Secukinumab

MoonLake Immunotherapeutics Reports Third Quarter 2024 Financial Results and Provides a Business Update Ended the third quarter with $493.9 million in cash, cash equivalents and short-term marketable debt securities, expected to support a roadmap rich in potential catalysts and a cash runway to the end of 2026Strong market performance of other IL-17 inhibitors in hidradenitis suppurativa (HS) and other inflammatory indications validating large market opportunity for sonelokimabPhase 3 clinical program in HS is progressing as per plan with primary endpoint readout anticipated as of mid-2025Preparations for Phase 3 clinical program in psoriatic arthritis (PsA) completed with patient enrollment expected to commence imminentlyAdditional Phase 2 programs, including trials in palmoplantar pustulosis (PPP) and axial spondyloarthritis (axSpA), and Phase 3 trial in adolescent HS, on track to commence around year-end ZUG, Switzerland, November 7, 2024 – MoonLake Immunotherapeutics (NASDAQ:MLTX) (“MoonLake” or the “Company”), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced its financial results for the third quarter of 2024. During this period, MoonLake has made significant progress with the clinical development of its Nanobody® sonelokimab, which targets IL-17A and IL-17F dimers and are heavily implicated in the pathology of several Type 3 dermatological and rheumatological inflammatory conditions. Dr. Jorge Santos da Silva, Chief Executive Officer of MoonLake Immunotherapeutics, said: “MoonLake continued to make good clinical progress with sonelokimab in the third quarter across several large dermatology and rheumatology indications, with multiple Phase 3 and Phase 2 trials either underway or starting soon. The strong clinical data that we continue to build on suggests that the ability to inhibit all IL-17A and IL-17F containing dimers, together with the molecular advantages of our Nanobody®, translate into higher clinical responses for patients, and provide ample opportunity for differentiation of sonelokimab versus all competitors. We look forward to 2025 with multiple data catalysts, including the expected primary readout of our Phase 3 VELA program in HS as of mid-year.” Q3 highlights: Phase 3 HS program progressing well: clinical study sites across North America and Europe are actively enrolling patients into the identical VELA-1 and VELA-2 studies, to enable the anticipated primary endpoint readout as of mid-2025Preparations for the Phase 3 PsA program completed: imminent enrollment of first patients into the IZAR-1 study for bio-naïve* patients and into the IZAR-2 study for TNF-IR** patients, the first study including an IL-23 inhibitor as an active reference armPreparation for first ever dedicated clinical trial in adolescent HS on track: Phase 3 VELA TEEN clinical trial scheduled to commence around year-endPreparations for three additional Phase 2 trials advancing well: the LEDA trial in PPP and the S-OLARIS trial in axSpA anticipated to start around year-end, and the P-OLARIS trial in patients with seronegative spondylarthritis scheduled to start in early 2025Strong commercial performance of other IL-17 inhibitors in both HS and other inflammatory indications continues to outperform “street” expectations, leading to greater awareness and diagnosis, driving market growth and further validating the significant commercial opportunity for sonelokimab with its highly differentiated molecular characteristics (small Nanobody® size and both IL17A and IL-17F dimer binding) and potentially best in class clinical data to date * Patients without previous exposure to biologics ** Patients with an inadequate response to TNF inhibitors Third quarter 2024 financial results As of September 30, 2024, MoonLake held cash, cash equivalents and short-term marketable debt securities of $493.9 million. Research and development expenses for the quarter ended September 30, 2024, were $35.7 million, compared to $23.7 million in the previous quarter. The increase was primarily due to expenses pertaining to the ramp-up of the Phase 3 VELA program in HS and to prepare for the start of the new clinical trials in PsA, PPP and axSpA. General and administrative expenses for the quarter ended September 30, 2024 were $7.4 million, compared to the $6.9 million incurred in the previous quarter. The increase was primarily due to personnel-related costs to support organizational growth. Matthias Bodenstedt, Chief Financial Officer at MoonLake Immunotherapeutics, said: “MoonLake delivered a solid financial performance in Q3, with a strong cash position to at least the end of 2026. We continue to maintain a tight control of costs with a laser focus on value and delivery of our core company goals. We are incredibly fortunate to be custodians of sonelokimab which, as a pipeline-in-a-product across multiple large indications, could be worth over $8bn in sales by 2035 across the indications we are currently targeting. To optimally capture this opportunity, we continue to invest into our large clinical development programs (enrolling over 2,500 patients globally) whilst