Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Analysis by Size, Share, Growth, Trends up to 2025

Latest Market Research Report on “Tumor Necrosis Factor (TNF) Inhibitor Drugs Market size | Industry Segment by Applications (Rheumatoid Arthritis, Psoriasis, Psoriatic Arthritis, Crohns Disease, Ulcerative Colitis, Ankylosing Spondylitis, Juvenile Idiopathic Arthritis, Hidradenitis Suppurativa and Others), by Type (Humira, Enbrel, Remicade, Simponi/Simponi Aria, Cimzia and Biosimilars), Regional Outlook, Market Demand, Latest Trends, Tumor Necrosis Factor (TNF) Inhibitor Drugs Industry Share & Revenue by Manufacturers, Company Profiles, Growth Forecasts – 2025.” Analyzes current market size and upcoming 5 years growth of this industry.

In accordance with the Tumor Necrosis Factor (TNF) Inhibitor Drugs market report, the industry is anticipated to amass returns while accounting a profitable yearly growth rate in the predictable time period. It provides an outline of Tumor Necrosis Factor (TNF) Inhibitor Drugs industry and also offers details related to the valuation the Tumor Necrosis Factor (TNF) Inhibitor Drugs market currently holds, breakdown of the Tumor Necrosis Factor (TNF) Inhibitor Drugs market, along with the growth opportunities in the business vertical. 

Report Scope: 

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Tumor Necrosis Factor (TNF) Inhibitor Drugs market competition by top Manufacturers: 

  • AbbVie Inc.
  • Amgen Inc.
  • UCB S.A.
  • Novartis International AG
  • Johnson & Johnson Services
  • Inc.
  • Pfizer
  • Inc.
  • Merck & co.
  • Inc

Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Outlook by Applications: 

  • Rheumatoid Arthritis
  • Psoriasis
  • Psoriatic Arthritis
  • Crohns Disease
  • Ulcerative Colitis
  • Ankylosing Spondylitis
  • Juvenile Idiopathic Arthritis
  • Hidradenitis Suppurativa
  • Others

Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Statistics by Types: 

  • Humira
  • Enbrel
  • Remicade
  • Simponi/Simponi Aria
  • Cimzia
  • Biosimilars

Ideas and concepts covered in the report:

The region-based analysis of the Tumor Necrosis Factor (TNF) Inhibitor Drugs market

  • The report also speaks about the product’s use throughout the regional areas.
  • Assessment held by all the zones and the market share registered by each region is present in the report.
  • The report sums up the product consumption growth rate present across the regions along with the consumption market share.
  • The Tumor Necrosis Factor (TNF) Inhibitor Drugs market consumption rate of all regions based on applications and product types are provided in the report.

A brief of the market segmentation

  • As per the product type, the Tumor Necrosis Factor (TNF) Inhibitor Drugs market is categorized into Humira, Enbrel, Remicade, Simponi/Simponi Aria, Cimzia and Biosimilars. Moreover, the market share of every single product along with the projected valuation is mentioned in the report.
  • Facts related to the product’s sales price, growth rate over the time period, as well as revenue is present in the report.
  • Speaking of applications, the Tumor Necrosis Factor (TNF) Inhibitor Drugs market is divided into Rheumatoid Arthritis, Psoriasis, Psoriatic Arthritis, Crohns Disease, Ulcerative Colitis, Ankylosing Spondylitis, Juvenile Idiopathic Arthritis, Hidradenitis Suppurativa and Others. The market share of each product application in tandem with the revenue that every single application may register is present in the report.

Factors and challenges described in the report

  • Information about the drivers affecting the commercialization scale of the Tumor Necrosis Factor (TNF) Inhibitor Drugs market as well as their impact on the revenue graph of this vertical is present in the report.
  • Latest trends driving the Tumor Necrosis Factor (TNF) Inhibitor Drugs market along with the challenges in the industry is encompassed in the report.

Marketing strategies in the report

  • Several tactics that are implemented by the shareholders with regards to the product marketing is provided in the report.
  • As per the report, brief regarding the sales channels opted by the companies are present in the report.
  • Dealers of these products in tandem with the brief of customers for the same is mentioned in the report.

Analysis of the competitors in the industry:

  • An outline of the manufacturers presents in the Tumor Necrosis Factor (TNF) Inhibitor Drugs market comprising with the distribution limits as well as sales area is involved in the report.
  • Details of every competitor consisting of company profile as well as their range of products described is induced in the report.
  • Data related to the product sales, revenue generation, price models as well as gross margins is described in the report.

The report also speaks about several other information such as assessment of the competitive landscape, data related to the market concentration rate and concentration ratio in the upcoming years.

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Global Hidradenitis Suppurativa Treatment Market 2020 | Present Scenario and Growth Prospects 2026

Hidradenitis Suppurativa: Causes, Symptoms, Diagnosis, Stages, and ...

This research report titled Global Hidradenitis Suppurativa Treatment Market 2020 by Company, Regions, Type and Application, Forecast to 2025 was prepared to present an analysis of the current trends, a financial overview of the industry, historical data evaluation, and complete market dynamics. Both the growth and the decline of the global Hidradenitis Suppurativa Treatment market are described in the report. The research report offers market opportunities, emerging growth factors, drivers, challenges, application, innovation, openings, future guides, and market share. The historical market value of the year 2020, along with the upcoming market value of the year 2025 is determined in the market report. The report identifies threats, obstacles, risks, and uncertainties that can harm market growth.

Market Segmentation:

The product type segmentation of the global Hidradenitis Suppurativa Treatment market provides the names and definitions of the various varieties of products present in the markets. The description of the products comprises the various ex-factors, production & consumption rates and other factors about the products. The application-based segmentation gives applications of the various markets and their products at various levels. The regional segmentation is offered on the basis of the study conducted in the local and international markets.

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Moreover, the report explores Hidradenitis Suppurativa Treatment business policies, trading, market channels, market volume, providers of raw material and customer data, demand & supply ratio. Apart from that, geographic division relies on United States, Canada, Mexico, Germany, France, United Kingdom, Russia, Italy, China, Japan, Korea, India, Southeast Asia, Australia, Brazil and Saudi Arabia, etc..

For competitor segment, the report includes global key players of the market as well as some small players: , GlaxoSmithKline, Pfizer, Johnson & Johnson, AstraZeneca, Merck, Allergan, AbbVie,

On the basis of the product segment, this report covers: , Medications, Surgery, Other

On the basis of the application segment, this report covers: , Hospitals, Clinics, Other

Key Strategic Developments:

The report highlights the key strategic developments of the global Hidradenitis Suppurativa Treatment market, comprising R&D, new product launch, M&A, agreements, collaborations, partnerships, joint ventures, and regional growth of the leading competitors operating in the market on a global and regional scale. The report further evaluates key market features, including revenue, price, capacity, capacity utilization rate, gross, production, production rate, consumption, market share, CAGR, and gross margin.

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Market Coverage of This Report Includes:

  • The report provides an advance knowledge of market considering a perspective on different factors driving or restraining Hidradenitis Suppurativa Treatment market growth
  • Key product segments and their expected futures
  • The report delivers analysis of varying competition dynamics, helping every manufacturer with respect to the company profile, a generic overview, and the products
  • It helps in regional marketing type analysis, international trade type analysis, and SWOT analysis
  • The report provides an understanding of manufacturing cost structure, raw material, and suppliers, manufacturing process, industry chain structure.

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Global Hidradenitis Suppurativa Treatment Market to Record Robust Compound Annual Growth Rate During the Forecast Period 2019 – 2029 – Lake Shore Gazette

Hidradenitis suppurativa treatment also called as acne inversa, is a long term dermatological disease which occur due to swollen lumps. They are painful and break open, and release fluid or pus. The most affected areas of the body are underarms, under the breasts, and groin. Additionally, disease generally occurs due to secondary infection, obstruction of hair follicles, and inflammation of certain sweat glands which are boosting the market growth of Hidradenitis suppurativa treatment.

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Furthermore, this can also cause cellulitis which is a dermatological infection that can spread in bloodstream leading occurrence sepsis that is influencing the growth of hidradenitis suppurativa treatment market. This medical condition is most common absorbed between 20-40 years of age. Prevalence of hidradenitis suppurative is seen three times more in females than in males. Moreover, rise in population and the changes in lifestyle of individual towards smoking and obesity causing rise of dermatological diseases are some of the factors that are positively influencing the Hidradenitis suppurativa treatment market growth during the forecast period.

Major factors driving the Hidradenitis suppurativa treatment market growth are rise in clinical trials coupled with evolving treatment options, rise prevailing cases of various dermatological affected disorders, and rise investment in research and development activities. Additionally, technological advanced treatments such as laser surgeries are boosting the Hidradenitis suppurativa treatment market growth in near future. Furthermore, FDA approvals for drug delivery and clinical trials are propelling the Hidradenitis suppurativa treatment market growth. Moreover, rise in association of Hidradenitis suppurativa with inflammatory bowel disease, cardiovascular risk factors, and metabolic syndrome are also some of the factors that are influencing the Hidradenitis suppurativa treatment market growth. However, due to low approval chances of phase II drugs, high cost of therapy, chance of side effects, development of drug reagents to many agents used in treatment, delay in process of  treatment  completion which might be due to unawareness of disease to physicians are the factors hampering the Hidradenitis suppurativa treatment market growth in near future.

The global Hidradenitis suppurativa treatment market is classified on the basis of clinical stages, medications, Route of administration, end users, distribution channel and region.

Based on clinical stage, Hidradenitis suppurativa treatment market is segmented as:

  • Hurley Stage 1- low,
  • Hurley Stage 2-moderate
  • Hurley Stage 3-high

Based on treatment, Hidradenitis suppurativa treatment market is segmented as:

  • Medication
    • Biologics
    • Antibiotics
    • Hormonal therapy
    • Immune suppurativa drugs
    • Zinc supplements
    • Pain medications
  • Surgery
  • Others

Based on Route of administration, Hidradenitis suppurativa treatment market is segmented as:

Based on end users, Hidradenitis suppurativa treatment market is segmented as:

  • hospitals
  • home centers
  • others

Based on distribution channels, Hidradenitis suppurativa treatment market is segmented as:

  • hospital pharmacy
  • online pharmacy
  • retail pharmacy
  • others

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The global market for Hidradenitis suppurativa treatment is anticipated to experience a steady growth during the forecast period. Owing to the increase in prevalence of dermatological diseases associated with various other chronic diseases creates a more lucrative opportunity for manufactures present in the Hidradenitis suppurativa treatment market. Furthermore, increase in new product launches, technological advancement in treatment, clinical trials and others are propelling the market Hidradenitis suppurativa treatment growth over the years.

Hidradenitis suppurativa treatment Market: Regional Wise Outlook

Geographically, the hidradenitis suppurativa treatment market is segmented into North America, Europe, Latin America, South Asia, East Asia, Oceania, Middle East and Africa. North America is dominating the Hidradenitis suppurativa treatment market owing to rise in rise in dermatological infections, increase in clinical practices, clinically trained professionals. Asia Pacific is second largest contributor in the Hidradenitis suppurativa treatment market due to rise in inflammatory skin disease, healthcare awareness, and government support. However, Middle East and Africa are expected to experience lucrative market growth of Hidradenitis suppurativa treatment due to lack of availability skilled professionals, lack of technological penetration of healthcare treatments and others.

Some of the key players of the hidradenitis suppurativa treatment market are: Pfizer Inc., GlaxoSmithKline plc. AstraZeneca, Johnson & Johnson, AbbVie Inc.,  Merck & Co., Inc., TARGET Pharma Solutions, Inc.,  and Novartis AG.

The report on Hidradenitis suppurativa treatment market covers exhaustive analysis on:

  • Market Segments
  • Market Dynamics
  • Historical Actual Market Size, 2014 – 2018
  • Market Size & Forecast 2019 to 2029
  • Supply & Demand Value Chain
  • Market Current Trends/Issues/Challenges
  • Competition & Companies involved
  • Technology
  • Value Chain
  • Market Drivers and Restraints

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Regional analysis for Hidradenitis suppurativa treatment market includes

  • North America
  • Latin America
  • Europe
  • East Asia
  • South Asia
  • Oceania
  • Middle East & Africa

Report on Hidradenitis suppurativa treatment market highlights:

  • Shifting industry dynamics
  • In-depth market segmentation
  • Historical, current and projected industry size
  • Recent industry trends
  • Key competition landscape
  • Strategies of key players and product offerings
  • Potential and niche segments/regions exhibiting promising growth
  • A neutral perspective towards market performance

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Tumor Necrosis Factor Inhibitor Drugs Market – Short Term And Long Term Impact Of Covid-19 On The Market-2020-2025, AbbVie Inc., Amgen Inc., Johnson & Johnson Services etc.

Tumor Necrosis Factor Inhibitor Drugs Market

The COVID-19 pandemic has disrupted lives and is challenging the business landscape globally. Pre and Post COVID-19 market outlook is covered in this report. This is the most recent report, covering the current economic situation after the COVID-19 outbreak.

The report contains a thorough summary of Tumor Necrosis Factor Inhibitor Drugs market  that includes several well-known organizations, key market players who are leading in terms of sales, variable market change, revenue, end-user demands, conformity through trustworthy services, restricted elements, products and other processes. Technical advancements, surplus capacity in developing markets, market bifurcation, globalization, regulations and environmental guidelines, production and packaging are some trends that are explained in the market report.
The report also displays the regional properties of the market history of every product type, technology, and volume during the forecast period. Apart from the mentioned information, the growth rate of the Global Tumor Necrosis Factor Inhibitor Drugs Market is also explained throughout a couple of years. Moreover, the report explains the market size and year-to-year development rate of the specific product or technology.

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The Major Manufacturers Covered in this Report:
AbbVie Inc., Amgen Inc., Johnson & Johnson Services, Inc., UCB S.A., Novartis International AG, Pfizer, Inc., Merck & co., Inc., 

Product Type Coverage:
Humira
Enbrel
Remicade
Simponi/Simponi Aria
Cimzia
Biosimilars
Application Coverage:
Rheumatoid Arthritis
Psoriasis
Psoriatic Arthritis
Crohn’s Disease
Ulcerative Colitis
Ankylosing Spondylitis
Juvenile Idiopathic Arthritis
Hidradenitis Suppurativa
Others

Regional Segmentation:

  • North America (United States, Canada, and Mexico)
  • Europe (UK, Germany, France, Russia, and Italy)
  • Asia-Pacific (China, Korea, Japan, India, and Southeast Asia)
  • South America (Brazil, Colombia, Argentina, etc.)
  • The Middle East and Africa (Saudi Arabia, UAE, Nigeria, Egypt, and South Africa)
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    Important Features of the report:

    • Detailed analysis of the Tumor Necrosis Factor Inhibitor Drugs market
    • Fluctuating market dynamics of the industry
    • Detailed market segmentation
    • Historical, current and projected market size in terms of volume and value
    • Recent industry trends and developments
    • Competitive landscape of the market
    • Strategies of key players and product offerings
    • Potential and niche segments/regions exhibiting promising growth
    • A neutral perspective towards market performance

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    To conclude, the Tumor Necrosis Factor Inhibitor Drugs Industry report mentions the key geographies, market landscapes alongside the product price, revenue, volume, production, supply, demand, market growth rate, and forecast, etc. This report also provides SWOT analysis, investment feasibility analysis, and investment return analysis.

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    InflaRx Reports Full Year 2019 Financial & Operating Results

    • End of Phase 2 FDA meeting scheduled to discuss the path forward for IFX-1 in Hidradenitis Suppurativa
    • Initial promising results reported in Pyoderma Gangraenosum
    • Part 1 of adaptive randomized trial in severe COVID-19 pneumonia fully enrolled
    • Executed clinical collaboration agreement in oncology with Merck & Co, Inc., Kenilworth, NJ, USA (known as MSD outside the US and Canada)
    • Senior executives hired for key positions
    • Cash, cash equivalents and financial assets were €115.8 million as of December 31, 2019

    JENA, Germany, April 29, 2020 (GLOBE NEWSWIRE) — InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today financial results for the year ending December 31, 2019.

    “The Company underwent significant changes in 2019 and has selected a compelling set of high unmet medical need indications for its lead drug candidate IFX-1,” said Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx. “The Company has also provided new evidence supporting the activity of IFX-1 in neutrophil-driven skin diseases, which continue to be a clear focus. With our current cash position and future value inflection points, we believe InflaRx is well positioned to weather the current global environment.”

    Prof. Riedemann continued, “With the recently initiated trial in severe progressed COVID-19 pneumonia, our Company is making a strong contribution to help identify potential treatment options for patients during this global pandemic, which is based on several years of in-house research on the role of C5a-driven lung injury and viral pneumonia.” 

    Corporate and R&D highlights – 2019 through early 2020

    Corporate

    • Entered into a clinical collaboration agreement with Merck & Co, Inc., Kenilworth, NJ, USA (known as MSD outside the US and Canada) to evaluate the combination of IFX-1 and Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with an undisclosed tumor type. Under the terms of the agreement, InflaRx will conduct a Phase IIa clinical study with two IFX-1 arms, including one with KEYTRUDA®. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., Whitehouse Station, New Jersey, U.S.A, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
    • Hired senior executives for key positions – Jordan Zwick (formerly of Bausch Health) as Global Head of Business Development and Corporate Strategy and Dr. Korinna Pilz as Global Head of Clinical Research and Development (>20 years of clinical development experience in different pharmaceutical companies, including Roche, Bayer, Boehringer Ingelheim and others).
    • Expanding research and development activities supported by growth in number of employees to 45 as of December 31, 2019 (up from 38 in 2018).

    Lead product candidate, IFX-1, first-in-class anti-human complement factor C5a antibody

    Hidradenitis Suppurativa (HS)

    • On June 5, 2019, the Company announced top-line results of the international SHINE Phase IIb study, investigating the safety and efficacy of IFX-1 in patients suffering from moderate to severe Hidradenitis Suppurativa (HS). The randomized, double-blind, placebo-controlled, multicenter study enrolled a total of 179 patients in four active dose arms and a placebo arm at over 40 sites in 9 countries in North America and Europe. The primary endpoint of the trial was not met, which was a dose response signal, assessed by HiSCR1 at week 16. The primary statistical analysis by multiple-comparison procedure modelling (MCP-mod) showed no significant dose response, but the IFX-1 treatment was well tolerated.
    • On July 18, 2019 the Company published a post-hoc analysis demonstrating additional signals of efficacy for the IFX-1 high dose group compared to the placebo group within the initial phase of the SHINE study, including reductions in all combined inflammatory lesions, on draining fistula and on the International Hidradenitis Suppurativa Severity Score 4 (IHS4), which scores all inflammatory lesions.  IHS4 was developed by an international expert group to score severity and track treatment response, although the score has not been utilized as a primary endpoint in late stage clinical studies in HS. The IHS4 weighs the most fluctuating lesions: inflammatory nodules (1 point), less than abscesses (2 points) or draining fistulas (4 points).
    • On November 6, 2019, the Company reported positive results from the open label extension (OLE) part of the international SHINE Phase IIb study. The data were from a snapshot analysis at the end of the overall 9-month study treatment period (week 40). A total of 156 patients entered the 6-month OLE period upon completion of the 16-week initial phase of the SHINE study. Overall, patients completing the OLE period showed a sustained improvement in inflammatory lesion count at week 40 compared to baseline counts of the OLE treatment group on day 1 of the SHINE study.
    • In Q1 2020, the Company requested an FDA End of Phase II meeting to discuss the path forward for a pivotal program with IFX-1 in HS. The meeting has been scheduled for mid-year.

    ANCA-associated vasculitis (AAV)

    • Since October 2018, 19 patients have been recruited in the randomized, triple-blind, placebo-controlled US Phase II IXPLORE study with IFX-1 in patients with AAV. The main objective of the study is to evaluate the efficacy and safety of two dose regimens of IFX-1 in patients with moderate to severe AAV when dosed on top of standard of care, which includes treatment with high dose glucocorticoids. The trial originally planned to enroll approximately 36 patients at centers in the US. Based on a blinded interim analysis and assessment of the potential impact of the COVID-19 pandemic, the Company has decided to stop the study and read out the existing results earlier than initially planned as part of a strategy to align and streamline the US and EU AAV development program.
    • In May 2019, the Company initiated a randomized, double-blind, placebo-controlled European Phase II IXCHANGE study with IFX-1 in patients with AAV. The main objective of the study is to evaluate the efficacy and safety of IFX-1 in patients with moderate to severe AAV. The primary endpoint of the study is a 50% reduction in Birmingham Vasculitis Activity Score (BVAS) at week 16. The study was originally planned to enroll approximately 80 patients at about 60 sites in up to 12 European countries and Russia. The study is being conducted in two parts. In Part 1, patients are being randomized to receive either IFX-1 plus a reduced dose of glucocorticoids or placebo plus a standard dose of glucocorticoids. Patients in both arms receive the standard of care dosing of immunosuppressive therapy (rituximab or cyclophosphamide). In Part 2 of the study, patients will be randomized to receive either IFX-1 plus placebo glucocorticoids or placebo plus a standard dose of glucocorticoids (both on top of standard of care immunosuppressive therapy with rituximab or cyclophosphamide). The first part of the study has been fully enrolled. After analyzing the impact of COVID-19 on the study, a blinded interim analysis of Part 1 has been completed. Based on the analysis, the Company intends to continue with Part 2 of the study but decrease the number of enrolled patients.

    Pyoderma Gangraenosum (PG)

    • In February 2019, the Company received approval from Health Canada to initiate an open label Phase IIa exploratory study with a plan to enroll 18 patients with moderate to severe PG. The objectives of this study are to evaluate the safety and efficacy of IFX-1 in this patient population.
    • In February 2020, the Company announced positive initial data from the first 5 patients dosed in this Phase IIa open label study. Of these 5 initial patients dosed with IFX-1, 2 patients achieved complete closure of the target ulcer and complete healing of all other PG ulcers. The drug was well tolerated and no drug-related severe adverse events (SAEs) have been recorded to date in the study. The study continues to enroll patients with the addition of two higher dose cohorts.

    COVID-19 Pneumonia

    • In March 2020, the Company initiated a Phase II clinical development program with IFX-1 in COVID-19 patients with severely progressed pneumonia and enrolled the first patient at the Amsterdam University Medical Centers in the Netherlands. Additional centers have since been opened in the Netherlands. In the study, patients are being randomized to two treatment arms – either Arm A, best supportive care and IFX-1, or Arm B, best supportive care alone. The primary endpoint is the relative percentage change from baseline to day 5 in the Oxygenation Index (PaO2 / FiO2). After all patients have been treated in the first part of the trial, an interim analysis will be performed to assess the clinical benefit of the treatment using the assessed clinical parameters in order to potentially adapt the confirmatory second part of the study.  Part 1 is fully enrolled with 30 patients as of April 24, 2020.

    2019 financial highlights

    Research and development expenses increased by €19.6 million to €44.6 million in 2019, from €25.0 million in 2018. This increase was primarily attributable to a €20.9 million increase in clinical research and manufacturing organizations (CRO and CMO) costs related to IFX-1 in connection with the Phase IIb clinical trial in patients with HS, the Phase II clinical program in patients with AAV, the Phase II clinical program in patients with PG, the preparation of a Phase II clinical program in oncology as well as with the ongoing manufacturing activities for clinical trial-related material. In addition, there was a €1.8 million decrease in employee-related costs mainly due to a €2.6 million anticipated decrease in expenses related to non-cash share-based compensation.

    General and administrative expenses decreased by €0.3 million to €12.5 million in 2019, from €12.8 million in 2018. This decrease was primarily attributable to a €1.6 million decrease in employee-related costs associated with a €2.6 million anticipated decrease in non-cash share-based compensation, partially offset by €1.0 million higher personnel expense due to new hires. Legal, consulting and audit fees and other expenses increased by €0.2 million to €2.2 million in 2019, from €2.0 million in 2018, the increase being mainly attributable to higher consulting costs. The increase in other expenses of €1.1 million is primarily related to higher D&O insurance costs, IT and office expenses.

    Net financial result decreased by €4.2 million to €3.5 million in 2019, from €7.7 million in 2018. This change was mainly attributable to lower foreign exchange gains, which decreased by €4.8 million, partially offset by interest on marketable securities, which increased by €0.6 million.

