PHC3

Ad hoc announcement pursuant to Art. 53 LR Full year (continuing operations2) 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) Fourth quarter (continuing operations) 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: Fabhalta FDA approval for treatment of adults with PNH (both previously treated and treatment-naïve)Cosentyx FDA approval for the treatment of moderate to severe HS in adultsCosentyx FDA approval for intravenous formulation in three indications (PsA, AS, nr-axSpA)Iptacopan Ph3 APPLAUSE-IgAN met its primary endpoint in IgAN patientsAtrasentan Ph3 ALIGN study met its primary endpoint in IgAN patientsIptacopan Ph3 APPEAR-C3G met its primary endpoint in C3G patientsScemblix Ph3 ASC4FIRST study met its primary endpoints in 1L Ph+ CML-CP patients (January) Dividend, 2024 guidance; updated mid-term guidance Dividend of CHF 3.30 per share, an increase of 3.1%, proposed for 20232024 guidance3 – Net sales expected to grow mid single digit and core operating income expected to grow high single digitUpdated mid-term guidance – Net sales expected to grow 5% cc CAGR 2023-2028 with core operating income margin expanding to ~40%+ by 2027 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. 3 Please see detailed guidance assumptions on page 7Basel, January 31, 2024 - commenting on 2023 results, Vas Narasimhan, CEO of Novartis, said: “Novartis completed its strategic transformation into a pure-play innovative medicines company and continued its relentless pursuit of sustainable shareholder value creation. Our robust operational performance continues, with strong double-digit top and bottom-line growth, for the quarter and full year. We delivered ten positive Ph3 readouts on assets with significant sales potential, over the past year. The very strong performance of our key growth drivers and pipeline underscores the confidence in our growth (5% cc CAGR 2023-2028) and margin (40%+ by 2027) mid-term guidance.” Key figures1 Continuing operations Q4 2023Q4 2022% changeFY 2023FY 2022% change USD m USD mUSDcc USD m USD mUSDccNet sales11 42310 576810 45 44042 206810Operating income2 5821 7554768 9 7697 9462339Net income2 6381 315101130 8 5726 0494262EPS (USD)1.290.62108140 4.132.774970Free cash flow2 1413 462-38 13 16012 1239 Core operating income3 8213 645513 16 37214 7941118Core net income3 1262 963611 13 44611 9461319Core EPS (USD)1.531.391016 6.475.481825 Strategy Update Our focus During 2023, Novartis completed our transformation into a “pure-play” innovative medicines business. 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. Strengthening foundations: Unleashing the power of our people, scaling data science and technology and continuing to build trust with society. Financials Following the September 15, 2023, shareholders’ approval of the spin-off of the Sandoz business the Company reported its consolidated financial statements for the current and prior years as “continuing operations” and “discontinued operations.” Continuing operations include the retained business activities of Novartis, comprising the innovative medicines business and the continuing corporate activities. Discontinued operations include the Sandoz Division and selected portions of corporate activities attributable to Sandoz’s business, as well as certain expenses related to the spin-off. Following the spin-off of the Sandoz business, Novartis operates as a single global operating segment focused innovative medicines company. The commentary below focuses on continuing operations. We also provide information on discontinued operations, which mainly includes Sandoz and allocated corporate activities. Continuing operations Fourth quarter Net sales were USD 11.4 billion (+8%, +10% cc) in the fourth quarter driven by volume growth of 13 percentage points. Generic competition had a negative impact of 3 percentage points and pricing had no impact. Operating income was USD 2.6 billion (+47%, +68% cc), mainly driven by higher net sales and lower restructuring charges, partly offset by higher SG&A and R&D investments. Net income was USD 2.6 billion (+101%, +130% cc), mainly driven by higher operating income and non-recurring favorable tax impacts. EPS was USD 1.29 (+108%, +140% cc), benefiting from lower weighted average number of shares outstanding. Core operating income was USD 3.8 billion (+5%, +13% cc), mainly driven by higher net sales, partly offset by higher SG&A and R&D investments. Core operating income growth in USD was impacted by negative 2 percentage points from the effect of mid-December currency devaluation in Argentina1. Core operating income margin was 33.5% of net sales, decreasing 1.0 percentage point (+1.0 percentage point cc). Core net income was USD 3.1 billion (+6%, +11% cc), mainly due to higher core operating income. Core EPS was USD 1.53 (+10%, +16% cc), benefiting from lower weighted average number of shares outstanding. Free cash flow from continuing operations amounted to USD 2.1 billion (-38% USD), compared with USD 3.5 billion in the prior year quarter driven by lower net cash flows from operating activities. 