ramping up preparations for regulatory filings, and other pre-commercial activities.” Upcoming investor and medical conferences: American College of Rheumatology (ACR) Conference, November 14-19 Washington DC, USJefferies London Healthcare Conference, November 19-21, 2024, London, UKCiti’s 19th Annual BioPharma Conference, December 3-5, Miami, USJP Morgan Annual Healthcare Conference, January 13-16, San Francisco, US14th Conference of the European Hidradenitis Suppurativa Foundation e.V., Vilnius, Lithuania, February 12-14American Academy of Dermatology 2025 Annual Meeting, 7-11 March, Orlando, Florida -Ends- About MoonLake Immunotherapeutics MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody® for the treatment of inflammatory disease, to revolutionize outcomes for patients. Sonelokimab inhibits IL-17A and IL-17F by inhibiting the IL-17A/A, IL-17A/F, and IL17F/F dimers that drive inflammation. The company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa and psoriatic arthritis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquartered in Zug, Switzerland. Further information is available at www.moonlaketx.com. About Sonelokimab Sonelokimab (M1095) is an investigational ~40 kDa humanized Nanobody® consisting of three VHH domains covalently linked by flexible glycine-serine spacers. With two domains, sonelokimab selectively binds with high affinity to IL-17A and IL-17F, thereby inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers. A third central domain binds to human albumin, facilitating further enrichment of sonelokimab at sites of inflammatory edema. Sonelokimab is being assessed in two lead indications, HS and PSA, and MoonLake is pursuing other indications in dermatology and rheumatology. For HS, sonelokimab is being assessed in the Phase 3 trials, VELA-1 and VELA-2, following the successful outcome of MoonLake’s end-of-Phase 2 interactions with the FDA and as well as positive feedback from its interactions with the EMA announced in February 2024. In June 2023, topline results of the MIRA trial (NCT05322473) at 12 weeks showed that the trial met its primary endpoint, the Hidradenitis Suppurativa Clinical Response (HiSCR)75, which is a higher measure of clinical response versus the HiSCR50 measure used in other clinical trials, setting a landmark milestone. In October 2023, the full dataset from the MIRA trial at 24 weeks showed that maintenance treatment with sonelokimab led to further improvements in HiSCR75 response rates and other high threshold clinical and patient relevant outcomes. The safety profile of sonelokimab in the MIRA trial was consistent with previous trials with no new safety signals detected. For PsA, sonelokimab is being assessed in the Phase 3 trials, IZAR-1 and IZAR-2, following the announcement in March 2024 of the full dataset from the global Phase 2 ARGO trial (M1095-PSA-201) evaluating the efficacy and safety of the Nanobody® sonelokimab over 24 weeks in patients with active PsA. Significant improvements were observed across all key outcomes, including up to 61% of patients treated with sonelokimab achieving an American College of Rheumatology (ACR) 50 response and Minimal Disease Activity (MDA) at week 24. This followed the positive top-line results in November 2023, where the trial met its primary endpoint with a statistically significant greater proportion of patients treated with either sonelokimab 60mg or 120mg (with induction) achieving ACR50 response compared to those on placebo at week 12. All key secondary endpoints in the trial were met for the 60mg and 120mg doses with induction. The safety profile of sonelokimab in the ARGO trial was consistent with previous trials with no new safety signals detected. A Phase 2 trial is expected to be initiated in 2024 for palmo-plantar pustulosis (PPP), a debilitating inflammatory skin condition affecting a significant number of patients. In addition, in 2024, a Phase 3 trial is expected to be initiated in adolescent HS, a condition that typically manifests at this early stage of a patient’s life, and the period in which irreversible damage and inflammatory remission is most critical. Sonelokimab also is also planned to be assessed for seronegative spondyloarthritis with a Phase 2 trial in radiographic and non-radiographic axial spondyloarthritis (axSpA) expected to start by end of 2024, and a Phase 2 trial in axSpA with PsA in 2025. The trials are expected to feature an innovative design complementing traditional clinical outcomes with modern imaging techniques. Sonelokimab has also been assessed in a randomized, placebo-controlled third party Phase 2b trial (NCT03384745) in 313 patients with moderate-to-severe plaque-type psoriasis. High threshold clinical responses (Investigator’s Global Assessment Score 0 or 1, and Psoriasis Area and Severity Index 90/100) were observed in patients with moderate-to-severe plaque-type psoriasis. Sonelokimab was generally well tolerated, with a safety profile similar to the active control, secukinumab (Papp KA, et al. Lancet. 