    Net loss for the year 2019 was €53.3 million or €2.05 per common share, compared to €29.8 million or €1.19 per common share for the year 2018. On December 31, 2019, the Company’s total funds available were €115.8 million, mostly composed of cash and cash equivalents (€33.1 million) and marketable securities (€81.9 million).

    Net cash used in operating activities increased to €43.2 million in 2019, from €21.5 million in 2018, mainly due to the increase in research and development expenditures and higher personnel costs, excluding stock-based compensation.

    Additional information regarding these results is included in the notes to the consolidated financial statements as of December 31, 2019 and “ITEM 18. Financial statements,” which will be included in InflaRx’s Annual Report on Form 20-F as filed with the U.S. Securities and Exchange Commission on April 29, 2020.

     

    InflaRx N.V. and subsidiary
    Consolidated Statements of Comprehensive Loss for the Years Ended December 31, 2019, 2018 and 2017
























    in € 2019   2018   2017
           
    Operating Expenses      
    Research and development expenses (44,582,136 )   (25,028,554 )   (14,414,628 )
    General and administrative expenses (12,501,048 )   (12,786,869 )   (5,138,498 )
    Total Operating Expenses (57,083,184 )   (37,815,422 )   (19,553,126 )
    Other income 400,253     303,860     115,525  
    Other expenses (85,242 )   (4,802 )   (7,644 )
    Operating Result (56,768,173 )   (37,516,364 )   (19,445,245 )
    Finance income 6,220,320     10,432,695     130,032  
    Finance expenses (2,706,964 )   (2,730,964 )   (4,922,535 )
    Net Financial Result 3,513,355     7,701,731     (4,792,503 )
    Loss for the Period (53,254,817 )   (29,814,634 )   (24,237,748 )
           
    Share Information      
    Weighted average number of shares outstanding 26,004,519     25,095,027     9,410,524  
    Loss per share in euro (basic/diluted) (2.05 )   (1.19 )   (2.58 )
                     
    Loss for the Period (53,254,817 )   (29,814,634 )   (24,237,748 )
    Other comprehensive income that may be re­clas­si­fied to profit or loss in subsequent periods:      
    Exchange differences on translation of operations in foreign currency 2,177,033     50,196      
    Total Comprehensive Loss (51,077,785 )   (29,764,438 )   (24,237,748 )
     

     

    InflaRx N.V. and subsidiary
    Consolidated Statements of Financial Position as of December 31, 2019 and 2018







































    in € 2019   2018
         
    ASSETS    
    Non-current assets    
    Property, plant and equipment 1,413,297     624,668  
    Intangible assets 452,400     222,866  
    Non-current other non-financial assets 452,217      
    Non-current financial assets 272,614     207,444  
    Total non-current assets 2,590,528     1,054,979  
    Current assets    
    Current other non-financial assets 3,500,884     1,588,702  
    Current financial assets 82,353,867     101,184,240  
    Cash and cash equivalents 33,131,280     55,386,240  
    Total current assets 118,986,031     158,159,183  
    TOTAL ASSETS 121,576,558     159,214,161  
         
    EQUITY AND LIABILITIES    
    Equity    
    Issued capital 3,132,631     3,115,725  
    Share premium 211,006,606     211,021,835  
    Other capital reserves 25,142,213     18,310,003  
    Accumulated deficit (134,362,006 )   (81,107,188 )
    Other components of equity 2,227,228     50,196  
    Total equity 107,146,673     151,390,571  
    Non-current liabilities    
    Lease liabilities 330,745      
    Provisions and Government grants 39,013     67,945  
    Total non-current liabilities 369,758     67,945  
    Current liabilities    
    Lease liabilities 515,203      
    Employee Benefits 975,629     789,800  
    Social securities, other tax and non-financial liabilities 105,634     308,533  
    Trade and other payables 12,413,662     6,657,312  
    Provisions 50,000      —  
    Total current liabilities 14,060,128     7,755,645  
    Total Liabilities 14,429,886     7,823,590  
    TOTAL EQUITY AND LIABILITIES 121,576,558     159,214,161  
     

     

    InflaRx N.V. and subsidiary
    Consolidated Statements of Changes in Shareholders’ Equity for the Years Ended December 31, 2019, 2018 and 2017









































    in € Issued capital   Share  premium   Other  capital  re­serves   Ac­cu­mulated deficit   Other  compo­nents of equity   Total  equity
                                   
    Balance at January 1, 2017 31,428       1,325,006   (27,054,806 )   8,839     (25,689,533 )
    Loss for the Period         (24,237,748 )       (24,237,748 )
    Exchange differences on translation of operations in foreign currency                  
    Total Comprehensive Loss         (24,237,748 )       (24,237,748 )
    Transactions with owners of the Company              
    Contributions              
    Issue of common shares 848,175   90,055,312               90,903,488  
    Transaction costs   (9,114,770 )             (9,114,770 )
    Equity-settled share-based payment       4,550,105           4,550,105  
    Total Contributions 848,175   80,940,542     4,550,105           86,338,823  
    Changes in ownership interests              
    Reorganization 1,977,849   80,698,025     350,242           83,026,115  
    Liquidation of a Subsidiary             (8,839 )   (8,839 )
    Total changes in ownership interests 1,977,849   80,698,025     350,242       (8,839 )   83,017,276  
    Total transactions with owners of the Company 2,826,024   161,638,566     4,900,347       (8,839 )   169,356,099  
    Balance at December 31, 2017 2,857,452   161,638,566     6,225,353   (51,292,555 )       119,428,816  
    Loss for the period         (29,814,634 )       (29,814,634 )
    Exchange differences on translation of operations in foreign currency             50,196     50,196  
    Total comprehensive loss         (29,814,634 )   50,196     (29,764,438 )
    Transactions with owners of the Company              
    Contributions              
    Issue of common shares 222,000   52,768,733               52,990,733  
    Transaction costs   (3,801,265 )             (3,801,265 )
    Equity-settled share-based pay­ment       12,084,651           12,084,651  
    Share options exercised 36,273   415,801               452,074  
    Total Contributions 258,273   49,383,269     12,084,651           61,726,193  
    Total transactions with own­ers of the Company 258,273   49,383,269     12,084,651           61,726,193  
    Balance at December 31, 2018 3,115,725   211,021,835     18,310,003   (81,107,188 )   50,196     151,390,571  
    Loss for the period         (53,254,817 )       (53,254,817 )
    Exchange differences on translation of operations in foreign currency             2,177,033     2,177,033  
    Total comprehensive loss         (53,254,817 )   2,177,033     (51,077,784 )
    Transactions with owners of the Company              
    Contributions              
    Equity-settled share-based pay­ment       6,832,210           6,832,210  
    Share options exercised 16,905   (15,229 )             1,676  
    Total Contributions 16,905   (15,229 )   6,832,210           6,833,886  
    Total transactions with own­ers of the Company 16,905   (15,229 )   6,832,210    —      —     6,833,886  
    Balance at December 31, 2019 3,132,631   211,006,606     25,142,213   (134,362,006 )   2,227,228     107,146,673  

     

    InflaRx N.V. and subsidiary
    Consolidated Statements of Cash Flows for the Years ended December 31, 2019, 2018 and 2017






































    in € 2019   2018   2017
           
    Operating activities      
    Loss for the period (53,254,817 )   (29,814,634 )   (24,237,748 )
    Adjustments for:      
    Depreciation & Amortization 663,166     173,630     70,910  
    Net Financial Result (3,513,355 )   (7,701,731 )   4,792,503  
    Share based payment expense 6,832,210     12,084,651     4,550,105  
    Other non-cash adjustments (307,849 )   196,699     24,076  
    Changes in:      
    Other non-financial assets (2,364,399 )   (893,602 )   (522,818 )
    Current financial assets     (316,112 )   89,599  
    Employee benefits 235,500     494,837     132,305  
    Social securities, other tax and non-financial liabilities (209,948 )   304,627     (30,024 )
    Trade and other payables 5,734,795     2,243,137     2,912,740  
    Interest received 3,001,109     1,679,250     66,391  
    Interest paid (20,903 )        
    Net cash flows from operating activities (43,204,492 )   (21,549,248 )   (12,151,962 )
    Investing activities      
    Cash outflow from the purchase of intangible assets, laboratory and office equipment (594,889 )   (806,531 )   (148,542 )
    Cash outflow for the investment in non-current other financial assets (75,543 )   (209,705 )   (18,481 )
    Proceeds from the disposal of non-current other financial assets     21,811      
    Proceeds from the disposal of current financial assets or repayment of maturing securities 103,559,395     7,990,204      
    Purchase of current & non-current financial assets (82,547,409 )   (106,445,120 )    
    Net cash flows from investing activities 20,341,554     (99,451,341 )   (167,023 )
    Financing activities      
    Proceeds from issuance of share capital     52,990,733     90,903,488  
    Transaction cost from issuance of share capital     (3,801,265 )   (9,114,770 )
    Proceeds from exercise of share options 1,676     452,075      
    Proceeds from issuance of preferred shares         27,012,050  
    Repayment of leasing debt (296,020 )        
    Net cash flows from financing activities (294,344 )   49,641,542     108,800,767  
    Effect of exchange rate changes 902,321     3,461,399     (2,316,631 )
    Net change in cash and cash equivalents (22,254,960 )   (71,357,047 )   94,165,152  
    Cash and cash equivalents at beginning of period 55,386,240     123,281,888     29,116,737  
    Cash and cash equivalents at end of period 33,131,280     55,386,240     123,281,888  
           

     

    About IFX-1:

    IFX-1 is a first-in-class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Thus, IFX-1 leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism, which is not the case for molecules blocking the cleavage of C5. IFX-1 has been demonstrated to control the inflammatory response driven tissue and organ damage by specifically blocking C5a as a key “amplifier” of this response in pre-clinical studies. IFX-1 is believed to be the first monoclonal anti-C5a antibody introduced into clinical development. Approximately 300 people have been treated with IFX-1 in clinical trials, and the antibody has been shown to be well tolerated. IFX-1 is currently being developed for various indications, including Hidradenitis Suppurativa, ANCA-associated vasculitis, Pyoderma Gangraenosum and COVID-19 pneumonia.

    About InflaRx N.V.:

    InflaRx (Nasdaq: IFRX) is a clinical-stage biopharmaceutical company focused on applying its proprietary anti-C5a technology to discover and develop first-in-class, potent and specific inhibitors of C5a. Complement C5a is a powerful inflammatory mediator involved in the progression of a wide variety of autoimmune and other inflammatory diseases. InflaRx was founded in 2007, and the group has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA. For further information please visit www.inflarx.com.

    Contacts:

    InflaRx N.V.

    Jordan Zwick – Global Head of Business Development & Corporate Strategy

    Email: jordan.zwick[at]inflarx.de

    Tel: +1 917-338-6523

    MC Services AG

    Katja Arnold, Laurie Doyle, Andreas Jungfer

    Email: inflarx[at]mc-services.eu

    Europe: +49 89-210 2280

    US: +1 339-832-0752

    FORWARD-LOOKING STATEMENTS

    This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue” and similar expressions. Forward-looking statements appear in a number of places throughout this release and may include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, our ongoing and planned preclinical development and clinical trials, the impact of the COVID-19 pandemic on the Company, the timing and our ability to commence and conduct clinical trials, potential results from current or potential future collaborations, our ability to make regulatory filings, obtain positive guidance from regulators, and obtain and maintain regulatory approvals for our product candidates, our intellectual property position, our ability to develop commercial functions, expectations regarding clinical trial data, our results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which we operate, the trends that may affect the industry or us and the risks, uncertainties and other factors described under the heading “Risk Factors” in InflaRx’s periodic filings with the U.S. Securities and Exchange Commission. These statements speak only as of the date of this press release and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.

    1 HiSCR response defined as: At least a 50% reduction in total AN count (abscesses & inflammatory nodules) with no increase in the number of abscesses from baseline and no increase in the number of draining fistulas from baseline

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    Hidradenitis Suppurativa Treatment Market (COVID-19 Updated) 2020-2026 By Key Players Like Merck, Pfizer, AbbVie, Allergan, AstraZeneca

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    Novartis : Q1 2020 Results Presentation







    04/28/2020 | 04:18am EDT

    Novartis AG

    Investor Relations

    Q1 2020 Results

    Investor Presentation

    April 28, 2020

    Disclaimer

    This presentation 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 “potential,” “expected,” “will,” “planned,” “pipeline,” “outlook,” 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 f uture revenues from any such products; or regarding potential manufacturing or supply chain disruptions; or regarding our estimates of the impact of past and f uture COVID-19 related forward purchasing on sales and on core operating income in the future; or regarding the impact of the COVID-19 pandemic on clinical trials, and research and development timelines; or regarding potential future or pending transactions; or regarding potential future sales or earnings of the Group or any of its divisions or potential shareholder returns; or by discussions of strategy, plans, expectations or intentions; or regarding the Group’s liquidity or cash flow positions and its ability to meet its ongoing financial obligations and operational needs; or regarding drug discovery collaboration efforts and support of clinical trials for existing Novartis medicines and a commitment to donate up to 130 million doses of generic hydroxychloroquine to support the global COVID-19 pandemic response. 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: disruptions of our manufacturing or supply chain impacting our ability to meet demand for our products in the f uture; liquidity or cash flow disruptions affecting our ability to meet our ongoing financial obligations and to support our ongoing business activities; uncertainties regarding the impact of past and future COVID-19 related forward purchasing on sales and core operating income in the future; the impact of the COVID-19 pandemic on enrollment in, initiation and completion of our clinical trials in the future, and research and development timelines; 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 potential significant breaches of data security or data privacy, or disruptions of our information technology systems; regulatory actions or delays or government regulation generally, including potential regulatory actions or delays with respect to the development of the products described in this presentation; the potential that the strategic benefits, synergies or opportunities expected from the acquisition of the Japanese business of Aspen Global Incorporated, and other transactions described, may not be realized or may be more difficult or take longer to realize than expected; potential adverse reactions to the transaction by customers, suppliers or strategic partners; dependence on key personnel of Aspen Global Incorporated; dependence on third parties to fulfill manufacturing and supply obligations; the uncertainties involved in predicting shareholder returns; the uncertainties in the research and development of new healthcare products, including clinical trial results and additional analysis of existing clinical data; 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 that commenced in prior years and is expected to continue this year; safety, quality, data integrity, or manufacturing issues; uncertainties involved in the development or adoption of potentially transformational technologies and business models; uncertainties regarding actual or potential legal proceedings, including, among others, product liability litigation, disputes and litigation with business partners or business collaborators, government investigations generally, litigation and investigations regarding sales and marketing practices, and intellectual property disputes; our performance on environmental, social and governance measures; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; 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 presentation 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.

    Enbrel®is a registered trademark of Amgen, I nc. Humira®and Skyrizi®are registered trademarks of Abbvie Inc. Siliq®is a registered trademark Valeant Pharmaceuticals International, I nc. Stelara®, Tremfya®and Simponi®are registered trademarks of Janssen Biotech, Inc. Taltz®is a registered trademark of Eli Lilly and Company. Cimzia®is a registered trademark of UCB Group of Companies.

    2 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Participants

    Vas Narasimhan

    John Tsai

    Chief Executive Officer

    Head of Global Drug Development and CMO

    Harry Kirsch

    Richard Saynor

    Chief Financial Officer

    CEO, Sandoz

    Marie-France Tschudin

    Shannon Thyme Klinger

    President, Novartis Pharmaceuticals

    Group General Counsel

    Susanne Schaffert

    President, Novartis Oncology

    3 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    4 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Maintaining strong operational performance while supporting the global response to COVID-19

    Strong operational performance

    Pipeline delivering

    Robust pandemic response

    Positive CHMP opinion;

    Continuing operations

    1

    +34%

    Japan approval

    Stable manufacturing & supply

    % cc vs. PY

    100% sites operational

    Positive CHMP opinion in nr-axSpA

    Key regulatory submissions on track

    Ofatumumab

    Filing accepted in US, EU

    >9,100 remote monitoring visits

    +13%

    New ways of working

    Inclisiran

    Filing accepted in US, EU

    22%

    400+ disease education online sessions in China

    HFpEF submitted in US

    9%

    External collaborations

    Approval in EU, JP, others3

    Therapeutics Accelerator, ACTIV partnership

    Sales

    Core OpInc

    Clinical investigation

    Capmatinib

    Priority Review

    Estimate2:

    3 sponsored trials, 32 IIT proposals supported

    COVID-19 related forward purchases

    TQJ230

    Fast Track designation

    COVID-19 response funds and donations

    Excluding COVID-19 related forward purchases

    USD 40m fund, 130m doses hydroxychloroquine

    1. Refers to continuing operations as defined on page 33 of the Condensed Interim Financial Report, excludes Alcon, includes the businesses of Innovative Medicines and Sandoz, as well as the continuing corporate functions.

    2. We provide these management estimates based on the best data available to Novartis, as we believe this information is helpful to our investors to better understand Q1 underlying business performance 3. Switzerland, Canada, Australia

    5 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    COVID-19 response

    Relentless commitment to our associates, patients, HCPs and society while helping to ensure business continuity

    Associates

    Patients

    HCPs

    Society

    Focusing on

    Helping ensure

    Embracing new

    Playing a pivotal

    employees’

    safety and

    ways of working

    role in the global

    health and safety

    uninterrupted supply

    response

    Business continuity

    Clinical trials

    Manufacturing and supply chain

    Medical and commercial activities

    6 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Business continuity – manufacturing and supply chain

    Mitigating actions in place to facilitate supply chain integrity and safeguard our people and patients

    Suppliers

    Own Operations

    Customers

    All major suppliers operational,

    All internal sites operational,

    Strong supply reliability performance,

    no impact foreseen

    stable supply outlook

    all launch brands on track

    Mitigating actions

    Transparency across the value chain

    • Close collaboration with suppliers
    • End-to-endsupply chain tracking
    • Assessment of critical materials and alternative sources

    Assess and adjust inventory

    • Assessment of inventory levels/policies
    • Stock replenishments

    Adapt how we operate

    • Supporting employee health and safety
    • Scenario planning and optimize capacity
    • Close collaboration with local HAs

    Identify and secure logistics capacity

    • Change mode of transport,re-route,pre-book, leverage freight capacity jointly

    Assess realistic customer demand

    • Market insights to estimate demand
    • Respond to shortage/buying behavior

    Strong financial condition, cash collections or liquidity

    <2%

    >6months

    >99.5%

    Sales supported by APIs single-sourced

    Inventory for key brands

    Customer Service Level

    from China and India

    across Innovative Medicines YTD

    7 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Business continuity – clinical trials

    Regulatory submissions for 2020 remain on track while COVID-19 impacts on clinical trials are manageable

    Key regulatory submissions on track

    Inclisiran (KJX839)

    Hyperlipidemia (EU)

    Entresto®

    HFpEF (US)

    AVXS-101 IT

    SMA

    Alpelisib (BYL719)

    PROS

    177Lu-PSMA-617

    mCRPC

    Spartalizumab (PDR001) combo

    Metastatic melanoma

    Clinical trial strategy

    Continuous trial-by-trial assessment of safety & data integrity

    300+ trials1| 96,000 patients

    Planning(25% of clinical trials1) Continue study start-up planning activities

    Recruitment (22%)

    Paused in affected areas, while pivoting to and fully leveraging recovering areas

    Maintenance (37%)

    Continue with current mitigations

    Close out (16%)

    Continue database lock and clinical study report submissions

    Slowdowns in new enrollments of ongoing studies and start-up of new studies

    Mitigation to minimize impact

    Enabled by real-time digital technologies

    Direct-to-patient medication delivery Home nursing services

    Remote medical monitoring Virtual safety assessments

    >9,100 remote monitoring visits2+2,500 users on SENSE platform <24h time to detect, evaluate, respond to site-level actions

    1. GDD trials only 2. As of April 24, 2020

    8 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Associates

    Broad array of initiatives implemented to support our associates throughout the crisis

    Job safety

    Employee wellbeing

    Ways of working & reward

    No job losses related to COVID-19

    12 calendar days paid leave

    Paused ongoing restructurings

    Childcare assistance

    Give back to society

    Virtual volunteering

    GlobalGiving via SPARK

    Wellbeing initiatives

    TIGNUM X App

    Virtual coaching sessions

    Online learning

    Coursera for family / friends

    Khan Academy

    Digital tools for Field Force

    Adapted sales incentive schemes

    Increased protective measures

    Recognition payment

    9 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    HCPs and patients

    Quickly embraced new ways of working with HCPs and patients

    Patients

    Prioritized patient-oriented

    HCPs

    Scaled up multi-channel

    digital solutions

    engagement

    Access to online drug refill

    China: partnered with top 3 e-pharmacies

    Online disease education live broadcasting

    China: ~12m people, 400+ sessions

    Access to direct-to-patient services US: Patient platform Phreesia processing ~60m patient intakes annually

    Supporting patient organizations

    Web meetings

    China: 900k HCPs in 31k web meetings1

    South Korea: 20x participants increase in webinars

    Rep-triggered WeChat and email

    China: engaged ~64k HCPs1

    Free licenses for remote detailing Veeva Engage licenses

    HCP portal

    Partnerships with P2P HCP and in-workflow platforms

    US: Doximity with >1m HCPs

    1. From February 1 to April 17

    10 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Society

    Playing an important role in addressing COVID-19 pandemic to make a material difference

    COVID-19 response funds and donations

    USD 40mCOVID-19 Response Funds

    Hydroxychloroquine: commitment

    to donate 130m dosesthrough May, reaching over 60 countries, 50m doses shipped to date to 25countries.