1 IFRS® Accounting Standards requires for our Argentina subsidiary, as it operates in a hyperinflation economy, to translate for consolidation purposes their full year income statement to our USD presentation currency using the ARS closing rate, and not using the average exchange rate for the period. This results in the 9-months and the Q4 devaluation impact being recognized in Q4. Full year Net sales were USD 45.4 billion (+8%, +10% cc) in the full year, driven by volume growth of 16 percentage points, partly offset by price erosion of 2 percentage points and the negative impact from generic competition of 4 percentage points. Operating income was USD 9.8 billion (+23%, +39% cc), mainly driven by higher net sales, lower restructuring charges, and income from legal matters, partly offset by higher impairments and higher SG&A and R&D investments. Net income was USD 8.6 billion (+42%, +62% cc), mainly driven by higher operating income and non-recurring favorable tax impacts. EPS was USD 4.13 (+49%, +70% cc). Core operating income was USD 16.4 billion (11%, +18% cc), mainly driven by higher net sales, partly offset by higher SG&A and R&D investments. Core operating income margin was 36.0% of net sales, increasing 0.9 percentage points (+2.4 percentage points cc). Core net income was USD 13.4 billion (+13%, +19% cc), mainly due to higher core operating income. Core EPS was USD 6.47 (+18%, +25% cc), benefiting from lower weighted average number of shares outstanding. Free cash flow from continuing operations amounted to USD 13.2 billion (+9% USD), compared with USD 12.1 billion in 2022 driven by higher net cash flows from operating activities. Discontinued operations Discontinued operations include the Sandoz generic pharmaceuticals and biosimilars division, certain corporate activities attributable to Sandoz prior to the spin-off up to the distribution date of October 3, 2023, and certain other expenses related to the spin-off. Included in 2023 is also the IFRS Accounting Standards non-cash, non-taxable net gain on the distribution of Sandoz Group AG to Novartis AG shareholders of USD 5.9 billion, representing mainly the excess amount of the IFRS Accounting Standards distribution liability, which is the estimated fair value of the Sandoz business distributed to Novartis AG shareholders, over the then carrying value of Sandoz business net assets. There were no operating results for the fourth quarter 2023 following the distribution date. The prior year includes the results for the full period. Fourth quarter Net income from discontinued operations amounted to USD 5.8 billion, driven by the IFRS Accounting Standards non-cash, non-taxable, net gain on distribution of Sandoz Group AG to Novartis AG shareholders of USD 5.9 billion, compared to USD 151 million in prior year. Full year Discontinued operations net sales in 2023 were USD 7.4 billion, compared to USD 9.4 billion in 2022 and operating income amounted to USD 265 million compared to USD 1.3 billion in 2022. Net income from discontinued operations in 2023 amounted to USD 6.3 billion, compared to USD 906 million in 2022, driven by the IFRS Accounting Standards non-cash, non-taxable, net gain on distribution of Sandoz Group AG to Novartis AG shareholders, which amounted to USD 5.9 billion. Total Company Fourth quarter Total Company net income was USD 8.5 billion in 2023, compared to USD 1.5 billion in 2022 and basic EPS was USD 4.14 compared to USD 0.69 in prior year, driven by the IFRS Accounting Standards non-cash, non-taxable, net gain on distribution of Sandoz Group AG to Novartis AG shareholders of USD 5.9 billion. Net cash flows from operating activities for total Company amounted to USD 2.5 billion and free cash flow amounted to USD 2.1 billion. Full year Total Company, net income amounted to USD 14.9 billion in 2023, compared to USD 7.0 billion in 2022, and basic earnings per share was USD 7.15 compared to USD 3.19 in prior year, driven by the IFRS Accounting Standards non-cash, non-taxable, net gain on distribution of Sandoz Group AG to Novartis AG shareholders of USD 5.9 billion. Net cash flows from operating activities for the total company amounted to USD 14.5 billion, and free cash flow amounted to USD 13.2 billion. Q4 key growth drivers Underpinning our financial results in the quarter is a continued focus on key growth drivers (ranked in order of contribution to Q4 growth) including: Entresto(USD 1 635 million, +26% cc) sustained robust demand-led growth, with