2021; 397:1564-1575). In an earlier third party Phase 1 trial in patients with moderate-to-severe plaque-type psoriasis, sonelokimab has been shown to decrease (to normal skin levels) the cutaneous gene expression of pro-inflammatory cytokines and chemokines (Svecova D. J Am Acad Dermatol. 2019;81:196–203). About Nanobodies® Nanobodies® represent a new generation of antibody-derived targeted therapies. They consist of one or more domains based on the small antigen-binding variable regions of heavy-chain-only antibodies (VHH). Nanobodies® have a number of potential advantages over traditional antibodies, including their small size, enhanced tissue penetration, resistance to temperature changes, ease of manufacturing, and their ability to be designed into multivalent therapeutic molecules with bespoke target combinations. The terms Nanobody® and Nanobodies® are trademarks of Ablynx, a Sanofi company. About the VELA program The VELA program is expected to enroll 800 patients across two similarly designed Phase 3 trials (VELA-1 and VELA-2) with the aim to evaluate the efficacy and safety of the Nanobody® sonelokimab, administered subcutaneously, in adult patients with active moderate-to-severe hidradenitis suppurativa. Similar to the design of the landmark Phase 2 MIRA trial, the primary endpoint of the program is the percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75), defined as a ≥75% reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess or draining tunnel count relative to baseline. The trial will also evaluate a number of secondary endpoints, including the proportion of patients achieving Hidradenitis Suppurative Clinical Response (HiSCR50), the change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4), the proportion of patients achieving a Dermatology Life Quality Index (DLQI) total score of ≤5, and the proportion of patients achieving at least 30% reduction from baseline in Numerical Rating Scale (NRS30) in the Patient’s Global Assessment of Skin Pain (PGA Skin Pain). Further details are available under NCT06411379 and NCT06411899 at www.clinicaltrials.gov. About IZAR IZAR-1 (NCT06641076) and IZAR-2 (NCT06641089) are global, randomized, double-blind, placebo-controlled Phase 3 trials designed to evaluate the efficacy and safety of sonelokimab compared with placebo in a total of approximately 1,500 adults with active PsA, with a primary endpoint of superiority to placebo in ACR 50 response at Week 16. IZAR-1 will enroll biologic-naïve patients and include an evaluation of radiographic progression, while IZAR-2 will enroll patients with an inadequate response to tumor necrosis factor-α inhibitors (TNF-IR) — reflecting patients commonly seen in clinical practice — and will be the first PsA trial to include a risankizumab active reference arm. Both trials will also assess a range of secondary endpoints reflecting the multiple disease manifestations characteristic of PsA. These include skin and nail outcomes, multidomain outcomes, and patient-reported outcome measures such as pain and quality of life assessments. About Hidradenitis Suppurativa Hidradenitis suppurativa is a severely debilitating chronic skin condition resulting in irreversible tissue destruction. HS manifests as painful inflammatory skin lesions, typically around the armpits, groin, and buttocks. Over time, uncontrolled and inadequately treated inflammation can result in irreversible tissue destruction and scarring. The disease affects 0.05–4.1% of the global population, with three times more females affected than males. Real-world data in the US indicates that at least 2 million unique patients have been diagnosed with and treated for HS between 2016 and 2023 alone, highlighting a significant unmet need and impact on healthcare systems, and a market opportunity exceeding $10bn by 2035. Onset typically occurs in early adulthood and HS has a profound negative impact on quality of life, with a higher morbidity than other dermatologic conditions. There is increasing scientific evidence to support IL-17A- and IL-17-mediated inflammation as a key driver of the pathogenesis of HS, with other identified risk factors including genetics, cigarette smoking, and obesity. About Psoriatic Arthritis Psoriatic arthritis (PsA) is a chronic, progressive and complex inflammatory disease that manifests across multiple domains, leading to substantial functional impairment and decreased quality of life. The clinical features of PsA are diverse, comprising both musculoskeletal (peripheral arthritis, spondylitis, dactylitis, and enthesitis) and non-musculoskeletal (skin and nail disease) domains. PsA occurs in up to 30% of patients with psoriasis, most commonly those aged between 30 and 60 years. Although the exact mechanism of disease is not fully understood, evidence suggests that activation of the IL-17 pathway plays an important role in the disease pathophysiology. Cautionary Statement Regarding Forward Looking Statements This press release contains certain “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding MoonLake’s expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding: plans for and timing of clinical trials, including initiation of Phase 3 VELA TEEN trial of sonelokimab in adolescents with HS, commencement of clinical trials of sonelokimab in PPP, axSpA and seronegative spondylarthritis, topline results of the Phase 3 VELA program of sonelokimab in HS and enrollment of first patents into Phase 3 IZAR-1 and IZAR-2 trials, the efficacy and safety of sonelokimab for the treatment of HS, PsA, PPP, axSpA and seronegative spondylarthritis, including in comparison to existing standards or care or other competing therapies, clinical trials and research and development programs and the anticipated timing of the results from those studies and trials, potential market opportunities for sonelokimab and our anticipated cash usage and the period of time we anticipate such cash to be available. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward- looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking. Forward-looking statements are based on current expectations and assumptions that, while considered reasonable by MoonLake and its management, as the case may be, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with MoonLake’s business in general and limited operating history, difficulty enrolling patients in clinical trials, state and federal healthcare reform measures that could result in reduced demand for MoonLake’s product candidates and reliance on third parties to conduct and support its preclinical studies and clinical trials and the other risks described in or incorporated by reference into MoonLake’s Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent filings with the Securities and Exchange Commission. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. MoonLake does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or in the events, conditions or circumstances on which any such statement is based. CONTACT MoonLake Immunotherapeutics Investors Carla Bretes, Director IR & BD ir@moonlaketx.com MoonLake Immunotherapeutics Media Patricia Sousa, Director Corporate Affairs media@moonlaketx.com ICR Healthcare Mary-Jane Elliott, Ashley Tapp, Namrata Taak Tel: +44 (0) 20 3709 5700 MoonLake@ICRHealthcare.com MOONLAKE IMMUNOTHERAPEUTICSCONDENSED CONSOLIDATED BALANCE SHEETS (Amounts in USD, except share data) September 30, 2024 (Unaudited) December 31.2023Current assets Cash and cash equivalents $ 375,656,291 $ 451,169,337Short-term marketable debt securities 118,268,400 59,838,900Other receivables 2,407,062 1,056,862Prepaid expenses - current 15,984,425 2,102,203Total current assets 512,316,178 514,167,302 Non-current assets Operating lease right-of-use assets 3,251,197 3,628,480Property and equipment, net 581,378 320,865Prepaid expenses - non-current 2,064,575 8,423,468Total non-current assets 5,897,150 12,372,813Total assets $ 518,213,328 $ 526,540,115 Current liabilities Trade and other payables $ 10,710,603 $ 1,837,684 Short-term portion of operating lease liabilities 1,444,893 1,197,876Accrued expenses and other current liabilities 7,925,524 6,930,120Total current liabilities 20,081,020 9,965,680 Non-current liabilities Long-term portion of operating lease liabilities 1,935,709 2,499,990Pension liability 694,959 583,426Total non-current liabilities 2,630,668 3,083,416Total liabilities 22,711,688 13,049,096Commitments and contingencies (Note 15) Equity Class A Ordinary Shares: $0.0001 par value; 500,000,000 shares authorized; 63,046,025 shares issued and outstanding as of September 30, 2024; 60,466,453 shares issued and outstanding as of December 31, 2023 6,305 6,047Class C Ordinary Shares: $0.0001 par value; 100,000,000 shares authorized; 841,269 shares issued and outstanding as of September 30, 2024; 2,505,476 shares issued and outstanding as of December 31, 2023 84 251Additional paid-in capital 675,343,443 609,969,236Accumulated deficit (189,988,477) (116,657,472)Accumulated other comprehensive income 2,833,970 2,357,621Total shareholders’ equity 488,195,325 495,675,683Noncontrolling interests 7,306,315 17,815,336Total equity 495,501,640 513,491,019Total liabilities and equity $ 518,213,328 $ 526,540,115 MOONLAKE IMMUNOTHERAPEUTICSCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(Unaudited) (Amounts in USD, except share and per share data) For the Three Months Period Ended September 30, June 30, 2024 2024Operating expenses Research and development $ (35,735,514) $ (23,662,147)General and administrative (7,376,495) (6,916,054)Total operating expenses (43,112,009) (30,578,201)Operating loss (43,112,009) (30,578,201) Other income, net 7,089,691 5,898,148Loss before income tax (36,022,318) (24,680,053) Income tax expense (92,106) (78,701)Net loss $ (36,114,424) $ (24,758,754)Of which: net loss attributable to controlling interests shareholders (35,390,337) (24,267,012)Of which: net loss attributable to noncontrolling interests shareholders (724,087) (491,742) Net unrealized gain (loss) on marketable securities and short term investments (325,510) 652,097Actuarial gain (loss) on employee benefit plans (115,629) (76,479)Other comprehensive income (loss) (441,139) 575,618Comprehensive loss $ (36,555,563) $ (24,183,136)Comprehensive loss attributable to controlling interests shareholders (35,822,526) (23,703,201Comprehensive loss attributable to noncontrolling interests (733,037) (479,935) Weighted-average number of Class A Ordinary Shares, basic and diluted 62,896,782 62,874,637Basic and diluted net loss per share attributable to controlling interests shareholders $ (0.56) $ (0.39)