    External collaborations

    Co-chairedCOVID-19

    Therapeutics Accelerator under

    coordination of Bill & Melinda GatesFoundation

    Member ofCOVID-19 direct

    partnershiporganized by Innovative Medicines Initiative

    Member ofACTIV¹ partnership

    planned by NIH²

    Member ofR&D Leaders

    Consortium

    Internal discovery

    Launched drug discovery efforts including collaborationwith University of California, Berkeley

    Screening selected chemical librariesinternally for potential antiviral activity

    Identified partners to contribute our unique biomarker capabilities and

    expertise

    Clinical investigations

    Novartis-sponsored studies

    Investigator-Initiated Trials (IIT) proposals supported

    Approved Managed Access requests and institution /government requests

    1. Accelerating COVID-19 Therapeutic Interventions and Vaccines. 2. NIH: National Institutes of Health

    11 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Society – clinical investigations

    Supporting clinical investigations for promising drugs both company-led and investigator-initiated

    Novartis-sponsored

    32 IIT proposals supported

    Phase 3 studies

    including:

    Canakinumab

    Secukinumab

    (Cytokine storm)

    (Cytokine storm)

    Ruxolitinib¹

    Imatinib

    (Cytokine storm)

    (SARS-CoV replication)

    Hydroxychloroquine

    Valsartan

    (Anti-viral and immunomodulator)

    (ACE2 expression)

    Omalizumab

    (Antiviral effect)

    Access initiatives

    IP initiative to support broad hydroxychloroquine access if approved for COVID-19 (e.g. non-exclusive voluntary licenses)

    Individual MAP requests approved in ~4 hours

    697 individual MAP requests and

    23 institution / government requests approved2

    As of April 24, 2020 1. In collaboration with Incyte 2. Canakinumab, ruxolitinib, tesidolumab/LFG316

    12 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Monitoring potential impact of the pandemic

    Patient / physician

    Payor / healthcare

    Clinical trial /

    dynamics

    system dynamics

    regulatory dynamics

    13 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Strong operational performance from growth drivers

    Key growth driver sales Q1 2020

    Sales

    Growth vs. PY

    Growth vs. PY

    USD Million

    USD Million

    cc

    Key growth drivers and launches, as % of Innovative Medicines sales

    569

    212

    62%

    170

    170

    nm

    930

    139

    19%

    403

    96

    33%

    90

    90

    nm

    74

    74

    nm

    161

    70

    82%

    366

    69

    26%

    68

    68

    nm

    213

    62

    44%

    318

    60

    27%

    93

    48

    109%

    nm – not meaningful

    46%

    36%

    29%

    23%

    Q1 2017

    Q1 2018

    Q1 2019

    Q1 2020

    1. Includes Tasigna®, Xolair®, Aimovig®and Luxturna®

    Adakveo®

    Mayzent®

    Beovu®

    Piqray®

    Xiidra®

    Kymriah®

    Lutathera®

    Kisqali®

    Zolgensma®

    Ilaris®

    Jakavi®

    Tafinlar+Mekinist®

    Promacta®

    Entresto®

    Cosentyx®

    Other1

    14 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Sandoz: Strong underlying momentum in Q1, further benefiting from COVID-19 related forward purchasing

    Biopharmaceutical sales

    USD million

    +31% cc

    450

    335351

    Q1’18 Q1’19 Q1’20

    Performance

    • Sales of USD 2.5bn +11% cc (includingCOVID-19 related forward purchasing), driven by biosimilars which continue to grow strongly
    • Europe sales USD 1.4bn +19% cc
    • Strong underlying operational results
    • COVID-19supports Q1 retail growth
    • Successful ongoing Sandoz and NTO transformation with core gross margin improvement and functional cost decline

    US divestment to Aurobindo

    • Mutual agreement to terminate
    • Opportunity to optimize US business

    15 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Zolgensma®: US growth momentum continues; robust IV data presented, CHMP positive opinion

    Q1 highlights

    USD 170m

    Continued broad access & patient

    demand drove Q1 sales

    Intravenous data showed significant,

    clinically meaningful benefit including

    prolonged event-free survival, motor

    milestone achievement and durability

    up to 5 years post-dosing

    FDA completed review of its August

    2019 Form 483 response with no

    further enforcement action

    Regulatory milestones

    CHMP positive opinion (March)

    EC decision confirming approval expected by June 2020

    Japan approval (March)

    Reimbursement expected by the end of

    H1 2020, pending agreement

    OthersDecisions anticipated late 2020 or early 2021 in Switzerland, Canada, Australia, Argentina, South Korea, Brazil

    16 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    AVXS-101 IT: Compelling clinical profile; regulatory engagement ongoing

    STRONG data demonstrates compelling profile

    Strong efficacy

    Robust response

    Replaces chronic administration

    Safety profile

    With a mean 6-point increase in Hammersmith1, twice the clinically meaningful threshold

    With nearly all (92%) achieving a clinically meaningful response

    With a single, one-time dose

    Consistent with IV AVXS-101 program

    Additional pre-clinical data requested by FDA to lift IT clinical hold expected to be generated in studies planned / initiated

    Plan to engage with FDA Q2 to clarify scope of data required

    Plan to approach FDA for pre-BLA meeting based on STRONG data, which confirm the positive benefit/risk of IT formulation

    BLA submission timing: dependent on FDA feedback, could range from H2 2020 to 2021

    1. Efficacy data reflective of patients between 2-5 years of age who received Dose B

    17 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    On track for 2020 catalysts

    Maintaining long-term momentum

    Potential catalysts

    Major approvals1

    Major submissions3

    Major readouts5(Phase 3)

    Phase 3 starts

    Selected examples

    Ofatumumab (OMB157)

    Capmatinib (INC280)7

    Inclisiran (KJX839)

    Relapsing MS

    NSCLC

    Hyperlipidemia (US)

    QVM / QMF 149

    Cosentyx®2

    Asthma

    nr-AxSpA

    Inclisiran (KJX839)

    AVXS-101 IT4

    Alpelisib (BYL719)

    Hyperlipidemia (EU)

    SMA

    PROS

    177Lu-PSMA-617

    Spartalizumab (PDR001) combo

    Entresto®

    mCRPC

    Metastatic melanoma

    HFpEF (US)

    177Lu-PSMA-617

    Beovu®

    Entresto®

    mCRPC

    DME

    Post-acute MI (IA)

    Asciminib (ABL001)

    Kisqali®

    Jakavi®

    Chronic Myeloid Leukemia

    Breast cancer(MONALEESA-2 OS)

    Chronic GvHD

    TQJ2308

    LNP023

    MBG453

    CVRR

    PNH

    MDS

    Tropifexor (LJN452)

    Alpelisib (BYL719)

    Beovu®

    NASH

    Multiple indications6

    PDR

    1. First approval in any market. 2. Positive CHMP received

    3. First submission in any market

    4. FDA placed a partial clinical hold based on findings in a small preclinical animal study

    5. Readouts enabling submission, label change

    or pivotal trial initiation 6. HER2+ aBC, TNBC, ovarian cancer, head and neck cancer 7. Received FDA Priority Review designation 8. Received FDA Fast Track designation

    18 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    19 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Strong Q1 performance and news flow, setting Pharmaceuticals up for continued growth in 2020

    Pharmaceuticals net sales

    Strong underlying momentum across portfolio

    (incl. COVID-19 related forward purchasing)

    Solid demand for growth drivers and established brands

    USD billion, growth in % cc

    +14%

    Q1 COVID-19 effects net positive, expected to reverse

    6.1

    Benefit of forward buying for orals / self-administered

    therapies, expected to reverse in later quarters

    5.5

    0.4

    Negative impact on HCP-administered products

    1.6

    2.0

    Rich newsflow on launch brands

    3.9

    3.7

    Beovu®approved in EU and JP

    Positive CHMP opinion for Cosentyx®nr-axSpA

    Inclisiran file accepted in US and EU

    Q1 2019

    Q1 2020

    Ofatumumab submitted in EU

    Growth drivers1

    Recent launches2

    Established products3

    1. Cosentyx®, Entresto®, Ilaris®, Xolair®2. Zolgensma®, Xiidra®, Aimovig®, Luxturna®, Mayzent®and Beovu®

    3. All other brands.

    20 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Cosentyx®: Solid start in 2020 with 19% YoY growth and further evidence of efficacy in joints

    Sales evolution

    USD million, % cc

    Ex-US

    US

    +19%

    930

    791

    354

    317

    474576

    Strong underlying demand across indications

    • PsO TRx +27% YoY vs. market +17%1
    • SpA TRx +30% YoY vs. market +13%2

    Strengthened value proposition

    • Positive CHMP opinion fornr-axSpA
    • FDA approval forup-titration to 300mg in AS
    • EMA submission of 300mg / 2mL PFS and autoinjector
    • ULTIMATE showed early significant effect on joint synovitis

    Significant additional growth potential

    • nr-axSpAlaunch expected Q2, completing axSpA spectrum
    • Large remaining biologic penetration potential in all indications3

    1. IQVIA National Prescription Audit for Dermatology WE 03/27/2020; market includes Enbrel®, Humira®, Siliq®, Skyrizi, Stelara®, Taltz®, Tremfya®. 2. IQVIA National Prescription Audit for Rheumatology WE 03/27/2020; SpA market includes Cimzia®, Enbrel®, Humira®, Simponi®, Stelara®, Taltz®. 3. PsO: Prevalent to mod+ severe Treated pool is from DRG; Bx treated : DRG + IQVIA patient equivalents. PsA and Axial SpA: Epidemiology, diagnosed, treated and Bx pool and aligned with DRG, latest country inputs (internal assumption based multiple data sources).

    21 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Entresto®: Strong Q1 fueled by demand acceleration in key markets

    Sales evolution

    USD million, % cc

    Ex-US

    US

    +62%

    569

    276

    357

    158

    199

    293

    Q1 2019

    Q1 2020

    1. IQVIA NPA – TRx March ’20;

    2. DRG, IQVIA; NRDL- National Reimbursement Drug List.

    Ejection Fraction

    Strong momentum across geographies

    • All-timehighs in US NBRx >4,500, TRx +46% YoY1
    • Strong acceleration in China following NRDL listing
    • Co-promotionagreement with Otsuka in JP, ahead of expected launch in H2 2020

    Poised for continued growth

    • ~75% of 3.4m eligible HFrEF patient population remaining in G72
    • Submitted HFpEF file to FDA
    • PARADISEpost-AMI on track for readout mid-2021

    AHA – American Heart Association; QoL – Quality of Life; NRDL – National Reimbursement Drug List; HFpEF – Heart Failure with preserved

    22 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Beovu®: Strong initial uptake based on efficacy. Working with RS community to understand rare safety signal1

    After thorough SRC review, Novartis continues to consider benefit-risk to be positive

    Retinal vasculitis2

    1.30/ 10,000 injections

    Retinal vascular occlusion3

    1.95/ 10,000

    injections

    Retinal vasculitis + retinal

    2.60/ 10,000

    injections

    vascular occlusion2

    • Rare safety signal1transparently communicated
    • Updating safety information in Beovu®PI

    Continuing root-cause analysis/ clinical trial program and progressing access to Beovu®

    • Extensive investigation in collaboration with external experts to identify root cause of signal
    • Continuing most comprehensive Ph3/4 aVEGF clinical trial program to date
    • DME studies and MERLIN fully recruited, other studies subject to evolution ofCOVID-19
    • Approved in top 9ex-US markets4in Q1 2020
    • Long exclusivity in US and EU

    SRC = Safety Review Committee; PI = Prescribing Information; IOI = intraocular inflammation; specific diagnoses vary depending on the exact location in the eye and can include iritis and uveitis, among others; DME = Diabetic Macular Edema;

    1. Retinal vasculitis and/or Retinal vascular occlusion that may result in severe vision loss. Typically these events occur in the presence of IOI. brolucizumab.info will be updated to reflect these updated rates regularly.Event rates are discrete: There is no double counting between categories. 2. Inflammation of retinal blood vessels that can be a specific diagnosis or part of localized (e.g., IOI) or systemic inflammatory disorder. For some of the cases assessed, it was not clear whether the occlusion was of arterial and/or venous origin. Events typically occur in the presence of IOI. 3. Blockage of any retinal blood vessel – artery or vein – due to any number of causes. Includes physician reports of retinal artery occlusion, retinal artery thrombosis, retinal artery embolism, retinal ischaemia, arterial occlusive disease and retinal vascular occlusion. 4. EU5, UK, CH, JP, Canada

    23 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Ophthalmology franchise severely affected by COVID-19, with significant impact on prescriptions across conditions

    Franchise sales evolution

    USD million, % cc

    +5%

    1,196

    1,161

    68

    Beovu®

    533

    90

    Xiidra®

    487

    Lucentis®

    628

    551Other

    Significant impact of COVID-19 on ophthalmology care

    • Clinic shutdowns, emergency only appointments, elective surgeries postponed, reduced patient flow
    • “Injection-only”visits fixed schedule visits1

    Reduced prescriptions in the 4 weeks ending April 103

    aVEGF scripts

    Down 15%TRx, down 12%NBRx2

    Dry eye disease

    Down 6%TRx, down 46%NBRx2

    Other ophthalmology

    Down 33%TRx2

    1. Retina Society recommendations 2. IQVIA prescription data; w/e 10 April 2020 3. 4 weeks average vs. prior 4 weeks average

    24 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Ofatumumab: Has potential to set a new standard for simple, broad and early B-cell therapy use in RMS

    Can provide broad and early high efficacy treatment for RMS

    Potential to be first choice for broad range of RMS patients

    Powerful sustained efficacy

    MS market volume

    mAbs

    Favorable safety

    share by class3

    22%

    Precise and targeted B-cell therapy

    44%Orals

    Flexibility through at home self-administration

    Based on strong ASCLEPIOS I&II data

    34%

    Superior efficacy for relapses, MRI activity

    BRACE

    Substantial reductions in disability progression1

    • Lower levels of NfL2
    • No significant signals of infections/ malignancies

    PDUFA date June 2020, CHMP expected Q1 2021

    1. CDW, confirmed disability worsening and CDP, confirmed disability progression are interchangeable terms, defined by an increase ≥1.5 EDSS points for patients with baseline EDSS of 0, increase of ≥1.0 EDSS points patients with baseline EDSS of 1.0-5.0 and increase of t ≥0.5 EDSS points for patients with baseline EDSS of 5.5 2. NfL levels at month three measured as adjusted geometric mean levels and difference is geometric mean ratio (GMR) 3. MS Market = BRACE + Orals + mAbs ; Volume = Standard Units converted to days of therapy (DOT); DOT normalizes dosing schedules to be comparable for different therapies Source: IQVIA PADDS

    25 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Inclisiran: Preparing to launch first-in-class siRNA cholesterol-lowering treatment with twice yearly dosing

    Persistent and underserved patient population in ASCVD

    #1

    CV disease and greatest cause of death

    globally1

    50m

    Patients with ASCVD or FH in key markets2

    60%

    Patients treated with statins do not meet goal3

    and are at risk of LDL-C accumulation over time

    On track for approval as early as December 2020

    • Regulatory submissions accepted by FDA/ EMA
    • ORION-9,ORION-10,ORION-11 published in NEJM4
      • durable and potentLDL-C reduction up to 52%
      • twice yearly dosing
      • administration by HCP
    • Progressing health systems partnering to accelerate access and improve patient outcomes

    CV = Cardiovascular; ACVD = Aherosclerotic Cardiovascular Disease; FH = Familial Hypercholesterolemia; LDL-C = Low Density Lipoproein Cholesterol; HCP = Healthcare Professional; 1. McClellan M, et al. Circulation. 2019;139:e44-e54,

    2. DRG (2019); 3. Boekholdt et al. Very Low LDL-C levels and CVD Risk JACC VOL 64.No 5 2014:485-94. 4. Raal FJ., et al. NEJM. March 18 2020. DOI: 10.1056/NEJMoa1913805, Ray K., et al. NEJM. March 18, 2020. DOI:10.1056/NEJMoa1912387

    26 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    27 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Recent launches and growth drivers off to a strong start in Q1 2020

    Oncology net sales

    (incl. COVID-19 related forward purchasing) USD billion, % cc

    +12%

    3.6

    0.4

    3.3

    0.2

    0.9

    1.1

    2.2

    2.1

    Q1 2019

    Q1 2020

    Recent launches1

    Growth drivers2

    Base business3

    Q1 key highlights

    • Strong uptake of recent launches, including Piqray®and Adakveo®, as well as Kisqali®(USD 161m, +82% cc)
    • Growth drivers continueddouble-digit performance, led by Promacta®/Revolade®(USD 403m, +33% cc), Tafinlar®+ Mekinist®(USD 366m, +26% cc)
    • Net positive impact fromCOVID-19-related forward purchasing, expected to reverse in later quarters
    • Delivered strong growth despite significant Gx erosion

    1. Recent launches include Kisqali®, Kymriah®, Lutathera®, Piqray®, Adakveo®2.Growth drivers include Promacta®/Revolade®, Jakavi®(marketed by Novartis ex-US), Tafinlar®+ Mekinist®.

    3. Base business – other brands.

    28 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Piqray®: Growth momentum reflects strong launch execution and clear unmet need

    Net sales

    74

    67

    USD million

    43

    6

    Q2’19 Q3’19 Q4’19 Q1’20

    • Q1 sales driven by expanded coverage and strong Rx momentum; blockbuster potential in current indication alone
    • Continued uptake in PIK3CA testing, with goal to reach a rate of 40% by YE 2020
    • Foundation Medicine PIK3CA CDx plasma anticipated Q2 2020
    • Expanding geographical footprint with approvals in 13 markets; CHMP opinion expected Q2 2020
    • Progressing with “EPIK” development programs: study protocols for HER2+ advanced BC, TNBC, ovarian cancer, PROS1have been aligned with the FDA

    29 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Adakveo®: Off to a strong start in the US with net sales of USD 15m in Q1

    Strong uptake in Q1

    320

    Accounts have ordered Adakveo®and

    ~75% have repeated orders

    60%

    Of high-volume accounts1have ordered

    Adakveo®, while 40% await P&T review

    96%

    Brand awareness among surveyed

    hematologists

    Payer coverage and further expansion

    C / JC code as of April 1, J code as of July 1, improving

    reimbursement confidence

    12

    State Medicaid programs from the top 23 states for

    SCD prevalence have published policies

    2

    Ex-US approvals (Brazil, India)

    EU approval expected H2 2020

    SCD – Sickle cell disease 1. High patient volume accounts defined as accounts with >200 patients

    30 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Financial review and 2020 guidance

    31 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Strong underlying performance and COVID-19 related forward purchasing drove Q1 results

    Continuing operations1

    Q1

    Change vs. PY

    USD million

    2020

    % USD

    % cc2

    Net Sales

    12,283

    11

    13

    Core Operating income 2

    4,177

    28

    34

    Operating income

    2,744

    22

    30

    Net Income

    2,173

    16

    24

    Core EPS (USD)2

    1.56

    29

    34

    EPS (USD)

    0.96

    19

    27

    Free Cash Flow 2

    2,021

    8

    Excluding COVID-19 related forward purchases and lower than expected spend, we estimate3:

    • Sales growth to be approximately9% (cc)
    • Core operating income growth to be approximately22% (cc)

    The COVID-19 related impacts, +USD 0.4bnon sales and core operating income, are expected to reverse in the remainder of 2020

    1. Refers to continuing operations as defined on page 33 of the Condensed Interim Financial Report, excludes Alcon, includes the businesses of Innovative Medicines and Sandoz, as well as the continuing corporate functions 2. Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 43 of the Condensed Interim Financial Report 3. We provide these management estimates based on the best data available to Novartis, as we believe this information is helpful to our investors to better understand Q1 underlying business performance

    32 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Strong underlying performance excluding COVID-19 benefits with core margin expansion of +3%pts

    Continuing operations1

    1

    The COVID-19 related impacts are expected to reverse in the remainder of 2020

    1. Refers to continuing operations as defined on page 33 of the Condensed Interim Financial Report, excludes Alcon, includes the businesses of Innovative Medicines and Sandoz, as well as the continuing corporate functions 2. Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 43 of the Condensed Interim Financial Report 3. We provide these management estimates based on the best data available to Novartis, as we believe this information is helpful to our investors to better understand Q1 underlying business performance

    33 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Operational sales momentum expected to remain throughout the year while investing in new launches

    Sales growth (cc), illustrative

    13%

    Mainly lapping Xiidra®

    9%

    acquisition and H2

    2019 launches

    Q1 2020

    COVID-19 Stocking

    Q1 vs. PY excl.

    Gx Erosion

    Others

    FY 2020

    vs. PY

    normalization

    COVID-19 estimate1

    vs. PY

    Core OpInc growth (cc), illustrative

    34%

    Sales and investments

    22%

    in upcoming launches

    including Inclisiran

    High single to

    low double digit

    Q1 2020

    COVID-19 Stocking

    Q1 vs. PY excl.

    Gx Erosion

    Launches &

    FY 2020

    vs. PY

    normalization

    COVID-19 estimate1

    Growth Drivers

    vs. PY

    1. We provide these management estimates based on the best data available to Novartis, as we believe this information is helpful to our investors to better understand Q1 underlying business performance

    34 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    FY 2020 key assumptions

    Barring unforeseen events (in cc)

    Continuing operations full year guidance key assumptions

    Sales and core

    Retaining the Sandoz US Oral Solids and Dermatology businesses

    operating income

    impacts sales and core operating income growth by approximately -1%pt

    Return to normal prescription and consumption dynamics during Q2 in

    our major markets

    No Gilenya®or Sandostatin®LAR generics enter in 2020 in the US

    Core net

    Expenses expected to increase by around 0.2bn vs. 2019 reflecting

    financial result

    additional financing costs to acquire The Medicines Company

    We will closely monitor the business dynamics and provide any additional guidance at Q2 earnings

    35 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    2020 Novartis full year guidance confirmed

    Barring unforeseen events; growth vs. PY in cc

    Continuing operations | full year guidance1

    Including the expected impact from retaining the Sandoz US oral solids & dermatology businesses2

    Sales expected to grow mid to high single digit

    • IM Division expected to growmid to high single digit
    • Sandoz expected to growlow single digit

    Core operating income expected to grow high single to low double digit

    1. Includes the forecast assumption that we see a return to normal prescription and consumption dynamics during Q2 in our major markets. The guidance also includes the forecast assumption that no Gilenya®and no Sandostatin®LAR generics enter in 2020 in the US 2. 1%pt negative impact on both sales and core operating income growth

    36 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Q1 free cash flow increased to USD 2bn

    Continuing operations1free cash flow2

    USD billion

    +8%

    Key drivers vs. PY:

    2.0

    +Higher operating income

    1.9

    (adjusted for non-cash items)

    Higher working capital*

    Accounts receivables, supporting sales growth

    Accounts payables, due to lower spending

    Q1 2019

    Q1 2020

    *Overall cash conversion cycle measures broadly in line with historical average

    1. Refers to continuing operations as defined on page 33 of the Condensed Interim Financial Report, excludes Alcon, includes the businesses of Innovative Medicines and Sandoz, as well as the continuing corporate functions
    2. Free cash flow is anon-IFRS measure. An explanation of non-IFRS measures can be found on page 43 of the Condensed Interim Financial Report

    37 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Expected currency impact for full year 2020

    Currency impact vs. PY

    %pts, assuming late-April exchange rates prevail in 2020

    FX impact on net sales

    FX impact on core operating income

    -3

    -2

    -4

    -3

    -5

    -6

    -6

    -7

    FY

    Q1

    Q2

    FY

    FY

    Q1

    Q2

    FY

    Actual Simulation

    38 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    39 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Conclusion

    • Advancing broad range of efforts with our associates, patients, HCPs and society to support the global response toCOVID-19
    • Continuing to deliver our medicines and advance our innovative pipeline as reflected in our strong operational performance in Q1
    • Maintaining our full year outlook

    40 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Net debt increased by USD 13.9bn mainly due to acquisitions and the annual dividend payment

    -13.9

    -15.9

    -7.0

    0.3

    -29.8

    0.7

    -9.9

    2.0

    Dec 31, 2019

    Dividends

    M&A

    Free Cash

    Treasury share

    Others

    Mar 31, 2020

    transactions1

    Flow

    transactions, net

    1. Mainly the acquisition of The Medicines Company for USD 9.6bn (excluding cash acquired of USD 0.1bn)

    42 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    2020 expected pipeline milestones

    H1 2020

    H2 2020

    Achieved

    Missed

    Regulatory

    Beovu®

    nAMD (EU/JP)

    Adakveo®

    Sickle cell disease (EU)

    Cosentyx®

    nr-axSpA (EU/US)

    2

    Capmatinib (INC280)

    NSCLC (US/JP)

    decisions and

    Cosentyx®

    AS (CN)

    Cosentyx®

    Pediatric psoriasis (EU)

    opinions

    Ofatumumab (OMB157)

    Relapsing MS (US)

    Cosentyx®

    nr-axSpA (JP)

    Piqray®

    HR+/HER2- aBC with PIK3CA

    Entresto®

    HFpEF (US)

    mutation (EU)

    QVM149

    Asthma (EU/JP)

    Inclisiran (KJX839)

    Hyperlipidemia (US)

    Tafinlar®& Mekinist®

    Adjuvant melanoma (CN)

    Xolair®

    Nasal polyposis (US/EU)

    Xiidra®

    DED (EU)

    Zolgensma®IV

    SMA (EU/JP)

    3

    Major

    Entresto®

    HFpEF (US)

    Alpelisib (BYL719)

    PROS (US)

    Inclisiran (KJX839)

    Hyperlipidemia (EU)

    AVXS-101 IT4

    SMA (US)

    expected

    Juvenile PsA / enthesitis-related

    submissions

    Cosentyx®

    arthritis (US/EU)

    Spartalizumab (PDR001)

    Metastatic melanoma (US/EU)

    and Tafinlar®& Mekinist®

    177Lu-PSMA-617

    mCRPC (US)

    Major

    Entresto®

    Post-acute MI

    Asciminib (ABL001)

    CML 3L

    expected trial

    Tropifexor (LJN452)

    NASH

    Beovu®

    DME

    readouts1

    UNR844

    Presbyopia

    Jakavi®

    chronic GVHD

    Kisqali®

    aBC (MONALEESA-2 OS)

    177Lu-PSMA-617

    mCRPC

    1. Achieved = on-time readout of data, irrespective of trial outcome

    2. Positive CHMP received, filing underway in US

    3. Positive CHMP received, JP approval received

    4. Now expected to file H2 2020 to H1 2021

    43 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Our pipeline projects at a glance

    Phase 1/2

    Phase 3

    Registration

    Total

    O N C O LO G Y

    52

    21

    3

    76

    P H A R MA C E U T IC A LS

    58

    20

    11

    89

    Cardiovascular, Renal, Metabolism

    12

    5

    1

    18

    Immunology, Hepatology, Dermatology

    22

    5

    3

    30

    Neuroscience

    5

    3

    2

    10

    Ophthalmology

    5

    3

    1

    9

    Respiratory

    8

    2

    3

    13

    Global Health

    6

    2

    1

    9

    B IO S IMILA R S

    0

    1

    0

    1

    Total

    110

    42

    14

    166

    CRM: Cardiovascular, Renal & Metabolism. IHD: Immunology, Hepatology & Dermatology.

