NVS - Novartis AG

Sandoz presents compelling investment proposition as standalone company at Capital Markets Day

Sandoz well positioned to deliver continued mid-single digit sales growth; core EBITDA margin of 24-26% and Free Cash Flow to more than double over mid term European champion committed to further extending global leadership in attractive and growing generics and biosimilars market, via purpose-driven strategy with focus on access and sustainability Six strategic levers to drive long-term investor value; attractive financial outlook, including targeted investment grade credit profile and progress

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  Novartis' Sandoz wagers its standalone future on biosimilar success

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Novartis Kisqali® significantly reduced the risk of recurrence by 25% across a broad population of patients with early breast cancer; clinically meaningful benefit was consistent across subgroups

Kisqali is the first and only CDK4/6 inhibitor to demonstrate a consistent, clinically meaningful benefit across a broad population of patients with HR+/HER2- early breast cancer, regardless of disease stage, menopausal or nodal status1 Results were also consistent across all secondary endpoints, including distant disease-free survival and recurrence-free survival, with a trend for improved overall survival*1 The safety profile of Kisqali was favorable at 400 mg with low rates of symptomatic adv

Sandoz plans move to new central Basel headquarters by mid-2024, following proposed spin-off as standalone company

Sandoz AG to remain based in Basel, Switzerland following proposed spin-off from Novartis Announcement of planned city-center HQ marks important milestone as Sandoz prepares to become independent company Basel, as a global life sciences center, ideally located to attract top talent Basel, June 1, 2023 — Sandoz AG, a global leader in generic and biosimilar medicines, has announced the location of its future permanent headquarters in central Basel. The Sandoz AG headquarters plans to move to a lan

Sandoz Marketing Authorization Applications for proposed biosimilar denosumab accepted by EMA

Submissions supported by comprehensive analytical and clinical data package including a Phase I PK/PD similarity study and the integrated Phase I/III ROSALIA clinical trialDenosumab is indicated for treating a variety of conditions, including osteoporosis in postmenopausal women, prevention of skeletal related complications in cancer that has spread to the bone and unresectable giant cell tumor of the bone1,2 Sandoz continues to build its biosimilars portfolio to increase patient access to high-

New Sandoz Board of Directors appointed

Novartis Board of Directors approves the recommendation of Sandoz Chairman-designate for the future Sandoz Board of Directors, to start preparatory work in June, followed by formal constitution in H2 2023 Experienced and diverse group of corporate leaders with a track record of growing businesses and driving value for the organization and society will help set strategic direction for Sandoz and support its future development Basel, May 15, 2023 — Sandoz takes the next steps to prepare for the pl

Novartis to feature new PNH and CML scientific data from broad hematology portfolio at European Hematology Association Annual Meeting

Updated iptacopan data confirm hemolysis control in paroxysmal nocturnal hemoglobinuria (PNH) patients from Phase III APPLY-PNH and APPOINT-PNH studies Head-to-head data from Phase III ASCEMBL trial reaffirm Scemblix superiority over Bosulif* in patients with chronic myeloid leukemia (CML) in chronic phase, previously treated with two or more tyrosine kinase inhibitors Preliminary global results from large-scale Survey on Unmet Needs in CML disrupt notion that CML is solved and underscore import

Sandoz strengthens pipeline expansion through partnership to develop and manufacture multiple biosimilars

Sandoz and Just - Evotec Biologics announce partnership to develop and manufacture multiple biosimilars with an option for expansion Sandoz gains access to proprietary AI-driven technology platform that delivers fully integrated drug substance development and continuous manufacturing Partnership supports Sandoz pipeline expansion to 24 biosimilar assets, provides opportunity to enhance integrated development and manufacturing network Basel, May 9, 2023 — Sandoz, a global leader in off-patent (ge

Sandoz to exclusively commercialize six products in the US, reinforcing global leadership position in off-patent medicines

Agreement offers exclusive rights to commercialize six products in key areas of anti-infectives and oncology. Products from Adalvo slated for near- to mid-term launches, with four out of six anticipated to be first-to-market Sandoz continues to expand patient access to much-needed medications, drive patient savings, and ensure the sustainability of healthcare systems worldwide Basel, May 4, 2023 – Sandoz, a global leader in generic pharmaceuticals and biosimilars, today announced that it has sig

Novartis Cosentyx® gains positive CHMP opinion for hidradenitis suppurativa

Positive opinion paves way for first new treatment option in hidradenitis suppurativa (HS) in nearly a decade Committee for Medicinal Products for Human Use (CHMP) opinion based on robust Phase III data showing Cosentyx® (secukinumab) provided rapid symptom relief from as early as Week 4, with response rates continuing to improve up to 1 year1–4 Safety findings were consistent with the known safety profile of Cosentyx across its five approved indications1 Regulatory decision from the US Food and

