Latest news with #Kesimpta
Cision Canada
07-08-2025
- Health
- Cision Canada
Access to multiple sclerosis (MS) treatments inadequate in British Columbia
VANCOUVER, BC, Aug. 7, 2025 /CNW/ - Teresa Alfeld, a filmmaker who was recently diagnosed with multiple sclerosis (MS), is calling for the provincial government to fund a medication that is available in every other province in Canada – but not BC. Teresa was diagnosed with MS in 2024, 20 years after her Type 1 diabetes diagnosis. Because of her diabetes, she was recommended to treat her MS with ofatumumab (Kesimpta), because some of the other available treatments for MS could worsen her Type 1 diabetes. Hower, this medication is not covered by PharmaCare. BC is the only province in Canada that does not provide public coverage for Health Canada-approved, anti-CD20 therapies for relapsing MS – ofatumumab (Kesimpta) and ocrelizumab (Ocrevus). "My diagnosis was a gut-punch. After years of hard work building my filmmaking career, my future was suddenly in jeopardy," says Teresa. "On top of processing this life-changing diagnosis, I've had to fight for access to ofatumumab, a drug that I could easily access if I lived anywhere else in Canada." Ofatumumab is the only monoclonal antibody available as a subcutaneous self-injection rather than being delivered via infusion at a specialty clinic. This fills a significant gap in MS treatment for persons with MS who are recommended to be treated with a high-efficacy monoclonal antibody, like Teresa. Funding high-efficacy medications reduces the financial burden to health and social systems through fewer MS relapses requiring hospitalization and loss of employment. According to the Conference Board of Canada, as disability from MS worsens, costs incurred outside the health care system, such as informal care and productivity losses, continue to increase until they comprise two-thirds of all health costs. The appropriate use of disease-modifying therapies (DMTs) can provide significant health and economic benefits to people living with MS. Teresa and her family are now considering moving out of the province so she can access ofatumumab to manage her MS. "Not having access to Kesimpta doesn't just affect my health – it affects my ability to plan ahead and build a stable life," says Teresa. "This is an equity issue, plain and simple. I'm not asking for special treatment from the government, but for fair treatment for myself and every other British Columbian living with MS." MedAccessBC Urges Government to Take Action Teresa's story highlights a larger, systemic issue that the Medicines Access Coalition — BC (MedAccessBC) has been working to address for over two decades. MedAccessBC represents over 30 patient care organizations and advocates for fair, timely, and equitable access to medications for British Columbians. "People living with MS in BC should be able to access all Health Canada-approved treatments, which all other Canadians can access," says Don Bindon, co-chair of MedAccessBC. "MS is a disease that strikes people in the prime of their lives, and access to high-efficacy medications soon after diagnosis can delay disease progression. The provincial government should consider the productivity advantages of funding ofatumumab and ocrelizumab for relapsing MS." As a non-profit coalition, MedAccessBC continues to collaborate with patient communities, healthcare professionals, and policy makers to ensure that health decisions prioritize outcomes and do not compromise patient well-being in the name of cost containment. Call to Action MedAccessBC is urging the provincial government to approve and fund ofatumumab and ocrelizumab for relapsing MS through the BC PharmaCare program without further delay. Teresa's message to decision makers is simple: "While MS is unpredictable, treatment shouldn't be. I'm asking for the ability to manage my disease based on what works for me, not what PharmaCare happens to cover." About multiple sclerosis (MS) Canada has one of the highest rates of multiple sclerosis (MS) in the world. On average, 12 Canadians are diagnosed every day. MS is a neurological disease of the central nervous system (brain, spinal cord). Most people are diagnosed with MS between the ages of 20 and 49. MS is a continuous disease process that progresses through different stages over time, and everyone experiences it differently as severity, symptoms and response to treatment can vary from one person to the next. The unpredictable, episodic yet progressive nature of MS makes it particularly challenging to maintain an adequate quality of life. About the Medicines Access Coalition of BC: MedAccess BC advocates for improved access to medications and health technologies for individuals with chronic diseases. Representing over 30 patient organizations, it has been working since 1997 to improve access to evidence-based medicines through BC's PharmaCare program.