    NS: NeuroScience.

    44 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Novartis submission schedule

    New medical entities: lead and new indications

    2020

    2021

    2022

    2023

    ≥2024

    TQJ230

    spartalizumab

    Lead

    asciminib

    Lead

    ECF843

    Lead

    LAG525

    Lead

    177Lu-PSMA-R2

    Lead

    ianalumab

    Lead

    UNR844

    Lead

    PDR001

    ABL001

    Dry eye

    Solid Tumors

    177Lu-PSMA-R2

    VAY736

    Presbyopia

    CVRR-Lp(a)

    m BRAF V600+ melanoma

    (+Taf/Mek)

    CML 3L

    Prostate cancer

    AIH

    ganaplacide

    177Lu-PSMA-617

    Lead

    MBG453

    Lead

    LOU064

    Lead

    177Lu-NeoB

    Lead

    LNA043

    Lead

    CPK850

    Lead

    INDICATIONS

    177Lu-PSMA-617

    HR-MDS

    Chronic spontaneous urticaria

    177Lu-NeoB

    Osteoarthritis

    RP

    KAF156

    mCRPC 3L

    Multiple Solid Tumors

    Malaria uncomplicated

    ligelizumab

    Lead

    iscalimab

    Lead

    VPM087

    Lead

    tropifexor

    Lead

    LMI070

    Lead

    cipargamin

    QGE031

    CFZ533

    1st line CRC / 1st line RCC

    LJN452

    SMA

    KAE609

    Chronic urticaria

    Renal Tx

    NASH

    Malaria severe

    CSJ117

    Lead

    adriforant

    Lead

    tropifexor&cenicriviroc

    Lead

    MIJ821

    Lead

    LXE408

    Severe asthma

    ZPL389

    LJC242

    Depression

    Visceral leishmaniasis

    Atopic dermatitis

    NASH

    LEAD

    LNP023

    Lead

    CEE321

    Lead

    SAF312

    Lead

    QBW251

    Lead

    PNH

    Atopic Dermatitis

    COSP

    COPD

    AVXS-201

    Lead

    OAV201

    Rett syndrome

    canakinumab

    LCM

    canakinumab

    LCM

    capmatinib

    LCM

    spartalizumab

    LCM

    LOU064

    LCM

    LNP023

    INDICATIONS

    ACZ885

    ACZ885

    LCM

    INC280

    LCM

    PDR001

    LCM

    SjS

    iMN

    LNP023

    MBG453

    ianalumab

    NSCLC 2L

    Adjuvant NSCLC

    Solid tumors

    Malignant melanoma (combo)

    canakinumab

    LCM

    LNP023

    LCM

    crizanlizumab

    LCM

    iscalimab

    Lead

    tropifexor

    LCM

    inclisiran

    ACZ885

    C3G

    SEG101

    CFZ533

    LJN452

    KJX839

    NSCLC 1L

    Sickle cell anaemia w ith crisis ped

    Liver Tx

    NASH (combos)

    CVRR-LDLC

    LNP023

    LCM

    MBG453

    LCM

    iscalimab

    LCM

    ofatumumab

    LCM

    cipargamin

    IgAN

    Maintenance for MRD+ AML

    CFZ533

    OMB157

    KAE609

    SjS

    Ped MS

    Malaria uncomplicated

    NEW

    aHUS

    Unfit AML

    VAY736

    pSjS

    Compared to past reports, we have categorized submission schedules into NMEs (lead & new indications) and supplementary indications for existing brands

    45 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Lead

    Lead

    Lead

    Lead

    LCM

    LCM

    LCM

    Novartis submission schedule

    Supplementary indications for existing brands

    alpelisib, BYL719

    LCM

    Kymriah

    PROS

    tisagenlecleucel-T, CTL019

    r/r DLBCL 1st relapse

    KisqaliLCM

    ribociclib, LEE011 HR+/HER2- BC (adj)

    PiqrayLCM

    alpelisib, BYL719

    TNBC

    PiqrayLCM

    alpelisib, BYL719 HNSCC 2/3L

    Kymriah

    tisagenlecleucel-T, CL019 r/r DLBCL (+ pembro)

    LCMJakavi

    ruxolitinib, INC424 Pediatrics Chronic GVHD

    LCM

    Cosentyx

    LCM

    secukinumab, AIN457

    Lupus Nephritis

    CosentyxLCM

    secukinumab, AIN457 Psoriasis 2ml Auto-injector

    Cosentyx

    LCM

    secukinumab, AIN457

    PsA H2H

    Cosentyx US

    LCM

    secukinumab, AIN457

    Ped Psoriasis

    AVXS-101LCM

    onasemno-geneabepar-vovec, OAV101

    SMA IT

    XolairLCM

    omalizumab, IGE025 CSU (for CN)

    EntrestoLCM

    valsartan+sacubitril, LCZ696 HFpEF

    Kymriah

    tisagenlecleucel-T, CTL019 r/r Follicular lymphoma

    Tafinlar

    dabrafenib, DRB436 HGG/LGG – Pediatrics

    Promacta

    eltrombopag, ETB115

    Food effect free formulation

    Jakavi

    ruxolitinib, INC424

    Steroid refractory chronic GVHD

    Jakavi

    ruxolitinib, INC424

    Steroid refractory acute GVHD

    Beovu

    brolucizumab, RTH258

    DME

    Xolair

    omalizumab, IGE025 Food allergy

    Xolair

    omalizumab, IGE025 Auto-injector

    Entresto

    valsartan+sacubitril, LCZ696 Post-AMI

    Lamprene US

    clofazimine, LAM320 Tuberculosis

    LCM

    LCM

    LCM

    LCM

    LCM

    LCM

    LCM

    LCM

    LCM

    LCM

    PromactaLCM

    eltrombopag, ETB115 Radiation sickness syndrome

    AdakveoLCM

    crizanlizumab, SEG101

    Sickle cell anaemia new formulations

    Cosentyx

    LCM

    secukinumab, AIN457

    SpA IV

    Cosentyx

    LCM

    secukinumab, AIN457

    Hidradenitis suppurativa

    Cosentyx

    LCM

    secukinumab, AIN457

    AS H2H

    Entresto EUa

    LCM

    valsartan+sacubitril, LCZ696

    Pediatric HF

    PiqrayLCM

    alpelisib, BYL719 HER2+ adv BC

    PiqrayLCM

    alpelisib, BYL719 Ovarian cancer

    KymriahLCM

    tisagenlecleucel-T, CTL019 Adult r/r ALL

    TafinlarLCM

    dabrafenib, DRB436 Tyroid cancer

    BeovuLCM

    brolucizumab, RTH258 Diabetic retinopathy

    BeovuLCM

    brolucizumab, RTH258

    RVO

    CoartemLCM

    artemether + lumefantrine, CCA566 Malaria uncomplicated, <5kg patients

    denosumabBioS

    GP2411

    anti RANKL mAb

    JakaviLCM

    ruxolitinib, INC424 Pediatrics Acute GVHD

    KymriahLCM

    tisagenlecleucel-T, CTL019

    1L high risk ALL, pediatrics & young adults

    Lutathera

    177Lu-oxodotreotideb)GEP-NET 1L

    Jakavi

    ruxolitinib, INC424 Myelofibrosis (combination)

    LCMCosentyx

    secukinumab, AIN457

    GCA

    LCMCosentyx

    secukinumab, AIN457 Lichen Planus

    LCM

    Mayzent

    LCM

    siponimod, BAF312

    Ped MS

    LCM

    1. Approved in US
    2. 177Lu-dotatate in US

    Compared to past reports, we have categorized submission schedules into NMEs (lead & new indications) and supplementary indications for existing brands

    46 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Novartis pipeline in registration

    6 lead indications

    Lead indication

    Oncology

    Code

    Name

    Mechanism

    Indication(s)

    BYL719

    Piqray

    PI3Kα inhibitor

    PIK3CA mutant HR+, HER2 (-) postmenopausal adv BC 2nd line

    (+fulv)

    INC280

    capmatinib

    Met Inhibitor

    NSCLC

    SEG101

    Adakveo®

    P-selectin Inhibitor

    Sickle cell disease

    Immunology, Hepatology, Dermatology

    Code

    Name

    Mechanism

    Indication(s)

    AIN457

    Cosentyx

    IL17A Inhibitor

    Ped Psoriasis

    nr-axSpA

    Psoriasis 2ml Auto-injector

    Ophthalmology

    Code

    Name

    Mechanism

    Indication(s)

    LIF606

    Xiidra EU

    LFA-1 antagonist

    Dry Eye

    Neuroscience

    Code

    Name

    M echanism

    Indication(s)

    OAV101

    Zolgensma®

    Gene therapy

    SMA IV

    OMB157

    ofatumumab

    CD20 Antagonist

    r MS

    Respiratory Disease

    Code

    Name

    Mechanism

    Indication(s)

    IGE025

    Xolair

    IgE Inhibitor

    Nasal polyps

    QMF149

    Indacaterol acetate

    Long acting β2-adrenergic

    Asthma

    +mometasone furoate

    agonist + inhaled corticosteroid

    QVM149

    Indacaterol acetate

    Long acting β2-adrenergic

    Asthma

    +mometasone fuorate

    agonist + long-acting muscarinic

    +glycopyrrnium bromide

    antagonist + inhaled

    corticosteroid

    Cardiovascular, Renal, Metabolism

    Code

    Name

    Mechanism

    Indication(s)

    KJX839

    inclisiran

    siRNA (PCSK9)

    Hyperlipidemia

    Global Health

    Code

    Name

    Mechanism

    Indication(s)

    LAM320

    Lamprene®

    SMPD1 Inhibitor

    Tuberculosisa)

    47 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Novartis pipeline in Phase 3

    5 lead indications

    Lead indication

    Oncology

    Code

    Name

    Mechanism

    Indication(s)

    177Lu-PSMA-617

    177Lu-PSMA-617

    Targeted Radioligand Therapy

    mCRPC

    177Lu-

    Lutathera®

    Targeted Radioligand Therapy

    GEP-NET 1L

    oxodotreotide 3)

    ABL001

    asciminib

    BCR-ABL Inhibitor

    CML 3L

    ACZ885

    canakinumab

    IL-1b Inhibitor

    NSCLC 1L

    NSCLC 2L

    Adjuvant

    NSCLC

    BYL719

    Piqray®

    PI3Kα inhibitor

    HER2+ adv BC

    TNBC

    HNSCC 2/3L

    Ovarian cancer

    CTL019

    Kymriah

    CD19 CART

    r/r Follicular

    1L high risk

    r/r DLBCL 1st

    Adult r/r ALL

    lymphoma

    ALL, pediatrics

    relapse

    and young

    adults

    ETB115

    Promacta®

    Thrombopoietin receptor (TPO-R)

    Radiation sickness syndrome

    Food effect free formulation

    Agonist

    INC424

    Jakavi

    JAK1/2 Inhibitor

    Acute GVHD

    Chronic GVHD

    LEE011

    Kisqali®

    CDK4 Inhibitor

    HR+/HER2- BC (adj)

    PDR001

    Spartalizumab

    PD1 Inhibitor

    m BRAF V600+ melanoma (+Taf/Mek)

    SEG101

    crizanlizumab

    P-selectin Inhibitor

    Sickle cell anemia new formulation

    Immunology, Hepatology, Dermatology

    Code

    Name

    Mechanism

    Indication(s)

    AIN457

    Cosentyx

    IL17A Inhibitor

    Lupus

    Hidradenitis

    AS H2H

    SpA IVIV

    Nephritis

    suppurativa

    QGE031

    ligelizumab

    IgE Inhibitor

    Chronic spontaneous urticaria

    Ophthalmology

    Code

    Name

    Mechanism

    Indication(s)

    RTH258

    Beovu®

    VEGF Inhibitor

    Diabetic retinopathy

    RVO

    DME

    1. FDA placed a partial hold onAVXS-101 intrathecal clinical trials for SMA patients based on findings in a small pre-clinical animal study
    2. Approved in US
    3. 177Lu-dotatate in US

    Neuroscience

    Code

    Name

    Mechanism

    Indication(s)

    BAF312

    Mayzent®

    S1P1 Modulator

    Ped MS

    OAV101

    AVXS-101

    Survival motor neuron protein

    SMA IT 1)

    gene therapy

    OMB157

    ofatumumab

    CD20 Antagonist

    Ped MS

    Respiratory Disease

    Code

    Name

    Mechanism

    Indication(s)

    IGE025

    Xolair®

    IgE Inhibitor

    Food allergy

    Auto-injector

    Cardiovascular, Renal, Metabolism

    Code

    Name

    Mechanism

    Indication(s)

    KJX839

    inclisiran

    siRNA (PCSK9)

    CVRR-LDLC

    LCZ696

    Entresto®

    AT-II / NEP,NEP,AGTR1,AGTR2 Inhibitor

    Post-AMI

    Pediatric HF 2)

    HFpEF

    TQJ230

    TQJ230

    Anti-Apo(a) ASO targeting Lp(a)

    CVRR-Lp(a)

    Global Health

    Code

    Name

    Mechanism

    Indication(s)

    COA566

    Coartem®

    Malaria uncomplicated, <5kg patients

    LAM320

    Lamprene®

    SMPD1 Inhibitor

    Tuberculosis US

    Biosimilars

    Code

    Name

    Mechanism

    Indication(s)

    GP2411

    denosumab

    anti RANKL mAb

    Denosumab BioS

    48 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Novartis pipeline in Phase 2

    30 lead indications

    Lead indication

    Code

    Name

    M echanism

    Indication(s)

    BYL719

    alpelisib

    PI3Kα inhibitor

    PROS

    CTL019

    Kymriah

    CD19 CART

    r/r DLBCL (+ pembro)

    EGF816

    nazartinib+capmatinib Opdivo EGFR Inhibitor

    NSCLC

    INC280

    capmatinib

    MET Inhibitor

    Solid tumors

    MET Inhibitor + spartalizumab

    HCC

    INC424

    Jakavi®

    JAK1/2 Inhibitor

    Myelofibrosis (combination)

    LAG525

    LAG525

    LAG3 Inhibitor

    Solid Tumors

    MBG453

    MBG453

    TIM3 Antagonist

    HR-MDS

    Unfit AML

    NIR178

    NIR178, spartalizumab

    Ad2AR Inhibitor, PD1 Inhibitor

    Cancers

    PDR001

    spartalizumab

    PD1 Inhibitor

    Solid tumors (combo)

    Metastatic melanoma (combo)

    SEG101

    crizanlizumab

    P-selectin Inhibitor

    Ped sickle cell anaemia with

    crisis

    Immunology, Hepatology, Dermatology

    Code

    Name

    M echanism

    Indication(s)

    AIN457

    Cosentyx®

    IL17A Inhibitor

    GCA

    Lichen Planus

    CFZ533

    iscalimab

    CD40 Inhibitor

    Renal/Liver Tx

    SjS

    HS

    LJC242

    tropifexor&cenicriviroc

    CCR2 Inhibitor, FXR agonist

    NASH (combos)

    LJN452

    tropifexor

    FXR agonist

    NASH

    NASH (combos)

    LNA043

    LNA043

    ANGPTL3 Agonist

    Osteoarthritis

    LOU064

    LOU064

    BTK Inhibitor

    CSU

    SjS

    LYS006

    LYS006

    Anti-inflammatory

    Acne

    Colitis ulcerative

    VAY736

    ianalumab

    BAFF-R Inhibitor

    pSjS

    AIH

    SLE

    ZPL389

    adriforant

    HRH4 Antagonist

    AD

    Code

    Name

    Mechanism

    Indication(s)

    BAF312

    Mayzent®

    S1P1 Modulator

    Stroke

    BLZ945

    BLZ945

    CSF-1 Inhibitor

    ALS

    LMI070

    branaplam

    Survival motor neuron protein

    SMA

    MIJ821

    MIJ821

    NR2B Inhibitor

    Depression

    Respiratory Disease

    Code

    Name

    Mechanism

    Indication(s)

    ACZ885

    canakinumab

    IL-1b Inhibitor

    Sarcoidosis

    CJM112

    CJM112

    IL-17A Inhibitor

    Asthma

    CSJ117

    CSJ117

    TSLP Inhibitor

    Severe asthma

    LOU064

    LOU064

    BTK Inhibitor

    Asthma

    QBW251

    QBW251

    CFTR Potentiator

    COPD

    VAY736

    ianalumab

    BAFF-R Inhibitor

    IPF

    Cardiovascular, Renal, Metabolism

    Code

    Name

    Mechanism

    Indication(s)

    CFZ533

    iscalimab

    CD40 Inhibitor

    Lupus Nephritis

    T1DM

    LCZ696

    Entresto®

    AT-II / NEP,NEP,AGTR1,AGTR2

    nHCM

    Inhibitor

    LMB763

    nidufexor

    FXR Agonist

    Diabetic Nephropathy

    LNP023

    LNP023

    CFB Inhibitor

    PNH

    IgAN

    C3G

    iMN

    aHUS

    LTW980

    LTW980

    Hypertriglyceridemia

    Ophthalmology

    Code

    Name

    Mechanism

    Indication(s)

    CPK850

    CPK850

    RLBP1 AAV

    RP

    ECF843

    ECF843

    rh-Lubricin

    Dry eye

    LKA651

    LKA651

    EPO Inhibitor

    DME

    SAF312

    SAF312

    TRPV1 Antagonist

    COSP

    UNR844

    UNR844

    disulfide bonds Modulator

    Presbyopia

    Global Health

    Code

    Name

    Mechanism

    Indication(s)

    AFQ056

    AFQ056

    mGluR5 Antagonist

    Addiction

    KAE609

    cipargamin

    PfATP4 inhibitor

    Malaria Severe

    Malaria uncomplicated

    KAF156

    ganaplacide

    Malaria uncomplicated

    LXE408

    LXE408

    Protozoan Inhibitor

    Visceral leishmaniasis

    49 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Novartis pipeline in Phase 1 (1 of 2)

    37 lead indications

    Lead indication

    Oncology

    Code

    Name

    Mechanism

    Indication(s)

    177Lu-NeoB

    177Lu-NeoB

    Radioligand therapy target GRPR

    Multiple solid tumors

    177Lu-PSMA-R2

    177Lu-PSMA-R2

    Radioligand therapy target PSMA

    Prostate cancer

    ADPT01

    NIR178, LAG525, spartalizumab, canakinumab, capmatinib

    LAG3 Inhibitor,PD1 Inhibitor

    TNBC

    BLZ945

    BLZ945 + spartalizumab

    CSF-1 Inhibitor + PD1 Inhibitor

    Solid tumors

    CSJ137

    CSJ137

    Growth Factor Inhibitor

    Anaemia

    CTL019

    Kymriah®

    CD19 CART

    Lymphoma

    r/r DLBCL (+ pembro)

    DKY709

    DKY709 + spartalizumab

    Cancers

    EGF816

    nazartinib + LXH254, ribociclib, capmatinib, Opdivo, Mekinist

    EGFR Inhibitor

    NSCLC

    HDM201

    HDM201 + MBG453, venetoclax

    MDM2 Inhibitor

    Haematological malignancy

    INC424

    Jakavi

    JAK1/2 Inhibitor

    Myelofibrosis (combination)

    JEZ567

    JEZ567

    CD123 CART

    AML

    JJO686

    JJO686

    CD22 CART

    ALL

    KAZ954

    KAZ954

    Solid tumors

    LHC165

    LHC165 + spartalizumab

    TLR7 Agonist

    Solid tumors

    LXF821

    LXF821

    EGFR CART, PD1 Inhibitor

    Glioblastoma multiforme

    LXH254

    LXH254 (combos)

    cRAF Inhibitor

    Solid tumors

    Solid tumors

    MAK683

    MAK683

    EED Inhibitor

    Cancers

    MAS825

    MAS825

    Inflammatory diseases

    MBG453

    MBG453 (combos)

    TIM3 Antagonist

    Cancers

    MCM998

    MCM998, LXG250

    BCMA CART, CD19 CART

    Multiple myeloma

    MIK665

    MIK665

    MCL1 Inhibitor

    AML (combo)

    Haematological malignancy

    NIS793

    NIS793, spartalizumab

    TGFB1 Inhibitor, PD1 Inhibitor

    Solid tumors

    NIZ985

    NIZ985, spartalizumab

    IL-15 Agonist

    Solid tumors

    NJH395

    NJH395

    Solid tumors

    NZV930

    NZV930, spartalizumab, NIR178

    CD73 Antagonist

    Solid tumors

    PDR001

    spartalizumab (combos)

    PD1 Inhibitor, TIM3 Antagonist

    AML

    Solid tumors (combo)

    SQZ622

    SQZ622

    CD123xCD3 Modulator

    AML

    TNO155

    TNO155

    SHP2 Inhibitor

    Solid tumors (single agent)

    Solid tumors (combo)

    VAY736

    ianalumab + ibrutinib

    BAFF-R Inhibitor,BTK Inhibitor

    Haematological malignancy

    VOB560

    VOB560

    Cancers

    VPM087

    VPM087

    IL1B Antagonist

    1st line CRC / 1st line RCC

    WNT974

    WNT974 + spartalizumab

    Porcupine Inhibitor

    Solid tumors

    WVT078

    WVT078

    Multiple myeloma

    YTB323

    YTB323 ±ibrutinib

    CD19 CART

    Haematological malignancy

    50 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Novartis pipeline in Phase 1 (2 of 2)

    Lead indication

    37 lead indications

    Immunology, Hepatology, Dermatology

    Global Health

    Code

    Name

    Mechanism

    Indication(s)

    Code

    Name

    Mechanism

    Indication(s)

    DFV890

    DFV890

    Multiple Indications

    KAF156

    ganaplacide

    Malaria prophylaxis

    CEE321

    CEE321

    Pan JAK Inhibitor

    AD

    LRX712

    LRX712

    Osteoarthritis

    MHS552

    MHS552

    Autoimmune Indications

    MHV370

    MHV370

    SLE

    Neuroscience

    Code

    Name

    Mechanism

    Indication(s)

    OAV201

    AVXS-201

    MECP2 gene therapy

    Rett syndrome

    Respiratory Disease

    Code

    Name

    Mechanism

    Indication(s)

    CMK389

    CMK389

    IL-18 Inhibitor

    Sarcoidosis

    LTP001

    LTP001

    Respiratory Diseases

    Cardiovascular, Renal, Metabolism

    Code

    Name

    Mechanism

    Indication(s)

    HSY244

    HSY244

    Atrial fibrillation

    MBL949

    MBL949

    Diabetes

    1. FDA placed a partial hold on AVXS-101 intrathecal clinical trials for SMA patients based on findings in a small pre-clinical animal study

    51 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Clinical Trials Update

    Includes selected ongoing or recently concluded global trials of Novartis development programs/products which are in confirmatory development or marketed (typically Phase 2 or later).

    For further information on all Novartis clinical trials, please visit: www.novartisclinicaltrials.com

    Cardiovascular, Renal and Metabolic

    Entresto®– Angiotensin receptor neprilysin inhibitor (ARNI)

    Study

    NCT02678312 PANORAMA HF (CLCZ696B2319)

    NCT03785405 (CLCZ696B2319E1 – extension study)

    Indication

    Heart failure in pediatric patients

    Heart failure in pediatric patients

    Phase

    Phase 2/3

    Phase 3

    Patients

    360

    240

    Primary Outcome

    Part 1: Pharmacodynamics and pharmacokinetics of

    Number of participants with Adverse Events (AEs) and

    sacubitril/valsartan LCZ696 analytes

    Measures

    Serious Adverse Events (SAEs)

    Part 2: Efficacy and safety compared with enalapril

    • Part 1: Sacubitril/valsartan 0.8 mg/kg or 3.1 mg/kg or

    both; 0.4 mg/kg or 1.6 mg/kg or both (single doses).

