Novartis (NVS) announced that the European Commission (“EC”) has approved its breast cancer drug Kisqali (ribociclib) for a broad population.The EC has approved Kisqali in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) at high risk of recurrence.Kisqali is a selective cyclin-dependent kinase inhibitor, a class of drugs that helps slow the progression of ...

Approval is based on Phase III NATALEE data showing Kisqali® (ribociclib) plus adjuvant endocrine therapy (ET) demonstrated clinically meaningful invasive disease-free survival (iDFS) benefit in patients with stage II or III HR+/HER2- early breast cancer (EBC), consistent across all subgroups1,2With this broad indication, nearly twice as many EBC patients in Europe, including those with node-negative disease, could now be eligible for treatment with Kisqali to help reduce their risk of recurrence3Despite ET ...

Novartis (NVS) announced that it has increased its sales guidance for the mid-term. The company now expects total sales to witness a compound annual growth rate (CAGR) of 6% during 2023-2028 compared with the previous estimate of 5%.The rise in guidance was due to the strong momentum of NVS’ key drugs and its upcoming launches.Shares of Novartis have risen 4% year to date compared with the industry’s growth of 4.8%.Image Source: Zacks Investment ResearchNVS Raises Mid-Term OutlookFor 2024-2029, sales are ex ...

Ad hoc announcement pursuant to Art. 53 LR Mid-term sales guidance upgraded to +6% CAGR 2023-2028 and +5% 2024-2029Strong momentum in the business with 8 in-market brands with USD 3bn+ to USD 8bn+ peak sales potential and 15+ near-term submission-enabling readouts 30+ high-value medicines in the pipeline expected to support continued mid-single digit sales growth beyond 2029 Basel, November 21, 2024 – Today Novartis announced an upgrade to its mid-term guidance, in advance of its Meet Novartis Management ev ...

The Index spotlights Novartis leadership in research and development, and governance of access, with Novartis ranking first in these sub-topics Novartis malaria access plans, widespread registration of products in LMICs, and inclusive business model to improve access to products in multiple countries were all highlighted as Best Practice across the industry Novartis has risen three places to secure the top spot on the 2024 Access to Medicine Index Basel, November 19, 2024 – Novartis has ranked first in the ...

Ratio to receive upfront, and potential milestones and tiered royalty paymentsBOSTON, Nov. 18, 2024 /PRNewswire/ -- Ratio Therapeutics Inc. (Ratio), a pharmaceutical company employing innovative technologies to develop best-in-class radiopharmaceuticals for cancer treatment and monitoring, entered today into an exclusive worldwide license and collaboration agreement with Novartis Pharma AG, a subsidiary of Novartis AG (NYSE: NVS). The collaboration leverages Ratio's radioligand therapy discovery and develop ...

The price trend for Novartis (NVS) has been bearish lately and the stock has lost 5.1% over the past two weeks. However, the formation of a hammer chart pattern in its last trading session indicates that the stock could witness a trend reversal soon, as bulls might have gained significant control over the price to help it find support.While the formation of a hammer pattern is a technical indication of nearing a bottom with potential exhaustion of selling pressure, rising optimism among Wall Street analysts ...

I'm an investment analyst with several years of clinical experience and a Master of Business Administration, now expanding my focus beyond biotech and healthcare into a range of sectors. Since 2017, I've had the privilege of sharing my insights on Seeking Alpha. My work emphasizes financial modeling techniques, such as Discounted Cash Flow (DCF) analysis, to uncover hidden assumptions within stock valuations across multiple industries. By deconstructing metrics like revenue growth rates and cash flow margin ...

