- NVS Dashboard
- Financials
- Filings
-
Holdings
- Transcripts
- ETFs
-
Insider
- Institutional
- Shorts
-
6-K Filing
Novartis (NVS) 6-KCurrent report (foreign)
Filed: 31 Jan 24, 7:43am
Ad hoc announcement pursuant to Art. 53 LR FINANCIAL RESULTS | RÉSULTATS FINANCIERS | FINANZERGEBNISSE | Novartis International AG Novartis Global Communications CH-4002 Basel Switzerland https://www.novartis.com |
• | Net sales grew +10% (cc, +8% USD) with core operating income growing +18% (cc, +11% USD) |
• | Sales growth was mainly driven by continued strong performance from Entresto (+31% cc), Kesimpta (+99% cc), Kisqali (+75% cc), Pluvicto (+261% cc) and Scemblix (+179% cc) |
• | Operating income increased +39% (cc, +23% USD). Net income increased +62% (cc, +42% USD). Free cash flow from continuing operations was USD 13.2 billion (+9% USD) |
• | EPS grew +70% (cc, +49% USD) to USD 4.13. Core EPS was USD 6.47 growing +25% (cc, +18% USD) |
• | Net sales grew +10% (cc, +8% USD) with core operating income growing +13% (cc, +5% USD), |
• | Sales growth was mainly driven by continued strong performance from Entresto (+26% cc), Kisqali (+76% cc), Kesimpta (+73% cc), Cosentyx (+21% cc) and Pluvicto (+53% cc) |
• | Q4 selected innovation milestones: |
o | Fabhalta FDA approval for treatment of adults with PNH (both previously treated and treatment-naïve) |
o | Cosentyx FDA approval for the treatment of moderate to severe HS in adults |
o | Cosentyx FDA approval for intravenous formulation in three indications (PsA, AS, nr-axSpA) |
o | Iptacopan Ph3 APPLAUSE-IgAN met its primary endpoint in IgAN patients |
o | Atrasentan Ph3 ALIGN study met its primary endpoint in IgAN patients |
o | Iptacopan Ph3 APPEAR-C3G met its primary endpoint in C3G patients |
o | Scemblix Ph3 ASC4FIRST study met its primary endpoints in 1L Ph+ CML-CP patients (January) |
• | Dividend of CHF 3.30 per share, an increase of 3.1%, proposed for 2023 |
• | 2024 guidance3 – Net sales expected to grow mid single digit and core operating income expected to grow high single digit |
• | Updated mid-term guidance – Net sales expected to grow 5% cc CAGR 2023-2028 with core operating income margin expanding to ~40%+ by 2027 |
Continuing operations | |||||||||
Q4 2023 | Q4 2022 | % change | FY 2023 | FY 2022 | % change | ||||
USD m | USD m | USD | cc | USD m | USD m | USD | cc | ||
Net sales | 11 423 | 10 576 | 8 | 10 | 45 440 | 42 206 | 8 | 10 | |
Operating income | 2 582 | 1 755 | 47 | 68 | 9 769 | 7 946 | 23 | 39 | |
Net income | 2 638 | 1 315 | 101 | 130 | 8 572 | 6 049 | 42 | 62 | |
EPS (USD) | 1.29 | 0.62 | 108 | 140 | 4.13 | 2.77 | 49 | 70 | |
Free cash flow | 2 141 | 3 462 | -38 | 13 160 | 12 123 | 9 | |||
Core operating income | 3 821 | 3 645 | 5 | 13 | 16 372 | 14 794 | 11 | 18 | |
Core net income | 3 126 | 2 963 | 6 | 11 | 13 446 | 11 946 | 13 | 19 | |
Core EPS (USD) | 1.53 | 1.39 | 10 | 16 | 6.47 | 5.48 | 18 | 25 |
1. | Accelerate growth: Renewed attention to deliver high-value medicines (NMEs) and focus on launch excellence, with a rich pipeline across our core therapeutic areas. |
2. | 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. |
3. | Strengthening foundations: Unleashing the power of our people, scaling data science and technology and continuing to build trust with society. |
Entresto | (USD 1 635 million, +26% cc) sustained robust demand-led growth, with increased patient share across all geographies |
Kisqali | (USD 610 million, +76% cc) sales grew strongly across all regions, based on increasing recognition of consistently reported overall survival in HR+/HER2- advanced breast cancer |
Kesimpta | (USD 641 million, +73% cc) sales grew across all regions driven by increased demand and strong access |
Cosentyx | (USD 1 303 million, +21% cc) US sales grew (+17%) and ex-US sales (+26% cc), benefitting from lower prior year base (including revenue deduction adjustments in the US) |