Ad hoc announcement pursuant to Art. 53 LR Q3 net sales grew +10% (cc1, +9% USD) with core operating income up +20% (cc, +17% USD) Sales growth driven by continued strong performance from Entresto (+26% cc), Cosentyx (+28% cc), Kisqali (+43% cc), Kesimpta (+28% cc), Pluvicto (+50% cc) and Leqvio (+119% cc)Core operating income margin 40.1%, +340 basis points (cc), mainly driven by higher net sales Q3 operating income grew +123% (cc, +106% USD); net income up +121% (cc, +111% USD)Q3 core EPS grew +20% (cc, +18% USD) to USD 2.06Q3 free cash flow1 of USD 6.0 billion (+18% USD) driven by higher net cash flows from operating activitiesStrong nine months performance with sales up +11% (cc, +9% USD) and core operating income up +20% (cc, +17% USD)Q3 selected innovation milestones: Kisqali FDA approval and positive CHMP opinion for HR+/HER2- stage II and III eBC Fabhalta FDA accelerated approval for IgANPluvicto FDA filing for pre-taxane mCRPC Full-year 2024 guidance raised2 Net sales expected to grow low double-digit (from high single to low double-digit)Core operating income expected to grow high teens (from mid to high teens) Basel, October 29, 2024 – commenting on Q3 2024 results, Vas Narasimhan, CEO of Novartis, said: “Novartis delivered another quarter of strong operational performance in Q3, with sales up 10% and core operating income up 20%. All key growth drivers contributed to the momentum. We achieved important indications expansions for Kisqali in early breast cancer and Fabhalta in IgA nephropathy, and we completed our PSMAfore filing for Pluvicto in the US. With the momentum in our business and pipeline, we were able to once again upgrade our full-year guidance and remain highly confident in our mid-term outlook.” Key figuresContinuing operations3 Q3 2024Q3 2023% change9M 20249M 2023% change USD m USD mUSDcc USD m USD mUSDccNet sales12 82311 782910 37 16434 017911Operating income3 6271 762106123 11 0147 1875361Net income3 1851 513111121 9 1195 9345462EPS (USD)1.580.73116127 4.502.845867Free cash flow5 9655 04318 12 61811 01915 Core operating income5 1454 4051720 14 63512 5511720Core net income4 1333 5851517 11 82210 3201518Core EPS (USD)2.061.741820 5.834.951821 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 46 of the 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. 3. As defined on page 35 of the Interim 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.StrategyOur focus In 2023, Novartis completed its 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, shareholder approval of the spin-off of Sandoz, Novartis reported its consolidated financial statements 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. While the commentary below focuses on continuing operations, we also provide information on discontinued operations. Continuing operations Third quarter Net sales were USD 12.8 billion (+9%, +10% cc), with volume contributing 12 percentage points to growth. Generic competition had a negative impact of 2 percentage points and pricing was flat. Operating income was USD 3.6 billion (+106%, +123% cc), mainly driven by lower impairments and higher net sales, partly offset by higher R&D investments. Net income was USD 3.2 billion (+111%, +121% cc), mainly driven by higher operating income. EPS was USD 1.58 (+116%, +127% cc), benefiting from the lower weighted average number of shares outstanding. Core operating income was USD 5.1 billion (+17%, +20% cc), mainly driven by higher net sales, partly offset by higher R&D investments. Core operating income margin was 40.1% of net sales, increasing 2.7 percentage points (+3.4 percentage points cc). Core net income was USD 4.1 billion (+15%, +17% cc), mainly due to higher core operating income. Core EPS was USD 2.06 (+18%, +20% cc), benefiting from the lower weighted average number of shares outstanding. Free cash flow from continuing operations amounted to USD 6.0 billion (+18% USD), compared with USD 5.0 billion in the prior-year quarter, driven by higher net cash flows from operating activities from continuing operations. Nine months Net sales were USD 37.2 billion (+9%, +11% cc) with volume contributing 14 percentage points to growth. Generic competition had a negative impact of 2 percentage points and pricing had a negative impact of 1 percentage point. Operating income was USD 11.0 billion (+53%, +61% cc), mainly driven by higher net sales, lower impairments and restructuring charges, partly offset by prior-year one-time income from legal matters and higher R&D investments. Net income was USD 9.1 billion (+54%, +62% cc), mainly driven by higher operating income. EPS was USD 4.50 (+58%, +67% cc), benefiting from the lower weighted average number of shares outstanding. Core operating income was USD 14.6 billion (+17%, +20% cc), mainly driven by higher net sales, partly offset by higher R&D