    • Part 2: enalapril/placebo 0.2 mg/kg bid (ped. formulation

    • Single arm, open label sacubitril/valsartan (pediatric

    Arms/Intervention

    1mg/ml) and adult formulation (2.5, 5, 10 mg bid);

    formulation granules (12.5, 31.25 mg in capsules); liquid

    Sacubitril/valsartan (LCZ696)/placebo: Ped. formulation

    formulation (1mg/ml and 4mg/ml concentration) and

    granules (12.5, 31.25 mg in capsules); liquid formulation

    adult formulation (50, 100, 200 mg bid))

    (1mg/ml and 4mg/ml concentration) and adult

    formulation (50, 100, 200 mg bid)

    Pediatric patients from 1 month to < 18 years of age with

    Pediatric patients with heart failure due to systemic left

    Target Patients

    heart failure due to systemic left ventricle systolic

    ventricle systolic dysfunction who have completed study

    dysfunction

    CLCZ696B2319

    H2-2021; (Analysis of 110 pts from Part 2 formed the basis

    for pediatric submission in Apr-2019 and approval by the US

    Expected Completion

    FDA in Oct-2019 for the treatment of symptomatic HF with

    2022

    systemic left ventricular systolic dysfunction in children aged

    1 year and older)

    Publication

    TBD

    TBD

    54Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Entresto®– Angiotensin receptor neprilysin inhibitor (ARNI)

    Study

    NCT02884206 PERSPECTIVE (CLCZ696B2320)

    NCT02468232 PARALLEL-HF (CLCZ696B1301)

    Indication

    Heart failure

    Heart failure, reduced ejection fraction

    Phase

    Phase 3

    Phase 3

    Patients

    592

    225

    Primary Outcome

    Change from baseline in the CogState Global Cognitive

    Time to the first occurrence of the composite endpoint –

    either cardiovascular (CV) death or heart failure (HF)

    Measures

    Composite Score (GCCS)

    hospitalization

    • Sacubitril/valsartan 50, 100, and 200 mg bid with

    Sacubitril/valsartan 50 mg, 100 mg, 200 mg bid/placebo

    Arms/Intervention

    placebo of valsartan

    of enalapril

    • Valsartan 40, 80, and 160 mg bid tablets with placebo

    Enalapril 2.5 mg, 5 mg, 10 mg bid / placebo of

    for sacubitril/valsartan

    sacubitril/valsartan

    Target Patients

    Patients with chronic heart failure with preserved ejection

    Japanese heart failure patients (NYHA Class II-IV) with

    fraction

    reduced ejection fraction

    Expected Completion

    2022

    Q1-2019(actual);H1-2021(open-label extension)

    Publication

    TBD

    Planned in H1-2020: Core study primary manuscript in Circ

    J

    55Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Entresto®– Angiotensin receptor neprilysin inhibitor (ARNI)

    Study

    NCT01920711 PARAGON-HF (CLCZ696D2301)

    NCT03066804 PARALLAX (CLCZ696D2302)

    Indication

    Heart failure, preserved ejection fraction

    Heart failure, preserved ejection fraction

    Phase

    Phase 3

    Phase 3

    Patients

    4,822

    2,572

    Primary Outcome

    Cumulative number of primary composite events of

    Change in NT-proBNP from baseline to week 12

    cardiovascular (CV) death and total (first and recurrent) HF

    and change in 6 minute walk distance (6MWD) from

    Measures

    hospitalizations

    baseline to Week 24

    • Sacubitril/valsartan 50 mg, 100 mg and 200 mg bid and

    Sacubitril/valsartan or placebo 50 mg, 100 mg, and 200

    matching placebo

    Enalapril 2.5 mg, 5 mg and 10 mg bid and matching

    Arms/Intervention

    mg bid

    placebo

    Valsartan or placebo 40 mg, 80 mg, and 160 mg bid

    • Valsartan 40 mg, 80 mg, 160 mg bid and matching

    placebo

    Target Patients

    Heart failure patients (NYHA Class II-IV) with preserved

    Heart failure patients (NYHA Class II-IV) with preserved

    ejection fraction

    ejection fraction

    Expected Completion

    2019(actual)

    2019(actual)

    • Sep-2019: Primary manuscript (ARNI in HFpEF.

    Solomon S et al; NEJM. DOI: 10.1056/NEJMoa1908655)

    Q2-2020 Study design publication (manuscript is

    • Sep-2019: ESC: Late breaker presentation of primary

    accepted in ESC Heart Failure)

    Publication

    results

    Q3-2020 Baseline data publication

    • Mar-2020: Effects across full range of EF, effects on

    • Q3-2020 Primary data presentation at ESC congress

    NTproBNP in HFpEF, SBP in HFpEF, Subgroups (mode

    Q3/Q4-2020 Primary data publication

    of death, MRA, age, gender).

    56Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Entresto®– Angiotensin receptor neprilysin inhibitor (ARNI)

    Study

    NCT03909295 (CLCZ696D1301E1 – extension study)

    NCT02924727 PARADISE-MI (CLCZ696G2301)

    Indication

    Heart failure chronic

    Post-acute myocardial infarction

    Phase

    Phase 3

    Phase 3

    Patients

    52

    5,670

    Primary Outcome

    Number of participants with Adverse Events (AEs) and

    Time to the first occurrence of a confirmed composite

    endpoint (cardiovascular (CV) death, heart failure (HF)

    Measures

    Serious Adverse Events (SAEs)

    hospitalization, or outpatient heart failure)

    • Sacubitril/valsartan 50 mg, 100 mg, 200 mg bid / placebo

    Arms/Intervention

    • Sacubitril/valsartan 50 mg,100 mg,200 mg film coated

    of ramipril/valsartan

    tablets

    • Ramipril 1.25 mg, 2.5 mg, and 5 mg bid / placebo of

    sacubitril/valsartan / placebo for valsartan

    Japanese heart failure patients (NYHA Class II-IV) with

    Post-AMI patients with evidence of LV systolic dysfunction

    Target Patients

    preserved ejection fraction after CLCZ696D2301

    and/or pulmonary congestion, with no known prior history of

    (PARAGON-HF)

    chronic HF

    Expected Completion

    Q4-2019(actual)

    H1-2021

    Publication

    TBD

    TBD

    57Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    KJX839 – small interfering RNA (siRNA) inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9)

    Study

    NCT03060577 ORION-3 (CKJX839A12201E1)

    NCT03814187 ORION-4 (CKJX839A1KJX839B12301)

    Hypercholesterolemia inc. Atherosclerotic Cardiovascular

    Hypercholesterolemia inc. Heterozygous Familial

    Indication

    Disease (ASCVD) and ASCVD risk equivalents

    Hypercholesterolaemia (HeFH)

    Heterozygous Familial Hypercholesterolaemia (HeFH)

    Phase

    Phase 2

    Phase 3

    Patients

    ~374: 284 in Group 1 and 90 in Group 2

    ~15,000

    A composite of major adverse cardiovascular events,

    LDL-C reduction at Day 210 for Group 1 subjects

    defined as:

    Primary Outcome

    Changes in other lipids and lipoproteins and reduction of

    Coronary heart disease (CHD) death;

    Measures

    LDL-C of more than 50% for patients that are above LDL-C

    Myocardial infarction;

    goal ; longer term exposure and safety.

    Fatal or non-fatal ischaemic stroke; or

    • Urgent coronary revascularization procedure

    Arms/Intervention

    Target Patients

    Expected Completion

    Publication

    Group 1 – inclisiran 300mg sc every 6 months until day

    Arm 1: every 6 month treatment KJX839 300mg (given by

    720 and then on Day 810, followed by every 6 months for a

    subcutaneous injection on the day of randomization, at 3

    planned duration of 4 years

    months and then every 6-months) for a planned median

    Group 2- Evolocumab 140mg s.c. injection every 2

    duration of about 5 years

    weeks for 360 days, followed by inclisiran 300mg on Day

    Arm 2: matching placebo (given bysubcutaneous injection

    360, Day 450 and then every 6 months for a planned

    on the day of randomization, at 3 months and then every 6-

    duration of 4 years.

    months) for a planned median duration of about 5 years.

    Patients with HeFH or pre-existing atherosclerotic

    Patient population with mean baseline LDL-C ≥ 100mg/dL;

    cardiovascular disease (ASCVD) on background statin +/-

    long- 5 year- follow-up time is designed to show best in-

    ezetimibe therapy

    class CV outcomes (25% benefit).

    Primary endpoint: 2022

    Primary endpoint: 2024

    TBD

    TBD

    58Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    KJX839 – small interfering RNA (siRNA) inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9)

    Study

    NCT03851705 ORION-5 (CKJX839A12304)

    NCT03399370 ORION-8 (CKJX839A12305B)

    Hypercholesterolemia inc. Homozygous Familial

    Hypercholesterolemia inc. Heterozygous Familial

    Indication

    Hypercholesterolaemia (HeFH) and Homozygous Familial

    Hypercholesterolemia (HoFH)

    Hypercholesterolemia (HoFH)

    Phase

    Phase 3

    Phase 3

    Patients

    56 randomized 2:1 inclisiran: placebo

    2967 entered the study

    Primary Outcome Measures

    Arms/Intervention

    Target Patients

    LDL-C reduction at Day 150

    The effect of inclisiran treatment on the proportion of

    subjects achieving prespecified low density lipoprotein

    Changes in PCSK9, other lipids and lipoproteins and

    cholesterol(LDL-C)targets at end of study. The safety and

    reduction of LDL-C of more than 20%

    tolerability profile of long term use of inclisiran

    • Part 1: inclisiran 300mg on Day 1 and Day 90 or placebo

    on Day 1 and Day 90

    Inclisiran 300mg on day 1 (placebo patients in feeder study)

    • Part 2: placebo on Day 180, inclisiran on Day 270 and

    or placebo on Day 1 (inclisiran patients in feeder study )

    then every 6 months for a planned duration of 2 years or

    then inclisiran 300mg on Day 90 and every 6 months for a

    for placebo patients in part 1 inclisiran on Day 180, Day

    planned duation of 3 years

    270 and then every 6 months for a planned duration of 2

    years

    Patients with HeFH or pre-existing atherosclerotic

    Patients with HoFH

    cardiovascular disease (ASCVD) on background statin +/-

    ezetimibe therapy and risk equivalents. Patients from

    ORION 9, 10 & 11 studies

    Expected Completion

    Primary endpoint: 2021

    Primary endpoint: 2023

    Publication

    TBD

    TBD

    59Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    LNP023 – Factor B inhibition of the complement alternative pathway

    Study

    NCT03373461 (CLNP023X2203)

    NCT04154787 (CLNP023D12201)

    Indication

    IgA nephropathy (IgAN)

    Idiopathic membranous nephropathy (iMN)

    Phase

    Phase 2

    Phase 2

    Patients

    146

    72

    Primary Outcome

    Change from baseline of log transformed UPCR derived

    Measures

    from the 24h urine collections at Baseline and Day 90

    Change from baseline of UPCR derived from 24hr urine collections at Baseline and Week 24

    Arms/Intervention

    Target Patients

    Expected Completion

    Publication

    • LNP023 Dose 1 – 10mg bid

    • LNP023 Dose – 200mg bid

    • LNP023 Dose 2 – 50mg bid

    • LNP023 Dose – 50mg bid

    LNP023 Dose 3

    – 200mg bid

    • Rituximab

    LNP023 Dose 4

    – 100mg bid (Part 2 only)

    Patients with biopsy proven iMN who are at high risk of

    Patients with biopsy-verified IgA nephropathy

    disease progression defined on the basis of antibody anti-

    PLA2R titre and proteinuria

    H2-2021

    2022

    TBD

    TBD

    60Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    LNP023 – Factor B inhibition of the complement alternative pathway

    Study

    NCT03832114 (CLNP023X2202)

    NCT03955445 (CLNP023B12001B)

    Indication

    C3 glomerulopathy (C3G)

    C3 glomerulopathy (C3G)

    Phase

    Phase 2

    Phase 2 (open-label extension)

    Patients

    27

    27 (from ongoing Phase 2, potential patient from Ph3)

    Cohort A: Ratio to Baseline of UPCR to Week 12 derived from 24hr urine collection

    Cohort B: Change from Baseline in C3 Deposit Score (based on immunofluorescence microscopy) at Week 12

    Characterize the effect of LNP023 treatment on a composite renal response endpoint at 9 months (1. a stable or improved eGFR and, 2. a reduction in proteinuria and 3. an increase in C3 compared to the CLNP023X2202 baseline visit)

    Arms/Intervention

    Target Patients

    Expected Completion

    Publication

    Increasing doses of LNP023 up to 200mg bid:

    • Cohort A: Native kidney patients

    • Open-label LNP023 200mg bid

    • Cohort B: Kidney transplanted patients

    Patients with C3 glomerulopathy

    Patients with C3 glomerulopathy

    H1-2021

    2025

    TBD

    TBD

    61Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    LNP023 – Factor B inhibition of the complement alternative pathway

    Study

    NCT03439839 (CLNP023X2201)

    NCT03896152 (CLNP023X2204)

    Indication

    Paroxysmal nocturnal hemoglobinuria (PNH)

    Paroxysmal nocturnal hemoglobinuria (PNH)

    Phase

    Phase 2

    Phase 2

    Patients

    15

    10

    Reduction of chronic hemolysis, based on LDH level at

    Reduction of PNH associated hemolysis, based on

    percentage of patients with 60% reduction in LDH or LDH

    Week 13

    below upper limit of normal up to 12 weeks of treatment.

    • Cohort 1: 10 patients receiving LNP023 200mg bid, in

    addition to SoC, for 13 weeks with 3yr treatment extension period

    • Cohort 2: 5 patients receiving LNP023 50mg bid, in addition to SoC, for minimum 2 weeks with 3yr treatment extension period. Dose may be increased D15 onwards to 200mg bid if LDH not within limit of normal or reduced by at least 60% compared to Baseline.
    • Arm 1: 4wks treatment LNP023 25mg bid followed by 8wk treatment LNP023 100mg bid and 2yr extension LNP023 100mg bid
    • Arm 2: 4wks treatment LNP023 50mg bid followed by 8wk treatment LNP023 200mg bid and 2yr extension LNP023 200mg bid

    Target Patients

    Expected Completion

    Publication

    Patients with PNH, showing signs of active hemolysis

    Patients with PNH, showing signs of active hemolysis, not

    despite treatment with SoC (defined as an antibody with anti

    treated with any other complement inhibitor less than 3

    C5 activity).

    months prior to study start Day 1

    Primary endpoint: Q4-2020

    Primary endpoint: Q4-2020

    Extension period: 2023

    Extension period: 2022

    In preparation

    TBD

    62Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    TQJ230 – Antisense oligonucleotide targeting apolipoprotein(a) mRNA

    Study

    NCT04023552 Lp(a)HORIZON (CTQJ230A12301)

    Indication

    Cardiovascular risk reduction

    Phase

    Phase 3

    Patients

    7,680

    Primary Outcome

    Time to the first occurrence of MACE (cardiovascular death,

    non-fatal MI, non-fatal stroke and urgent coronary re-

    Measures

    vascularization)

    Arms/Intervention

    TQJ230 80 mg injected monthly subcutaneously or

    matched placebo

    Target Patients

    Patients with a history of Myocardial infarction or Ischemic

    Stroke, or a clinically significant symptomatic Peripheral

    Artery Disease, and Lp(a) ≥ 70 mg/dL

    Expected Completion

    2024

    Publication

    TBD

    63Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Immunology, Hepatology & Dermatology

    CFZ533 – Blocking, non-depleting,Fc-silent,anti-CD40 monoclonal antibody

    Study

    NCT03663335 CIRRUS I (CCFZ533A2201)

    NCT03905525 TWINSS (CCFZ533B2201)

    Indication

    Kidney transplantation

    Sjögren’s syndrome

    Phase

    Phase 2B

    Phase 2B

    Patients

    676

    260

    Primary Outcome Measures

    Arms/Intervention

    Composite event (BPAR, Graft Loss or Death) over 12

    Change in EULAR Sjögren’s syndrome Disease Activity

    months post-transplantation and post conversion (for

    Index (ESSDAI) score and EULAR Sjögren’s syndrome

    maintenance cohort)

    Patient Reported Index (ESSPRI) score

    • Two cohorts: de novo TX and maintenance

    • Three dose arms of CFZ533

    • Test Arms: CFZ533 + MMF + corticosteroids

    • Placebo

    • Standard of Care: TAC + MMF + corticosteroids

    Target Patients

    Kidney transplant recipients

    Patients with Sjögren’s syndrome

    Expected Completion

    2022

    2022

    Publication

    Manuscript of PoC trial to be submitted in Q1-2020

    Manuscript of PoC trial published in The Lancet-

    Rheumatology January 23, 2020

    65Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    CFZ533 – Blocking, non-depleting,Fc-silent,anti-CD40 monoclonal antibody

    Study

    NCT03781414 CONTRAIL I (CCFZ533A2202)

    Indication

    Liver transplantation

    Phase

    Phase 2

    Patients

    128

    Primary Outcome

    Proportion of patients with composite event (BPAR, Graft

    Measures

    Loss or Death) over 12 months

    • Control/Standard of Care: TAC + MMF + Corticosteroids

    Arms/Intervention

    • CFZ533 dose A + MMF + Corticosteroids

    • CFZ533 dose B + MMF + Corticosteroids

    Target Patients

    Expected Completion

    Publication

    Liver transplant recipients

    2023

    TBD

    66Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Cosentyx®– Anti IL-17

    Study

    NCT03504852 (CAIN457A2324)

    NCT03589885 MATURE (CAIN457A2325)

    Indication

    Psoriasis

    Psoriasis

    Phase

    Phase 3B

    Phase 3

    Patients

    331

    122

    Primary Outcome

    PASI 90 response and IGA mod 2011 0 or 1 response after

    PASI 75 response and IGA mod 2011 0 or 1 response after

    Measures

    16 weeks of treatment

    12 weeks of treatment

    Arms/Intervention

    Target Patients

    Expected Completion

    Publication

    Secukinumab 300 mg every 2 weeks after weekly doses

    Secukinumab 2 mL (300 mg) auto-injector

    till Week 4

    Secukinumab 2 x 1 mL (150 mg each) prefilled syringe

    Secukinumab 300 mg every 4 weeks after weekly doses

    Placebo 2 mL auto-injector

    till Week 4

    Placebo 2 x 1 mL prefilled syringe

    Subjects (≥90kg) with moderate to severe plaque psoriasis

    Subjects with moderate to severe plaque psoriasis

    Q3-2020

    Q4-2020

    TBD

    TBD

    67Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Cosentyx®– Anti IL-17

    Study

    NCT02471144 (CAIN457A2310)

    NCT03668613 (CAIN457A2311)

    Indication

    Psoriasis

    Psoriasis

    Phase

    Phase 3

    Phase 3

    Patients

    162

    84

    Primary Outcome

    Psoriasis Area and Severity Index (PASI) 75 response and

    Psoriasis Area and Severity Index (PASI) 75 response and

    Investigators’ Global Assessment (IGA) 0 or 1 response at

    Investigators’ Global Assessment (IGA) 0 or 1 response at

    Measures

    week 12

    week 12

    Secukinumab low dose

    Arms/Intervention

    Secukinumab high dose

    Secukinumab low dose

    Placebo

    Secukinumab high dose

    Etanercept (comparator)

    Target Patients

    Patients from 6 to less than 18 years of age with severe

    Pediatric patients of age 6 to <18 years, with moderate to

    chronic plaque psoriasis

    severe plaque psoriasis

    Expected Completion

    2023

    2023

    Publication

    TBD

    TBD

    68Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Cosentyx®– Anti IL-17

    Study

    NCT03066609 (CAIN457A2318)

    Indication

    Psoriasis

    Phase

    Phase 3

    Patients

    543

    Primary Outcome

    Psoriasis Area and Severity Index (PASI) 75 response and

    Measures

    Investigators’ Global Assessment (IGA) 0 or 1 response at

    week 12

    Arms/Intervention

    Target Patients

    Expected Completion

    Publication

    • Secukinumab 300 mg
    • Secukinumab 150 mg
    • Placebo

    Patients with moderate to severe chronic plaque-type psoriasis with or without psoriatic arthritis comorbidity

    Q1-2019(actual)

    • Week 16 results: Poster presented at: 2019 American Academy of Dermatology (AAD) Annual Meeting,
    • March1-5, 2019, Washington, D.C.
    • 52-weekresults: Poster at EADV 2019, Madrid 9-13 October, 2019
    • Manuscript Publication under assessment

    69Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Cosentyx®– Anti IL-17

    Study

    NCT03031782 (CAIN457F2304)

    NCT03769168 (CAIN457F2304E1 – extension study)

    Indication

    Psoriatic arthritis

    Psoriatic arthritis

    Phase

    Phase 3

    Phase 3

    Patients

    80

    64

    Primary Outcome

    Time to 33 flares

    Number of participants with JIA ACR30 response

    Measures

    Arms/Intervention

    Secukinumab (pre-filled syringe) 75 mg

    Secukinumab 75 mg/0.5 ml

    Placebo

    Secukinumab 150 mg/1.0 ml

    Target Patients

    Juvenile idiopathic arthritis subtypes of psoriatic and

    Patients with juvenile idiopathic arthritis subtypes of juvenile

    enthesitis-related arthritis

    psoriatic arthritis and enthesitis related arthritis

    Expected Completion

    H1-2021

    2025

    Publication

    TBD

    TBD

    70Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Cosentyx®– Anti IL-17

    Study

    NCT01892436 FUTURE 1 extension (CAIN457F2306E1)

    NCT01649375 MEASURE 2 (CAIN457F2310)

    Indication

    Psoriatic arthritis

    Ankylosing spondylitis

    Phase

    Phase 3

    Phase 3

    Patients

    460

    219

    Primary Outcome

    Proportion of subjects that have a positive clinical response

    Assessment of SpondyloArthritis International Society /

    to treatment (individual improvement) in disease activity

    Measures

    ASAS 20 response

    according to ACR20 (or ACR50 or ACR 70)

    Secukinumab 75 mg

    Secukinumab 75 mg

    Arms/Intervention

    Secukinumab 150 mg

    Secukinumab 150 mg

    Placebo

    Target Patients

    Patients with active psoriatic arthritis

    Patients with active ankylosing spondylitis

    Expected Completion

    2018(actual)

    2018(actual)

    • 3 year results: ACR 2016; Mease PJ et al. Arthritis

    • Primary 52 week results: Baeten D & Sieper J, et al. N

    Rheumatol. 2016; 68 (suppl 10)

    Engl J Med 2015;373:2534-48

    3 years results: Manuscript published in September

    2 year results: Marzo-Ortega, et al. Arthritis Care Res

    2018 (Mease PJ, et al. RMD Open 2018;4:e000723.

    2017 Feb 24. doi: – 10.1002/acr.23233

    doi:10.1136/rmdopen-2018-000723)

    3 year results: Marzo-Ortega, et al. RMD 2017

    Publication

    5 year results: Philip J. Mease, Arthur Kavanaugh,

    5 year results: EULAR 2019; Marzo-Ortega H, et al.

    Andreas Reimold, et al. “Secukinumab Provides

    FRI0379. Annals of the Rheumatic Diseases

    Sustained Improvements in the Signs and Symptoms of

    2019;78:873.

    Psoriatic Arthritis: Final 5year Results from the Phase 3

    5 year results; manuscript accepted and to be published

    FUTURE 1 Study.” ACR Open Rheumatology. November

    in Q2-2020

    14, 2019. https://doi.org/10.1002/acr2.11097

    71Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Cosentyx®– Anti IL-17

    Study

    NCT01752634 FUTURE 2 (CAIN457F2312)

    NCT02008916 MEASURE 3 (CAIN457F2314)

    Indication

    Psoriatic arthritis

    Ankylosing spondylitis

    Phase

    Phase 3

    Phase 3

    Patients

    399

    222

    Primary Outcome

    Proportion of subjects achieving American College of

    Assessment of Spondyloarthritis International Society

    Measures

    Rheumatology 20 (ACR20) response criteria

    criteria / ASAS 20 response

    Secukinumab (AIN457) 150 mg s.c.

    Secukinumab 10 mg/kg / 300 mg

    Secukinumab (AIN457) 75 mg s.c.

    Arms/Intervention

    Secukinumab 10 mg/kg / 150 mg

    Secukinumab (AIN457) 300 mg s.c.

    Placebo

    Placebo s.c.

    Target Patients

    Patients with active psoriatic arthritis

    Patients with active ankylosing spondylitis

    Expected Completion

    2019(actual)

    2018(actual)

    • 16 weeks results: PANLAR congress in Apr-2016

    Primary results: McInnes IB, et al. Lancet.