Pluvicto | (USD 273 million, +53% cc) continued sales growth in the US. Supply now unconstrained, focusing on initiating new patients |
Ilaris | (USD 376 million, +29% cc) sales grew across all regions |
Leqvio | (USD 123 million, +190% cc) launch is ongoing, with focus on patient on-boarding, removing access hurdles and enhancing medical education |
Scemblix | (USD 125 million, +143% cc) continued its strong launch uptake demonstrating the high unmet need in CML |
Jakavi | (USD 444 million, +14% cc) sales grew in emerging growth markets, Europe and Japan, driven by strong demand in both myelofibrosis and polycythemia vera indications |
Xolair | (USD 378 million, +16% cc) sales grew across all regions |
Tafinlar + Mekinist | (USD 486 million, +7% cc) sales grew mainly in the US and emerging growth markets, partly offset by decline in Europe |
Promacta/Revolade | (USD 563 million, +4% cc) sales grew mainly in the US driven by increased use in chronic ITP and severe aplastic anemia |
Piqray | (USD 131 million, +18% cc) sales grew mainly in the US |
Lutathera | (USD 147 million, +13% cc) sales grew across all regions due to increased demand |
Emerging Growth Markets* | Grew +18% (cc) overall. China grew (+38% cc) to USD 0.8 billion, due to lower prior year base. For the full year, China grew +17% (cc) *All markets except the US, Canada, Western Europe, Japan, Australia, and New Zealand |
Q4 2023 | % change | FY 2023 | % change | |||
USD m | USD | cc | USD m | USD | cc | |
Entresto | 1 635 | 27 | 26 | 6 035 | 30 | 31 |
Cosentyx | 1 303 | 21 | 21 | 4 980 | 4 | 5 |
Promacta/Revolade | 563 | 4 | 4 | 2 269 | 9 | 10 |
Kesimpta | 641 | 74 | 73 | 2 171 | 99 | 99 |
Kisqali | 610 | 71 | 76 | 2 080 | 69 | 75 |
Tafinlar + Mekinist | 486 | 5 | 7 | 1 922 | 9 | 11 |
Tasigna | 446 | -6 | - 6 | 1 848 | -4 | -3 |
Jakavi | 444 | 14 | 14 | 1 720 | 10 | 12 |
Lucentis | 301 | -24 | - 25 | 1 475 | -21 | -20 |
Xolair | 378 | 17 | 16 | 1 463 | 7 | 9 |
Ilaris | 376 | 25 | 29 | 1 355 | 20 | 22 |
Sandostatin | 316 | 4 | 5 | 1 314 | 6 | 8 |
Zolgensma | 286 | -7 | - 4 | 1 214 | -11 | -9 |
Pluvicto | 273 | 53 | 53 | 980 | 262 | 261 |
Gilenya | 154 | -55 | - 55 | 925 | -54 | -54 |
Exforge Group | 156 | -2 | - 1 | 713 | -4 | -1 |
Galvus Group | 153 | -27 | - 17 | 692 | -19 | -11 |
Diovan Group | 147 | 4 | 6 | 613 | -6 | -1 |
Lutathera | 147 | 15 | 13 | 605 | 28 | 28 |
Gleevec/Glivec | 128 | -27 | - 25 | 561 | -25 | -22 |
Top 20 brands total | 8 943 | 13 | 14 | 34 935 | 10 | 12 |
Fabhalta (iptacopan) | Approved in the US as the first oral monotherapy for the treatment of adults (both previously treated and treatment-naïve patients) with paroxysmal nocturnal hemoglobinuria (PNH) |
Cosentyx | Approved in the US as the first new biologic therapy for the treatment of moderate to severe hidradenitis suppurativa (HS) in adults in nearly a decade Approved in the US as an intravenous formulation in three indications: psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial SpA |
Scemblix (asciminib) | Ph3 ASC4FIRST study met both primary endpoints (major molecular response rate vs. imatinib or investigator-selected tyrosine kinase inhibitors) with clinically meaningful and statistically significant results in newly diagnosed patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). Additionally, Scemblix showed a favorable safety and tolerability profile. Data will be presented at an upcoming medical conference and submitted to regulatory authorities in 2024 |
Ph3 ASCEMBL study, median follow-up of almost 4 years, in patients with Ph+ CML-CP continue to support the efficacy, safety and tolerability profile compared with bosutinib in 3L+ setting. Data presented at ASH 2023 | |