increased patient share across all geographiesKisqali(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 cancerKesimpta(USD 641 million, +73% cc) sales grew across all regions driven by increased demand and strong accessCosentyx(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 regionsLeqvio(USD 123 million, +190% cc) launch is ongoing, with focus on patient on-boarding, removing access hurdles and enhancing medical educationScemblix(USD 125 million, +143% cc) continued its strong launch uptake demonstrating the high unmet need in CMLJakavi(USD 444 million, +14% cc) sales grew in emerging growth markets, Europe and Japan, driven by strong demand in both myelofibrosis and polycythemia vera indicationsXolair(USD 378 million, +16% cc) sales grew across all regionsTafinlar + Mekinist(USD 486 million, +7% cc) sales grew mainly in the US and emerging growth markets, partly offset by decline in EuropePromacta/Revolade(USD 563 million, +4% cc) sales grew mainly in the US driven by increased use in chronic ITP and severe aplastic anemiaPiqray(USD 131 million, +18% cc) sales grew mainly in the USLutathera(USD 147 million, +13% cc) sales grew across all regions due to increased demandEmerging 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 Net sales of the top 20 brands in 2023 Q4 2023% changeFY 2023% change USD mUSDccUSD mUSD ccEntresto1 63527 266 0353031Cosentyx1 30321 214 98045Promacta/Revolade5634 42 269910Kesimpta64174 732 1719999Kisqali61071 762 0806975Tafinlar + Mekinist4865 71 922911Tasigna446-6- 61 848-4-3Jakavi44414 141 7201012Lucentis301-24- 251 475-21-20Xolair37817 161 46379Ilaris37625 291 3552022Sandostatin3164 51 31468Zolgensma286-7- 41 214-11-9Pluvicto27353 53 980262261Gilenya154-55- 55 925-54-54Exforge Group156-2- 1 713-4-1Galvus Group153-27- 17 692-19-11Diovan Group1474 6 613-6-1Lutathera14715 13 6052828Gleevec/Glivec128-27- 25 561-25-22Top 20 brands total8 94313 1434 9351012 R&D update - key developments from the fourth quarter New approvals 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) CosentyxApproved 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 Results from ongoing trials and other highlights 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 2023Fabhalta(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 2023atrasentan 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 2026remibrutinibPh3 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 2023Kisqali(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 2023Early-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 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. In 2023, Novartis repurchased a total of 87.5 million shares for USD 8.4 billion on the SIX Swiss Exchange second trading line. These repurchases included 52.8 million shares (USD 4.9 billion) under the USD 15 billion share buyback (announced in December 2021 and completed in June 2023) and 23.0 million shares (USD 2.3 billion) under the new up-to USD 15 billion share buyback announced in July 2023 (which is continuing as planned, with up-to USD 12.7 billion remaining). In addition, 11.7 million shares (USD 1.2 billion) were repurchased to mitigate dilution related to participation plans of associates. Furthermore, 1.6 million shares (for an equity value of USD 0.1 billion) were repurchased from associates. In the same period, 13.5 million shares (for an equity value of USD 1.1 billion) were delivered as a result of options exercised and share deliveries related to participation plans of associates. Consequently, the total number of shares outstanding decreased by 75.6 million versus December 31, 2022. These treasury share transactions resulted in an equity decrease of USD 7.4 billion and a net cash outflow of USD 8.6 billion. As of December 31, 2023, net debt increased to USD 10.2 billion compared to USD 7.2 billion at December 31, 2022. The increase was mainly due to the USD 7.3 billion annual dividend payment, net cash outflow for treasury share transactions of USD 8.6 billion and net cash outflow for M&A / intangible assets transactions of USD 3.3 billion. This increase in net debt was partially offset by USD 13.2 billion free cash flow and a USD 3.0 billion reduction in the net debt position of Novartis related to the Sandoz spin-off. As of Q4 2023, the long-term credit rating for the Company is A1 with Moody’s Investors Service and AA- with S&P Global Ratings. 