    52 weeks results: Pavelka et al. Arthritis Research &

    Therapy 2017

    2015;386:1137-46

    2 year results: Presented at ACR in Nov-2017

    Publication

    2 years results: McInnes et al, Rheumatology

    3 year (EOS) results: To be presented (ORAL) at

    2017;56:1993-2003

    PANLAR April 2019

    5 years: published Lancet Rheumatology in March 2020

    • 3 year (EOS) manuscript published in ACR Open

    Rheumatology in January 2020

    72Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Cosentyx®– Anti IL-17

    Study

    NCT02745080 EXCEED (CAIN457F2366)

    Indication

    Psoriatic arthritis

    Phase

    Phase 3

    Patients

    850

    Primary Outcome

    American College of Rheumatology 20 (ACR20) response

    Measures

    Arms/Intervention

    Secukinumab 300 mg s.c.

    • Adalimumab 40 mg s.c.

    Target Patients

    Patients with active psoriatic arthritis

    Expected Completion

    Q1-2020

    Publication

    Manuscript will be published in Apr-2020

    73Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Cosentyx®– Anti IL-17

    Study

    NCT02696031 PREVENT (CAIN457H2315)

    NCT03259074 SURPASS (CAIN457K2340)

    Indication

    Non-radiographic axial spondyloarthritis

    Ankylosing spondylitis

    Phase

    Phase 3

    Phase 3

    Patients

    555

    837

    Primary Outcome

    The proportion of participants who achieved an ASAS 40

    No radiographic structural progression as measured by

    response (Assessment of SpondyloArthritis International

    modified Stoke Ankylosing Spondylitis Spine Score

    Measures

    Society criteria);

    (mSASSS)

    Secukinumab 150 mg load

    Secukinumab 150/300 mg

    Arms/Intervention

    Secukinumab 150 mg no load

    Adalimumab biosimilar 40 mg

    Placebo

    Target Patients

    Patients with non-radiographic axial spondyloarthritis

    Patients with active ankylosing spondylitis

    Expected Completion

    Week 52: Q3-2019(actual); Final: H1-2021

    2022

    • Abstract (16 week results) submitted as a late breaker to

    Publication

    ACR 2019

    TBD

    Manuscript submitted in Mar-2020

    74Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Cosentyx®– Anti IL-17

    Study

    NCT03713619 SUNSHINE (CAIN457M2301)

    NCT04179175 (CAIN457M2301E1)

    Indication

    Hidradenitis Suppurativa (HS)

    Hidradenitis Suppurativa (HS)

    Phase

    Phase 3

    Phase 3

    Patients

    471

    745

    Primary Outcome

    Proportion of participants with Hidradenitis Suppurativa

    Proportion of patients with Hidradenitis Suppurativa Clinical

    Measures

    clinical response (HiSCR)

    Response (HiSCR)

    • Secukinumab 300 mg every 2 weeks

    Arms/Intervention

    Secukinumab 300 mg every 4 weeks

    Secukinumab 300 mg every 2 weeks

    Placebo (every 2 weeks)

    Secukinumab 300 mg every 4 weeks

    Placebo (every 4 weeks)

    Patients with moderate to severe hidradenitis suppurativa

    Target Patients

    Patients with moderate to severe Hidradenitis Suppurativa

    completing either of the core trials AIN457M2301 (NCT

    0313632) or AIN567M2302 (NCT03713619)

    Expected Completion

    H2-2021

    2025

    Publication

    Preliminary results in EADV (most likely) in 2021

    TBD

    75Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Cosentyx®– Anti IL-17

    Study

    NCT03713632 SUNRISE (CAIN457M2302)

    Indication

    Hidradenitis Suppurativa (HS)

    Phase

    Phase 3

    Patients

    471

    Primary Outcome

    Proportion of patients with Hidradenitis Suppurativa Clinical

    Measures

    Response (HiSCR)

    • Secukinumab 300 mg every 2 weeks

    Arms/Intervention

    Secukinumab 300 mg every 4 weeks

    Placebo (every 2 weeks)

    Placebo (every 4 weeks)

    Target Patients

    Expected Completion

    Subjects with moderate to severe Hidradenitis Suppurativa

    H2-2021

    Publication

    Preliminary results in EADV (most likely) in 2021

    76Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Cosentyx®– Anti IL-17

    Study

    NCT04156620 INVIGORATE-1 (CAIN457P12301)

    NCT04209205 INVIGORATE-2 (CAIN457P12302)

    Indication

    Axial spondyloarthritis

    Axial spondyloarthritis

    Phase

    Phase 3

    Phase 3

    Patients

    500

    380

    Primary Outcome

    The proportion of subjects achieving an ASAS40

    The proportion of subjects achieving American College of

    (Assessment of SpondyloArthritis International Society

    Measures

    Rheumatology 50 (ACR50) response criteria

    criteria) response

    Arms/Intervention

    Secukinumab intravenous (i.v.) regimen

    Secukinumab intravenous (i.v.) regimen

    Placebo intravenous (i.v.) regimen

    Placebo intravenous (i.v.) regimen

    Target Patients

    Patients with active axial spondyloarthritis

    Patients with active psoriatic arthritis (PsA) despite current

    or previous NSAID, DMARD and/or anti-TNF therapy

    Expected Completion

    2022

    2022

    Publication

    TBD

    TBD

    77Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Ilaris®– Anti IL-1β

    Study

    NCT02296424 (CACZ885G2306)

    Indication

    SJIA – Systemic Juvenile Idiopathic Arthritis

    Phase

    Phase 3B/4

    Patients

    182

    Proportion of patients in clinical remission on

    Primary Outcome

    canakinumab who are able to remain in remission

    following canakinumab dose tapering (reduced

    Measures

    canakinumab dose or prolonged canakinumab dosing

    interval)

    Arms/Intervention

    Canakinumab dose reduction

    Canakinumab dose interval prolongation

    Target Patients

    Patients with Systemic Juvenile Idiopathic Arthritis (SJIA)

    (Pediatric)

    Expected Completion

    2018(actual)

    • Remission & flexible dosing – presented at ISSAID &

    Publication

    EULAR in Q2-2019

    • Planned manuscript in 2019: Remission & flexible

    dosing submitted in Q4-2019

    78Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    LJN452 – FXR Agonist

    Study

    NCT02855164 (CLJN452A2202)

    NCT04065841 ELIVATE (CLJN452D12201C)

    Indication

    Non-alcoholic steatohepatitis (NASH)

    Non-alcoholic steatohepatitis (NASH)

    Phase

    Phase 2

    Phase 2

    Patients

    345

    210

    Adverse event profile of different doses; determine the dose

    relationship of LJN452 on markers of hepatic inflammation

    Proportion of patients with resolution of NASH and no

    Primary Outcome

    in NASH (ALT and AST); determine dose-response

    worsening of fibrosis OR improvement in fibrosis by at least

    Measures

    relationship of LJN452 on liver fat content by changes in

    one stage without worsening of NASH at Week 48

    quantitative MRI; determine effect of LJN452 on liver fibrosis

    compared with baseline

    by biopsy

    • Arm A: combination therapytropifexor + licogliflozin

    • Arm B: tropifexor monotherapytropifexor (+ licogliflozin

    Arms/Intervention

    Multiple LJN452 doses and placebo

    placebo)

    • Arm C: licogliflozin monotherapylicogliflozin (+ tropifexor

    placebo)

    Target Patients

    Patients with non-alcoholic steatohepatitis (NASH)

    Adult patients with non-alcoholic steatohepatitis (NASH)

    and liver fibrosis

    Expected Completion

    Q2-2020

    2022

    • Primary (interim) data abstract submitted to AASLD in

    Publication

    Q3-2019

    Planned in H1-2023

    Manuscript to be submitted in Q4-2020

    79Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    LOU064 – Bruton’s tyrosine kinase (BTK) inhibitor

    Study

    NCT03926611 (CLOU064A2201)

    NCT04109313 (CLOU064A2201E1)

    Indication

    Chronic spontaneous urticaria (CSU)

    Chronic spontaneous urticaria (CSU)

    Phase

    Phase 2

    Phase 2

    Patients

    308

    250

    Primary Outcome Measures

    Change from baseline in weekly Urticaria Activity Score (UAS7) at Week

    Long-term safety and tolerability

    4

    Arm 1 Low dose of LOU064 orally in the morning (once daily) and

    matching placebo in the evening from Day 1 to 85

    Arm 2 Medium dose of LOU064 orally in the morning (once daily) and

    matching placebo in the evening from Day 1 to 85

    Arms/Intervention

    Arm 3 High dose of LOU064 orally in the morning (once daily) and

    Selected dose of LOU064 taken orally twice a day

    matching placebo in the evening from Day 1 to 85

    (morning and evening) from day 1 to week 52

    • Arm 4 Low dose of LOU064 orally, twice daily from Day 1 to 85

    • Arm 5 Medium dose of LOU064 orally, twice daily from Day 1 to 85

    • Arm 6 High dose of LOU064 orally, twice daily from Day 1 to 85

    Placebo arm Matching placebo, orally, twice daily from Day 1 to 85

    Target Patients

    Adults with CSU inadequately controlled by H1-antihistamines

    Patients with CSU who have participated in preceding

    studies with LOU064

    Expected Completion

    Q3-2020

    2022

    Publication

    TBD

    TBD

    80Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    LJC242 – FXR agonist + CCR2/CCR5 inhibitor

    Study

    NCT03517540 TANDEM (CLJC242A2201J)

    Indication

    Non-alcoholic steatohepatitis

    Phase

    Phase 2

    Patients

    193

    Primary Outcome

    • Evaluation of safety and tolerability of combination

    Measures

    therapy (tropifexor + cenicriviroc) by monitoring adverse

    event profile, vital signs and laboratory parameters

    Arms/Intervention

    Target Patients

    Expected Completion

    Publication

    • Tropifexor
    • Cenicriviroc
    • Tropifexor + cenicriviroc

    Adult patients with non-alcoholic steatohepatitis (NASH) and liver fibrosis

    Q4-2020

    Manuscript to be submitted in H1-2021

    81Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    QGE031 – Anti-IgE

    Study

    NCT02477332 (CQGE031C2201)

    NCT02649218 (CQGE031C2201E1)

    Indication

    Chronic spontaneous urticaria / Chronic idiopathic urticaria

    Chronic spontaneous urticaria / Chronic idiopathic urticaria

    Phase

    Phase 2B

    Phase 2B

    Patients

    382

    226

    Primary Outcome

    Establish dose-response relationship of QGE031 with respect

    Long-term safety; number of participants with treatment-

    Measures

    to achievement of complete hives response at week 12

    emergent adverse events

    Ligelizumab 24mg q4wks for 20 weeks

    Ligelizumab 72mg q4wks for 20 weeks

    Arms/Intervention

    Ligelizumab 240mg q4wks for 20 weeks

    Ligelizumab 240 mg q4wks open label for 52 weeks

    • Ligelizumab 120mg single dose

    Omalizumab 300mg q4wks for 20 weeks

    Placebo q 4wks for 20 weeks

    Adult patients with chronic spontaneous urticaria inadequately

    Adult patients with chronic spontaneous urticaria inadequately

    controlled with H1-antihistamines at approved or increased

    Target Patients

    controlled with H1-antihistamines at approved or increased

    doses, alone or in combination with H2-antihistamines or

    doses, alone or in combination with H2-antihistamines or

    leukotriene receptor antagonists.

    leukotriene receptor antagonists.

    Expected Completion

    2017(actual)

    2019(actual)

    • Primary results: Presented at EAACI 2018, EADV 2018,

    • Primary results: AAD 2019;

    • Secondary results presented in 2019 at: AAD, EAACI,

    and GUF 2018; NEJM publication (3 Oct 2019);

    WCD, EADV, PAAM, ACAAI, UCARE

    • Secondary results presented in 2019 at: AAD, EAACI,

    Publication

    • Exploratory results presented/ planned in 2020: AAAAI,

    WCD, EADV, PAAM, ACAAI, UCARE.

    EAACI, EADV, ACAAI; Encoring all at GUF

    Exploratory results presented/ planned in 2020: AAAAI,

    • 5 Manuscripts 2020: core results extension; time to loss

    EAACI, EADV, ACAAI; Encoring all at GUF

    response, fast response; angioedema; data visualization

    82Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    QGE031 – Anti-IgE

    Study

    NCT03437278 (CQGE031C2202)

    Indication

    Chronic spontaneous urticarial / Chronic idiopathic urticaria

    Phase

    Phase 2

    Patients

    48

    Primary Outcome

    Change in the 7 day Urticaria Activity Score (UAS7)

    Measures

    • Ligelizumab high dose q4wks for 24 weeks

    Arms/Intervention

    Ligelizumab low dose q4wks for 24 weeks

    Placebo / ligelizumab high dose q4wks for 8 / 16 weeks

    Target Patients

    Expected Completion

    Adolescents from 12 to <18 years of age, with chronic spontaneous urticaria

    H2-2021

    • Study design was presented at PAAM (Peds Allergy &

    Asthma Meeting) and at UCARE meeting 2019

    Publication

    Primary results to be presented in 2022 (e.g. EAACI,

    PAAM, EADV)

    Manuscript to be submitted in 2022

    83Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    QGE031 – Anti-IgE

    Study

    NCT03580369 Pearl 1 (CQGE031C2302)

    NCT03580356 Pearl 2 (CQGE031C2303)

    Indication

    Chronic spontaneous urticaria

    Chronic spontaneous urticaria

    Phase

    Phase 3

    Phase 3

    Patients

    1,050

    1,050

    Primary Outcome

    Absolute change from baseline in UAS7 (Urticaria Activity

    Absolute change from baseline in UAS7 (Urticaria Activity

    Measures

    Score) at week 12

    Score) at week 12

    Ligelizumab dose A q4w for 52 weeks

    Ligelizumab dose A q4w for 52 weeks

    Ligelizumab dose B q4w for 52 weeks

    Ligelizumab dose B q4w for 52 weeks

    Arms/Intervention

    Omalizumab 300 mg q4w for 52 weeks

    Omalizumab 300 mg q4w for 52 weeks

    Placebo q4w from randomization to wk20, then

    Placebo q4w from randomization to wk20, then

    ligelizumab dose B from wk24 to wk52

    ligelizumab dose B from wk24 to wk52

    Target Patients

    Adolescents and adults with chronic spontaneous urticaria

    Adolescents and adults with chronic spontaneous urticaria

    inadequately controlled with H1-antihistamines

    inadequately controlled with H1-antihistamines

    Expected Completion

    H2-2021

    H2-2021

    • Study design presented at UCARE 2018

    Publication

    • 2020: C2302E1 extension study (NCT04210843) design EAACI

    • Primary results to be presented in 2022 (e.g. EAACI, PAAM, EADV)

    Manuscript to be submitted in 2022

    84Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    VAY736 – Fully human IgG1/κ anti-BAFF-R mAb

    Study

    NCT02962895 (CVAY736A2201)

    NCT03217422 AMBER (CVAY736B2201)

    Indication

    Primary Sjögren’s syndrome

    Autoimmune hepatitis

    Phase

    Phase 2B

    Phase 2/3

    Patients

    180

    80

    Primary Outcome

    Safety and efficacy of VAY736 in primary Sjögren’s

    Alanine aminotransferase (ALT) normalization

    Measures

    syndrome (pSS)

    Arms/Intervention

    VAY736

    • VAY736

    Placebo

    • Placebo control with conversion to active VAY736

    Target Patients

    Patients with moderate to severe primary Sjögren’s

    Autoimmune hepatitis patients with incomplete response or

    syndrome (pSS)

    intolerant to standard treatment of care

    Expected Completion

    Q2-2020

    2023

    Publication

    Manuscript to be submitted in 2020

    TBD

    85Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    ZPL389 – H4 receptor antagonist

    Study

    NCT03517566 ZEST (CZPL389A2203)

    NCT03948334 ZESTExt (CZPL389A2203E1 – extension

    study)

    Indication

    Atopic dermatitis

    Atopic dermatitis

    Phase

    Phase 2

    Phase 2

    Patients

    360

    360

    Primary Outcome

    IGA (Investigator’s global assessment) response at week 16

    Frequency of Adverse Events (AEs) and Serious Adverse

    Measures

    Events (SAEs)

    ZPL389 dose 1

    ZPL389 Dose 1 + Topical Corticosteroids (TCS) and /or

    ZPL389 dose 2

    Topical Calcineurin Inhibitors (TCI)

    Arms/Intervention

    ZPL389 dose 3

    ZPL389 Dose 2 + Topical Corticosteroids (TCS) and /or

    ZPL389 dose 4

    Topical Calcineurin Inhibitors (TCI)

    Placebo

    Target Patients

    Patients with moderate to severe atopic dermatitis

    Adult patients with atopic dermatitis

    Expected Completion

    H1-2021

    2023

    Publication

    TBD

    TBD

    86Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Aimovig®– CGRP receptor antagonist

    Study

    NCT03096834 LIBERTY (CAMG334A2301)

    NCT03333109 EMPOWER (CAMG334A2302)

    Indication

    Migraine

    Migraine

    Phase

    Phase 3

    Phase 3

    Patients

    246

    900

    Primary Outcome

    Percentage of patients with a 50% response in the reduction

    Change from baseline in monthly migraine days at the last

    Measures

    of Monthly Migraine Days (MMD)

    month (Month 3) of the double-blind treatment period

    Subcutaneous injection of AMG334 (erenumab)

    AMG334 (erenumab) Dose 1

    Arms/Intervention

    AMG334 (erenumab) Dose 2

    Subcutaneous injection of placebo

    Placebo

    Target Patients

    Adult episodic migraine patients who have failed prophylactic

    Adult episodic migraine patients

    migraine treatments

    Expected Completion

    2017 DBT phase (actual); H1-2021 OLE phase (final DBL)

    Q2-2020

    • Planned for Q1-2020 (Neurology): PROs and

    prespecified subgroup analysis (DBT phase)

    Publication

    • Planned for Q2-2020: 1Y OLE

    Planned for H2-2020

    • Planned for Q4 2020: 2Y OLE – TBC. Potentially

    abstract only

    88Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Aimovig®– CGRP receptor antagonist

    Study

    NCT03867201 DRAGON (CAMG334A2304)

    Indication

    Migraine

    Phase

    Phase 3

    Patients

    550

    Primary Outcome

    Change from baseline in monthly migraine days during the

    Measures

    last 4 weeks of the 12-week treatment period

    Arms/Intervention

    • Subcutaneous injection of AMG334 (erenumab) 70 mg

    • Subcutaneous injection of placebo

    Target Patients

    Adult chronic migraine patients

    Expected Completion

    2022 DBT phase; 2024 OLE phase

    Publication

    Planned in Q4-2023 (DBT)

    89Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Gilenya®– S1P-R modulator

    Study

    NCT01633112 ASSESS (CFTY720D2312)

    Indication

    Relapsing remitting multiple sclerosis (RRMS)

    Phase

    Phase 3B

    Patients

    1,064

    Primary Outcome

    Comparison of 2 doses (0.25 mg and 0.5 mg) of fingolimod

    to glatiramer acetate (20 mg) in reducing the annualized

    Measures

    relapse rate up to 12 months

    • Fingolimod 0.5 mg orally

    Arms/Intervention

    Fingolimod 0.25mg orally

    • Copaxone®20 mg s.c.

    Target Patients

    Patients with relapsing-remitting multiple sclerosis

    Expected Completion

    2018(actual)

    • Primary data presentation at AAN in 2019

    Publication

    Primary manuscript submitted in February 2020,

    publication expected by Jun-2020

    90Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    LMI070 – SMN2 RNA splice modulator

    Study

    NCT02268552 (CLMI070X2201)

    Indication

    Type 1 spinal muscular atrophy

    Phase

    Phase 1/2

    Patients

    39

    Primary Outcome

    Number of participants with adverse events (AEs), serious

    Measures

    adverse events (SAEs) and deaths

    Branaplam oral, once weekly:

    • Part 1: 5 ascending doses

    Arms/Intervention

    • Part 2: 2 different dose levels

    • Part 3: patients continue on initial dose assigned in Part

    1 or Part 2

    Target Patients

    Patients with type 1 spinal muscular atrophy

    Expected Completion

    Q3-2020 (Part 2)

    Publication

    TBD

    91Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Mayzent ®– S1P-R modulator

    Study

    NCT01665144 -EXPAND (CBAF312A2304)

    Indication

    Secondary progressive multiple sclerosis

    Phase

    Phase 3

    Patients

    1,652

    Primary Outcome Measures

    The delay in time to confirmed disability progression as

    measured by EDSS (Expanded Disability Status Scale)

    Arms/Intervention

    Target Patients

    Expected Completion

    Publication

    • BAF312(5-day titration: 0.25mg to 1.25mg; Maintenance
      dose: 2mg (day 6))
    • Placebo

    Patients with secondary progressive multiple sclerosis

    Core in 2016/Extension in 2023

    The Lancet Neurology, Volume 39, No.10127, p1237-1330, March 2018

    92Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    OMB157 – Anti-CD20

    Study

    NCT02792218 Asclepios I (COMB157G2301)

    NCT02792231 Asclepios II (COMB157G2302)

    Indication

    Multiple sclerosis

    Multiple sclerosis

    Phase

    Phase 3

    Phase 3

    Patients

    900

    900

    Primary Outcome

    Annualized Relapse Rate (ARR) – number of confirmed

    Annualized Relapse Rate (ARR) – number of confirmed

    relapses in a year calculated based on cumulative number

    relapses in a year calculated based on cumulative number

    Measures

    of relapses by patient adjusted for time-in-study by patient

    of relapses by patient adjusted for time-in-study by patient

    Arms/Intervention

    Ofatumumab subcutaneous

    Ofatumumab subcutaneous

    Teriflunomide oral

    Teriflunomide oral

    Target Patients

    Patients with relapsing forms of multiple sclerosis

    Patients with relapsing forms of multiple sclerosis

    Expected Completion

    Q3-2019(actual)

    Q3-2019(actual)

    Publication

    Primary manuscript planned in H1-2020

    Primary manuscript planned in H1-2020

    93Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    OMB157 – Anti-CD20

    Study

    NCT03249714 APOLITOS (COMB157G1301)

    NCT03650114 ALITHIOS (COMB157G2399)

    Indication

    Multiple sclerosis

    Multiple Sclerosis

    Phase

    Phase 2

    Phase 3

    Patients

    60

    2010

    Primary Outcome

    Reduced cumulative number of Gd-enhanced T1 lesions

    Evaluate the long-term safety and tolerability of ofatumumab

    across 4 MRI scans at week 12, 16, 20 and 24 (ofatumumab

    20 mg subcutaneous (sc) once every 4 (q4) weeks in

    Measures

    vs placebo)

    subjects with RMS from the first dose of ofatumumab

    Arms/Intervention

    Ofatumumab 20 mg subcutaneous injections

    • Ofatumumab 20 mg every 4 weeks

    Placebo

    Target Patients

    Patients with relapsing forms of multiple sclerosis

    Patients with relapsing MS

    Expected Completion

    Q1-2020(actual)

    2025

    Publication

    TBD

    TBD

    94Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Zolgensma®– SMN1 gene replacement therapy

    Study

    NCT03461289 STRIVE-EU(CL-302)

    NCT03306277 STRIVE (CL-303)

    Indication

    Type 1 spinal muscular atrophy

    Type 1 spinal muscular atrophy

    Phase

    Phase 3

    Phase 3

    Patients

    33

    22

    Primary Outcome

    • Achievement of independent sitting for at least 30

    Proportion of participants sitting without support

    seconds

    Measures

    • Event-free survival

    Arms/Intervention

    Open-label,single-arm,single-dose, intravenous

    Open-label,single-arm,single-dose, intravenous

    Target Patients

    Patients with spinal muscular atrophy Type 1

    Patients with Spinal Muscular Atrophy Type 1

    Expected Completion

    H2-2020

    Q4-2019(actual)

    Publication

    ICNMD 2020, Manuscript planned H1-2021

    MDA 2020, Manuscript planned H2-2020

    95Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Zolgensma®– SMN1 gene replacement therapy

    Study

    NCT03505099 SPR1NT (CL-304)

    NCT03837184 STRIVE Asia Pacific (CL-306)