investments. Core operating income margin was 39.4% of net sales, increasing 2.5 percentage points (+3.2 percentage points cc). Core net income was USD 11.8 billion (+15%, +18% cc), mainly due to higher core operating income. Core EPS was USD 5.83 (+18%, +21% cc), benefiting from the lower weighted average number of shares outstanding. Free cash flow from continuing operations amounted to USD 12.6 billion (+15% USD), compared with USD 11.0 billion in the prior-year period, driven by higher net cash flows from operating activities from continuing operations. Discontinued operations Discontinued operations include the Sandoz generic pharmaceuticals and biosimilars division, certain corporate activities attributable to Sandoz and certain other expenses related to the spin-off of the Sandoz business. Third quarter As the Sandoz spin-off was completed on October 3, 2023, there were no operating results in the third quarter of 2024 related to discontinued operations. In the third quarter of 2023, discontinued operations net sales were USD 2.5 billion, operating loss amounted to USD 86 million and net income from discontinued operations was USD 250 million. For further details see Note 3 “Significant acquisition of businesses and spin-off of Sandoz business” and Note 11 “Discontinued operations” to the condensed interim consolidated financial statements. Nine months As the Sandoz spin-off was completed on October 3, 2023, there were no operating results in the first nine months of 2024 related to discontinued operations. In the first nine months of 2023, discontinued operations net sales were USD 7.4 billion, operating income amounted to USD 265 million and net income from discontinued operations was USD 440 million. For further details see Note 3 “Significant acquisition of businesses and spin-off of Sandoz business” and Note 11 “Discontinued operations” to the condensed interim consolidated financial statements. Total Company Third quarter Total Company net income was USD 3.2 billion in 2024, compared to USD 1.8 billion in 2023 and basic EPS was USD 1.58 compared to USD 0.85 in prior year quarter. Net cash flows from operating activities for total Company amounted to USD 6.3 billion and free cash flow amounted to USD 6.0 billion. Nine months Total Company net income was USD 9.1 billion in 2024, compared to USD 6.4 billion in 2023 and basic EPS was USD 4.50 compared to USD 3.05 in prior year. Net cash flows from operating activities for total Company amounted to USD 13.4 billion and free cash flow amounted to USD 12.6 billion. Q3 key growth drivers Underpinning our financial results in the quarter is a continued focus on key growth drivers (ranked in order of contribution to Q3 growth) including: Entresto(USD 1 865 million, +26% cc) sustained robust, demand-led growth, with increased penetration in the US and Europe following guideline-directed medical therapy in heart failure, as well as in China with increased penetration in hypertensionCosentyx(USD 1 693 million, +28% cc) sales grew mainly in the US, Europe and emerging growth markets, driven by recent launches (including the HS indication and the IV formulation in the US) and volume growth in core indicationsKisqali(USD 787 million, +43% cc) sales grew strongly across all regions, based on increasing recognition of its overall survival benefit in HR+/HER2- advanced breast cancer and Category 1 NCCN guidelines recommendationKesimpta(USD 838 million, +28% cc) sales grew reflecting increased demand for a high efficacy product with convenient self-administered dosing; the prior-year period benefited from a one-time revenue deduction adjustment in EuropePluvicto(USD 386 million, +50% cc) sales grew in the US and Europe. Q3 sales benefited from a one-time revenue deduction adjustment in Europe. With supply now unconstrained, the focus is on increasing share in established RLT sites, while opening new sites and referral pathways, and initiating new patientsLeqvio(USD 198 million, +119% cc) continued to show steady growth, with a focus on increasing account and patient adoption, and continuing medical educationJakavi(USD 500 million, +18% cc) sales grew across all regions driven by strong demand across indicationsScemblix(USD 182 million, +72% cc) sales grew across all regions demonstrating the continued high unmet need in CMLTafinlar + Mekinist(USD 534 million, +12% cc) sales grew mainly in the US and emerging growth markets, driven by increased demandXolair(USD 418 million, +15% cc) grew mainly in emerging growth markets and EuropeFabhalta(USD 44 million) launch continues in PNH with an approval in IgAN in Q3Ilaris(USD 372 million, +12% cc) sales grew across all regions, led by the US and EuropeLutathera(USD 190 million, +19% cc) sales grew across all regions due to increased demand and earlier line adoption (within indication) in the US and Japan Emerging Growth Markets*Grew +12% (cc) overall. China grew +18% (cc) to USD 1.0 billion, mainly driven by Entresto, Cosentyx and Leqvio *All markets except the US, Canada, Western Europe, Japan, Australia, and New Zealand Net sales of the top 20 brands in the third quarter and nine months Q3 2024 % change9M 2024 % change USD mUSDccUSD mUSD ccEntresto1 86526265 6422830Cosentyx1 69327284 5452425Kesimpta- excl. PY revenue deduction adjust. 