Yahoo
18-07-2025
- 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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Business Insider
17-07-2025
- Business
- Business Insider
Is NVS Stock (NVS) a Buy Ahead of Q2 Earnings?
Pharmaceutical giant Novartis (NVS) is set to release its Q2 earnings report this week. This has some investors wondering whether it's a good idea to buy shares of NVS stock beforehand. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week. What Wall Street Expects Wall Street is expecting Novartis to announce quarterly earnings of $2.38 per share, up 20.8% on the same period last year. Revenues are projected to reach $14.04 billion, increasing 9% from the same quarter last year. Will NVS be able to beat these estimates? As one can see below, it has a very strong track record in doing just that. Key Issues Ahead of Earnings Novartis has had a strong start to 2025, with its stock soaring nearly 27%. It has been helped by some landmark wins such as recently winning approval for a new baby malaria treatment. Its cardiovascular drug Entresto has also performed well, helped by increased demand in China and Japan. Its breast cancer drug Kisqali and multiple sclerosis treatment Kesimpta will also likely have boosted sales in the quarter. There are challenges, however, emanating from the Trump administration over drug prices and advertising. It will be interesting to hear from Novartis what kind of short and long-term impact these might have both for it and its peers. Is NVS a Good Stock to Buy Now? On TipRanks, NVS has a Moderate Sell consensus based on 2 Hold and 1 Sell ratings. Its highest price target is $139.13.
Yahoo
17-07-2025
- Business
- Yahoo
Novartis reports strong Q2 with double-digit sales growth and core margin expansion; raises FY 2025 core operating income guidance
Ad hoc announcement pursuant to Art. 53 LR Q2 net sales grew +11% (cc1, +12% USD) with core operating income1 up +21% (cc, +20% USD) Sales growth driven by continued strong performance from Kisqali (+64% cc), Entresto (+22% cc), Kesimpta (+33% cc), Scemblix (+79% cc), Leqvio (+61% cc) and Pluvicto (+30% cc) Core operating income margin1 reached 42.2%, +340 basis points (cc), mainly driven by higher net sales Q2 operating income grew +25% (cc, +21% USD); net income up +26% (cc, +24% USD) Q2 core EPS1 grew +24% (cc, +23% USD) to USD 2.42 Q2 free cash flow1 of USD 6.3 billion (+37% USD) driven by higher net cash flows from operating activities H1 net sales up +13% (cc, +12% USD) and core operating income up +24% (cc, +21% USD) Q2 selected innovation milestones: Phase III PSMAddition study positive readout in PSMA+ mHSPC (atrasentan) FDA accelerated approval for IgAN OAV101 IT US and EU submissions for SMA Votoplam Phase II PIVOT-HD study positive readout in Huntington's disease Remibrutinib Phase II study positive readout in food allergy Initiating up-to USD 10 billion share buyback to be completed by year-end 2027 Full-year 2025 guidance2 raised for core operating income Sales expected to grow high single digit (unchanged) Core operating income expected to grow low teens (from low double-digit) 1. Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 40 of the Condensed Interim Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year. 2. Please see detailed guidance assumptions on page 7. Basel, July 17, 2025 – Commenting on Q2 2025 results, Vas Narasimhan, CEO of Novartis, said:'Novartis delivered another strong quarter, with double-digit sales and core operating income growth. We continue to drive strong performance on our ongoing launches for Kisqali, Pluvicto, and Scemblix, demonstrating the replacement power in our portfolio. We also delivered important pipeline milestones including a third positive Phase III readout for Pluvicto in hormone-sensitive prostate cancer and global filings for OAV101 IT in SMA. Our robust balance sheet and confidence in our mid and long-term growth enable us to initiate an up-to USD 10 billion share buyback as part of our commitment to balanced capital allocation." Key figures Q2 2025 Q2 2024 % change H1 2025 H1 2024 % change USD m USD m USD cc USD m USD m USD cc Net sales 14 054 12 512 12 11 27 287 24 341 12 13 Operating income 4 864 4 014 21 25 9 527 7 387 29 33 Net income 4 024 3 246 24 26 7 633 5 934 29 31 EPS (USD) 2.07 1.60 29 32 3.91 2.91 34 37 Free cash flow 6 333 4 615 37 9 724 6 653 46 Core operating income 5 925 4 953 20 21 11 500 9 490 21 24 Core net income 4 710 4 008 18 19 9 192 7 689 20 22 Core EPS (USD) 