Financial Data and Key Metrics Changes - In Q3 2024, Novartis reported a 10% increase in net sales and a 20% increase in core operating income in constant currency, with a core margin of 40.1%, reflecting a 340 basis point improvement year-over-year [8][34] - For the first nine months of 2024, net sales grew 11%, core operating income also increased by 20%, and core EPS was $5.83, up 21% [35][36] - Free cash flow reached $6 billion in Q3, the highest ever achieved in a single quarter, and $12.6 billion for the first nine months, a 15% increase [34][35] Business Line Data and Key Metrics Changes - Entresto's sales increased by 26% in Q3, marking its 10th consecutive year of growth, with strong performance in hypertension in China and Japan [11] - Cosentyx grew by 28%, driven by new launches, with a 38% increase in the U.S. and 16% outside the U.S. [12] - Kesimpta saw a 28% growth, with a 56% increase in constant currencies when excluding a one-time adjustment [14] - Kisqali achieved 43% growth, with a 50% increase in the U.S. and a 36% increase outside the U.S. [16] - Pluvicto grew by 50% in Q3, with a focus on preparing for the PSMAfore launch in 2025 [19] - Scemblix grew by 72% in Q3, becoming the preferred option for third-line CML [24] - Fabhalta received accelerated approval in the U.S. for IgA nephropathy, with strong early performance [28] Market Data and Key Metrics Changes - Novartis expects continued strong performance across key growth drivers, with a 5% sales growth guidance extended to 2028 [10] - The market for Cosentyx in HS is projected to expand significantly, potentially reaching over $5 billion [13] - The PSMAfore launch is expected to triple the patient population eligible for Pluvicto [20] Company Strategy and Development Direction - Novartis raised its full-year guidance for the third time, indicating strong underlying momentum across growth drivers and new launches [36][42] - The company is focused on innovation, with multiple Phase III readouts and submissions planned for key products [42] - Novartis is committed to a shareholder-friendly capital allocation strategy, including ongoing share buybacks and investments in R&D [38] Management's Comments on Operating Environment and Future Outlook - Management noted that the coverage gap reform in 2025 is expected to have a neutral impact on the business, with adjustments already factored into long-term guidance [47] - The company remains confident in its ability to grow top and bottom lines in 2025, despite anticipated headwinds from generic entries [53] - Management emphasized the importance of maintaining strong market positions for key products, particularly in the face of increasing competition [58] Other Important Information - Novartis is actively pursuing M&A opportunities to strengthen its pipeline and technology platforms, particularly in RLT and immunology [38][81] - The company is also focused on legislative efforts to amend the IRA, which could impact pricing and market access for its products [112][113] Q&A Session Summary Question: Impact of coverage gap reform on Cosentyx and Entresto - Management indicated that the coverage gap reform will have both positive and negative impacts, but overall is expected to be neutral and already factored into guidance [47] Question: Timing of promotional efforts for Pluvicto - Management stated that promotional efforts would take about six months to show impact, with significant growth expected post-PSMAfore launch [50] Question: Tailwinds and headwinds for 2025 - Management highlighted new indications and launches as tailwinds, while LoEs for certain products are anticipated as headwinds [54] Question: Competitive dynamics for Cosentyx in HS - Management expressed confidence in Cosentyx's market position due to strong clinical data and established relationships with dermatologists [58] Question: Growth expectations for Pluvicto - Management noted that growth in the ex-U.S. market is ongoing, but pricing dynamics are currently limiting revenue translation [62] Question: Kisqali patent expiry - Management confirmed that the estimated patent expiry for Kisqali in Europe is August 2032 [68] Question: Future M&A appetite - Management indicated a balanced approach to capital allocation, with ongoing share buybacks and M&A opportunities being pursued [81][92] Question: Impact of GLP-1s on Pelacarsen study - Management clarified that while GLP-1s have modest effects on Lp(a), the focus of the study is on patients with significantly elevated Lp(a) levels [77] Question: Update on IRA legislation - Management provided an update on ongoing legislative efforts to amend the IRA, highlighting bipartisan support for proposed changes [112][113]

Swiss pharma giant Novartis AG (NVS) reported better-than-expected results for the third quarter of 2024. Core earnings (excluding one-time charges) of $2.06 per share beat the Zacks Consensus Estimate of $1.94 and were up from $1.74 reported a year ago. The year-over-year growth was driven by an increase in sales. Revenues of $12.8 billion climbed 9% from the year-ago figure. On a constant currency basis, sales increased 10%, driven by the momentum in Entresto, Kesimpta, Kisqali, Cosentyx, Pluvicto and Leq ...