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Merck Stock Rise as New PAH Drug Winrevair Meets Goal in Another Study
ZACKS· 2025-11-19 16:56
Core Insights - Merck's phase II CADENCE study for Winrevair, a drug for pulmonary arterial hypertension (PAH), successfully met its primary endpoint, demonstrating significant efficacy in reducing pulmonary vascular resistance (PVR) in adults with combined post and precapillary pulmonary hypertension (CpcPH) due to heart failure with preserved ejection fraction (HFpEF) [1][8] Study Results - The CADENCE study showed a statistically significant and clinically meaningful reduction in PVR from baseline at 24 weeks compared to placebo [2][8] - Safety outcomes in the CADENCE study were consistent with the known safety profile of Winrevair [4][8] - Merck plans to present the findings at a future scientific conference and initiate phase III studies for Winrevair in the target patient population [3][8] Market Performance - Following the announcement of the CADENCE study results, Merck's shares increased by 3.8% [2] - Year-to-date, Merck's shares have decreased by 2.9%, contrasting with the industry's growth of 14.3% [6] Product Development - Winrevair was approved by the FDA for treating PAH in March 2024 and received a similar approval in the European Union in August 2024 [9] - The FDA recently updated Winrevair's product label based on data from the ZENITH study, expanding its indication to include components of clinical worsening events [10] Financial Outlook - Winrevair generated sales of $976 million in the first nine months of 2025, with positive CADENCE study data likely to create label expansion opportunities [13] - The drug is expected to contribute to Merck's long-term growth, especially as the company prepares for the loss of exclusivity of its blockbuster drug Keytruda in 2028 [12][13] Competitive Landscape - Winrevair faces competition in the PAH market from major players like United Therapeutics and Johnson & Johnson, which have established products and significant sales in the PAH segment [15][16]
Generic Revlimid Fades, But Teva's Broader Generics Outlook Remains Strong
Benzinga· 2025-07-29 18:44
Financial Results - Teva Pharmaceutical Industries Ltd. is set to release its second-quarter 2025 financial results on July 30, expecting earnings of 62 cents and sales of approximately $4.29 billion [1] Generics Business Performance - Teva's generics business has shown a rebound with a 5% increase in revenue across regions, and the company anticipates five new product launches from its top-three global portfolio by 2027 [1] - The first quarter of 2025 is expected to demonstrate the strongest year-over-year growth for the generics business, despite rising competition affecting the generic Revlimid's impact [2][3] Prescription Growth - Prescription volumes for Austedo have increased by approximately 19% year-to-date, while Uzedy prescriptions rose by about 21% in the second quarter of 2025 and 17% in the first quarter [4] Future Outlook - Analysts suggest that 2025 may represent a low point for EBITDA, with cost-saving measures and efficiency improvements anticipated to benefit profits starting in 2026 [5] - Teva's branded drug business is expected to gain more influence, with a long-acting injectable version of olanzapine launching in late 2026 and a $5 billion innovative medicines franchise projected to be operational by 2030 [5] - Teva is not expected to face significant loss of exclusivity issues until well into the 2030s, which supports a case for a higher valuation multiple [6]
Pfizer to Face Several Headwinds: Can It Successfully Navigate Them?
ZACKS· 2025-06-24 15:26
Core Viewpoint - Pfizer is expected to face multiple challenges in the coming years, including declining sales from COVID products and significant revenue impacts from patent expirations and Medicare Part D redesign [2][3][4]. Group 1: Revenue Challenges - Sales from COVID products, Comirnaty and Paxlovid, are projected to decline, with revenues in 2025 expected to be similar to 2024 [2]. - The loss of exclusivity (LOE) for key products like Eliquis, Vyndaqel, Ibrance, Xeljanz, and Xtandi is anticipated to have a significant negative impact from 2026 to 2030 [3]. - The redesign of Medicare Part D under the Inflation Reduction Act (IRA) is expected to adversely affect Pfizer's revenues by approximately $1 billion starting in 2025, particularly impacting higher-priced drugs [4]. Group 2: Market Environment - The appointment of Robert F. Kennedy Jr. as Secretary of Health and Human Services has put additional pressure on vaccine manufacturers like Pfizer [5]. - Broader economic factors, including tariff uncertainties and geopolitical tensions, are contributing to muted economic growth [5]. Group 3: Growth Prospects - Despite the challenges, Pfizer's key drugs such as Vyndaqel, Padcev, and Eliquis, along with new products, are expected to drive top-line growth [6]. - Pfizer is implementing significant cost-reduction measures and improving R&D productivity, which should support profit growth despite anticipated revenue declines [6]. Group 4: Valuation and Earnings Estimates - Pfizer's stock has decreased by 6.2% this year, compared to a 1.3% decline in the industry [9]. - The company is trading at a forward P/E ratio of 7.82, below the industry average of 14.81 and its own 5-year mean of 10.89, indicating attractive valuation [11]. - The Zacks Consensus Estimate for 2025 earnings has increased from $2.99 to $3.06 per share, while the estimate for 2026 has risen from $3.02 to $3.09 per share over the past 60 days [12].
Pfizer Stock Down Almost 11% YTD: Should You Buy the Dip?
ZACKS· 2025-06-09 15:20
Core Viewpoint - Pfizer's stock has declined 10.7% year-to-date, underperforming its industry, sector, and the S&P 500, and is trading below its 50-day and 200-day moving averages [1][2][9] Group 1: Sales and Revenue Trends - Sales of Pfizer's COVID-19 products, Comirnaty and Paxlovid, are projected to drop to approximately $11 billion in 2024 from $56.7 billion in 2022, with similar revenues expected in 2025 [7] - Despite declining COVID revenues, non-COVID operational revenues improved in 2024, driven by key products like Vyndaqel, Padcev, and Eliquis, as well as newly acquired products [10][24] - Oncology revenues grew 7% on an operational basis in Q1 2025, supported by drugs such as Xtandi, Lorbrena, and Padcev [13] Group 2: Challenges and Headwinds - Pfizer faces challenges from declining sales of COVID-19 products, headwinds from U.S. Medicare Part D redesign in 2025, and significant impacts from patent expirations expected between 2026-2030 [3][15][16] - The company anticipates an unfavorable impact of approximately $1 billion from the Medicare Part D redesign, particularly affecting higher-priced drugs [16] - The stock has been under pressure due to uncertainties around tariffs and the macroeconomic environment, despite pharmaceuticals being exempted from initial tariffs [4][5] Group 3: Strategic Developments - Pfizer's acquisition of Seagen has strengthened its position in oncology, with ongoing advancements in its oncology clinical pipeline [12][14] - The company is focusing on cost cuts and internal restructuring, aiming for savings of $7.7 billion by the end of 2027 [25] - Pfizer's valuation appears attractive, trading at a price/earnings ratio of 7.60, significantly lower than the industry average of 15.12 [19] Group 4: Future Outlook - The Zacks Consensus Estimate for 2025 earnings has increased from $2.98 to $3.06 per share, indicating positive earnings momentum [22] - Pfizer's diversified portfolio, particularly in oncology, is expected to support top-line growth in 2025 and beyond [11][24] - The company offers a dividend yield of around 7.4%, appealing to income investors [25][26]