2024 outlook Barring unforeseen events; growth vs prior year in cc Net salesExpected to grow mid single digitCore operating incomeExpected to grow high single digit Key assumptions: Our guidance assumes that no Entresto generics launch in the US in 2024 Foreign exchange impactIf late-January exchange rates prevail for the remainder of 2024, the foreign exchange impact for the year would be negative 1 percentage point on net sales and negative 3 percentage points on core operating income. The estimated impact of exchange rates on our results is provided monthly on our website. Annual General Meeting Dividend proposalThe Novartis Board of Directors proposes a dividend payment of CHF 3.30 per share for 2023, up 3.1% from CHF 3.20 per share in the prior year, representing the 27th consecutive dividend increase since the creation of Novartis in December 1996. Shareholders will vote on this proposal at the Annual General Meeting on March 5, 2024. Reduction of share CapitalThe Novartis Board of Directors proposes to cancel 87 547 255 shares (repurchased under the authorization of March 4, 2022) and to reduce the share capital accordingly by CHF 42.9 million, from CHF 1 115 964 098.48 to CHF 1 073 065 943.53. Elections of the Board Chair and the members of the Board of Directors The Board of Directors proposes the re-election of all current members of the Board of Directors (including the Board Chair).Key figures1 Continuing operations2Q4 2023Q4 2022% change FY 2023FY 2022% change USD m USD mUSDcc USD m USD mUSDccNet sales11 42310 576810 Net sales45 44042 206810Operating income2 5821 7554768 Operating income9 7697 9462339As a % of sales22.616.6 As a % of sales21.518.8 Net income2 6381 315101130 Net income8 5726 0494262EPS (USD)1.290.62108140 EPS (USD)4.132.774970Cash flows from operating activities2 5473 768-32 Cash flows from operating activities14 22013 0399 Non-IFRS measures Non-IFRS measures Free cash flow 2 1413 462-38 Free cash flow 13 16012 1239 Core operating income3 8213 645513 Core operating income16 37214 7941118As a % of sales33.534.5 As a % of sales36.035.1 Core net income3 1262 963611 Core net income13 44611 9461319Core EPS (USD)1.531.391016 Core EPS (USD)6.475.481825 Discontinued operations2Q4 2023Q4 2022% change FY 2023FY 2022% change USD m USD mUSDcc USD m USD mUSDccNet sales 2 374nmnm Net sales7 4289 372nmnmOperating income 194nmnm Operating income2651 251nmnmAs a % of sales 8.2 As a % of sales3.613.3 Net income5 842151nmnm Net income6 282906nmnmNon-IFRS measures Non-IFRS measures Core operating income 385nmnm Core operating income1 1851 871nmnmAs a % of sales 16.2 As a % of sales16.020.0 Total CompanyQ4 2023Q4 2022% change FY 2023FY 2022% change USD m USD mUSDcc USD m USD mUSDccNet income8 4801 466nmnm Net income14 8546 955nmnmEPS (USD)4.140.69nmnm EPS (USD)7.153.19nmnmCash flows from operating activities2 5474 111nmnm Cash flows from operating activities14 45814 236nmnmNon-IFRS measures Non-IFRS measures Free cash flow 2 1413 713nmnm Free cash flow 13 17913 038nmnmCore net income3 1273 251nmnm Core net income14 33613 352nmnmCore EPS (USD)1.531.52nmnm Core EPS (USD)6.906.12nmnm nm= not meaningful 1Constant 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.2As 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/ Disclaimer This 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 “may,” “continue,” “ongoing,” “grow,” “launch,” “expect,” “deliver,” “transformation,” “focus,” “address,” “accelerate,” “remain,” “scaling,” “guidance,” “outlook,” “long-term,” “driven,” “priority,” “potential,” “can,” “will,” “propose,” 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 ongoing or future share repurchases; 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; or regarding the consequences of the spin-off of Sandoz and our transformation into a “pure-play” innovative medicines company. 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. In particular, our expectations could be affected by, among other things: 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; uncertainties regarding the use of new and disruptive technologies, including artificial intelligence; global trends toward healthcare cost containment, including ongoing government, payer and general public pricing and reimbursement pressures and requirements for increased pricing transparency; uncertainties regarding our ability to realize the strategic benefits, operational efficiencies or opportunities expected from our external business opportunities; our ability to realize the intended benefits of our separation of Sandoz into a new publicly traded standalone company; 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 in the development or adoption of potentially transformational digital technologies 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 political, macroeconomic and business developments, including impact of the 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 current Form 20-F on file with 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 more than 250 million people worldwide. Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter 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 https://www.novartis.com/investors/event-calendar. Detailed financial results accompanying this press release are included in the condensed 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 https://www.novartis.com/investors/event-calendar. Important dates March 5, 2024Annual General MeetingApril 23, 2024First quarter 2024 resultsMay 15-16, 2024Meet Novartis Management 2024 (Cambridge, MA, USA)July 18, 2024 Second quarter & Half year 2024 resultsOctober 29, 2024Third quarter & Nine months 2024 results Please find full media release in English attached and on the following link:Media release (PDF) German version is available through the following link:Medienmitteilung (PDF) French version is available through the following link:Communiqué aux médias (PDF)

PLAINSBORO, N.J., Oct. 2, 2023 /PRNewswire/ -- Novo Nordisk announced today that the U.S. Food and Drug Administration (FDA) has approved RivflozaTM (nedosiran) injection 80 mg, 128 mg, or 160 mg, a once-monthly subcutaneous ribonucleic acid interference (RNAi) therapy, to lower urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function.1 Primary hyperoxaluria (PH) is a rare genetic disease that causes overproduction of oxalate by the liver that is estimated to affect 1 in 38,600 individuals worldwide.2 PH1 is the most clinically prevalent (roughly ~80% of PH patients) and severe of the three subtypes of PH.3 PH1 is a progressive metabolic disorder that primarily affects the kidneys and can lead to progressive kidney damage.2 In the U.S., it is estimated that over 2,000 people are living with PH1.4 "The FDA approval of RivflozaTM builds on Novo Nordisk's legacy of advancing research, fostering innovation and creating strategic partnerships to expand treatment options in rare diseases," said Blandine Lacroix, Senior Vice President, Strategy and Rare Disease at Novo Nordisk Inc. "We are committed to driving change on behalf of people living with rare diseases and helping address the significant unmet needs of the PH1 community. We look forward to making our first RNAi treatment available to people living with PH1 and the healthcare professionals partnering on their care." This approval is based on the results of the pivotal phase 2 PHYOXTM2 clinical trial and interim data from the ongoing phase 3 PHYOXTM3 extension study.1 PHYOXTM2 met its primary endpoint, showing that patients treated with RivflozaTM achieved a marked reduction from baseline in 24 hour-urinary oxalate (Uox) excretion from Day 90 to Day 180.1,5 The percent change from baseline in 24-hour Uox was measured using an area under the curve (AUC) analysis. The least-squares (LS) mean between group difference of AUC24-hour Uox was 4976 (95% CI: 2803, 7149; p<0.0001), which was significant between the RivflozaTM and placebo groups over the 90 days.1 The most common adverse reaction (reported in ≥20% of patients) is injection site reactions.1 Interim results from the PHYOXTM3 extension study showed reductions in 24-hour Uox excretion were maintained in the 13 patients with PH1 who had received an additional six months of treatment with RivflozaTM.1 "RNA interference is a proven treatment approach for individuals with PH1. With the approval of RivflozaTM, we now have a novel treatment that lowers oxalate production safely and effectively," said Dr. David S. Goldfarb, MD Clinical Chief, Nephrology division, NYU Langone Medical Center and Professor of Medicine and Physiology, NYU Grossman School of Medicine. "Using the GalXC™ RNAi platform, RivflozaTM targets the liver-specific lactate dehydrogenase enzyme, which is the final step of oxalate production in PH1." Reflecting on the approval of RivflozaTM and its potential impact, Kim Hollander, Executive Director, Oxalosis & Hyperoxaluria Foundation, said, "We appreciate Novo Nordisk's commitment to rare disease and welcome the addition of RivflozaTM as a new treatment option that provides those 9 and older living with PH1 and their loved ones with more choices when working with their healthcare professional to select what treatment pathway is best for them." RivflozaTM, the first RNAi therapeutic by Novo Nordisk, was developed using the proprietary GalXCTM RNAi technology platform. RivflozaTM is designed to inhibit the expression of liver enzyme lactate dehydrogenase, a liver enzyme that catalyzes the final common step in the glyoxylate metabolism pathway which leads to the oxalate overproduction in patients with PH1. RivflozaTM was developed by Dicerna Pharmaceuticals, Inc. which was acquired by Novo Nordisk in 2021. Novo Nordisk plans to make RivflozaTM available for eligible patients in early 2024. What is RivflozaTM? RivflozaTM (nedosiran) injection 80 mg, 128 mg, or 160 mg is a prescription medicine used to lower urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function. It