838 285528562 27449614962Kisqali 78740432 1314548Promacta/Revolade 569-101 633-4-3Tafinlar + Mekinist 53411121 53179Jakavi 50017181 4491416Tasigna 419-10-91 260-10-9Xolair 41813151 2441517Ilaris 37211121 0961216Pluvicto- excl. revenue deduction adjust. 38651375036 1 04147424742Sandostatin Group 305-10-8 973-3-1Zolgensma 30801 95234Lucentis 245-33-32 834-29-28Exforge Group 174-7-4 544-21Lutathera 1901919 5341717Leqvio 198120119 531129130Scemblix 1827272 4826769Galvus Group 159-12-6 458-15-8Diovan Group 150-22 450-31Top 20 brands total10 292171829 6041719 R&D update - key developments from the third quarter New approvals Kisqali(ribociclib)FDA approved Kisqali with a broad indication for HR+/HER2- stage II and III early breast cancer (eBC) at high risk of recurrence, approximately doubling the population eligible for CDK4/6 inhibitor adjuvant therapy, with the inclusion of those without nodal involvement. In addition, the CHMP issued a positive opinion for Kisqali in eBC in October. Fabhalta(iptacopan)FDA granted accelerated approval to Fabhalta for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. Regulatory updates Pluvicto (lutetium Lu177 vipivotide tetraxetan)Completed FDA submission for Pluvicto pre-taxane mCRPC label expansion based on the positive Phase III PSMAfore study.Scemblix(asciminib)FDA granted Priority Review status to Scemblix for the treatment of newly diagnosed adult patients with Philadelphia chromosome-positive CML in chronic phase (Ph+ CML-CP). Scemblix is also under regulatory review in this indication in key international markets worldwide, including in China and Japan.Fabhalta(iptacopan)Submissions for the treatment of C3 glomerulopathy (C3G) completed in the EU, China and Japan. Results from ongoing trials and other highlights Kisqali(ribociclib)Results from a four-year post-hoc analysis of the pivotal Phase III NATALEE trial showed the addition of Kisqali to endocrine therapy (ET) in patients with stage II and III HR+/HER2- eBC reduced the risk of recurrence by 28.5% compared to ET alone. This invasive disease-free survival benefit was consistent across all pre-specified patient subgroups, including those with node-negative disease. Results were also consistent across secondary efficacy endpoints, with a trend for improvement in overall survival. Safety and tolerability remained consistent with previously reported results. Data presented at ESMO Congress 2024.Leqvio(inclisiran)In the Phase III V-MONO study, Leqvio demonstrated clinically meaningful and statistically significant low-density lipoprotein cholesterol (LDL-C) lowering versus both placebo and ezetimibe in patients who were at low or moderate risk of developing atherosclerotic cardiovascular disease (ASCVD) and not receiving lipid-lowering therapy. Novartis plans to present results from this trial at an upcoming medical meeting and share with regulatory agencies including FDA.Kesimpta(ofatumumab)Data from the ALITHIOS open-label extension study showed first-line Kesimpta treatment for up to six years led to less disability and disease progression in recently diagnosed (≤3 years) and treatment-naïve people with relapsing multiple sclerosis (RMS), compared to those who switched from teriflunomide.In the separate US-based single-arm OLIKOS Phase IIIb study, all clinically stable RMS patients who switched from intravenous anti-CD20 therapy to Kesimpta showed no new gadolinium-enhancing (Gd+) T1 lesions at 12 months. Data from both studies were presented at the ECTRIMS 2024 Annual Meeting.PelabresibBased on Novartis review of 48-week data from the Phase III MANIFEST-2 study, longer follow-up time is needed to determine, in consultation with Health Authorities, the regulatory path for pelabresib in myelofibrosis. We will continue to follow patients in MANIFEST-2 and evaluate the potential for additional studies to support registration. The 48-week data will be presented at an upcoming medical meeting.XXB750Novartis will not advance further development of XXB750 in resistant hypertension and heart failure, following current scientific assessment and review of available data from early investigational studies.BD&LNovartis, in collaboration with Versant Ventures, established Borealis Biosciences, an independent, discovery-stage biotechnology company focused on developing next-generation RNA-based medicines for kidney diseases. Under the agreement, Novartis has the option to acquire two future development-ready programs to augment its renal portfolio, a strategic area of focus for the company.Novartis entered into a collaboration agreement with Generate: Biomedicines to discover and develop protein therapeutics across multiple disease areas with generative AI. The collaboration will combine Generate’s AI platform with Novartis expertise and capabilities in target biology, biologics development, and clinical development to create novel therapeutics and to accelerate the pace of drug discovery and development. 