Consensus and EPS Surprise Gilead Sciences, Inc. price-consensus-eps-surprise-chart | Gilead Sciences, Inc. Quote Biktarvy sales increased 13% to $13.4 billion in 2024. Given the strong data from the phase III PURPOSE 1 and PURPOSE2 trials, a potential approval of lenacapavir is in the cards that should further solidify GILD's robust HIV franchise. Per GILD, lenacapavir, with its twice-yearly dosing, could set a new bar for HIV prevention and allow PrEP to reach a larger number of people who could benefit from a prevention regimen. Approval of better HIV treatments should strengthen the HIV franchise in the wake of increasing competition from the likes of GSK plc GSK. GSK posted 13% growth in HIV sales in 2024, driven by strong patient demand for long-acting injectable medicines (Cabenuva and Apretude) and Dovato. However, total revenues in 2025 are likely to be impacted by approximately $1.1 billion as a result of the new Medicare Part D model. HIV revenues might be impacted by $900 million. Consequently, GILD expects HIV revenues to remain roughly flat in 2025. The FDA approval of Livdelzi for PBC strengthens GILD's liver disease portfolio. Seladelpar was added to GILD's portfolio/pipeline through the acquisition of CymaBay Therapeutics Inc. for $4.3 billion in March 2024. A potential approval in the EU should boost sales. Gilead currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the biotech sector are Immunocore Holdings plc IMCR and Alnylam Pharmaceuticals ALNY. While IMCR sports a Zacks Rank #1 (Strong Buy) at present, ALNY carries a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 Rank stocks here. In the past 90 days, estimates for Immunocore's 2024 loss per share have remained unchanged at 94 cents. Loss per share estimates for 2025 have narrowed from $1.66 to $1.62 in the past seven days. IMCR's earnings beat estimates in two of the trailing four quarters and missed the same in the other two, the average surprise being 25.57%. In the past 30 days, estimates for Alnylam Pharmaceuticals' 2024 loss per share have remained constant at 39 cents. The consensus estimate for 2025 earnings per share is currently pegged at 41 cents. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report GSK PLC Sponsored ADR (GSK) : Free Stock Analysis Report Alnylam Pharmaceuticals, Inc. (ALNY) : Free Stock Analysis Report Gilead Sciences, Inc. (GILD) : Free Stock Analysis Report Immunocore Holdings PLC Sponsored ADR (IMCR) : Free Stock Analysis Report To read this article on click here. Zacks Investment Research Sign in to access your portfolio
