Latest news with #Kisqali
Medscape
2 days ago
- Health
- Medscape
NICE Widens Access to Ribociclib for Early Breast Cancer
The National Institute for Health and Care Excellence (NICE) has recommended ribociclib (Kisqali, Novartis) for routine NHS use in adjuvant treatment of hormone receptor-positive, HER2-negative early breast cancer in patients at high risk of recurrence. The drug is now recommended for use alongside an aromatase inhibitor after initial treatments, such as surgery. In pre-menopausal women, the aromatase inhibitor should be combined with a luteinising hormone-releasing hormone agonist. Targeted Therapy for Common Breast Cancer Subtype Ribociclib is a cyclin-dependent kinase (CDK) 4/6 inhibitor. It works by blocking proteins that drive cancer cell growth and division. NICE said the treatment 'represents a significant advance' in managing hormone receptor-positive, HER2-negative early breast cancer. Breast cancer is the most common cancer in the UK. Hormone receptor-positive, HER2-negative breast cancer is the most common subtype, accounting for about 68% of all UK cases. Expanded NHS Use Follows Evidence Submission Until now, NHS access in England was limited to patients whose cancer had spread to nearby lymph nodes. NICE approved this use of ribociclib in April 2025 but asked Novartis for more evidence to justify broader access. Following further review, NICE concluded in final draft guidance that ribociclib with an aromatase inhibitor offers clinical benefit and value for money. It is now considered a cost-effective use of NHS resources. Trial Shows Delayed Recurrence A clinical trial involving more than 5000 patients showed that ribociclib combined with an aromatase inhibitor delayed disease recurrence compared with the aromatase inhibitor alone. The latest analysis, based on a mean of 33 months' follow-up, continued to show improved invasive disease-free survival across key subgroups. However, NICE said that it remained unclear whether the combination increased overall survival and that more mature data, including predictions of longer-term outcomes, is needed. Further data from the trial are expected in May 2026. Comparable to Other Options Indirect evidence suggests that ribociclib plus an aromatase inhibitor is as effective as abemaciclib plus endocrine therapy. Abemaciclib is currently used for node-positive breast cancer. Ribociclib in combination with fulvestrant is already recommended for treating hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer in adults who have had previous endocrine therapy. This demonstrated 'the drug's versatility across different stages of the disease,', NICE said. Helen Knight, director of medicines evaluation at NICE, described the latest decision as 'fantastic news for the tens of thousands of patients and their loved ones'. An estimated 5700 people with early breast cancer could benefit from expanded access to the combination treatment. Relapse after initial treatment occurs in about 30% of people with early breast cancer. Patient experts told the NICE committee that the high risk of recurrence has a considerable impact on quality of life. 'The fear of the cancer returning is a common cause of stress and anxiety for people and their families, affecting physical and psychological wellbeing,' they said. Treatment options are limited and have unpleasant side effects. Having different options is particularly important because people often choose treatments based on their side-effect profiles. Both patient and clinical experts emphasised the importance of treatment choice. Dosage, Side Effects, and Pricing Ribociclib is taken orally, which may improve convenience and adherence compared with alternatives. The usual dose of ribociclib is: 400 mg once daily (two 200 mg tablets) for primary breast cancer 600 mg once daily (three 200 mg tablets) for locally advanced or secondary disease Common side effects include leukopaenia and increased infection risks, anaemia, anorexia, nausea and vomiting, diarrhoea and constipation, abdominal pain, fatigue, sore mouth, shortness of breath, cough, rashes, and hair loss. The list prices of ribociclib 200-mg tablets are: £983.33 for 21 tablets £1966.67 for 42 tablets £2950.00 for 63 tablets A simple patient access scheme allows the NHS to purchase the drug at a confidential discount. Knight said the expanded access was 'also due in no small part to the willingness of companies to engage with us constructively, as in the case with ribociclib, to ensure the benefits of their treatments are properly presented and appropriately priced'.
Yahoo
2 days ago
- Business
- Yahoo
Novartis AG (NVS) Q2 2025 Earnings Call Highlights: Strong Growth and Strategic Initiatives ...