Novartis to present new data across oncology portfolio including Kisqali Phase III NATALEE trial in early breast cancer at ASCO

Primary analysis of NATALEE, the first and only positive Phase III study of a CDK4/6 inhibitor in a broad population of patients with stage II and III HR+/HER2- early breast cancer at risk of recurrence, including those with no nodal involvement, to be presentedNew analyses from the Pluvicto VISION trial in prostate cancer and the JDQ443 KontRASt-01 trial in KRAS G12C-mutated lung cancer among 40+ Novartis abstracts accepted at ASCO, underscoring strength of Novartis oncology portfolio and thera

Novartis Phase III APPOINT-PNH trial shows investigational oral monotherapy iptacopan improves hemoglobin to near-normal levels, leading to transfusion independence in all treatment-naïve PNH patients

Data at EBMT show primary endpoint met – estimated* 92.2% of complement-inhibitor-naïve patients with paroxysmal nocturnal hemoglobinuria (PNH) achieving 2 g/dL or more hemoglobin-level increase from baseline without the need for blood transfusions1 Secondary endpoints show clinically meaningful benefits, including achieving 12 g/dL or more hemoglobin levels and blood-transfusion independence in the vast majority of patients, no cases of clinical breakthrough hemolysis, reduction of lactate dehy

Novartis delivers strong sales growth, robust margin expansion and major innovation milestones. Raises FY guidance

Ad hoc announcement pursuant to Art. 53 LR Q1 sales grew +8% (cc1, +3% USD) and core operating income grew +15% (cc, +8% USD) Innovative Medicines (IM) sales grew +7% (cc, +3% USD) and core operating income +18% (cc, +11% USD)IM core margin 38.7%, +360 bps cc, driven by higher sales and productivity programsGrowth driven by strong performance of Entresto, Pluvicto, Kesimpta, Kisqali and ScemblixSandoz sales grew +8% (cc, +4% USD) and core operating income +3% (cc, -2% USD) Operating income grew

Novartis presents new five-year data on disability outcomes and safety of Kesimpta® (ofatumumab) in people living with relapsing multiple sclerosis

The ALITHIOS open-label extension study showed continuous treatment with Kesimpta® (ofatumumab) for up to five years in relapsing multiple sclerosis (RMS) patients was associated with reduced risk of disability progression versus those who switched later from teriflunomide to Kesimpta1Outcomes related to both disability progression and brain volume change up to five years favored earlier initiation of Kesimpta in people living with RMS1A separate ALITHIOS analysis showed consistent safety profil

Sandoz receives approval by European Commission for Hyrimoz® (adalimumab) high-concentration formulation

Biosimilar Hyrimoz® (adalimumab) citrate-free high-concentration formulation (HCF) is now approved in the EU for use in all indications of reference medicine Humira®*HCF formulation adalimumab offers patients enhanced yet familiar experience through increased convenience and reduced injection volumeApproval further solidifies expansion of Sandoz biosimilar immunology portfolio in Europe Basel, April 3, 2023 — Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announc

Novartis Entresto receives positive CHMP opinion for pediatric heart failure

If subsequently approved, Entresto will be the first and only approved therapy for the treatment of symptomatic chronic heart failure patients aged 1 to <18 years in the European Union Pediatric heart failure is an important cause of childhood morbidity and mortality – up to a third of all pediatric cardiac admissions are due to heart failure; these hospitalizations are associated with a 20-fold increase in the risk of death1,2 The positive opinion is based on final data from the 52-week Phase I

Novartis Kisqali® Phase III NATALEE trial meets primary endpoint at interim analysis demonstrating clinically meaningful benefit in broad population of patients with early breast cancer

Ad hoc announcement pursuant to Art. 53 LR Kisqali plus endocrine therapy (ET) significantly reduced the risk of disease recurrence compared to standard ET alone in the adjuvant setting1 NATALEE is the first and only positive Phase III study of a CDK4/6 inhibitor demonstrating consistent benefit in a broad population of patients with stage II and III HR+/HER2- early breast cancer (EBC) at risk of recurrence, including those with no nodal involvementApproximately 30-60% of people with HR+/HER2- s

Sandoz receives US FDA approval for biosimilar Hyrimoz® (adalimumab-adaz) high-concentration formulation