Fabhalta (iptacopan) | Ph3 APPLAUSE-IgAN study interim analysis demonstrated clinically meaningful and highly statistically significant proteinuria reduction in patients with IgA nephropathy. The trial met its pre-specified interim analysis (9 months) primary endpoint, demonstrating superiority vs. placebo in proteinuria reduction, with safety consistent with previously reported data. Novartis plans to review interim data with regulatory authorities for accelerated approval; study continues with final readout at 24 months Ph3 APPEAR-C3G study met its primary endpoint, demonstrating superiority of iptacopan vs placebo in proteinuria reduction at six-month analysis and provided clinically meaningful and statistically significant proteinuria reduction in patients with C3G on top of background therapy. Iptacopan’s safety profile was consistent with previously reported data. Data to be presented at an upcoming medical meeting. Study continues with all patients receiving active therapy for six-months Ph3 APPLY-PNH extension data showed sustained efficacy and long-term safety of Fabhalta in adults with paroxysmal nocturnal hemoglobinuria (PNH). Data showed sustained clinically meaningful hemoglobin-level increases to near-normal (≥12 g/dL), blood transfusion avoidance, and improved patient-reported fatigue in the majority of patients. Comparable benefits were seen in those patients switching from anti-C5 therapy to Fabhalta. Safety profile at 48 weeks was similar to 24 week data. Data presented at ASH 2023 |
atrasentan | Ph3 ALIGN study met its primary endpoint, demonstrating superiority of atrasentan vs placebo in proteinuria reduction at 36-week interim analysis with clinically meaningful and highly statistically significant reduction in proteinuria in IgAN patients receiving supportive care. Safety profile of atrasentan was consistent with previously reported data. Data to be presented at an upcoming medical meeting. Study continues with final readout expected in 2026 |
remibrutinib | Ph3 REMIX-1 and REMIX-2 trials showed clinically meaningful and statistically significant reduction in weekly urticaria activity (UAS7), itch (ISS7) and hives (HSS7) at Week 12 vs placebo in patients with CSU. Significant improvement in symptom control was seen as early as Week 2 and sustained up to Week 12. Remibrutinib was well-tolerated and demonstrated a favorable safety profile with rates of overall adverse events comparable to placebo and balanced liver function tests across both studies. Studies are ongoing with final (52-week) readout and regulatory submissions in 2024. Data presented at AAAI 2023 |
Kisqali (ribociclib) | Final protocol-specified iDFS analysis of Ph3 NATALEE trial (with a median follow-up of 33.3 months and 78.3% of patients having completed ribociclib) reinforces 25% reduction in risk of recurrence across broad population of patients with HR+/HER2- early breast cancer and continues to support regulatory submissions. iDFS benefit remains consistent across key patient subgroups, with stability in secondary endpoints including overall survival (OS). Among patients with stage II and stage III tumors, ribociclib lowered risk of disease recurrence by 30% and 24.5%, respectively. Safety profile was in line with previously reported results. Data presented at SABCS 2023. NATALEE data submitted to the FDA in December 2023 |
Early-stage business development in core therapeutic areas and technologies | Cardiovascular-Renal-Metabolic: • Chong Kun Dang (LMW, lead asset CKD-510 for diseases in which the enzyme HDAC6 is thought to play a role, including some cardiovascular diseases) • SanReno (LMW and mAb, securing worldwide rights for Atrasentan/Zigakibart) • Argo Biopharma (xRNA, undisclosed targets) Neuroscience: • Voyager Therapeutics (Gene therapy, strategic collaboration and capsid license agreement for potential Huntington’s Disease and spinal muscular atrophy therapies) |