2.42 1.97 23 24 4.69 3.77 24 27 Strategy Our focus Novartis is a 'pure-play' innovative medicines company. We have a clear focus on four core therapeutic areas (cardiovascular-renal-metabolic, immunology, neuroscience and oncology), with multiple significant in-market and pipeline assets in each of these areas, that address high disease burden and have substantial growth potential. In addition to two established technology platforms (chemistry and biotherapeutics), three emerging platforms (gene & cell therapy, radioligand therapy and xRNA) are being prioritized for continued investment into new R&D capabilities and manufacturing scale. Geographically, we are focused on growing in our priority geographies – the US, China, Germany and Japan. Our priorities Accelerate growth: Renewed attention to deliver high-value medicines (NMEs) and focus on launch excellence, with a rich pipeline across our core therapeutic areas. Deliver returns: Continuing to embed operational excellence and deliver improved financials. Novartis remains disciplined and shareholder-focused in our approach to capital allocation, with substantial cash generation and a strong capital structure supporting continued flexibility. Strengthen foundations: Unleashing the power of our people, scaling data science and technology and continuing to build trust with society. Financials Second quarter Net sales were USD 14.1 billion (+12%, +11% cc), with volume contributing 12 percentage points to growth. Generic competition had a negative impact of 2 percentage points, pricing had a positive impact of 1 percentage point, and currency had a positive impact of 1 percentage point. Operating income was USD 4.9 billion (+21%, +25% cc), mainly driven by higher net sales, partly offset by higher investments behind priority brands and launches and net expense from legal matters. Net income was USD 4.0 billion (+24%, +26% cc), mainly driven by higher operating income, partly offset by higher net financial expense. EPS was USD 2.07 (+29%, +32% cc), benefiting from the lower weighted average number of shares outstanding. Core operating income was USD 5.9 billion (+20%, +21% cc), mainly driven by higher net sales, partly offset by higher investments behind priority brands and launches. Core operating income margin was 42.2% of net sales, increasing 2.6 percentage points (3.4 percentage points cc). Core net income was USD 4.7 billion (+18%, +19% cc), mainly due to higher core operating income, partly offset by higher income taxes and net financial expense. Core EPS was USD 2.42 (+23%, +24% cc), benefiting from the lower weighted average number of shares outstanding. Free cash flow amounted to USD 6.3 billion (+37% USD), compared with USD 4.6 billion in the prior-year quarter, driven by higher net cash flows from operating activities. First half Net sales were USD 27.3 billion (+12%, +13% cc), with volume contributing 14 percentage points to growth. Generic competition had a negative impact of 2 percentage points, pricing had a positive impact of 1 percentage point, benefiting from revenue deduction adjustments mainly in the US, and currency had a negative impact of 1 percentage point. Operating income was USD 9.5 billion (+29%, +33% cc), mainly driven by higher net sales and contingent consideration adjustments, partly offset by higher investments behind priority brands and launches. Net income was USD 7.6 billion (+29%, +31% cc), mainly driven by higher operating income, partly offset by higher income taxes and net financial expense. EPS was USD 3.91 (+34%, +37% cc), benefiting from the lower weighted average number of shares outstanding. Core operating income was USD 11.5 billion (+21%, +24% cc), mainly driven by higher net sales, partly offset by higher investments behind priority brands and launches. Core operating income margin was 42.1% of net sales, increasing 3.1 percentage points (3.7 percentage points cc). Core net income was USD 9.2 billion (+20%, +22% cc), mainly due to higher core operating income, partly offset by higher income taxes and net financial expense. Core EPS was USD 4.69 (+24%, +27% cc), benefiting from the lower weighted average number of shares outstanding. Free cash flow amounted to USD 9.7 billion (+46% USD), compared with USD 6.7 billion in the prior-year period, driven by higher net cash flows from operating activities. Q2 priority brands Underpinning our financial results in the quarter is a continued focus on key growth drivers (ranked in order of contribution to Q2 