Biosimilar Hyrimoz® (adalimumab-adaz) high-concentration formulation (HCF) approved for seven indications of reference medicine Humira®* With this approval, Sandoz adalimumab HCF biosimilar will offer US patients reduced injection volume in citrate-free formulationSandoz continues to expand patient access to much-needed medications, increase healthcare savings and fuel innovation through increased competition Basel, March 21, 2023 – Sandoz, a global leader in generic pharmaceuticals and biosimil

Novartis shares Zolgensma long-term data demonstrating sustained durability up to 7.5 years post-dosing; 100% achievement of all assessed milestones in children treated prior to SMA symptom onset

Children in LT-001 treated after SMA symptom onset maintained or achieved additional milestones up to 7.5 years post one-time intravenous infusionAll children (100%) in the presymptomatic intravenous cohort of LT-002 maintained or achieved all assessed motor milestones, including independent walkingTo date, more than 3,000 children with spinal muscular atrophy have been treated with Zolgensma across clinical trials, managed access programs and in the commercial setting1 Additionally, children wi

Novartis Tafinlar + Mekinist approved by FDA for pediatric patients with BRAF V600E low-grade glioma, the most common pediatric brain cancer

New approval based on TADPOLE trial showing overall response rate (ORR) of 47% and median progression-free survival (mPFS) of 20.1 months for Tafinlar + Mekinist compared to 11% ORR and 7.4 months mPFS for standard of care1,2 Approval also received for liquid formulation options for ease of administration across multiple approved indicationsTafinlar + Mekinist is now approved in six indications across multiple BRAF V600E solid tumors, including melanoma, thyroid cancer and lung cancer1,2 Basel,

Sandoz signs Memorandum of Understanding to build new biologics production plant in Slovenia, to support increasing global demand for biosimilar medicines

Sandoz investment expected to be at least USD 400m – MOU signed today in Ljubljana at ceremony led by Slovenian Prime Minister and Sandoz CEO New project underpins Sandoz ambition to drive future growth of biosimilars, addressing increasing global demand One of largest-ever international private-sector investments in Slovenia, reinforces extensive Europe-wide Sandoz production network Basel, March 9, 2023 – Sandoz, a global leader in generic and biosimilar medicines, today signed a Memorandum of

Novartis shareholders approve all resolutions proposed by the Board of Directors at the Annual General Meeting

Shareholders approve 26th consecutive dividend increase to CHF 3.20 (+3.2%) per share for 2022; representing a 4.0% yield1 and approximately 61% payout of free cash flow Shareholders confirm Joerg Reinhardt as Chair of the Board of Directors as well as all other members who stood for re-election; John D. Young newly elected to the Board of Directors Shareholders approve all other proposals of the Board of Directors, including the amendment of the Articles of Incorporation, the 2022 Compensation

Voyager Therapeutics to Receive $25 Million Payment for License of Next-Generation AAV Capsids for Multiple Neurologic Disease Targets

Options exercised on two targets; Voyager eligible to receive associated development, regulatory, and commercial milestones, plus tiered royalties With option exercise, potential to expand agreement to include capsids for up to two additional targets extends for next 18 months CAMBRIDGE, Mass., March 06, 2023 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company dedicated to breaking through barriers in gene therapy and neurology, today announced that Novartis AG

Novartis announces the appointment of the Chairman-Designate of Sandoz Board of Directors

Gilbert Ghostine, CEO of the Swiss multi-national fragrances business Firmenich appointed Chairman-Designate of the future Sandoz BoardMr Ghostine to begin role as Sandoz Chairman following the spin-off from Novartis Basel, February 20, 2022 — Novartis Board of Directors announced today the appointment of Gilbert Ghostine as Chairman-designate of the new Board of Directors of Sandoz. Mr. Ghostine has served as CEO of Geneva-based Firmenich, the world's largest privately owned perfume and taste c

Sandoz Biologics License Application for proposed biosimilar denosumab accepted by US FDA

Submission supported by comprehensive analytical and clinical data package Denosumab indicated for treating variety of conditions including osteoporosis in postmenopausal women1,2 Sandoz continues to build biosimilars portfolio to increase patient access to high-quality therapies and support healthcare system sustainability Basel, February 06, 2023 — Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced that the US Food and Drug Administration (FDA) has accept

Patients with hidradenitis suppurativa experienced sustained efficacy and symptom improvement at one year when treated with Novartis Cosentyx®

In two of the largest Phase III trials conducted in hidradenitis suppurativa (HS), Cosentyx® (secukinumab) treatment response rates continued to improve beyond the primary endpoint analysis at Week 16 to more than 55% at Week 52, as evaluated by the HS Clinical Response (HiSCR) measure1 Safety findings were consistent with the well-established safety profile of Cosentyx in its approved indications1 HS is a recurrent skin disease affecting one in 100 people worldwide, causing painful, boil-like a