Immunology: • Calypso (Biotherapeutics, lead asset CALY-002 a promising anti-IL-15 mAB, to be investigated in a range of autoimmune indications) Oncology: • Legend Biotech (Cell Therapy, targeting DLL3, a ligand highly expressed in several cancers) Isomorphic Labs – Leveraging AI including next generation AlphaFold model, to discover novel small molecule therapeutics against undisclosed targets |
Net sales | Expected to grow mid single digit |
Core operating income | Expected to grow high single digit |
• | Our guidance assumes that no Entresto generics launch in the US in 2024 |
Continuing operations2 | Q4 2023 | Q4 2022 | % change | FY 2023 | FY 2022 | % change | ||||
USD m | USD m | USD | cc | USD m | USD m | USD | cc | |||
Net sales | 11 423 | 10 576 | 8 | 10 | Net sales | 45 440 | 42 206 | 8 | 10 | |
Operating income | 2 582 | 1 755 | 47 | 68 | Operating income | 9 769 | 7 946 | 23 | 39 | |
As a % of sales | 22.6 | 16.6 | As a % of sales | 21.5 | 18.8 | |||||
Net income | 2 638 | 1 315 | 101 | 130 | Net income | 8 572 | 6 049 | 42 | 62 | |
EPS (USD) | 1.29 | 0.62 | 108 | 140 | EPS (USD) | 4.13 | 2.77 | 49 | 70 | |
Cash flows from operating activities | 2 547 | 3 768 | -32 | Cash flows from operating activities | 14 220 | 13 039 | 9 | |||
Non-IFRS measures | Non-IFRS measures | |||||||||
Free cash flow | 2 141 | 3 462 | -38 | Free cash flow | 13 160 | 12 123 | 9 | |||
Core operating income | 3 821 | 3 645 | 5 | 13 | Core operating income | 16 372 | 14 794 | 11 | 18 | |
As a % of sales | 33.5 | 34.5 | As a % of sales | 36.0 | 35.1 | |||||
Core net income | 3 126 | 2 963 | 6 | 11 | Core net income | 13 446 | 11 946 | 13 | 19 | |
Core EPS (USD) | 1.53 | 1.39 | 10 | 16 | Core EPS (USD) | 6.47 | 5.48 | 18 | 25 | |
Discontinued operations2 | Q4 2023 | Q4 2022 | % change | FY 2023 | FY 2022 | % change | ||||
USD m | USD m | USD | cc | USD m | USD m | USD | cc | |||
Net sales | 2 374 | nm | nm | Net sales | 7 428 | 9 372 | nm | nm | ||
Operating income | 194 | nm | nm | Operating income | 265 | 1 251 | nm | nm | ||
As a % of sales | 8.2 | As a % of sales | 3.6 | 13.3 | ||||||
Net income | 5 842 | 151 | nm | nm | Net income | 6 282 | 906 | nm | nm | |
Non-IFRS measures | Non-IFRS measures | |||||||||
Core operating income | 385 | nm | nm | Core operating income | 1 185 | 1 871 | nm | nm | ||
As a % of sales | 16.2 | As a % of sales | 16.0 | 20.0 | ||||||
Total Company | Q4 2023 | Q4 2022 | % change | FY 2023 | FY 2022 | % change | ||||
USD m | USD m | USD | cc | USD m | USD m | USD | cc | |||
Net income | 8 480 | 1 466 | nm | nm | Net income | 14 854 | 6 955 | nm | nm | |
EPS (USD) | 4.14 | 0.69 | nm | nm | EPS (USD) | 7.15 | 3.19 | nm | nm | |
Cash flows from operating activities | 2 547 | 4 111 | nm | nm | Cash flows from operating activities | 14 458 | 14 236 | nm | nm | |
Non-IFRS measures | Non-IFRS measures | |||||||||
Free cash flow | 2 141 | 3 713 | nm | nm | Free cash flow | 13 179 | 13 038 | nm | nm | |
Core net income | 3 127 | 3 251 | nm | nm | Core net income | 14 336 | 13 352 | nm | nm | |
Core EPS (USD) | 1.53 | 1.52 | nm | nm | Core EPS (USD) | 6.90 | 6.12 | nm | nm | |
nm= not meaningful |
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 49 of the Condensed Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year. 2 As defined on page 37 of the Condensed Financial Report, Continuing operations include the retained business activities of Novartis, comprising the innovative medicines business and the continuing Corporate activities and Discontinued operations include operational results from the Sandoz business. Detailed financial results accompanying this press release are included in the Condensed Financial Report at the link below: https://ml-eu.globenewswire.com/resource/download/a507329c-1dd6-43c6-8a9b-9d0b86d9bf20/ |
March 5, 2024 | Annual General Meeting |
April 23, 2024 | First quarter 2024 results |
May 15-16, 2024 | Meet Novartis Management 2024 (Cambridge, MA, USA) |
July 18, 2024 | Second quarter & Half year 2024 results |
October 29, 2024 | Third quarter & Nine months 2024 results |