Sales Growth: Up 11% in constant currency for Q2 2025. Core Operating Income: Increased by 21% in constant currency. Core Margin: Improved by 340 basis points to 42.2%. Core EPS: $2.42, up 24%. Free Cash Flow: $6.3 billion, up 37% in US dollars. Priority Brands Growth: Up 30% in constant currencies; excluding Entresto, up 33%. Kisqali Growth: 64% increase in Q2, with 100% growth in the US. Kesimpta Growth: 33% increase in Q2, with 28% growth in the US. Pluvicto Growth: 30% increase in Q2, with 40% growth in new patient starts. Leqvio Growth: 61% increase in Q2, with 47% growth in the US. Scemblix Growth: 79% increase in constant currency. Cosentyx Growth: 6% increase in Q2. Entresto Sales: $1.2 billion in Q2 2025. Full Year Guidance: High single-digit sales growth; core operating income to grow in the low teens. New Share Buyback Program: Up to $10 billion targeted for completion by the end of 2027. Warning! GuruFocus has detected 4 Warning Sign with MMC. Release Date: July 17, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Positive Points Novartis AG (NYSE:NVS) reported double-digit sales growth of 11% in constant currency for Q2 2025. Core operating income increased by 21% in constant currency, reflecting strong financial performance. The company upgraded its full-year 2025 bottom line guidance, indicating confidence in continued growth. Key brands like Kisqali, Kesimpta, and Pluvicto showed robust growth, with Kisqali achieving 64% growth in the quarter. A new $10 billion share buyback program was announced, demonstrating strong cash flow and commitment to returning capital to shareholders. Negative Points Cosentyx growth moderated to 6% in Q2, with challenges from new competitor entries and geographic-specific headwinds. The company faces potential impacts from US generic entry for Entresto, which could affect future sales. There is a slowdown in pharmaceutical spending in China, impacting growth for certain products like Cosentyx and Entresto. The competitive environment in the US remains challenging, particularly with Medicare Part D redesign affecting rebates. Uncertainties remain regarding the resolution of US drug pricing reforms, which could impact future pricing strategies. Q & A Highlights Q: Can you update on your level of confidence in the Phase II data for Sjogren's disease and clarify whether both studies need to be positive for a filing process? A: We are excited about the opportunity in Sjogren's disease, but acknowledge the challenges as no drug has shown significant benefit on the SIs. We have strong Phase II data and believe in the mechanism, but it's a tough indication. Whether both studies need to be positive depends on the data. We've had robust discussions with the FDA on primary and secondary endpoints, and based on the data, we'll determine the best path forward. We plan to inform the market based on the results of both studies simultaneously. - Vasant Narasimhan, CEO Q: How significant is the impact of healthcare spending tightening in China on Cosentyx, and how are you adapting your strategy to maintain growth? A: We've seen a notable slowdown in China, with our business growth coming down from over 20% last year. We expect China to grow in the high single-digit to low-teens range, which is factored into our guidance. The slowdown impacts medicines on the NRDL listing, like Cosentyx and Entresto. However, the out-of-pocket market for Leqvio has been strong, and we are considering whether to move it into the NRDL listing. - Vasant Narasimhan, CEO Q: What is the latest you've heard from CMS, HHS, or your people on the hill about the administration's plans for drug pricing in the US? A: Conversations with the administration have been productive, focusing on having OECD markets pay more for innovative medicines and reducing US patient costs by cutting out intermediaries. We're moving forward with proposals, and HHS is evaluating them. The administration aims to maintain US leadership in biopharmaceutical innovation, balancing innovation rewards with patient affordability. - Vasant Narasimhan, CEO Q: Can you elaborate on the price/volume dynamics for Cosentyx and why you see the competitive environment as a temporary factor? A: The Medicare Part D redesign has impacted Cosentyx, increasing rebates. The competitive entry has caused an initial impact, but we expect the market to settle. We have strong frontline access across indications, and we're educating on dosing options to moderate switches. We see opportunities in the first switch off anti-TNFs and expect HS to be a $3 billion-plus market, with Cosentyx delivering $1 billion in sales. - Vasant Narasimhan, CEO & Harry Kirsch, CFO Q: How are you thinking about using Pluvicto in earlier lines, and are there concerns about its impact on continence and sexual function? A: We haven't heard concerns about continence and sexual function with Pluvicto. Its safety profile is compelling, with primary topics being salivary glands and bone marrow. We expect significant use in HSPC, with compelling RPFS data and maturing OS data. Ex-US, the topic is comparator choice, and we're confident in Pluvicto's peak sales guidance. Actinium PSMA is planned for post-Pluvicto settings, with potential earlier use depending on safety profile. - Vasant Narasimhan, CEO For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. 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Yahoo