growth) including:(USD 1 177 million, +64% cc) sales grew strongly across all regions, including +100% growth in the US with strong momentum from the recently launched early breast cancer indication as well as continued share gains in metastatic breast cancer(USD 2 357 million, +22% cc) sustained robust, demand-led growth globally(USD 1 077 million, +33% cc) sales grew across all regions driven by increased demand and strong access(USD 298 million, +79% cc) sales grew across all regions, demonstrating the continued high unmet need in CML and continued strong momentum from the recently launched early-line indication in the US(USD 298 million, +61% cc) continued steady growth, with a focus on increasing account and patient adoption, and continuing medical education(USD 454 million, +30% cc) showed encouraging demand uptake in the US following the pre-taxane metastatic castration-resistant prostate cancer (mCRPC) approval, as well as continued access expansion ex-US in the post-taxane mCRPC setting(USD 1 629 million, +6% cc) sales grew mainly in the US and Europe, driven by recent launches as well as volume growth in core indications(USD 120 million) sales grew driven by continued launch execution across all markets in PNH as well as recent launches in IgAN and C3G in the US(USD 207 million, +17% cc) sales grew mainly in the US, Europe and Japan due to increased demand and earlier-line adoption, particularly in the US and Japan(USD 297 million, -17% cc) sales declined reflecting a lower incidence of SMA compared to prior year, while demand remained robust Net sales of the top 20 brands in the second quarter and first half Q2 2025 % change H1 2025 % change USD m USD cc USD m USD cc Entresto 2 357 24 22 4 618 22 22 Cosentyx 1 629 7 6 3 163 11 11 Kisqali 1 177 64 64 2 133 59 60 Kesimpta 1 077 35 33 1 976 38 38 Tafinlar + Mekinist 573 10 7 1 125 13 13 Promacta/Revolade 502 -8 -9 1 048 -2 -1 Jakavi 524 11 8 1 016 7 8 Xolair 443 4 2 899 9 10 Ilaris 477 30 27 896 24 24 Pluvicto 454 32 30 825 26 26 Tasigna 327 -27 -27 704 -16 -15 Zolgensma 297 -15 -17 624 -3 -3 Sandostatin Group 303 -3 -3 620 -7 -6 Leqvio 298 64 61 555 67 66 Scemblix 298 82 79 536 79 78 Lutathera 207 18 17 400 16 16 Exforge Group 191 7 7 370 0 3 Lucentis 173 -37 -39 362 -39 -38 Diovan Group 154 -4 -4 304 1 3 Galvus Group 123 -18 -17 247 -17 -14 Top 20 brands total 11 584 16 14 22 421 16 17 R&D update - key developments from the second quarter New approvals (atrasentan) FDA granted accelerated approval for Vanrafia for the reduction of proteinuria in adults with primary IgA nephropathy (IgAN) at risk of rapid disease progression. Vanrafia can be seamlessly added to supportive care in IgAN and used as a foundational therapy. (artemether and lumefantrine) In July, Swissmedic approved Coartem Baby, the first clinically proven malaria treatment specifically designed for newborns and infants between 2-5 kg. This milestone paves the way for registration in eight African countries through the Marketing Authorization for Global Health Products (MAGHP) procedure. Regulatory updates OAV101 IT (onasemnogene abeparvovec) Regulatory submissions for OAV101 IT in patients with spinal muscular atrophy (SMA) were completed in the US and EU. Results from ongoing trials and other highlights (lutetium Lu177 vipivotide tetraxetan) At a prespecified interim analysis, the Phase III PSMAddition trial in PSMA+ metastatic hormone-sensitive prostate cancer (mHSPC) met its primary endpoint with a statistically significant and clinically meaningful benefit in radiographic progression-free survival (rPFS) in patients treated with Pluvicto plus standard of care (SoC) versus SoC alone. The study also showed a positive trend in overall survival in favor of the Pluvicto arm. Data will be presented at an upcoming medical meeting and, based on FDA feedback, submitted for regulatory review in H2 2025. (secukinumab) In the Phase III GCAptAIN study, Cosentyx did not demonstrate a statistically significant improvement in sustained remission compared to placebo in adults with newly diagnosed or relapsing giant cell arteritis (GCA). Safety in GCA was consistent with the known safety profile of Cosentyx. (ribociclib) A new subgroup analysis of the Phase III NATALEE trial in HR+/HER2- early breast cancer (eBC) showed that patients receiving Kisqali plus endocrine therapy continued to see consistent reductions in risk of recurrence across all efficacy measures, regardless of age and menopausal status, at median follow-up of 44.2 months. Data