    Indication

    Spinal muscular atrophy

    Type 1 spinal muscular atrophy

    Phase

    Phase 3

    Phase 3

    Patients

    30

    6

    • [2 copies of SMN2] Percentage of participants achieving

    functional independent sitting for at least 30 seconds at

    Primary Outcome

    any visit

    Proportion of participants sitting without support

    Measures

    • [3 copies of SMN2] Percentage of participants achieving

    the ability to stand without support for at least 3 seconds

    at any visit

    Arms/Intervention

    Open-label,single-arm,single-dose, intravenous

    Open-label,single-arm,single-dose, intravenous

    Target Patients

    Pre-symptomatic patients with spinal muscular atrophy and

    Patients with spinal muscular atrophy Type 1

    multiple copies SMN2

    Expected Completion

    H2-2021

    H2-2021

    Publication

    MDA 2020 (interim)

    TBD

    96Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Zolgensma®– SMN1 gene replacement therapy

    Study

    NCT03381729 STRONG (CL-102)

    Indication

    Type 2 spinal muscular atrophy

    Phase

    Phase 1

    Patients

    51

    Primary Outcome

    Safety and tolerability, incidence of adverse events

    Proportion of patients achieving Standing Milestone

    Measures

    • Change in Hammersmith Functional Motor Scale

    Arms/Intervention

    Open-label,single-arm,single-dose, intrathecal

    Target Patients

    Patients with spinal muscular atrophy with 3 copies of SMN2

    Expected Completion

    Q4-2019 [Cohort B] (actual)

    Publication

    MDA 2020, Manuscript planned for 2H 2020

    97Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    ABL001 – Specific, allosteric Bcr-Abl kinase inhibitor

    Study

    NCT03106779 ASCEMBL (CABL001A2301)

    Indication

    Phase

    Patients

    Primary Outcome Measures

    Arms/Intervention

    Target Patients

    Expected Completion

    Publication

    Chronic myeloid leukaemia (CML)

    Phase 3

    233

    Major Molecular Response (MMR) rate at 24 weeks

    • ABL001 40 mg bid
    • Bosutinib 500 mg

    Patients with chronic myelogenous leukemia in chronic phase, previously treated with 2 or more tyrosine kinase inhibitors

    Q3-2020

    • Manuscript submissionQ4-2020
    • Abstract submission to congressQ3-2020

    99Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    ACZ885 – IL-1β inhibitor

    Study

    NCT03447769 CANOPY-A (CACZ885T2301)

    NCT03631199 CANOPY-1 (CACZ885U2301)

    Indication

    Adjuvant NSCLC

    1stLine Non-small cell lung cancer (NSCLC)

    Phase

    Phase 3

    Phase 3

    Patients

    1,500

    627

    Primary Outcome Measures

    Arms/Intervention

    Target Patients

    • Safety run-in part: Incidence of dose limiting toxicities

    Disease free survival (primary), overall survival (key

    Double-blind, randomized, placebo-controlled part:

    secondary)

    Progression free survival (PFS)

    Overall survival (OS)

    Canakinumab 200mg q3w sc for 18 cycles

    Canakinumab or matching placebo in combination with

    pembrolizumab and platinum-based doublet

    Placebo q3w sc for 18 cycles

    chemotherapy

    Patients with:

    Patients with

    High-risk NSCLC (AJCC/UICC v.8 stage II-IIIA and IIIB

    Histologically confirmed Stage IIIB, IV NSCLC with no

    (T>5cm N2)) after complete resection and standard of

    prior systemic anticancer therapy

    care adjuvant cisplatin-based chemotherapy

    Squamous and non-squamous NSCLC

    All histologies

    • No EGFR mutation and ALK rearrangement

    Expected Completion

    Interim Analysis: 2022; Final: 2023

    Interim Analysis: Q4-2020 (PFS); Final: 2022 (OS)

    Johnson B et al. Presented at AACR-NCI-EORTC 2019

    Publication

    TBD

    (safety run-in)

    Manuscript submission Q4-2020 (safety run-in)

    Abstract submission to congress H1-2021

    100Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    ACZ885 – IL1β inhibitor

    Study

    NCT03626545 CANOPY-2 (CACZ885V2301)

    Indication

    Phase

    Patients

    Primary Outcome Measures

    Arms/Intervention

    Target Patients

    Expected Completion

    Publication

    2nd/ 3rdLine Non-small cell lung cancer (NSCLC)

    Phase 3

    240

    • Safetyrun-in part: Incidence of dose limiting toxicities
    • Double-blind,randomized, placebo-controlled part: Overall Survival
    • canakinumab in combination with docetaxel
    • canakinumabmatching-placebo in combination with docetaxel

    Patients with:

    • Stage IIIB or IV NSCLCwithout EGFR, ALK,ROS-1 or B- RAF mutation
    • Previously treated with platinum therapy and PD(L)1- inhibitor

    H1-2021

    Abstract submission to congress H1-2021

    101Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    BYL719 – Alpha-specific PI3K inhibitor

    Study

    NCT02437318 SOLAR-1 (CBYL719C2301)

    Indication

    HR+/HER2- advanced breast cancer with PIK3CA mutation

    Phase

    Phase 3

    Patients

    572

    Primary Outcome

    Progression-free survival (PFS) for patients with PIK3CA

    Measures

    mutant status

    Arms/Intervention

    • Fulvestrant 500 mg + alpelisib 300 mg

    • Fulvestrant 500 mg + placebo

    Men and postmenopausal women with hormone receptor

    Target Patients

    positive, HER2-negative advanced breast cancer which

    progressed on or after aromatase inhibitor treatment

    Expected Completion

    2018(actual)

    • Andre F, et al. Presentation at ESMO 2018

    Publication

    • Andre et al. Manuscript N Engl J Med 2019;380:1929-

    1940.

    102Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Exjade®– Iron chelation of bis-hydroxy-phenyl triazole type

    Study

    NCT00940602 TELESTO (CICL670A2302)

    Indication

    Iron overload

    Phase

    Phase 2

    Patients

    224

    Primary Outcome

    To compare deferasirox to placebo with regard to event-free

    survival in low and int-1 risk MDS patient with transfusional

    Measures

    iron overload

    Arms/Intervention

    Deferasirox, iron chelator

    Placebo

    Target Patients

    Patients with myelodysplastic syndromes (low/int-1 risk) and

    transfusional iron overload

    Expected Completion

    2018(actual)

    • Angelucci E, et al. Presentation at ASH 2018

    Publication

    Angelucci E, et al. Manuscript Ann Intern Med 2020 Mar

    24 [Online ahead of print]

    103Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    INC280 – MET Inhibitor

    Study

    NCT02414139 (CINC280A2201)

    Indication

    EGFR Wild-type, ALK negative advanced Non-small Cell

    Lung Cancer (NSCLC)

    Phase

    Phase 2

    Patients

    364

    Primary Outcome

    Overall Response Rate (ORR)

    Measures

    Pre-treated pts. with MET GCN: ≥ 6; ≥ 4 and < 6; < 4

    • Pre-treated pts. with MET mutations regardless of

    cMET GCN as second or third line

    Arms/Intervention

    Treatment-naïve pts. with MET dysregulation

    Pre-treated pts with MET dysregulation – second line

    • Treatment-naïve pts with cMET mutations regardless of cMET GCN

    Target Patients

    Expected Completion

    Publication

    Adult patients with EGFR wild-type (wt), ALK-negative advanced/ metastatic NSCLC with either MET amplification or MET mutations

    2019(actual)

    • Wolf J, et al. Presented at ASCO 2019
    • Wolf J, et al. Manuscript submittedQ1-2020

    104Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Jakavi®– JAK1/2 inhibitor

    Study

    NCT02913261 REACH2 (CINC424C2301)

    NCT03112603 REACH3 (CINC424D2301)

    Indication

    Steroid-refractory acute graft vs. host disease (SR aGVHD)

    Steroid-refractory chronic graft vs. host disease (SR cGVHD)

    Phase

    Phase 3

    Phase 3

    Patients

    310

    330

    Primary Outcome

    Overall Response Rate (ORR) at 28 Days

    Overall Response Rate (ORR) at 183 Days

    Measures

    Arms/Intervention

    Ruxolitinib 10mg bid

    Ruxolitinib 10mg bid

    Best available therapy (BAT)

    Best available therapy (BAT)

    Target Patients

    Patients with SR aGVHD

    Patients with SR cGVHD

    Expected Completion

    2019(actual)

    Interim Analysis: 2019(actual); Final: Q3-2020

    • Zeiser R, et al. Manuscript N Engl J Med (accepted Q1-

    Publication

    2020, not yet published)

    Manuscript submission in H2-2020

    • Zeiser R, et al. Abstract accepted for presentation at

    Abstract submission to congress in H2-2020

    EBMT Q3-2020

    105Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Jakavi®– JAK1/2 inhibitor

    Study

    NCT03491215 REACH4 (CINC424F12201)

    NCT04097821 ADORE (CINC424H12201)

    Indication

    Acute graft versus host disease

    Myelofibrosis

    Phase

    Phase 2

    Phase 1/2

    Patients

    45

    130

    Primary Outcome Measures

    Arms/Intervention

    Target Patients

    Expected Completion

    Publication

    • Measurement of PK parameters

    • Incidence of dose limiting toxicities within the first 2

    cycles

    • Overall Response Rate (ORR)

    • Response rate at the end of cycle 6

    Ruxolitinib

    • Ruxolitinib

    Ruxolitinib+Siremadlin

    Ruxolitinib+Crizanlizumab

    Ruxolitinib+MBG453

    Pediatric patients with grade II-IV acute graft vs. host disease

    Patients with Myelofibrosis (MF)

    after allogeneic hematopoietic stem cell transplantation

    2023

    2024

    TBD

    TBD

    106Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Kisqali®– CDK 4/6 inhibitor

    Study

    NCT03701334 NATALEE (CLEE011O12301C)

    Indication

    Adjuvant treatment of hormone receptor (HR)-positive,

    HER2-negative, early breast cancer (EBC)

    Phase

    Phase 3

    Patients

    ~4,000

    Primary Outcome

    Invasive Disease-Free Survival for using STEEP criteria

    (Standardized Definitions for Efficacy End Points in adjuvant

    Measures

    breast cancer trials)

    Arms/Intervention

    Ribociclib + endocrine therapy

    Endocrine therapy

    Pre and postmenopausal women and men with HR-positive,

    Target Patients

    HER2-negative EBC, after adequate surgical resection, who

    are eligible for adjuvant endocrine therapy

    Expected Completion

    Interim Analysis: H1-2021;Final: H2-2022

    Publication

    TBD

    107Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Kymriah®– CAR-T therapy

    Study

    NCT02445248 JULIET (CCTL019C2201)

    NCT03568461 ELARA (CCTL019E2202)

    Indication

    Relapsed / refractory DLBCL

    Relapsed / refractory follicular lymphoma (FL)

    Phase

    Phase 2

    Phase 2

    Patients

    128

    113

    Primary Outcome Measures

    Arms/Intervention

    Target Patients

    Expected Completion

    Publication

    Overall response rate; efficacy and safety of CTL019

    Complete Response Rate (CRR)

    Single-arm study of single dose of CTL019

    Single-arm study of tisagenlecleucel

    Adult patients with relapsed or refractory diffuse large B-cell

    Adult patients with relapsed or refractory FL

    lymphoma (DLBCL)

    2017(actual)

    Interim Analysis: Q3-2020

    • Schuster et al. Presentations at ICML 2017; at EHA 2017; at ASH 2017; at ASH 2018; Borchmann et al.

    Presentation at EHA 2018; Bachanova et al.

    Abstract submission to congress in H2-2020

    Presentation at ICML 2019

    • Schuster et al. N Engl J Med.2019;380(1):45-56. doi: 10.1056/NEJMoa1804980. Epub 2018 Dec 1.

    108Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Kymriah®– CAR-T therapy

    Study

    NCT03876769 CASSIOPEIA (CCTL019G2201J)

    NCT03570892 BELINDA (CCTL019H2301)

    Indication

    1stline high risk acute lymphoblastic leukemia (ALL)

    2ndline Diffuse large B-cell lymphoma (DLBCL)

    Phase

    Phase 2

    Phase 3

    Patients

    160

    318

    Primary Outcome Measures

    Arms/Intervention

    Target Patients

    Expected Completion

    5 year Disease Free Survival (DFS)

    Event-free Survival (EFS)

    Single-arm study of tisagenlecleucel; retreatment allowed

    Tisagenlecleucel versus standard of care

    Adult patients with aggressive B-cellNon-Hodgkin

    Pediatric and young adult patients with 1stline high risk ALL

    Lymphoma after failure of rituximab and anthracycline-

    containing frontline immunochemotherapy

    2025

    H2-2021

    109Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    MBG453 – TIM-3 antagonist

    Study

    NCT03946670 STIMULUS MDS-1 (CMBG453B12201)

    Indication

    Myelodysplastic syndrome

    Phase

    Phase 2

    Patients

    120

    Primary Outcome

    Complete Remission (CR) rate and Progression Free

    Measures

    Survival (PFS)

    Arms/Intervention

    • Experimental: MBG453 + hypomethylating agents

    • Placebo comparator: Placebo + hypomethylating agents

    Target Patients

    Adult subjects with intermediate, high or very high risk

    Myelodysplastic Syndrome (MDS) as per IPSS-R criteria

    Expected Completion

    H2-2021

    Publication

    TBD

    110Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    PDR001 – PD-1 checkpoint inhibitor

    Study

    NCT02967692 COMBI-i (CPDR001F2301)

    Indication

    Phase

    Patients

    Primary Outcome Measures

    Arms/Intervention

    Target Patients

    BRAFV600 mutant metastatic melanoma

    Phase 3

    538

    Part 1 (safety-run in): 9; Part 2 (biomarker cohort): 27; Part 3

    (Phase III, randomized, placebo controlled): 532

    Progression-Free Survival (PFS)

    • Spartalizumab 400mg i.v. Q4W + Tafinlar 150mg bid + Mekinist 2 mg
    • Placebo + Tafinlar 150 mg bid + Mekinist 2 mg

    Previously untreated patients with unresectable or metastatic BRAF V600 mutant melanoma

    Expected Completion

    Q3-2020

    Publication

    Abstract submission to congress in Q3-2020

    Manuscript submission Q3-2020

    111Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    PDR001 – PD-1 checkpoint inhibitor

    Study

    NCT03484923 (CPDR001J2201)

    Indication

    Previously treated unresectable or metastatic melanoma

    Phase

    Phase 2

    Patients

    230

    Primary Outcome

    Objective Response Rate (ORR)

    Measures

    PDR001 400mg i.v. Q4W + LAG525 600 mg i.v. Q4W

    PDR001 400mg i.v. Q4W + capmatinib 400 mg bid orally

    Arms/Intervention

    PDR001 400mg i.v. Q4W + canakinumab 300 mg (s.c)

    Q4W

    • PDR001 400mg i.v. Q4W + ribociclib 600 mg p.o QD on Days 1 to 21 of a 28-day cycle

    Target Patients

    Expected Completion

    Publication

    Adult patients with previously treated unresectable or metastatic melanoma

    H2-2021

    TBD

    112Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Promacta®/Revolade®– Thrombopoetin receptor agonist

    Study

    NCT03025698 (CETB115E2201)

    NCT03988608 (CETB115E2202)

    Indication

    Previously untreated or relapsed/refractory severe aplastic

    Previously untreated or relapsed/refractory severe aplastic

    anemia or recurrent aplastic anemia

    anemia or recurrent aplastic anemia

    Phase

    Phase 2

    Phase 2

    Patients

    60

    20

    Primary Outcome

    PK of eltrombopag at steady state in pediatric patients with

    Hematologic response rate

    Measures

    SAA

    Arms/Intervention

    Target Patients

    Expected Completion

    • Eltrombopag 12.5, 25, 50, 75 mg FCT & 25 mg pFOS
    • Arm B: previously untreatedSAA-hATG/cyclosporine +

    eltrombopag

    • Eltrombopag 25 mg film-coated tablets

    • Arm A: relapsed/refractory SAA or AA:

    hATG/cyclosporine + eltrombopag or cyclosporine +

    eltrombopag

    Pediatric patients from age 1 <18 years with

    Chinese patients with refractory or relapsed severe aplastic

    relapsed/refractory SAA or recurrent AA after IST or

    anemia

    previously untreated SAA

    2025

    2023

    113Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Rydapt®– Multi-targeted kinase inhibitor

    Study

    NCT03280030 (CPKC412A2220)

    NCT03591510 (CPKC412A2218)

    Indication

    Acute myeloid leukemia

    Acute myeloid leukemia

    Phase

    Phase 2

    Phase 2

    Patients

    66

    50

    Primary Outcome

    Incidence of safety events and event free survival

    Occurrence of dose limiting toxicities

    Measures

    Event Free Survival ( EFS)

    Arms/Intervention

    Target Patients

    Expected Completion

    Midostaurin 50 mg

    • Chemotherapy followed by Midostaurin

    Placebo

    Newly diagnosed patients with FLT3-mutated acute myeloid

    Newly diagnosed pediatric patients with FLT3 mutated acute

    leukemia (AML) from pan-Asia countries

    myeloid leukemia (AML)

    Q2-2020

    H2-2022

    Publication

    Abstract submission to congress in Q4-2020

    TBD

    114Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    SEG101 – p-Selectin inhibitor

    Study

    NCT03264989 SOLACE-Adults (CSEG101A2202)

    NCT03474965 SOLACE-Kids (CSEG101B2201)

    Indication

    Prevention of Vaso-Occlusive Crises (VOC) in patients with

    Prevention of VOC in pediatric patients with SCD

    Sickle Cell Disease (SCD)

    Phase

    Phase 2

    Phase 2

    Patients

    55

    100

    Primary Outcome

    PK/PD and safety of SEG101 (crizanlizumab) at 5 mg/kg

    PK/PD and safety of SEG101 at 5 mg/kg

    Measures

    SEG101 (crizanlizumab) at a dose of 5.0 mg/kg (or 7.5

    SEG101 (crizanlizumab) at a dose of 5 mg/kg by IV infusion

    Arms/Intervention

    mg/kg for exploratory group) by IV infusion, ±

    ± Hydroxyurea/Hydroxycarbamide

    Hydroxyurea/Hydroxycarbamide

    Target Patients

    Adult SCD patients with VOC

    Pediatric SCD patients with VOC

    Expected Completion

    2018(actual)

    H2-2021 (pediatric patients ≥6 year old)

    2022 (pediatric patients 6 months – 6 year old)

    Publication

    Abstract submission to congress in Q3-2020 (7.5 mg group)

    Abstract submission to congress in Q3-2020

    115Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    SEG101 – p-Selectin inhibitor

    Study

    NCT03814746 STAND (CSEG101A2301)

    Indication

    Prevention of Vaso-Occlusive Crises (VOC) in patients with

    Sickle Cell Disease (SCD)

    Phase

    Phase 3

    Patients

    240

    Primary Outcome

    Rate of VOC events leading to healthcare visit

    Measures

    Arms/Intervention

    Target Patients

    Expected Completion

    Publication

    • Crizanlizumab 5.0 mg/kg
    • Crizanlizumab 7.5 mg/kg
    • Placebo

    Adolescent and adult SCD patients (12 years and older)

    H1-2022

    TBD

    116Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Tafinlar®– BRAF inhibitor

    Study

    NCT01677741 (CDRB436A2102)

    Indication

    BRAFV600 mutant cancers

    Phase

    Phase 1/2

    Patients

    86

    Primary Outcome

    Safety, tolerability and pharmacokinetics

    Measures

    Arms/Intervention

    Single-arm study of oral dabrafenib (dose based on age

    and weight)

    Target Patients

    Pediatric subjects aged 1 year to <18 years with advanced

    BRAF V600-mutation positive solid tumors

    Expected Completion

    H1-2021

    • Kieran MW et al. Manuscript Clin Cancer Res

    2019;25(24):7294-7302 (PK analysis)

    Publication

    • Hargrave DR et al. Manuscript Clin Cancer Res

    2019;25(24):7303-7311 (safety/efficacy in low-grade

    gliomas)

    117Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Tafinlar®+Mekinist®– BRAF inhibitor and MEK inhibitor

    Study

    NCT02684058 (CDRB436G2201)

    Indication

    BRAFV600 mutant gliomas

    Phase

    Phase 2

    Patients

    142

    Primary Outcome

    Objective response rate

    Measures

    Arms/Intervention

    Dabrafenib + trametinib (dose based on age and weight)

    Target Patients

    Children and adolescent patients with BRAF V600 mutation

    positive relapsed or refractory high grade glioma (HGG) or

    BRAF V600 mutation positive low grade glioma (LGG)

    Expected Completion

    2022

    Publication

    TBD

    118Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Tafinlar®+Mekinist®– BRAFV600 inhibitor and MEK inhibitor

    Study

    NCT02124772 (CTMT212X2101)

    Indication

    BRAFV600 mutant solid tumors

    Phase

    Phase 1/2A

    Patients

    142

    Primary Outcome

    Safety, tolerability and pharmacokinetics and clinical activity

    Measures

    Arms/Intervention

    Trametinib (dose based on age and weight)

    Dabrafenib + trametinib (dose based on age and weight)

    Target Patients

    Pediatric Subjects Aged 1 Month to <18 Years with

    Advanced V600-Mutation Positive Solid Tumors

    Expected Completion

    H1-2021

    Publication

    Abstract accepted for presentation at ASCO Q2-2020

    119Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Zykadia®– ALK inhibitor

    Study

    NCT02299505 ASCEND-8 (CLDK378A2112)

    Indication

    ALK activated NSCLC

    Phase

    Phase 2

    Patients

    306

    Primary Outcome

    Part 1: Pharmacokinetics when taken with food

    Measures

    Part 2: Overall Response Rate (ORR) when taken with food

    • Oral LDK378 450 mg once daily taken with food

    Arms/Intervention

    • Oral LDK378 600 mg once daily taken with food

    • Oral LDK378 750 mg once daily fasted

    Target Patients

    Adult patients with ALK-rearranged(ALK-positive) advanced non-small cell

    lung cancer

    Part 1 (PK): 2016 (actual)

    Expected Completion

    Part 2 (ORR): Q4-2018(actual)

    Final (ORR): Q3-2020

    • Part 1 (PK): Cho BC, et al. J Thorac Oncol. 2017 Sep; 12(9) 1357-1367

    Publication

    • Part 2 (ORR): Cho B et al. J Thorac Oncol. 2019 Jul; 14(7) 1255-1265

    • Final (ORR): Abstract submission to congress Q3-2020

    120Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    177Lu-PSMA-617 – Lu-labelled prostate specific membrane antigen (PSMA)

    Study

    NCT03511664 VISION (PSMA-617-01)

    Indication

    PSMA-positive Metastatic Castration-resistant Prostate

    Cancer (mCRPC)

    Phase

    Phase 3

    Patients

    831

    Primary Outcome

    Radiographic Progression Free Survival

    Measures

    Overall Survival

    Arms/Intervention

    177Lu-PSMA-617 plus BS/BSC

    BS/BSC alone

    Adult patients with PSMA-positive Metastatic Castration-

    Target Patients

    resistant Prostate Cancer (mCRPC)

    Expected Completion

    Q4-2020

    Publication

    TBD

    121Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Lucentis®– Anti-VEGF

    Study

    NCT02375971 RAINBOW (CRFB002H2301)

    NCT02640664 RAINBOW Extension (CRFB002H2301E1)

    Indication

    Retinopathy of Prematurity (ROP)

    Retinopathy of Prematurity (ROP)

    Phase

    Phase 3

    Phase 3

    Patients

    224

    180

    Absence of active Retinopathy of Prematurity (ROP) and

    Primary Outcome

    unfavorable structural outcome at Week 24, defined as, 1)

    To evaluate the visual function of patients by assessing the

    survival, 2) no intervention with a second modality for ROP,

    visual acuity in the better-seeing eye at the patient’s fifth

    Measures

    3) absence of active ROP and 4) absence of unfavorable

    birthday.

    structural outcome

    Ranibizumab 0.2 mg (up to 3 injections max)

    Ranibizumab 0.2 mg (up to Week 40, if warranted)

    Arms/Intervention

    Ranibizumab 0.1 mg (up to 3 injections max)

    Ranibizumab 0.1 mg (up to Week 40, if warranted)

    Laser therapy

    Target Patients

    Male and female preterm infants with bilateral retinopathy of

    Male and female preterm infants with bilateral retinopathy of

    prematurity (ROP) who require treatment.

    prematurity (ROP) who completed RAINBOW .