is not known if RivflozaTM is safe and effective in children younger than 9 years of age. Important Safety Information What are the possible side effects of RivflozaTM? The most common side effects of RivflozaTM include injection site reactions, such as reddening, pain, bruising, rash, or dimple at the site of injection. Please click here for Prescribing Information. About the PHYOX™2 & PHYOX™3 studies PHYOXTM2 was a pivotal, randomized, double-blind trial comparing RivflozaTM and placebo in patients with primary hyperoxaluria (PH)1 or PH2 and an eGFR ≥30 mL/min/1.73 m2.5,6 Too few PH2 patients were enrolled to evaluate efficacy in the PH2 population, therefore, RivflozaTM is only indicated for patients with PH1.5,6 In the PHYOXTM2 study, 35 patients with PH1 or PH2 received either RivflozaTM (n=23) or placebo (n=12) once monthly for six months.5,6 The primary endpoint of PHYOXTM2 was the percent change from baseline in 24-hour urinary oxalate (Uox) excretion as measured by area under the curve (AUC) from Day 90 to Day 180.5,6 The PHYOXTM3 study is an ongoing long-term, multidose, open-label, extension trial designed to further evaluate the long-term safety and efficacy of monthly subcutaneous nedosiran in individuals who completed a previous PHYOXTM trial.7 About primary hyperoxaluria type 1 (PH1) Primary hyperoxaluria type 1 (PH1) is a subtype of primary hyperoxalurias (PH), a family of rare, autosomal recessive genetic disorders of hepatic glyoxylate metabolism. The three genetically different subtypes of PH (PH1, PH2, and PH3) each have a distinct enzyme deficiency that causes an abnormal increase in glyoxylate levels. Glyoxylate is converted to the metabolic end-product oxalate by hepatic lactate dehydrogenase (LDH). Oxalate is normally filtered by the kidneys, but in case of excessive levels as occurs in PH (hyperoxaluria) the oxalate will precipitate with calcium to form calcium oxalate crystals in the renal tubules and kidneys. This ultimately leads to the formation of kidney stones and/or nephrocalcinosis, and may lead to chronic kidney damage. Genetic studies suggest approximately 1 in 38,600 individuals are affected by PH worldwide, and researchers believe a large portion of cases go undiagnosed.2 PH1 is the most clinically prevalent (roughly ~80% of PH patients) and severe of the three subtypes of PH.3 About RivflozaTM RivflozaTM (nedosiran) injection, developed by Dicerna Pharmaceuticals, Inc., is a once-monthly subcutaneous ribonucleic acid interference (RNAi) therapy indicated to lower urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function, e.g., eGFR ≥30 mL/min/1.73 m2.1 Utilizing Novo Nordisk's proprietary GalXCTM RNAi technology platform, RivflozaTM is designed to inhibit the expression of liver enzyme lactate dehydrogenase, that catalyzes the final common step in the glyoxylate metabolism pathway which leads to the oxalate overproduction in patients with PH1. About Novo Nordisk Novo Nordisk is a leading global healthcare company that has been making innovative medicines to help people with diabetes lead longer, healthier lives for 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity and rare blood and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. With U.S. headquarters in New Jersey and production and research facilities in seven states, Novo Nordisk employs nearly 6,000 people throughout the country. For more information, visit novonordisk-us.com, Facebook, Instagram, and Twitter. References RivflozaTM Prescribing Information Novo Nordisk Inc. September 2023 Hopp K, Cogal AG, Bergstralh EJ, et al. Phenotype-Genotype Correlations and Estimated Carrier Frequencies of Primary Hyperoxaluria. Journal of the American Society of Nephrology: JASN. 2015;26(10):2559-2570. doi:. American Kidney Fund.org. Primary hyperoxaluria and oxalate: Symptoms, causes and treatment. kidneyfund.org. Accessed September 8, 2023. . Novo Nordisk. Data on file. Baum MA, Langman C, Cochat P, et al. PHYOX2: a pivotal randomized study of nedosiran in primary hyperoxaluria type 1 or 2. Kidney International. 2023;103(1):207-217. doi:. ClinicalTrials.gov. A Study to Evaluate DCR-PHXC in Children and Adults With Primary Hyperoxaluria Type 1 and Primary Hyperoxaluria Type 2 (PHYOX2). Accessed Aug. 2023. . ClinicalTrials.gov. Long Term Extension Study in Patients with Primary Hyperoxaluria (PHYOX3). Accessed Aug. 2023. . RivflozaTM, PHYOXTM, and GalXCTM are registered trademarks of Novo Nordisk Health Care AG. Novo Nordisk is a registered trademark of Novo Nordisk A/S. © 2023 Novo Nordisk All rights reserved. US23NED00053 September 2023 SOURCE Novo Nordisk