presented at ASCO. (iptacopan) In the Phase IIIb APPULSE-PNH study, adult PNH patients with hemoglobin (Hb) levels ≥10g/dL who switched to Fabhalta from anti-C5 therapies experienced clinically meaningful improvements in Hb levels. The vast majority (92.7%) achieved Hb ≥12g/dL, reaching normal or near-normal levels. No patients treated with Fabhalta required transfusions, experienced breakthrough hemolysis or had any major adverse vascular events during the treatment period. Data presented at EHA. (asciminib) In the Phase IIIb ASC4START trial evaluating the tolerability and efficacy of Scemblix versus nilotinib in adult patients with newly diagnosed Ph+ CML-CP, patients treated with Scemblix had a 55% lower risk of discontinuation due to AEs vs nilotinib, and 12.7% more patients treated with Scemblix achieved major molecular responses by week 12 vs those treated with nilotinib. Data presented at ASCO and EHA. Votoplam The Phase II PIVOT-HD study of votoplam in patients with Stage 2 and Stage 3 Huntington's disease met its primary endpoint of reduction in blood Huntingtin (HTT) protein levels at Week 12 (p<0.0001), with durable, dose-dependent lowering observed through Month 12. Across all dose levels and disease stages, votoplam showed a favorable safety and tolerability profile, with no treatment-related serious adverse events or neurofilament light chain protein (NfL) spikes. Together with our partner, PTC Therapeutics, we are evaluating the results and plan to engage with the HD community and regulatory authorities to inform next steps. Remibrutinib A Phase II study with remibrutinib in food allergy met its primary endpoint with a statistically significant and clinically meaningful benefit. These data support remibrutinib's potential as a first-in-class oral BTK inhibitor that reduces the risk of severe allergic reactions, including anaphylaxis. Phase III study planning is underway. Ianalumab Novartis will not advance investigation of ianalumab in hidradenitis suppurativa following a Phase II proof-of-concept study which did not meet our target criteria despite demonstrating efficacy vs placebo. No new safety signals were observed and all other studies for ianalumab in B-cell driven diseases continue as planned. Rapcabtagene autoleucel (YTB323) A Phase I/II study of rapcabtagene autoleucel, a rapidly manufactured CD19 CAR-T therapy using the T-Charge platform, demonstrated the expansion of CAR-T cells, deep B cell depletion, early and sustained improvement in overall disease activity, and a favorable benefit/risk profile in 21 patients with severe refractory SLE up to 12 months after treatment. Data presented at EULAR. Zigakibart Updated results from the Phase I/II study for zigakibart in IgAN showed a robust and clinically meaningful reduction in proteinuria of 60.4% from baseline and eGFR stabilization over 100 weeks of treatment. To date, this is the longest duration of treatment reported for an anti-APRIL agent, demonstrating long-term safety and efficacy. Data presented at ERA. The Phase III BEYOND trial is ongoing with anticipated readout in 2026. Selected transactions Novartis has completed the acquisition of Regulus Therapeutics, a clinical-stage biopharmaceutical company focused on developing microRNA therapeutics. Regulus' lead asset, farabursen, is a potential first-in-class oligonucleotide targeting miR-17 for the treatment of autosomal dominant polycystic kidney disease (ADPKD) that recently completed Phase Ib. The acquisition is aligned with the therapeutic area focus of Novartis and leverages its strength and expertise in renal disease. In July, Novartis entered into an agreement with Sironax, granting Novartis an exclusive option to acquire its Brain Delivery Module (BDM) platform, a differentiated blood-brain-barrier crossing technology designed to enhance the brain delivery of therapeutics of various modalities. Capital structure and net debt Retaining a good balance between investment in the business, a strong capital structure, and attractive shareholder returns remains a priority. During the first half of 2025, Novartis repurchased a total of 48.8 million shares for USD 5.3 billion on the SIX Swiss Exchange second trading line under the USD 15 billion share buyback (announced in July 2023 and completed on July 1, 2025, with a total of 140.9 million shares repurchased over this period). In addition, 1.6 million shares (equity value of USD 0.2 billion) were repurchased from employees. In the same period, 11.2 million shares (equity