3 days ago
- Business
- Yahoo
Novartis Trims Operating Income Outlook After Strong Q2 Performance, Initiates $10 Billion Stock Buyback
Swiss pharmaceutical giant Novartis AG (NYSE:NVS) reported second-quarter 2025 earnings on Thursday and raised its full-year earnings forecast. Quarterly sales reached $14.05 billion, almost in line with the analysts' consensus estimate of $14.06 billion. Net sales grew 12% year over year (+11% on constant currency or cc) with core operating income up 20% to $5.93 billion (+21% on constant currency).Sales growth driven by performance from breast cancer treatment, Kisqali ($1.18 billion, +64% cc), Entresto ($2.36 billion, +22% cc), multiple sclerosis drug, Kesimpta ($1.08 billion, +33% cc), Scemblix ($298 million, +79% cc), Leqvio ($298 million, +61% cc), and Pluvicto ($454 million, +30% cc). Novartis reported adjusted earnings of $2.42 per share, beating the consensus of $2.38. The company also announced a substantial share buyback program. Novartis said it is initiating a share buyback of up $10 billion to be completed by year-end 2027. View more earnings on NVS 'Our robust balance sheet and confidence in our mid- and long-term growth enable us to initiate an up-to $10 billion share buyback as part of our commitment to balanced capital allocation,' stated CEO Vas Narasimhan in a statement on Thursday. Earlier in July, Novartis released topline results from the Phase 3 GCAptAIN study evaluating Cosentyx (secukinumab) for newly diagnosed or relapsing giant cell arteritis (GCA). The study evaluated Cosentyx with a 26-week steroid taper and compared it to a placebo plus a 52-week steroid taper. Cosentyx did not demonstrate a statistically significant improvement in sustained remission at Week 52 compared to placebo. Outlook For fiscal year 2025, Novartis reaffirms that net sales will grow in the high single digits. 2025 core operating income is expected to grow in the low teens, compared to the low double digits forecasted earlier. 'We continue to assume Entresto US generic entry in mid-2025 for forecasting purposes, though the timing of generic entry is subject to ongoing IP and regulatory litigation,' Novartis said in the release. Management Update In a separate announcement, Novartis provided a key leadership update: Chief Financial Officer Harry Kirsch will retire in March 2026, concluding an impressive 22-year tenure at the company, including 12 years in the CFO role since 2013. He will be succeeded by Mukul Mehta, who currently serves as the company's head of business planning and analysis, digital finance, and tax. Price Action: NVS stock is trading lower by 1.71% to $116.35 during the premarket session at last check Thursday. Read Next:Photo via Shutterstock UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga? NOVARTIS (NVS): Free Stock Analysis Report This article Novartis Trims Operating Income Outlook After Strong Q2 Performance, Initiates $10 Billion Stock Buyback originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
CNBC
3 days ago
- Business
- CNBC
Swiss pharma giant Novartis bets on a breast cancer blockbuster as sales rise
Swiss pharmaceutical firm Novartis said Thursday that it expects its Kisqali breast cancer treatment to be the next blockbuster drug within its portfolio, as it looks to shift reliance away from its Entresto heart failure therapy. Sales of Kisqali, which treats metastatic breast cancer, surged 64% globally on a constant currency basis in the three months to June, the company said in its second-quarter sales report. That includes 100% growth in the U.S. It follows a 56% increase in Kisqali sales in the first quarter to March. Speaking on an earnings call, CEO Vas Narasimhan said Kisqali was the drug with the greatest scope for outperformance. Global breast cancer diagnoses and deaths are projected to increase by 2050, according to the World Health Organization's cancer agency, with 1 in 20 women worldwide expected to be diagnosed with breast cancer in their lifetime. That could translate to 3.2 million new cases and 1.1 million deaths a year worldwide by 2050 if current trends continue, the study found — significantly higher than 2022's 2.3 million new cases and 670,000-related deaths. Narasimhan also cited Novartis' "strong pipeline" of other drugs, including its Pluvicto prostate cancer treatment and Scemblix for chronic myeloid leukemia, which