• UB-612 Phase 3 COVID-19 Heterologous Boost Trial on Track for Topline Readout in Fourth Quarter of 2022 • UB-312 Phase 1 Part B Trial for Parkinson’s Completes Last Patient Last Dose, and Remains on Track to Complete an End-of-Treatment Analysis in the Second Half of 2022 • Advanced UB-313 Anti-CGRP Vaccine for Migraine into First-in-Human Trial • Identified VXX-401 as Lead Anti-PCSK9 Vaccine Candidate for Hypercholesterolemia, Advanced to IND-Enabling Studies DALLAS, Aug. 11, 2022 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (Nasdaq: VAXX), a U.S. company pioneering the development of a new class of immunotherapeutic vaccines, today reported financial results for the second quarter ended June 30, 2022. “We continue to advance our vaccine candidates further in clinical development and are delighted with the recent progress. We recently enrolled the first set of subjects into a Phase 1 clinical trial to study UB-313, our anti-CGRP candidate for migraine, and announced preclinical proof-of-concept data for our latest vaccine candidate, VXX-401, which demonstrated a significant reduction in cholesterol over a sustained period, further showcasing the capabilities of our platform in chronic diseases,” said Mei Mei Hu, CEO of Vaxxinity. “We remain diligent on strengthening our execution to advance the company’s pipeline and look forward to sharing clinical data updates in the second half of this year, including UB-312 in Parkinson’s disease, as well as our COVID-19 heterologous booster, UB-612.” Second Quarter 2022 and Recent Updates UB-311 FDA Fast Track Designation Granted UB-311 targets toxic forms of aggregated amyloid-β in the brain to fight Alzheimer’s disease (AD). In May 2022, UB-311 received Fast Track designation from the FDA for the treatment of AD. This designation will facilitate the development and expedite the review of UB-311. Vaxxinity plans to advance UB-311 into a registration-quality Ph2b early AD treatment trial, and other pivotal development, with a strategic partner, which may affect the trial initiation timeline. UB-312 Phase 1 Clinical Trial Part B Completes Last Patient Last Dose UB-312 targets toxic forms of aggregated α-synuclein in the brain to fight Parkinson’s disease (PD) and other synucleinopathies. Phase 1 Part B trial evaluating UB-312 in PD has completed last patient last dose. Vaxxinity expects to complete an end-of-treatment analysis of Part B in the second half of 2022. Phase 1 Part A trial of UB-312 in healthy volunteers results published in Movement Disorders, April 15, 2022. UB-313 Phase 1 Clinical Trial Enrollment Started UB-313 targets calcitonin gene-related peptide (CGRP) for the preventive treatment of migraine. Subsequent to the quarter-end, Vaxxinity began enrolling healthy volunteers into a Phase 1 clinical trial evaluating UB-313 for safety, tolerability, and immunogenicity. The trial also includes target engagement as a secondary endpoint in the form of capsaicin-induced dermal blood flow, a well established biomarker. Vaxxinity expects to report initial data from the Phase 1 study in 1H23. VXX-401 Preclinical Proof-of-Concept Achieved, Advanced into IND-Enabling Studies VXX-401 targets proprotein convertase subtilisin/kexin type 9 (PCSK9) to lower low-density lipoprotein (LDL) and reduce the risk of cardiac events. Two back-to-back studies in non-human primates demonstrate that VXX-401 is well tolerated and provides long-lasting, significant LDL reduction versus placebo. Vaxxinity has advanced VXX-401 into IND-enabling studies and expects to initiate a FIH trial by early 2023. UB-612 Phase 3 Heterologous Boost Study Ongoing UB-612 employs a unique “multitope” approach to neutralizing the SARS-CoV-2 virus. Awarded CEPI grant for $9.2 million for Ph3 heterologous boost trial The Phase 3 heterologous boost study evaluating UB-612 against COVID-19 in subjects who have received primary immunization from mRNA, adenovirus vector, or inactivated viral vaccines is ongoing. Vaxxinity expects a topline readout in the second half of 2022, and if successful, these data will support global marketing authorization applications. Data on neutralizing antibodies against SARS=CoV-2 Omicron BA.1 and BA.2 following a booster dose of UB-612 published in The Journal of Infectious Diseases, June 20, 2022. Second Quarter 2022 Financial Results As of June 30, 2022, cash and cash equivalents were $109.1 million, as compared to $144.9 million on December 31, 2021. As of June 30, 2022, the Company also has a Restricted Cash balance of $4.7 million of which $4.6 million is restricted for the reimbursement of certain research and development expenses related to our UB-612 Covid vaccine program. Research and development (R&D) expenses for the three months ended June 30, 2022 were $10.7 million compared to $19.0 million for the three months ended June 30, 2021. The $8.3 million decrease consisted of decreases in