value of USD 0.6 billion) were delivered to employees related to equity-based compensation plans. Novartis aims to offset the dilutive impact from equity-based compensation plans of employees over the remainder of the year. Consequently, the total number of shares outstanding decreased by 39.2 million versus December 31, 2024. These treasury share transactions resulted in an equity decrease of USD 4.9 billion and a net cash outflow of USD 5.4 billion. Net debt increased to USD 23.8 billion at June 30, 2025, compared to USD 16.1 billion at December 31, 2024. The increase was mainly due to the free cash flow of USD 9.7 billion being more than offset by the USD 7.8 billion annual dividend payment, cash outflows for treasury share transactions of USD 5.4 billion and net cash outflow for M&A, intangible assets transactions and other acquisitions of USD 3.1 billion. As of Q2 2025, the long-term credit rating for the company is Aa3 with Moody's Ratings and AA- with S&P Global Ratings. 2025 outlook Barring unforeseen events; growth vs. prior year in cc Net sales Expected to grow high single-digit Core operating income Expected to grow low-teens Key assumption: We continue to assume Entresto US generic entry in mid-2025 for forecasting purposes, though timing of generic entry is subject to ongoing IP and regulatory litigation Foreign exchange impact If mid-July exchange rates prevail for the remainder of 2025, the foreign exchange impact for the year would be positive 1 percentage point on net sales and negative 1 percentage point on core operating income. The estimated impact of exchange rates on our results is provided monthly on our website. Key figures1 Q2 2025 Q2 2024 % change H1 2025 H1 2024 % change USD m USD m USD cc USD m USD m USD cc Net sales 14 054 12 512 12 11 27 287 24 341 12 13 Operating income 4 864 4 014 21 25 9 527 7 387 29 33 As a % of sales 34.6 32.1 34.9 30.3 Net income 4 024 3 246 24 26 7 633 5 934 29 31 EPS (USD) 2.07 1.60 29 32 3.91 2.91 34 37 Net cash flows from operating activities 6 664 4 875 37 10 309 7 140 44 Non-IFRS measures Free cash flow 6 333 4 615 37 9 724 6 653 46 Core operating income 5 925 4 953 20 21 11 500 9 490 21 24 As a % of sales 42.2 39.6 42.1 39.0 Core net income 4 710 4 008 18 19 9 192 7 689 20 22 Core EPS (USD) 2.42 1.97 23 24 4.69 3.77 24 27 1. Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 40 of the Condensed Interim Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year. Detailed financial results accompanying this press release are included in the Condensed Interim Financial Report at the link below: DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can generally be identified by words such as 'anticipate,' 'can,' 'will,' 'continue,' 'ongoing,' 'growth,' 'launch,' 'expect,' 'expand,' 'deliver,' 'accelerate,' 'guidance,' 'outlook,' 'priority,' 'potential,' 'momentum,' 'commitment,' or similar expressions, or by express or implied discussions regarding potential new products, potential new indications for existing products, potential product launches, or regarding potential future revenues from any such products; or regarding results of ongoing clinical trials; or regarding potential future, pending or announced transactions; regarding potential future sales or earnings; or by discussions of strategy, plans, expectations or intentions, including discussions regarding our continued investment into new R&D capabilities and manufacturing; or regarding our capital structure. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. You should not place undue reliance on these statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. Neither can there be any guarantee that the expected benefits or synergies from the transactions described in this press release will be achieved in the expected timeframe, or at all. In particular, our expectations could be affected by, among other things: uncertainties concerning global healthcare cost containment, including ongoing government, payer and general public pricing and reimbursement pressures and requirements for increased pricing transparency; uncertainties regarding the success of key products, commercial priorities and strategy; uncertainties in the research and development of new products, including clinical trial results and additional analysis of existing clinical data; our ability to obtain or maintain proprietary intellectual property protection, including the ultimate extent of the impact on Novartis of the loss of patent protection and exclusivity on