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 nine months of 2024, Novartis repurchased a total of 52.7 million shares for USD 5.7 billion on the SIX Swiss Exchange second trading line. These purchases included 45.4 million shares (USD 4.8 billion) under the up-to USD 15 billion share buyback announced in July 2023 (with up to USD 7.9 billion still to be executed). In addition, 7.3 million shares (USD 0.9 billion) were repurchased to mitigate dilution related to participation plans of associates, with the remainder of repurchases for this purpose to be executed in Q4 2024. Further, 1.1 million shares (for an equity value of USD 0.1 billion) were repurchased from associates. In the same period, 9.1 million shares (for an equity value of USD 0.8 billion) were delivered as a result of share deliveries related to participation plans of associates. Consequently, the total number of shares outstanding decreased by 44.7 million versus December 31, 2023. These treasury share transactions resulted in an equity decrease of USD 5.0 billion and a net cash outflow of USD 5.5 billion. As of September 30, 2024, net debt increased to USD 16.3 billion compared to USD 10.2 billion net debt at December 31, 2023. The increase was mainly due to the free cash flow of USD 12.6 billion being more than offset by the USD 7.6 billion annual dividend payment, net cash outflow for M&A / intangible assets transactions of USD 5.5 billion, and cash outflow for treasury share transactions of USD 5.5 billion. As of Q3 2024, the long-term credit rating for the company is Aa3 with Moody’s Ratings and AA- with S&P Global Ratings. 2024 outlook Barring unforeseen events; growth vs prior year in ccPrevious guidanceNet salesExpected to grow low double-digit(from high single to low double-digit)Core operating incomeExpected to grow high teens(from mid to high teens) Key assumptions: We assume Tasigna, Promacta and Entresto US generic entry mid-2025 for forecasting purposes Foreign exchange impact If late-October 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 to negative 4 percentage points on core operating income. The estimated impact of exchange rates on our results is provided monthly on our website. Key figures1 Continuing operations2Q3 2024Q3 2023% change 9M 20249M 2023% change USD m USD mUSDcc USD m USD mUSDccNet sales12 82311 782910 37 16434 017911Operating income3 6271 762106123 11 0147 1875361As a % of sales28.315.0 29.621.1 Net income3 1851 513111121 9 1195 9345462EPS (USD)1.580.73116127 4.502.845867Cash flows from operating activities6 2865 30419 13 42611 67315 Non-IFRS measures Free cash flow 5 9655 04318 12 61811 01915 Core operating income5 1454 4051720 14 63512 5511720As a % of sales40.137.4 39.436.9 Core net income4 1333 5851517 11 82210 3201518Core EPS (USD)2.061.741820 5.834.951821 Discontinued operations2Q3 2024Q3 2023% change 9M 20249M 2023% change USD m USD mUSDcc USD m USD mUSDccNet sales 2 476nmnm 7 428nmnmOperating (loss)/income -86nmnm 265nmnmAs a % of sales -3.5 3.6 Net income 250nmnm 440nmnmNon-IFRS measures Core operating income 250nmnm 1 185nmnmAs a % of sales 10.1 16.0 Total CompanyQ3 2024Q3 2023% change 9M 20249M 2023% change USD m USD mUSDcc USD m USD mUSDccNet income3 1851 763nmnm 9 1196 374nmnmEPS (USD)1.580.85nmnm 4.503.05nmnmCash flows from operating activities6 2865 378nmnm 13 42611 911nmnmNon-IFRS measures Free cash flow 5 9655 043nmnm 12 61811 038nmnmCore net income4 1333 784nmnm 11 82211 209nmnmCore EPS (USD)2.061.83nmnm 5.835.37nmnm 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 46 of the Interim Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year.2. As defined on page 35 of the Interim 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 Interim Financial Report at the link below:https://ml-eu.globenewswire.com/resource/download/6504f5e3-a14c-43ba-8b72-44dcc5a45156/ 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 “may,” “can,” “will,” “continue,” “ongoing,” “grow,” “launch,” “expect,” “deliver,” “focus,” “address,” “accelerate,” “deliver,” “remain,” “scaling,” “guidance,” “outlook,” “long-term,” “priority,” “potential,” “momentum,” 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; 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. 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 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 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 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 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 9:00 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 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 https://www.novartis.com/investors/event-calendar. Important dates November 20-21, 2024Meet Novartis Management 2024 (London, UK)December 9, 2024Impact & Sustainability annual investor event (virtual)January 31, 2025 Fourth quarter & full year 2024 results Please find full media release in English attached and on the following link:Media Release (PDF) Further language version is available through the following link: German version is available through the following link:Medienmitteilung (PDF)