program-specific costs of $13.7 million and increases in non-program costs of $5.3 million. Of the program-specific decrease, $16.9 million was related to our UB-612 Covid vaccine program, partially offset by increases in spend of $1.3 million on our UB-313 migraine program and $0.7 million on our UB-312 Parkinson’s Disease program. The non-program increase was driven primarily by an increase of $4.2 million in personnel costs (including $0.6 million of stock-based compensation) as we added staff to advance our pipeline, and related overhead costs associated with our Florida lab space. General and administrative (G&A) expenses for the three months ended June 30, 2022 were $6.6 million compared to $5.8 million for the three months ended June 30, 2021. The $0.8 million increase was primarily driven by an increase of $0.9 million in Directors and Officers (D&O) insurance and $0.7 million of salaries and personnel costs (including $0.4 million of stock-based compensation), partially offset by decreases of $1.0 million in consulting costs and professional services. Net loss for the three months ended June 30, 2022 was $17.3 million or $0.14 per share compared to $26.9 million or $0.39 per share for the three months ended June 30, 2021. About Vaxxinity Vaxxinity, Inc. is a purpose-driven biotechnology company committed to democratizing healthcare across the globe. Vaxxinity’s is pioneering a new class of synthetic, peptide-based immunotherapeutic vaccines aimed at disrupting the existing treatment paradigm for chronic disease, increasingly dominated by monoclonal antibodies, which suffer from prohibitive costs and cumbersome administration. Vaxxinity’s proprietary technology platform has enabled the innovation of novel pipeline candidates designed to bring the efficiency of vaccines to the treatment of chronic diseases, including Alzheimer’s, Parkinson’s, migraine, and hypercholesterolemia. The technology is also implemented as part of a COVID-19 vaccine program. Vaxxinity has optimized its pipeline to achieve a potentially historic, global impact on human health. For more information about Vaxxinity, Inc., visit and follow us on social media @vaxxinity. Forward-looking Statement This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including “look forward,” “may,” “expect,” “potentially,” and “will” and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve substantial risks and uncertainties, and are based on the current expectations and assumptions of Vaxxinity’s management. Forward-looking statements include statements about the development of a new class of immunotherapeutic vaccines, the innovation and potential efficacy of Vaxxinity’s product candidates, and the anticipated outcomes from the studies we are conducting or will conduct for our product candidates. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements. Additional important factors to be considered in connection with forward-looking statements are described in the "Risk Factors" section of the Vaxxinity’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 24, 2022 and other reports we the Securities and Exchange Commission. The forward-looking statements are made as of this date and Vaxxinity does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. VAXXINITY, INC. Statement of Operations (In thousands, except number of shares and per share amounts) Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 Revenue $ 0 $ 0 $ 0 $ 17 Cost of revenue 0 1,927 0 1,928 Gross (loss) profit 0 (1,927 ) 0 (1,911 ) Operating expenses: Research and development 10,664 19,020 22,142 30,708 General and administrative 6,560 5,846 13,246 14,430 Total operating expenses 17,224 24,866 35,388 45,138 Loss from operations (17,224 ) (26,793 ) (35,388 ) (47,049 ) Other (income) expense: Interest expense, net 105 109 210 620 Interest income (75 ) (2 ) (80 ) (2 ) Change in fair value of convertible notes 0 0 0 2,667 Change in fair value of simple agreement for future equity 0 0 0 8,365 Change in fair value of warrant liability 0 0 0 214 Foreign currency loss, net (2 ) 8 (3 ) 16 Other (income) expense 28 115 127 11,880 Loss before income taxes (17,252 ) (26,908 ) (35,515 ) (58,929 ) Provision for income taxes 0 0 0 0 Net loss $ (17,252 ) $ (26,908 ) $ (35,515 ) $ (58,929 ) Net loss per share, basic and diluted (0.14 ) (0.39 ) (0.28 ) (0.86 ) Weighted average common shares outstanding, basic and diluted 125,948,595 68,702,833 125,829,764 68,627,943 VAXXINITY, INC. Selected Balance Sheet Data (in Thousands) June 30, December 31, 2022 2021 Cash and cash equivalents $ 109,066 $ 144,885 Total assets 136,996 166,673 Total liabilities 39,655 38,054 Total stockholder's equity (deficit) 97,341 128,619 Investor Contact Ben Matone benm@vaxxinity.com Press Contact Kate Coyle media@vaxxinity.com