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.
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.
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.
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.
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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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.
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:
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 treatmentmarket covers exhaustive analysis on:
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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.
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.
https://i2.wp.com/higenix.com/wp-content/uploads/2020/04/kkk-market.jpg?fit=700%2C350&ssl=1350700Stevehttps://higenix.com/wp-content/uploads/2018/09/higenix-hs-treatment.pngSteve2020-04-29 21:49:222020-04-29 21:49:22Tumor 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.
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
The Global Hidradenitis Suppurativa Treatment Market 2020 is said to be a huge pool for the presence of countless contenders, which has provided a great start up to a greatly competitive manufacturers scenario to exist. The Worldwide Hidradenitis Suppurativa Treatment Market is nothing but a new addition to our vast collection of research reports. With the brand new members entering this Hidradenitis Suppurativa Treatment industry on a daily basis, the worldwide market is anticipated to witness an extremely magnifying competition in the upcoming years.
NOTE: Our reports include the analysis of the impact of COVID-19 on this industry. Our new sample is updated which correspond in new report showing impact of Covid-19 on Industry trends. Also we are offering 20% discount
On the basis of the increases awareness related to the market trends for the Hidradenitis Suppurativa Treatment Market, the global demand for Hidradenitis Suppurativa Treatment industry is determined to observe a great improvement throughout the forecast period (2020-2026). The global Hidradenitis Suppurativa Treatment Market is expected reaching a massive market volume in forthcoming years.
The Hidradenitis Suppurativa Treatment Market report has been positively influenced along with a rapid gain in expandable investment across the major geographies of the world. According to the study provided by our analyst’s team, one of the vital challenges seemed for the growth of Hidradenitis Suppurativa Treatment Market is the existence of the simulated products. And, therefore, the Hidradenitis Suppurativa Treatment industry is registering the entry of a wide range of alternative products that uses different tools and techniques so as to conquer a potential risk factors for consumers.
The research report on Hidradenitis Suppurativa Treatment Market offers a detailed analysis of the industry with several components such as Hidradenitis Suppurativa Treatment Market introduction, driving forces of the market, scope of the product growth and risks integrated with the product. Besides this, the report also delivers the competitive overview of the major pioneers of the Hidradenitis Suppurativa Treatment Market based on the market share, sales, and revenue over forthcoming years.
Most of the key vendors operating in Hidradenitis Suppurativa Treatment Market are anticipated to enlarge their observance by mainly focusing on development as well as product diversification in order to gather a leading share of the industry. Expansion in emerging nations to estimate the growth of Hidradenitis Suppurativa Treatment Market and product sale is also determined as the biggest strategies generated by the list of players who are functioning in the global Hidradenitis Suppurativa Treatment Market. Essentially, it’s because of the unexploited elements in the informed economies with respect to the revenue generation and product pricing.
Leading players in the global Hidradenitis Suppurativa Treatment Market are:
GlaxoSmithKline Johnson & Johnson Merck Pfizer AbbVie Allergan AstraZeneca
Global Hidradenitis Suppurativa Treatment Market analysis through Product Type:
Medications Surgery Others
Applications of Hidradenitis Suppurativa Treatment Market can be fragmented as:
Our newly formed report help you to understand the key marketing strategies of the Hidradenitis Suppurativa Treatment Market along with a valuable introduction of the development history, different marketing channels, vendor’s analysis, potential buyers and industry chain analysis of the market and other key details that act as resourceful guide for all new entrants of the industry.
Reportedly, the Hidradenitis Suppurativa Treatment Market relies on two major factors such as revenue generation as well as production scale. Along with the comprehensive market data, the Hidradenitis Suppurativa Treatment report also explains the geographical areas across the globe. This report deeply describes several characteristics of the market including Hidradenitis Suppurativa Treatment Market growth and limitations, in order to determine the massive industrial stance of the market all over the world.
This research report contains precise domain for international marketplace along with primary market knowledge, different criteria, that are exclusively supporting the Hidradenitis Suppurativa Treatment Market framework. The report also covers highly operating domains of the Hidradenitis Suppurativa Treatment industry on the basis of its performance. This report is nothing but a huge analysis of industry-oriented details like regulations, market chain and recent polices. It also studies several considerable ingredients such as key players, product & its production chain, supply and demand, revenue format for particular business. The report mainly profiles the detailed analysis, producing limits, the successive presentation of the Hidradenitis Suppurativa Treatment Market globally, and characteristics of demand.
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.
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
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
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).
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
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
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
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
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
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
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
*Overall cash conversion cycle measures broadly in line with historical average
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
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
Compared to past reports, we have categorized submission schedules into NMEs (lead & new indications) and supplementary indications for existing brands
Compared to past reports, we have categorized submission schedules into NMEs (lead & new indications) and supplementary indications for existing brands
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
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)
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
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
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
https://higenix.com/wp-content/uploads/2018/09/higenix-hs-treatment.png00Stevehttps://higenix.com/wp-content/uploads/2018/09/higenix-hs-treatment.pngSteve2020-04-28 11:51:202020-04-28 11:51:20Cutaneous immune-mediated diseases may not have higher risk for severe COVID-19
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.
This report collated by analysts of marketresearchhub.us on the Hidradenitis Suppurativa Clinical Trials market provides a bird’s eye view of the current proceedings within the Hidradenitis Suppurativa Clinical Trials market. Further, the report highlights the various factors that are likely to impact the overall dynamics of the Hidradenitis Suppurativa Clinical Trials market over the forecast period (20XX-20XX) including the ongoing trends, opportunities, limitations, and more.
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.
Doubts Related to the Hidradenitis Suppurativa Clinical Trials Market Explained in the Report:
What are the organic and inorganic strategies incorporated by market players?
Which are the current proceedings of the most prominent players in the Hidradenitis Suppurativa Clinical Trials market?
What are the various factors that could inhibit the growth of the Hidradenitis Suppurativa Clinical Trials market?
What is the market attractiveness of the Hidradenitis Suppurativa Clinical Trials market in region 2?
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.
The report enhances the decision making capabilities and helps to create an effective counter strategies to gain competitive advantage.
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 – Helps in identifying prominent locations for conducting clinical trials which saves time and cost – Provides top level analysis of Global Clinical Trials Market which helps in identifying key business opportunities – Supports understanding of trials count and enrollment trends by country in global therapeutics market – Aids in interpreting the success rates of clinical trials by providing a comparative scenario of completed and uncompleted (terminated, suspended or withdrawn) trials – 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.
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:
Country-wise evaluation of the Hidradenitis Suppurativa Clinical Trials market in different geographies
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
https://higenix.com/wp-content/uploads/2020/04/1587988185_images167300Stevehttps://higenix.com/wp-content/uploads/2018/09/higenix-hs-treatment.pngSteve2020-04-27 11:49:442020-04-27 11:49:44How 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