key products; uncertainties regarding our ability to realize the strategic benefits, operational efficiencies or opportunities expected from our external business opportunities; uncertainties in the development or adoption of potentially transformational digital technologies, including artificial intelligence, and business models; uncertainties surrounding the implementation of our new IT projects and systems; uncertainties regarding potential significant breaches of information security or disruptions of our information technology systems; uncertainties regarding actual or potential legal proceedings, including regulatory actions or delays or government regulation related to the products and pipeline products described in this press release; safety, quality, data integrity, or manufacturing issues; our performance on and ability to comply with environmental, social and governance measures and requirements; major macroeconomic and geo- and socio-political developments, including the impact of any potential tariffs on our products or the impact of war in certain parts of the world; uncertainties regarding future global exchange rates; uncertainties regarding future demand for our products; and other risks and factors referred to in Novartis AG's most recently filed Form 20-F and in subsequent reports filed with, or furnished to, the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise. All product names appearing in italics are trademarks owned by or licensed to Novartis. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide. Reimagine medicine with us: Visit us at and connect with us on LinkedIn, Facebook, X and Instagram. Novartis will conduct a conference call with investors to discuss this news release today at 14:00 Central European time and 8:00 Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Novartis website. A replay will be available after the live webcast by visiting Detailed financial results accompanying this press release are included in the Condensed Interim Financial Report at the link below. Additional information is provided on our business and pipeline of selected compounds in late-stage development. A copy of today's earnings call presentation can be found at Important dates October 28, 2025 Third quarter & nine months 2025 results November 19-20, 2025 Meet Novartis Management 2025 (London, UK) December 1, 2025 Social Impact & Sustainability annual investor event (virtual) February 4, 2026 Fourth quarter & full year 2025 results # # # Novartis Media RelationsE-mail: Novartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: Please find full media release in English attached and on the following link: Media release (PDF) Further language versions are available through the following links: German version is available through the following link:Medienmitteilung (PDF)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
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10-07-2025
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- Yahoo
UBS Maintains a Buy on Genmab (GMAB) With a DKK2,500 PT
Genmab A/S (NASDAQ:GMAB) is one of the 13 Cheap Healthcare Stocks with Huge Upside Potential. On June 25, UBS analyst Xian Deng maintained a Buy rating on Genmab A/S (NASDAQ:GMAB) and set a price target of DKK2,500.00. A scientist in a lab using a microscope to develop new treatments for Multiple Myeloma. The company reported $715 million in revenue for the first three months of 2025 compared to $603 million in the same period last year. This translates to a growth of 19% or $112 million, which the company attributed to increased DARZALEX and Kesimpta royalties attained under its collaborations with Johnson & Johnson and Novartis Pharma AG, respectively. EPKINLY net product sales also contributed to this growth. Royalty revenue for the quarter also rose to $589 million, experiencing an increase of $137 million, or 30%. This growth was driven by an increase in net sales of DARZALEX and Kesimpta. Genmab A/S (NASDAQ:GMAB) is an international biotechnology company that develops human antibody therapeutics for the treatment of cancer and other diseases. Its product pipeline includes DARZALEX to treat certain indications of multiple myeloma, TEPEZZA for the treatment of thyroid eye disease, and Arzerra to treat certain indications of chronic lymphocytic leukemia. While we acknowledge the potential of GMAB as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now. Disclosure: None. This article is originally published at Insider Monkey.