    Expected Completion

    2018(actual)

    2023

    EURETINA: Sep-2018

    AAO: Oct-2018

    Primary manuscript published online by The Lancet in

    Sep-2019

    Publication

    (https://www.thelancet.com/pdfs/journals/lancet/PIIS0140

    Submission of publication of 2 year data (Interim Analysis 2)

    -6736(19)31344-3.pdf)

    in 2020

    • Submission of manuscript on Pop PK/PD analysis in

    2020

    • Submission of manuscript on time-course of clinical

    response to treatment in 2020

    123Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    RTH258 – Anti-VEGF

    Study

    NCT02434328 HARRIER (CRTH258A2302)

    NCT02307682 HAWK (CRTH258A2301)

    Indication

    Neovascular age-related macular degeneration (nAMD)

    Neovascular age-related macular degeneration (nAMD)

    Phase

    Phase 3

    Phase 3

    Patients

    743

    1,082

    Primary Outcome

    Change in Best Corrected Visual Acuity (BCVA) from

    Change in Best Corrected Visual Acuity (BCVA) from

    Measures

    baseline at week 48

    baseline at week 48

    Brolucizumab (RTH258) 6 mg/50 µL

    Brolucizumab (RTH258) 3 mg/50 µL

    Arms/Intervention

    Brolucizumab (RTH258) 6 mg/50 µL

    Aflibercept 2 mg/50 µL

    Aflibercept 2 mg/50 µL

    Target Patients

    Subjects with exudative age-related macular degeneration

    Subjects with exudative age-related macular degeneration

    Expected Completion

    2018(actual)

    2018(actual)

    • Year 1 Manuscript: Dugel P, et al. Ophthalmology 2019 Apr 12; HAWK and HARRIER: Phase 3, Multicenter,

    Randomized, Double-Masked Trials of Brolucizumab for Neovascular Age-Related Macular Degeneration.

    Publication

    Secondary publications planned for 2020 are: Fluid resolution, PCV and CNV subtypes, CST variability, the IPDA, safety

    and VFQ outcomes submitting in Q1-Q3 of 2020

    • Abstracts submissions on superior anatomic outcomes/Fluid/PostHoc results are planned for key retinal congresses (WOC; ARVO; ASRS, EURETINA AAO and APVRS) throughout 2020

    124Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    RTH258 – Anti-VEGF

    Study

    NCT03386474 (CRTH258A2301E1)

    NCT03481634 KESTREL (CRTH258B2301)

    Indication

    Neovascular age-related macular degeneration (nAMD)

    Diabetic eye disease

    Phase

    Phase 3

    Phase 3

    Patients

    150

    534

    Primary Outcome

    Number of treatment-emergent adverse events

    Change from baseline in best-corrected visual acuity

    Measures

    (BCVA)

    Brolucizumab (RTH258) 6 mg/50 µL

    Brolucizumab (RTH258) 3 mg/50 µL

    Arms/Intervention

    Brolucizumab (RTH258) 6 mg/50 µL

    Aflibercept 2 mg/50 µL

    Aflibercept 2mg/50 uL

    Target Patients

    Patients with neovascular age-related macular degeneration

    Patients with visual impairment due to diabetic macular

    who have completed the CRTH258A2301 study

    edema (DME)

    Expected Completion

    2018(actual)

    H2-2021

    Publication

    Planned publication of the attributes of brolucizumab and

    Week 52 safety and efficacy data to be submitted as an

    durability in Q1-2020

    abstract in H1-2021 (KITE and KESTREL)

    125Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    RTH258 – Anti-VEGF

    Study

    NCT03481660 KITE (CRTH258B2302)

    NCT04058067 KINGLET (CRTH258B2304)

    Indication

    Diabetic eye disease

    Diabetic macular edema

    Phase

    Phase 3

    Phase 3

    Patients

    356

    268

    Primary Outcome

    Change from baseline in best-corrected visual acuity

    Change in best-corrected visual acuity (BCVA)

    Measures

    (BCVA)

    Arms/Intervention

    Brolucizumab (RTH258) 6 mg/50 µL

    Brolucizumab (RTH258) 6 mg/50 µL

    Aflibercept 2 mg/50 µL

    Aflibercept 2 mg/50 µL

    Target Patients

    Patients with visual impairment due to diabetic macular

    Chinese patients with visual impairment due to diabetic

    edema (DME)

    macular edema

    Expected Completion

    H2-2021

    2022

    Publication

    Week 52 safety and efficacy data to be submitted as an

    Publication planned for 2023

    abstract H1 2021 (KITE and KESTREL)

    126Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    RTH258 – Anti-VEGF

    Study

    NCT03917472 KINGFISHER (CRTH258B2305)

    NCT03802630 RAPTOR (CRTH258C2301)

    Indication

    Diabetic macular edema

    Retinal vein occlusion

    Phase

    Phase 3

    Phase 3

    Patients

    500

    500

    Primary Outcome

    Change in best-corrected visual acuity (BCVA) from

    Change from baseline in best-corrected visual acuity

    Measures

    baseline up to week 52

    (BCVA) at week 24

    Arms/Intervention

    Brolucizumab (RTH258) 6 mg/50 µL

    Brolucizumab (RTH258) 6 mg/50 µL

    Aflibercept 2 mg/50 µL

    Aflibercept 2 mg/50 µL

    Target Patients

    Patients with visual impairment due to diabetic macular

    Adult patients with visual impairment due to macular edema

    edema

    secondary to branch retinal vein occlusion

    Expected Completion

    H2-2021

    2022

    Publication

    Publication submission planned for 2022

    Publication submission planned for 2022

    127Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    RTH258 – Anti-VEGF

    Study

    NCT03810313 RAVEN (CRTH258C2302)

    NCT04047472 HOBBY (CRTH258A2307)

    Indication

    Retinal vein occlusion

    Macular degeneration

    Phase

    Phase 3

    Phase 3

    Patients

    750

    494

    Primary Outcome Measures

    Arms/Intervention

    Change from baseline in best-corrected visual acuity

    Change from baseline in best-corrected visual acuity

    (BCVA) at week 24

    (BCVA) at week 48

    Brolucizumab (RTH258) 6 mg/50 µL

    Brolucizumab (RTH258) 6 mg/50 µL

    Aflibercept 2 mg/50 µL

    Aflibercept 2 mg/50 µL

    Target Patients

    Adult patients with visual impairment due to macular edema

    Chinese patients with neovascular age-related macular

    secondary to central retinal vein occlusion

    degeneration

    Expected Completion

    2023

    2023

    Publication

    TBD

    TBD

    128Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    UNR844 – Disulfide bonds modulator

    Study

    NCT03809611 (CUNR844A2203)

    Indication

    Presbyopia

    Phase

    Phase 2

    Patients

    124

    Primary Outcome

    Change in binocular distance-corrected near visual acuity

    Measures

    (DNCVA) from baseline at month 3

    Arms/Intervention

    1.5% solution UNR844-Cl

    Placebo

    Target Patients

    Patients with presbyopia

    Expected Completion

    Q1-2020

    Publication

    TBD (Original plan to publish at ASCRS in 2020, but ASCRS

    got cancelled due to COVID-19)

    129Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    QBW251 – CFTR potentiator

    Study

    NCT04072887 (CQBW251B2201)

    Indication

    Chronic obstructive pulmonary disease (COPD)

    Phase

    Phase 2

    Patients

    900

    Primary Outcome

    Trough FEV1 (Forced Expiratory Volume in 1 second)

    Measures

    change from baseline after 12 weeks of treatment

    QBW251 450 mg

    QBW251 300 mg

    Arms/Intervention

    QBW251 150 mg

    QBW251 75 mg

    QBW251 25 mg

    Placebo

    Target Patients

    Expected Completion

    Publication

    COPD patients on background triple inhaled therapy (LABA / LAMA / ICS)

    H2-2021

    TBD

    131Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    QMF149 – Long-acting beta2 agonist and inhaled corticosteroid

    Study

    NCT02892019 (CQMF149G2202)

    Indication

    Asthma

    Phase

    Phase 2

    Patients

    80

    Primary Outcome

    Trough FEV1

    Measures

    Arms/Intervention

    • Indacaterol acetate 75 μg od (via Concept1 inhaler)

    • Indacaterol acetate 150 μg od (via Concept1 inhaler)

    Target Patients

    Children ≥ 6 to < 12 years of age with asthma

    Expected Completion

    2019(actual)

    Publication

    Planned in H2-2020

    132Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    QVM149 – Long-acting beta2 agonist, Long-acting muscarinic antagonist and inhaled corticosteroid

    Study

    NCT02554786 PALLADIUM (CQVM149B2301)

    NCT02571777 IRIDIUM (CQVM149B2302)

    Indication

    Asthma

    Asthma

    Phase

    Phase 3

    Phase 3

    Patients

    2,216

    3,092

    Primary Outcome

    Trough FEV1

    Trough FEV1

    Measures

    QMF149 150/160 µg od

    QVM149 150/50/160 µg od

    QMF149 150/320 µg od

    • QVM149 150/50/80 µg od

    Arms/Intervention

    • MF 400 µg od

    • QMF149 150/160 µg od

    • MF 400 µg bid

    • QMF149 150/320 µg od

    Salmeterol 50 µg /fluticasone 500 µg bid

    Salmeterol 50 µg /fluticasone 500 µg bid

    Adult and adolescent (≥12 years) patients with asthma

    Adult (≥18 years) patients with asthma inadequately

    Target Patients

    inadequately controlled on medium/high-dose ICS or low-

    controlled on medium/high-dose of LABA/ICS (GINA step ≥4)

    dose LABA/ICS (GINA step ≥ 3)

    Expected Completion

    2019(actual)

    2019(actual)

    Publication

    Planned in H1-2020

    Planned in H1-2020

    Abstract: van Zyl-Smit et al, presented at BTS Dec-2019

    Abstract ATS Q2-2020

    133Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    QVM149 – Long-acting beta2 agonist, Long-acting muscarinic antagonist and inhaled corticosteroid

    Study

    NCT03100500 (CQVM149B1305)

    NCT03100825 (CQVM149B1304)

    Indication

    Asthma

    Asthma

    Phase

    Phase 3

    Phase 3

    Patients

    51

    94

    Primary Outcome

    Long-term safety/tolerability: Incidence and severity of

    Long-term safety/tolerability: Incidence and severity of

    treatment emergent adverse events during the 52 weeks

    treatment emergent adverse events during the 52 weeks

    Measures

    study

    study

    Arms/Intervention

    • Single arm: QMF149 150/320 μg od

    • Single Arm: QVM149 150/50/160 μg od

    Target Patients

    Japanese patients with asthma inadequately controlled

    Japanese patients with asthma inadequately controlled

    Expected Completion

    2019(actual)

    2019(actual)

    • Japanese J Allergo (B1304/1305 combined); Planned in

    • Japanese J Allergo (B1304/1305 combined); Planned in

    Publication

    H2-2020

    H2-2020

    • Abstract for ATS in Q2-2020

    • Abstract for ATS in Q2-2020

    134Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    QVM149 – Long-acting beta2 agonist, Long-acting muscarinic antagonist and inhaled corticosteroid

    Study

    NCT02892344 QUARTZ (CQVM149B2303)

    NCT03158311 ARGON (CQVM149B2306)

    Indication

    Asthma

    Asthma

    Phase

    Phase 3

    Phase 3

    Patients

    802

    1,251

    Primary Outcome

    Trough FEV1

    Non-inferiority of Asthma Quality of Life Questionnaire

    Measures

    (AQLQ)

    QMF149 150/80 µg od

    • QVM149 150/50/80 μg od

    Arms/Intervention

    QVM149 150/50/160 μg od

    • MF 200 µg od

    Salmeterol/fluticasone 50/500 μg bid + tiotropium 5 μg od

    Adult and adolescent (≥12 years) patients with mild asthma

    Target Patients

    inadequately controlled on low-dose ICS or low-dose

    Patients with uncontrolled asthma

    LABA/ICS (Gina step 2-3)

    Expected Completion

    2019(actual)

    2019(actual)

    Publication

    O. Kornmann et al. Respiratory Medicine 161 (2020)

    Resp Med; Planned in Q2-2020

    • Abstract: D’Andrea et al, presented at ERS Sep-2019

    Abstract ATS Q2-2020

    135Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Xolair ®– anti-IgE antibody

    Study

    NCT03369704 (CIGE025F1301)

    Indication

    Seasonal allergic rhinitis: Severe Japanese Cedar Pollinosis

    Phase

    Phase 3

    Patients

    337

    Primary Outcome Measures

    Mean nasal symptom score, consists of severity of sneezing, rhinorrhea and nasal congestion.

    In addition to standard of care:

    Arms/Intervention

    Omalizumab per approved allergic asthma dosing table for IgE/body weight combinations

    Placebo

    Target Patients

    Expected Completion

    Publication

    Patients with severe Japanese cedar pollinosis, whose symptoms were inadequately controlled with current recommended therapies

    2019(actual)

    • Late breaking abstract was published at AAAAI (American Association of Allergy, Asthma and Immunology) annual meeting, Feb 2019
    • Poster published at EAACI (the European Academy of Allergy and Clinical Immunology), Jun 2019
    • Oral presentations were made at JRS (Japanese Rhinologic Society), Oct 2019, and Asian Pacific Society of Respirology congress, Nov 2019
    • Manuscript submitted to JACI in Practice,Q1-2020

    136Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Sandoz Biopharmaceuticals

    Hyrimoz®– Biosimilar adalimumab

    Study

    NCT02744755 ADMYRA (GP17-302)

    Indication

    Immunology

    Phase

    Phase 3

    Patients

    353

    Primary Outcome

    Change in DAS28-CRP score from baseline to week 12 in

    patients treated with GP2017 and patients treated with

    Measures

    Humira®

    Arms/Intervention

    GP2017

    • US licensed Humira®adalimumab

    Target Patients

    Patients with moderate to severe active rheumatoid arthritis

    Expected Completion

    2018(actual)

    • Wiland, P. et al., presented at EULAR 2019

    Publication

    Wiland, P. et al., BioDrugs, Q2 2020

    138Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    GP2411 – Biosimilar denosumab

    Study

    NCT03974100 (CGP24112301)

    Indication

    Osteoporosis

    Phase

    Phase 3

    Patients

    522

    Primary Outcome

    Percent change from baseline (%CfB) in lumbar spine Bone

    Measures

    Mineral Density

    GP2411 60 mg /mL subcutaneous injection every 6

    Arms/Intervention

    months

    Prolia®60 mg /mL subcutaneous injection every 6

    months

    Target Patients

    Expected Completion

    Publication

    Postmenopausal women with osteoporosis

    2022

    Study data publications expected for 2024 and beyond. The overall study design will be published at WCO and ECTS congresses 2020.

    139Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    KAF156 – Plasmodium Falciparum Inhibitor – PfCARL mediated

    Study

    NCT03167242 (CKAF156A2202)

    Indication

    Malaria

    Phase

    Phase 2

    Patients

    ~500

    Primary Outcome

    PCR-corrected adequate clinical and parasitological

    Measures

    response (ACPR)

    Arms/Intervention

    • KAF156 and LUM-SDF (different combinations)

    • Coartem

    Target Patients

    Adults and children with uncomplicated Plasmodium

    Falciparum Malaria

    Expected Completion

    H2-2021

    Publication

    TBD

    141Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    KAE609 – Plasmodium Falciparum Inhibitor – spiroindolone against PfATP4

    Study

    NCT03334747 (CKAE609A2202)

    Indication

    Malaria

    Phase

    Phase 2

    Patients

    186

    Primary Outcome

    CTCAE grades increase from baseline in alanine

    aminotransferase (ALT) or aspartate aminotransferase

    Measures

    (AST)

    Arms/Intervention

    KAE609

    Coartem

    Target Patients

    Adults with uncomplicated Plasmodium Falciparum malaria

    Expected Completion

    Q1-2020(actual)

    Publication

    TBD

    142Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Abbreviations

    AIH

    Autoimmune hepatitis

    mCRPC

    Metastatic castration-resistant prostate cancer

    aHUS

    atypical Hemolytic Uremic Syndrome

    MDR

    Multi-drug resistant

    ALL

    Acute lymphoblastic leukemia

    MDS

    Myelodysplastic syndrome

    ALS

    Amyotrophic lateral sclerosis

    MS

    Multiple sclerosis

    AMI

    Acute myocardial infarction

    nAMD

    Neovascular (wet) age-related macular degeneration

    AML

    Acute myeloid leukemia

    NASH

    Non-alcoholic steatohepatitis

    AS H2H

    Ankylosing spondylitis head-to-head study versus adalimumab

    nHCM

    Non-obstructive hypertrophic cardiomyopathy

    BC

    Breast cancer

    nr-axSpA

    Non-radiographic axial spondyloarthritis

    C3G

    C3 glomerulopathy

    NSCLC

    Non-small cell lung cancer

    CCF

    Congestive cardiac failure

    PDR

    Proliferative diabetic retinopathy

    CLL

    Chronic lymphocytic leukemia

    PEF

    Preserved ejection fraction

    CML

    Chronic myeloid leukemia

    PNH

    Paroxysmal nocturnal haemoglobinuria

    CRC

    Colorectal cancer

    PsA H2H

    Psoriatic arthritis head-to-head study versus adalimumab

    COPD

    Chronic obstructive pulmonary disease

    RCC

    Renal cell carcinoma

    COSP

    Chronic ocular surface pain

    PROS

    PIK3CA related overgrowth spectrum

    CSU

    Chronic spontaneous urticaria

    RA

    Rheumatoid arthritis

    CVRR-Lp(a)

    Secondary prevention of cardiovascular events in patients with elevated levels of lipoprotein (a)

    rMS

    Relapsing multiple sclerosis

    CVRR-LDLC

    Secondary prevention of cardiovascular events in patients with elevated levels of LDLC

    ROP

    Retinopathy of prematurity

    DME

    Diabetic macular edema

    RP

    Retinitis pigmentosa

    DLBCL

    Diffuse large B-cell lymphoma refractory

    RVO

    Retinal vein occlusion

    GCA

    Giant cell arteritis

    SAA

    Severe aplastic anemia

    GVHD

    Graft-versus-host disease

    SjS

    Sjögren’s syndrome

    HCC

    Hepatocellular carcinoma

    SLE

    Systemic lupus erythematosus

    HFpEF

    Chronic heart failure with preserved ejection fraction

    SMA Type 1

    Spinal muscular atrophy type 1

    HF-rEF

    Chronic heart failure with reduced ejection fraction

    SMA Type 2/3

    Spinal muscular atrophy type 2/3

    HNSCC

    Head and neck squamous cell carcinoma

    SpA

    Spondyloarthritis

    HS

    Hidradenitis suppurativa

    SPMS

    Secondary progressive multiple sclerosis

    IgAN

    IgA nephropathy

    TNBC

    Triple negative breast cancer

    iMN

    Membranous nephropathy

    T1DM

    Type 1 Diabetes melitus

    IPF

    Idiopathic pulmonary fibrosis

    143 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation

    Disclaimer

    Novartis AG published this content on 28 April 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 28 April 2020 08:17:06 UTC

    Sales 2020 50 197 M
    EBIT 2020 15 365 M
    Net income 2020 9 209 M
    Debt 2020 18 048 M
    Yield 2020 3,53%
    P/E ratio 2020 20,8x
    P/E ratio 2021 18,5x
    EV / Sales2020 4,37x
    EV / Sales2021 4,07x
    Capitalization 201 B


    Duration :


    Period :



    Novartis Technical Analysis Chart | MarketScreener

    Technical analysis trends NOVARTIS

    Short Term Mid-Term Long Term
    Trends Bullish Neutral Neutral

    Income Statement Evolution

    Consensus



    Sell

    Buy

    Mean consensus OUTPERFORM
    Number of Analysts 23
    Average target price
    100,01  $
    Last Close Price
    90,19  $
    Spread / Highest target 39,1%
    Spread / Average Target 10,9%
    Spread / Lowest Target -20,1%

    1st jan. Capitalization (M$)
    NOVARTIS -6.45% 204 428



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    Cutaneous immune-mediated diseases may not have higher risk for severe COVID-19

    Patients with cutaneous immune-mediated diseases, such as psoriasis, atopic dermatitis and hidradenitis suppurativa, may not have an increased risk …

    Source link

    How Coronavirus Pandemic Will Impact Hidradenitis Suppurativa Clinical Trials Market 2020- Global Leading Players, Industry Updates, Future Growth, Business Prospects, Forthcoming Developments And Future Investments By Forecast To 2026 – 3w Market News Reports

    COVID-19 (Coronavirus) pandemic has forced many companies in the Hidradenitis Suppurativa Clinical Trials market to halt their business operations in order comply with the new government rulings. This pause in operations are directly impacting the revenue flow of the Hidradenitis Suppurativa Clinical Trials market. Thus, companies in the Hidradenitis Suppurativa Clinical Trials market can purchase our reports that showcase a fresh analysis of COVID-19 and its repercussions on the market landscape.

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    As per the report, the global Hidradenitis Suppurativa Clinical Trials market is projected to register a CAGR growth of ~XX% during the assessment period and reach a value of ~US$XX by the end of 20XX. Further, the report suggests that the growth of the Hidradenitis Suppurativa Clinical Trials market is primarily influenced by a range of factors with key emphasis on innovations done by market players.

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    Doubts Related to the Hidradenitis Suppurativa Clinical Trials Market Explained in the Report:

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    2. Which are the current proceedings of the most prominent players in the Hidradenitis Suppurativa Clinical Trials market?
    3. What are the various factors that could inhibit the growth of the Hidradenitis Suppurativa Clinical Trials market?
    4. What is the market attractiveness of the Hidradenitis Suppurativa Clinical Trials market in region 2?
    5. Why is the adoption of product 1 more than that of product 2?

    Competition Landscape

    The report provides critical insights related to the establised companies operating in the Hidradenitis Suppurativa Clinical Trials market. The revenue generated, product range, and financials of each company is included in the report.

    Summary

    GlobalData’s clinical trial report, Hidradenitis Suppurativa Global Clinical Trials Review, H1, 2020″ provides an overview of Hidradenitis Suppurativa Clinical trials scenario. This report provides top line data relating to the clinical trials on Hidradenitis Suppurativa. Report includes an overview of trial numbers and their average enrollment in top countries conducted across the globe. The report offers coverage of disease clinical trials by region, country (G7 & E7), phase, trial status, end points status and sponsor type. Report also provides prominent drugs for in-progress trials (based on number of ongoing trials). GlobalData Clinical Trial Reports are generated using GlobalDatas proprietary database – Pharma eTrack Clinical trials database. Clinical trials are collated from 80+ different clinical trial registries, conferences, journals, news etc across the globe. Clinical trials database undergoes periodic update by dynamic process.

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    Note: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease.

    Scope

    – The report provides a snapshot of the global clinical trials landscape
    – Report provides top level data related to the clinical trials by Region, Country (G7 & E7), Trial Status, Trial Phase, Sponsor Type and End point status
    – The report reviews top companies involved and enlists all trials (Trial title, Phase, and Status) pertaining to the company
    – The report provides all the unaccomplished trials (Terminated, Suspended and Withdrawn) with reason for unaccomplishment
    – The Report provides enrollment trends for the past five years
    – Report provides latest news for the past three months

    Note: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease.

    Reasons to buy

    – Assists in formulating key business strategies with regards to investment
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    – Facilitates clinical trial assessment of the indication on a global, regional and country level

    Note: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease.

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    Regional Landscape

    The regional landscape section of the report provides resourceful insights related to the scenario of the Hidradenitis Suppurativa Clinical Trials market in different regions. Further, the market attractiveness assessment of each region provides players a clear understanding of the overall growth potential in each regional market.

    End-User Analysis

    The report provides an in-depth understanding of the various end-users of the Hidradenitis Suppurativa Clinical Trials along with the market share, size, and revenue generated by each end-user.

    Important Information that can be extracted from the Report:

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    • Market entry strategies adopted by emerging market players
    • Pricing and marketing strategies adopted by prominent market players
    • Assessment of the different factors likely to impact the growth of the Hidradenitis Suppurativa Clinical Trials market
    • Year-on-Year growth of each market segment over the forecast period

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