he said was also "on track to be a blockbuster." "We continue to drive strong performance on our ongoing launches for Kisqali, Pluvicto, and Scemblix, demonstrating the replacement power in our portfolio," he added in a statement accompanying the results. The comments come as Novartis seeks to shake its reliance on its top-selling Entreso heart failure drug, which faces U.S. patent expiry next year. Entresto brought in $7.8 billion in 2024, accounting for around 15% of the company's overall global sales. It said Thursday that it expects generic drug makers to begin producing copycat versions of the drug by mid-2025, although that timeline is "subject to ongoing IP [intellectual property] and regulatory litigation." On Wednesday, a U.S. federal judge rejected Novartis' request for a preliminary injunction to stop MSN Pharmaceuticals from selling a generic version of the drug before the patent expires. Sales of Entresto rose 22% in the second quarter, in line with the prior three-month period. "Short-term it's an important product for us," outgoing chief financial officer Harry Kirsch said of Entresto Thursday. "We have IP that we're defending. Should we be successful in further defending our appeal, each month we'll have some nice significant upside," he added. Overall, Novartis' second-quarter net sales rose 11% on a constant currency basis to $14.05 billion, just shy of the $14.18 billion estimated by analysts in an LSEG poll. Quarterly adjusted core operating income, meanwhile, rose 21% to $5.93 billion, slightly above the $5.69 billion expected. Novartis said it now expects full-year core operating income to grow by "low teens," up from "low double-digit" previously, while it retained its forecast for sales growth in the high single digits. The company also announced an up to $10 billion share buyback, citing "confidence" in its mid- and long-term growth.
Yahoo
3 days ago
- Business
- Yahoo
Novartis Trims Operating Income Outlook After Strong Q2 Performance, Initiates $10 Billion Stock Buyback
Swiss pharmaceutical giant Novartis AG (NYSE:NVS) reported second-quarter 2025 earnings on Thursday and raised its full-year earnings forecast. Quarterly sales reached $14.05 billion, almost in line with the analysts' consensus estimate of $14.06 billion. Net sales grew 12% year over year (+11% on constant currency or cc) with core operating income up 20% to $5.93 billion (+21% on constant currency).Sales growth driven by performance from breast cancer treatment, Kisqali ($1.18 billion, +64% cc), Entresto ($2.36 billion, +22% cc), multiple sclerosis drug, Kesimpta ($1.08 billion, +33% cc), Scemblix ($298 million, +79% cc), Leqvio ($298 million, +61% cc), and Pluvicto ($454 million, +30% cc). Novartis reported adjusted earnings of $2.42 per share, beating the consensus of $2.38. The company also announced a substantial share buyback program. Novartis said it is initiating a share buyback of up $10 billion to be completed by year-end 2027. View more earnings on NVS 'Our robust balance sheet and confidence in our mid- and long-term growth enable us to initiate an up-to $10 billion share buyback as part of our commitment to balanced capital allocation,' stated CEO Vas Narasimhan in a statement on Thursday. Earlier in July, Novartis released topline results from the Phase 3 GCAptAIN study evaluating Cosentyx (secukinumab) for newly diagnosed or relapsing giant cell arteritis (GCA). The study evaluated Cosentyx with a 26-week steroid taper and compared it to a placebo plus a 52-week steroid taper. Cosentyx did not demonstrate a statistically significant improvement in sustained remission at Week 52 compared to placebo. Outlook For fiscal year 2025, Novartis reaffirms that net sales will grow in the high single digits. 2025 core operating income is expected to grow in the low teens, compared to the low double digits forecasted earlier. 'We continue to assume Entresto US generic entry in mid-2025 for forecasting purposes, though the timing of generic entry is subject to ongoing IP and regulatory litigation,' Novartis said in the release. Management Update In a separate announcement, Novartis provided a key leadership update: Chief Financial Officer Harry Kirsch will retire in March 2026, concluding an impressive 22-year tenure at the company, including 12 years in the CFO role since 2013. He will be succeeded by Mukul Mehta, who currently serves as the company's head of business planning and analysis, digital finance, and tax. Price Action: NVS stock is trading lower by 1.71% to $116.35 during the premarket session at last check Thursday. Read Next:Photo via Shutterstock UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga? NOVARTIS (NVS): Free Stock Analysis Report This article Novartis Trims Operating Income Outlook After Strong Q2 Performance, Initiates $10 Billion Stock Buyback originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
